RESTON, Va., April 25, 2017 – NII Holdings, Inc. [NASDAQ: NIHD] (the “Company”), today announced that Roberto Rittes has been appointed as Nextel Brazil’s new CEO. Mr. Rittes, 43, brings over a decade of senior level experience, having served as a key officer for Brazilian telecom companies Brasil Telecom and Oi Paggo. Most recently, Mr. Rittes was a principal at H.I.G. Capital, a leading global private equity investment firm, from 2016 to 2017. Mr. Rittes holds an M.B.A. from Harvard Business School and an undergraduate degree in business from Fundação Getúlio Vargas (EAESP-FGV).
“We are excited to have Roberto join us in leading our focus on growing our 3G and LTE business by attracting and retaining customers who value the high quality wireless services we offer,” said Steve Shindler, the Company’s Chief Executive Officer.
The Company also announced that Francisco Valim has stepped down as President of Nextel Brazil. “I want to thank Francisco for the tremendous efforts in leading the turnaround of our business in Brazil. His expertise in transforming companies and managing organizational change resulted in a significant improvement in our operations, leaving solid foundations on which to keep building,” said Mr. Shindler.
Mr. Shindler has agreed to remain in his position as NII’s CEO to assist Mr. Rittes as he transitions into his role.
About NII Holdings, Inc.
NII Holdings, Inc., a publicly held company based in Reston, Virginia, is a provider of differentiated mobile communication services for businesses and high value consumers in Brazil. NII Holdings, operating under the Nextel brand, offers fully integrated wireless communication tools with digital cellular voice services, data services and wireless Internet access. Visit the Company’s website at www.nii.com.
Nextel, the Nextel logo and Nextel Direct Connect are trademarks and/or service marks of Nextel Communications, Inc.
Visit NII Holdings’ news room for news and to access our markets’ news centers: nii.com/newsroom.
Straight Path Communications Inc. (“Straight Path”) (NYSE MKT: STRP) announced today that the Straight Path Board of Directors (the “Straight Path Board”) determined that an unsolicited offer from a multi-national telecommunications company (the “Bidder”) to acquire 100% of the issued and outstanding shares of Straight Path for $104.64 per share (reflecting an enterprise value of $1.8 billion), which will be paid in Bidder stock in an all-stock transaction constitutes a “Superior Proposal” as defined in Straight Path’s previously announced definitive agreement and plan of merger with AT&T Inc. (“AT&T”) (NYSE MKT: T) and Switchback Merger Sub Inc., dated as of April 9, 2017 (the “AT&T Merger Agreement”). Under the terms of the AT&T Merger Agreement, AT&T agreed to acquire Straight Path in an all-stock transaction in which Straight Path stockholders would receive $95.63 per share (reflecting an enterprise value of $1.6 billion), which would be paid using AT&T stock.
Straight Path has notified AT&T of the Straight Path Board’s determination and, pursuant to the AT&T Merger Agreement, AT&T has the option for the next five (5) business days (the “Negotiation Period”) to negotiate a possible amendment of that agreement to match or exceed the Bidder’s offer. Straight Path is required, and intends to, negotiate in good faith with AT&T during the Negotiation Period. Straight Path is not permitted to enter into the Bidder’s merger agreement or to change its recommendation in favor of the AT&T transaction unless, at the end of the Negotiation Period, the Straight Path Board determines that the Bidder’s offer continues to constitute a “Superior Proposal” and satisfies certain other requirements under the AT&T Merger Agreement. The Bidder has stated that its offer will remain outstanding until 11:59 p.m. New York City time on May 3, 2017.
Under the AT&T Merger Agreement, Straight Path is required to pay a $38 million termination fee to AT&T if the Straight Path Board terminates the AT&T Merger Agreement in order to enter into an agreement with the Bidder. The Bidder has agreed to pay the termination fee to AT&T on Straight Path’s behalf in such event. Straight Path would be required to repay the Bidder for the AT&T termination fee under certain circumstances in connection with a termination of the Bidder’s merger agreement.
At this time, Straight Path remains subject to the AT&T Merger Agreement and the Straight Path Board has not changed its recommendation in support of the AT&T transaction, the existing AT&T Merger Agreement, or its recommendation that Straight Path’s stockholders adopt the AT&T Merger Agreement. There can be no assurances that a transaction with the Bidder will result from the Bidder’s offer, or that any other transaction will be consummated. There can be no assurance that AT&T will seek to negotiate with Straight Path or will make a revised offer.
