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ARGS $ NEWS $ Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC). The Company also provided perspective on its decision to continue the trial.
A total of 462 patients were enrolled in the ADAPT study and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm). For both arms, the protocol permits switching to other standard-of-care treatments for mRCC for reasons such as intolerance to therapy or disease progression. The primary efficacy endpoint for the study is a statistically significant improvement in overall survival, with secondary efficacy endpoints evaluated to date of progression-free survival, objective response rate and disease control rate, and an exploratory efficacy endpoint of immune response. The trial was opened in January 2013 and completed enrollment in July 2015 at 107 sites across North America, Europe and Israel.
The most recent interim analysis was conducted by the Independent Data Monitoring Committee (IDMC) in February 2017 (data cut-off as of February 3, 2017) after 75% of the targeted number of 290 events (deaths) for the analysis of the primary endpoint of overall survival had occurred. In accordance with the statistical analysis plan, median overall survival was estimated using the Kaplan-Meier method. At the time of the interim analysis, the estimated median overall survival for the combination arm was 27.7 months (95% Confidence Interval (CI): 23.0, 35.9) compared to 32.4 months (95% CI: 22.5, -) for the control arm. The hazard ratio was 1.10 (95% CI: 0.83, 1.46), which was greater than the pre-defined futility boundary for the final interim analysis of 0.98. As a result, the IDMC recommended that the study be discontinued for futility. The IDMC concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination arm, utilizing the intent-to-treat population, the primary endpoint of the study. The IDMC also noted that Rocapuldencel-T was generally well-tolerated in the trial.
As previously reported, notwithstanding the IDMC recommendation, the Company determined to continue to conduct the trial pending further review and analysis of the data and discussions with the FDA. This determination was made after discussion of the results of the interim analysis with the ADAPT trial principal investigators, Robert Figlin, MD (Cedars Sinai) and Christopher Wood, MD (MD Anderson Cancer Center). In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of long-term memory immune responses, and the IDMC’s assessment of the safety profile of Rocapuldencel-T. Of note, at the time of the IDMC’s February interim analysis, the median duration of follow-up was 20.0 months and more than half the patients in both treatment groups were still alive.
Subsequent to the IDMC meeting, to explore the hypothesis that longer follow-up time may provide useful information to identify a potential beneficial effect of Rocapuldencel-T, the Company conducted a post-hoc subgroup analysis of overall survival in the first third of patients enrolled in the study (n=154). In these patients, for whom generally the longest follow-up data was available, the estimated median overall survival for the combination arm was 30.1 months (95% CI: 23.3, -) compared to 22.2 months (95% CI: 17.2, -) for the control arm. The hazard ratio in this post-hoc subgroup analysis was 0.88 (95% CI: 0.56, 1.36).
In addition, also subsequent to the IDMC meeting, the Company began conducting a pre-defined analysis of immune responses, an exploratory efficacy endpoint, using multi-parametric flow cytometry. Data available as of March 31, 2017 included 109 of the 190 samples from patients in the combination arm, with analysis of the remaining samples ongoing. Samples were collected from patients in the combination arm enrolled at US sites who provided consent for immune monitoring. Of the 109 subjects for whom this analysis was completed, 96 (88%) met the criterion for inclusion in the pre-defined subgroup of immune responders, suggesting that Rocapuldencel-T is having its intended effect of stimulating an immune response in the majority of patients. Immune responders are defined as patients who have an increase of more than two standard deviations from the patient-specific baseline in the number of memory T cells (CD8+/CD28+/CD45RA-) at one or more time points. Of note, median overall survival at the time of the February interim analysis had not yet been reached in the subgroup of immune responders (95% CI: 30.1, -). Additionally, consistent with the mechanism of action of Rocapuldencel-T, a statistically significant correlation was observed between the increase from baseline in the number of Rocapuldencel-T-induced memory T cells (CD8+/CD28+/CD45RA-) and overall survival in patients for whom immune response data has been analyzed and who received at least seven doses of Rocapuldencel-T (including both immune responders and non-responders, n=72).
The Company continues to analyze the data from the trial and plans to meet with the FDA in May 2017, but currently believes based on the data it has reviewed that the trial should be continued until completion. Based on these analyses and discussions, the Company will make a determination as to the next steps for the Rocapuldencel-T clinical program.
Conference Call and Webcast Details
Argos executive management will host a conference call beginning at 4:30 p.m. Eastern Time today to discuss these results and to answer questions. Argos management will be presenting slides during the conference call and the slides will be viewable under the Investors section of the Company’s website at www.argostherapeutics.com. To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 8568073. A live and archived audio webcast with the accompanying slide presentation can be accessed through the Investors section of the Company's website at www.argostherapeutics.com. The archived webcast and accompanying slide presentation will remain available on the Company's website for twelve (12) months following the call.
About the Arcelis® Technology Platform
Arcelis® is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient's individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis® process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient's own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient's plasma, and administered via intradermal injection as an individualized immunotherapy.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, Rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). In addition, Rocapuldencel-T is being studied in a Phase 2 investigator-initiated clinical trial as neoadjuvant therapy for renal cell carcinoma (RCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients.
Forward Looking Statements�
Any statements in this press release about Argos' future expectations, plans and prospects, including statements about the ADAPT trial and the interim data from the trial, Argos' anticipated meeting with the FDA, clinical development of Argos' product candidates and future expectations and plans and prospects for Argos and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund its continuing operations for the periods anticipated and through completion of the trial; the impact of the planned analysis of the data and discussions with the FDA on the development of rocapuldencel-T; the impact of the recommendation of the IDMC on the continuation of the ADAPT trial; whether preliminary or interim clinical data such as the interim data reported in this release will be indicative of the final data from a clinical trial; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether Argos can successfully establish commercial manufacturing operations on a timely basis or at all; and other factors discussed in the "Risk Factors" section of Argos' Form 10-K for the year ended December 31, 2016, which is on file with the SEC, and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos' views as of the date hereof. Argos anticipates that subsequent events and developments will cause Argos' views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos' views as of any date subsequent to the date hereof.
A total of 462 patients were enrolled in the ADAPT study and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm). For both arms, the protocol permits switching to other standard-of-care treatments for mRCC for reasons such as intolerance to therapy or disease progression. The primary efficacy endpoint for the study is a statistically significant improvement in overall survival, with secondary efficacy endpoints evaluated to date of progression-free survival, objective response rate and disease control rate, and an exploratory efficacy endpoint of immune response. The trial was opened in January 2013 and completed enrollment in July 2015 at 107 sites across North America, Europe and Israel.
The most recent interim analysis was conducted by the Independent Data Monitoring Committee (IDMC) in February 2017 (data cut-off as of February 3, 2017) after 75% of the targeted number of 290 events (deaths) for the analysis of the primary endpoint of overall survival had occurred. In accordance with the statistical analysis plan, median overall survival was estimated using the Kaplan-Meier method. At the time of the interim analysis, the estimated median overall survival for the combination arm was 27.7 months (95% Confidence Interval (CI): 23.0, 35.9) compared to 32.4 months (95% CI: 22.5, -) for the control arm. The hazard ratio was 1.10 (95% CI: 0.83, 1.46), which was greater than the pre-defined futility boundary for the final interim analysis of 0.98. As a result, the IDMC recommended that the study be discontinued for futility. The IDMC concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination arm, utilizing the intent-to-treat population, the primary endpoint of the study. The IDMC also noted that Rocapuldencel-T was generally well-tolerated in the trial.
