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Alnylam Pharmaceuticals, Inc. Message Board

robert.vince 89 posts  |  Last Activity: Apr 9, 2014 11:47 AM Member since: Aug 30, 2012
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  • Reply to

    CTSO

    by gssolutions Jan 22, 2014 12:33 PM
    robert.vince robert.vince Jan 24, 2014 10:51 AM Flag

    I have both too, one moves, then the other, but I believe both will be in the money.

  • robert.vince robert.vince Jan 25, 2014 11:07 AM Flag

    Nice find Andy! Love seeing articles like this. The only thing that worries me about AEMD and CTSO is the market. If it crashes, people throw the babies out with the bathwater. Otherwise I see nothing but up for these companies. Keep up the good work.

  • robert.vince by robert.vince Jan 30, 2014 8:35 AM Flag

    Melbourne, Australia; Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow report for the period ended 31 December 2013.

    The cash balance at 31 December 2013 was $27.8 million, a net cash burn of $3.7 million for the quarter. The cash balance excludes the Company’s anticipated R&D tax incentive refund of $4.7 million receivable this financial year.

    The cash burn for the quarter includes expenditure relating to a number of clinical trials. This includes the recently commenced Phase 1 clinical trial of DEPTM Docetaxel, and also the advanced preparations for Phase 3 prevention of bacterial vaginosis (BV) clinical program for VivaGel®.

    During the quarter and ahead of the clinical trial, Starpharma reported highly positive preclinical results for DEPTM Docetaxel compared to the commercial version of docetaxel (Taxotere®). Animals treated with Starpharma’s DEPTM Docetaxel formulation exhibited a lack of neutropenia (low white blood cells). In contrast, animals treated with Taxotere® exhibited severe neutropenia, a sign of bone marrow toxicity and the most important dose-limiting side effect of Taxotere® in humans.

  • Reply to

    Potential news out of left feild

    by croupier77777 Jan 28, 2014 3:53 PM
    robert.vince robert.vince Feb 6, 2014 4:08 PM Flag

    'Keep this to yourself'?......I'm finally LOL, I mean noise actually left my throat in a giggly sort of way. Shhhhhh, don't tell anyone you just hit 'post' on an international bulletin board.....if we keep whispering reply's, maybe nobody will hear your initial post. Shhhhhhh......

  • Reply to

    ????

    by lqsi12 Feb 7, 2014 11:16 PM
    robert.vince robert.vince Feb 10, 2014 1:24 PM Flag

    I'm a paid member of the gumshoes. There is a wonderful ongoing discussion about SBOTF on the site. I do not recall seeing anything about failures. The only thing people are discussing is its potential, which most seem to think is unlimited.

  • Reply to

    S- 1/A form submitted

    by dk1949 Feb 10, 2014 3:11 PM
    robert.vince robert.vince Feb 10, 2014 3:17 PM Flag

    Definition of 'SEC Form S-1'

    The initial registration form for new securities required by the Securities and Exchange Commission (SEC) for public companies. Any security that meets the criteria must have an S-1 filing before shares can be listed on a national exchange.

    Form S-1 requires companies to provide information on the planned use of capital proceeds, detail the current business model and competition, as well provide a a brief prospectus of the planned security itself, offering price methodology, and any dilution that will occur to other listed securities. The SEC also requires the disclosure of any material business dealings between the company and its directors and outside counsel.

    Form S-1 is also known as the "Registration Statement Under the Securities Exchange Act of 1933".
    Investopedia Says
    Investopedia explains 'SEC Form S-1'

    Investors can view S-1 filings online to perform due diligence on new offerings prior to their issue. The form is sometimes amended as material information changes or general market conditions cause a delay in the offering.

    The Securities Exchange Act of 1933, often referred to as the "truth in securities" law, requires that these registration forms are filed to disclose important information upon registration of a company's securities. This helps the SEC achieve the objectives of this act, which is requiring investors to receive significant information regarding securities offered, and to prohibit fraud in the sale of the offered securities.

    A less rigid registration form is the S-3, which is for companies that don't have the same ongoing reporting requirements.

