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News Article | May 11, 2017
Site: globenewswire.com

MINNEAPOLIS, May 11, 2017 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today provides financial results for the first quarter ending March 31, 2017. As previously announced, during the first quarter, Sun BioPharma, Inc. entered into Note Purchase Agreements with a number of accredited purchasers in private transactions raising gross proceeds of $3.1 million. These funds are expected to enable the Company  to complete its Phase 1a dose escalation study, currently underway. The objective of this Phase 1a study is to determine the safety and tolerability of SBP-101 in the treatment of Pancreatic Ductal Adenocarcinoma (“PDA”). Once the Maximum Tolerated Dose (“MTD”) is confirmed, the study will be expanded into Phase 1b in order to move to the next step in the clinical trial process. On March 27, 2017, Sun BioPharma, Inc. entered into debt-for-equity exchange agreements with the holders of convertible promissory and demand notes payable by the Company pursuant to which the Company agreed to convert all outstanding principal and accrued interest payable through March 31, 2017 into shares of our common stock at a rate of $0.75 per share. In accordance with these exchange agreements, on March 31, 2017, the Company issued an aggregate of 4,183,333 shares of our common stock in exchange for the cancellation of convertible promissory and demand notes totaling $3,000,000 aggregate principal amount and $137,500 accrued but previously unpaid interest. “We anticipate completion of Phase 1a sometime in the late third quarter of this year, and we are very grateful to our patients, investigators and clinical teams for their support and dedication to our efforts to improve the care of patients suffering from pancreatic cancer,” said David Kaysen, President and CEO. “In addition, we appreciate the support of our investors converting outstanding debt to common stock during this first quarter which helped us significantly improve our balance sheet.” Financial Results Research and development (R&D) expenses increased 50.6% to $744,000 in the first quarter of 2017 up from $494,000 in the first quarter of 2016. The increase in R&D expenses is due primarily to increased costs related to the Company’s Phase 1 clinical trial and non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. General and administrative (“G&A”) expenses increased 159.9% to $1.3 million in the first quarter of 2017 up from $481,000 in the first quarter of 2016. The increase was due primarily to non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. Other income and expense, net, was a net expense of $3.7 million and net income of $36,000 for the three months ended March 31, 2017 and 2016, respectively. Other expense in the current quarter includes a non-cash charge of $3.7 million related to the induced conversions of $2.9 million of convertible promissory notes, including accrued but unpaid interest, originally issued in 2013 and 2014, and $250,000 aggregate principal amount of demand notes originally issued in September 2015. These expenses were partially offset by a foreign currency transaction gain recognized by the Company’s Australian subsidiary. Net loss in the first quarter of 2017 was $5.6 million, or $0.17 per diluted share, compared to a net loss of $900,000, or $0.03 per diluted share, in the first quarter of 2016. Balance Sheet and Cash Flow Total cash resources were $2.4 million as of March 31, 2017, compared to $438,000 as of December 31, 2016. Total current assets were $3.0 million and $877,000 as of March 31, 2017, and December 31, 2016, respectively. These increases resulted from our current quarter sale convertible promissory notes raising gross proceeds of approximately $3.1 million partially offset by the use of cash to fund operations. Current liabilities decreased to $2.4 million as of March 31, 2017, compared to $5.5 million as of December 31, 2016. The decrease in current liabilities resulted primarily from the conversion of approximately $3.1 million of previously outstanding debt and accrued interest into 4,183,333 shares of our common stock. Net cash used in operating activities was $1.1 million in the three-months ended March 31, 2017, compared to $542,000 in the same period of the prior year. The net cash used in each of these periods primarily reflects the net loss for these periods, and was partially offset by the effects of changes in operating assets and liabilities. In the three months ended March 31, 2017, the net loss is also offset by non-cash charges recorded for the loss on induced debt conversion and share-based compensation. About SBP-101 SBP-101 is a first-in-class, proprietary, polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas. Sun BioPharma originally licensed SBP-101 from the University of Florida in 2011. The molecule has been shown to be highly effective in preclinical human pancreatic cancer models, demonstrating superior activity to existing FDA-approved chemotherapy agents. Combination therapy potential has also been shown for pancreatic cancer. SBP-101 is expected to differ from current pancreatic cancer therapies in that it specifically targets the exocrine pancreas and has shown efficacy against primary and metastatic disease in animal models of human pancreatic cancer. Therefore management believes that SBP-101 may effectively treat both primary and metastatic pancreatic cancer, while leaving the insulin-producing islet cells and non-pancreatic tissue unharmed. About Sun BioPharma Sun BioPharma Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for urgent unmet medical needs. The Company’s development programs target diseases of the pancreas, including pancreatitis and pancreatic cancer; the Company’s initial product candidate is SBP-101 for the treatment of patients with pancreatic cancer. SBP-101 was invented by Raymond Bergeron, Ph.D., a Distinguished Professor Emeritus at the University of Florida. Sun BioPharma has scientific collaborations with pancreatic disease experts at Cedars Sinai Medical Center in Los Angeles, the University of Miami, the University of Florida, the Mayo Clinic Scottsdale, the Austin Health Cancer Trials Centre in Melbourne, Australia and the Ashford Cancer Centre in Adelaide, Australia. Further information can be found at: www.sunbiopharma.com. Sun BioPharma’s common stock is currently quoted on the OTCQB tier of the over-the-counter markets administered by the OTC Markets Group, Inc. under the symbol: SNBP. Forward-Looking Statements Safe Harbor Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Sun BioPharma, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute “forward-looking statements” for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1955. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will”, “believes,” “may,” “anticipates,” “expects,” “estimates” or “plans”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, our need to obtain additional capital to support our business plan, which may not be available on acceptable terms or at all, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect Sun BioPharma and its business, particularly those disclosed from time to time in Sun BioPharma’s filings with the Securities and Exchange Commission. Shareholders and other readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Sun BioPharma disclaims any intent or obligation to update these forward-looking statements. Sun BioPharma, Inc. Consolidated Statements of Operations and Comprehensive Loss (unaudited) (In thousands, except share and per share amounts)


