CLNN Clene Inc

$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 From today's PR, cash runway is extended beyond mid Q1 2027, so now the focus shifts to NDA submission and acceptance. The offering was made without a placement agent, underwriter, broker or dealer, and is expected to provide Clene with sufficient cash to fund its operations through mid-first quarter 2027, which is beyond the potential U.S. Food and Drug Administration (FDA) decision for accepting the New Drug Application (NDA) for review of CNM-Au8® for treatment of amyotrophic lateral sclerosis (ALS) under the accelerated approval pathway. In addition, if the FDA accepts the NDA from Clene for review, the Company could potentially receive $6.7 million to $7.8 million in proceeds from common stock warrants issued in a January 2026 financing that could further extend the Company’s cash runway.

$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 Form 4s are out. Pretty notable insider participation in the $4M raise: • David Matlin: 434,451 shares — $1.425M • Kensington/Mosca: 198,171 — $650K • Rob Etherington: 15,244 — $50K Combined: 647,866 shares / $2.125M, or 53.1% of the entire 1.219M-share offering. Matlin nearly doubled his direct position, from ~478K to 912K shares. That means more than half the raise is already accounted for by Matlin, Kensington and Rob Now I’m interested to see who took the remaining ~572K shares.

$CLNN honestly it’s f’n nuts that we are sitting here crossing our fingers to cross $4 today. That’s me assuming I’m not alone. 😂

$CLNN $LUCD $VANI FYI - for the benefit of my fellow long-suffering longs, here are my 3 bio-tech stocks: Clene is a bio-pharma working on neurodegenerative diseases with a current focus on ALS (but also have plans for MS and PD) After years of testing, they are working with the FDA for an Accel Approval - appl sb submitted within the next 3-4 weeks. My largest holding of the 3. Lucid is well down the path towards commercialization of an FDA approved screening process for esophageal cancer. They are waiting (patiently) for Medicare approval after a very good CAC meeting a year ago. Assuming a positive LCD, they have a strong opportunity to begin to really ramp rev including Medicare 1 yr look back and getting commercial ins coverage with a huge TAM. Vivani - has a proprietary drug implant technology that allows drugs to be admin sub-dermal. Signed a non-exclusive deal with NovoNordisk to test usage with Wegovy. Doing a Phase I trial with results expected in Nov. Could be huge.

$CLNN I also think it was a good chat. However he did not provide any clarity related to the cash runway question. I guess that is to be expected, however the true vagueness of what the 'modest' raise will look like, makes it difficult for investors to buy into the story. The only things that is clear is that cash will be needed and needed soon, likely even before we know if the nda is accepted or not. We may have to deal with more near term pain, but I still like the longer term prospects of this investment. I also liked the insight into how the company plans to launch IF the FDA gives them a thumbs up. That would help in trying to model cash burn if we get the approval. Good luck longs

$CLNN On the optimistic side, I think it could trend upward from October through next August, while on the pessimistic side, it might head up from December 2026 to August 2027. Since it has a history of spiking after the C-type meeting only to drop back down, I'm not going to get too carried away by short-term ups and downs. I'll keep DCAing in whenever it's below $6, which is the private equity firms' average cost basis. Hang in there, everyone!

$CLNN As we wait for the NDA to be filed, I’ve been thinking about the recent reauthorization of the ACT for ALS and whether there could be a bigger-picture dynamic here that the market is overlooking. The original ACT for ALS program directed hundreds of millions toward ALS research, with CLNN receiving a $45.1M NIH grant for CNM-Au8 (the largest grant in the program). Congress just reauthorized the program through 2031. So here’s the question: if CNM-Au8 is a close call for Accelerated Approval, could there be some institutional/political pressure at the margins to see this succeed? Not suggesting the FDA would approve a drug that doesn’t meet its standards. But think about the optics. Congress created the ACT for ALS specifically to accelerate promising ALS therapies. Wouldn’t it be a pretty powerful example of that program working if one of its largest-funded programs ultimately produced an FDA-approved therapy? (1/2)

$CLNN Shakeoffs of retail traders to sweep stop-losses will continue until they feel they've had enough or volume starts coming in.

$CLNN You have to look at the macro picture as well. With yields hitting decade highs, you see a lot of money losing microcap stocks getting blitzed. Esp in the bio space. The recent weak performance of the stock may have absolutely nothing to do with the company. Keep in mind, CLNN's cash runway is still short even after the recent financing. Algos scan for money losing bio's low on cash. We will not know if the NDA is accepted until the end of dec or Jan so there are no obvious catalysts for the next 2+ months. Unfortunately, this stock could go lower before it eventually recovers on fundamentals. Grab cheapies if you like the investment thesis here. JMO of course.

$CLNN I don’t care about the noise. The fact that CLNN executives are putting their own money into CLNN stock speaks volumes about their conviction in CNM-Au8. What more confirmation do you need beyond management buying shares with their own money, combined with the FDA’s indication that the clinical data may support an NDA submission? They’re putting their money where their mouth is. Now we wait for the NDA.

$CLNN I think after the FDA package submission in the coming weeks they should turn to REPAIR-MS P3 trial design and announce trial site partners. Also, an update on the current P2 EAP would be nice. Other things they can work on while the FDA takes their sweet time evaluating data packages?

$CLNN Understand that the surging 10 year bond is likely putting additional downward pressure on this stock. Algos are on the hunt for money losing companies with short cash runways. The recent weakness in the stock may have nothing to do with the fundamentals of the company. The market cap is now just above $40M. Why do investors buy individual stocks that carry so much risk, when you can own a fund or an etf? Simple. You are trying to take advantage of inefficiencies in the market. In the case of CLNN, I THINK the biggest risk right now is around the financials. Yes there is a chance the NDA is not accepted and CNM-Au8 is not approved for ALS. However, this is a risk for all preclinical bios with a mature pipeline candidate. The Market Cap should reflect the risk/reward profile of the candidate/pipeline. In this case, most here would agree the MC does NOT properly reflect the risk/reward profile. I think this is an opportunity if you have risk tolerance. JMO

$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 if you’d listen to the presentation yesterday, you will be excited and very bullish!

$CLNN I’m not sure what’s going on here. I saw good things. I know the lights are on and people are moving around. But this dip is not cool…

$CLNN Management have to file the NDA until Friday 16th of October in order to be in time for late Q4 - end of the year acceptance decision. 74 calendar days after filing they will receive the ''Day 74 Letter'' from FDA as a formal communication for the NDA acceptance. If filing goes beyond the 16th, acceptance decision goes accordingly to January with all holidays in between.

$CLNN Latest ChatGPT odds - I'd break the regulatory path into roughly four hurdles: Hurdle My assessment FDA accepts NDA for review ~75–90% FDA agrees accelerated-approval pathway is appropriate ~55–70% FDA concludes NfL evidence + clinical evidence supports benefit-risk ~50–60% Actual accelerated approval ~40–55% What could push the odds toward 60–70% The biggest positive catalyst would be an FDA response to the NDA indicating that: the NfL effect is sufficiently large and reproducible; the NfL-to-clinical-benefit relationship is persuasive; the responder analysis adequately addresses the post-hoc nature of the data; the safety profile remains favorable; and FDA is comfortable relying on RESTORE-ALS as the confirmatory trial. CNM-Au8's safety profile is actually a relative strength. The planned Phase 3 trial is also designed specifically to prospectively evaluate the NfL relationship, which addresses one of the biggest weaknesses.

$CLNN someone still seems to sell stocks in “larger” chunks (4-8k range). Really hard to understand at this price and with the upcoming milestones, but whatever. We will finish this year back in double digits