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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
On September 15, 2026 the FDA’s Office of Generic Drugs reclassified the one remaining deficiency in NRx’s abbreviated application for preservative-free intravenous ketamine from major to minor, and the acknowledgement letter set a GDUFA goal date of November 10, 2026. That is the only date in this company’s file certified by an agency rather than announced by the company. Everything else — the branded application, the DARPA trial, the clinic spin-off — is an intention without a date, and one of them is not what the previous version of this page called it. This hub separates the two.
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This is the only date on the page set by an agency. The application was filed in September 2025 after the FDA granted a suitability petition allowing a move from multidose to single-dose presentation. On July 30, 2026 the agency reported the first review cycle: no major deficiency in the drug’s components, a label update to match the reference listed drug, and one major deficiency — the twist-off cap on the luer lock vial, on a concern that the vial tip could deform in clinical use.
A clarification meeting on August 6, 2026 set out what was needed: signed manufacturer certifications that the product runs on the same lines, machinery and plastics as three already-approved applications. On September 15, 2026 the agency’s Director of Regulatory Operations confirmed the amendment had been reclassified from major to minor, and the acknowledgement letter put the goal date at November 10, 2026. Ketamine is on the FDA drug shortage list.
The quarterly report states in terms that substantial doubt exists about the company’s ability to continue as a going concern for at least twelve months, and the auditor added the same paragraph to the 2025 annual accounts. At June 30, 2026 there was $26.686 million of cash against total liabilities of $34.330 million, a stockholders’ deficit of $170 thousand and a working-capital deficit of $4.7 million, on a burn of about $3.0 million a month.
And the two forward-looking statements issued three days apart do not match. The filing says the cash funds drug-development operations “through at least the first quarter of 2027”; the press release of the same results says “at least one year.” Both are reproduced in full later on this page. Nothing more recent exists: the September-quarter report is not due until mid-November.
There is a real, dated, agency-set event inside six weeks, and it got closer rather than further away. The November 10, 2026 goal date follows a first review cycle that found no major deficiency in the drug’s components and left a single objection about a vial cap, which the agency then downgraded from major to minor on September 15 after a clarification meeting attended by the Office of Generic Drugs and senior review leadership. Ketamine is on the FDA shortage list, five million launch doses are in production, and the company puts post-launch capacity at a million units a month. Separately there is now actual revenue: $2.169 million over the half from six clinics in Florida, against zero a year earlier. The balance-sheet debt was eliminated in December 2025, the June equity raise brought in $20.7 million net, and on the branded application the FDA agreed in February 2026 to review existing patient-level data as substantial evidence of efficacy without requiring new trials.
The company states itself that substantial doubt exists about going concern, and at June 30 total liabilities of $34.330 million exceeded total assets, leaving a stockholders’ deficit. Cash was $26.686 million against a burn near $3.0 million a month, and the two runway statements issued with the same results do not agree. The share count went from 31,734,333 at the year end to 43,295,767 in under eight months, with an open at-the-market programme and a $150 million shelf behind it. The branded application was guided for the second quarter of 2026 and was not filed. The DARPA item is a selection for negotiation, not a signed contract, and its trial is still listed as not yet recruiting past its own stated start date. The clinic spin-off has been announced since 2024 with no registration statement and no date, one clinic acquisition collapsed into arbitration, and short interest is 22.6 per cent of the share count at 16.27 days to cover.
