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CEL-SCI Corporation Message Board

seecuriityman 26 posts  |  Last Activity: Jul 29, 2015 7:26 AM Member since: Jun 23, 2011
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  • -- Conference Call Scheduled for Monday, August 10, 2015 at 8:30 a.m. EDT --

    Sentiment: Hold

  • seecuriityman by seecuriityman Jul 17, 2015 6:28 AM Flag

    http://secfilings.com/searchresultswide.aspx?link=1&filingid=10811276

    Sentiment: Hold

  • seecuriityman by seecuriityman Jul 9, 2015 6:22 AM Flag

    Can't post.

    Sentiment: Hold

  • PRESS RELEASE
    Synthetic Biologics' Initiates SYN-010 Phase 2 Clinical Trial to Treat Irritable Bowel Syndrome with Constipation (IBS-C)

    By
    Published: June 29, 2015 6:57 a.m. ET

    0
    -- Study to Evaluate Effect of SYN-010 in Reducing Methane Production in the Gut ---- Methane Production is Perceived as the Underlying Cause of Pain, Bloating and Constipation Associated with IBS-C --

    ROCKVILLE, Md., June 29, 2015 /PRNewswire/ -- Synthetic Biologics, Inc. (nyse mkt:SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported the initiation of a Phase 2 clinical trial of its proprietary SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C). This is a placebo-controlled study to evaluate the ability of two dose strengths of SYN-010 to reduce the production of methane in breath methane-positive patients with IBS-C. Breath methane is strongly associated with constipation in IBS-C and higher methane levels are proportional to constipation severity.

    IBS affects an estimated 10 to 15 percent of the population, or as many as 45 million people in North America[i]. The illness affects both men and women; however, two-thirds of diagnosed sufferers are women. It has been reported that up to 20 percent of all IBS patients have IBS-C. Current U.S. Food and Drug Administration (FDA)-approved therapies for the treatment of IBS-C include AMITIZA® (lubiprostone) and LINZESS® (linaclotide), and prescription and over-the-counter laxatives. These products provide patients with temporary symptomatic relief, but do not treat the underlying cause of pain, bloating and constipation associated with IBS-C.

    SYN-010 is a proprietary, modified-release formulation of the classic statin, lovastatin, that is intended to reduce methane production by certain microorganisms (M. smithii) in the gut while minimizing disruption to the microbiome. Methane produced by M. smithii is perceived as the underlying cause of pain, bloating, and constipation associated with IBS-C. SYN-010 is intended to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting the major cause of IBS-C, not just the symptoms. To access the SYN-010 mechanism of action video on Synthetic Biologics' website, please click here.

    "Initiating this Phase 2 clinical trial is an important first step to moving Synthetic Biologics' IBS-C program through the clinic," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "Patients who complete this first Phase 2 clinical trial of SYN-010, may enroll in a second, SYN-010 only, Phase 2 extension clinical trial that will evaluate the ability of SYN-010 to sustain the reduction in breath methane levels. We anticipate initiating the second Phase 2 trial and reporting topline results from the first Phase 2 clinical trial during the second half of 2015."

    This Phase 2, randomized, double-blind, parallel-group, placebo-controlled, multi-dose study is expected to be conducted at multiple centers in the United States. The primary objective of this study is to evaluate the change from baseline in breath methane, as determined by a lactulose breath test, in methane-positive patients with IBS-C after seven days of treatment with one of two formulations of SYN-010 compared with placebo. Approximately 60 patients will be enrolled and randomly assigned in a 1:1:1 ratio to one of three groups, including two different SYN-010 dose groups and a placebo group. Patients are scheduled to receive single oral doses of SYN-010 each day for 28 days.

