Eltek LTD (NASDAQ: ELTK) is our new profile-  Small 5.02M shares in the float 

 

Under the radar!

EBITDA  $2.64M

Revenue (TTM) $45.54M

Revenue per share $4.10

50% of the 10M outstanding shares held by insiders

Earnings due out tomorrow pre-market

Chart timing and setup looks ready for a breakout

Last two quarters showing improved net profit 

 

Eltek Reports Net Profit in the Third Quarter of 2015
— Net Profit of $624,000
— Gross Margin Increased to 15.9% from 12.8%

Link- http://finance.yahoo.com/news/eltek-reports-net-profit-third-083400502.html

 

Eltek Reports Net Profit in the Second Quarter of 2015
— Net Profit of $424,000
— Gross Margin Increased to 18.3% from 13.9%

link- http://finance.yahoo.com/news/eltek-reports-net-profit-second-071500382.html

 

About Eltek

Eltek is a global manufacturer and supplier of technologically advanced solutions in the field of Printed Circuit Boards, and is the Israeli leader in this industry. PCBs are the core circuitry of most electronic devices. Eltek specializes in the manufacture and supply of complex and high quality PCBs, HDI, multilayered and flex-rigid boards for the high-end market. Eltek has ITAR, AS-9100 and NADCAP Electronics permits and its customers include top of the line companies in the defense, aerospace and medical industries in Israel, the United States, Europe and Asia.

Eltek was founded in 1970. The Company’s headquarters, and R&D, Production and Marketing Center is located in Israel. Eltek operates also through its subsidiaries, Eltek USA (100%) in North America and Kubatronik (79%) in Europe and by agents and distributors in Europe, India, South Africa and South America.

Recent contracts awarded 

Nov. 23rd, 2015- Eltek Receives Orders Amounting to $1.4 Million from Customers in India

http://finance.yahoo.com/news/eltek-receives-orders-amounting-1-094000929.html

 

August 19th, 2015- Eltek Receives Orders Amounting to $1.1 Million From Three U.S. Customers in the Medical Device Sector – http://finance.yahoo.com/news/eltek-receives-orders-amounting-1-075000327.html

 

Earnings due March, 23rd 2016 pre-market , conference call scheduled 9:30AM

Barchart opinion 100% medium term buy and 80% near term “Buy”- http://www.barchart.com/opinions/stocks/ELTK

 

 

ELTK has shown a good history of moves to the upside in a hurry!

 

We will be back with more very soon on ELTK

 

The Team

 

 

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1 March, 2016

RedHill’s advanced pipeline includes three Phase III programs, several Phase II programs and additional early-stage programs.

RedHill maintains a strong and debt-free balance sheet, allowing the Company to continue to execute its development plans.

 

 Key potential highlights for 2016 include:

 

• RedHill has completed enrollment of over half of the patients in the RHB-104 Phase III study for Crohn’s disease and expects interim analysis of the Phase III study in H2/2016

 

• Top-line results from the Phase III study with BEKINDA^™ for gastroenteritis are expected in H2/2016

 

• Initiation of a confirmatory Phase III study with RHB-105 for H. pylori infection is expected in Q3/16

 

• Initiation of a Phase II study with BEKINDA^™ for IBS-D and interim top-line results from the Phase IIa proof-of-concept study with RHB-104 for multiple sclerosis are expected in the coming weeks

 

• Following initial non-clinical studies, RedHill continues to advance its collaboration with a U.S. government agency to test its proprietary experimental combination therapy for treatment of Ebola virus disease

  

TEL-AVIV, Israel, March 1, 2016 RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced select key research and development milestones and events anticipated in 2016.

RedHill’s pipeline includes several Phase III and Phase II-stage programs, as well as earlier–stage development programs. Select potential highlights for 2016 include:

RHB-104 – Crohn’s disease (Phase III) and multiple sclerosis (Phase IIa)

• RedHill has completed enrollment of over half of the planned 270 patients in the Phase III MAP US study for Crohn’s disease in the U.S. and additional countries. Interim analysis of the MAP US study is expected in the second half of 2016, after half of the patients enrolled in the study complete 26 weeks of treatment. If approved for marketing, RHB-104 is expected to become a potential paradigm changer in the treatment of Crohn’s disease, targeting a worldwide market estimated to exceed $6 billion in 2017¹.

 

• Interim top-line results from the CEASE-MS study, an open label Phase IIa, proof-of-concept clinical study exploring RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing-remitting multiple sclerosis (RRMS), are expected in the coming weeks.

 

• RedHill and Quest Diagnostics (Q Squared Solutions LLC) continue to make progress with the development of theMycobacterium avium subspecies paratuberculosis(MAP) companion diagnostic test following a pre-submission meeting held with the U.S. Food and Drug Administration (FDA) in 2015.

 

RHB-105 – H. pylori bacterial infection (Phase III)

• A meeting with the FDA is scheduled for April 2016 to discuss the planned confirmatory Phase III study with RHB-105 in the U.S. for the treatment of H. pylori infection.