At June 30, 2026 cash was $26.686 million against total liabilities of $34.330 million and a stockholders’ deficit of $170 thousand, on a burn near $3.0 million a month. The company states that substantial doubt exists about going concern; financial debt is only a $412 thousand insurance loan, and clinic revenue was $2.169 million over the half. Source
NRx Pharmaceuticals is a clinical-stage company with clinic revenue and no approved product. The central question is whether approval on the November 10, 2026 GDUFA goal date for its generic preservative-free ketamine, whose remaining deficiency was cut from major to minor on September 15, 2026, arrives before the company must raise again. At June 30, 2026 it held $26.686 million of cash against a burn near $3.0 million a month, with a stated going-concern doubt and shares up 36 percent in under eight months. The FDA’s decision and the September-quarter report decide the outcome. Source Source
The FDA’s Director of Regulatory Operations in the Office of Generic Drugs tells the company that its amendment, previously classified as a major amendment, has been reclassified as minor. The acknowledgement letter sets the GDUFA goal date at November 10, 2026. The distinction is mechanical and it matters: a major amendment restarts a long review clock, a minor one does not. Form 8-K (SEC) →
HOPE Therapeutics and its management company notify termination for cause of the Kadima transaction, agreed in May 2025 and never completed. The company had already started arbitration, Kadima had started litigation, and both remain pending. Five days later the second-quarter results carry a runway statement — “at least one year” — that does not match the one in the filing, which says “through at least the first quarter of 2027.” Form 10-Q (SEC) →
A subsidiary receives a letter from the Defense Advanced Research Projects Agency notifying that its proposal for the SPARC-TMS trial has been selected for negotiation of a potential award. The filing is explicit, in its own words: the selection “does not constitute a notice of award, a commitment by DARPA to make an award or an authorization for the Company to incur costs.” The expected budget is put at more than $11.5 million of non-dilutive funding. No later filing announces that a contract has been signed, and the trial is listed as not yet recruiting. NCT07227103 (ClinicalTrials.gov) →
An underwritten public offering of 5,714,286 shares at $3.50, with a 30-day option over a further 857,142. The quarterly report shows 6,378,942 shares issued in total, so 664,656 of the option was exercised — about 78 per cent, not all of it. Gross proceeds were $22.3 million against the $23.0 million the prospectus put on a full exercise, and the cash-flow statement records $20.716 million net. The August 17 release describes the exercise as full; the share count in the filing three days earlier does not support that, and the filing is what this page follows. Sixty-day lock-up for the company, directors and officers. Separately the at-the-market programme produced $11.828 million net over the half, $8.404 million of it in the June quarter alone. Prospectus supplement (SEC) →
How robust or fragile the company looks over the next twelve to eighteen months, scored 1 to 5 across five weighted pillars. Assessed on October 1, 2026, on market data to the September 30, 2026 close.
| Balance sheet and runway · 30% | 2.0 / 5 | The company states that substantial doubt exists about continuing as a going concern, and the auditor added the same paragraph to the 2025 annual accounts. At June 30, 2026 total liabilities of $34.330 million exceeded total assets of $34.160 million, leaving a stockholders’ deficit and negative working capital of $4.7 million, on $26.686 million of cash, no marketable securities, and a burn near $3.0 million a month. The two runway statements published with the same results do not agree. What holds the score off the floor is real: the debt is trivial at a $412 thousand insurance loan, the old lender debt was converted away in December 2025, and $18.550 million of the liability total is a non-cash warrant derivative rather than money owed. |
| Catalyst · 30% | 3.5 / 5 | The strongest pillar, and unusually so for a company in this condition. There is an agency-set date six weeks away: a GDUFA goal date of November 10, 2026 on the abbreviated application for preservative-free ketamine, reached after a first cycle with no major deficiency in the drug’s components and after the one remaining objection was cut from major to minor on September 15. The drug is on the FDA shortage list. The quarterly report lands within days of it. What caps the score is that everything else is undated: the branded application was guided for the second quarter of 2026 and not filed, the DARPA item is a selection for negotiation rather than a contract, the defence trial is past its start date and not recruiting, and the clinic spin-off has no registration and no date. |
| Dilution · 20% | 2.0 / 5 | Shares went from 31,734,333 at the year end to 43,295,767 by August 14 — up 36 per cent in under eight months — through an underwritten raise at $3.50 — whose over-allotment was only about 78 per cent taken, 6,378,942 shares in all for $20.716 million net — and an at-the-market programme that sold 4,812,972 shares over the half at an implied average gross price near $2.51, including a block around $1.80 in February and March. The programme stays open against a $150 million shelf whose remaining capacity the company does not disclose. Adding 8,986,823 warrants at a weighted $3.50, the options and the July grants takes fully diluted to about 53.4 million, roughly 23 per cent above basic. A warrant tranche was repriced to $1.65 under full-ratchet clauses, adding 1,870,960 shares. Shareholders raised the plan evergreen to as much as 5 per cent of fully diluted shares, with 42.9 per cent of votes cast against. |
| Liquidity · 10% | 2.5 / 5 | Tradeable but thinning, with a large position on the other side. 1,172,268 shares traded on September 30 against a 63-session average of 889,018, and the heaviest session of the year was January 14 at 21,977,300. The complication is the short side: 9,773,562 shares at the September 15 settlement, about 22.6 per cent of the share count, at 16.27 days to cover — up from 2,459,826 in February, with the days-to-cover figure tripling because volume fell while the position grew. On ownership the record is unusually thin: only four beneficial-ownership filings and no Schedule 13D, with the largest reported holder’s filing never amended since August 2025, and no aggregate institutional figure sourceable from the issuer’s own filings. |
| Execution · 10% | 1.5 / 5 | The pattern is of things described as further along than the documents support. The branded application was guided for the second quarter of 2026 and was not filed. The DARPA letter is explicitly not an award, and its trial is past its registered start date and still not recruiting. The spin-off has been announced since 2024 with no registration and a risk factor reserving the right to abandon it; of three clinic transactions, one closed, one has no completion filing, and one collapsed into arbitration and litigation. The litigation note contradicts itself within the same note. No insider has bought on the open market, no Form 4 has been filed in six months, and the July 2026 executive grants are not yet reported. Against that: the Nasdaq deficiency was a missed annual meeting and was cured in March, the auditor change was clean with no disagreements and no restatement, the debt was genuinely eliminated, and the clinics now produce $2.169 million of half-year revenue against zero a year earlier. |
This is not an indication to buy or sell. It is a description of financial and operational robustness, not a rating, a target price or a recommendation, and it says nothing about whether the shares are worth their price.