    Mark Pimentel, M.D., FRCP(C), Director of the GI Motility Program and Laboratory at Cedars-Sinai, and lead investigator of the team whose pioneering discoveries established the foundation of Synthetic Biologics' IBS-C program, stated "With up to 9 million people suffering from IBS-C in the U.S., the development of SYN-010 has an opportunity to address a significant unmet medical need. Current treatments are focused on relieving symptoms, whereas SYN-010 has therapeutic potential to diminish the production of methane in the gut, treating a major cause of IBS-C, not just the symptoms."

    Synthetic Biologics anticipates a 505(b)(2) regulatory pathway for SYN-010 which is designed to reduce the impact of methane producing organisms on IBS-C. A portfolio of granted use patents and pending applications for SYN-010 has been licensed by Cedars-Sinai to the Company. Additional worldwide patent filings covering composition of matter claims, which were filed by Cedars-Sinai in 2014 and licensed to Synthetic Biologics, could extend patent protection of SYN-010 to 2035.

    Sentiment: Hold

  • http://secfilings.com/searchresultswide.aspx?link=1&filingid=10761788

    Sentiment: Hold

  • http://www.marketwatch.com/story/intrexon-forms-multi-year-collaboration-with-new-dedicated-fund-2015-06-15?siteid=nbkh

    Sentiment: Hold

  • They deleted the post before. I'll leave the body off.

    Sentiment: Hold

  • PRESS RELEASE
    Synthetic Biologics Expands Clinical & Regulatory Leadership Team with Addition of Klaus Gottlieb, MD, FACG

    By
    Published: June 2, 2015 6:57 a.m. ET

    0
    -- GI Clinician and Scientist Most Recently Served in Leadership Positions at Quintiles and the U.S. Food & Drug Administration (FDA) --

    ROCKVILLE, Md., June 2, 2015 /PRNewswire/ -- Synthetic Biologics, Inc. (nyse mkt:SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, announced Klaus Gottlieb, MD, FACG, has joined the Company as Vice President, Clinical & Regulatory Affairs, effective June 22, 2015. Dr. Gottlieb's appointment expands the clinical and regulatory leadership team as the Company moves into Phase 2 clinical trials for its irritable bowel syndrome with constipation (IBS-C) and C. difficile programs. He will report to Joseph Sliman, MD, MPH, Synthetic Biologics' Senior Vice President, Clinical & Regulatory Affairs.

    Dr. Gottlieb is an experienced board-certified internist and gastroenterologist with a strong clinical science, business and drug development background. He has led cross-functional teams in a variety of settings in industry, academia, private practice and with the FDA. He joins Synthetic Biologics after serving as Senior Medical Director-Therapeutic Strategy Lead Gastroenterology of Quintiles, a Fortune 500 company and the world's largest provider of biopharmaceutical development and commercial outsourcing services. At Quintiles, Dr. Gottlieb served as Global Medical Advisor for three separate large Phase 3 inflammatory bowel disease (IBD) trials and provided significant input on the shaping, design and evaluation of numerous IBD and other gastrointestinal (GI) clinical trials throughout all stages of development programs. Prior to joining Quintiles in 2013, he was with the FDA in Silver Spring, MD as a Senior Clinical Reviewer for the Division of Gastroenterology and Inborn Errors Products. Previously, Dr. Gottlieb spent 11 years at Sacred Heart Medical Center, a 500-bed full service hospital in Spokane, WA.

    "Klaus Gottlieb's broad clinical and regulatory experience makes him the ideal candidate to join our team as we prepare to advance several Phase 2 programs in the clinic," said Dr. Sliman. "His accomplishments in the GI and microbiome areas are critical to Synthetic Biologics' continued successful product development. We believe Klaus' knowledge of clinical pathways to commercialize products for the treatment of GI diseases will be especially valuable to us as our team moves the SYN-010 therapeutic program to address IBS-C into Phase 2 later this month, and the SYN-004 program to protect the microbiome and prevent C. difficile infection and antibiotic-associated diarrhea into a Phase 2b during the third quarter of this year."

