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News Article | November 29, 2016
Site: globenewswire.com

COPENHAGEN, Denmark, Nov. 29, 2016 (GLOBE NEWSWIRE) -- Forward Pharma A/S (NASDAQ:FWP) (“we” or “Forward” or the “Company”), today reported financial results for the third quarter ended September 30, 2016.  Net loss for the third quarter ended September 30, 2016 was $11.0 million, or $0.23 per basic share versus a net loss of $15.8 million, or $0.34 per basic share for the third quarter of 2015.  On a non-GAAP basis, after removing the effect of non-cash income and expense items, our third quarter net loss for 2016 would have been $7.3 million, or $0.15 per basic share. As of September 30, 2016, the Company had $150.2 million in cash, cash equivalents and marketable securities, with no debt outstanding.  “We continue to advance our clinical programs and our intellectual property portfolio and look forward to the oral argument on our interference case to be held tomorrow at the USPTO,” said Peder Andersen, Chief Executive Officer of Forward. Third Quarter ended September 30, 2016 Financial and Operational Results The net loss for the third quarter of 2016 was $11.0 million compared to a net loss of $15.8 million for the comparable period in 2015. Research and development costs for the three month periods ended September 30, 2016 and 2015 were $7.7 million and $10.8 million, respectively. This decrease in the third quarter 2016 versus the prior year was related to a reduction in the use of contract manufacturers and clinical research organizations during our evaluation of options for an alternative Phase 3 clinical plan for FP187 in relapsing-remitting multiple sclerosis (RRMS). Research and development costs incurred in the third quarter of 2016 to conduct the ongoing interference case at the U.S. Patent and Trademark Office (USPTO) and opposition proceedings with the European Patent Office (EPO) were flat with the comparable period in 2015. Share-based compensation for the three month period ended September 30, 2016 was $1.6 million. We expect our use of contract manufacturers and clinical research organizations will likely return to historical levels in our further preparation for the start of our Phase 3 trial.  We expect our overall rate of research and development spending will increase in future quarters as our clinical and pharmaceutical development programs and patent office matters, including our pending interference action, advance. General and administrative costs for the three month periods ended September 30, 2016 and 2015 were $3.2 million and $4.6 million, respectively.  The decrease in expenses in the third quarter 2016 versus the prior year was principally due to a reduction in share-based compensation as well as lower legal, accounting and consulting fees.  In the third quarter 2016, share-based compensation decreased by $0.4 million versus the comparable period in 2015 to $1.7 million in connection with the vesting of equity awards issued during the years ended December 31, 2015 and 2014. We expect our rate of general and administrative spending could increase in the future in support of our expected increase in research and development related activities as well as the protection of our intellectual property portfolio including expenditures in connection with the lawsuits against Biogen in Europe. Non-cash stock-based compensation expense included in total operating expenses was $3.3 million for the third quarter of 2016 versus $3.8 million for the third quarter of 2015. We continue to advance our intellectual property portfolio.  As previously reported, on August 19, 2015, the USPTO re-declared the interference between Forward Pharma and a subsidiary of Biogen, Inc. regarding claims to the treatment of multiple sclerosis (MS), with a 480 mg daily dose of dimethyl fumarate (DMF), the active ingredient in Tecfidera®. The USPTO confirmed Forward Pharma as the senior party based on having an earlier benefit date of our U.S. Patent Application No. 11/576,871.  Biogen was deemed the junior party with respect to its U.S. Patent No. 8,399,514.  In August 2015, the parties filed priority statements and motions related to validity and benefit. The parties filed oppositions to motions on June 1, 2016.  Both parties filed replies to the oppositions on August 8, 2016.  