  • Stellar Biotechnologies, Inc. ("Stellar" or “the Company”) (OTCQB: SBOTF) (TSX-V: KLH), announced today the presentation of a poster at Aquaculture America 2014 (Seattle, February 9-12, 2014), describing a new method for verifying authenticity of Keyhole Limpet Hemocyanin (KLH) product.

    KLH is an important protein widely used in the pharmaceutical industry as a hapten carrier in active immune therapies and as an injectable product for immune function testing. KLH product is obtained only from the hemolymph of the Giant Keyhole Limpet (Megathura crenulata), a relatively scarce marine gastropod.

    The poster titled “When Is A Keyhole Limpet a Giant?: A Rapid Assay to Verify Megathura Crenulata Hemocyanin” is the result of work conducted jointly by California State University, Fullerton and Stellar’s scientists. The study goal was to design a rapid, cost-effective test to distinguish Megathura crenulata KLH from hemocyanins of non-Megathura crenulata source.

    The project involved development of a rapid, cost-effective method of verifying the source of a hemolymph product; specifically, a PCR-based test to positively identify if hemolymph is actually KLH (keyhole limpet hemocyanin), not from another gastropod species. The method relies on polymerase chain reaction (PCR), a molecular technique that amplifies DNA for analysis.

    “Verification of starting material is the foundation for ensuring KLH authenticity and quality,” said Catherine Brisson, Ph.D., Stellar’s Chief Operating Officer. “At Stellar, we are continually assessing advanced analytical methods for use in KLH production; a hallmark of our leading position in KLH manufacture and quality control.”

    Aquaculture America 2014 is the largest aquaculture conference in the Western hemisphere. It is hosted by the U.S. Aquaculture Society, a chapter of the World Aquaculture Society, dedicated to the exchange of information among the diverse aquaculture in the advancement of aquaculture industry.

  • Aethlon Medical (OTC BB:AEMD) filed their 10-Q for the fiscal third quarter 2014 ending 12/31/2013 on February 11th. Revenue of $76k was entirely from work under the subcontract agreement that the company has with Battelle related to the $22.8 million systems integrator contract with DARPA. Revenue missed our $496k estimate as AEMD did not book any DARPA related milestone revenue during the quarter but subsequent to quarter end billed DARPA $353k.

    Through December AEMD had billed $3.4 million under the DAPRA awards, which represents $1.97 million under the initial year-1 contract and $1.42 million under the year-2 contract (worth $1.6 million and containing eight milestones), which was awarded to the company in August 2012. We forecasted the final $197k milestone under the year-2 contract and ~$300k under the year-3 contract (which was awarded to the company in September and, initially was to pay up to $1.53 million if all eight milestones were met) to be paid in Q3. We have now pushed back these forecasted receipts to fiscal Q4 and Q1 2015.

    DARPA has the option of entering into the remainder of the proposed contract for years four and five. In the 10-Q AEMD notes that due to budget restrictions, DARPA plans to reduce the scope of AEMD's contract for years three through five. The three through five year contracts were initially worth ~$3.2M. Due to the budget change, this amount will now be ~$2.4M (the breakdown per contract-year was not disclosed). We have adjusted our model to account for the change.

  • Reply to

    Encouraging Meeting With CEO Jim Joyce

    by robert.vince Feb 13, 2014 9:41 AM
    robert.vince robert.vince Feb 13, 2014 9:42 AM Flag

    We also model additional, although relatively minimal revenue from the Battelle contract throughout fiscal 2014 and into 2015. As a reminder, AEMD's subcontract is a time and materials contract so the total that AEMD will eventually bill will not be known until their work is completed. We do, however, think it's likely that there will be additional revenue contribution from this contract.

    Q3 operating expenses were $1.3M, compared to our $1.1M estimate - the majority of the difference related to expenses of Exosome Sciences. Operating loss was $1.2M, compared to our $514k estimate - the difference mostly related to the delayed revenue relative to our forecast. Q3 net income and EPS were ($2.3) million and ($0.01) and included a $1.0M accrual related to a possible lawsuit settlement (if settled, it would be in the form of equity).