News Article | May 11, 2017
Site: globenewswire.com

MINNEAPOLIS, May 11, 2017 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today provides financial results for the first quarter ending March 31, 2017. As previously announced, during the first quarter, Sun BioPharma, Inc. entered into Note Purchase Agreements with a number of accredited purchasers in private transactions raising gross proceeds of $3.1 million. These funds are expected to enable the Company  to complete its Phase 1a dose escalation study, currently underway. The objective of this Phase 1a study is to determine the safety and tolerability of SBP-101 in the treatment of Pancreatic Ductal Adenocarcinoma (“PDA”). Once the Maximum Tolerated Dose (“MTD”) is confirmed, the study will be expanded into Phase 1b in order to move to the next step in the clinical trial process. On March 27, 2017, Sun BioPharma, Inc. entered into debt-for-equity exchange agreements with the holders of convertible promissory and demand notes payable by the Company pursuant to which the Company agreed to convert all outstanding principal and accrued interest payable through March 31, 2017 into shares of our common stock at a rate of $0.75 per share. In accordance with these exchange agreements, on March 31, 2017, the Company issued an aggregate of 4,183,333 shares of our common stock in exchange for the cancellation of convertible promissory and demand notes totaling $3,000,000 aggregate principal amount and $137,500 accrued but previously unpaid interest. “We anticipate completion of Phase 1a sometime in the late third quarter of this year, and we are very grateful to our patients, investigators and clinical teams for their support and dedication to our efforts to improve the care of patients suffering from pancreatic cancer,” said David Kaysen, President and CEO. “In addition, we appreciate the support of our investors converting outstanding debt to common stock during this first quarter which helped us significantly improve our balance sheet.” Financial Results Research and development (R&D) expenses increased 50.6% to $744,000 in the first quarter of 2017 up from $494,000 in the first quarter of 2016. The increase in R&D expenses is due primarily to increased costs related to the Company’s Phase 1 clinical trial and non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. General and administrative (“G&A”) expenses increased 159.9% to $1.3 million in the first quarter of 2017 up from $481,000 in the first quarter of 2016. The increase was due primarily to non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. Other income and expense, net, was a net expense of $3.7 million and net income of $36,000 for the three months ended March 31, 2017 and 2016, respectively. Other expense in the current quarter includes a non-cash charge of $3.7 million related to the induced conversions of $2.9 million of convertible promissory notes, including accrued but unpaid interest, originally issued in 2013 and 2014, and $250,000 aggregate principal amount of demand notes originally issued in September 2015. These expenses were partially offset by a foreign currency transaction gain recognized by the Company’s Australian subsidiary. Net loss in the first quarter of 2017 was $5.6 million, or $0.17 per diluted share, compared to a net loss of $900,000, or $0.03 per diluted share, in the first quarter of 2016. Balance Sheet and Cash Flow Total cash resources were $2.4 million as of March 31, 2017, compared to $438,000 as of December 31, 2016. Total current assets were $3.0 million and $877,000 as of March 31, 2017, and December 31, 2016, respectively. These increases resulted from our current quarter sale convertible promissory notes raising gross proceeds of approximately $3.1 million partially offset by the use of cash to fund operations. Current liabilities decreased to $2.4 million as of March 31, 2017, compared to $5.5 million as of December 31, 2016. The decrease in current liabilities resulted primarily from the conversion of approximately $3.1 million of previously outstanding debt and accrued interest into 4,183,333 shares of our common stock. Net cash used in operating activities was $1.1 million in the three-months ended March 31, 2017, compared to $542,000 in the same period of the prior year. The net cash used in each of these periods primarily reflects the net loss for these periods, and was partially offset by the effects of changes in operating assets and liabilities. In the three months ended March 31, 2017, the net loss is also offset by non-cash charges recorded for the loss on induced debt conversion and share-based compensation. About SBP-101 SBP-101 is a first-in-class, proprietary, polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas. Sun BioPharma originally licensed SBP-101 from the University of Florida in 2011. The molecule has been shown to be highly effective in preclinical human pancreatic cancer models, demonstrating superior activity to existing FDA-approved chemotherapy agents. Combination therapy potential has also been shown for pancreatic cancer. SBP-101 is expected to differ from current pancreatic cancer therapies in that it specifically targets the exocrine pancreas and has shown efficacy against primary and metastatic disease in animal models of human pancreatic cancer. Therefore management believes that SBP-101 may effectively treat both primary and metastatic pancreatic cancer, while leaving the insulin-producing islet cells and non-pancreatic tissue unharmed. About Sun BioPharma Sun BioPharma Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for urgent unmet medical needs. The Company’s development programs target diseases of the pancreas, including pancreatitis and pancreatic cancer; the Company’s initial product candidate is SBP-101 for the treatment of patients with pancreatic cancer. SBP-101 was invented by Raymond Bergeron, Ph.D., a Distinguished Professor Emeritus at the University of Florida. Sun BioPharma has scientific collaborations with pancreatic disease experts at Cedars Sinai Medical Center in Los Angeles, the University of Miami, the University of Florida, the Mayo Clinic Scottsdale, the Austin Health Cancer Trials Centre in Melbourne, Australia and the Ashford Cancer Centre in Adelaide, Australia. Further information can be found at: www.sunbiopharma.com. Sun BioPharma’s common stock is currently quoted on the OTCQB tier of the over-the-counter markets administered by the OTC Markets Group, Inc. under the symbol: SNBP. Forward-Looking Statements Safe Harbor Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Sun BioPharma, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute “forward-looking statements” for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1955. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will”, “believes,” “may,” “anticipates,” “expects,” “estimates” or “plans”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, our need to obtain additional capital to support our business plan, which may not be available on acceptable terms or at all, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect Sun BioPharma and its business, particularly those disclosed from time to time in Sun BioPharma’s filings with the Securities and Exchange Commission. Shareholders and other readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Sun BioPharma disclaims any intent or obligation to update these forward-looking statements. Sun BioPharma, Inc. Consolidated Statements of Operations and Comprehensive Loss (unaudited) (In thousands, except share and per share amounts)