The oral argument remains scheduled for November 30, 2016. Our development plan for our lead drug, FP187, is focused primarily on the RRMS indication. In consultation with a clinical research organization, we are continuing to prepare for our Phase 3 trial in RRMS. In addition to the single beta interferon-controlled design, we are evaluating options for an alternative Phase 3 clinical strategy in RRMS, which could shorten our time to commercialization and/or reduce costs. We expect to complete these evaluations as we continue to upscale production of FP187 during 2016, in anticipation of beginning the Phase 3 trial in mid-2017. We are currently performing additional Phase 1 studies on FP187. Our nonclinical development plan for FP187 is designed to support regulatory submissions with a complete toxicology package. This press release uses a non-GAAP financial measure of net loss that is not calculated in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IASB"). The Company believes that the presentation of non-GAAP net loss is useful to investors because it excludes certain non-cash items that do not affect the Company’s liquidity, and foreign exchange rate changes are not within the control of the Company.  Non-cash items include: (i) share-based compensation expense and (ii) non-cash foreign exchange gains or (losses). However, there are limitations in the use of non-GAAP financial measures as they exclude certain income and expenses. Furthermore, the Company's non-GAAP financial measure may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented herein should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with IFRS. USPTO Interference with Biogen: The related documents are publicly available on the USPTO interference website at https://acts.uspto.gov/ifiling/PublicView.jsp, using interference number 106023. Forward Pharma U.S. and European patents and patent applications can be found by using the following links:  USPTO: http://www.uspto.gov/ USPTO Public Pair: http://portal.uspto.gov/pair/PublicPair EPO: https://register.epo.org/regviewer About Forward Pharma: Forward Pharma A/S is a Danish biopharmaceutical company developing FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications. Since our founding in 2005, we have worked to advance unique formulations of DMF, which is an immune modulator, as a therapeutic agent to improve the health and well-being of patients with immune disorders including multiple sclerosis. FP187, our clinical candidate, is a DMF formulation in a delayed and slow release oral dose. Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark, and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP). For more information about the Company’s products and developments, please visit our web site at http://www.forward-pharma.com. Forward Looking Statements: Certain statements in this press release may constitute “forward-looking statements” of the Company within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as “believe,” “expect,” “anticipate,” “hope,” “would” and “potential.” Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company’s ability to obtain, maintain and defend issued patents with protective claims; the issuance and term of patents; the Company’s ability to prevail in or obtain a favorable decision in any patent interference or infringement action; the Company’s ability to recover damages in any patent infringement action; uncertainties relating to our development plans and activities, including the commencement of any clinical trial and the results, timing, cost and location thereof; risks and uncertainties related to the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property rights of third parties; our ability to commercialize and generate revenue from our sole clinical candidate, FP187; clinical development, and clinical trials of FP187 may not be successful; completion of required clinical trials may take longer than we anticipate, which could result in increased costs, limit our access to funding and delay or limit our ability to obtain regulatory approval for FP187; and our evaluation of alternative Phase 3 clinical strategies in RRMS may not be successful or shorten our time to commercialization and/or reduce costs. These and other factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2015.