    Cash
    Aethlon continues to successfully raise operating capital on a regular basis and continues to make progress on cleaning up the balance sheet. During Q3 AEMD raised $3.2M from the sale of equity and repaid $200k of notes payable. We view the pricing, size and terms of the most recent equity raise as indicative of the continued and, potentially, growing interest in AEMD. Subsequent to quarter end another $17k in debt was repaid. Aethlon exited fiscal Q3 with $1.9M in cash and equivalents, compared to $9k at the end of fiscal Q2 2014 (9/30/2013). Cash used in operations was $839k in Q3.

    We continue to expect cash generated from government and other contracts along with additional funds raised through the sale of securities to fund the company over the near-to-mid term.

  • Reply to

    Encouraging Meeting With CEO Jim Joyce

    by robert.vince Feb 13, 2014 9:41 AM
    robert.vince robert.vince Feb 13, 2014 9:42 AM Flag

    Along with their ongoing ability to continue to raise operating capital, we have been encouraged, from the standpoint of strengthening their financial position and balance sheet, by the success of converting some of their outstanding debt to stock. While a substantial portion of debt remains in default, the company continues to make progress on cleaning up their balance sheet, which we view as meaningful from a de-risking perspective. We reiterate, however, as we have in the past, that Aethlon will need to raise a substantial amount of cash, enter into partnering arrangements or score additional valuable contracts/grants in order to complete the recently announced U.S. safety study and to be able to maintain operations for the longer-term. Nonetheless, we believe management's recent progress should not be marginalized.

    On the operational side, AEMD now has another potentially significant iron in the fire with its Exosome Sciences business. In late 2013 Exosome Sciences was resumed and a lab opened in New Jersey where that business is working from. The recent relatively large capital raise provided initial funding to commence work at the lab. Initially this is expected to focus on exosomes' role in cancer diagnosis. We met with Jim Joyce at the JP Morgan healthcare conference in San Francisco in January and came away encouraged that the Exosome Sciences team has already made progress in advancing their lead diagnostic ELLSA assay. With research on exosomes still in its infancy, AEMD clearly sees a real opportunity with the potential to be at the cusp of research and a leading knowledge base in the role that exosomes play in the progression of cancer.

  • Reply to

    Encouraging Meeting With CEO Jim Joyce

    by robert.vince Feb 13, 2014 9:41 AM
    robert.vince robert.vince Feb 13, 2014 9:42 AM Flag

    And while we do not currently model a contribution from the Exosome Sciences business, we do view this has possessing potential upside to AEMD's core business, particularly over the longer-term. We will update our model to incorporate a contribution from Exosome Sciences depending on its progression and when there's more insight into likelihood and timing of revenue generation.

    Relative to Hemopurifier AEMD remains focused on not only the HCV opportunity but also sees real potential with cancer secreted exosomes and other areas, including for bioterror agents and pathogens. Aethlon also remains encouraged that there is a potential opportunity for use of Hemopurifier therapy for compassionate use.

    We have updated our model for Q3 results and made minor changes as a result of the decrease in DARPA budget related to contract years 3,4 and 5.

  • Reply to

    Stellar named 2014 TSX Venture 50(R) Company

    by kab3466 Feb 13, 2014 9:43 AM
    robert.vince robert.vince Feb 13, 2014 12:09 PM Flag

    Stellar Biotechnologies, Inc. ("Stellar" or “the Company”) (OTCQB: SBOTF) (TSX-V: KLH), announced today that the Company has been named to the 2014 TSX Venture 50®, an exclusive ranking of the top performing companies on the TSX Venture Exchange.

    Stellar Biotechnologies is the top ranked company across all five industry sectors of the 2014 TSX Venture 50® list.

    The TSX Venture 50® is an annual ranking conducted by the TMX Group of the fifty strongest-performing companies on the Canadian TSX Venture Exchange, categorized by industry sector. The list is chosen based on four equally weighted criteria; market capitalization growth, share price, trading volume, and analyst coverage. The TMX Group, which owns the Toronto Stock Exchange and Toronto Venture Exchange, describes the winning companies as those having “shown impressive results in key measures of market performance.”

    “We are pleased to have this public market acknowledgement of Stellar’s accomplishments and growth potential,” said Frank Oakes, President and CEO. “We have a solid foundation and we continue to work diligently to deliver strong future returns to our shareholders and partners.”