As previously reported, notwithstanding the IDMC recommendation, the Company determined to continue to conduct the trial pending further review and analysis of the data and discussions with the FDA. This determination was made after discussion of the results of the interim analysis with the ADAPT trial principal investigators, Robert Figlin, MD (Cedars Sinai) and Christopher Wood, MD (MD Anderson Cancer Center). In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of long-term memory immune responses, and the IDMC’s assessment of the safety profile of Rocapuldencel-T. Of note, at the time of the IDMC’s February interim analysis, the median duration of follow-up was 20.0 months and more than half the patients in both treatment groups were still alive.
Subsequent to the IDMC meeting, to explore the hypothesis that longer follow-up time may provide useful information to identify a potential beneficial effect of Rocapuldencel-T, the Company conducted a post-hoc subgroup analysis of overall survival in the first third of patients enrolled in the study (n=154). In these patients, for whom generally the longest follow-up data was available, the estimated median overall survival for the combination arm was 30.1 months (95% CI: 23.3, -) compared to 22.2 months (95% CI: 17.2, -) for the control arm. The hazard ratio in this post-hoc subgroup analysis was 0.88 (95% CI: 0.56, 1.36).
In addition, also subsequent to the IDMC meeting, the Company began conducting a pre-defined analysis of immune responses, an exploratory efficacy endpoint, using multi-parametric flow cytometry. Data available as of March 31, 2017 included 109 of the 190 samples from patients in the combination arm, with analysis of the remaining samples ongoing. Samples were collected from patients in the combination arm enrolled at US sites who provided consent for immune monitoring. Of the 109 subjects for whom this analysis was completed, 96 (88%) met the criterion for inclusion in the pre-defined subgroup of immune responders, suggesting that Rocapuldencel-T is having its intended effect of stimulating an immune response in the majority of patients. Immune responders are defined as patients who have an increase of more than two standard deviations from the patient-specific baseline in the number of memory T cells (CD8+/CD28+/CD45RA-) at one or more time points. Of note, median overall survival at the time of the February interim analysis had not yet been reached in the subgroup of immune responders (95% CI: 30.1, -). Additionally, consistent with the mechanism of action of Rocapuldencel-T, a statistically significant correlation was observed between the increase from baseline in the number of Rocapuldencel-T-induced memory T cells (CD8+/CD28+/CD45RA-) and overall survival in patients for whom immune response data has been analyzed and who received at least seven doses of Rocapuldencel-T (including both immune responders and non-responders, n=72).
The Company continues to analyze the data from the trial and plans to meet with the FDA in May 2017, but currently believes based on the data it has reviewed that the trial should be continued until completion. Based on these analyses and discussions, the Company will make a determination as to the next steps for the Rocapuldencel-T clinical program.
Conference Call and Webcast Details
Argos executive management will host a conference call beginning at 4:30 p.m. Eastern Time today to discuss these results and to answer questions. Argos management will be presenting slides during the conference call and the slides will be viewable under the Investors section of the Company’s website at www.argostherapeutics.com. To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 8568073. A live and archived audio webcast with the accompanying slide presentation can be accessed through the Investors section of the Company's website at www.argostherapeutics.com. The archived webcast and accompanying slide presentation will remain available on the Company's website for twelve (12) months following the call.
About the Arcelis® Technology Platform
Arcelis® is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient's individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis® process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient's own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient's plasma, and administered via intradermal injection as an individualized immunotherapy.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, Rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). In addition, Rocapuldencel-T is being studied in a Phase 2 investigator-initiated clinical trial as neoadjuvant therapy for renal cell carcinoma (RCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients.
Forward Looking Statements�
Any statements in this press release about Argos' future expectations, plans and prospects, including statements about the ADAPT trial and the interim data from the trial, Argos' anticipated meeting with the FDA, clinical development of Argos' product candidates and future expectations and plans and prospects for Argos and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund its continuing operations for the periods anticipated and through completion of the trial; the impact of the planned analysis of the data and discussions with the FDA on the development of rocapuldencel-T; the impact of the recommendation of the IDMC on the continuation of the ADAPT trial; whether preliminary or interim clinical data such as the interim data reported in this release will be indicative of the final data from a clinical trial; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether Argos can successfully establish commercial manufacturing operations on a timely basis or at all; and other factors discussed in the "Risk Factors" section of Argos' Form 10-K for the year ended December 31, 2016, which is on file with the SEC, and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos' views as of the date hereof. Argos anticipates that subsequent events and developments will cause Argos' views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos' views as of any date subsequent to the date hereof.
Antwort auf Beitrag Nr.: 54.761.581 von t-haier am 19.04.17 18:51:10Bin seit einer Woche dabei.Das Ding kommt von 5$ und ich hoffe nach News das wir wieder 1$ + sehen.
Antwort auf Beitrag Nr.: 54.762.199 von herku am 19.04.17 20:44:30Boden bei 0,4 hält, könnte bald abheben!
Das Ding kommt von 5$,das kann man ewig nntenhalten siehe Dcth!
ARGS bekommt nun 6M Dollar und es kommt Bewegung rein!
Trading Spotlight
Antwort auf Beitrag Nr.: 55.187.284 von herku am 22.06.17 18:47:08Wieder einen Blick wert,kommt hier noch was Großes?
ARGS $ Argos Therapeutics $ News
Heute war ja was los, ohne einen trächtigen Grund stieg die Aktie um 70% und sank auf aktuell 5% wieder runter.
Ein Zeichen das die Marktkapitalisierung viel zu niedrig ist ?
Ein Zeichen das die Marktkapitalisierung viel zu niedrig ist ?
!
Dieser Beitrag wurde von CloudMOD moderiert. Grund: bitte das Threathema beachten
wie kommst du drauf?
See headlines for ARGS
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Argos Announces Issuance of Patent Covering the Foundation for Manufacturing its HIV Immunotherapy
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Argos Announces Issuance of Patent Covering the Foundation for Manufacturing its HIV Immunotherapy
By GlobeNewswire, February 15, 2018, 08:30:00 AM EDT
Vote upAAA
Patent Related to Strain-Independent Amplification of HIV Nucleic Acid Sequences
DURHAM, N.C., Feb. 15, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today announced the issuance of U.S. patent 9,879,053, covering the strain-independent amplification of human immunodeficiency virus, or HIV, nucleic acid sequences for use in vaccinations.
The methods described in this patent form the foundation for the manufacture of AGS-004, Argos' novel, dendritic cell-based immunotherapy for HIV. AGS-004 consists of autologous dendritic cells electroporated with amplified virus RNA and CD40L RNA that are designed to stimulate T cells to attack HIV-infected cells. Because HIV has a high mutation rate, viral variants are different in each patient. The methods described in this patent are used to amplify RNA encoding the unique viral variants in an individual from a small amount of blood or infectious plasma from which the virus can be isolated. This allows the generation of immunotherapies that are matched to the unique pathogen mutations in a specific individual, thus facilitating the development of a customized immunotherapy that may be more effective at controlling or eliminating the pathogen. The claims in this patent are directed to AGS-004, methods of manufacturing AGS-004 and methods of treatment utilizing AGS-004.
AGS-004 is currently being evaluated in an investigator sponsored Phase 2 clinical trial in combination with the latency-reversing agent vorinostat under the direction of David Margolis, M.D., Professor of Medicine, Division of Infectious Diseases, and Director of the HIV Cure Center at the University of North Carolina. The latent viral reservoir consists of infected immune cells in which the HIV virus is dormant and therefore hidden from attack by the immune system. Largely because of the latent viral reservoir, currently available agents for the treatment of HIV, while able to limit the proliferation of the HIV virus, have not been successful in eradicating the virus and thus curing HIV. The trial is designed to test the hypothesis that boosting antiviral immunity with AGS-004 combined with a latency reversing drug to expose the virus in latently infected cells to the immune system may enable eradication of the virus.
