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-- Presented additional Phase 3 EPIC and CARE trial data highlighting the safety and efficacy of plazomicin during late-breaker session at ECCMID -- -- Plazomicin registration activities on track; NDA submission planned for the second half of 2017 -- SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today reported financial results for the first quarter 2017, and provided an update on its corporate and clinical development activities. "Advancing plazomicin registration activities is our top priority; we are encouraged by our progress with manufacturing and had a productive pre-NDA meeting with FDA in April. We remain on track with our plans to file the plazomicin NDA in the second half of 2017,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. “We have made excellent progress with our C-Scape program and plan to initiate a Phase 1 clinical trial in the second quarter of 2017.” Plazomicin has successfully completed two Phase 3 clinical trials and the Company plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2017 and to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018. The EPIC (Evaluating Plazomicin In cUTI) trial is expected to serve as a single registration trial supporting an NDA for plazomicin in the United States and an MAA in the European Union. The second study, the Phase 3 CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial was a resistant pathogen trial designed to evaluate the efficacy and safety of plazomicin in patients with serious bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE) and provides additional data supporting the NDA and plazomicin therapy in these patients. C-Scape – Achaogen is developing an orally-available antibacterial candidate, C-Scape, that is a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, with the potential to treat patients with cUTI due to MDR pathogens such as extended spectrum beta-lactamase (ESBL) producing Escherichia coli and Klebsiella pneumoniae. Unrestricted cash, cash equivalents and short-term investments totaled $132.0 million at March 31, 2017 compared to $145.9 million at December 31, 2016. Contract revenue totaled $7.5 million for the first quarter of 2017 compared to $5.8 million for the same period of 2016. The increase in contract revenue during the quarter was primarily due to the increased research and development activities under the contract Option 3 with BARDA. As of March 31, 2017, $0.1 million and $0.6 million remains on the BARDA and NIAID contracts, respectively. Achaogen derived all of its revenue from funding provided under U.S. government contracts in connection with the research and development of product candidates. Research and development (R&D) expenses were $18.6 million for the first quarter of 2017 compared to $13.9 million reported for the same period in 2016. The increase in R&D expenses during the first quarter were attributable to: a) concluding the plazomicin clinical trials and initiation of engineering and validation manufacturing campaigns, b) initiation of the C-Scape program, and c) continued advancement of the Company’s earlier stage pipeline. General and Administrative (G&A) expenses were $6.8 million for the first quarter of 2017 compared to $3.8 million for the same period in 2016. The increase in G&A expenses was primarily attributable to higher personnel related expenses and increased activity to prepare for registration and potential commercialization of plazomicin. Change in warrant and derivative liabilities were $15.0 million for the first quarter of 2017 compared to nil for the same period in 2016. The increase was primarily related to non-cash charges for the revaluation of warrants issued in the private placement of common stock and warrants to purchase common stock in June 2016. Net loss for the first quarter of 2017 was $33.3 million, or $0.93 per share, compared to a net loss of $12.2 million, or $0.66 per share, for the first quarter of 2016. As of March 31, 2017, there were approximately 35.8 million shares of common stock outstanding. Conference Call The Company will host a conference call today, May 8, 2017 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. To participate by telephone, please dial 877-719-9786 (Domestic) or 719-325-4773 (International). The conference ID number is 3868586. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.achaogen.com. The archived audio webcast will remain available on the Company's website for 30 days following the conference call. About Achaogen Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen's lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen's plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen's gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. All product candidates are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen's expectations regarding potential regulatory approval of plazomicin, Achaogen's commercial objectives and Achaogen's pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA or NIAID could terminate Achaogen's contract for the funding of the plazomicin or LpxC inhibitor development programs, respectively; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.


