CLNN Clene Inc

$CLNN Any level of improvement in my MS symptoms and disability is worth taking CNM-Au8 for, as far as I'm concerned, and I know everyone else feels the same.

$CLNN I scrubbed around for Clene job postings. Found three current openings at the Maryland manufacturing facility: • Production Technician, Manufacturing • Micro QC & Biology Analyst I/II • QC P-Chem Analyst I/II The P-Chem Analyst posting is new, posted within the last couple days. Interesting that all three are manufacturing/QC roles🤔

$CLNN “The submission of our NDA for CNM-Au8 represents an important achievement for Clene, CNM-Au8, and especially for people living with ALS,” said Rob Etherington, President and Chief Executive Officer of Clene. “We appreciate the FDA’s constructive engagement throughout this process and look forward to working closely with the Agency during its review.” “Reaching this stage reflects years of dedicated work by the Clene team, our clinical investigators, patients and families, and our partners,” continued Mr. Etherington. “We remain focused on advancing CNM-Au8 through the regulatory process as efficiently as possible while continuing our preparations for the confirmatory Phase 3 RESTORE-ALS study. People living with ALS urgently need additional treatment options, and we believe CNM-Au8 has the potential to restore and protect neuronal health and function and improve survival.”

$CLNN KOD on NASDAQ also soared from $1.92 last year to $101 just a few days ago! CLNN’s current stock price isn't reflecting the potential we're seeing. Time will unlock that potential. I’m honestly grateful to those clueless shorts who don't even know basic physics. If we get accelerated approval, I believe the stock could hit anywhere from $300 to $400 per share. If I buy 100 shares a week putting in $400, they're going to turn my $400 into $40,000! I'm just depositing money into this literal money printer! Let's go, everyone!

$CLNN Fda asked them to send this application that is the key difference here. Someone asking me for something vs me asking someone to ask me for something. which would strongly imply i want to go give it. Why there has not been too much interest baffles me

$CLNN The $7.2 mil NIH grant could cover a substantial portion of eligible program expenses, freeing up existing cash for corporate operations and regulatory work. It could be possible for CLNN to reach FDA decision ( Q2 2027) without raising significant additional capital.

$CLNN The ball is with the FDA now. There will be stock tantrums. Along the way will crawl out cockroaches (AF, MS, etc.) pontificating us ignorants that CLENE is a hackjob. I have waited 1.5 years for this day. Massive (20x-100x) next 6 months. Price target: Triple digits 🧨🧨🧨 The fun begins 🕰️

$CLNN congrats on NDA advancing the ball should have a decision in June 2027 on FDA..Good luck hope is what the patients need. From a $COYA guy...Much success.

$CLNN Thinking about it, the endorsement from I AM ALS carries a lot of weight. They have been following patients on CNM-AU8 for years and clearly, if there was no positive effect on patients, they wouldn’t endorse approval. They have seen first hand on how CNM-AU8 improves the quality of life. Obviously the NDA will be under heavy scrutiny, but there is also a lot of pressure on the FDA to get this approved and I am very optimistic that they will

$CLNN FDA's acceptance and pdufa date could come much earlier than 74 days. Given that the FDA has already extensively evaluated the data over the last 6 meetings, I expect late-nov acceptance, and April pdufa.

$CLNN if we can grow the sp in a slow controlled manner for the next 60 days it’s much better than giant volume spikes and retreats. IMO. 🍀🍀🍀

$CLNN yes, this new $7.2M NIH grant is a positive development for shareholders. While the funds are designated for the ALS Expanded Access Program, they could help preserve corporate cash and reduce near-term financing pressure. With the previous $4M raise reportedly providing runway through Q1 2027, this additional support may help bridge the gap toward a potential FDA NDA milestone in Q2 2027. If additional capital is still needed, CLNN may be able to get by with a smaller offering, potentially minimizing dilution.

$CLNN My high-risk, high-reward bet for the next 6 months! CLNN has submitted its NDA to the FDA for accelerated approval of CNM-Au8 for ALS. This is a major milestone. My thesis: FDA previously indicated the proposed data may support an NDA under the accelerated approval pathway. NfL biomarker data showed encouraging associations with survival and functional outcomes. ALS has a tremendous unmet medical need. My speculative bet - 20-50% personal estimate of approval probability, with potential upside exceeding 2,000% if things go right. High risk, potentially massive reward. Watching the next FDA milestone closely!

$CLNN not a terrible volume given how low it normally is. Good to see some momentum, hopefully that lasts. A bit painful to still be red, even though we are in it for so much longer lol At the end of the day it won’t matter once we reach a $1B+ market cap

$CLNN today's next NIH tranche (7,2m$) is a huge improvement in terms of cash run rate. Yes, this money is meant to be used for the EAP. But the EAP was part in the previous' years costs too. Consequently, each calculation of cash runway contains the EAP costs too. As a result you can regard the NIH funds like cash raised through dilution. At least in the usage, its only different in the balance sheet

$CLNN is a low market cap, low volume biotech with a massive short interest and short ratio. Shorts are just hammering it down, assuming "you can't treat ALS with gold particle water." ​But being able to isolate responders from non-responders means we can precisely target the right patient population, just like Tofersen! ​Target % of ALS patients: ​Tofersen = 2% (genetic) ​AU8 = ~40% (energy metabolism) ​$CLNN successfully isolated the metabolic impairment group as responders, meaning it can effectively treat ALS patients suffering from this exact issue. ​For accelerated approval, the FDA will likely require a Phase 3 trial that pre-identifies responsive patients and replicates clinically meaningful efficacy in that specific group. 🚀

$CLNN If Clene wants a PDUFA date announced by ~20 Dec (before FDA goes on year-end vacation), NDA filing must happen by 5 Oct. Thu, Fri, Mon. All hell is about to break lose. Price target: $400 - $800

$CLNN This is positive. "Clene secured a fourth-year NIH subaward worth up to $7.2 million for CNM-Au8 ALS treatment"

$CLNN I suspect that the private placement on May 5—issuing 1 million shares at $7 per share—was Empery Asset Management. They reported owning around 916K shares on June 30. Then, on September 30, filings showed they sold roughly 694K shares. ​They likely sold because they found a better yield source. Judging by the stock price action, they probably took at least a 30% to 40% loss. ​I'm not sure if they hedged their short positions alongside the sell-off, but if they aren't dumping their remaining 220K shares, the selling pressure shouldn't be that strong anymore.

$CLNN - December 14th! I’m circling December 14th on my calendar. 60 days after last Thursday ( Oct 15th).