"We believe that our ability to customize the immune response to patients' unique viral variants, particularly to those variants persisting in the latent viral reservoir, offers a scientifically compelling rationale for this study," noted Irina Tcherepanova, Ph.D., vice president of translational medicine, Argos Therapeutics. Initial data from the ongoing clinical trial is expected during the second half of 2018.
Es scheint wieder Leben rein zu kommen.
View Print Version
More from GlobeNewswire
Argos Announces Issuance of Patent Covering the Foundation for Manufacturing its HIV Immunotherapy
Argos Obtains Option to License PD1 Checkpoint Inhibitors
Argos Announces One-for-Twenty Reverse Stock Split
Referenced Stocks
ARGS 100% Rate It
Argos Announces Issuance of Patent Covering the Foundation for Manufacturing its HIV Immunotherapy
By GlobeNewswire, February 15, 2018, 08:30:00 AM EDT
Vote upAAA
Patent Related to Strain-Independent Amplification of HIV Nucleic Acid Sequences
DURHAM, N.C., Feb. 15, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today announced the issuance of U.S. patent 9,879,053, covering the strain-independent amplification of human immunodeficiency virus, or HIV, nucleic acid sequences for use in vaccinations.
The methods described in this patent form the foundation for the manufacture of AGS-004, Argos' novel, dendritic cell-based immunotherapy for HIV. AGS-004 consists of autologous dendritic cells electroporated with amplified virus RNA and CD40L RNA that are designed to stimulate T cells to attack HIV-infected cells. Because HIV has a high mutation rate, viral variants are different in each patient. The methods described in this patent are used to amplify RNA encoding the unique viral variants in an individual from a small amount of blood or infectious plasma from which the virus can be isolated. This allows the generation of immunotherapies that are matched to the unique pathogen mutations in a specific individual, thus facilitating the development of a customized immunotherapy that may be more effective at controlling or eliminating the pathogen. The claims in this patent are directed to AGS-004, methods of manufacturing AGS-004 and methods of treatment utilizing AGS-004.
AGS-004 is currently being evaluated in an investigator sponsored Phase 2 clinical trial in combination with the latency-reversing agent vorinostat under the direction of David Margolis, M.D., Professor of Medicine, Division of Infectious Diseases, and Director of the HIV Cure Center at the University of North Carolina. The latent viral reservoir consists of infected immune cells in which the HIV virus is dormant and therefore hidden from attack by the immune system. Largely because of the latent viral reservoir, currently available agents for the treatment of HIV, while able to limit the proliferation of the HIV virus, have not been successful in eradicating the virus and thus curing HIV. The trial is designed to test the hypothesis that boosting antiviral immunity with AGS-004 combined with a latency reversing drug to expose the virus in latently infected cells to the immune system may enable eradication of the virus.
"We believe that our ability to customize the immune response to patients' unique viral variants, particularly to those variants persisting in the latent viral reservoir, offers a scientifically compelling rationale for this study," noted Irina Tcherepanova, Ph.D., vice president of translational medicine, Argos Therapeutics. Initial data from the ongoing clinical trial is expected during the second half of 2018.
Es scheint wieder Leben rein zu kommen.
Bei welchem Kurs sollte man einsteigen? 
Ich hab mich gestern in Position gebracht! 
Ein Zock sollte schon möglich sein! 
Bin gespannt hier nächste Woche. Werden hier noch Earnings erwartet ?
Antwort auf Beitrag Nr.: 57.373.958 von rush1291 am 23.03.18 21:07:46Ich hoffe auf eine Bodenbildung!
Wenn das noch weiter runter geht können sie gleich wieder einen RS machen!
Oder gleich Chapter 11
Tja was sagt ihr? Hoffnung oder...
Antwort auf Beitrag Nr.: 57.415.472 von Magnificient am 28.03.18 20:09:49Geht gleich wieder hoch!
Hoffentlich
Von der FDA sollte im ersten Halbjahr auch noch ein Update kommen!
Das meine ich mit dem FDA Update
An analysis was conducted to evaluate the relationship between the percentage of regulatory T-cells at baseline and survival for patients in both arms of the trial. Samples from patients in the combination arm (n=176) were divided into two groups: those with above median percentage of regulatory T-cells at baseline, and those with below median percentage of regulatory T-cells at baseline. Comparison of the Kaplan-Meier curves for these two groups revealed that those with higher than median percentage of regulatory T-cells at baseline demonstrated improved survival. This finding was in contrast to the control arm (n=79), where a greater percentage of regulatory T-cells at baseline was associated with poorer survival. One hypothesis that could potentially explain this result is that Rocapuldencel-T may be acting to convert regulatory T-cells to effector T-cells.
Commenting on the additional immunology data, Charles Nicolette, Chief Scientific Officer of Argos Therapeutics, noted, "As we have conducted additional analyses of the immunology data from the February 2017 interim analysis, we have been pleased to see that the data are generally supportive of our hypothesis regarding the intended mechanism of action of Rocapuldencel-T to induce an immune response against the tumor in patients with metastatic renal cell carcinoma. While we await further data from the next planned interim data analysis that we expect to be conducted during the first half of 2018, pending agreement with the FDA on a revised protocol that we plan to submit, we are encouraged to see these positive indicators of activity."
As previously reported, the February 2017 interim analysis was conducted by the ADAPT trial's Independent Data Monitoring Committee (IDMC) after 75% of the originally targeted number of 290 events (deaths) for the analysis of the primary endpoint of overall survival had occurred. At the time of the analysis, with more than half of the patients still alive in each arm and a median follow-up time of ~20 months, the IDMC concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended that the trial be discontinued for futility. However, the ADAPT trial principal investigators and Argos considered the data too immature to observe the delayed effects typically associated with immunotherapy and decided to continue the trial pending further review and analysis of the data and discussions with the U.S. Food and Drug Administration (FDA). In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of a long-term memory immune response, and the IDMC's assessment of the safety profile of Rocapuldencel-T. This determination was subsequently further supported by the extended durability of tumor responses in the combination arm, as previously reported.
Following the IDMC's interim analysis, the Company met with the FDA to discuss the ADAPT trial and the future direction of the Rocapuldencel-T program in April 2017. The FDA agreed with the Company's decision to continue the ADAPT trial, and further agreed to review a protocol amendment to extend the trial beyond the originally targeted 290 events and a revised statistical analysis plan that the Company plans to submit.
Quelle
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
An analysis was conducted to evaluate the relationship between the percentage of regulatory T-cells at baseline and survival for patients in both arms of the trial. Samples from patients in the combination arm (n=176) were divided into two groups: those with above median percentage of regulatory T-cells at baseline, and those with below median percentage of regulatory T-cells at baseline. Comparison of the Kaplan-Meier curves for these two groups revealed that those with higher than median percentage of regulatory T-cells at baseline demonstrated improved survival. This finding was in contrast to the control arm (n=79), where a greater percentage of regulatory T-cells at baseline was associated with poorer survival. One hypothesis that could potentially explain this result is that Rocapuldencel-T may be acting to convert regulatory T-cells to effector T-cells.
Commenting on the additional immunology data, Charles Nicolette, Chief Scientific Officer of Argos Therapeutics, noted, "As we have conducted additional analyses of the immunology data from the February 2017 interim analysis, we have been pleased to see that the data are generally supportive of our hypothesis regarding the intended mechanism of action of Rocapuldencel-T to induce an immune response against the tumor in patients with metastatic renal cell carcinoma. While we await further data from the next planned interim data analysis that we expect to be conducted during the first half of 2018, pending agreement with the FDA on a revised protocol that we plan to submit, we are encouraged to see these positive indicators of activity."