 

• The FDA meeting follows positive top-line results from the ERADICATE Hp first Phase III study with RHB-105, conducted in the U.S., which successfully met its primary endpoint, demonstrating 89.4% efficacy in eradicatingH. pylori with high statistical significance (p<0.001). The Complete Study Report (CSR) is expected in the coming weeks.

 

• The FDA has granted RHB-105 Qualified Infectious Disease Product (QIDP) designation under the GAIN Act, allowing for a total of eight years of market exclusivity, Fast-Track development and Priority Review status which shortens review time for future marketing applications. RHB-105 is targeting a potential worldwide market estimated at approximately $4.83 billion in 2015².

  

BEKINDA^™ (RHB-102) – acute gastroenteritis (Phase III) and IBS-D (Phase II)

• Top-line results from the GUARD Phase III study with BEKINDA^™ 24 mg in the U.S. for acute gastroenteritis and gastritis are expected in the second half of 2016. If approved for marketing by the FDA, BEKINDA^™ is expected to be the first-ever 5-HT3 antagonist drug indicated for acute gastroenteritis, targeting a potential worldwide market estimated to exceed $650 million annually³.

 

• A Phase II study with BEKINDA^™12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) is planned to be initiated in the U.S. in the coming weeks, subject to regulatory clearance. The U.S. potential market for IBS-D treatments is estimated to exceed $1.3 billion by 2020⁴.

 

• RedHill is also pursuing potential marketing approval of BEKINDA^™in Europe for the oncology support indications of chemotherapy and radiotherapy-induced nausea and vomiting, pending additional discussions and feedback from European Member States as to whether additional clinical and CMC work is required.

 

YELIVA^™ (ABC294640) – diffuse large B-cell lymphoma (Phase I/II), refractory or relapsed multiple myeloma (Phase I/II) and radioprotection (Phase II)

• A Phase I/II clinical study was initiated to evaluate YELIVA^™ in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL). The study is being conducted at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans and is supported by a grant awarded to Apogee Biotechnology Corp. (“Apogee”), from which RedHill acquired the rights to YELIVA^™, from the NCI Small Business Technology Transfer (STTR) program, as well as additional support from RedHill.

 

• A Phase I/II study with YELIVA^™for the treatment of refractory or relapsed multiple myeloma is planned to be initiated during the second quarter of 2016. The study will be conducted at Duke University Medical Center and is supported by a $2 million grant from the NCI Small Business Innovation Research Program (SBIR) awarded to Apogee in conjunction with Duke University, with additional support from RedHill.

 

• A Phase II clinical study to evaluate YELIVA™ as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy is planned to be initiated in the U.S. during the second half of 2016, subject to regulatory and other conditions.

 

• RedHill is pursuing additional oncology and gastrointestinal indications with YELIVA^™ and plans to initiate additional clinical programs, subject to regulatory and other conditions.

 

MESUPRON^® and RP101 – orally-administered oncology drug candidates (Phase II-stage)

• RP101 – Results from the ongoing pre-clinical studies conducted in collaboration with the Fraunhofer Institute for Cell Therapy and Immunology (IZI), are expected during the first half of 2016. The research collaboration tests RP101 in pre-clinical oncology models, including pancreatic cancer, in combination with standard-of-care chemotherapies, and is intended to support the existing Phase I and Phase II clinical data with RP101 and to assess the drug’s clinical development path.

 

• MESUPRON^® – Nonclinical studies are currently ongoing and are intended to support the clinical data from previous Phase I and Phase II studies with MESUPRON^®.

 

RIZAPORT^™ (RHB-103) – acute migraines

• In 2015, the Federal Institute for Drugs and Medical Devices of Germany (BfArM) granted marketing authorization of RIZAPORT^™ 5 mg and 10 mg under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State. RedHill and IntelGenx Corp. (“IntelGenx”) continue to work together to obtain national-phase approvals of RIZAPORT^™ in additional European DCP territories.

 

• RedHill and IntelGenx also continue to work together to bring RIZAPORT^™ to the U.S. market. The companies expect to re-submit the RIZAPORT^™ New Drug Application (NDA) to the FDA and receive a new PDUFA (Prescription Drug User Fee) date in the fourth quarter of 2016.

 

Ebola virus disease – early stage, non-clinical development program

•  Following positive initial non-clinical studies, RedHill continues to advance its collaboration with a U.S. government agency to test the antiviral activity of its proprietary experimental combination therapy of orally-administered actives for the treatment of Ebola virus disease.