    Dr. Gottlieb graduated from medical school in 1987 and received a Dr. med. degree from the University of Bonn, Germany, for bench research conducted in Medical Microbiology, a Masters of Business Administration degree from Indiana University in 2000 and a Masters of Science in Biotechnology from Johns Hopkins University in 2012. Widely published, his academic contributions have been recognized by an appointment as Professor of Medicine (Clinical) at George Washington University and the following elected fellowships: Fellow American College of Physicians, Fellow American College of Gastroenterology, Fellow American Society of Gastrointestinal Endoscopy.

    Sentiment: Hold

  • Reply to

    Chief Financial Officer is Buying.

    by mundomayagold Jun 1, 2015 5:27 PM
    seecuriityman seecuriityman Jun 1, 2015 6:10 PM Flag

    FORM 4
    [ ] Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION
    Washington, D.C. 20549
    STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES

    OMB APPROVAL
    OMB Number: 3235-0287
    Estimated average burden
    hours per response... 0.5

    Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934 or Section 30(h) of the Investment Company Act of 1940

    1. Name and Address of Reporting Person *
    SHALLCROSS STEVEN A 2. Issuer Name and Ticker or Trading Symbol
    Synthetic Biologics, Inc. [ SYN ] 5. Relationship of Reporting Person(s) to Issuer (Check all applicable)
    _____ Director _____ 10% Owner
    __ X __ Officer (give title below) _____ Other (specify below)
    Chief Financial Officer
    (Last) (First) (Middle)
    C/O SYNTHETIC BIOLOGICS, INC.,, 155 GIBBS STREET, SUITE 412 3. Date of Earliest Transaction (MM/DD/YYYY)
    6/1/2015
    (Street)
    ROCKVILLE, MD 20850
    (City) (State) (Zip)
    4. If Amendment, Date Original Filed (MM/DD/YYYY)

    6. Individual or Joint/Group Filing (Check Applicable Line)
    _ X _ Form filed by One Reporting Person
    ___ Form filed by More than One Reporting Person

    Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
    1.Title of Security
    (Instr. 3) 2. Trans. Date 2A. Deemed Execution Date, if any 3. Trans. Code
    (Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
    (Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
    (Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
    Code V Amount (A) or (D) Price

    Table II - Derivative Securities Beneficially Owned ( e.g. , puts, calls, warrants, options, convertible securities)
    1. Title of Derivate Security
    (Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Trans. Date 3A. Deemed Execution Date, if any 4. Trans. Code
    (Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D)
    (Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date 7. Title and Amount of Securities Underlying Derivative Security
    (Instr. 3 and 4) 8. Price of Derivative Security
    (Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form of Derivative Security: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4)
    Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
    Stock Options $2.16 6/1/2015 A 900000 (1) 7/1/2015 (1) 5/31/2025 Common Stock 900000 $0 900000 D
    Explanation of Responses:
    ( 1) These options will vest monthly on a pro rated basis over 36 consecutive months.

    Reporting Owners
    Reporting Owner Name / Address
    Relationships
    Director 10% Owner Officer Other
    SHALLCROSS STEVEN A
    C/O SYNTHETIC BIOLOGICS, INC.,
    155 GIBBS STREET, SUITE 412
    ROCKVILLE, MD 20850

    Chief Financial Officer

    Signatures
    /s/ Steven A. Shallcross 6/1/2015
    ** Signature of Reporting Person Date

    Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
    * If the form is filed by more than one reporting person, see Instruction 4(b)(v).
    ** Intentional misstatements or omissions of facts constitute Federal Criminal Violations. See 18 U.S.C. 1001 and 15 U.S.C. 78ff(a).
    Note: File three copies of this Form, one of which must be manually signed. If space is insufficient, see Instruction 6 for procedure.
    Persons who respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB control number.