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This company announces a great deal, and the announcements are not all the same kind of thing. One of them is a goal date set by the FDA in an acknowledgement letter. One is a letter from a defence agency saying a proposal has been selected for negotiation, which is explicit in the filing that it is not an award. One is a spin-off described in a risk factor the company may “pursue, modify or abandon… at any time.” This page sorts them, gives each its document and its date, and says plainly where the record is silent — including on the three things a reader would most expect to find and will not: a confirmed Nasdaq compliance notice, a Form 4 in the last six months, and any registration for the clinic business.
These are reading frames, not forecasts, and none of them is a recommendation. Each is written so that a reader can say which document would confirm or break it.
| Scenario | What it assumes | What would confirm it | What would break it |
|---|---|---|---|
| Bull | The generic approval lands on or near November 10, 2026 and turns a development-stage company into one with a product. The case for it is in the review history rather than in the company’s language: the first cycle found no major deficiency in the drug’s components, the single remaining objection was about a vial cap, and on September 15 the agency downgraded that amendment from major to minor — which keeps the clock short instead of restarting it. Ketamine is on the FDA shortage list, five million launch doses are in production, and there is already clinic revenue underneath: $2.169 million over the half from six Florida sites. Add the February 2026 agreement that the branded application can be reviewed on existing patient-level data without new trials, and a company at a $126 million market value has two applications in front of one agency. | An approval or a tentative approval announced on or about November 10; first commercial sales disclosed with a number attached; a September-quarter report in mid-November that keeps the burn near $3 million a month and shows clinic revenue still growing. | A second major amendment on the vial cap, which restarts the review; or a November report whose cash position forces a raise at the current price before the decision. |
| Base | The approval slips or arrives narrow, and the balance sheet becomes the story. The company itself says substantial doubt exists about going concern; at June 30 liabilities of $34.330 million exceeded assets and working capital was negative $4.7 million. The at-the-market programme is open against a $150 million shelf, and it has already been used hard — $11.828 million net over the half. So the likeliest shape is an approval that is real but smaller than the announcements implied, funded through continuing issuance, with the share count grinding up from the 43,295,767 of August 14 while the branded application, the DARPA contract and the clinic spin-off all stay where they are: announced, undated, unsigned. | A November quarterly report with a restated runway and further at-the-market sales; an approval without a disclosed revenue figure; no signed DARPA contract and no registration statement for the clinic business. | Either a clean approval that generates disclosed revenue quickly, or a refusal that removes the only certified date from the file. |
| Bear | The company has a pattern of describing things as further along than the documents support, and the market is now short 22.6 per cent of the share count. The branded application was guided for the second quarter of 2026 and was not filed. The DARPA item is, in the filing’s own words, not an award and not an authorisation to incur costs, and its trial is still not recruiting past its own stated start date. The clinic spin-off has been announced since 2024 with no registration and a risk factor reserving the right to abandon it. One clinic acquisition collapsed into arbitration and litigation. The auditor was changed in November 2025, and the previous one’s opinions on both prior years carried going-concern paragraphs. No insider has bought on the open market, and no Form 4 has been filed in six months. | A major amendment or a refusal on the generic application; a September-quarter report that shortens the runway; continued absence of any Form 4; short interest holding above 20 per cent of the count. | An approval on November 10 with disclosed launch revenue, or a signed DARPA contract bringing more than $11.5 million of non-dilutive funding. |
What distinguishes NRx from most small-cap biotech names is that the near catalyst is not a clinical readout and is not binary in the usual way. A generic application for a drug already on the market, whose only open objection concerns a container closure, is a manufacturing and paperwork question with a date on it. That makes the November 10 event more legible than a trial result — and it also means the balance sheet, not the science, is what decides whether the company gets to the other side of it on its own terms.