 

About RedHill Biopharma Ltd.:

RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is a biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of inflammatory and gastrointestinal diseases, including cancer. RedHill’s current pipeline of proprietary products includes: (i) RHB-105 – an oral combination therapy for the treatment of Helicobacter pylori infection with successful top-line results from a first Phase III study; (ii) RHB-104 – an oral combination therapy for the treatment of Crohn’s disease with an ongoing first Phase III study and an ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA^™ (RHB-102) – a once-daily oral pill formulation of ondansetron with an ongoing Phase III study in the U.S. for acute gastroenteritis and gastritis and a planned Phase II study for IBS-D; (iv)RHB-106 – an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA^™ (ABC294640) – an orally-administered first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications with a Phase I/II study initiated for refractory/relapsed diffuse large B-cell lymphoma (DLBCL); (vi) MESUPRON^® – a Phase II-stage first-in-class uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumors; (vii) RP101 – currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (viii) RIZAPORT^™ (RHB-103) – an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015; and (ix) RHB-101 – a once-daily oral pill formulation of the cardio drug carvedilol.

 

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to establish and maintain corporate collaborations; (vi) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (vii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company’s business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 25, 2016. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.

Company contact: Adi Frish Senior VP Business Development & Licensing RedHill Biopharma +972-54-6543-112 adi@redhillbio.com

IR contact (U.S.): Marcy Nanus Senior Vice President The Trout Group +1-646-378-2927 Mnanus@troutgroup.com

 

 

¹ EvaluatePharma, Crohn’s disease indication report.

² Jerry Rosenblatt, Ph.D., a member of RedHill’s Advisory Board and Partner at Foster Rosenblatt, RedHill Biopharma press release: RedHill Biopharma’s Investor Webcast Forum Provides Update on the RHB-105 Phase III Program and Potential H. pylori Eradication Market, May 18, 2015.

³ Graves S. Nancy, Acute Gastroenteritis, Prim Care Clin Office Pract 40 (2013) 727–741 and Company analysis.

⁴ GlobalData, EvaluatePharma.

• Today’s submission represents the Company’s first application to register a new medicine
• If approved, abaloparatide-SC would be the first new bone anabolic in Europe since 2003
• Company provides update on timing for NDA submission

WALTHAM, Mass., Nov. 17, 2015 (GLOBE NEWSWIRE) — Radius Health (Nasdaq:RDUS), today announced that it has submitted a Marketing Authorization Application (MAA) for an investigational, once-daily subcutaneous injection of abaloparatide, a novel synthetic peptide. In addition to other data, the MAA is supported by clinical studies exploring the use of abaloparatide for the treatment of women with postmenopausal osteoporosis, including the pivotal 18-month ACTIVE study which enrolled 2463 women. The announcement is being made during the Company’s Investor Day meeting being held today in New York City.

“Today marks a major milestone for Radius Health with the submission of our MAA in Europe for the investigational drug abaloparatide-SC for the potential treatment of postmenopausal osteoporosis.” said Robert E. Ward, President and CEO of Radius Health. “This is the first step towards achieving our goal to make abaloparatide available to patients around the world who are suffering from the burden of osteoporosis.”

At Investor Day, Radius Management discussed the Company’s latest progress and plans for the further development and, subject to receipt of approval following positive regulatory review, commercialization of abaloparatide, RAD1901 and RAD140. A replay of the webcast of the Company’s presentation will be available on the Company’s website approximately two hours following the completion of the event.

Abaloparatide

Following the completion and reporting of the positive top line results for the Phase 3 ACTIVE trial and the first six months of ACTIVExtend, Radius has now submitted the MAA for the investigational drug abaloparatide-SC in the EU.  The Company is now turning its focus to the completion of the work streams necessary for the submission of the New Drug Application (NDA) to the FDA for the investigational drug abaloparatide-SC. For the MAA, the Company has submitted 6-month stability data for abaloparatide in accordance with European requirements. As additional data become available, they will be submitted in support of our targeted 3-year shelf life for the commercial product following receipt of regulatory approval.

In the US, the FDA requires that 12-month stability data be submitted at the time of the NDA. The 12-month time point for the abaloparatide stability samples will be reached in December 2015 and Radius expects to initiate data analysis in January 2016. To accommodate this analytic plan, the Company announced a change in the NDA submission timing to the end of the first quarter of 2016. Similar to the European submission, as additional stability data become available they will be submitted in support of Radius’ targeted 3-year shelf life for the commercial product following receipt of regulatory approval. The Company believes that the stability data supporting both the MAA submission and the planned NDA submission will be sufficient to meet the regulatory standards for approval.

Radius plans to commence a clinical evaluation for an optimized abaloparatide transdermal patch by the end of 2015.

Radius confirmed that partnership discussions regarding abaloparatide commercialization are ongoing and that the Company expects to announce a partnership by the time of first commercial launch. Radius Health’s ideal partner for abaloparatide would have experience in the development and commercialization of therapeutics to treat osteoporosis and related bone metabolic disorders.

The Company reviewed the high unmet medical need associated with osteoporosis noting that, according to the International Osteoporosis Foundation, there is an osteoporosis-related fracture every three seconds worldwide. A Mayo Clinic paper published in 2015 estimates that the number of days of hospitalization related to osteoporotic fractures is significantly greater than the days of hospitalization for myocardial infarction, stroke, or breast cancer.