    Sentiment: Hold

  • PRESS RELEASE
    Synthetic Biologics to Host Microbiome Analyst & Investor Meeting

    By
    Published: June 1, 2015 6:58 a.m. ET

    0
    -- Leading Clinicians to Discuss Novel Approaches to Treating IBS-C and Preventing C. difficile ---- Webcast Scheduled at 9:00 a.m. EDT on Wednesday, June 3, 2015 --

    ROCKVILLE, Md., June 1, 2015 /PRNewswire/ -- Synthetic Biologics, Inc. (nyse mkt:SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, today announced that the Company is hosting its Microbiome Analyst & Investor Meeting on Wednesday, June 3, 2015, at the Grand Hyatt New York Hotel. Synthetic Biologics will provide an overview of the clinical, regulatory and commercial pathways of the Company's clinical-stage therapeutics, including SYN-010 to reduce the impact of methane producing organisms on irritable bowel syndrome with constipation (IBS-C), and SYN-004 to protect the gut microbiome from intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection.

    The program includes presentations by Synthetic Biologics' President and Chief Executive Officer Jeffrey Riley and Senior Vice President, Clinical & Regulatory Affairs, Joseph Sliman, M.D., MPH. In addition, keynote speakers, Mark Pimentel, M.D., FRCP(C), Director, GI Motility Program and Laboratory, and Professor of Medicine at Cedars-Sinai in Los Angeles, and Professor Mark H. Wilcox, M.D., FRCPath, Consultant/Head of Microbiology at the Leeds Teaching Hospitals NHS Trust, Professor of Medical Microbiology at the University of Leeds and the Lead on C. difficile Infection, Public Health England (PHE), will discuss Synthetic Biologics' novel approaches to treating IBS-C and preventing C. difficile.

    A live webcast of the presentations will begin on June 3, 2015, at 9:00 a.m. EDT and the webcast is scheduled to conclude by 11:30 a.m. EDT. The live webcast of the event will be available via the internet at: https://tallen.webcasts.com/starthere.jsp?ei=1066312. An archived webcast will be available at the same website following the meeting.

    Sentiment: Hold

  • seecuriityman by seecuriityman May 27, 2015 11:46 AM Flag

    People can post all this #$%$ just don't post fact.
    The next time I post on the CVM MB is after I sell.

    Sentiment: Hold

  • Cel Sci Corp [CVM]
    files SEC Form 424B5

    Filed Pursuant to Rule 424(b)(5)
    Registration No. 333-196243

    CEL-SCI CORPORATION

    Up to 20,253,164 Shares of Common Stock
    Warrants to Purchase up to 20,253,164 Shares of Common Stock

    _________________

    We are offering up to 20,253,164 shares of common stock and warrants (Series V) to purchase up to 20,253,164 shares of common stock. Each share of common stock is being sold together with a warrant to purchase one share of our common stock for the combined purchase price of $0.79. Each warrant can be exercised at any time on or before May 28, 2020 at a price of $0.79 per share. The shares of common stock and warrants will be issued separately. This prospectus also registers the issuance of the shares of common stock issuable upon exercise of the warrants being offered.

    Our common stock is currently traded on the NYSE MKT (formerly known as the NYSE Amex) under the symbol “CVM.” On May 21, 2015, the closing price of our common stock on the NYSE MKT was $0.79 per share. There is presently no public market for the warrants we are offering by means of this Prospectus Supplement, and it is not anticipated that a public market for the warrants will develop in the future. We will not apply to list the warrants on NYSE MKT. For a more detailed description of our common stock and warrants, see the section entitled “Description of Securities” beginning on page S-55 of this Prospectus Supplement.