The reading on this page is that one date is certified and the rest are intentions, that the balance sheet is tighter than the announcements suggest, and that the gap between what is said and what is filed is itself the thing to watch. Each of the following would damage that reading, and each is checkable against a document.
None of these is a prediction. They are the observations that would make the rest of this page wrong, listed so that a reader can check them rather than take the reading on trust.
NRx Pharmaceuticals is a clinical-stage company that has recently started earning revenue from a clinic business, with two applications in front of the FDA and no approved product. Six facts set the frame.
There is one date set by an agency, and it is close. The abbreviated application for preservative-free intravenous ketamine — the generic path, branded KETAFREE — has a GDUFA goal date of November 10, 2026. It was set by an acknowledgement letter after the FDA, on September 15, 2026, reclassified the one remaining deficiency from major to minor. The first review cycle had found no major deficiency in the drug’s components; the single objection concerns the twist-off cap on a luer lock vial.
The DARPA item is not a contract. On July 21, 2026 a subsidiary received a letter saying its proposal had been selected for negotiation of a potential award. The filing states in its own words that this “does not constitute a notice of award, a commitment by DARPA to make an award or an authorization for the Company to incur costs.” The expected budget is more than $11.5 million. No later filing announces a signed contract, and the trial is listed as not yet recruiting past its own stated start date of September 1, 2026.
The company states that substantial doubt exists about going concern. At June 30, 2026 there was $26.686 million of cash and no marketable securities, against total liabilities of $34.330 million, a stockholders’ deficit of $170 thousand and a working-capital deficit of $4.7 million. The auditor added a going-concern paragraph to the 2025 annual accounts. Accumulated deficit is $324.845 million.
Two runway sentences were published three days apart and they do not match. The filing says the cash funds drug-development operations “through at least the first quarter of 2027”; the press release on the same results says “at least one year.” Both appear verbatim later on this page. Operating cash use was $13.170 million over the half, of which the June quarter accounted for $8.875 million — about $3.0 million a month.
The short position is unusually large for a company this size. 9,773,562 shares at the September 15 settlement, about 22.6 per cent of the 43,295,767 shares outstanding, at 16.27 days to cover. At the February 27 settlement it was 2,459,826. That is close to a fourfold increase in seven months, and the days-to-cover figure has tripled because the reported average daily volume in that series fell while the position grew.
There is now revenue, and the clinic business is the only part of the company that generates any. Net patient service revenue was $1.101 million in the June quarter and $2.169 million over the half, against zero in both 2025 comparatives, from six clinics in Florida held through a majority-owned subsidiary. A partial spin-off of that subsidiary has been announced since 2024; it has no registration statement, no date, and a risk factor reserving the right to abandon it.
The one-line version. Strip out the announcements and what is left is a company with a $126 million market value, $26.7 million of cash, a stated going-concern doubt, and one agency-certified date six weeks away on a generic application whose only open objection is a vial cap. If the approval lands, the company has a product in a drug on the shortage list. If it slips, the balance sheet decides what happens next, and the at-the-market programme is already open against a $150 million shelf. The reason to read the documents rather than the headlines here is that the company’s announcements and its filings describe the same events in materially different registers — and the previous version of this page took one of those announcements at face value.