About Straight Path Communications Inc.
Straight Path (NYSE MKT: STRP) holds an extensive portfolio of 39 GHz and 28 GHz wireless spectrum licenses. Straight Path is developing next generation wireless technology through its Straight Path Ventures subsidiary. Straight Path holds licenses and conducts other business related to certain patents through its Straight Path IP Group subsidiary. Additional information is available on Straight Path’s websites.
IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC
Straight Path plans to file with the SEC and mail to its stockholders a Proxy Statement/Prospectus in connection with the proposed transaction. THE PROXY STATEMENT/PROSPECTUS WILL CONTAIN IMPORTANT INFORMATION ABOUT AT&T, STRAIGHT PATH, THE PROPOSED TRANSACTION AND RELATED MATTERS. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS CAREFULLY WHEN THEY BECOME AVAILABLE. Investors and security holders will be able to obtain free copies of the Proxy Statement/Prospectus and the other documents filed with the SEC by Straight Path through the web site maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of the Proxy Statement/Prospectus by phone, e-mail or written request by contacting the investor relations department of Straight Path at the following:
|Straight Path Communications Inc.|
|Address:||5300 Hickory Park Dr., Suite 218|
|Glen Allen, VA 23059|
|Attention: Investor Relations|
PARTICIPANTS IN THE SOLICITATION
Straight Path and its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the proposed transactions contemplated by the AT&T Merger Agreement. Information regarding Straight Path’s directors and executive officers is contained in Straight Path’s Form 10-K for the year ended July 31, 2016 and its proxy statement dated November 22, 2016, which are filed with the SEC. A more complete description will be available in the Proxy Statement/Prospectus.
In this press release, all statements that are not purely about historical facts, including, but not limited to, those in which we use the words “believe,” “anticipate,” “expect,” “plan,” “intend,” “estimate, “target” and similar expressions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. While these forward-looking statements represent our current judgment of what may happen in the future, actual results may differ materially from the results expressed or implied by these statements due to numerous important factors, including, but not limited to, those described in our Annual Report on Form 10-K for the fiscal year ended July 31, 2016 and our other periodic filings with the SEC (under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”). We are under no obligation, and expressly disclaim any obligation, to update the forward-looking statements in this press release, whether as a result of new information, future events or otherwise.
No Offer or Solicitation
This document does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Yonatan Cantor, 804-433-1523
Interim Efficacy and Safety Data from Ongoing Phase 2 Study in Follicular Lymphoma and DLBCL Selected for Plenary Presentation at the International Conference on Malignant Lymphoma
Management to Host Conference Call on June 14 at 10:30 a.m. ET
CAMBRIDGE, Mass., April 25, 2017 — Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to tazemetostat, the Company’s first-in-class EZH2 inhibitor, for the treatment of patients with relapsed or refractory follicular lymphoma, either wild type EZH2 or with EZH2 activating mutations. Fast Track designation is intended to provide expedited processes for the development and FDA review of drugs that may reduce development time and costs associated with bringing a drug to market.
Epizyme also announced that interim efficacy and safety data from all five study cohorts in its ongoing Phase 2 study of tazemetostat in patients with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) has been selected for a plenary session on Wednesday, June 14, 2017 at 2:00 p.m. CET at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. In addition, results from a biomarker study of tazemetostat in patients with NHL will be presented in a poster session during ICML. The Company plans to hold a conference call to discuss these clinical findings on Wednesday, June 14 at 10:30 a.m. ET.
“This is an important milestone for our NHL program, with tazemetostat now having FDA Fast Track designation for relapsed or refractory diffuse large B-cell lymphoma with EZH2 activating mutations and for relapsed or refractory follicular lymphoma, regardless of EZH2 mutation,” said Robert Bazemore, president and chief executive officer, Epizyme. “In addition to this regulatory recognition of tazemetostat’s therapeutic potential, the selection of interim Phase 2 data for the opening plenary session underscores the lymphoma community’s enthusiasm for our lead product candidate. Our development goal is to bring tazemetostat to patients as quickly as possible and we look forward to advancing this study throughout 2017.”