    See “Risk Factors” beginning on page S-12 of this prospectus supplement and the risks set forth under the caption “Item 1A. Risk Factors” included in our most recent Annual Report on Form 10-K/A, which is incorporated by reference herein, for certain risks relevant to an investment in shares of our securities.
    _________________

    Price to Public
    Placement Agent Commissions (1)
    Proceeds, Before Expenses, To Us

    Per Share $ 0.78 $ 0.0546 $ 0.7254
    Per Warrant $
    0.01
    $
    0.0007
    $ 0.0093
    Total (2) $ 0.79 $ 0.0553 $ 0.7347

    Sentiment: Hold

  • seecuriityman by seecuriityman May 22, 2015 9:22 AM Flag

    Left and right.

  • PRESS RELEASE
    Synthetic Biologics' SYN-004 Microbiome-Protecting Preclinical Data Highlighted in Late-Breaking Poster at Digestive Disease Week® 2015

    By
    Published: May 19, 2015 9:30 a.m. ET

    0
    -- Company's Program for Prevention of C. difficile Infection in Phase 2a Clinical Trial and on Target for Phase 2b Clinical Trial Initiation in 2H 2015 --

    ROCKVILLE, Md., May 19, 2015 /PRNewswire/ -- Synthetic Biologics, Inc. (nyse mkt:SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, presented preclinical results in a late-breaking poster at Digestive Disease Week® (DDW) 2015 in Washington, DC today. The research supports the development of SYN-004, the Company's candidate therapy designed to degrade certain intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract and maintain the natural balance of the gut microbiome for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD). Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone.

    The "SYN-004, a Clinical Stage Oral Beta-Lactamase Therapy, Protects the Intestinal Microflora from Antibiotic-Mediated Damage in Humanized Pigs" poster summarized preclinical efficacy data that support the ability of SYN-004 to degrade certain beta-lactam antibiotics in the GI tract, with the following conclusions:

    In fistulated dogs, oral delivery of SYN-004 resulted in efficient degradation of ceftriaxone in the GI tract, and
    In humanized pigs, SYN-004 protected the intestinal microflora from ceftriaxone and maintained the natural balance of the microbiome.
    "The data suggest that SYN-004 has the potential to protect the human microbiome and to become the first prophylactic therapy designed to prevent antibiotic-mediated microbiome damage, including C. difficile infection, in patients receiving beta-lactam antibiotics," stated Michael Kaleko, M.D., Ph.D., Senior Vice President, Research & Development of Synthetic Biologics.

    "These findings support our ongoing Phase 2a clinical trial that is evaluating the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of up to 20 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream," noted Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "We are on schedule to report topline data from the Phase 2a clinical trial of SYN-004 this quarter, with a Phase 2b clinical trial anticipated to initiate during the second half of this year."

    The U.S. Centers for Disease Control and Prevention (CDC) has categorized C. difficile as an "urgent public health threat," and has stated the need for research to better understand the role of normal gut bacteria. SYN-004 is intended to block the unintended harmful effects of certain IV antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infections[i] and 30,000 C. difficile-related deaths[ii] in the United States each year. Approximately 118 million doses of IV beta-lactam antibiotics[iii] that could be inactivated in the GI tract by SYN-004, were administered to approximately 14 million hospitalized U.S. patients during 2012.

    Sentiment: Hold

  • Reply to

    IBS-C NEWS on CBS nightly NEWS tonight

    by fanellisbackin May 18, 2015 6:51 PM
    seecuriityman seecuriityman May 19, 2015 7:11 AM Flag

    Did hear part of it this morning at 6:30 on WCBS 880.

    Sentiment: Hold

  • ...

    Sentiment: Hold

  • PRESS RELEASE
    Synthetic Biologics' Novel SYN-010 Preclinical Data Featured in Digestive Disease Week® Poster

    By
    Published: May 18, 2015 11:17 a.m. ET

    0
    -- Company's Irritable Bowel Syndrome with Constipation (IBS-C) Program to Reduce the Impact of Methane Gas in the Gut on Target to Initiate Phase 2 Clinical Trial in 2Q 2015 --

    ROCKVILLE, Md., May 18, 2015 /PRNewswire/ -- Synthetic Biologics, Inc. (nyse mkt:SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, announced that preclinical results supporting the development of SYN-010, the Company's candidate therapy to reduce the impact of methane producing organisms on irritable bowel syndrome with constipation (IBS-C), were presented in a poster at Digestive Disease Week® (DDW) 2015 in Washington DC today. The research was sponsored by Synthetic Biologics and performed at Cedars-Sinai under the direction of Mark Pimentel, M.D., FRCP(C), Director of Cedars-Sinai's GI Motility Program and Laboratory, and Chairman of Synthetic Biologics' IBS-C Clinical Advisory Board.