News Article | May 11, 2017
Site: globenewswire.com

MINNEAPOLIS, May 11, 2017 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today provides financial results for the first quarter ending March 31, 2017. As previously announced, during the first quarter, Sun BioPharma, Inc. entered into Note Purchase Agreements with a number of accredited purchasers in private transactions raising gross proceeds of $3.1 million. These funds are expected to enable the Company  to complete its Phase 1a dose escalation study, currently underway. The objective of this Phase 1a study is to determine the safety and tolerability of SBP-101 in the treatment of Pancreatic Ductal Adenocarcinoma (“PDA”). Once the Maximum Tolerated Dose (“MTD”) is confirmed, the study will be expanded into Phase 1b in order to move to the next step in the clinical trial process. On March 27, 2017, Sun BioPharma, Inc. entered into debt-for-equity exchange agreements with the holders of convertible promissory and demand notes payable by the Company pursuant to which the Company agreed to convert all outstanding principal and accrued interest payable through March 31, 2017 into shares of our common stock at a rate of $0.75 per share. In accordance with these exchange agreements, on March 31, 2017, the Company issued an aggregate of 4,183,333 shares of our common stock in exchange for the cancellation of convertible promissory and demand notes totaling $3,000,000 aggregate principal amount and $137,500 accrued but previously unpaid interest. “We anticipate completion of Phase 1a sometime in the late third quarter of this year, and we are very grateful to our patients, investigators and clinical teams for their support and dedication to our efforts to improve the care of patients suffering from pancreatic cancer,” said David Kaysen, President and CEO. “In addition, we appreciate the support of our investors converting outstanding debt to common stock during this first quarter which helped us significantly improve our balance sheet.” Financial Results Research and development (R&D) expenses increased 50.6% to $744,000 in the first quarter of 2017 up from $494,000 in the first quarter of 2016. The increase in R&D expenses is due primarily to increased costs related to the Company’s Phase 1 clinical trial and non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. General and administrative (“G&A”) expenses increased 159.9% to $1.3 million in the first quarter of 2017 up from $481,000 in the first quarter of 2016. The increase was due primarily to non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. Other income and expense, net, was a net expense of $3.7 million and net income of $36,000 for the three months ended March 31, 2017 and 2016, respectively. Other expense in the current quarter includes a non-cash charge of $3.7 million related to the induced conversions of $2.9 million of convertible promissory notes, including accrued but unpaid interest, originally issued in 2013 and 2014, and $250,000 aggregate principal amount of demand notes originally issued in September 2015. These expenses were partially offset by a foreign currency transaction gain recognized by the Company’s Australian subsidiary. Net loss in the first quarter of 2017 was $5.6 million, or $0.17 per diluted share, compared to a net loss of $900,000, or $0.03 per diluted share, in the first quarter of 2016. Balance Sheet and Cash Flow Total cash resources were $2.4 million as of March 31, 2017, compared to $438,000 as of December 31, 2016. Total current assets were $3.0 million and $877,000 as of March 31, 2017, and December 31, 2016, respectively. These increases resulted from our current quarter sale convertible promissory notes raising gross proceeds of approximately $3.1 million partially offset by the use of cash to fund operations. Current liabilities decreased to $2.4 million as of March 31, 2017, compared to $5.5 million as of December 31, 2016. The decrease in current liabilities resulted primarily from the conversion of approximately $3.1 million of previously outstanding debt and accrued interest into 4,183,333 shares of our common stock. Net cash used in operating activities was $1.1 million in the three-months ended March 31, 2017, compared to $542,000 in the same period of the prior year. The net cash used in each of these periods primarily reflects the net loss for these periods, and was partially offset by the effects of changes in operating assets and liabilities. In the three months ended March 31, 2017, the net loss is also offset by non-cash charges recorded for the loss on induced debt conversion and share-based compensation. About SBP-101 SBP-101 is a first-in-class, proprietary, polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas. Sun BioPharma originally licensed SBP-101 from the University of Florida in 2011. The molecule has been shown to be highly effective in preclinical human pancreatic cancer models, demonstrating superior activity to existing FDA-approved chemotherapy agents. Combination therapy potential has also been shown for pancreatic cancer. SBP-101 is expected to differ from current pancreatic cancer therapies in that it specifically targets the exocrine pancreas and has shown efficacy against primary and metastatic disease in animal models of human pancreatic cancer. Therefore management believes that SBP-101 may effectively treat both primary and metastatic pancreatic cancer, while leaving the insulin-producing islet cells and non-pancreatic tissue unharmed. About Sun BioPharma Sun BioPharma Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for urgent unmet medical needs. The Company’s development programs target diseases of the pancreas, including pancreatitis and pancreatic cancer; the Company’s initial product candidate is SBP-101 for the treatment of patients with pancreatic cancer. SBP-101 was invented by Raymond Bergeron, Ph.D., a Distinguished Professor Emeritus at the University of Florida. Sun BioPharma has scientific collaborations with pancreatic disease experts at Cedars Sinai Medical Center in Los Angeles, the University of Miami, the University of Florida, the Mayo Clinic Scottsdale, the Austin Health Cancer Trials Centre in Melbourne, Australia and the Ashford Cancer Centre in Adelaide, Australia. Further information can be found at: www.sunbiopharma.com. Sun BioPharma’s common stock is currently quoted on the OTCQB tier of the over-the-counter markets administered by the OTC Markets Group, Inc. under the symbol: SNBP. Forward-Looking Statements Safe Harbor Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Sun BioPharma, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute “forward-looking statements” for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1955. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will”, “believes,” “may,” “anticipates,” “expects,” “estimates” or “plans”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, our need to obtain additional capital to support our business plan, which may not be available on acceptable terms or at all, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect Sun BioPharma and its business, particularly those disclosed from time to time in Sun BioPharma’s filings with the Securities and Exchange Commission. Shareholders and other readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Sun BioPharma disclaims any intent or obligation to update these forward-looking statements. Sun BioPharma, Inc. Consolidated Statements of Operations and Comprehensive Loss (unaudited) (In thousands, except share and per share amounts)