The FDA Fast Track program is designed to facilitate the development of important new drugs and to provide patients access to those drugs more quickly. The designation enables early and frequent communication between FDA and a product sponsor throughout the drug development and review process. Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted.
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for both relapsed/refractory follicular lymphoma with or without an EZH2 activating mutation and DLBCL with EZH2 activating mutations, as well as Orphan Drug designation for malignant rhabdoid tumors.
About Epizyme, Inc.
Epizyme, Inc. is a clinical-stage biopharmaceutical company committed to rewriting cancer treatment through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy and in relapsed and front-line disease. Using the Company’s proprietary platform, Epizyme has pioneered the identification and development of small molecule inhibitors of chromatin modifying proteins (CMPs), such as tazemetostat. CMPs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of CMPs, which can allow cancer cells to grow and proliferate. By focusing on the genetic drivers of cancers, Epizyme’s science seeks to match targeted medicines with the specific patients that need it. For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; whether results from clinical studies will warrant meetings with regulatory authorities or submissions for regulatory approval; expectations for regulatory approvals to conduct trials or to market products; whether the Company’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the “Risk Factors” section of the Company’s most recent Form 10-K filed with the SEC and in the Company’s other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.
Contacts: Cheya Pope, Epizyme, Inc. firstname.lastname@example.org 617-229-7561 Monique Allaire, THRUST IR email@example.com (617) 895-9511
Maximizes Efficiency of Global Development and Commercialization
Committed Capital and Potential Milestone Payments from Otsuka of up to $865 Million, Including $208 million or More in Upfront Payment and Development Funding, as well as Tiered, Double-Digit Royalties
Total Committed Development Funding from all of Akebia’s Vadadustat Collaborations Plus Cash Exceeds $600 Million
Akebia to Host Conference Call at 4:30 p.m. Eastern Time Today
Akebia Therapeutics, Inc. (NASDAQ:AKBA) and Otsuka Pharmaceutical Co., Ltd. today announced that they have expanded their collaboration for vadadustat by entering into a collaboration and license agreement for Europe, China and other territories. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia associated with chronic kidney disease (CKD). Anemia related to CKD arises from the kidney’s failure to produce adequate amounts of erythropoietin, a key hormone stimulating the production of red blood cells.1 Left untreated, anemia significantly accelerates patients’ overall deterioration of health with increased morbidity and mortality.2, 3
This agreement follows a previously announced collaboration between the companies in which they equally share the costs of developing and commercializing vadadustat in the United States, as well as the profits from potential future sales of vadadustat in the $3.5 billion renal anemia market. The total committed development funding from all vadadustat collaborations, combined with Akebia’s cash, is expected to exceed $600 million.
Under the terms of this collaboration agreement, Akebia will receive $208 million or more in committed capital from Otsuka, including $73 million upon signing and $135 million or more of development funding. In addition, Akebia is eligible to receive up to $657 million in milestone payments, representing a total transaction value of approximately $865 million. Otsuka will also make tiered, double-digit royalty payments of up to 30% on net sales of vadadustat in Otsuka’s territory, which includes Europe, Russia, China, Canada, Australia and the Middle East, but excludes Latin America and other previously licensed countries. In the five major markets in Europe, sales of erythropoiesis stimulating agents (ESAs), the current standard of care for the treatment of renal anemia, were approximately $1.5 billion.4
Mr. Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical Co., Ltd., commented, “Thanks to Akebia’s expertise in developing vadadustat, we anticipate that it holds significant promise for renal anemia. We are also convinced that by strengthening our cardio-renal portfolio with a drug candidate like this, following our own tolvaptan, we can contribute to changing the standard of care worldwide for patients with complex kidney diseases.”
“We are very pleased to expand our strategic relationship with Otsuka, a company who shares our vision to improve the lives of patients with kidney disease,” stated John P. Butler, President and Chief Executive Officer of Akebia. “We now have a single, strong collaborator for the two largest markets, the U.S. and Europe. This simplifies governance and decision making, maximizing the efficiency of our global Phase 3 development program and ultimately the commercialization of vadadustat. We are able to accomplish this while obtaining substantial funding for our vadadustat development program and retaining significant long-term value for Akebia.”