RAD1901

The investigational drug RAD1901, a selective estrogen receptor degrader, is currently being studied for potential use in metastatic breast cancer. Despite the introduction of new treatment options for metastatic breast cancer patients over the past decade, there remains a significant unmet medical need and a high rate of treatment resistance across first and second line therapies. Radius believes that a once-daily oral therapy such as the investigational drug RAD1901 may hold the potential to provide an important option as a single agent for overcoming endocrine resistance and to offer a profile well suited for use in combination therapy as well. Upcoming milestones for RAD1901 are:

• Radius plans to provide an update on the ongoing Phase 1 dose escalation study in metastatic breast cancer patients at the San Antonio Breast Cancer Symposium in December 2015.
• Radius expects to initiate an additional Phase I clinical trial in metastatic breast cancer patients in the European Union in December 2015.
• Radius intends to commence a Phase 2b trial for low-dose RAD1901 for vasomotor symptoms in December 2015.

RAD140

The investigational drug RAD140, a nonsteroidal selective androgen receptor modulator, or SARM, is currently in preclinical development as a potential treatment for breast cancer.  The androgen receptor (AR) is highly expressed in many estrogen receptor (ER)-positive breast cancers.

• Radius expects to commence a Phase 1 trial for the investigational drug RAD140 after making an Investigational New Drug (IND) submission in 2016.

About Radius Health

Radius is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers. Radius’ lead development candidate is the investigational drug abaloparatide for subcutaneous injection, currently in Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone driven, or hormone resistant, metastatic breast cancer, and vasomotor symptoms. www.radiuspharm.com

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the progress and timing of abaloparatide-SC in the regulatory process in Europe and the United States, the timing and sufficiency of data to meet approval requirements in Europe and the United States, expected shelf life for commercialized abaloparatide-SC, expectations regarding the timing and type of partnership for abaloparatide-SC, the unmet medical need for treatments of and the burden associated with osteoporosis, upcoming milestones for RAD1901, the timing of announcements of data from clinical trials for RAD1901, the progress and timing of clinical trials for abaloparatide-TD, RAD1901, RAD140 and the potential uses for RAD1901 and abaloparatide.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have no product revenues; our need for additional funding, which may not be available; we are not currently profitable and may never become profitable; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; failure of the financial institutions in which we hold our cash and cash equivalents; market, interest, and credit risk; our dependence on the success of abaloparatide-SC, and our inability to ensure that abaloparatide-SC will obtain regulatory approval or be successfully commercialized; risks related to clinical trials, including having most of our products in early stage clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates; product candidates for which we obtain marketing approval, if any, could be subject to restrictions or withdrawal from the market and we may be subject to penalties; failure to achieve market acceptance of our product candidates; risks related to the use of our limited resources on particular product candidates and not others; delays in enrollment of patients in our clinical trials, which could delay or prevent regulatory approvals; the dependence of our drug development program upon third-parties who are outside of our control; the risk that a regulatory or government official will determine that third-parties with a financial interest in the outcome of the Phase 3 study of abaloparatide-SC affected the reliability of the data from the study; our reliance on third parties to formulate and manufacture our product candidates; failure to establish additional collaborations; our lack of experience selling, marketing and distributing products and our lack of internal capability to do so; failure to compete successfully against other drug companies; developments by competitors may render our products or technologies obsolete or non-competitive; risks related to the fact that our drugs may sell for inadequate prices or patients may be unable to obtain adequate reimbursement; the effects of product liability lawsuits on commercialization of our products; failure to comply with obligations of our intellectual property licenses; failure to protect our intellectual property or failure to secure necessary intellectual property related to abaloparatide-SC, abaloparatide-TD, RAD1901 and/or RAD140; our or our licensors’ inability to obtain and maintain patent protection for technology and products; risks related to our compliance with patent application and maintenance requirements; failure to protect the confidentiality of our trade secrets; risks related to our infringement of third parties’ rights or the costs of defending against infringement by third parties; claims of wrongful disclosure or use of trade secrets by employees’ former employers; risks associated with intellectual property litigation, including expending substantial resources and distracting personnel from their normal responsibilities; risks associated with healthcare reform; our failure to comply with healthcare laws and regulations; our exposure to claims associated with the use of hazardous materials and chemicals; as we become involved in drug commercialization, risk related to our inability to successfully manage our growth and expanded operations; risks relating to business combinations and acquisitions; our reliance on key executive officers and advisors; our inability to hire additional qualified personnel; volatility in the price of our common stock; capital appreciation is the only source of gain for our common stock; risks related to the costs and compliance initiatives associated with operating as a public company; our directors, executive officers and principal stockholders have substantial influence over us and could delay or prevent a change in control; future sales and issuances of our common stock could depress the price of our common stock; risks related to securities or industry analysts ceasing to publish research about us or publishing inaccurate or unfavorable information about us, which could cause the price of our common stock to decline; provisions in our charter documents and Delaware law that could discourage takeover attempts; and our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.  These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 5, 2015, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  Any such forward-looking statements represent management’s estimates as of the date of this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 