    The "Lovastatin Improves Stool Form in Methanobrevibacter smithii Colonized Rats with Constipation" poster summarized preclinical efficacy data that support advancing Synthetic Biologics' novel SYN-010, toward the clinic. The poster presented key data from a rat model, which confirmed findings from previous studies conducted by Dr. Pimentel, with the following conclusions:

    Lovastatin reduced Methanobrevibacter smithii (M. smithii) levels in the ileum (but not other intestinal segments) of rats administered a high-fat diet; and
    Lovastatin improved stool water content in these rats.
    "The data suggest that SYN-010 has therapeutic potential to diminish the production of methane in the gut, treating the cause of IBS-C, not just the symptoms," said Dr. Mark Pimentel.

    "The presentation at the DDW meeting highlighted the therapeutic potential of SYN-010 for IBS-C," stated Jeffrey Riley, Chief Executive Officer for Synthetic Biologics. "This research, along with the fact that SYN-010 is a new modified-release formulation of a widely prescribed statin drug, provides a strong body of evidence as Synthetic Biologics seeks to move our IBS-C program into a Phase 2 clinical trial during the second quarter of this year, with topline results anticipated to follow during the second half of this year."

    Dr. Pimentel led the investigational team at Cedars-Sinai whose discoveries established the foundation of Synthetic Biologics' IBS-C program. SYN-010 is a proprietary modified-release formulation of the classic statin, Lovastatin, that is optimal for reducing methane-production by certain microorganisms (M. smithii) in the gut while minimizing disruption to the microbiome. Methane produced by M. smithii is perceived as the underlying cause of bloating, pain and constipation associated with IBS-C, and may contribute to the pathology of other diseases. SYN-010 is intended to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting the cause of IBS-C, not just the symptoms.

    According to reports published by The International Foundation for Functional Gastrointestinal Disorders (IFFGD), IBS affects an estimated 10 to 15 percent of the population, or as many as 40 million Americans. The illness affects both men and women; however, two-thirds of diagnosed sufferers are women. The onset of IBS can begin anytime from adolescence to adulthood. It has been reported that up to one-third of all IBS patients have IBS-C. Current Food and Drug Administration (FDA)-approved therapies for the treatment of IBS-C include AMITIZA® (lubiprostone) and LINZESS® (linaclotide), and along with prescription and over-the-counter laxatives, provide patients with symptomatic relief and do not treat the underlying cause of bloating, pain and constipation associated with IBS-C.

    Synthetic Biologics anticipates a 505(b)(2) regulatory pathway for SYN-010 which is designed to reduce the impact of methane producing organisms on IBS-C. An extensive portfolio of granted use patents and pending applications for SYN-010 has been licensed by Cedars-Sinai to the Company. Additional worldwide patent filings covering composition of matter claims, which were filed by Cedars-Sinai in 2014 and licensed to Synthetic Biologics, could extend patent protection of SYN-010 to 2035.

    Sentiment: Hold

  • PRESS RELEASE
    CEL-SCI Receives Authorization to Conduct Its Phase 3 Multikine Trial in ItalyBy
    Published: May 13, 2015 9:00 a.m. ET

    0 Italy is 23rd country to authorize CEL-SCI’s trial for patient enrollmentVIENNA, Va., May 13, 2015 (BUSINESS WIRE) -- CEL-SCI Corporation (nyse mkt:CVM)(“CEL SCI” or the “Company”) today announced that the Italian Medicines Agency (AIFA) has authorized the Company to commence patient enrollment for its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer. Italy is the 23rd country to authorize CEL-SCI’s Phase 3 trial for patient enrollment.