Akebia has established three significant collaborations for vadadustat in a little over a year, which together total more than $2.2 billion in potential value and include $573 million or more in upfront payments and committed development funding. In addition to this agreement and the U.S. collaboration with Otsuka, Akebia has established a collaboration with Mitsubishi Tanabe Pharma Corporation for the development and commercialization of vadadustat in Japan, Taiwan, South Korea, Indonesia, India and select other countries in Asia.
Conference Call and Webcast
Akebia management will host a conference call to review the details of the transaction beginning at 4:30 p.m. Eastern Time today, Tuesday, April 25, 2017. A live audio webcast of the presentation will be available on the company’s website at http://ir.akebia.com/events.cfm. An archived presentation will be available for 90 days.
To access the conference call, follow these instructions:
Dial: (877) 458-0977 (U.S.); (484) 653-6724 (international)
Conference ID: 12787133
Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in development for the treatment of anemia related to chronic kidney disease. Vadadustat exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery.
About Anemia Associated with CKD
Anemia results from the body’s inability to coordinate red blood cell production in response to lower oxygen levels due to the progressive loss of kidney function with inadequate erythropoietin production. Left untreated, anemia significantly accelerates patients’ overall deterioration of health with increased morbidity and mortality. Anemia is currently treated with injectable recombinant erythropoiesis stimulating agents, which are associated with inconsistent hemoglobin responses and well-documented safety risks.5 The prevalence of anemia increases with the severity of CKD and is higher in people with CKD who are over age 60.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through hypoxia-inducible factor biology. Akebia’s lead product candidate, vadadustat, is an oral, investigational therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Akebia’s global Phase 3 program for vadadustat, which includes the PRO2TECT studies for non-dialysis patients with anemia secondary to chronic kidney disease and the INNO2VATE studies for dialysis-dependent patients, is currently ongoing. For more information, please visit our website at www.akebia.com.
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd., headquartered in Tokyo, Japan, with 2016 consolidated sales of approximately $11 billion.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at www.otsuka.co.jp/en/.
This press release includes forward-looking statements. Such forward-looking statements include those about Akebia’s strategy, future plans and prospects, including statements regarding the potential indications and benefits of vadadustat, the potential commercialization of vadadustat if approved by regulatory authorities, anticipated contributions from Otsuka pursuant to the Collaboration and License Agreement, Otsuka’s responsibilities pursuant to the Agreement, and the amount of collaboration-related funds able to be realized by Akebia. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development program for vadadustat; the funding required to develop Akebia’s product candidates and operate the company, and the actual expenses associated therewith; the actual costs incurred in the global Phase 3 studies of vadadustat and the availability of financing to cover such costs; the timing of any additional studies initiated by Akebia or its collaborators for vadadustat; the timing and content of decisions made by regulatory authorities; the rate of enrollment in clinical studies of vadadustat; the actual time it takes to initiate and complete clinical studies; Akebia’s ability to satisfy its obligations under the Collaboration and License Agreement; early termination of the Collaboration and License Agreement by Akebia or Otsuka, the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; and Akebia’s ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat around the world. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia’s Annual Report on Form 10-K for the year ended December 31, 2016, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
1Iseki K and Kohagura K. Anemia as a risk factor for chronic kidney disease. Kidney Int Suppl. 2007;107: S4-9.
2Culleton B, Manns B, Zhang J, et al. Impact of anemia on hospitalization and mortality in older adults. Blood. 2006;107(10): 3841-3846.
3Portolés J, Gorriz J, Rubio E, et al. The development of anemia is associated to poor prognosis in NKF/KDOQI stage 3 chronic kidney disease. BMC Nephrology. 2013;14 (1):2.
4IMS MIDAS, 2016.
5Singh AK. What is causing the mortality in treating the anemia of chronic kidney disease: erythropoietin dose or hemoglobin level? Curr Opin Nephrol Hypertens. 2010;19:420-424.
Theresa McNeely, 617-844-6113
SVP, Corporate Communications and Investor Relations
Jeffrey Gilbert, 81-3-6361-7379
Leader, Pharmaceutical Public Relations
(In the US)
Otsuka America Pharmaceutical, Inc.