News Article | May 11, 2017
Site: globenewswire.com

MINNEAPOLIS, May 11, 2017 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today provides financial results for the first quarter ending March 31, 2017. As previously announced, during the first quarter, Sun BioPharma, Inc. entered into Note Purchase Agreements with a number of accredited purchasers in private transactions raising gross proceeds of $3.1 million. These funds are expected to enable the Company  to complete its Phase 1a dose escalation study, currently underway. The objective of this Phase 1a study is to determine the safety and tolerability of SBP-101 in the treatment of Pancreatic Ductal Adenocarcinoma (“PDA”). Once the Maximum Tolerated Dose (“MTD”) is confirmed, the study will be expanded into Phase 1b in order to move to the next step in the clinical trial process. On March 27, 2017, Sun BioPharma, Inc. entered into debt-for-equity exchange agreements with the holders of convertible promissory and demand notes payable by the Company pursuant to which the Company agreed to convert all outstanding principal and accrued interest payable through March 31, 2017 into shares of our common stock at a rate of $0.75 per share. In accordance with these exchange agreements, on March 31, 2017, the Company issued an aggregate of 4,183,333 shares of our common stock in exchange for the cancellation of convertible promissory and demand notes totaling $3,000,000 aggregate principal amount and $137,500 accrued but previously unpaid interest. “We anticipate completion of Phase 1a sometime in the late third quarter of this year, and we are very grateful to our patients, investigators and clinical teams for their support and dedication to our efforts to improve the care of patients suffering from pancreatic cancer,” said David Kaysen, President and CEO. “In addition, we appreciate the support of our investors converting outstanding debt to common stock during this first quarter which helped us significantly improve our balance sheet.” Financial Results Research and development (R&D) expenses increased 50.6% to $744,000 in the first quarter of 2017 up from $494,000 in the first quarter of 2016. The increase in R&D expenses is due primarily to increased costs related to the Company’s Phase 1 clinical trial and non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. General and administrative (“G&A”) expenses increased 159.9% to $1.3 million in the first quarter of 2017 up from $481,000 in the first quarter of 2016. The increase was due primarily to non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. Other income and expense, net, was a net expense of $3.7 million and net income of $36,000 for the three months ended March 31, 2017 and 2016, respectively. Other expense in the current quarter includes a non-cash charge of $3.7 million related to the induced conversions of $2.9 million of convertible promissory notes, including accrued but unpaid interest, originally issued in 2013 and 2014, and $250,000 aggregate principal amount of demand notes originally issued in September 2015. These expenses were partially offset by a foreign currency transaction gain recognized by the Company’s Australian subsidiary. Net loss in the first quarter of 2017 was $5.6 million, or $0.17 per diluted share, compared to a net loss of $900,000, or $0.03 per diluted share, in the first quarter of 2016. Balance Sheet and Cash Flow Total cash resources were $2.4 million as of March 31, 2017, compared to $438,000 as of December 31, 2016. Total current assets were $3.0 million and $877,000 as of March 31, 2017, and December 31, 2016, respectively. These increases resulted from our current quarter sale convertible promissory notes raising gross proceeds of approximately $3.1 million partially offset by the use of cash to fund operations. Current liabilities decreased to $2.4 million as of March 31, 2017, compared to $5.5 million as of December 31, 2016. The decrease in current liabilities resulted primarily from the conversion of approximately $3.1 million of previously outstanding debt and accrued interest into 4,183,333 shares of our common stock. Net cash used in operating activities was $1.1 million in the three-months ended March 31, 2017, compared to $542,000 in the same period of the prior year. The net cash used in each of these periods primarily reflects the net loss for these periods, and was partially offset by the effects of changes in operating assets and liabilities. In the three months ended March 31, 2017, the net loss is also offset by non-cash charges recorded for the loss on induced debt conversion and share-based compensation. About SBP-101 SBP-101 is a first-in-class, proprietary, polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas. Sun BioPharma originally licensed SBP-101 from the University of Florida in 2011. The molecule has been shown to be highly effective in preclinical human pancreatic cancer models, demonstrating superior activity to existing FDA-approved chemotherapy agents. Combination therapy potential has also been shown for pancreatic cancer. SBP-101 is expected to differ from current pancreatic cancer therapies in that it specifically targets the exocrine pancreas and has shown efficacy against primary and metastatic disease in animal models of human pancreatic cancer. Therefore management believes that SBP-101 may effectively treat both primary and metastatic pancreatic cancer, while leaving the insulin-producing islet cells and non-pancreatic tissue unharmed. About Sun BioPharma Sun BioPharma Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for urgent unmet medical needs. The Company’s development programs target diseases of the pancreas, including pancreatitis and pancreatic cancer; the Company’s initial product candidate is SBP-101 for the treatment of patients with pancreatic cancer. SBP-101 was invented by Raymond Bergeron, Ph.D., a Distinguished Professor Emeritus at the University of Florida. Sun BioPharma has scientific collaborations with pancreatic disease experts at Cedars Sinai Medical Center in Los Angeles, the University of Miami, the University of Florida, the Mayo Clinic Scottsdale, the Austin Health Cancer Trials Centre in Melbourne, Australia and the Ashford Cancer Centre in Adelaide, Australia. Further information can be found at: www.sunbiopharma.com. Sun BioPharma’s common stock is currently quoted on the OTCQB tier of the over-the-counter markets administered by the OTC Markets Group, Inc. under the symbol: SNBP. Forward-Looking Statements Safe Harbor Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Sun BioPharma, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute “forward-looking statements” for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1955. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will”, “believes,” “may,” “anticipates,” “expects,” “estimates” or “plans”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, our need to obtain additional capital to support our business plan, which may not be available on acceptable terms or at all, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect Sun BioPharma and its business, particularly those disclosed from time to time in Sun BioPharma’s filings with the Securities and Exchange Commission. Shareholders and other readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Sun BioPharma disclaims any intent or obligation to update these forward-looking statements. Sun BioPharma, Inc. Consolidated Statements of Operations and Comprehensive Loss (unaudited) (In thousands, except share and per share amounts)