News Article | November 29, 2016
Site: globenewswire.com

COPENHAGEN, Denmark, Nov. 29, 2016 (GLOBE NEWSWIRE) -- Forward Pharma A/S (NASDAQ:FWP) (“we” or “Forward” or the “Company”), today reported financial results for the third quarter ended September 30, 2016.  Net loss for the third quarter ended September 30, 2016 was $11.0 million, or $0.23 per basic share versus a net loss of $15.8 million, or $0.34 per basic share for the third quarter of 2015.  On a non-GAAP basis, after removing the effect of non-cash income and expense items, our third quarter net loss for 2016 would have been $7.3 million, or $0.15 per basic share. As of September 30, 2016, the Company had $150.2 million in cash, cash equivalents and marketable securities, with no debt outstanding.  “We continue to advance our clinical programs and our intellectual property portfolio and look forward to the oral argument on our interference case to be held tomorrow at the USPTO,” said Peder Andersen, Chief Executive Officer of Forward. Third Quarter ended September 30, 2016 Financial and Operational Results The net loss for the third quarter of 2016 was $11.0 million compared to a net loss of $15.8 million for the comparable period in 2015. Research and development costs for the three month periods ended September 30, 2016 and 2015 were $7.7 million and $10.8 million, respectively. This decrease in the third quarter 2016 versus the prior year was related to a reduction in the use of contract manufacturers and clinical research organizations during our evaluation of options for an alternative Phase 3 clinical plan for FP187 in relapsing-remitting multiple sclerosis (RRMS). Research and development costs incurred in the third quarter of 2016 to conduct the ongoing interference case at the U.S. Patent and Trademark Office (USPTO) and opposition proceedings with the European Patent Office (EPO) were flat with the comparable period in 2015. Share-based compensation for the three month period ended September 30, 2016 was $1.6 million. We expect our use of contract manufacturers and clinical research organizations will likely return to historical levels in our further preparation for the start of our Phase 3 trial.  We expect our overall rate of research and development spending will increase in future quarters as our clinical and pharmaceutical development programs and patent office matters, including our pending interference action, advance. General and administrative costs for the three month periods ended September 30, 2016 and 2015 were $3.2 million and $4.6 million, respectively.  The decrease in expenses in the third quarter 2016 versus the prior year was principally due to a reduction in share-based compensation as well as lower legal, accounting and consulting fees.  In the third quarter 2016, share-based compensation decreased by $0.4 million versus the comparable period in 2015 to $1.7 million in connection with the vesting of equity awards issued during the years ended December 31, 2015 and 2014. We expect our rate of general and administrative spending could increase in the future in support of our expected increase in research and development related activities as well as the protection of our intellectual property portfolio including expenditures in connection with the lawsuits against Biogen in Europe. Non-cash stock-based compensation expense included in total operating expenses was $3.3 million for the third quarter of 2016 versus $3.8 million for the third quarter of 2015. We continue to advance our intellectual property portfolio.  As previously reported, on August 19, 2015, the USPTO re-declared the interference between Forward Pharma and a subsidiary of Biogen, Inc. regarding claims to the treatment of multiple sclerosis (MS), with a 480 mg daily dose of dimethyl fumarate (DMF), the active ingredient in Tecfidera®. The USPTO confirmed Forward Pharma as the senior party based on having an earlier benefit date of our U.S. Patent Application No. 11/576,871.  Biogen was deemed the junior party with respect to its U.S. Patent No. 8,399,514.  In August 2015, the parties filed priority statements and motions related to validity and benefit. The parties filed oppositions to motions on June 1, 2016.  Both parties filed replies to the oppositions on August 8, 2016.  The oral argument remains scheduled for November 30, 2016. Our development plan for our lead drug, FP187, is focused primarily on the RRMS indication. In consultation with a clinical research organization, we are continuing to prepare for our Phase 3 trial in RRMS. In addition to the single beta interferon-controlled design, we are evaluating options for an alternative Phase 3 clinical strategy in RRMS, which could shorten our time to commercialization and/or reduce costs. We expect to complete these evaluations as we continue to upscale production of FP187 during 2016, in anticipation of beginning the Phase 3 trial in mid-2017. We are currently performing additional Phase 1 studies on FP187. Our nonclinical development plan for FP187 is designed to support regulatory submissions with a complete toxicology package. This press release uses a non-GAAP financial measure of net loss that is not calculated in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IASB"). The Company believes that the presentation of non-GAAP net loss is useful to investors because it excludes certain non-cash items that do not affect the Company’s liquidity, and foreign exchange rate changes are not within the control of the Company.  Non-cash items include: (i) share-based compensation expense and (ii) non-cash foreign exchange gains or (losses). However, there are limitations in the use of non-GAAP financial measures as they exclude certain income and expenses. Furthermore, the Company's non-GAAP financial measure may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented herein should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with IFRS. USPTO Interference with Biogen: The related documents are publicly available on the USPTO interference website at https://acts.uspto.gov/ifiling/PublicView.jsp, using interference number 106023. Forward Pharma U.S. and European patents and patent applications can be found by using the following links:  USPTO: http://www.uspto.gov/ USPTO Public Pair: http://portal.uspto.gov/pair/PublicPair EPO: https://register.epo.org/regviewer About Forward Pharma: Forward Pharma A/S is a Danish biopharmaceutical company developing FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications. Since our founding in 2005, we have worked to advance unique formulations of DMF, which is an immune modulator, as a therapeutic agent to improve the health and well-being of patients with immune disorders including multiple sclerosis. FP187, our clinical candidate, is a DMF formulation in a delayed and slow release oral dose. Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark, and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP). For more information about the Company’s products and developments, please visit our web site at http://www.forward-pharma.com. Forward Looking Statements: Certain statements in this press release may constitute “forward-looking statements” of the Company within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as “believe,” “expect,” “anticipate,” “hope,” “would” and “potential.” Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company’s ability to obtain, maintain and defend issued patents with protective claims; the issuance and term of patents; the Company’s ability to prevail in or obtain a favorable decision in any patent interference or infringement action; the Company’s ability to recover damages in any patent infringement action; uncertainties relating to our development plans and activities, including the commencement of any clinical trial and the results, timing, cost and location thereof; risks and uncertainties related to the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property rights of third parties; our ability to commercialize and generate revenue from our sole clinical candidate, FP187; clinical development, and clinical trials of FP187 may not be successful; completion of required clinical trials may take longer than we anticipate, which could result in increased costs, limit our access to funding and delay or limit our ability to obtain regulatory approval for FP187; and our evaluation of alternative Phase 3 clinical strategies in RRMS may not be successful or shorten our time to commercialization and/or reduce costs. These and other factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2015.