-- Presented additional Phase 3 EPIC and CARE trial data highlighting the safety and efficacy of plazomicin during late-breaker session at ECCMID -- -- Plazomicin registration activities on track; NDA submission planned for the second half of 2017 -- SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today reported financial results for the first quarter 2017, and provided an update on its corporate and clinical development activities. "Advancing plazomicin registration activities is our top priority; we are encouraged by our progress with manufacturing and had a productive pre-NDA meeting with FDA in April. We remain on track with our plans to file the plazomicin NDA in the second half of 2017,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. “We have made excellent progress with our C-Scape program and plan to initiate a Phase 1 clinical trial in the second quarter of 2017.” Plazomicin has successfully completed two Phase 3 clinical trials and the Company plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2017 and to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018. The EPIC (Evaluating Plazomicin In cUTI) trial is expected to serve as a single registration trial supporting an NDA for plazomicin in the United States and an MAA in the European Union. The second study, the Phase 3 CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial was a resistant pathogen trial designed to evaluate the efficacy and safety of plazomicin in patients with serious bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE) and provides additional data supporting the NDA and plazomicin therapy in these patients. C-Scape – Achaogen is developing an orally-available antibacterial candidate, C-Scape, that is a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, with the potential to treat patients with cUTI due to MDR pathogens such as extended spectrum beta-lactamase (ESBL) producing Escherichia coli and Klebsiella pneumoniae. Unrestricted cash, cash equivalents and short-term investments totaled $132.0 million at March 31, 2017 compared to $145.9 million at December 31, 2016. Contract revenue totaled $7.5 million for the first quarter of 2017 compared to $5.8 million for the same period of 2016. The increase in contract revenue during the quarter was primarily due to the increased research and development activities under the contract Option 3 with BARDA. As of March 31, 2017, $0.1 million and $0.6 million remains on the BARDA and NIAID contracts, respectively. Achaogen derived all of its revenue from funding provided under U.S. government contracts in connection with the research and development of product candidates. Research and development (R&D) expenses were $18.6 million for the first quarter of 2017 compared to $13.9 million reported for the same period in 2016. The increase in R&D expenses during the first quarter were attributable to: a) concluding the plazomicin clinical trials and initiation of engineering and validation manufacturing campaigns, b) initiation of the C-Scape program, and c) continued advancement of the Company’s earlier stage pipeline. General and Administrative (G&A) expenses were $6.8 million for the first quarter of 2017 compared to $3.8 million for the same period in 2016. The increase in G&A expenses was primarily attributable to higher personnel related expenses and increased activity to prepare for registration and potential commercialization of plazomicin. Change in warrant and derivative liabilities were $15.0 million for the first quarter of 2017 compared to nil for the same period in 2016. The increase was primarily related to non-cash charges for the revaluation of warrants issued in the private placement of common stock and warrants to purchase common stock in June 2016. Net loss for the first quarter of 2017 was $33.3 million, or $0.93 per share, compared to a net loss of $12.2 million, or $0.66 per share, for the first quarter of 2016. As of March 31, 2017, there were approximately 35.8 million shares of common stock outstanding. Conference Call The Company will host a conference call today, May 8, 2017 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. To participate by telephone, please dial 877-719-9786 (Domestic) or 719-325-4773 (International). The conference ID number is 3868586. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.achaogen.com. The archived audio webcast will remain available on the Company's website for 30 days following the conference call. About Achaogen Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen's lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen's plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen's gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. All product candidates are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen's expectations regarding potential regulatory approval of plazomicin, Achaogen's commercial objectives and Achaogen's pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA or NIAID could terminate Achaogen's contract for the funding of the plazomicin or LpxC inhibitor development programs, respectively; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.


-- Presented additional Phase 3 EPIC and CARE trial data highlighting the safety and efficacy of plazomicin during late-breaker session at ECCMID -- -- Plazomicin registration activities on track; NDA submission planned for the second half of 2017 -- SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today reported financial results for the first quarter 2017, and provided an update on its corporate and clinical development activities. "Advancing plazomicin registration activities is our top priority; we are encouraged by our progress with manufacturing and had a productive pre-NDA meeting with FDA in April. We remain on track with our plans to file the plazomicin NDA in the second half of 2017,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. “We have made excellent progress with our C-Scape program and plan to initiate a Phase 1 clinical trial in the second quarter of 2017.” Plazomicin has successfully completed two Phase 3 clinical trials and the Company plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2017 and to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018. The EPIC (Evaluating Plazomicin In cUTI) trial is expected to serve as a single registration trial supporting an NDA for plazomicin in the United States and an MAA in the European Union. The second study, the Phase 3 CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial was a resistant pathogen trial designed to evaluate the efficacy and safety of plazomicin in patients with serious bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE) and provides additional data supporting the NDA and plazomicin therapy in these patients. C-Scape – Achaogen is developing an orally-available antibacterial candidate, C-Scape, that is a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, with the potential to treat patients with cUTI due to MDR pathogens such as extended spectrum beta-lactamase (ESBL) producing Escherichia coli and Klebsiella pneumoniae. Unrestricted cash, cash equivalents and short-term investments totaled $132.0 million at March 31, 2017 compared to $145.9 million at December 31, 2016. Contract revenue totaled $7.5 million for the first quarter of 2017 compared to $5.8 million for the same period of 2016. The increase in contract revenue during the quarter was primarily due to the increased research and development activities under the contract Option 3 with BARDA. As of March 31, 2017, $0.1 million and $0.6 million remains on the BARDA and NIAID contracts, respectively. Achaogen derived all of its revenue from funding provided under U.S. government contracts in connection with the research and development of product candidates. Research and development (R&D) expenses were $18.6 million for the first quarter of 2017 compared to $13.9 million reported for the same period in 2016. The increase in R&D expenses during the first quarter were attributable to: a) concluding the plazomicin clinical trials and initiation of engineering and validation manufacturing campaigns, b) initiation of the C-Scape program, and c) continued advancement of the Company’s earlier stage pipeline. General and Administrative (G&A) expenses were $6.8 million for the first quarter of 2017 compared to $3.8 million for the same period in 2016. The increase in G&A expenses was primarily attributable to higher personnel related expenses and increased activity to prepare for registration and potential commercialization of plazomicin. Change in warrant and derivative liabilities were $15.0 million for the first quarter of 2017 compared to nil for the same period in 2016. The increase was primarily related to non-cash charges for the revaluation of warrants issued in the private placement of common stock and warrants to purchase common stock in June 2016. Net loss for the first quarter of 2017 was $33.3 million, or $0.93 per share, compared to a net loss of $12.2 million, or $0.66 per share, for the first quarter of 2016. As of March 31, 2017, there were approximately 35.8 million shares of common stock outstanding. Conference Call The Company will host a conference call today, May 8, 2017 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. To participate by telephone, please dial 877-719-9786 (Domestic) or 719-325-4773 (International). The conference ID number is 3868586. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.achaogen.com. The archived audio webcast will remain available on the Company's website for 30 days following the conference call. About Achaogen Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen's lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen's plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen's gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. All product candidates are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen's expectations regarding potential regulatory approval of plazomicin, Achaogen's commercial objectives and Achaogen's pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA or NIAID could terminate Achaogen's contract for the funding of the plazomicin or LpxC inhibitor development programs, respectively; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.