CONTACT:

Investor Relations
Barbara Ryan
Partner
Clermont Partners
203-274-2825
bryan@radiuspharm.com

Media
Alice Pomponio
Radius Health
617-551-4099

— Management to host conference call today at 8:30 a.m. ET to provide business update and review fourth quarter and fiscal year 2015 financial results —

CAMBRIDGE, Mass.–(BUSINESS WIRE)–BIND Therapeutics, Inc. (NASDAQ: BIND), a biotechnology company developing targeted and programmable therapeutics called ACCURINS®, today reported financial results for the fourth quarter and full year 2015. Additionally, the Company announced a shift in its research and discovery strategy to focus on the development of innovative medicines, primarily in cancer. Moving forward, BIND plans to focus on the development of therapeutics that leverage the ability of ACCURINS® to incorporate novel combinations of targeting ligands and unique payloads including oligonucleotides and potent kinase inhibitors, creating synergistic properties in a single particle.

“Our new strategy is to build a pipeline of innovative medicines that address challenges that small molecule chemistry or antibody engineering have not been able to overcome,” said Andrew Hirsch, president and chief executive officer, BIND Therapeutics. “Historically, nanoparticle-based therapies have used previously approved medicines as therapeutic payloads to provide equivalent efficacy with improved safety. Our new strategy leverages the unique attributes of ACCURINS®, specifically their ability to precisely target cells and tissues with ligand-mediated binding while containing high concentrations of novel therapeutic payloads. We believe this approach will lead to innovative medicines with the potential to achieve therapeutic outcomes unachievable through existing therapeutic modalities.”

ACCURINS® possess several advantageous properties. The surface of ACCURINS® can be functionalized with ligands that can achieve tissue localization, cellular internalization or biological activity, thereby increasing the number of therapeutic strategies available. In addition, the modular nature of ACCURINS® enables the functionalization of more than one type of ligand on the surface. ACCURINS® are also able to incorporate novel therapeutic payloads with diverse physical and chemical properties, including oligonucleotides and potent kinase inhibitors. The release rate of Accurin payloads can also be controlled to optimize the amount of drug getting to the target tissue over the optimal amount of time.

“Our internal discovery efforts leverage the modular nature of ACCURINS®, allowing us to efficiently engineer ideal combinations of tumor-directed targeting ligands and new classes of therapeutic payloads,” said Jonathan Yingling, Ph.D., chief scientific officer of BIND. “When encapsulating oligonucleotide-based payloads, ACCURINS® have the potential to protect against enzymatic degradation and clearance in the plasma, target tissues beyond the liver, and concentrate them in target cells through ligand-mediated binding that results in tumor cell death. By incorporating small molecule kinase inhibitors, we believe ACCURINS® can control the biological activity of tumor-protective immune cells and reverse the immunosuppressed tumor microenvironment. Following optimization of lead product candidates and completion of preclinical studies, we anticipate initiation of clinical testing for one or more of our proprietary innovative product candidates as early as 2018.”

BIND remains committed to its ongoing collaborations and clinical-stage programs. The Company’s collaborations with AstraZeneca and Pfizer are intended to enable greater inhibition of important cellular pathways with our collaborators’ proprietary kinase inhibitors. Additionally, the Company expects to communicate topline data from the ongoing iNSITE 1 and 2 trials with BIND-014 in squamous cell non-small cell lung cancer (NSCLC), advanced cervical cancer and head and neck cancer in April 2016. As previously announced, further development of BIND-014 is contingent upon data from these trials.

Anticipated 2016 Milestones:

• Report topline data on the full 40 patients in iNSITE 1 squamous NSCLC trial with BIND-014
• Report Stage 1 data from iNSITE 2 trial with BIND-014 in advanced cervical and head and neck cancers
• Report in vivo proof-of-concept (POC) data for targeting tumor associated macrophages
• Identify first ACCURINS®-based immuno-oncology product concept
• Report initial in vivo POC data for discovery programs, with preclinical pharmacokinetic and efficacy data expected in second half of 2017
  • In vivo POC data for targeting guanylate cyclase-C (GC-C) receptors expressed on tumors, specifically GI malignancies
  • Further in vivo POC data in delivering single and double stranded RNA fragments to target cells and achieving target knock-down
  • Demonstrate in vitro and in vivo POC for achieving endosomal escape with double stranded RNA