News Article | November 29, 2016
Site: globenewswire.com

COPENHAGEN, Denmark, Nov. 29, 2016 (GLOBE NEWSWIRE) -- Forward Pharma A/S (NASDAQ:FWP) (“we” or “Forward” or the “Company”), today reported financial results for the third quarter ended September 30, 2016.  Net loss for the third quarter ended September 30, 2016 was $11.0 million, or $0.23 per basic share versus a net loss of $15.8 million, or $0.34 per basic share for the third quarter of 2015.  On a non-GAAP basis, after removing the effect of non-cash income and expense items, our third quarter net loss for 2016 would have been $7.3 million, or $0.15 per basic share. As of September 30, 2016, the Company had $150.2 million in cash, cash equivalents and marketable securities, with no debt outstanding.  “We continue to advance our clinical programs and our intellectual property portfolio and look forward to the oral argument on our interference case to be held tomorrow at the USPTO,” said Peder Andersen, Chief Executive Officer of Forward. Third Quarter ended September 30, 2016 Financial and Operational Results The net loss for the third quarter of 2016 was $11.0 million compared to a net loss of $15.8 million for the comparable period in 2015. Research and development costs for the three month periods ended September 30, 2016 and 2015 were $7.7 million and $10.8 million, respectively. This decrease in the third quarter 2016 versus the prior year was related to a reduction in the use of contract manufacturers and clinical research organizations during our evaluation of options for an alternative Phase 3 clinical plan for FP187 in relapsing-remitting multiple sclerosis (RRMS). Research and development costs incurred in the third quarter of 2016 to conduct the ongoing interference case at the U.S. Patent and Trademark Office (USPTO) and opposition proceedings with the European Patent Office (EPO) were flat with the comparable period in 2015. Share-based compensation for the three month period ended September 30, 2016 was $1.6 million. We expect our use of contract manufacturers and clinical research organizations will likely return to historical levels in our further preparation for the start of our Phase 3 trial.  We expect our overall rate of research and development spending will increase in future quarters as our clinical and pharmaceutical development programs and patent office matters, including our pending interference action, advance. General and administrative costs for the three month periods ended September 30, 2016 and 2015 were $3.2 million and $4.6 million, respectively.  The decrease in expenses in the third quarter 2016 versus the prior year was principally due to a reduction in share-based compensation as well as lower legal, accounting and consulting fees.  In the third quarter 2016, share-based compensation decreased by $0.4 million versus the comparable period in 2015 to $1.7 million in connection with the vesting of equity awards issued during the years ended December 31, 2015 and 2014. We expect our rate of general and administrative spending could increase in the future in support of our expected increase in research and development related activities as well as the protection of our intellectual property portfolio including expenditures in connection with the lawsuits against Biogen in Europe. Non-cash stock-based compensation expense included in total operating expenses was $3.3 million for the third quarter of 2016 versus $3.8 million for the third quarter of 2015. We continue to advance our intellectual property portfolio.  As previously reported, on August 19, 2015, the USPTO re-declared the interference between Forward Pharma and a subsidiary of Biogen, Inc. regarding claims to the treatment of multiple sclerosis (MS), with a 480 mg daily dose of dimethyl fumarate (DMF), the active ingredient in Tecfidera®. The USPTO confirmed Forward Pharma as the senior party based on having an earlier benefit date of our U.S. Patent Application No. 11/576,871.  Biogen was deemed the junior party with respect to its U.S. Patent No. 8,399,514.  In August 2015, the parties filed priority statements and motions related to validity and benefit. The parties filed oppositions to motions on June 1, 2016.  Both parties filed replies to the oppositions on August 8, 2016.  The oral argument remains scheduled for November 30, 2016. Our development plan for our lead drug, FP187, is focused primarily on the RRMS indication. In consultation with a clinical research organization, we are continuing to prepare for our Phase 3 trial in RRMS. In addition to the single beta interferon-controlled design, we are evaluating options for an alternative Phase 3 clinical strategy in RRMS, which could shorten our time to commercialization and/or reduce costs. We expect to complete these evaluations as we continue to upscale production of FP187 during 2016, in anticipation of beginning the Phase 3 trial in mid-2017. We are currently performing additional Phase 1 studies on FP187. Our nonclinical development plan for FP187 is designed to support regulatory submissions with a complete toxicology package. This press release uses a non-GAAP financial measure of net loss that is not calculated in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IASB"). The Company believes that the presentation of non-GAAP net loss is useful to investors because it excludes certain non-cash items that do not affect the Company’s liquidity, and foreign exchange rate changes are not within the control of the Company.  Non-cash items include: (i) share-based compensation expense and (ii) non-cash foreign exchange gains or (losses). However, there are limitations in the use of non-GAAP financial measures as they exclude certain income and expenses. Furthermore, the Company's non-GAAP financial measure may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented herein should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with IFRS. USPTO Interference with Biogen: The related documents are publicly available on the USPTO interference website at https://acts.uspto.gov/ifiling/PublicView.jsp, using interference number 106023. Forward Pharma U.S. and European patents and patent applications can be found by using the following links:  USPTO: http://www.uspto.gov/ USPTO Public Pair: http://portal.uspto.gov/pair/PublicPair EPO: https://register.epo.org/regviewer About Forward Pharma: Forward Pharma A/S is a Danish biopharmaceutical company developing FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications. Since our founding in 2005, we have worked to advance unique formulations of DMF, which is an immune modulator, as a therapeutic agent to improve the health and well-being of patients with immune disorders including multiple sclerosis. FP187, our clinical candidate, is a DMF formulation in a delayed and slow release oral dose. Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark, and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP). For more information about the Company’s products and developments, please visit our web site at http://www.forward-pharma.com. Forward Looking Statements: Certain statements in this press release may constitute “forward-looking statements” of the Company within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as “believe,” “expect,” “anticipate,” “hope,” “would” and “potential.” Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company’s ability to obtain, maintain and defend issued patents with protective claims; the issuance and term of patents; the Company’s ability to prevail in or obtain a favorable decision in any patent interference or infringement action; the Company’s ability to recover damages in any patent infringement action; uncertainties relating to our development plans and activities, including the commencement of any clinical trial and the results, timing, cost and location thereof; risks and uncertainties related to the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property rights of third parties; our ability to commercialize and generate revenue from our sole clinical candidate, FP187; clinical development, and clinical trials of FP187 may not be successful; completion of required clinical trials may take longer than we anticipate, which could result in increased costs, limit our access to funding and delay or limit our ability to obtain regulatory approval for FP187; and our evaluation of alternative Phase 3 clinical strategies in RRMS may not be successful or shorten our time to commercialization and/or reduce costs. These and other factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2015.