News Article | April 17, 2017
Site: www.washingtonpost.com

Democrats in Congress are accusing the Trump administration of ordering officials in federal departments and agencies to withhold information they need to carry out their duties, such as preparing for committee hearings. Party leaders say officials have routinely provided documents and detailed explanations of programs in the past, but now at least two ranking Democrats on congressional committees say their staff members were told directly by workers in agencies that they could no longer speak with them. The issue started in January and grew into such a concern that House Minority Leader Nancy Pelosi (D-Calif.) asked Rep. John Sarbanes (D-Md.) to track Democrats’ correspondence to the executive branch that have gotten no response. So far, Sarbanes said, there are more than 100 cases from the House. “House Democrats have sent more than 100 letters to the Trump administration seeking answers to urgent questions … and received no response,” said Ashley Etienne, a spokeswoman for Pelosi’s office. “If there is a concerted effort by the Trump administration not to respond to House Democrats … we will take appropriate action to address it.” [The Endangered Species Act may be in the fight of its life] The Trump administration did not respond to a request from The Washington Post to address the allegations of an apparent gag order, but at least one administration spokeswoman denied that her department forbids officials to speak to minority-party lawmakers. Although responding to letters from lawmakers in the opposition party is a common courtesy practiced by previous administrations, they don’t always respond to every one. Each of the letters Sarbanes shared with The Post were written in March, and some appeared to require time for an adequate response. A few of the letters seemed political in nature, such as a March 2 letter from Rep. Elijah E. Cummings (Md.), the ranking Democrat on the Oversight and Government Reform Committee, questioning Attorney General Jeff Sessions’s communications with the Russian ambassador to the United States and calling on Sessions to resign. But most sought answers or action seemingly on behalf of constituents. Rep. Tim Ryan (D-Ohio) asked the administration on March 7 to maintain a $9 billion fund to fight opioid and prescription drug abuse in the United States. Rep. Keith Ellison (D-Minn.) asked Sessions to investigate the slayings of transgender women around the country as hate crimes. Rep. Annie McLane Kuster (D-N.H.) asked the Secretary of Defense James Mattis for information on reports that up to 30,000 Marines were under investigation for sharing and commenting on obscene photos of female Marines. Rep. John Garamendi (D-Calif.) and other Democrats in California’s congressional delegation called on President Trump to declare a major disaster in the state after storms caused mudslides and overflowing reservoirs. Sen. Thomas R. Carper (D-Del.), the ranking minority member on the Senate Environment and Public Works Committee, released an angry statement after meeting with officials at the General Services Administration in March. Carper wanted to know whether the use of public land by a Trump hotel in Washington financially benefited the president. At the end of a list of complaints, Carper stated that “I am even more disturbed by the explicit statements made by GSA officials during this briefing that, beginning on Jan. 20, 2017, the Trump administration changed GSA’s long-standing practice of providing certain documents requested by minority members of Congress. “During the briefing,” Carper continued, “agency personnel stated that its new practice only assures that such documents will be provided to the committee’s chairman.” Both congressional chambers and their committees are controlled by Republicans, putting Democrats at a disadvantage that did not exist during previous administrations. Rep. Raul Grijalva (D-Ariz.) said a similar thing happened when he asked his staff to gather information from the U.S. Fish and Wildlife Service under the Department of Interior last month. Grijalva was stunned when his chief of staff informed him that the staffer tasked with retrieving the information from a congressional liaison office was turned away. Grijalva said he was told that Fish and Wildlife workers couldn’t speak to minority staff unless they were called as a witness at a hearing. “I’ve been on this committee going on my 15th year,” Grijalva said. “This kind of response is unprecedented.” Department of Interior spokeswoman Heather Swift denied that Fish and Wildlife workers have been silenced. “There is no gag order,” Swift wrote in an email last week. “The office of congressional and legislative affairs for both Interior and Fish and Wildlife has been in regular contact with both the majority and minority staff. They have supplied information for a number of requests, and Interior officials have consistently testified at hearings, including yesterday.” Grijalva’s office responded that the “contact” Swift mentioned was personnel who “told us directly they have been order by the Office of the Secretary not to answer our questions about hearings at which administration witnesses are not present, and have refused to answer … questions.” Without guidance from Fish and Wildlife, Democrats on a Natural Resources subcommittee said they were powerless to refute claims from witnesses called by Republicans who said the Endangered Species Acts cost projects millions of dollars as a result of delays. [These creatures were on the brink of extinction. The Endangered Species Act is why they still exist.] Rep. Rob Bishop (R-Utah), the committee’s chairman, said he wants to repeal the act that has saved eagles, manatees, condors and other animals from extinction. His office sent quotes from witnesses at the hearing to media that support the chairman’s view that the act slows development. “Nearly 100,000 projects had to undergo time-consuming and expensive consultation even though none of them would likely jeopardize a listed species or its habitat,” said Jonathan Wood, a staff attorney for the Pacific Legal Foundation. “In many cases, project approval would improve conditions for a