  • Dendrimer-Docetaxel to enter human clinical trials
    Starpharma’s internal drug delivery program is approaching a major milestone
    and entering human clinical trials with its dendrimer-reformulated version of
    Docetaxel.
    A Phase 1 clinical trial of Dendrimer-Docetaxel – an enhanced version of the
    off-patent blockbuster anti-cancer drug docetaxel (Taxotere®) – is due to begin
    early in the New Year. The move into the clinic follows the successful results of a
    number of pre-clinical studies. Docetaxel, which is now generic, has reported
    annual sales of US$3.1 billion.
    The latest of these studies compared Dendrimer-Docetaxel to Taxotere®
    and demonstrated that Starpharma’s Dendrimer-Docetaxel did not cause
    neutropenia (reduced circulating neutrophil numbers) and other important bone
    marrow-related toxicities (refer below). Severe neutropenia occurs in more than
    75% of patients treated
    with Taxotere®. Dendrimer-Docetaxel treated rats were also free from thrombocytopenia
    (low platelets) which, along with neutropenia, was observed in Taxotere®
    treated animals. Bone marrow toxicities are the most important doselimiting
    side effects of Taxotere®. Taxotere® carries a FDA “black box” warning
    (refer right) in its Product Information regarding toxicities including neutropenia,
    contraindications and management requirements for certain patients.
    Another toxicity-reducing benefit attributed to Dendrimer-Docetaxel is the
    removal of the detergent – Polysorbate 80 – from its formulation. Dendrimer-
    Docetaxel has markedly improved solubility making the Dendrimer-Docetaxel
    formulation water soluble so it is free of detergent (Polysorbate 80). Drugs
    containing Polysorbate 80 (eg. Taxotere® and other docetaxel formulations) can
    trigger hypersensitivity reactions, or fatal anaphylaxis, in patients and this is also
    noted in the “black box” warning for all docetaxel formulations including
    Polysorbate 80.

  • Reply to

    December 13th Shareholder Letter

    by robert.vince Feb 14, 2014 11:01 AM
    robert.vince robert.vince Feb 14, 2014 11:02 AM Flag

    Apart from these reduced toxicities, earlier pre-clinical studies of
    Starpharma’s Dendrimer-Docetaxel have also demonstrated its
    significantly superior anti-cancer effectiveness – across a range of
    important cancer types including breast, prostate, lung and ovarian
    cancer – compared to Taxotere®. Starpharma’s dendrimers have also
    shown broad applicability to the delivery of drugs outside of oncology.
    It is estimated that dendrimers are applicable to more than 50% of
    leading pharmaceuticals – this includes small molecule drug, proteins
    (including insulin) and biologics such as antibodies.

  • Reply to

    December 13th Shareholder Letter

    by robert.vince Feb 14, 2014 11:01 AM
    robert.vince robert.vince Feb 14, 2014 11:04 AM Flag

    VivaGel® Phase 3 trial for prevention of recurrent BV
    Starpharma’s lead women’s health product VivaGel® will soon progress to
    pivotal Phase 3 clinical trials to confirm its ability to prevent recurrence of
    bacterial vaginosis (R-BV) infection. This trial will build on the positive
    results of a Phase 2 efficacy study earlier this year, which demonstrated both
    reduced overall risk of R-BV in patients using 1% VivaGel® and delayed time to
    first recurrence, compared with placebo. “Positive Phase 2 data was observed
    in April this year. We are now progressing VivaGel® to a phase 3 trial for a
    prevention of R-BV indication, and our preparations for this pivotal trial program
    are well advanced,” said Starpharma chief executive Dr Jackie Fairley.
    Preparations for the Phase 3 studies including designing the trial with
    regulatory input, as well as selection of trial sites and appointment of a leading
    global Contract Research Organisation.
    Existing treatments for BV are considered suboptimal. They do not offer
    a long term solution and are associated with high rates of recurrence, unpleasant
    side-effects, and high levels of bacterial resistance. There are currently no
    approved products to prevent R-BV, so VivaGel® has the potential to be a 1st in
    class therapeutic for prevention of R-BV.
    BV is the most common cause of vaginal infection worldwide and BV
    prevalence is known to vary by country and population group. A recent review of
    almost 1,700 BV research papers, identified BV prevalence approaching
    60% of women in some African nations.
    In the US, overall BV prevalence was 29.2% and highest among non-Hispanic
    blacks (51.4%) followed by Hispanics (31.9%) then non-Hispanic whites
    (23.2%). In the UK, overall BV prevalence was 10.9%.