As previously reported, the February 2017 interim analysis was conducted by the ADAPT trial's Independent Data Monitoring Committee (IDMC) after 75% of the originally targeted number of 290 events (deaths) for the analysis of the primary endpoint of overall survival had occurred. At the time of the analysis, with more than half of the patients still alive in each arm and a median follow-up time of ~20 months, the IDMC concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended that the trial be discontinued for futility. However, the ADAPT trial principal investigators and Argos considered the data too immature to observe the delayed effects typically associated with immunotherapy and decided to continue the trial pending further review and analysis of the data and discussions with the U.S. Food and Drug Administration (FDA). In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of a long-term memory immune response, and the IDMC's assessment of the safety profile of Rocapuldencel-T. This determination was subsequently further supported by the extended durability of tumor responses in the combination arm, as previously reported.
Following the IDMC's interim analysis, the Company met with the FDA to discuss the ADAPT trial and the future direction of the Rocapuldencel-T program in April 2017. The FDA agreed with the Company's decision to continue the ADAPT trial, and further agreed to review a protocol amendment to extend the trial beyond the originally targeted 290 events and a revised statistical analysis plan that the Company plans to submit.
Quelle
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
Ich bin bereit für den Start 
wann kommt update zum ags-004?
Antwort auf Beitrag Nr.: 57.416.642 von severin2000 am 28.03.18 21:45:42Gucks du hier
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
ja. ich kenn das alles,ich meine update zum trial
Antwort auf Beitrag Nr.: 57.417.077 von severin2000 am 28.03.18 22:27:09Deine Updates bekommst du am Montag
Argos Therapeutics to Report Fourth Quarter and Year-End 2017 Financial Results and Operational Highlights on Monday, April 2, 2018
DURHAM, N.C., March 28, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today announced that it will report fourth quarter and year-end 2017 financial results and operational highlights prior to the market open on Monday, April 2, 2018.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, Rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Funding for the development of AGS-004 has been provided by the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Collaboratory of Research for AIDS Eradication.
Investor Contact:
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
Argos Therapeutics to Report Fourth Quarter and Year-End 2017 Financial Results and Operational Highlights on Monday, April 2, 2018
DURHAM, N.C., March 28, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today announced that it will report fourth quarter and year-end 2017 financial results and operational highlights prior to the market open on Monday, April 2, 2018.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, Rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Funding for the development of AGS-004 has been provided by the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Collaboratory of Research for AIDS Eradication.
Investor Contact:
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
ja,hab die email auch bekommen.gespannt ob die was zum fda meeting sagen...ags004 update waere auch nicht schlecht,obwohl adapt wichtiger
Es wird spannend, darum hab ich nachgelegt!
Was für zahlen werden hier erwartet ?
Antwort auf Beitrag Nr.: 57.426.764 von rush1291 am 29.03.18 19:10:58Wir hoffen doch gute Zahlen!
Morgen ist in Amiland kein Handel und die Zahlen kommen Montag vor Handelsbeginn!
Mal sehn was heute noch geht!
Mal sehn was heute noch geht!
Ich tippe mal SK min. 1$
Antwort auf Beitrag Nr.: 57.427.313 von Lucky72 am 29.03.18 20:08:39Knapp daneben....! 
Guten morgen
Heute gehts um die Wurst!
Kein Handel in FFM wegen Feiertag!
Dann müssen wir wohl auf die Amis warten!
Dann müssen wir wohl auf die Amis warten!
Argos Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results and Operational Highlights
DURHAM, NC, April 02, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported financial results and operational highlights for the fourth quarter and full year 2017.
Jeff Abbey, CEO of Argos Therapeutics, stated, "Although we faced a very challenging 2017, we have been able to continue the Phase 3 ADAPT clinical trial of Rocapuldencel-T for the treatment of metastatic renal cell carcinoma, and look forward to the next interim data analysis, which we expect to occur during the second quarter of 2018. In addition to continuing the ADAPT study, we look forward to initial results from the ongoing study of AGS-004 in combination with the latency-reversing agent vorinostat in adult HIV patients being conducted by the University of North Carolina, which we expect will be reported towards the end of 2018 or early 2019. We were also pleased to have recently secured an option to a PD1 checkpoint inhibitor, and, subject to obtaining additional funding, plan to conduct a clinical trial of Rocapuldencel-T in combination either with this agent or with an approved checkpoint inhibitor. Also of note, we have strengthened our financial position by raising net proceeds of approximately $23 million since June 2017 through our at-the-market facility, and believe that we now have sufficient capital to fund planned operations through the end of this year."
ADAPT Study Update
The Company is currently finalizing an amendment to the protocol for the ADAPT trial, which includes an amended primary endpoint analysis, and plans to submit it to the FDA prior to the interim data analysis planned for the second quarter of 2018. The Company expects that the interim data analysis will occur after such time as approximately 55 new events (deaths) have occurred subsequent to the February 2017 interim analysis. The amended primary endpoint analysis in the planned amended ADAPT protocol includes the following four co-primary endpoints:
Overall survival for all randomized patients when approximately 375 events have occurred (under the same analysis that was originally planned for 290 events);
The percentage of patients surviving at least five years;
Overall survival for patients who remained alive at the time of the February 2017 interim analysis, to be evaluated when approximately 155 new events have occurred; and
Overall survival for all patients for whom at least 12 months of follow-up is available (excluding patients who died or were lost to follow-up within the first 12 months after enrollment).
Operational and Corporate Highlights
Since the end of the third quarter of 2017, the Company has reported the following events:
In November 2017, the Company announced the receipt of a $1.5 million milestone payment from Lummy (Hong Kong) Co., Ltd. ("Lummy"), the Company's licensee for Rocapuldencel-T in China and certain other territories, related to the successful transfer of technology related to the manufacturing of Rocapuldencel-T.
In November 2017, the Company reported updated immunology data from the Phase 3 ADAPT study at the 32nd Annual Meeting of the Society for the Immunotherapy of Cancer that were generally supportive of the hypothesis regarding the intended mechanism of action of Rocapuldencel-T to induce an immune response against the tumor in patients with metastatic renal cell carcinoma.
In November 2017, the Company announced that it had reached agreement with Saint-Gobain Corporation ("Saint-Gobain"), one of the Company's vendors, regarding the payment of deferred fees. The Company agreed to settle its obligations to Saint-Gobain through a combination of a $0.5 million cash payment, delivery of 34,500 shares of common stock (as adjusted for the one-for-twenty reverse stock split), issuance of an approximately $2.4 million unsecured convertible promissory note and return of certain specified equipment previously provided to the Company.
In November 2017, the Company reported that the landlord of the facility in Durham County, NC that Argos had previously intended to utilize as its primary manufacturing facility ("Centerpoint"), had, with Argos' full consent, successfully completed the sale of this facility to a third party. In connection with this transaction, Argos entered into a lease termination agreement pursuant to which Argos received cash proceeds of approximately $1.8 million.
In January 2018 the Company entered into a stock purchase agreement with Lummy under which the Company agreed to issue and sell to Lummy in a private financing 375,000 shares of common stock (as adjusted for the one-for-twenty reverse stock split) for an aggregate purchase price of $1.5 million. In March 2018, the stock purchase agreement was amended to reduce the aggregate purchase price for the shares to $450,000. Concurrent with such amendment, the license agreement with Lummy was amended to provide for a $1.05 million milestone payment, which the Company has earned. Payments with respect to these amended agreements are expected to be received during April 2018.