    Having surpassed its originally planned milestone of receiving authorization to conduct the Phase 3 study from 21 countries, CEL-SCI is now aiming to expand the trial into a total of approximately 100 clinical centers in about 25 countries. As of April 30, 2015, 437 patients had been enrolled in the global Phase 3 study.

    Sentiment: Hold

  • PRESS RELEASE
    Synthetic Biologics Reports First Quarter 2015 Financial Results and Operational HighlightsBy
    Published: May 11, 2015 4:01 p.m. ET

    0 -- Initiated Phase 2 for Prevention of C. difficile, Expected to Initiate Phase 2 for IBS-C by end of June 2015, and Expanded Leadership Team as Company Moves into Next Development Stage ---- Conference Call Today, May 11, 2015, at 4:30 p.m. EDT --
    ROCKVILLE, Md., May 11, 2015 /PRNewswire/ -- Synthetic Biologics, Inc. (nyse mkt:SYN), a microbiome-focused, clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported financial results for the three months ended March 31, 2015, and provided an operational update.

    "We've made great progress during the first quarter of 2015," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "We've advanced our C. difficile program into Phase 2 clinical trials, plan to initiate Phase 2 clinical trials for our irritable bowel syndrome with constipation (IBS-C) program before the end of June, and expect to have Phase 2 data from both programs focused on protecting the microbiome by year end. Due to the nature of these microbiome programs, the time spent in the clinic is less than the typical drug development program, and we are positioned to create value for our shareholders at multiple points during the remainder of 2015."

    Mr. Riley added, "We've recently expanded our leadership team with the appointment of Steve Shallcross as our Chief Financial Officer beginning June 1st, and Maureen Early joining the team in the newly created position of Vice President, Commercial. We are very optimistic about the potential of Synthetic Biologics to meet unmet medical needs while generating significant returns for our shareholders."

    Clinical Programs Update

    Prevention of C. difficile infection – SYN-004:

    Completed Phase 1a and 1b clinical trials; reported positive topline safety and tolerability data from both studies
    Reported positive pharmacokinetic (PK) results from both the Phase 1a and 1b clinical trials, with supportive evidence for no active enzyme absorption into bloodstream observed
    Initiated a Phase 2a clinical trial to evaluate gastrointestinal (GI) antibiotic-degrading effects and safety
    Presenting poster of late-breaking preclinical data for protection of microbiome at Digestive Disease Week® (May 2015)
    Presenting poster of clinical data for protection of microbiome at American Society of Microbiology 2015 (June 2015)
    Expect topline data from Phase 2a clinical trial (2Q 2015)
    Plan to initiate a Phase 2b proof-of-concept clinical trial (2H 2015); expect topline data (2H 2015)
    IBS-C – SYN-010:

    Poster presentation of preclinical data by lead principal investigator of Cedars-Sinai Medical Center at Digestive Disease Week® (May 2015)
    Expect to submit an Investigational New Drug (IND) application to initiate clinical trials (2Q 2015)
    Plan to initiate Phase 2 clinical trials (2Q 2015); expect topline data (2H 2015)
    Pertussis (whooping cough) – SYN-005:

    Presented two posters at ECCMID 2015 (European Congress of Clinical Microbiology and Infectious Diseases) that highlighted positive preclinical data regarding the monoclonal antibody combination, SYN-005, for the treatment and prophylaxis of whooping cough
    Seeking non-dilutive funding to support preclinical and clinical development (ongoing)
    RRMS – Trimesta™:

    MRI brain scan analyses underway by University of California, Los Angeles (UCLA) to evaluate changes in the brain that correlate with improvements seen in clinical outcomes; topline data expected from UCLA (2Q 2015)
    As previously disclosed, active discussions with a number of potential strategic partners may accelerate development of Trimesta, pending data from UCLA (ongoing)
    A separate multi-center U.S. Phase 2 trial is underway focused exclusively on cognition utilizing Trimesta with a variety of currently marketed MS drugs
    Three Months Ended March 31, 2015 Financial Results

    General and administrative expenses increased to $1.7 million for the three months ended March 31, 2015, compared to $1.1 million for the same period in 2014. This increase of approximately 53% is primarily the result of increased employee costs, audit fees related to the additional procedures required under the accelerated filer status and stock compensation expense for the three months ended March 31, 2015. Non-cash charges related to stock-based compensation were $582,000 for the three months ended March 31, 2015, compared to $255,000 for the same period in 2014.

    Research and development expenses increased to $6.5 million for the three months ended March 31, 2015, compared to $2.7 million for the same period in 2014. This increase of approximately 139% is primarily the result of increased program costs associated with expanded clinical development, manufacturing and research activities within our pathogen-specific, microbiome-focused pipeline, including the Company's C. difficile, IBS-C and Pertussis programs. Research and development expenses also include a $1.0 million expense for achieving the third milestone as set forth in the Asset Purchase Agreement with Prev ABR LLC, dated November 28, 2012, related to the C. difficile program. Prev ABR LLC exercised its option to receive the milestone payments in shares of Synthetic Biologics' common stock, issued in April 2015. Non-cash charges related to stock-based compensation were $246,000 for the three months ended March 31, 2015, compared to $107,000 for the same period in 2014.

    Other expense was $4.2 million for the three months ended March 31, 2015, compared to other income of $1,000 for the same period in 2014. Other expense for the three months ended March 31, 2015 is primarily the result of a non-cash charge of $4.2 million related to the change in fair value of warrants. The increase in the fair value of the warrants was due to the increase in the stock price from the previous period. There was no non-cash income or expense relating to fair value warrants for the three months ended March 31, 2014.

    Cash at March 31, 2015 was $12.0 million compared to $17.5 million at December 31, 2014.

    Conference Call

    Synthetic Biologics will hold a conference call today, Monday, May 11, 2015, at 4:30 p.m. EDT. The dial-in information for the call is as follows: U.S. toll free: 1-888-347-5280, Canada toll free: 1-855-669-9657 and International: +1 412-902-4280.

    Participants are asked to dial in 15 minutes before the start of the call to register. Registered callers may ask to be placed in the queue for the Question & Answer Session. The call will also be webcast over the Internet athttp://www.videonewswire.com/event.asp?id=102272.

    An archive of the call will be available for approximately 90 days at the same URL,http://www.videonewswire.com/event.asp?id=102272, beginning approximately one hour after the call's conclusion.

    Sentiment: Hold

  • PRESS RELEASE
    CEL-SCI Receives Authorization to Conduct Its Phase 3 Multikine Trial in SpainBy
    Published: May 11, 2015 8:00 a.m. ET

    0 Spain is 22nd country to authorize CEL-SCI’s trial for patient enrollmentVIENNA, Va., May 11, 2015 (BUSINESS WIRE) -- CEL-SCI Corporation (nyse mkt:CVM)(“CEL SCI” or the “Company”) today announced that Spain’s Agency for Medicinal Products and Medicinal Devices has authorized the Company to commence patient enrollment for its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer. Spain is the 22nd country to authorize CEL-SCI’s Phase 3 trial for patient enrollment.

    CEL-SCI recently announced it had reached a key milestone of receiving authorization to conduct the Phase 3 study from 21 countries, as originally planned. The Company is aiming to expand the trial into a total of approximately 100 clinical centers in about 25 countries. As of April 30, 2015, 437 patients had been enrolled in the global Phase 3 study.

    Sentiment: Hold

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