threatened species while also bringing much needed economic development to rural America,” said Doug Stiles, general manager of the Hecla Mining Company of Idaho. The statement, emailed by committee spokeswoman Molly Block, didn’t list the species or areas that Wood and Stiles referenced. Unlike Fish and Wildlife experts, neither of the witnesses are scientists who have expertise in animal habitat and the impacts of development on species. With no experts present, Grijalva had no idea if their statements, which could influence future legislation, carried any truth. “Is it true that the ESA is responsible for an economic downturn?” Grijalva asked. “Or are they scapegoating the ESA with the intent to limit it or make it toothless? What’s the reality? This limits our ability to counter those points because you don’t have an agency there that has the information this decision should be based on.” Weird tales of animal smugglers caught by U.S. Fish and Wildlife police The cutest little porpoise in the world is almost extinct


Thermo Fisher Scientific to develop and then commercialize its assay for measuring the concentration of plazomicin SOUTH SAN FRANCISCO, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that they have achieved a strategic milestone in their ongoing efforts to develop an assay enabling therapeutic drug management (TDM) of plazomicin. Achaogen is developing plazomicin for the potential treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). In Achaogen’s Phase 3 CARE trial in patients with serious infections due to CRE, an investigational assay enabling plazomicin TDM was used to help ensure that targeted exposures of plazomicin were achieved in the critically ill patients enrolled in the trial. If plazomicin is approved, Achaogen and Thermo Fisher plan to develop and have a commercial assay for plazomicin available at product launch. Achaogen plans to submit a New Drug Application (NDA) for plazomicin to the Food and Drug Administration (FDA) in the second half of 2017. Achaogen also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018. “Thermo Fisher is a world leader in developing and providing high-quality commercial assays to achieve precise and accurate quantitative results crucial for monitoring drug levels. We are pleased with the progress made in our collaboration with Thermo Fisher and with achieving this important milestone of demonstrating assay feasibility, a key step toward enabling therapeutic drug management of plazomicin for those patients most likely to benefit from TDM,” said Blake Wise, Achaogen’s Chief Operating Officer. “In certain high-risk patient populations, such as the critically ill, we believe TDM has the potential to provide significant utility in optimizing plazomicin dosing.” The two companies have been collaborating on assay development since 2015. Under terms of their collaboration agreement, Thermo Fisher leads the development, regulatory approval, and commercialization of an assay for measuring plazomicin drug levels. Achaogen brings plazomicin expertise to the collaboration, including the discovery of plazomicin-specific antibodies utilizing their state-of-the-art antibody discovery platform. “The agreement reflects our mutual commitment to providing a broadly-available plazomicin assay at launch so that healthcare providers can measure plazomicin drug levels in critically ill patients with bacterial infections,” said John Kody, Vice President/General Manager Clinical Diagnostics - Niche Products at Thermo Fisher Scientific. “During the feasibility period, our two teams have developed an assay that compares very well to traditional analytical chemistry techniques. Thermo Fisher’s QMS™ TDM assays are conveniently ready-to-use, with excellent precision and accuracy, and are optimized for performance on a wide range of analyzers.” In December 2016, Achaogen announced positive results from its plazomicin Phase 3 clinical trials in complicated urinary tract infections (cUTI) and infections due to CRE. In the Phase 3 EPIC registration trial in patients with cUTI and acute pyelonephritis (AP), plazomicin met the objective of non-inferiority compared to meropenem for FDA-specified primary efficacy endpoints, and achieved superiority for the EMA-specified primary efficacy endpoints. In addition, in the Phase 3 CARE trial in patients with serious infections due to CRE, a lower rate of mortality or serious disease-related complications was observed for plazomicin-treated patients compared with those on colistin therapy. In the Phase 3 CARE trial, TDM with an investigational assay helped to confirm that the targeted-exposure of plazomicin was achieved in these critically ill patients. About Therapeutic Drug Management and Plazomicin Therapeutic Drug Management is the practice of measuring the concentration of medication in blood and adjusting the dose of that drug based on the results. Healthcare providers routinely use TDM for certain drugs to help improve patient care by individually adjusting the dose as appropriate.  Critically ill patients with bacterial infections often have abnormal and fluctuating renal function as well as an altered volume of drug distribution in the body. This can lead to these patients being either under or over-dosed with what are potentially life-saving therapies. Initial data from Achaogen’s plazomicin CARE study in critically ill patients with CRE infections confirmed drug concentration variability within and among patients and importantly, showed that TDM helped to ensure that the targeted-exposure of plazomicin was achieved in these patients. About Achaogen Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including LpxC inhibitors for the treatment of serious bacterial infections including MDR gram-negative bacteria. Achaogen's LpxC inhibitor program has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. LpxC inhibitors are the second class of molecules from Achaogen's gram-negative antibiotic discovery engine. For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risk of failure to successfully validate, develop and obtain regulatory clearance or approval for the in vitro diagnostic (IVD) assay for plazomicin; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.