This is the part of the file with a date on it, so it is worth following in sequence. The product is preservative-free intravenous ketamine in a single-dose presentation, pursued as a generic of an existing reference product rather than as a new drug.
| Date | Event | Why it matters |
|---|---|---|
| September 23, 2025 | FDA grants a suitability petition, allowing the move from a multidose presentation with preservative to a single-dose presentation without one | Without this there is no generic route at all. It is the procedural permission to differ from the reference product in that one respect |
| September 2025 | Abbreviated application filed | Starts the review clock |
| July 30, 2026 | First-cycle determination. No major deficiency relating to the drug’s components. Label update required to match the reference listed drug. One major deficiency: the twist-off cap on the luer lock vial, on a concern the vial tip could deform in clinical use | The substance of the product passed. The objection is to a container closure, which is classified as major because closure integrity is a safety matter |
| August 6, 2026 | Clarification meeting granted, attended by the Office of Generic Drugs and senior review leadership. Requirement: signed manufacturer certifications that the product runs on the same lines, machinery and plastics as three already-approved applications. The agency undertakes to restart review immediately and complete it in the shortest possible cycle | This is the specific, limited thing that had to be produced. It is documentation, not a study |
| September 15, 2026 | The Director of Regulatory Operations confirms the amendment is reclassified from major to minor. The acknowledgement letter sets the GDUFA goal date at November 10, 2026 | The mechanical point of the whole sequence. A major amendment restarts a long review clock; a minor one does not |
Why the reclassification is the fact to hold, and not the date. A goal date is a target the agency works to, not a guarantee, and the generic programme has no advisory committee and no public docket a reader can follow. What the reclassification tells you is something more durable: the agency moved the objection out of the category that forces a long re-review and into the category that does not. That is a statement about how much work it thinks is left.
Two supporting facts belong beside it. Ketamine is on the FDA drug shortage list, which is relevant to how an agency prioritises a generic application. And the company says five million launch doses are in production with post-launch capacity of about a million units a month, with first commercial sales targeted in 2026 — that last part being a company statement, not an agency one.
Three things a reader might assume are not in the record and are not asserted here. No approval, tentative approval or refusal has been issued — November 10 is a goal date, not a decision. No revenue figure for the product exists, because it has not been sold. And no filing confirms that the manufacturer certifications requested on August 6 were accepted as sufficient; the reclassification on September 15 is strong evidence that they were, but it is inference from an outcome rather than a statement of acceptance.
Everything in this section is either a company intention, a registry record, or an agency meeting outcome. None of it has a date that an agency has committed to, and one item is routinely described as something it is not.
The same molecule, pursued as a new drug application rather than a generic, for suicidal ideation in depression. The application was started in the fourth quarter of 2024 and has never been completed. The annual report filed March 23, 2026 guided the filing to the second quarter of 2026; it did not happen. The August 17, 2026 release says the company is “poised to finalize its NDA, aiming for 2027 approval,” and the quarterly report filed three days earlier is more specific: it anticipates submitting the application by the end of the third quarter of 2026. That quarter closed on September 30 and no filing announces a submission, which makes it the second missed self-set date on this programme in a year. There is no PDUFA date, because there is no filed application, and there has been no complete response letter and no refuse-to-file in the record.
What did happen is a meeting worth understanding, because it changed the shape of the path. At a Type C meeting on February 11, 2026 attended by a Deputy Director of the drug centre and the directors of the neuroscience office and the psychiatry division, the agency:
The real-world dataset is the unusual asset here. The company puts it at more than 65,000 patients treated with intravenous ketamine against about 6,000 with intranasal esketamine, with an interim analysis of the first 20,000 suggesting faster onset and larger effect. Separately, Fast Track designation was broadened on August 8, 2025 to suicidal ideation in depression including bipolar depression, from a 2017 designation limited to bipolar depression, and the letter contains an explicit unmet-medical-need finding — a qualifying condition for a national priority voucher programme the company says it has applied to. No outcome of that application exists in the record.
An oral D-cycloserine and lurasidone combination carrying Breakthrough Therapy designation from November 2018, Fast Track from 2017, and a Special Protocol Agreement from April 2018. Its application has been started with the manufacturing module only, with a request for rolling review. The reported Phase 2 result is a statistically significant reduction in depression at p=0.04 and in suicidal ideation at p=0.02 against lurasidone alone over 42 days. The licensing milestone remaining is modest: $187,500 on first FDA approval. Of the registered trials, three are completed and three carry an unknown status with no update since January 2024; one expanded-access record remains available.
This is the item most often described as something it is not, and the filing is unambiguous about it. On July 21, 2026 a newly formed subsidiary received a letter from DARPA’s Defense Sciences Office notifying that its proposal for the SPARC-TMS trial — NRX-101 combined with robotic transcranial magnetic stimulation — had been selected for negotiation of a potential award. Verbatim from the filing: the selection “does not constitute a notice of award, a commitment by DARPA to make an award or an authorization for the Company to incur costs. Any potential award remains subject to the successful negotiation of definitive terms.”