In January 2018, the Company implemented a one-for-twenty reverse stock split, and subsequently regained compliance with the Nasdaq $1.00 minimum bid price requirement. The Company was also granted an extension until April 24, 2018 to regain compliance with the $2.5 million minimum shareholders' equity requirement for continued listing on the Nasdaq Capital Market.
From June 2017 through December 31, 2017, the Company raised net proceeds of $15.5 million through the issuance of common stock in an at-the-market offering under the Company's original sales agreement with Cowen & Company, LLC ("Cowen"). In February 2018, the original sales agreement with Cowen was amended to increase the maximum aggregate offering price of the shares of the Company's common stock which may be sold under the agreement from $30 million to $45 million. As of March 16, 2018, an additional $7.3 million of net proceeds had been raised through the sale of the Company's common stock subsequent to December 31, 2017 and $15.8 million remained available for sale.
In February 2018, the Company announced that it had entered into an option agreement with Pharmstandard International, S.A., the Company's partner in Russia and certain other territories, and Actigen Limited under which the Company has an option to license a group of fully human anti-PD1 monoclonal antibodies (PD1 checkpoint inhibitors) and related technology.
In February 2018, the Company announced the issuance of a patent covering the strain-independent amplification of human immunodeficiency virus, or HIV, nucleic acid sequences for use in vaccinations. The methods described in this patent form the foundation for the manufacture of AGS-004, Argos' experimental dendritic cell-based immunotherapy for HIV.
Financial Results
Fourth Quarter 2017 Financials
Revenue for the fourth quarter ended December 31, 2017 was $1.7 million compared to $0.2 million during the fourth quarter of 2016. The increase in revenue during the fourth quarter of 2017 compared with the fourth quarter of 2016 resulted from the receipt of a $1.5 million milestone payment from Lummy related to the transfer of technology for the manufacture of Rocapuldencel-T.
Research and development expense for the fourth quarter ended December 31, 2017 was $4.1 million compared to $10.3 million during the fourth quarter of 2016. The decrease in research and development expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial and the Company's decision not to proceed with the development of commercial manufacturing capabilities as well as to significantly reduce the size of its workforce engaged in research and development activities following the independent data monitoring committee's ("IDMC") recommendation in February 2017 to discontinue the ADAPT trial for futility.
General and administrative expense for the fourth quarter ended December 31, 2017 was $2.7 million compared to $4.8 million during the fourth quarter of 2016. The decrease in general and administrative expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was primarily due to decreased consulting and personnel costs.
Additionally, during the fourth quarter of 2017 the Company recognized a gain on disposal of impaired property of $2.8 million resulting from proceeds of $1.8 million that were received in connection with the sale of the Centerpoint facility and a $1.0 million gain from the disposal of certain property from the Saint-Gobain debt restructuring, as well as a $0.6 million gain on the early extinguishment of debt related to the Saint-Gobain debt restructuring. During the fourth quarter ended December 31, 2016, the Company recorded an impairment charge of $0.7 million, which was partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $0.6 million.
Interest expense for the fourth quarter ended December 31, 2017 was $0.2 million compared to $0.3 million during the fourth quarter of 2016. The decrease in interest expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was primarily due to a lower average balance of debt outstanding.
Reflecting the factors noted above, net loss for the fourth quarter ended December 31, 2017 was $1.9 million compared to a net loss of $15.4 million during the fourth quarter of 2016.
Full Year 2017 Financials
Revenue for the year ended December 31, 2017 was $1.9 million compared to $0.9 million during 2016. The increase in revenue for 2017 compared with 2016 resulted primarily from the receipt of a $1.5 million milestone payment from Lummy during 2017, which was partially offset by the $0.6 million decrease in reimbursement under the Company's contract with the National Institutes of Health and the National Institute of Allergy and Infectious Diseases primarily reflecting the achievement of certain specified development milestones under the Company's AGS-004 program during 2016.
Research and development expense for the year ended December 31, 2017 was $21.7 million compared to $38.3 million during 2016. The decrease in research and development expense for 2017 compared with 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial and the Company's decision not to proceed with the development of commercial manufacturing capabilities and to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC in February 2017 to discontinue the ADAPT trial for futility.
General and administrative expense for the year ended December 31, 2017 was $12.2 million compared to $14.2 million during 2016. The decrease in general and administrative expense for 2017 compared with 2016 was primarily due to decreased consulting and personnel costs.
Additionally, during the year ended December 31, 2017 the Company incurred impairment charges of $27.3 million and restructuring charges of $6.0 million related to the Company's decision to discontinue preparation for commercial manufacturing and reduce the size of its workforce, which amounts were partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $20.8 million, a gain on the disposal of impaired property of $2.8 million, and a gain on the early extinguishment of debt of $2.4 million. During the year ended December 31, 2016, the Company recorded a non-cash gain due to the decrease in the value of the warrant liability of $1.0 million, which was partially offset by an impairment charge of $0.7 million.
Interest expense for the year ended December 31, 2017 was $1.3 million compared to $1.8 million during 2016. The decrease in interest expense for 2017 compared with 2016 was primarily due to a lower average balance of debt outstanding, partially offset by the decision to no longer capitalize the interest related to construction of the Centerpoint facility following the decision not to proceed with plans to develop this facility.
Reflecting the factors noted above, net loss for the year ended December 31, 2017 was $40.6 million compared to a net loss of $53.0 million during 2016.
As of December 31, 2017, cash and cash equivalents totaled $15.2 million. The Company expects that its current cash and cash equivalents, including approximately $7.3 million in net proceeds that the Company has raised from the sale of its common stock in its at-the-market facility during the first quarter of 2018, will be sufficient to fund its planned operations through the end of 2018.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, Rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Funding for the development of AGS-004 has been provided by the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Collaboratory of Research for AIDS Eradication.
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
DURHAM, NC, April 02, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported financial results and operational highlights for the fourth quarter and full year 2017.
Jeff Abbey, CEO of Argos Therapeutics, stated, "Although we faced a very challenging 2017, we have been able to continue the Phase 3 ADAPT clinical trial of Rocapuldencel-T for the treatment of metastatic renal cell carcinoma, and look forward to the next interim data analysis, which we expect to occur during the second quarter of 2018. In addition to continuing the ADAPT study, we look forward to initial results from the ongoing study of AGS-004 in combination with the latency-reversing agent vorinostat in adult HIV patients being conducted by the University of North Carolina, which we expect will be reported towards the end of 2018 or early 2019. We were also pleased to have recently secured an option to a PD1 checkpoint inhibitor, and, subject to obtaining additional funding, plan to conduct a clinical trial of Rocapuldencel-T in combination either with this agent or with an approved checkpoint inhibitor. Also of note, we have strengthened our financial position by raising net proceeds of approximately $23 million since June 2017 through our at-the-market facility, and believe that we now have sufficient capital to fund planned operations through the end of this year."
ADAPT Study Update
The Company is currently finalizing an amendment to the protocol for the ADAPT trial, which includes an amended primary endpoint analysis, and plans to submit it to the FDA prior to the interim data analysis planned for the second quarter of 2018. The Company expects that the interim data analysis will occur after such time as approximately 55 new events (deaths) have occurred subsequent to the February 2017 interim analysis. The amended primary endpoint analysis in the planned amended ADAPT protocol includes the following four co-primary endpoints:
Overall survival for all randomized patients when approximately 375 events have occurred (under the same analysis that was originally planned for 290 events);
The percentage of patients surviving at least five years;
Overall survival for patients who remained alive at the time of the February 2017 interim analysis, to be evaluated when approximately 155 new events have occurred; and
Overall survival for all patients for whom at least 12 months of follow-up is available (excluding patients who died or were lost to follow-up within the first 12 months after enrollment).