News Article | February 27, 2017
Site: www.businesswire.com

FAIRFAX, Va.--(BUSINESS WIRE)--ICF (NASDAQ:ICFI), a consulting and technology services provider to government and commercial clients around the world, reported results for the fourth quarter and twelve months ended December 31, 2016. “2016 was a year of solid execution for ICF in which we achieved mid-single-digit organic revenue growth consistent with our expectations. Revenue from commercial clients increased 4.8 percent, driven by the strong performance of energy markets, which includes energy efficiency programs for utilities, and modest year-on-year growth in our marketing services. A similar 4.6 percent growth in our government business reflected a 4.1 percent increase in federal government revenue and double-digit growth in state and local government revenue, which more than offset the anticipated decline in revenue from international government business. Diluted earnings per share growth outpaced revenue growth by a factor of four, demonstrating the strength of our balanced portfolio and the benefit of reduced amortization expense, a lower share count and a lower tax rate,” said Sudhakar Kesavan, ICF’s Chairman and Chief Executive Officer. “In the fourth quarter, we experienced slower-than-expected work flow on certain federal government contracts and postponements of specific asset valuation and M&A assignments in our commercial energy advisory group. Strong performance in other areas, particularly energy efficiency and state and local infrastructure programs, mostly offset the revenue impact. However, reduced service revenue2 levels resulted in fourth quarter diluted earnings per share being below our guidance range, although earnings were markedly ahead of last year. Since the beginning of 2017, we have seen a return to our expected levels of activity in our federal government business and commercial energy advisory work. “ICF’s business development programs continued to yield positive results in 2016. It was a record year for us in terms of contract awards, with the majority representing new business wins. We ended 2016 with a record fourth quarter backlog, and the funded portion increased significantly from 2015 levels, in part reflecting the greater mix of commercial business,” Mr. Kesavan noted. Fourth quarter 2016 revenue was $289.6 million, a 3.1 percent increase from $280.8 million in the fourth quarter of 2015. Service revenue was stable at approximately $207 million. Net income was $12.7 million in the fourth quarter of 2016, or $0.65 per diluted share, up 18.2 percent from $0.55 per diluted share in the prior year period. Non-GAAP EPS increased 4.1 percent to $0.76 per diluted share in the fourth quarter of 2016 compared to $0.73 in the prior year. EBITDA3 was $29.5 million, up from $27.5 million in the fourth quarter of 2015. Fourth quarter 2016 EBITDA margin was 10.2 percent, a 40 basis point increase from the 9.8 percent reported in the comparable period last year. Adjusted EBITDA4, which excludes special charges related to severance for staff realignment, acquisition-related expenses and international office closures of $0.4 million, was $29.9 million, or 10.3 percent of revenue, up from last year’s $28.3 million or 10.1 percent of revenue. For 2016, revenue was $1.19 billion, up 4.7 percent over the $1.13 billion reported for full year 2015. Service revenue was $864.8 million, or 1.8 percent above the prior year. Net income was $46.6 million, or $2.40 per diluted share for full year 2016 compared to $39.4 million or $2.00 per diluted share in the prior year. The increase in diluted earnings per share represented a 20 percent year-on-year increase. Non-GAAP EPS was $2.87 per share in 2016, an increase of 8.7 percent from the $2.64 per share reported in 2015. For 2016, EBITDA was $111.9 million, a 3.0 percent increase as compared to $108.6 million for 2015. Adjusted EBITDA in 2016 was $113.9 million, a 2.8 percent increase as compared to $110.7 million for 2015. Adjusted EBITDA excluded special charges related to severance for staff realignment, acquisition-related expenses and international office closures of $2.0 million in 2016 and $2.1 million in 2015. Operating cash flow was $79.6 million for 2016 compared to $76.3 million in 2015, a 4.3 percent increase. During 2016, the company used $52.1 million in cash to pay down debt and $11.9 million to repurchase company shares. Total backlog was $2.1 billion at the end of the fourth quarter of 2016. Funded backlog was $1.0 billion, or approximately 48 percent of the total backlog. The total value of contracts awarded in the 2016 fourth quarter was $296 million, up 31 percent year-on-year. For full year 2016, contract awards were $1.5 billion, up 13 percent year-on-year and representing a book-to-bill ratio of 1.26. ICF was awarded more than 90 U.S. federal contracts and task orders and more than 200 additional contracts from state and local and international governments. The largest awards were: Other government contract wins with a value greater than $1 million included: training and technical assistance, and research and evaluation services, for the U.S. Department of Health and Human Services’ Administration for Children and Families; regulatory, operational, communications, training, and other administrative and analytic support for the U.S. Department of Homeland Security; policy and communications support for the U.S. Department of Energy Oak Ridge National Laboratory; program management services for the Defense Contract Management Agency; support for block grant evaluations and the diabetes prevention program at the Centers for Disease Control and Prevention; technology support services for the Office of the Secretary of the Navy; change management support for the U.S. Department of Veterans Affairs; and enterprise strategy and management services for the U.S. Department of State’s Bureau of Consular Affairs. Commercial sales were $158.7 million in the fourth quarter of 2016, and ICF was awarded more than 500 commercial projects globally during the period. The largest awards were: Other commercial contract wins with a value of at least $1 million included: customer loyalty program services for a national auto parts chain, two national retail chains, a financial services company, and a major international hotel chain; program support and communications services for a number of U.S. utilities; brand and digital solutions services for a national health insurer; marketing and digital solutions services for a regional financial institution; marketing services for a floor care product manufacturer; and public relations support and digital solutions for a major manufacturer of access control products. “ICF ended 2016 with key measures of future performance, notably, contract wins, backlog and business development pipeline at record levels. In setting expectations for 2017, we have made certain assumptions regarding the transition to a new administration, particularly after a two-term president, that could affect federal government revenue this year. Importantly, ICF is well positioned in several key government priority areas, including infrastructure renewal and resilience, energy, public health and veterans affairs. Similarly, in our commercial business, we are executing on more than 150 energy efficiency programs for over 40 utilities across the United States and Canada, and we continue to leverage our marketing and communications services across our client base. “Based on our current visibility, we expect full year 2017 diluted earnings per share to be in the range of $2.50 to $2.75 per share on revenue ranging from $1.20 billion to $1.24 billion. Underpinning this guidance are the following assumptions: “Operating cash flow for 2017 is expected to be in the range of $90 million to $100 million,” Mr. Kesavan concluded. ICF (NASDAQ:ICFI) is a global consulting and technology services provider with more than 5,000 professionals focused on making big things possible for our clients. We are business analysts, public policy experts, technologists, researchers, digital strategists, social scientists and creatives. Since 1969, government and commercial clients have worked with ICF to overcome their toughest challenges on issues that matter profoundly to their success. Come engage with us at www.icf.com. Statements that are not historical facts and involve known and unknown risks and uncertainties are "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Such statements may concern our current expectations about our future results, plans, operations and prospects and involve certain risks, including those related to the government contracting industry generally; our particular business, including our dependence on contracts with U.S. federal government agencies; and our ability to acquire and successfully integrate businesses. These and other factors that could cause our actual results to differ from those indicated in forward-looking statements are included in the "Risk Factors" section of our securities filings with the Securities and Exchange Commission. The forward-looking statements included herein are only made as of the date hereof, and we specifically disclaim any obligation to update these statements in the future. 1 Non-GAAP EPS is a non-GAAP measurement. A reconciliation of all non-GAAP measurements is set forth below. 2, 3, 4 Service Revenue, EBITDA, and Adjusted EBITDA are non-GAAP measurements. A reconciliation of all non-GAAP measurements is set forth below.


-- Plazomicin NDA submission planned for the second half of 2017 -- -- Plan to initiate clinical trial of orally-administered antibacterial candidate for ESBL+ infections, C-Scape, in 2017 -- -- Advances in research expand unique pipeline of therapeutic candidates targeting the most critical priority pathogens -- SOUTH SAN FRANCISCO, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, held an R&D Day to provide an overview of its Research and Development programs including the Company's new orally-administered antibacterial candidate, C-Scape. The meeting consisted of presentations from members of Achaogen’s leadership team and medical community key opinion leaders. "We aspire to solve the growing issue of antimicrobial resistance and we are very pleased to announce that we now have two potential development candidates to further this vision,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. "We believe that with plazomicin, a pre-NDA candidate, and C-Scape, a 2017 Phase 1 candidate with potential for rapid development, we are positioned to advance our leadership in discovering, developing, and commercializing innovative antibacterials to treat the critical priority pathogens that cause highly resistant gram-negative infections.” The Achaogen R&D Day focused on the Company's antibacterial development pipeline to support the following corporate objectives: Plazomicin: The R&D Day provided an overview of the plazomicin program, including a review of the Phase 3 results, progress towards the planned New Drug Application (NDA) submission and preparation for commercialization: C-Scape: An overview of Achaogen’s newly announced, orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, was provided. Key highlights were as follows: Research Discovery and Development: Achaogen’s research and early development overview focused on novel approaches to address infections caused by MDR gram-negative pathogens. The early stage pipeline consists of the following research candidates: An audio webcast of the 2017 Achaogen R&D Day is available in the "Investors" section of Achaogen’s website, www.achaogen.com. A replay of the presentation will be available until April 2, 2017. About Achaogen Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen's lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen's plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen's gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. All product candidates are investigational only and have not been approved for commercialization.  For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA or NIAID could terminate Achaogen's contract for the funding of the plazomicin or LpxC inhibitor development programs, respectively; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.