The expected trial budget is put at more than $11.5 million of non-dilutive funding, with additional funds committed for military sites, and the company is named as prime contractor. No filing after July 22 announces that a contract has been signed. The trial is registered as NCT07227103, a Phase 2/3 of 400 estimated patients with a protocol cleared by the FDA and an institutional review board — and as of the September 25, 2026 registry record its status is not yet recruiting, against a stated start date of September 1, 2026 that has already passed. Primary completion is estimated December 31, 2027.
This is the only part of the company with revenue. HOPE was formed in February 2024 and NRx describes itself as founder and majority owner — a change from the “wholly owned” language used through 2025, which is itself worth noting.
| Item | What the record shows |
|---|---|
| Clinics | Six sites in Florida at June 30, 2026, including new locations in Sarasota and Boca Raton. First United States commercial site to treat patients with a cleared robotic navigation system for magnetic stimulation |
| Revenue | $1.101 million in the June quarter and $2.169 million over the half, against zero in both 2025 comparatives. The quarterly report does report it as a segment of its own, and on that basis the clinic business was profitable at the operating line: income from operations of $98 thousand in the quarter and $182 thousand over the half, with net income of $105 thousand and $193 thousand. Long-lived assets are small, $46 thousand net against $925 thousand for the parent |
| Completed acquisitions | One. Dura Medical, closing September 8, 2025 after state agency clearance, for cash plus convertible units plus contingent earn-outs. Provisional goodwill $1.793 million |
| Announced, not completed | Cohen & Associates, announced October 2025 as an “inclusion into the HOPE Network.” No completion filing exists. |
| Failed | Kadima. Agreement May 9, 2025. NRx started arbitration alleging conditions were never met; Kadima sued; HOPE notified termination for cause on August 12, 2026. Both proceedings pending |
| Spin-off | A partial distribution of 49 per cent of HOPE to NRx shareholders, announced and repeatedly described. HOPE is not an SEC registrant — no registration statement of any kind exists in its name. No date has been announced. The annual report carries it as a risk factor reserving the right to “pursue, modify or abandon such spin-off at any time” |
| A funding term sheet | January 2025, $25.0 million of preferred in HOPE convertible into a third of its fully diluted equity plus 730,000 NRx shares for $2.0 million. No filing documents a closing |
Two further subsidiaries were formed in 2026, neither with revenue: a defence-systems entity, and a monoclonal-antibody entity. The second is not an empty shell — the filing says it carries one clinical-stage candidate with data from three completed human trials, in multiple sclerosis, type 1 diabetes and long covid, alongside a preclinical programme in motor neurone disease whose first human dose is targeted for July 2027.
| Item | June 30, 2026 | December 31, 2025 |
|---|---|---|
| Cash and cash equivalents | $26.686M | $7.797M |
| Marketable securities | None. There is no such line. The $402 thousand “Investments” entry is an equity-method stake, not liquidity | — |
| Total assets | $34.160M | — |
| Total liabilities | $34.330M, of which $33.874M current | — |
| Stockholders’ deficit | $170 thousand. Liabilities exceed assets | — |
| Working capital | Negative $4.7M | — |
| Financial debt | $412 thousand insurance loan, and nothing else. No notes, no convertibles, no bank borrowings. Residual lender debt of $5.4 million was converted to equity in December 2025 | — |
| Warrant liabilities — non-cash | $18.550M, a fair-value derivative on warrants classified as liabilities. This is what makes the liability total look large | $12.304M |
| Alvogen repayment obligation | $5.8M inside accrued expenses — $4.8M of payments received plus $1.0M accrued interest, at one-month SOFR plus 6.0 per cent, about 10.8 per cent | — |
| Accumulated deficit | $324.845M | — |
The burn, separated properly. Operating cash use was $13.170 million over the first half. The first quarter accounted for $4.295 million of that, so the June quarter consumed $8.875 million — about $3.0 million a month, calculated rather than disclosed. The quarterly net loss was $16.5 million and the half-year loss $17.9 million, both much larger than the operating loss of $6.505 million and $11.250 million because of non-cash warrant revaluation. Research and development was $2.116 million in the quarter; general and administrative $4.745 million. For the full prior year, the net loss was $28.622 million and operating cash use $14.112 million.