Kimberly Whitefield, +1-609-535-9259
Critically ill patient successfully treated with personalized phage therapy under Emergency IND
AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a global leader in the development of therapies for drug-resistant bacterial infections using bacteriophage technology, announces that a case study highlighting the successful treatment of a critically ill patient with a multidrug-resistant (MDR) Acinetobacter baumannii (A. baumannii) infection will be featured in an oral presentation at the Centennial Celebration of Bacteriophage Research on April 26 at the Institut Pasteur in Paris. “Intravenous applications of phage therapy to treat a terminally ill patient who was infected with a multidrug-resistant A. baumannii” will be delivered by Dr. Biswajit Biswas of the U.S. Navy’s Medical Research Center-Biological Defense Research Directorate (NMRC-BDRD in Frederick, MD).
The case study involves a patient first diagnosed with an abdominal A. baumannii infection who had been treated with multiple courses of antibiotics over a four-month period, during which time the bacteria became resistant to cephalosporins, meropenem, gentamicin, amikacin, trimethoprim/sulfamethoxazole, tetracycline, ciprofloxacin and colistin. As the infection raged unchecked by antibiotics, the patient continued to deteriorate and eventually fell into a coma.
AmpliPhi was involved in a joint effort that included several academic institutions and the U.S. Navy laboratory that produced a customized bacteriophage therapy specifically targeted to the A. baumannii strain infecting the patient. In March 2016, therapy was initiated under an Emergency Investigational New Drug (IND) application approved by the U.S. Food and Drug Administration (FDA). Shortly after phage therapy was started, the patient emerged from the coma and continued to improve under ongoing phage therapy until the infection was cleared. To date, the infection has not returned.
The patient, Tom Patterson, Ph.D., a Professor at University of California, San Diego (UC San Diego), thanked the group that coalesced in the effort to save him and added, “I am living proof that MDR bacterial infections can be overcome. I am exceedingly grateful to the international community that made my recovery possible.”
Robert (Chip) Schooley, M.D., Professor of Medicine and Chief of the Division of Infectious Diseases at UC San Diego, who treated Dr. Patterson, remarked, “Phage therapy is a promising approach for treating patients suffering from serious bacterial infections that are highly resistant to currently available antibiotics. If successful, phage therapy could help tens of thousands of patients each year in the U.S. who have few or no other therapeutic options and, as a consequence, face severe disability or death.”
Previously, AmpliPhi’s wholly owned subsidiary, Special Phage Services, helped develop a personalized phage therapy that was used by Dr. Jonathan Iredell, Professor of Medicine and Microbiology at the University of Sydney and Westmead Institute of Medical Research, Director, Infectious Diseases, Westmead Hospital, to successfully treat an antibiotic-resistant Pseudomonas aeruginosa (P. aeruginosa) infection in the bladder of a female cancer patient. The results of this case were published in a manuscript in the Journal of Medical Microbiology and can be found at http://jmm.microbiologyresearch.org/content/journal/jmm/10.1099/jmm.0.029744-0#tab2.
In conjunction with the Centennial Celebration of Phage Research, Institut Pasteur is hosting a special symposium on April 27, entitled “Human Phage Therapy Day” http://www.bacteriophage100.org/phage-therapy-day2017. The gathering will bring together scientists, clinicians, veterinarians, pharmacists, legal experts and regulators from both the European Medicines Agency (EMA) and FDA and leaders at public and private institutions all with the goal of outlining what is needed to successfully reintroduce phage therapy as a solution to the growing crisis of antibiotic resistance.
About Antibiotic Resistance
Decades of misuse and over-use of antibiotics has led to the rise of multidrug-resistant and pan-resistant bacteria, commonly known as “superbugs.” These superbugs threaten to render existing antibiotic therapies useless, potentially thrusting the world into a “post-antibiotic” era where common infections may be life threatening. Hospitals regularly expose vulnerable patients to pathogenic bacteria. According to the World Health Organization, each year hundreds of millions of patients worldwide suffer from infections acquired in a hospital setting. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause at least 2 million infections per year in the U.S. alone, resulting in over 23,000 deaths and many more people die from other conditions that are complicated by antibiotic-resistant infections. The 2016 O’Neill Report commissioned by the UK government projects that the failure to respond to the threat of antibiotic resistance and the rise of superbugs could lead to an estimated 10 million deaths per year from antibiotic-resistant infections worldwide by 2050, with an accumulated global cost of $100 trillion and a 3.5% reduction in global GDP.