-- Completed Enrollment in Phase 3 Plazomicin Clinical Trials; Expect Results from EPIC and CARE Trials by End of 2016 -- -- Planning Plazomicin NDA Submission in the Second Half of 2017 -- -- Presented First Plazomicin CARE Trial Data in Patients with Carbapenem-Resistant Enterobacteriaceae (CRE) Infections at IDWeek™ 2016 -- -- Conference Call Today at 4:30 p.m. Eastern Time -- SOUTH SAN FRANCISCO, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today reported financial results for the third quarter of 2016, and announced the acceleration of the expected timeline for reporting results from the Phase 3 clinical trials of its lead product candidate, plazomicin, which is being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). "Thanks to the coordinated efforts of our team and participating clinical trial sites, we were successful in completing enrollment of the Phase 3 EPIC trial ahead of schedule, and now expect to announce top-line EPIC and CARE results before the end of 2016,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. “Also, at the recent IDWeek conference, we presented the first data from the CARE trial, which highlighted the role of therapeutic drug management in guiding targeted dosing of plazomicin in critically ill patients with antibiotic resistant gram-negative infections.” Plazomicin is currently being evaluated in two Phase 3 clinical trials. The EPIC (Evaluating plazomicin in cUTI) trial is expected to serve as a single registration trial supporting a New Drug Application (NDA) for plazomicin in the United States and a Marketing Authorization Application (MAA) in the European Union. The CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial is a supportive study in patients with serious bacterial infections due to CRE. Unrestricted cash, cash equivalents and short-term investments totaled $61.1 million at September 30, 2016 compared to $58.7 million at December 31, 2015. Contract revenue totaled $16.0 million for the third quarter of 2016 compared to $4.5 million for the same period of 2015. The increase in contract revenue during the quarter was primarily due to the increased research and development activities under the contract Option 3 with BARDA. Achaogen derived all of its revenue from funding provided under U.S. government contracts in connection with the research and development of product candidates. Research and development expenses were $20.5 million for the third quarter of 2016 compared to $10.0 million reported for the same period in 2015. The increase in research and development expenses during the quarter primarily relates to increased program costs associated with the Phase 3 EPIC trial, higher personnel-related expenses, as well as increased costs related to non-plazomicin research programs. General and Administrative (G&A) expenses were $4.5 million for the third quarter of 2016 compared to $3.0 million for the same period in 2015. The increase in G&A expenses during the quarter primarily relates to increased activity to support plazomicin development and manufacturing and to prepare for registration and commercialization. Net other expenses were $1.4 million for the third quarter of 2016 compared to nil for the same period in 2015. The increase was primarily related to non-cash charges for the revaluation of warrants issued in the private placement of common stock and warrants to purchase common stock in June 2016. Net loss for the third quarter of 2016 was $11.0 million, or $0.41 per share, compared to a net loss of $8.8 million, or $0.48 per share, for the third quarter of 2015. As of September 30, 2016, there were approximately 27.5 million shares of common stock outstanding. Conference Call The Company will host a conference call today, November 7, 2016 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. To participate by telephone, please dial 877-857-6163 (Domestic) or 719-325-4879 (International). The conference ID number is 6858559. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.achaogen.com. The archived audio webcast will remain available on the Company's website for 30 days following the conference call. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding (i) the timing of top-line results from the CARE trial and the EPIC trial, (ii) the timing of the submission of an NDA and an MAA for plazomicin, (iii) whether the CARE trial results will be submitted as supportive data with the plazomicin NDA submission, and (iv) the potential for plazomicin to treat serious bacterial infections due to MDR Enterobacteriaceae. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; specific risks related to the ongoing Phase 3 EPIC trial and Phase 3 CARE trial; the risk of failure to successfully validate, develop and obtain regulatory clearance or approval for the in vitro diagnostic (IVD) assay for plazomicin; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk that bacteria may evolve resistance to plazomicin; risks and uncertainties as to Achaogen's ability to raise additional capital to support the development of plazomicin and its other programs; uncertainties regarding the availability of adequate third-party coverage and reimbursement for newly approved products; Achaogen's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; Achaogen's dependence on its President and Chief Executive Officer; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA could terminate Achaogen's contract for the funding of the plazomicin development program; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2016. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise. About Achaogen Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including LpxC inhibitors for the treatment of serious bacterial infections including MDR gram-negative bacteria. Achaogen's LpxC inhibitor program has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. LpxC inhibitors are the second class of molecules from Achaogen's gram-negative antibiotic discovery engine. For more information, please visit www.achaogen.com.