The going-concern statement is the company’s own, and it is not hedged. Verbatim from the quarterly report: the company “has concluded that substantial doubt exists regarding the Company’s ability to continue as a going concern for a period of at least twelve months from the date of issuance of these consolidated financial statements.” The same note records that the auditor included a going-concern explanatory paragraph on the 2025 annual accounts. This is the opposite of the position at many companies this page covers, where the absence of such language is the notable feature.
And the two runway sentences do not say the same thing. From the filing: the company “has secured operating capital that it anticipates as sufficient to fund its drug development operations through at least the first quarter of 2027 solely from existing cash on hand,” adding that it expects to keep accruing clinic revenue and to use the at-the-market programme. From the press release on the same results, three days later: sufficient “to support operations for at least one year,” leaning on clinic revenue growth and the at-the-market facility. The filing is narrower in both scope and horizon — drug development specifically, and the first quarter of 2027 — and it is the document that carries legal weight. Both are reproduced here because the difference is the point.
There is no September 30 cash figure. The quarterly report is not due until mid-November, no results release has been issued since August 17, and the last cash number on the public record is the June 30 one.
| Date | Shares outstanding |
|---|---|
| December 31, 2025 | 31,734,333 |
| March 23, 2026 — annual report cover | 33,067,630 |
| June 30, 2026 | 43,157,744 |
| August 14, 2026 — quarterly report cover | 43,295,767 |
That is a 36 per cent increase in under eight months, and it came from two places. Authorised capital is 500,000,000 shares; no preferred is outstanding, the 2023 issue having converted in March 2024.
| Source | Detail | Proceeds |
|---|---|---|
| Underwritten offering, June 3–4, 2026 | 5,714,286 shares at $3.50, plus a 30-day option over 857,142 more. The filing shows 6,378,942 shares issued in all, so 664,656 of the option was taken — about 78 per cent, not the whole of it. Sixty-day lock-up for the company, directors and officers | Gross $22.3M against the $23.0M a full exercise would have produced; $20.716M net |
| At-the-market programme | Agreement dating to August 2023, suspended for eight months from August 2024, reinstated April 2025, and refreshed with a $20 million prospectus supplement on February 17, 2026 | $11.828M net over the half — $3.424M in the first quarter, $8.404M in the June quarter |
| Debt conversion, December 2025 | Residual lender debt of $5.4 million converted to equity. Across 2025 the three tranches totalled $12.6 million converted into about 7.3 million shares, valued at $18.9 million, with a $6.2 million loss on conversion | No cash; it removed the debt |
The at-the-market programme is more traceable than the proceeds figure alone suggests, and the number it yields is the uncomfortable one. The equity statement gives the share counts: 1,736,982 shares in the March quarter for $3.424 million net, and 3,075,990 in the June quarter for $8.404 million net — 4,812,972 shares over the half. That implies an average gross price near $2.51, which is well below the $3.50 of the June underwritten offering, because much of the selling happened earlier in the year at lower levels: the annual report discloses one block of 1,195,290 shares sold between February 18 and March 23 for about $2.1 million net, around $1.80 a share. What the company does not disclose is the remaining capacity, which can only be inferred from the $20 million supplement less gross sales.
The authority behind it is a $150 million shelf registration filed June 20, 2025, amended in December and declared effective December 22, 2025, carrying forward $78.6 million of unsold securities from its predecessor. On the question of whether the one-third-of-float cap applies: the prospectus supplement of June 2026 contains no such limitation statement, and the only disclosed non-affiliate float is $57.4 million at June 30, 2025 — below the $75 million threshold at that measurement date, but well exceeded by the time of the June 2026 raise. No filing states the non-affiliate float at any 2026 date.
There is no equity line and no purchase agreement of that kind in the record. The at-the-market agreement is the only facility of its type.