News Article | May 11, 2017
Site: globenewswire.com

MINNEAPOLIS, May 11, 2017 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today provides financial results for the first quarter ending March 31, 2017. As previously announced, during the first quarter, Sun BioPharma, Inc. entered into Note Purchase Agreements with a number of accredited purchasers in private transactions raising gross proceeds of $3.1 million. These funds are expected to enable the Company  to complete its Phase 1a dose escalation study, currently underway. The objective of this Phase 1a study is to determine the safety and tolerability of SBP-101 in the treatment of Pancreatic Ductal Adenocarcinoma (“PDA”). Once the Maximum Tolerated Dose (“MTD”) is confirmed, the study will be expanded into Phase 1b in order to move to the next step in the clinical trial process. On March 27, 2017, Sun BioPharma, Inc. entered into debt-for-equity exchange agreements with the holders of convertible promissory and demand notes payable by the Company pursuant to which the Company agreed to convert all outstanding principal and accrued interest payable through March 31, 2017 into shares of our common stock at a rate of $0.75 per share. In accordance with these exchange agreements, on March 31, 2017, the Company issued an aggregate of 4,183,333 shares of our common stock in exchange for the cancellation of convertible promissory and demand notes totaling $3,000,000 aggregate principal amount and $137,500 accrued but previously unpaid interest. “We anticipate completion of Phase 1a sometime in the late third quarter of this year, and we are very grateful to our patients, investigators and clinical teams for their support and dedication to our efforts to improve the care of patients suffering from pancreatic cancer,” said David Kaysen, President and CEO. “In addition, we appreciate the support of our investors converting outstanding debt to common stock during this first quarter which helped us significantly improve our balance sheet.” Financial Results Research and development (R&D) expenses increased 50.6% to $744,000 in the first quarter of 2017 up from $494,000 in the first quarter of 2016. The increase in R&D expenses is due primarily to increased costs related to the Company’s Phase 1 clinical trial and non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. General and administrative (“G&A”) expenses increased 159.9% to $1.3 million in the first quarter of 2017 up from $481,000 in the first quarter of 2016. The increase was due primarily to non-cash share-based compensation expense recorded during the quarter ended March 31, 2017. Other income and expense, net, was a net expense of $3.7 million and net income of $36,000 for the three months ended March 31, 2017 and 2016, respectively. Other expense in the current quarter includes a non-cash charge of $3.7 million related to the induced conversions of $2.9 million of convertible promissory notes, including accrued but unpaid interest, originally issued in 2013 and 2014, and $250,000 aggregate principal amount of demand notes originally issued in September 2015. These expenses were partially offset by a foreign currency transaction gain recognized by the Company’s Australian subsidiary. Net loss in the first quarter of 2017 was $5.6 million, or $0.17 per diluted share, compared to a net loss of $900,000, or $0.03 per diluted share, in the first quarter of 2016. Balance Sheet and Cash Flow Total cash resources were $2.4 million as of March 31, 2017, compared to $438,000 as of December 31, 2016. Total current assets were $3.0 million and $877,000 as of March 31, 2017, and December 31, 2016, respectively. These increases resulted from our current quarter sale convertible promissory notes raising gross proceeds of approximately $3.1 million partially