News Article | February 28, 2017
Site: www.prweb.com

Flatev, a startup company that plans to revolutionize the way consumers prepare a wide variety of flatbreads will be establishing its first worldwide manufacturing operation at the Rutgers Food Innovation Center business incubator facility in Bridgeton, NJ. The company, headquartered in Zurich, Switzerland, met with officials from Choose New Jersey, Inc., the Rutgers Food Innovation Center, and other business leaders today, and demonstrated their Flatev Artisan Baking System. The system gives consumers the ability to produce freshly baked, tasty, and nutritious artisanal flatbreads with the push of a button. The Flatev Artisan Baking System is a table-top household appliance that makes fresh tortillas, pita, roti, and other flatbreads, as well as cookies, with a single-serve dough portion, that is as consistent and easy-to-use as a single-serve coffee maker. The Flatev dough single-serves will be produced at the Rutgers Food Innovation Center during the fall of 2017. The appliance and single-serves will be sold to a limited number of service hotels, offices, and to consumers shortly thereafter. “The business began as a result of my interest in producing authentic, healthy tortillas, just like my mother made for me when I was a child growing up in Mexico,” said Carlos Ruiz, Founder, CEO and Chairman of Flatev. “Our Artisan Baking System produces organic, all natural tortillas and flatbreads, which are non-GMO and contain no artificial preservatives or additives. The hot just-baked tortillas, which are ready in less than two minutes, are scrumptious, fresh, and carry an amazing aroma.” Flatev raised almost $5 million in its initial round of funding, which has enabled the company to complete all of its appliance engineering and dough product development, finalize its prototypes, gain patents on its process, and build a team in both Switzerland and the US. “We are very pleased that Flatev has chosen to establish their first global operation within our FDA and USDA inspected facility in Bridgeton, New Jersey,” said Lou Cooperhouse, Executive Director of the Rutgers Food Innovation Center. “There is a clear consumer trend in conveniently packaged products that are freshly prepared at home, and away from home, and Flatev is pioneering this trend in a category where freshness is extremely important. The global kitchen appliance market also is expected to grow significantly in the years ahead, and we believe that Flatev’s growth can be quite substantial in both retail and foodservice markets.” Choose New Jersey, a private non-profit organization charged with encouraging and nurturing economic growth throughout the State, provided assistance to Flatev to ensure a smooth move to New Jersey, including an introduction to the resources available to food companies at the Rutgers Food Innovation Center. “We welcome Flatev to New Jersey’s growing food industry,” said Michele Brown, President and CEO of Choose New Jersey, Inc. “New Jersey has powerful assets, including the resources at the Food Innovation Center, to help pioneering start-up companies like Flatev flourish. Their first-to-market baking system will be a welcome addition to the Garden State’s growing list of innovative food products.” Choose New Jersey, Inc. is a privately funded 501(c)(3) corporation charged with encouraging and nurturing economic growth throughout New Jersey with a focus on its urban centers. Through marketing, business attraction and lead generation activities, Choose New Jersey markets New Jersey as a premiere business location to both domestic and international businesses. Choose New Jersey is a member of the Partnership for Action (PFA), which is led by Lt. Governor Kim Guadagno and also includes the New Jersey Business Action Center, the New Jersey Economic Development Authority and the Office of the Secretary of Higher Education. For more information, visit http://www.choosenj.com. Rutgers Food Innovation Center (FIC) is a globally recognized food business incubation and economic development accelerator program of the New Jersey Agricultural Experiment Station (NJAES) at Rutgers, The State University of New Jersey. The Center provides extensive programs in training and workforce development; customized and comprehensive business and technical mentoring services; and USDA- and FDA-inspected facilities that enable design, development, analysis, commercialization and manufacture of value-added food products for sale to retail and foodservice markets. The FIC has been named as the “Incubator of the Year” by the International Business Innovation Association (InBIA) and recognized as an “Agricultural Innovation Center Demonstration Program” by the USDA. In addition, the FIC has been designated as a Soft Landings site by InBIA, due to its focus on international business attraction, and is currently the only food-based incubation program in the world with this designation. For more information about the Rutgers Food Innovation Center, visit http://foodinnovation.rutgers.edu/. More about Flatev can be found on its website at: http://www.flatev.com Photo Caption: (From L to R) Lou Cooperhouse, Executive Director, Rutgers Food Innovation Center and Michele Brown, President and CEO, Choose New Jersey, Inc. welcome Scott Cross, Chief Business Development Officer, Jonas Mueller, Co-Founder and Chief Technology Officer and Carlos Ruiz, Co-Founder, Chairman and CEO of Flatev to New Jersey.


In an effort to provide easier access to voter information, the Office of the Secretary of State and Alabama Interactive announced on April 22 that they will be launching a new online portal. This portal will include voter information and access to voter history, not limited to county school districts, county commission districts and state house districts. "We are very excited to be able to offer this service to the citizens of Alabama," said Secretary John Merrill. "This new feature continues my efforts to increase transparency and will allow any interested citizen, candidate or elected official to be able to custom prepare and purchase the voter list they desire without having to contact another person to do it. The system will be secure, cost-efficient, and provide easy access to the available information." The Secretary of State already offers certified business documents, foreign LLC filings and certificates of existence. The development of this online portal will expand its offerings with voter data. However, official election results, poll lists and information pertaining to official election preparation will not be accessible through the portal, which can be accessed at www.alabamainteractive.org. Alabama is not the first state to offer this type of portal with voter information. Minnesota, Louisiana and South Dakota are just some of the many states to introduce these types of resources for residents throughout their respective areas. Voter information portals are designed to make it simpler for residents to access critical information, such as whether they are registered to vote. While the Alabama portal does not offer city wide of municipal district voter information, some portals do offer additional insight. Louisiana's portal, for instance, allows individuals to hone in on voter information down to an address level. Individuals who want to use Alabama's portal to purchase voter information online will be charged one cent per voter list information online. The price isn't steep, and it provides users with the transparency they desire when it comes to everything related to voting in Alabama. For safety and security purposes, provisions are in place to protect victims, as well as the parents of victims of domestic violence, under Code of Alabama 1975, Section 17-4-33(b). Any questions can be directed to the Office of the Secretary of State. © 2016 Tech Times, All rights reserved. Do not reproduce without permission.

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