News Article | November 29, 2016
Site: globenewswire.com

COPENHAGEN, Denmark, Nov. 29, 2016 (GLOBE NEWSWIRE) -- Forward Pharma A/S (NASDAQ:FWP) (“we” or “Forward” or the “Company”), today reported financial results for the third quarter ended September 30, 2016.  Net loss for the third quarter ended September 30, 2016 was $11.0 million, or $0.23 per basic share versus a net loss of $15.8 million, or $0.34 per basic share for the third quarter of 2015.  On a non-GAAP basis, after removing the effect of non-cash income and expense items, our third quarter net loss for 2016 would have been $7.3 million, or $0.15 per basic share. As of September 30, 2016, the Company had $150.2 million in cash, cash equivalents and marketable securities, with no debt outstanding.  “We continue to advance our clinical programs and our intellectual property portfolio and look forward to the oral argument on our interference case to be held tomorrow at the USPTO,” said Peder Andersen, Chief Executive Officer of Forward. Third Quarter ended September 30, 2016 Financial and Operational Results The net loss for the third quarter of 2016 was $11.0 million compared to a net loss of $15.8 million for the comparable period in 2015. Research and development costs for the three month periods ended September 30, 2016 and 2015 were $7.7 million and $10.8 million, respectively. This decrease in the third quarter 2016 versus the prior year was related to a reduction in the use of contract manufacturers and clinical research organizations during our evaluation of options for an alternative Phase 3 clinical plan for FP187 in relapsing-remitting multiple sclerosis (RRMS). Research and development costs incurred in the third quarter of 2016 to conduct the ongoing interference case at the U.S. Patent and Trademark Office (USPTO) and opposition proceedings with the European Patent Office (EPO) were flat with the comparable period in 2015. Share-based compensation for the three month period ended September 30, 2016 was $1.6 million. We expect our use of contract manufacturers and clinical research organizations will likely return to historical levels in our further preparation for the start of our Phase 3 trial.  We expect our overall rate of research and development spending will increase in future quarters as our clinical and pharmaceutical development programs and patent office matters, including our pending interference action, advance. General and administrative costs for the three month periods ended September 30, 2016 and 2015 were $3.2 million and $4.6 million, respectively.  The decrease in expenses in the third quarter 2016 versus the prior year was principally due to a reduction in share-based compensation as well as lower legal, accounting and consulting fees.  In the third quarter 2016, share-based compensation decreased by $0.4 million versus the comparable period in 2015 to $1.7 million in connection with the vesting of equity awards issued during the years ended December 31, 2015 and 2014. We expect our rate of general and administrative spending could increase in the future in support of our expected increase in research and development related activities as well as the protection of our intellectual property portfolio including expenditures in connection with the lawsuits against Biogen in Europe. Non-cash stock-based compensation expense included in total operating expenses was $3.3 million for the third quarter of 2016 versus $3.8 million for the third quarter of 2015. We continue to advance our intellectual property portfolio.  As previously reported, on August 19, 2015, the USPTO re-declared the interference between Forward Pharma and a subsidiary of Biogen, Inc. regarding claims to the treatment of multiple sclerosis (MS), with a 480 mg daily dose of dimethyl fumarate (DMF), the active ingredient in Tecfidera®. The USPTO confirmed Forward Pharma as the senior party based on having an earlier benefit date of our U.S. Patent Application No. 11/576,871.  Biogen was deemed the junior party with respect to its U.S. Patent No. 8,399,514.  In August 2015, the parties filed priority statements and motions related to validity and benefit. The parties filed oppositions to motions on June 1, 2016.  Both parties filed replies to the oppositions on August 8, 2016.  