2015 Business and Pipeline Highlights:

• Continued preclinical work, and generated promising initial data, on Accurin versions of anti-infective and oligonucleotide-based therapies
• Continued preclinical work related to targeting of tumor-associated macrophages
• Strengthened scientific leadership and corporate governance with appointment of Jonathan Yingling, Ph.D., as chief scientific officer for BIND, and appointment of Arthur Tzianabos, Ph.D., to Board of Directors
• Completed preclinical development for AZD2811, an Accurin containing AstraZeneca’s Aurora B Kinase inhibitor, for which AstraZeneca initiated a phase 1 clinical study in the fourth quarter of 2015
• Advanced collaboration with Pfizer following its exercise of its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate
• Achieved $4.0 million milestone with AstraZeneca for dosing first patient in Accurin AZD2811 phase 1 clinical trial
• Received $2.5 million option exercise fee from Pfizer to acquire an exclusive license for the development and commercialization of first compound covered by the agreement
• Recognized $14.3 million in 2015 in revenue from milestones, option exercises and reimbursable expenses related to our collaborations with AstraZeneca, Pfizer and Roche
• Enrolled patients in phase 2 iNSITE 1 and iNSITE 2 trials allowing the Company to report clinical data in April 2016
• Completed build out of dedicated manufacturing space, through an arrangement with a large contract manufacturing organization, that is capable of producing ACCURINS® at the double-digit kilogram scale

Fourth Quarter and Full Year 2015 Financial Results
Fourth quarter and full year 2015 revenue was $6.4 million and $15.4 million, compared to $3.0 million and $10.4 million for the same periods in 2014, respectively. The increase in revenue for the fourth quarter and full year 2015 was primarily due to the achievement of the $4 million milestone upon dosing of the first patient in Accurin AZD2811 phase 1 clinical trial.

Fourth quarter and full year 2015 research and development (R&D) expenses were $11.1 million and $37.3 millioncompared to $8.0 million and $28.9 million for the same periods in 2014, respectively. The increase in R&D expenses for the fourth quarter of 2015 compared to the fourth quarter of 2014 was primarily due to higher clinical development expenses of BIND-014 and reimbursable manufacturing expenses related to Accurin AZD2811. The increase in R&D expenses for the full year 2015 compared to the full year 2014 was primarily due to headcount growth to support the development of BIND’s internal programs and our collaborations, which led to an increase in salaries and benefits, higher reimbursable manufacturing expenses related to Accurin AZD2811 and increased clinical development expenses of BIND-014.

Fourth quarter and full year 2015 general and administrative expenses were $4.6 million and $17.6 million, respectively, compared to $4.2 million and $15.1 million for the fourth quarter and full year 2014, respectively.

Fourth quarter net loss was $7.6 million, or $0.37 per basic and diluted share, compared to a net loss of $8.5 million, or $0.51 per basic and diluted share for the fourth quarter of 2014. 2015 net loss was $36.6 million, or $1.81per basic and diluted share, compared to a net loss of $32.5 million, or $1.97 per basic and diluted share for 2014.

Cash, cash equivalents and short-term investments were $36.9 million as of December 31, 2015. The Company continues to expect its cash, cash equivalents and short-term investments will fund anticipated operations into the fourth quarter of 2016.

Conference Call Information

BIND’s management team will host a conference call and audio webcast today at 8:30 a.m. ET to discuss the fourth quarter and full year 2015 results and provide a corporate update. To access the conference call, please dial (877) 312-5844 (domestic) or (253) 237-1152 (international) at least five minutes prior to the start time and refer to conference ID 67565341.

An audio webcast of the call will also be available on the Investors & Media section of the Company’s websitewww.bindtherapeutics.com. An archived webcast will be available on the Company’s website approximately two hours after the event and will be available for 30 days.

About BIND Therapeutics
BIND Therapeutics is a biotechnology company developing novel targeted therapeutics, primarily for the treatment of cancer. Our product candidates are based on proprietary polymeric nanoparticles called ACCURINS®, which are engineered to target specific cells and tissues in the body at sites of disease. We are developing ACCURINS^® with three different therapeutic objectives, both through internal research programs and with collaborators: Innovative medicines; enabling potent pathway inhibitors; and differentiated efficacy with approved drugs. Our internal discovery efforts are focused on designing oligonucleotide and immuno oncology-based ACCURINS®. Our most clinically advanced Accurin, BIND-014, contains docetaxel and is currently in phase 2 clinical trials for the treatment of patients with squamous histology non-small cell lung cancer, advanced cervical cancer, and head and neck cancers.

BIND has announced ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd., Merck & Co., or Merck (known as Merck Sharp & Dohme outside the United States and Canada), Macrophage Therapeutics (a subsidiary of Navidea Biopharmaceuticals) and Synergy Pharmaceuticals to develop ACCURINS® based on their proprietary therapeutic payloads and/or targeting ligands. BIND’s collaboration with AstraZeneca has resulted in the Aurora B Kinase inhibitor Accurin AZD2811, which became the second Accurin candidate to enter clinical development. BIND’s collaboration with Pfizer has resulted in the selection of an Accurin candidate that is entering IND-enabling studies.

