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Clearside Biomedical, Inc. (CLSD)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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1.4700-0.0300 (-2.00%)
At close: 04:00PM EDT
1.4000 -0.07 (-4.76%)
Pre-Market: 08:16AM EDT
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  • G
    George
    Keep adding to my already large position, trying to lure Ann to short easy $$$ , this is going to be bought by the end of the year $ 14-22 mark this post.
  • M
    MRI_MRS
    If you search for the quarterly earnings transcript of Bausch & Lomb, you will find in the Question/Answer section one important remark of Joe Papa (CEO), when he is asked about Xiphere and it’s launch in 2Q. He says following sentences:

    But we clearly think that this is an opportunity because of our response that we've gotten from training of the physicians who've seen a very good reception as they've used this product. So more to stay tuned for that, more to happen, especially as we get additional reimbursement with the product. But we're excited about the initial launch. And most importantly, we're excited about how this is really helping patients by utilizing the suprachoroidal space. And we think the suprachoroidal space may be a platform for additional products in the future that we hope to have more to say about that in the future.

    At least Bausch & Lomb wants to cooperate more with CLSD. I personally hope for a takeover.
  • A
    Anonymous
    So what are they doing with the extra 100,000,000 shares that have been voted??
  • T
    THE-MAX
    Okay.. someone said $CLSD is better company than $SELB.. Let's look over a few numbers..
    Yr/Yr sales.. CLSD 347K/34K... SELB 34M/11M ... WINNER.. SELB
    PRETAX INCOME.. CLSD -7M/-7M.. SELB 28M/-24.5M.. WINNER.. SELB
    SOON TO GO POSITIVE.. CLSD ???... SELB YES.. WINNER.. SELB
    SHARES OUT CLSD 60M/57M.. SELB 127M/110M.. WINNER.. SELB with higher market share..
    ASSETS... CLSD 35M/27M.. SELB 145M/176M.. WINNER.. SELB with lower assets could mean lower inventory due to increasing sales.. CLSD possiblly increasing inventory due to low acceptance of items to market.
    Equity.. CLSD.. 37M/16M.. SELB 55M/-19M.. WINNER SELB.. with higher equity increases..
    DEBT.. CLSD.. 591M/916M.. SELB 35M/35M.. WINNER SELB with lower debt..
    FREE CASH FLOW.. CLSD.. -1M/-79M.. SELB -61M/-60M.. WINNER CLSD nearer to positive cash flow..

    Hope this helps a few of the lost souls out there.. hehe THE MAX
  • r
    r
    Follow the money: Yesterday, 06/17, after the close, 4 Aura directors filed Form 4s indicating each was given 16000 options on 06/15 to buy Aura at 13.72/sh. One of whom, Director Johnson, filed a Form 4 on 06/14, indicating that on 06/10, 06/13 he bought out of pocket 50000 Aura shares (https://ir.aurabiosciences.com/node/7141/html). Today, tomorrow and Mon., Aura is presenting "...AU-011, a first-in-class targeted therapy for the treatment of choroidal melanoma via intravitreal administration;" and "Phase 2 trial of a first-in-class targeted therapy for choroidal melanoma via suprachoroidal (SC) administration" at the at the International Society of Ocular Oncology (ISOO) 2022 Bi-Annual Meeting, the largest global ocular oncology meeting, being held June 17-21, 2022, in Leiden, the Netherlands.

    Aura's Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences states. “We remain on track with our Phase 2 SC study and we plan to finalize a decision on the route of administration and initiate our pivotal program before the end of the year."

    CLSD's Average Volume: 254,923 (50-day) 605,808 (200-day). Yesterday, up to, & after close, CLSD traded 736K shs, up .12 ... thus, ACCUMULATION.