offset by the use of cash to fund operations. Current liabilities decreased to $2.4 million as of March 31, 2017, compared to $5.5 million as of December 31, 2016. The decrease in current liabilities resulted primarily from the conversion of approximately $3.1 million of previously outstanding debt and accrued interest into 4,183,333 shares of our common stock. Net cash used in operating activities was $1.1 million in the three-months ended March 31, 2017, compared to $542,000 in the same period of the prior year. The net cash used in each of these periods primarily reflects the net loss for these periods, and was partially offset by the effects of changes in operating assets and liabilities. In the three months ended March 31, 2017, the net loss is also offset by non-cash charges recorded for the loss on induced debt conversion and share-based compensation. About SBP-101 SBP-101 is a first-in-class, proprietary, polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas. Sun BioPharma originally licensed SBP-101 from the University of Florida in 2011. The molecule has been shown to be highly effective in preclinical human pancreatic cancer models, demonstrating superior activity to existing FDA-approved chemotherapy agents. Combination therapy potential has also been shown for pancreatic cancer. SBP-101 is expected to differ from current pancreatic cancer therapies in that it specifically targets the exocrine pancreas and has shown efficacy against primary and metastatic disease in animal models of human pancreatic cancer. Therefore management believes that SBP-101 may effectively treat both primary and metastatic pancreatic cancer, while leaving the insulin-producing islet cells and non-pancreatic tissue unharmed. About Sun BioPharma Sun BioPharma Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for urgent unmet medical needs. The Company’s development programs target diseases of the pancreas, including pancreatitis and pancreatic cancer; the Company’s initial product candidate is SBP-101 for the treatment of patients with pancreatic cancer. SBP-101 was invented by Raymond Bergeron, Ph.D., a Distinguished Professor Emeritus at the University of Florida. Sun BioPharma has scientific collaborations with pancreatic disease experts at Cedars Sinai Medical Center in Los Angeles, the University of Miami, the University of Florida, the Mayo Clinic Scottsdale, the Austin Health Cancer Trials Centre in Melbourne, Australia and the Ashford Cancer Centre in Adelaide, Australia. Further information can be found at: www.sunbiopharma.com. Sun BioPharma’s common stock is currently quoted on the OTCQB tier of the over-the-counter markets administered by the OTC Markets Group, Inc. under the symbol: SNBP. Forward-Looking Statements Safe Harbor Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Sun BioPharma, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute “forward-looking statements” for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1955. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will”, “believes,” “may,” “anticipates,” “expects,” “estimates” or “plans”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, our need to obtain additional capital to support our business plan, which may not be available on acceptable terms or at all, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect Sun BioPharma and its business, particularly those disclosed from time to time in Sun BioPharma’s filings with the Securities and Exchange Commission. Shareholders and other readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Sun BioPharma disclaims any intent or obligation to update these forward-looking statements. Sun BioPharma, Inc. Consolidated Statements of Operations and Comprehensive Loss (unaudited) (In thousands, except share and per share amounts)


SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (Nasdaq: LJPC) (La Jolla) today announced that results of the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 (angiotensin II) have been published online by The New England Journal of Medicine (NEJM). The article, entitled “Angiotensin II for the Treatment of Vasodilatory Shock,” also will be published in the May 25, 2017 print issue of NEJM. “There is a major need for new treatment options for critically ill patients who do not adequately respond to available vasopressors,” stated Rinaldo Bellomo, M.D., Professor of Intensive Care Medicine at University of Melbourne and Director of Intensive Care Research at Austin Health. “In ATHOS-3, angiotensin II was shown to raise blood pressure with no increase in overall adverse events as compared to placebo in this highly treatment-resistant patient population. The effect of angiotensin II resulted in reduced use of other vasopressors. If approved, angiotensin II, in combination with other vasopressors, may allow clinicians to leverage all three major physiologic systems that regulate blood pressure.” The analysis of the primary efficacy endpoint of ATHOS-3, defined as the percentage of patients achieving a mean arterial pressure (MAP) ≥ 75 mmHg or a 10 mmHg increase from baseline MAP at 3 hours following the initiation of study treatment without an increase in standard-of-care vasopressors, was statistically significant: 23.4% of the 158 placebo-treated patients achieved the pre-specified blood pressure response, compared to 69.9% of the 163 angiotensin II-treated patients (p<0.001). In addition, a trend toward longer survival was observed for angiotensin II-treated patients (22% reduction in mortality risk through day 28; hazard ratio=0.78 [CI: 0.57, 1.07; p=0.12]). In this critically ill patient population, 91.8% of placebo-treated patients experienced at least one adverse event, compared to 87.1% of angiotensin II-treated patients, and 21.5% of placebo-treated patients discontinued treatment due to an adverse event, compared to 14.1% of angiotensin II-treated patients. The NEJM article can be found here and its Supplementary Appendix can be found here. The ATHOS-3 study was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study of LJPC-501 in patients with catecholamine resistant hypotension (CRH), which is a severe form of vasodilatory shock. A total of 344 patients were randomized across nine countries, 321 of whom received study treatment and are included in the primary analysis. Patients were randomized 1:1 to receive either LJPC-501 or placebo on a background of standard-of-care vasopressors selected by the investigators. Randomized patients received their assigned treatment via continuous intravenous infusion. The primary efficacy endpoint was the percentage of patients achieving a mean arterial pressure (MAP) ≥ 75 mmHg or a 10 mmHg increase from baseline MAP at 3 hours following the initiation of study treatment without an increase in standard-of-care vasopressors. The study was conducted under a Special Protocol Assessment (SPA) agreed to with the U.S. Food and Drug Administration (FDA) in 2015. The SPA stipulates that a study of this size and design could provide sufficient safety and efficacy data and an adequate evaluation of the risk/benefit to the patients to support FDA review and consideration for marketing approval. La Jolla reported positive top-line results in February 2017. LJPC-501 is La Jolla’s proprietary formulation of synthetic human angiotensin II. Angiotensin II, the major bioactive component of the renin-angiotensin system, serves as one of the body’s central regulators of blood pressure. LJPC-501 is being developed for the treatment of patients with CRH. LJPC-501 is the first synthetic human angiotensin II product candidate to be tested in a Phase 3 study. Catecholamine resistant hypotension (CRH) is a life-threatening syndrome in patients with vasodilatory (also known as distributive) shock (dangerously low blood pressure with adequate cardiac function) who cannot achieve target mean arterial pressure (MAP) despite adequate fluid resuscitation and treatment with currently available vasopressors (catecholamines and/or vasopressin). There are approximately 500,000 distributive shock cases in the United States per year, an estimated 200,000 of which develop CRH. More than 50% of CRH patients die within 30 days. La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has several product candidates in development. LJPC-501 is La Jolla's proprietary formulation of synthetic human angiotensin II for the potential treatment of catecholamine resistant hypotension. LJPC-401 is La Jolla's proprietary formulation of synthetic human hepcidin for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome. LJPC-30S is La Jolla's next-generation gentamicin derivative program that is focused on the potential treatment of serious bacterial infections as well as rare genetic disorders, such as cystic fibrosis and Duchenne muscular dystrophy. For more information on La Jolla, please visit www.ljpc.com. This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or the company’s future results of operations. These statements are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors, that may cause actual results to be materially different from those anticipated by the forward-looking statements. The company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the company’s filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC’s web site www.sec.gov. These risks include, but are not limited to, risks relating to: the timing of the planned NDA submission for LJPC-501 and prospects for approval of LJPC-501 by the FDA and the other regulatory authorities; risks relating to the scope of product labels (if approved) and potential market sizes, as well as the broader commercial opportunity; the anticipated timing for regulatory actions; and the success of future development activities; potential indications for which the company’s product candidates may be developed. The company expressly disclaims any intent to update any forward-looking statements to reflect the outcome of the consequent events.