 

Forward-Looking Statements Disclaimer
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the ability of our therapeutics to achieve therapeutic objectives unachievable through current treatment modalities; the timing of initiation of clinical testing for our proprietary innovative product candidates; the timing of release of results from the ongoing iNSITE 1 and 2 trials with BIND-014 and reporting of in vivo proof-of-concept data; anticipated 2016 milestones; expectations regarding the sufficiency of our cash, cash equivalents and short term investments; and our collaboration agreements with Pfizer, Merck, AstraZeneca, F. Hoffmann-La Roche Ltd., and Macrophage.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the fact that the Company has incurred significant losses since its inception and expects to incur losses for the foreseeable future; the Company’s need for additional funding, which may not be available, in order to continue as a going concern; effects of adverse capital market conditions on the Company’s liquidity; any default on the Company’s credit facility, which could impact its ability to continue as a going concern; adverse effects on the Company’s business due to the report of its independent registered public accounting firm on its financial statements for the year ended December 31, 2015, which contains an explanatory paragraph regarding the Company’s ability to continue as a going concern; raising additional capital may cause dilution to its stockholders, restrict its operations or require it to relinquish rights to its technologies or drug candidates; the Company’s limited operating history; limitations on the Company’s ability to utilize net operating loss carryforwards and certain other tax attributes; failure to use and expand its MEDICINAL ENGINEERING® platform to build a pipeline of drug candidates and develop marketable drugs; the early stage of the Company’s development efforts with only BIND-014 and Accurin AZD2811 in clinical development; failure of the Company or its collaborators to successfully develop and commercialize drug candidates; clinical drug development involves a lengthy and expensive process, with an uncertain outcome; delays or difficulties in the enrollment of patients in clinical trials; serious adverse or unacceptable side effects or limited efficacy observed during the development of the Company’s drug candidates; inability to maintain any of the Company’s collaborations, or the failure of these collaborations; inability to enter into a collaboration for BIND-014; the Company’s reliance on third parties to conduct its clinical trials and manufacture its drug candidates; the Company’s inability to obtain required regulatory approvals; the fact that a fast track or breakthrough therapy designation by the FDA for the Company’s drug candidates may not actually lead to a faster development or regulatory review or approval process; the inability to obtain orphan drug exclusivity for drug candidates; failure to obtain marketing approval in international jurisdictions; any post-marketing restrictions or withdrawals from the market; effects of recently enacted and future legislation; failure to comply with environmental, health and safety laws and regulations; failure to achieve market acceptance by physicians, patients, or third-party payors; failure to establish effective sales, marketing and distribution capabilities or enter into agreements with third parties with such capabilities; effects of substantial competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to retain key executives and attract, retain and motivate qualified personnel; difficulties in managing the Company’s growth; risks associated with operating internationally, including the possibility of sanctions with respect to our operations in Russia; the possibility of system failures or security breaches; failure to obtain and maintain patent protection for or otherwise protect our technology and products; effects of patent or other intellectual property lawsuits; the price of our common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company; and any securities class action litigation.

Our expectation regarding the sufficiency of our cash, cash equivalents and short-term investments is subject to a number of additional risks and uncertainties. This expectation is based on our current operating plans and R&D funding that we expect to receive under our existing collaborations but excludes any potential milestone payments under our collaboration agreements. This expectation also assumes that the scheduled payments to Hercules Technology III, L.P. (“Hercules”) under our credit facility are not accelerated. Under the terms of our credit facility, Hercules could accelerate our payment obligations upon the occurrence of a circumstance that would reasonably be expected to have a material adverse effect, as defined in the credit agreement, or another event of default. If our principal obligations under our credit facility are accelerated, we would need to secure additional financing to fund our operating expense and capital expenditure requirements as early as the middle of April 2016. In the event we are unable to secure the necessary financing, we may need to cease operations or file for bankruptcy protection.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 15, 2016, and our other reports filed with theSEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

BIND THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Amounts in thousands, except share data)
				December 31, 2015				December 31, 2014
ASSETS
Current assets:
Cash and cash equivalents				$	24,654			$	19,348
Short-term investments					12,288				21,582
Amounts due under collaboration agreements					1,377				2,892
Prepaid expenses and other current assets					2,100				2,141
Total current assets					40,419				45,963
Property and equipment, net					9,764				6,567
Restricted cash and other assets					559				1,538
Total				$	50,742			$	54,068
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current portion of long-term debt				$	5,203			$	1,792
Accounts payable					3,793				1,796
Accrued expenses					5,712				5,260
Current portion of deferred revenue					3,302				5,087
Total current liabilities					18,010				13,935
Long-term liabilities:
Long-term debt, less current					9,482				1,482
Deferred revenue, less current					2,691				481
Warrant liability					2,894				—
Other long-term liabilities					538				1,006
Total long-term liabilities					15,605				2,969
Total liabilities					33,615				16,904
Total stockholders’ equity					17,127				37,164
Total				$	50,742			$	54,068