  • Reply to

    December 13th Shareholder Letter

    by robert.vince Feb 14, 2014 11:01 AM
    robert.vince robert.vince Feb 14, 2014 11:07 AM Flag

    VivaGel®-coated
    condom: Consumer
    feedback
    The VivaGel®-coated condom is currently
    undergoing regulatory review and
    significant prelaunch activities have
    already been completed including
    consumer research, product positioning,
    packaging design and manufacturing
    validation.
    Consumer feedback on the VivaGel®-
    coated condom collected via formal
    market research this year shows positive
    feedback and demand. The international
    research demonstrated very positive
    results in terms of product relevance and
    benefits to consumers. 86% of
    participants rated the VivaGel®-coated
    condom as “very interesting” with 90%
    saying they would buy it.
    Actual consumer comments included:
    “I would buy this product right now”;
    “I think this product is amazing…This
    product is very special and
    interesting”; and
    “I have rated this product 5/5 as this is
    a major breakthrough in the condom
    market and for world health…”
    Starpharma has licensed commercial
    rights to Ansell and Okamoto for the
    VivaGel®-coated condom.

  • Reply to

    December 13th Shareholder Letter

    by robert.vince Feb 14, 2014 11:01 AM
    robert.vince robert.vince Feb 14, 2014 11:08 AM Flag

    Impressive results for Dendrimer - Enhanced Oxaliplatin
    Starpharma has recently released
    impressive pre-clinical results showing
    the superior performance of Dendrimer
    Enhanced Oxaliplatin (DEO) compared
    to oxaliplatin alone (Eloxatin®), a leading
    bowel cancer drug.
    The dendrimer-enhanced version of
    the drug has been shown, in animal
    models, to have:
    • improved anti-tumour efficacy
    • reduced toxicity for bone marrow,
    and
    • reduced toxicity for the nervous
    system (neurotoxicity).
    The neurotoxicity improvement is
    particularly important as this effect is
    Eloxatin®’s major dose-limiting toxicity
    and the cause of its most debilitating
    side-effects. Around 85-95% of patients
    who undergo Eloxatin® therapy will suffer
    irreversible nerve damage to the hands
    and feet (peripheral neuropathy). The
    drug also triggers a short-term
    heightened sensitivity to cold around
    the time of treatment (see case study).
    Starpharma’s novel, proprietary
    DEO showed significantly reduced
    neurotoxicity in validated animal models
    for both peripheral neuropathy and cold
    Mechanical Hypersensitivity
    as measured by the von
    Frey method
    “These findings are very significant
    because this condition is a serious
    clinical problem and the dendrimer
    version of oxaliplatin clearly shows
    a reduced level of neurotoxicity.
    We are unaware of any other
    examples of this effect reported
    for other oxaliplatin formulations
    in the literature.”
    Professor Susan Dorsey
    Director, Center for Pain Studies,
    University of Maryland
    sensitivity. In fact, DEO showed a
    significant reduction in both
    neurotoxicities even when DEO was
    used at twice the dose of oxaliplatin.

  • Reply to

    December 13th Shareholder Letter

    by robert.vince Feb 14, 2014 11:01 AM
    robert.vince robert.vince Feb 14, 2014 11:09 AM Flag