Operational and Corporate Highlights
Since the end of the third quarter of 2017, the Company has reported the following events:
In November 2017, the Company announced the receipt of a $1.5 million milestone payment from Lummy (Hong Kong) Co., Ltd. ("Lummy"), the Company's licensee for Rocapuldencel-T in China and certain other territories, related to the successful transfer of technology related to the manufacturing of Rocapuldencel-T.
In November 2017, the Company reported updated immunology data from the Phase 3 ADAPT study at the 32nd Annual Meeting of the Society for the Immunotherapy of Cancer that were generally supportive of the hypothesis regarding the intended mechanism of action of Rocapuldencel-T to induce an immune response against the tumor in patients with metastatic renal cell carcinoma.
In November 2017, the Company announced that it had reached agreement with Saint-Gobain Corporation ("Saint-Gobain"), one of the Company's vendors, regarding the payment of deferred fees. The Company agreed to settle its obligations to Saint-Gobain through a combination of a $0.5 million cash payment, delivery of 34,500 shares of common stock (as adjusted for the one-for-twenty reverse stock split), issuance of an approximately $2.4 million unsecured convertible promissory note and return of certain specified equipment previously provided to the Company.
In November 2017, the Company reported that the landlord of the facility in Durham County, NC that Argos had previously intended to utilize as its primary manufacturing facility ("Centerpoint"), had, with Argos' full consent, successfully completed the sale of this facility to a third party. In connection with this transaction, Argos entered into a lease termination agreement pursuant to which Argos received cash proceeds of approximately $1.8 million.
In January 2018 the Company entered into a stock purchase agreement with Lummy under which the Company agreed to issue and sell to Lummy in a private financing 375,000 shares of common stock (as adjusted for the one-for-twenty reverse stock split) for an aggregate purchase price of $1.5 million. In March 2018, the stock purchase agreement was amended to reduce the aggregate purchase price for the shares to $450,000. Concurrent with such amendment, the license agreement with Lummy was amended to provide for a $1.05 million milestone payment, which the Company has earned. Payments with respect to these amended agreements are expected to be received during April 2018.
In January 2018, the Company implemented a one-for-twenty reverse stock split, and subsequently regained compliance with the Nasdaq $1.00 minimum bid price requirement. The Company was also granted an extension until April 24, 2018 to regain compliance with the $2.5 million minimum shareholders' equity requirement for continued listing on the Nasdaq Capital Market.
From June 2017 through December 31, 2017, the Company raised net proceeds of $15.5 million through the issuance of common stock in an at-the-market offering under the Company's original sales agreement with Cowen & Company, LLC ("Cowen"). In February 2018, the original sales agreement with Cowen was amended to increase the maximum aggregate offering price of the shares of the Company's common stock which may be sold under the agreement from $30 million to $45 million. As of March 16, 2018, an additional $7.3 million of net proceeds had been raised through the sale of the Company's common stock subsequent to December 31, 2017 and $15.8 million remained available for sale.
In February 2018, the Company announced that it had entered into an option agreement with Pharmstandard International, S.A., the Company's partner in Russia and certain other territories, and Actigen Limited under which the Company has an option to license a group of fully human anti-PD1 monoclonal antibodies (PD1 checkpoint inhibitors) and related technology.
In February 2018, the Company announced the issuance of a patent covering the strain-independent amplification of human immunodeficiency virus, or HIV, nucleic acid sequences for use in vaccinations. The methods described in this patent form the foundation for the manufacture of AGS-004, Argos' experimental dendritic cell-based immunotherapy for HIV.
Financial Results
Fourth Quarter 2017 Financials
Revenue for the fourth quarter ended December 31, 2017 was $1.7 million compared to $0.2 million during the fourth quarter of 2016. The increase in revenue during the fourth quarter of 2017 compared with the fourth quarter of 2016 resulted from the receipt of a $1.5 million milestone payment from Lummy related to the transfer of technology for the manufacture of Rocapuldencel-T.
Research and development expense for the fourth quarter ended December 31, 2017 was $4.1 million compared to $10.3 million during the fourth quarter of 2016. The decrease in research and development expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial and the Company's decision not to proceed with the development of commercial manufacturing capabilities as well as to significantly reduce the size of its workforce engaged in research and development activities following the independent data monitoring committee's ("IDMC") recommendation in February 2017 to discontinue the ADAPT trial for futility.
General and administrative expense for the fourth quarter ended December 31, 2017 was $2.7 million compared to $4.8 million during the fourth quarter of 2016. The decrease in general and administrative expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was primarily due to decreased consulting and personnel costs.
Additionally, during the fourth quarter of 2017 the Company recognized a gain on disposal of impaired property of $2.8 million resulting from proceeds of $1.8 million that were received in connection with the sale of the Centerpoint facility and a $1.0 million gain from the disposal of certain property from the Saint-Gobain debt restructuring, as well as a $0.6 million gain on the early extinguishment of debt related to the Saint-Gobain debt restructuring. During the fourth quarter ended December 31, 2016, the Company recorded an impairment charge of $0.7 million, which was partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $0.6 million.
Interest expense for the fourth quarter ended December 31, 2017 was $0.2 million compared to $0.3 million during the fourth quarter of 2016. The decrease in interest expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was primarily due to a lower average balance of debt outstanding.
Reflecting the factors noted above, net loss for the fourth quarter ended December 31, 2017 was $1.9 million compared to a net loss of $15.4 million during the fourth quarter of 2016.
Full Year 2017 Financials
Revenue for the year ended December 31, 2017 was $1.9 million compared to $0.9 million during 2016. The increase in revenue for 2017 compared with 2016 resulted primarily from the receipt of a $1.5 million milestone payment from Lummy during 2017, which was partially offset by the $0.6 million decrease in reimbursement under the Company's contract with the National Institutes of Health and the National Institute of Allergy and Infectious Diseases primarily reflecting the achievement of certain specified development milestones under the Company's AGS-004 program during 2016.
Research and development expense for the year ended December 31, 2017 was $21.7 million compared to $38.3 million during 2016. The decrease in research and development expense for 2017 compared with 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial and the Company's decision not to proceed with the development of commercial manufacturing capabilities and to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC in February 2017 to discontinue the ADAPT trial for futility.
General and administrative expense for the year ended December 31, 2017 was $12.2 million compared to $14.2 million during 2016. The decrease in general and administrative expense for 2017 compared with 2016 was primarily due to decreased consulting and personnel costs.
Additionally, during the year ended December 31, 2017 the Company incurred impairment charges of $27.3 million and restructuring charges of $6.0 million related to the Company's decision to discontinue preparation for commercial manufacturing and reduce the size of its workforce, which amounts were partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $20.8 million, a gain on the disposal of impaired property of $2.8 million, and a gain on the early extinguishment of debt of $2.4 million. During the year ended December 31, 2016, the Company recorded a non-cash gain due to the decrease in the value of the warrant liability of $1.0 million, which was partially offset by an impairment charge of $0.7 million.
Interest expense for the year ended December 31, 2017 was $1.3 million compared to $1.8 million during 2016. The decrease in interest expense for 2017 compared with 2016 was primarily due to a lower average balance of debt outstanding, partially offset by the decision to no longer capitalize the interest related to construction of the Centerpoint facility following the decision not to proceed with plans to develop this facility.
Reflecting the factors noted above, net loss for the year ended December 31, 2017 was $40.6 million compared to a net loss of $53.0 million during 2016.
As of December 31, 2017, cash and cash equivalents totaled $15.2 million. The Company expects that its current cash and cash equivalents, including approximately $7.3 million in net proceeds that the Company has raised from the sale of its common stock in its at-the-market facility during the first quarter of 2018, will be sufficient to fund its planned operations through the end of 2018.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, Rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Funding for the development of AGS-004 has been provided by the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Collaboratory of Research for AIDS Eradication.