    And finally, Ciulla, at the JMP securities conf. 'fireside' on 06/15, referencing SCS administration pf Aura's AU-011 for choroidal melanoma (CM) stated, "...it's in the same tissue layer." So, Rich's alleged notion that there is actually a decision dilemma as to which route for AURA's prospective Ph. 3 trial, given apparently limited funds/ or justification for having already spent untold $$ on intravitreal delivery research, before licensing CLSD's microinjector in the first instance, appears to be disingenuous argument.
    SEC Filing | Aura Biosciences
    ir.aurabiosciences.com
  • S
    Suneil
    Listen to BCLO earnings call which happened today. Towards the very end of the call is a statement on SC delivery and the thinking that it’s a platform not just a product. I think they are hinting at either expanded development or a straight up buyout of CLSD.
  • A
    Anonymous
    PAPA RESIGNS FROM BLCO!!!! Is this good news or does it create more uncertainty for CLSD????
  • k
    khalid
    We went above the 50-day moving average of $1.56…
  • r
    r
    They have 22 days left before qtr.-end where they will again show neglible revenues for this 2nd qtr now, hence the existing stock price. They have just 34 EEs, no experience standing up a sales force to market a drug; and, no capital to do so, notwithstanding Lasezkay's prior comment re: CLS-AX, "I think we are going to keep this one." And so I think it is going to be incumbent upon them to enter into a co-development/collaboration deal for it as well, with big pharma, perhaps ABBV, who has locked up a deal with RGNX for their ["RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery."]

    So, ABBV knows where the SCS innovation is going, and they are really just 1 step removed from possibly doing a deal here. If RGNX, with far greater resources than CLSD, did a deal for development of their 314, far be it from CLSD to refuse claiming they are going to go it alone. Hopefully, Lasezkay won't get pantsed like he did with BHCO on Xipere.
  • D
    Dave
    Finally a little positive traction going on
  • G
    George
    BLCO IS BUYING CLSD FOR $ 18.00
  • k
    khalid
    Why no insiders are buying recently?
  • m
    monday
    i predict around $1.85 closing price today as we get very close to that mid year results announcement.
  • B
    BirdieMan
    Will be sold for $20 per share.
  • D
    DOWLAT
    CEO of Bausch Health Company, Joe Papa, recently stated at a Cowen healthcare conference:

    "..with the B&L IPO, the balance sheet's going to be a lot more flexible with that flexibility, we think we'll have an opportunity to invest both in the organic growth through the company but also through inorganic, both on opportunities for the business. I think that's going to also fuel the long-term opportunity in front of us. Now I don't want anyone to think I'm going to try to do $3 billion transaction as soon as we do an IPO. I'm really referring more to bolt on opportunities as we think about the future."
    Since Bausch has invested in training physicians on suprachoroidal delivery, they could benefit from acquiring Clearside and adopting the SCS microinjector platform for their own. They would also no longer have to pay milestones or royalties to Clearside on the sales of XIPERE. Bausch Health Company has been open that they don't currently have the financial flexibility given the company's outstanding debt payments. However, Bausch + Lomb has recently filed for an IPO
  • J
    Jeff
    Does anyone here think the increase shares is going to be for near future reverse split. If so can’t see why people would be buying today. Those RS never work out for average shareholders
  • k
    khalid
    What happened to the vote?
  • r
    r
    AU-011 is a biologic that requires the use of multiple devices, which may result in additional regulatory risks.

    AU-011 is a novel biologic for which the intended use requires activation by a laser, which is regulated as a medical device. We plan to file a single BLA for the review and approval of this combination in our initial target indication of indeterminate lesions and small choroidal melanoma, but subsequent indications and delivery systems may require different or additional applications for marketing authorization. In addition, consistent with recent FDA guidance as seen with the approval of Xipere, Clearside Biomedical’s SCS Microinjector® is also expected to be regulated as a medical device and suprachoroidal administration of AU-011 with this device is expected to constitute a combination product. As such, we may also include the SCS Microinjector in our BLA. There may be additional regulatory risks for biologic-device combination products. We may experience delays in obtaining regulatory approval of AU-011 given the increased complexity of the review process when approval of the product and a delivery device is sought under a single marketing application. In the United States, each component of a combination product is subject to the requirements established by the FDA for that type of component, whether a drug, biologic or device. Devices are subject to the FDA design control device requirements which comprise among other things, design verification, design validation, and testing to assess performance, cleaning, and robustness. Delays in or failure of the studies conducted by us, or failure of our company, our collaborators, if any, or our third-party providers or suppliers to maintain compliance with regulatory requirements could result in increased development costs, delays in or failure to obtain regulatory approval, and associated delays in AU-011 reaching the market.
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