BIND THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (Amounts in thousands, except share and per share data)
				Three Months Ended December 31,								Year Ended December 31,
				2015				2014				2015				2014
Revenue				$	6,417			$	3,037			$	15,401			$	10,426
Operating expenses:
Research and development					11,108				8,019				37,273				28,874
General and administrative					4,575				4,198				17,610				15,060
Total operating expenses					15,683				12,217				54,883				43,934
Loss from operations					(9,266	)			(9,180	)			(39,482	)			(33,508	)
Other income					1,627				686				2,903				971
Net loss					(7,639	)			(8,494	)			(36,579	)			(32,537	)
Net loss per share:
Basic and diluted				$	(0.37	)		$	(0.51	)		$	(1.81	)		$	(1.97	)
Weighted average common shares outstanding:
Basic and diluted					20,795,086				16,548,092				20,224,292				16,495,648

 

BIND Therapeutics, Inc.
Media:
Jeff Boyle, 617-301-8816
media@bindtherapeutics.com
or
Investors:
Tom Baker, 617-532-0624
investors@bindtherapeutics.com

Source: BIND Therapeutics, Inc.

News Provided by Acquire Media

PDUFA Date Set for May 1, 2016

SAN DIEGO–(BUSINESS WIRE)–Nov. 2, 2015– ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced that the New Drug Application (NDA) for NUPLAZID^™ (pimavanserin) has been accepted for review by the U.S. Food and Drug Administration (FDA) and the agency has granted it Priority Review. ACADIA is seeking FDA approval of NUPLAZID for the treatment of psychosis associated with Parkinson’s disease. The FDA granted NUPLAZID Breakthrough Therapy designation for this indication in 2014.

The FDA grants Priority Review to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. Priority Review accelerates the review timeline from 10 months to six months from the date of acceptance of filing. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of May 1, 2016.

“The FDA Priority Review designation underscores the potential for NUPLAZID to provide an important treatment to patients with Parkinson’s disease psychosis, a condition for which there is no FDA-approved therapy,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “We look forward to working with the FDA during the review.”

NUPLAZID is a new class of non-dopaminergic antipsychotic that acts as an SSIA (selective serotonin inverse agonist), preferentially targeting 5-HT_2A receptors. Through this novel mechanism, NUPLAZID has demonstrated significant efficacy in Parkinson’s disease psychosis.

According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. An estimated 40 percent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions, a diminished quality of life, and significant caregiver burden.

ACADIA’s NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of NUPLAZID for Parkinson’s disease psychosis. The NDA includes data from the pivotal Phase III -020 Study, in which NUPLAZID showed statistical improvement on all primary and secondary efficacy endpoints with no worsening of motor function. Detailed results of the -020 Study were published in The Lancet.

About NUPLAZID^™ (pimavanserin)

NUPLAZID is ACADIA’s proprietary small molecule that is a selective serotonin inverse agonist preferentially targeting 5-HT_2A receptors that play an important role in psychosis. ACADIA has reported positive Phase III trial results with NUPLAZID. The NDA for NUPLAZID for the treatment of psychosis associated with Parkinson’s disease is currently under Priority Review with the FDA. NUPLAZID is administered orally once-a-day. ACADIA discovered NUPLAZID and holds worldwide rights to this new chemical entity. The trade name NUPLAZID has been provisionally accepted by the FDA. The safety and efficacy of NUPLAZID have not been fully evaluated by any regulatory authority.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has a pipeline of product candidates led by NUPLAZID™ (pimavanserin), for which we have submitted a New Drug Application in Parkinson’s disease psychosis to the FDA and which has the potential to be the first drug approved in the United States for this condition. Pimavanserin is also in Phase II development for Alzheimer’s disease psychosis and has successfully completed a Phase II trial in schizophrenia. ACADIA also has clinical-stage programs for glaucoma and, in collaboration with Allergan, Inc., for chronic pain. ACADIA maintains a website at www.acadia-pharm.com to which we regularly post copies of our press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the timing of the potential approval of an NDA for NUPLAZID (pimavanserin); the potential for NUPLAZID to be the first drug approved in the United States for Parkinson’s disease psychosis; the potential benefits to be derived from ACADIA’s product candidates, including NUPLAZID; and the progress, timing and results of ACADIA’s drug discovery and development programs, either alone or with a partner, including the progress and expected timing of clinical trials. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development, approval and commercialization, and in collaborations with others, and the fact that past results of clinical trials and past regulatory decisions may not be indicative of future trial results or regulatory decisions, respectively. For a discussion of these and other factors, please refer to ACADIA’s annual report on Form 10-K for the year ended December 31, 2014 as well as ACADIA’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

 

Source: ACADIA Pharmaceuticals Inc.

Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, 858-558-2871
Director of Investor Relations
or
Media Contact:
Chandler Chicco Agency
David Polk, 310-309-1029 or 805-428-5775