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
Ist das geil wie die Amis abkacken!
nicht gut,offering and no hard data on adapt. wird nach unten gehen, naked shorted at maximum
Wieviele Aktien sind eigentlich auf dem Markt ? Bitte mit Quelle falls vorhanden.
Antwort auf Beitrag Nr.: 57.449.408 von rush1291 am 03.04.18 13:59:46Wenn ich das richtig sehe!
Common stock $0.001 par value; 200,000,000 shares authorized as of December 31, 2016 and 2017; 2,063,158 and 5,906,620 shares issued and outstanding as of December 31, 2016 and 2017
Common stock $0.001 par value; 200,000,000 shares authorized as of December 31, 2016 and 2017; 2,063,158 and 5,906,620 shares issued and outstanding as of December 31, 2016 and 2017
Antwort auf Beitrag Nr.: 57.453.902 von Lucky72 am 03.04.18 22:05:34Quelle: http://ir.argostherapeutics.com/secfiling.cfm?filingID=11718…
die haben um 10 millionen jetzt wenn ich mich nicht irre
Antwort auf Beitrag Nr.: 57.454.574 von severin2000 am 04.04.18 00:19:14Selbst wenn 10 Mio OS sind, dann ist die Market Cap trotzdem ein Witz!
klar, es sei denn das research is nicht viel wert
Heute geht was!
Irgendwelche News?
(Noch) keine News!
Pre Market gehts schon los!
ist shorted unfassbar,manchmal mehr als 100% des day volume
Ich hab gestern nochmal nachgelegt!
Argos Therapeutics Reports Results of Interim Analysis of the ADAPT Trial and Announces Review of Strategic Alternatives
- Company to terminate the ADAPT study —
- Company has retained Stifel to provide advice on possible strategic alternatives —
- Trading in the common stock to be transferred from Nasdaq to the OTCQB Venture Market -
DURHAM, N.C., April 19, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma. Based on these results, the Company has decided to discontinue the trial.
As previously reported, a total of 462 patients with previously untreated advanced or metastatic renal cell carcinoma were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm) after undergoing cytoreductive nephrectomy. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration providing for four co-primary endpoints focused on various measures of survival. Based upon review of the interim data, the Company does not believe that it would achieve these endpoints if the trial were to be continued. After consulting with the principal investigators of the trial, the Company has therefore decided to discontinue the trial and has informed the FDA of its decision.
The most recent interim analysis was conducted after 51 new events (deaths) had occurred since the time of the February 2017 interim analysis. Median overall survival for the intent-to-treat patient population, one of the four co-primary endpoints, was estimated using the Kaplan-Meier method. The estimated median overall survival for the combination arm was 28.2 months (95% Confidence Interval (CI): 23.4, 35.2) compared to 31.2 months (95% CI: 23.0, 44.5) for the control arm. The hazard ratio was 1.10 (95% CI: 0.85, 1.42). The two other co-primary endpoints that were evaluated at this time, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, also did not demonstrate a favorable result. A fourth endpoint, five-year survival, was not evaluated because there was insufficient data at this time to perform this analysis.
Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.
Argos does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. Argos does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.
Argos also today reported that it does not expect to regain compliance with The Nasdaq Capital Market continued listing requirements by the April 24, 2018 deadline. As a result, Argos expects that its common stock will be delisted from The Nasdaq Capital Market and that trading in the Company's common stock on The Nasdaq Capital Market will be suspended effective at the open of business on April 23, 2018. The Company has filed an application to transfer trading and quotation of its common stock to the OTCQB® Venture Market, operated by OTC Markets Group Inc., under its current trading symbol "ARGS," effective as of April 23, 2018. Quotation and trading information for the common stock will be available on www.otcmarkets.com.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos is developing an Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Funding for the development of AGS-004 has been provided by the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Collaboratory of Research for AIDS Eradication.
Forward Looking Statements
Any statements in this press release about Argos' future expectations, plans and prospects, including statements about Argos' financial prospects, future operations and sufficiency of funds for future operations, clinical development of Argos' product candidates, expectations regarding future clinical trials and FDA activities and future expectations and plans and prospects for Argos and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund its continuing operations for the period anticipated; what the impact of the transfer of Argos' common stock to the OTCQB® will have on the trading of Argos' common stock and ability to raise funds; whether preliminary or interim clinical data will be indicative of the final data from a clinical trial; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether Argos can successfully establish commercial manufacturing operations on a timely basis or at all; and other factors discussed in the "Risk Factors" section of Argos' Form 10-K for the year ended December 31, 2017, which is on file with the SEC, and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos' views as of the date hereof. Argos anticipates that subsequent events and developments will cause Argos' views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos' views as of any date subsequent to the date hereof.
Media and investor contact:
Richard Katz, MD, MBA
Chief Financial Officer
Argos Therapeutics, Inc.
919-287-6315
rkatz@argostherapeutics.com
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
- Company to terminate the ADAPT study —
- Company has retained Stifel to provide advice on possible strategic alternatives —
- Trading in the common stock to be transferred from Nasdaq to the OTCQB Venture Market -
DURHAM, N.C., April 19, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma. Based on these results, the Company has decided to discontinue the trial.
As previously reported, a total of 462 patients with previously untreated advanced or metastatic renal cell carcinoma were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm) after undergoing cytoreductive nephrectomy. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration providing for four co-primary endpoints focused on various measures of survival. Based upon review of the interim data, the Company does not believe that it would achieve these endpoints if the trial were to be continued. After consulting with the principal investigators of the trial, the Company has therefore decided to discontinue the trial and has informed the FDA of its decision.
The most recent interim analysis was conducted after 51 new events (deaths) had occurred since the time of the February 2017 interim analysis. Median overall survival for the intent-to-treat patient population, one of the four co-primary endpoints, was estimated using the Kaplan-Meier method. The estimated median overall survival for the combination arm was 28.2 months (95% Confidence Interval (CI): 23.4, 35.2) compared to 31.2 months (95% CI: 23.0, 44.5) for the control arm. The hazard ratio was 1.10 (95% CI: 0.85, 1.42). The two other co-primary endpoints that were evaluated at this time, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, also did not demonstrate a favorable result. A fourth endpoint, five-year survival, was not evaluated because there was insufficient data at this time to perform this analysis.
Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.
Argos does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. Argos does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.
Argos also today reported that it does not expect to regain compliance with The Nasdaq Capital Market continued listing requirements by the April 24, 2018 deadline. As a result, Argos expects that its common stock will be delisted from The Nasdaq Capital Market and that trading in the Company's common stock on The Nasdaq Capital Market will be suspended effective at the open of business on April 23, 2018. The Company has filed an application to transfer trading and quotation of its common stock to the OTCQB® Venture Market, operated by OTC Markets Group Inc., under its current trading symbol "ARGS," effective as of April 23, 2018. Quotation and trading information for the common stock will be available on www.otcmarkets.com.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos is developing an Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Funding for the development of AGS-004 has been provided by the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Collaboratory of Research for AIDS Eradication.
Forward Looking Statements
Any statements in this press release about Argos' future expectations, plans and prospects, including statements about Argos' financial prospects, future operations and sufficiency of funds for future operations, clinical development of Argos' product candidates, expectations regarding future clinical trials and FDA activities and future expectations and plans and prospects for Argos and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund its continuing operations for the period anticipated; what the impact of the transfer of Argos' common stock to the OTCQB® will have on the trading of Argos' common stock and ability to raise funds; whether preliminary or interim clinical data will be indicative of the final data from a clinical trial; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether Argos can successfully establish commercial manufacturing operations on a timely basis or at all; and other factors discussed in the "Risk Factors" section of Argos' Form 10-K for the year ended December 31, 2017, which is on file with the SEC, and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos' views as of the date hereof. Argos anticipates that subsequent events and developments will cause Argos' views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos' views as of any date subsequent to the date hereof.