MINNEAPOLIS, June 07, 2017 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc., (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today announced that David Kaysen, the Company’s Chief Executive Officer, is scheduled to present at the 2017 Marcum MicroCap Conference on Thursday, June 15, 2017 at 2:30 p.m. Eastern Time, in the Julliard room at The Grand Hyatt Hotel located at 109 East 42nd Street, New York, NY. The presentation will be webcast live at http://wsw.com/webcast/marcum5/snbp and can also be accessed through the Company’s website at http://www.sunbiopharma.com. A replay of the presentation will be available and archived for 90 days. Persons attending the Marcum conference who would like to schedule a 1-on-1 meeting with Sun BioPharma, Inc. management during such conference may do so by contacting David Kaysen at dkaysen@sunbiopharma.com or Scott Kellen at skellen@sunbiopharma.com. Sun BioPharma Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for urgent unmet medical needs. The Company’s development programs target diseases of the pancreas, including pancreatic cancer and pancreatitis; the Company’s initial product candidate is SBP-101 for the treatment of patients with pancreatic cancer. The Company is currently engaged in a Phase 1 dose-escalation with SBP-101. Sun BioPharma has scientific collaborations with pancreatic disease experts at Cedars Sinai Medical Center in Los Angeles, the University of Miami, the University of Florida, the Mayo Clinic Scottsdale, the Austin Health Cancer Trials Centre in Melbourne, Australia and the Ashford Cancer Centre in Adelaide, Australia. Further information can be found at: www.sunbiopharma.com. Sun BioPharma’s common stock is currently quoted on the OTCQB tier of the over-the-counter markets administered by the OTC Markets Group, Inc. under the symbol: SNBP.


A computerized method for monitoring cardiac output of a subject by a processor executing the method, the method comprising the steps of:


Patent
Melbourne Health, Austin Health and Southern Health | Date: 2012-05-23

The present invention relates to methods for determining the potential of hepatitis B virus, HBV, variants to exhibit reduced sensitivity to Adefovir dipivoxil, ADV, and/or Tenofovir, TFV. The present invention is also directed to isolated HBV variants exhibiting decreased sensitivity to ADV and/or TFV. The present invention further contemplates methods for detecting agents having inhibitory activity to such viral variants, as well as the uses of such viral variants in the rational design of anti-HBV agents and in the manufacture of medicaments for the treatment and/or prophylaxis of HBV infection.


Patent
Melbourne Health, Austin Health, Southern Health, St. Vincents Hospital Melbourne Ltd. trading as St. Vincents Hospital Melbourne and Alfred Health | Date: 2012-01-11

The present invention relates generally to viral variants exhibiting reduced sensitivity to particular agents and/or reduced interactivity with immunological reagents. More particularly, the present invention is directed to hepatitis B virus (HBV) variants exhibiting complete or partial resistance to nucleoside or nucleotide analogs and/or reduced interactivity with antibodies to viral surface components including reduced sensitivity to these antibodies. The present invention further contemplates assays for detecting such viral variants, which assays are useful in monitoring anti-viral therapeutic regimens and in developing new or modified vaccines directed against viral agents and in particular HBV variants. The present invention also contemplates the use of the viral variants to screen for and/or develop or design agents capable of inhibiting infection, replication and/or release of the virus.

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