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Clene

CLNN Rare disease Lead: NDA Submitted ★ Read the deep dive → 14 Biotech Distilled articles ↓ 34 filings & releases ↓ Cash $9.9M (Sep 30, 2026) ↓ 14 verdicts ↓ 1 timing quote ↓
Neurology Small Molecule

Market cap $56.9M 14.4M shares (10-Q, Nov 2, 2026) × $3.95 close Nov 6, 2026

Most recent annual filing: 2026-03-15

Catalyst timeline

4 trackedQuarter catalyst calendar →
  1. CLNN filingNov 2026CLNN filing, Nov 2026, notable
  2. Clene financials corporate updateNov 2026Clene financials corporate update, Nov 2026, routine
  3. RESTORE-ALS Phase 3 Ph3 start2Q 2027RESTORE-ALS Phase 3 Ph3 start, 2Q 2027, routine
  4. 2024 SSCP Notes corporate updateAug 13, 20272024 SSCP Notes corporate update, Aug 13, 2027, routine

Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.

Pipeline (5 active programs)

Technology platforms

CSN

Clean-surfaced nanotechnology (CSN) electro-crystal-chemistry platform producing catalytically-active, faceted nanocrystals and ionic solutions from transition elements. Enables development of nanotherapeutics targeting cellular energy impairments in neurodegenerative and other diseases. Flexible and tunable — can produce gold, gold-platinum, and other elemental or composite nanocrystals, plus ionic solutions of silver, zinc, and other transition elements.

Targets: NAD+, mitochondrial dysfunction, reactive oxygen species

electro-crystal-chemistry

Electro-crystal-chemistry drug development platform enabling production of concentrated, stable, highly active, clean-surfaced nanocrystal suspensions; focus on central nervous system disorders including ALS, MS, and Parkinson's disease

Capital (as filed)

Cash
$9.9M cash and cash equivalents · Sep 30, 2026 (10-Q)
Operating cash flow
−$4.6M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$9.9M cash, runway mid-first quarter 2027 per the update of Nov 4, 2026 — the company's own words as read there, not the filed figure

Offering documents (1)

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (14)

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (14 calls)

Every verdict Biotech Distilled has published on Clene, oldest first — the full history, never a selection. How calls are scored: the track record.

  1. 2025-12-30 Watch Clene Inc (CLNN): Scientific Due Diligence for CNM-Au8 and Pipeline Products Despite intriguing catalytic bioenergetics science and a clean safety profile, the severe dilution gap and binary regulatory risk make this uninvestable for conservative capital until financing clears or the FDA meeting de-risks the path.
  2. 2026-01-12 Speculative buy speculative UPDATE: Clene Inc. (CLNN) – The Dilution Gap Is Effectively Gone for 12-Months. Now It's Just Science The $28M registered direct offering removes the immediate insolvency risk, leaving the thesis as a pure-play binary bet on the FDA's willingness to accept the Tofersen Precedent for CNM-Au8.
  3. 2026-01-13 Speculative buy speculative UPDATE: Clene Inc. (CLNN) – A Sell the News Moment & The Science Behind It The ~19% post-financing drop is sell-the-news noise, not a verdict on the science; the new biomarker-to-survival linkage data is the strongest argument yet for the Tofersen Precedent and the Type C meeting is set.
  4. 2026-02-28 Speculative buy speculative UPDATE: Clene Inc. (CLNN) – The FDA Showdown Officially Gets a Timeline The catalyst calendar is now hard-coded with the Type C meeting imminent and runway confirmed through the key regulatory milestones, keeping the speculative thesis intact.
  5. 2026-03-14 Speculative buy speculative UPDATE: Clene Inc. (CLNN) – 2025 Earnings Confirm the Dilution Thesis and the Timeline Full-year 2025 results confirm no delays or surprise expenses, cash is secured for the near term, and the FDA meeting is days away — thesis unchanged.
  6. 2026-03-21 Speculative buy speculative UPDATE: Clene Inc. (CLNN) – The Hidden Catalyst of Non-Dilutive Funding An $8M NIH subaward provides non-dilutive funding for the EAP data the FDA is reviewing, and the pivotal Type C meeting is imminent — thesis intact.
  7. 2026-05-04 Buy core UPDATE: Clene Inc. (CLNN) – The Tofersen Precedent Just Landed The FDA's Type C minutes confirmed NfL could serve as a surrogate endpoint under the accelerated approval pathway, retiring the single biggest regulatory risk and validating the Tofersen Precedent thesis.
  8. 2026-05-05 Hold UPDATE: Clene Inc. (CLNN) - The Raise-Into-Strength Trade, Same Day The same-day $7M raise at a 13.5% discount collected the dilution tax flagged the prior day; the regulatory thesis is intact but the next catalyst is 4-5 months out, creating dead-money risk for those who didn't trim into the rip.
  9. 2026-05-15 Buy core UPDATE: Clene Inc. (CLNN) – The Q1 10-Q Answers Three Questions I Left Open The debt maturity pushed to August 2027, SymBiosis revealed as the 14.8% smart-money holder, and Tranche A warrant overhang set to expire — the financial path to the regulatory finish line has materially improved.
  10. 2026-08-11 Buy core UPDATE: Clene Inc. (CLNN) - Clene Did the FDA's Homework. The Tape Hasn't Noticed. The randomization-anchored principal stratum analysis (HR 0.593, p=0.026) with four null negative controls directly answers the FDA's magnitude-of-effect ask, making the NDA package materially more defensible despite the stock's 27% decline.
  11. 2026-08-12 Hold UPDATE: Clene Inc. (CLNN) - The 14.8% Holder Just Went to Zero The SymBiosis stake reporting 0.0% due to a manager transfer creates cap-table ambiguity and potential supply overhang into a financing, warranting patience rather than action until the successor filing resolves the uncertainty.
  12. 2026-08-15 Buy core UPDATE: Clene Inc. (CLNN) - A New Name Shows Up on the Cap Table Q2 cash of $9.7M with runway through late Q4 and Vivo Opportunity's 9.99% warrant-based position aligned with approval partially resolves the anchor-holder ambiguity, justifying a return to BUY for capital sized for total loss.
  13. 2026-09-16 Hold UPDATE: Clene Inc. (CLNN) - The Insiders Wrote the Check Themselves A $4M raise at a 21% discount sourced entirely from insiders with no outside bid signals materially worse access to institutional capital than assumed, warranting patience into the early-Q4 NDA filing rather than adding.
  14. 2026-10-20 Hold UPDATE: Clene Inc. (CLNN) - The Form Is Filed. Now the FDA Decides Whether to Read It. The NDA was submitted on schedule, validating the Tofersen Precedent thesis, but the acceptance-linked warrants are underwater and runway ends mid-Q1 2027, so patience until the FDA's ~December filing decision is the prudent posture.

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Timing, in the company's words (1 quote from 1 filing)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (34)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from May 5, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

11 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)