Media and investor contact:
Richard Katz, MD, MBA
Chief Financial Officer
Argos Therapeutics, Inc.
919-287-6315
rkatz@argostherapeutics.com
http://ir.argostherapeutics.com/releasedetail.cfm?ReleaseID=…
Der Letzte macht das Licht aus! 
65% Minus pre narket, man ist ja komplett abgestürzt hier.
Tja Game Over Delcath Nr. 2
Antwort auf Beitrag Nr.: 57.627.846 von Magnificient am 25.04.18 19:07:47Warum, läuft doch gut?! Ich hätte gedacht das sie noch weiter abkackt.
Es kommt wieder Bewegung rein!
Auf 16. Juli 2018 , der Verwaltungsrat (der "Vorstand") von Argos Therapeutics, Inc. (die "Gesellschaft") beschloss auf Empfehlung des Vergütungsausschusses des Verwaltungsrates, mit bestimmten leitenden Angestellten, einschließlich Jeffrey D. Abtei , der President und Chief Executive Officer des Unternehmens, Charles Nicolette , der Vizepräsident des Unternehmens für Forschung und Entwicklung und Chief Scientific Officer, und Richard D. Katz , der Vice President und Chief Financial Officer des Unternehmens.
Die Aufbewahrungsvereinbarungen, datiert 20. Juli 2018 Geben Sie das an oder um 20. Juli 2018 , wird das Unternehmen anfängliche Rückbehaltszahlungen in Höhe von ca. 97.000 $ , 78.000 $ , und $ 62.000 zu Mr. Abbey , Dr. Nicolette und Dr. Katz jeweils unter der Voraussetzung, dass der Geschäftsführer eine Forderungsauflösung vornimmt. Die Aufbewahrungsvereinbarungen sehen auch vor, dass 15. August 2018 , wird das Unternehmen zusätzliche Zahlungen von ca. 224.000 $ , $ 178.000 , und 149.000 $ zu Mr. Abbey , Dr. Nicolette und Dr. Katz jeweils unter der Voraussetzung, dass der leitende Angestellte (i) die Voraussetzungen für die Zahlung der ursprünglichen Selbstbehaltzahlung erfüllt hat, (ii) seine Freigabe von Ansprüchen bestätigt hat, (iii) entweder bei der Gesellschaft am 15. August 2018 oder seine Anstellung von der Gesellschaft aus wichtigem Grund vor diesem Zeitpunkt ohne Angabe von Gründen oder durch den Vorstand gekündigt wurde und (iv) mit der Gesellschaft einen Beratungsvertrag über die Erbringung von Beratungsleistungen für den Fall, dass es sich um den Vorstand handelt, abgeschlossen hat nicht mehr von der Gesellschaft beschäftigt. Die Aufbewahrungsvereinbarungen sehen ferner vor, dass die Gehälter von Mr. Abbey , Dr. Nicolette und Dr. Katz wird für den Zeitraum von erhöht werden 16. Juli 2018 zu 15. August 2018 , so dass sie eine zusätzliche Menge von etwa erhalten $ 20.000 , $ 16.000 , und 12.000 $ jeweils in Grundgehalt während dieser Zeit.
Im Zusammenhang mit dem Erhalt der Zurückbehaltungszahlungen und der Gehaltserhöhung, Mr. Abbey , Dr. Nicolette und Dr. Katz beide haben sich darauf geeinigt, auf alle Rechte zum Bezug von Abfindungen und anderen Leistungen nach Beendigung des Arbeitsverhältnisses im Rahmen ihrer Arbeitsverträge mit der Gesellschaft oder auf andere Weise zu verzichten. Wenn jedoch die Zurückbehaltungszahlungen oder der Betrag des erhöhten Gehalts vom geschäftsführenden Beauftragten zurückbezahlt werden müssen oder anderweitig von der Gesellschaft entwertet oder eingezogen werden oder wenn die Gesellschaft die zusätzliche Rückbehaltzahlung nicht leistet 15. August 2018 , dann wird eine solche Verzichtserklärung nicht länger anwendbar sein, und dieser leitende Angestellte behält alle Rechte auf Abfindungen und andere Leistungen nach Beendigung des Arbeitsverhältnisses.
© Edgar Online, Quelle Einblicke
Die Aufbewahrungsvereinbarungen, datiert 20. Juli 2018 Geben Sie das an oder um 20. Juli 2018 , wird das Unternehmen anfängliche Rückbehaltszahlungen in Höhe von ca. 97.000 $ , 78.000 $ , und $ 62.000 zu Mr. Abbey , Dr. Nicolette und Dr. Katz jeweils unter der Voraussetzung, dass der Geschäftsführer eine Forderungsauflösung vornimmt. Die Aufbewahrungsvereinbarungen sehen auch vor, dass 15. August 2018 , wird das Unternehmen zusätzliche Zahlungen von ca. 224.000 $ , $ 178.000 , und 149.000 $ zu Mr. Abbey , Dr. Nicolette und Dr. Katz jeweils unter der Voraussetzung, dass der leitende Angestellte (i) die Voraussetzungen für die Zahlung der ursprünglichen Selbstbehaltzahlung erfüllt hat, (ii) seine Freigabe von Ansprüchen bestätigt hat, (iii) entweder bei der Gesellschaft am 15. August 2018 oder seine Anstellung von der Gesellschaft aus wichtigem Grund vor diesem Zeitpunkt ohne Angabe von Gründen oder durch den Vorstand gekündigt wurde und (iv) mit der Gesellschaft einen Beratungsvertrag über die Erbringung von Beratungsleistungen für den Fall, dass es sich um den Vorstand handelt, abgeschlossen hat nicht mehr von der Gesellschaft beschäftigt. Die Aufbewahrungsvereinbarungen sehen ferner vor, dass die Gehälter von Mr. Abbey , Dr. Nicolette und Dr. Katz wird für den Zeitraum von erhöht werden 16. Juli 2018 zu 15. August 2018 , so dass sie eine zusätzliche Menge von etwa erhalten $ 20.000 , $ 16.000 , und 12.000 $ jeweils in Grundgehalt während dieser Zeit.
Im Zusammenhang mit dem Erhalt der Zurückbehaltungszahlungen und der Gehaltserhöhung, Mr. Abbey , Dr. Nicolette und Dr. Katz beide haben sich darauf geeinigt, auf alle Rechte zum Bezug von Abfindungen und anderen Leistungen nach Beendigung des Arbeitsverhältnisses im Rahmen ihrer Arbeitsverträge mit der Gesellschaft oder auf andere Weise zu verzichten. Wenn jedoch die Zurückbehaltungszahlungen oder der Betrag des erhöhten Gehalts vom geschäftsführenden Beauftragten zurückbezahlt werden müssen oder anderweitig von der Gesellschaft entwertet oder eingezogen werden oder wenn die Gesellschaft die zusätzliche Rückbehaltzahlung nicht leistet 15. August 2018 , dann wird eine solche Verzichtserklärung nicht länger anwendbar sein, und dieser leitende Angestellte behält alle Rechte auf Abfindungen und andere Leistungen nach Beendigung des Arbeitsverhältnisses.
© Edgar Online, Quelle Einblicke
Ist was im Busch?
Kommen bald News?
Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.
Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.
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