Bacteriophages, or more simply “phages,” are the natural predators of bacteria and are thought to be the most abundant life form on earth. Over eons, phages have evolved an incredible diversity of specialist strains that typically prey upon just one strain of bacteria, enabling phage therapies to precisely target pathogenic bacteria while sparing the beneficial microbiota. Phages can infect and kill bacteria, whether they are antibiotic-resistant or not, and even when they have formed protective biofilms.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation is a biotechnology company pioneering the development and commercialization of therapies for antibiotic-resistant infections using bacteriophage-based technology. AmpliPhi’s product development programs target infections that are often resistant to some or all existing antibiotic treatments. AmpliPhi has reported final results from two Phase 1 clinical trials of AB-SA01, one for the treatment of S. aureus in CRS patients and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. For more information, visit www.ampliphibio.com.
Forward Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the ability to rapidly manufacture customized therapies, the potential benefits of phage therapy, and AmpliPhi’s development of bacteriophage-based therapies. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. Among the factors that could cause actual results to differ materially from those indicated in these forward-looking statements are risks and uncertainties associated with AmpliPhi’s business and financial condition and the other risks and uncertainties described in AmpliPhi’s Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC, and other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
HERNANDO, FL–(Apr 19, 2017) – National Waste Management Holdings, Inc. (OTC: NWMH) (“National Waste”) today announces financial results for the full year ended December 31, 2016, demonstrating continued revenue growth and strength in acquisition-based growth strategy.
Full-year 2016 Highlights:
- Revenues for the twelve months ended December 31, 2016, increased 161% to $6.3 million;
- Cash flows from operating activities for the twelve months ended December 31, 2016, increased to over $1.0 million;
- Acquired Northeast Data and Recycling, LLC and Sivart Services, LLC during the year ended December 31, 2016;
- Continued to see positive results from acquisitions of WRE and Gateway;
- Engaged corporate communications firm to increase shareholder dialogue and transparency;
- Appointed as CFO, Dali Kranzthor, and expanded board of directors;
- Upgraded technology to improve efficiency and reporting
Louis Paveglio, CEO of National Waste Management Holdings Inc., stated, “We executed a number of achievements throughout 2016, and are pleased to report the positive impacts of these initiatives in several respects. Our significant increase in full-year revenues was driven by the performances of companies within our growing acquisition portfolio and subsequent vertical market reach. Additionally, we enjoyed the impact of a stronger economy, an expanded customer base, and an increase in construction activity in Florida — all of which also contributed to our top-line growth.”
Revenue for the 12 months ended December 31, 2016, increased 161% to $6.3 million, as compared to revenue of $2.4 million reported for the full year ended December 31, 2015. This increase is due to a stronger national economy, better utilization of resources, the WRE and Gateway acquisitions during 2015, and the May 2016 acquisition of Sivart, which added Cooperstown, New York, to National Waste’s geographical footprint in Upstate New York.
Net loss for the twelve months ended December 31, 2016, was $(765,208), as compared to a net loss of $(132,503) for the comparable period of 2015. Depreciation and amortization expense increased to $1.0 million during 2016, as compared to $271,311 in 2015. Adjusted earnings after adding back non-cash depreciation and amortization expense and a one-time non-cash impairment charge related to intangible assets of $159,977 in 2016 were $460,912 and $138,808, an increase of $322,104, or 232%. The increased adjusted earnings is attributable to the acquisitions of WRE and Gateway in 2015, Sivart in 2016, and increased operations at the Central Florida landfill.
“We continue to see exponential growth from our aggressive acquisition strategy as we pursue a strong pattern of vertical expansion,” says National Waste CFO Dali Kranzthor. “Our commitment to increased corporate and shareholder value is evidenced through the steps we took throughout 2016 to position National Waste Management as a market leader in 2017 and beyond.”
About National Waste Management Holdings Inc.
National Waste Management Holdings Inc. is a growing and emerging vertically integrated solid waste management company with a concentration on C&D collection, hauling and recycling. National Waste services Florida’s west coast and upstate New York and is a distinguished leader in solid waste services. More information may be found at the Company’s website: http://www.nationalwastemgmt.com.
This release contains certain statements that are, or may be deemed to be, forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934, and are made in reliance upon the protections provided by such Acts for forward-looking statements. We have identified forward-looking statements by using words such as “expect,” “believe,” and “should.” Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company’s Form SEC filings.
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