    Following treatment with DEO or
    oxaliplatin, mice were assessed to check
    for treatment-related neuropathy. The
    DEO treated mice had a statistically
    significant reduction in peripheral
    neuropathy seen by a lower change from
    baseline in the von Frey test (refer above)
    and a lower cold sensitivity as measured
    by the Cold Plate test, when compared
    to mice treated with oxaliplatin.
    Starpharma has also released the
    results of a separate pre-clinical study
    which demonstrated improved tumourinhibiting
    effectiveness in a colon cancer
    model and a reduction in bone
    marrow toxicity.
    “The reduction in neurotoxicity alone
    would represent a significant commercial
    and clinical advantage for DEO but when
    considered alongside the earlier
    improvements in efficacy and reduced
    bone marrow toxicity, this finding
    demonstrates that Starpharma’s
    dendrimer technology can deliver a
    considerable overall enhancement to
    this blockbuster drug,” said Starpharma
    CEO Dr Jackie Fairley.
    Oxaliplatin, sold as Eloxatin® by
    Sanofi, is primarily used to treat colon
    and colorectal cancer and the drug
    achieved sales of approximately US$2B
    in 2012.

  • Reply to

    December 13th Shareholder Letter

    by robert.vince Feb 14, 2014 11:01 AM
    robert.vince robert.vince Feb 14, 2014 11:10 AM Flag

    OXALIPLATIN CASE STUDY
    Sydney man Ben Bravery commenced
    a regime of chemotherapy called
    FOLFOX4 which includes oxaliplatin
    after he was diagnosed
    with stage 3 colorectal cancer in
    2011, when he was 28 years old.
    Mr Bravery’s cancer was surgically
    removed prior to chemotherapy and
    has not returned, however he has an
    ongoing reminder of the toxicity of his
    treatment.
    “I’m reminded on a daily basis of
    the chemotherapy I had,” said Mr
    Bravery, now aged 31.
    “I still have nerve damage in my
    fingers and feet, and this is something
    I’ll probably have to live with for the
    rest of my life. The nerve damage in my
    feet is such that I have to check them
    regularly for damage – because I won’t
    feel small cuts or abrasions, and that
    means they could go on to get infected
    if I’m not careful.”
    Mr Bravery also described the
    short-term heightened sensitivity to
    cold as like “drinking shattered glass”
    if he consumed anything that was not
    warm during the week after an infusion
    of oxaliplatin.
    “It was a very uncomfortable and
    sharp feeling and can be really painful,”
    he said.
    “With me, it gradually worsened
    during chemotherapy whereby I couldn’t
    drink beverages at room temperature,
    everything had to be heated up or it
    would upset my mouth and throat.
    “I went through chemo in spring and
    summer, but still had to wear gloves
    and shoes to keep my hands and feet
    warm because they were so sensitive to
    the cold. While touching or walking on
    cold surfaces wasn’t that painful at the
    time, the more you trigger this during
    chemo the worse the side-effect
    becomes.”
    Mr Bravery said he would welcome
    a form of oxaliplatin that had a reduced
    side-effect profile as “chemotherapy is
    already very tough”.
    “Anything that reduces the sideeffects
    is a good thing. Starpharma’s lab
    results are really promising and may go
    on to improve the lives of people having
    treatment for colorectal cancer in the
    future.”

  • Reply to

    December 13th Shareholder Letter

    by robert.vince Feb 14, 2014 11:01 AM
    robert.vince robert.vince Feb 14, 2014 11:11 AM Flag

    Progress continues in agrochemical activities
    Starpharma continues its agrochemical
    activities with agreements now signed
    with the majority of the top 10 agrochemical
    companies, the most recent
    being with Isagro for a partnership in
    fungicides. This builds on our previously
    announced agreements this year with
    Gowan and Makteshim Agan.
    Under the agreement, Isagro will test
    Starpharma’s Priostar® dendrimer
    technology with a number of its fungicides
    to assess potential performance
    gains over existing formulations. Isagro is
    an agrochemical company with global
    sales of approximately €150 million and
    620 employees.
    own complete formulations of
    selected generic actives with enhanced
    characteristics. A number of programs
    including glyphosate are underway with
    additional glyphosate field trials ongoing.
    Dendrimers enhance existing
    agrochemicals and create patentable
    formulations by improving formulation
    characteristics such as solubility and
    stability which lead to improved
    biological performance. New
    formulations using Priostar® dendrimers
    create superior agrochemical
    formulations with a strong patent
    position lifting the barrier to entry for
    competing products and hence raising
    the commercial
    value of the
    agrochemical.

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