The oral argument remains scheduled for November 30, 2016. Our development plan for our lead drug, FP187, is focused primarily on the RRMS indication. In consultation with a clinical research organization, we are continuing to prepare for our Phase 3 trial in RRMS. In addition to the single beta interferon-controlled design, we are evaluating options for an alternative Phase 3 clinical strategy in RRMS, which could shorten our time to commercialization and/or reduce costs. We expect to complete these evaluations as we continue to upscale production of FP187 during 2016, in anticipation of beginning the Phase 3 trial in mid-2017. We are currently performing additional Phase 1 studies on FP187. Our nonclinical development plan for FP187 is designed to support regulatory submissions with a complete toxicology package. This press release uses a non-GAAP financial measure of net loss that is not calculated in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IASB"). The Company believes that the presentation of non-GAAP net loss is useful to investors because it excludes certain non-cash items that do not affect the Company’s liquidity, and foreign exchange rate changes are not within the control of the Company.  Non-cash items include: (i) share-based compensation expense and (ii) non-cash foreign exchange gains or (losses). However, there are limitations in the use of non-GAAP financial measures as they exclude certain income and expenses. Furthermore, the Company's non-GAAP financial measure may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented herein should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with IFRS. USPTO Interference with Biogen: The related documents are publicly available on the USPTO interference website at https://acts.uspto.gov/ifiling/PublicView.jsp, using interference number 106023. Forward Pharma U.S. and European patents and patent applications can be found by using the following links:  USPTO: http://www.uspto.gov/ USPTO Public Pair: http://portal.uspto.gov/pair/PublicPair EPO: https://register.epo.org/regviewer About Forward Pharma: Forward Pharma A/S is a Danish biopharmaceutical company developing FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications. Since our founding in 2005, we have worked to advance unique formulations of DMF, which is an immune modulator, as a therapeutic agent to improve the health and well-being of patients with immune disorders including multiple sclerosis. FP187, our clinical candidate, is a DMF formulation in a delayed and slow release oral dose. Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark, and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP). For more information about the Company’s products and developments, please visit our web site at http://www.forward-pharma.com. Forward Looking Statements: Certain statements in this press release may constitute “forward-looking statements” of the Company within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as “believe,” “expect,” “anticipate,” “hope,” “would” and “potential.” Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company’s ability to obtain, maintain and defend issued patents with protective claims; the issuance and term of patents; the Company’s ability to prevail in or obtain a favorable decision in any patent interference or infringement action; the Company’s ability to recover damages in any patent infringement action; uncertainties relating to our development plans and activities, including the commencement of any clinical trial and the results, timing, cost and location thereof; risks and uncertainties related to the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property rights of third parties; our ability to commercialize and generate revenue from our sole clinical candidate, FP187; clinical development, and clinical trials of FP187 may not be successful; completion of required clinical trials may take longer than we anticipate, which could result in increased costs, limit our access to funding and delay or limit our ability to obtain regulatory approval for FP187; and our evaluation of alternative Phase 3 clinical strategies in RRMS may not be successful or shorten our time to commercialization and/or reduce costs. These and other factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2015.


Stecklum M.,Max Delbrück Center for Molecular Medicine | Stecklum M.,EPO GmbH | Wulf-Goldenberg A.,EPO GmbH | Purfurst B.,Max Delbrück Center for Molecular Medicine | And 6 more authors.
In Vitro Cellular and Developmental Biology - Animal | Year: 2014

In the present study, purified human cord blood stem cells were co-cultivated with murine hepatic alpha mouse liver 12 (AML12) cells to compare the effect on endodermal stem cell differentiation by either direct cell-cell interaction or by soluble factors in conditioned hepatic cell medium. With that approach, we want to mimic in vitro the situation of preclinical transplantation experiments using human cells in mice. Cord blood stem cells, cultivated with hepatic conditioned medium, showed a low endodermal differentiation but an increased connexin 32 (Cx32) and Cx43, and cytokeratin 8 (CK8) and CK19 expression was monitored by reverse transcription polymerase chain reaction (RT-PCR). Microarray profiling indicated that in cultivated cord blood cells, 604 genes were upregulated 2-fold, with the highest expression for epithelial CK19 and epithelial cadherin (E-cadherin). On ultrastructural level, there were no major changes in the cellular morphology, except a higher presence of phago(ly)some-like structures observed. Direct co-culture of AML12 cells with cord blood cells led to less incisive differentiation with increased sex-determining region Y-box 17 (SOX17), Cx32 and Cx43, as well as epithelial CK8 and CK19 expressions. On ultrastructural level, tight cell contacts along the plasma membranes were revealed. FACS analysis in co-cultivated cells quantified dye exchange on low level, as also proved by time relapse video-imaging of labelled cells. Modulators of gap junction formation influenced dye transfer between the co-cultured cells, whereby retinoic acid increased and 3-heptanol reduced the dye transfer. The study indicated that the cell-co-cultured model of human umbilical cord blood cells and murine AML12 cells may be a suitable approach to study some aspects of endodermal/hepatic cell differentiation induction. © 2014, The Society for In Vitro Biology.


Wulf-Goldenberg A.,Epo GmbH | Keil M.,Max Delbrück Center for Molecular Medicine | Keil M.,Charité - Medical University of Berlin | Fichtner I.,Max Delbrück Center for Molecular Medicine | Eckert K.,Max Delbrück Center for Molecular Medicine
Tissue and Cell | Year: 2012

In vivo studies concerning the function of human hematopoietic stem cells (HSC) are limited by relatively low levels of engraftment and the failure of the engrafted HSC preparations to differentiate into functional immune cells after systemic application. In the present paper we describe the effect of intrahepatically transplanted CD34 + cells from cord blood into the liver of newborn or adult NOD/SCID mice on organ engraftment and differentiation.Analyzing the short and long term time dependency of human cell recruitment into mouse organs after cell transplantation in the liver of newborn and adult NOD/SCID mice by RT-PCR and FACS analysis, a significantly high engraftment was found after transplantation into liver of newborn NOD/SCID mice compared to adult mice, with the highest level of 35% human cells in bone marrow and 4.9% human cells in spleen at day 70. These human cells showed CD19 B-cell, CD34 and CD38 hematopoietic and CD33 myeloid cell differentiation, but lacked any T-cell differentiation. HSC transplantation into liver of adult NOD/SCID mice resulted in minor recruitment of human cells from mouse liver to other mouse organs. The results indicate the usefulness of the intrahepatic application route into the liver of newborn NOD/SCID mice for the investigation of hematopoietic differentiation potential of CD34 + cord blood stem cell preparations. © 2011 Elsevier Ltd.


Harnack U.,Charité - Medical University of Berlin | Eckert K.,epo GmbH | Pecher G.,Charité - Medical University of Berlin
Anticancer Research | Year: 2011

Background: Beta-(1-3),(1-6)-D-glucans demonstrate antitumor effects in vivo due to the activation of innate immune cells. Cyclophosphamide (CY) enhances natural or therapeutically induced antitumor immune responses by reducing the number and activity of regulatory T (Treg) cells. Materials and Methods: We tested whether oral administration of soluble beta-glucan augmented the inhibitory effect of intraperitoneally injected low-dose CY (30 mg/kg) on subcutaneously growing A20-lymphoma in Balb/c-mice. Results: Administration of CY one week after tumor inoculation significantly diminished tumor growth (p=0.009) and the absolute number of Treg cells in the peripheral blood compared with phosphate buffered saline-treated mice (p=0.036). Treatment of CY pre-conditioned lymphoma-bearing mice with daily beta-glucan (400 μg/mouse) between day 9 and day 13 after tumor injection significantly delayed onset of tumor growth, compared to mice which received only CY (p=0.01). Conclusion: Beta-(1-3),(1-6)-D-glucan could be useful in the treatment of lymphoma after low-dose chemotherapy with CY.


Twardziok M.,Charité - Medical University of Berlin | Twardziok M.,Free University of Berlin | Kleinsimon S.,Charité - Medical University of Berlin | Rolff J.,EPO GmbH | And 4 more authors.
PLoS ONE | Year: 2016

Ewing sarcoma is the second most common bone cancer in children and adolescents, with poor prognosis and outcome in ~70% of initial diagnoses and 10-15% of relapses. Hydrophobic triterpene acids and hydrophilic lectins and viscotoxins from European mistletoe (Viscum album L.) demonstrate anticancer properties, but have not yet been investigated for Ewing sarcoma. Commercial Viscum album L. extracts are aqueous, excluding the insoluble triterpenes. We recreated a total mistletoe effect by combining an aqueous extract (viscum) and a triterpene extract (TT) solubilized with cyclodextrins. Ewing sarcoma cells were treated with viscum, TT and viscumTT in vitro, ex vivo and in vivo. In vitro and ex vivo treatment of Ewing sarcoma cells with viscum inhibited proliferation and induced apoptosis in a dose-dependent fashion, while viscumTT combination treatment generated a synergistic effect. Apoptosis occurred via intrinsic and extrinsic apoptotic pathways, evidenced by activation of both CASP8 and CASP9. We show that viscumTT treatment shifts the balance of apoptotic regulatory proteins towards apoptosis, mainly via CLSPN, MCL1, BIRC5 and XIAP downregulation. Viscum TT also demonstrated strong antitumor activity in a cell lineand patient-derived mouse model, and may be considered an adjuvant therapy option for pediatric patients with Ewing sarcoma. © 2016 Twardziok et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Busia L.,Bayer AG | Busia L.,Free University of Berlin | Faus H.,Bayer AG | Hoffmann J.,Bayer AG | And 2 more authors.
Molecular and Cellular Endocrinology | Year: 2011

The ovarian steroid hormone progesterone is essential for normal mammary gland physiology but may also play a role in breast cancer. Highly potent and selective antiprogestins may therefore represent a new treatment option for this disease. Here we studied the effects of the new antiprogestin Lonaprisan on the T47D breast cancer cell line. Strong inhibition of cell proliferation and arrest in the G0/G1 phase were observed, as well as induction of a senescence-like phenotype. This was accompanied by p21 induction through direct binding of Lonaprisan-bound progesterone receptor (PR) to the promoter. Reduction of p21 levels blunted the antiproliferative effects of Lonaprisan. Mutation analysis showed that intact PR DNA-binding properties were needed for p21 induction. Phosphorylation of PR Ser345 was stimulated by Lonaprisan, but this post-translational modification was not required for p21 promoter activation, nor was the interaction with c-Src needed. These results support the rationale for using antiprogestins in breast cancer treatment and warrant further studies to better understand their mode of action. © 2010 Elsevier Ireland Ltd.


Schmieder R.,Bayer AG | Hoffmann J.,EPO GmbH | Becker M.,EPO GmbH | Bhargava A.,Shakti BioResearch | And 9 more authors.
International Journal of Cancer | Year: 2014

Regorafenib, a novel multikinase inhibitor, has recently demonstrated overall survival benefits in metastatic colorectal cancer (CRC) patients. Our study aimed to gain further insight into the molecular mechanisms of regorafenib and to assess its potential in combination therapy. Regorafenib was tested alone and in combination with irinotecan in patient-derived (PD) CRC models and a murine CRC liver metastasis model. Mechanism of action was investigated using in vitro functional assays, immunohistochemistry and correlation with CRC-related oncogenes. Regorafenib demonstrated significant inhibition of growth-factor-mediated vascular endothelial growth factor receptor (VEGFR) 2 and VEGFR3 autophosphorylation, and intracellular VEGFR3 signaling in human umbilical vascular endothelial cells (HuVECs) and lymphatic endothelial cells (LECs), and also blocked migration of LECs. Furthermore, regorafenib inhibited proliferation in 19 of 25 human CRC cell lines and markedly slowed tumor growth in five of seven PD xenograft models. Combination of regorafenib with irinotecan significantly delayed tumor growth after extended treatment in four xenograft models. Reduced CD31 staining indicates that the antiangiogenic effects of regorafenib contribute to its antitumor activity. Finally, regorafenib significantly delayed disease progression in a murine CRC liver metastasis model by inhibiting the growth of established liver metastases and preventing the formation of new metastases in other organs. In addition, our results suggest that regorafenib displays antimetastatic activity, which may contribute to its efficacy in patients with metastatic CRC. Combination of regorafenib and irinotecan demonstrated an increased antitumor effect and could provide a future treatment option for CRC patients. What's new? Regorafenib is a multikinase inhibitor with antiangiogenic activity recently approved in the US and in Europe for the treatment of metastatic colorectal cancer in patients who failed previous therapies. Here, a research team led by Bayer Pharma AG, the discoverer of the drug, confirms inhibition of key mediators of angiogenesis and lymphangiogenesis (VEGFR2 and VEGFR3) as the potential antiangiogenic mechanism of action of the drug. Regorafenib further inhibited growth of established and prevented formation of new liver metastases, and in combination with the chemotherapeutic drug irinotecan led to significant tumor growth delay in four patient-derived colorectal cancer xenograft models. The authors speculate that combination treatments including regorafenib may provide novel therapeutic opportunities for patients with therapy-resistant colorectal cancer. © 2013 The Authors. Published by Wiley Periodicals, Inc. on behalf of UICC.

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