| Instrument | At June 30, 2026 | Terms |
|---|---|---|
| Warrants outstanding | 8,986,823 | Weighted-average exercise price $3.50, weighted-average remaining life 3.04 years, aggregate intrinsic value $12.778M. In the June quarter 14,375 were exercised at $0.33 and 358,512 expired at $11.50 |
| Of which, the repriced tranche | Four blocks issued August 2024 to January 2025 | All repriced to $1.65 under full-ratchet anti-dilution clauses, with the underlying increased by 1,870,960 shares. Fair-value effect of the ratchet $5.7 million |
| Options outstanding | 673,838, plus 25,000 granted July 28 | Weighted-average exercise price $5.34, 8.12 years remaining. Vested and exercisable 298,338 at $9.25 |
| Restricted stock and units | 32,895 unvested shares, plus 398,353 units granted July 28, 2026 | The July grants went to the executive chairman (150,000), the chief executive (75,000) and a new chief commercial officer (173,353), vesting in three annual tranches from July 2027 |
| Fully diluted — a calculation | ~53,412,676 | 43,295,767 shares plus 8,986,823 warrants plus 698,838 options plus 32,895 restricted shares plus 398,353 units. This figure appears in no filing; it is arithmetic on disclosed components, about 23 per cent above the basic count |
| Public warrants — gone | 344,886 underlying shares at $115 per whole share | Expired unexercised on May 31, 2026. The exchange filed the delisting notice on May 22. No Form 8-K reports it, because expiry is not a reportable default |
One governance detail sits underneath all of this. The equity plan’s annual evergreen was raised at the March 2026 meeting from the lesser of 1 per cent of fully diluted shares or board discretion, to the lesser of 3,187,234 shares, 5 per cent of fully diluted, or board discretion. That proposal drew 4,484,064 votes against 5,976,632 in favour — 42.9 per cent of the votes cast were against it, which is a notably high dissent for a plan amendment and is the one item on the ballot where shareholders split.
There was one listing deficiency in the last eighteen months, and it was not what a reader might assume. The notice of January 12, 2026 was for failure to hold an annual meeting within twelve months of the financial year end. It was not a minimum bid price deficiency, not a shareholders’ equity deficiency, not a market value deficiency and not a late-filing deficiency.
The company submitted a remediation plan, it was accepted, and an extension was granted to March 23, 2026, the date of the scheduled meeting. The meeting was held on March 23, 2026 and its results were filed the next day. The deficiency is therefore cured in fact.
What is missing is the confirmation. No filing records the exchange notifying the company in writing that compliance has been regained for this deficiency. The company has filed such a notice before — in January 2025, on an earlier and unrelated market-value deficiency, where the exchange wrote that the matter “is now closed.” Nothing equivalent exists for the 2026 item. The honest statement is therefore: the condition that caused the deficiency has been satisfied, and the formal closure is not on the public record. No further listing notice has been received, and no Nasdaq deadline is pending.
Separately, the warrants were delisted on May 22, 2026 — an exchange filing under the rule covering securities that have ceased to exist, because they expired on May 31. That is housekeeping, not enforcement, and the common stock remains listed. The company did not report it.
On November 20, 2025 the audit committee appointed Weinberg & Company for the 2025 financial year; the previous auditor, Salberg & Company, was dismissed around November 24. The facts that matter in an auditor change are the ones about disagreement, and here they are clean: no disagreements and no reportable events over the two prior years and the interim period, stated for both the departing auditor and the consultations with the incoming one, and the departing auditor confirmed agreement in its own letter to the regulator.
Three qualifications belong beside that. First, Salberg’s opinions on both 2024 and 2023 carried going-concern explanatory paragraphs — so the going-concern language did not arrive with the new auditor. Second, the incoming auditor was already the auditor of the clinic business NRx acquired, which is a relationship worth knowing even though it is disclosed and unremarkable in itself. Third, there is no Item 4.02 anywhere in the record — no restatement, no non-reliance determination — and only one late filing, a single notification in August 2025 for the June quarter, filed four days later. There is no late annual report in the record. Shareholders ratified the new auditor in March 2026 with 17,351,069 votes in favour against 256,023.
The ownership record here is thin, and the thinness is itself the finding. There are only four beneficial-ownership filings in the whole recent record and no Schedule 13D at all.
| Holder | Position | As of |
|---|---|---|
| Anson Funds | 1,736,737 shares, 4.9 per cent, shared voting and dispositive power, including warrant shares subject to a 4.99 per cent blocker | Event date March 31, 2026, filed May 15. The series is rising: 1,179,061 in May 2025, then 1,604,975 in August 2025, then this |
| The B Group | 3,000,000 shares, 12.62 per cent on the then-current base of 23,769,901 | Filed August 21, 2025 and never amended. If unchanged, that stake would be about 6.93 per cent of the 43,295,767 shares reported on August 14, 2026 — a calculation, since no filing confirms the position after August 2025. The same firm is named as lead investor in the June 2026 offering |
No aggregate institutional-ownership figure can be sourced from the company’s own filings, because quarterly manager reports are filed by the managers, not the issuer. Any percentage a reader sees quoted for institutional ownership of this stock does not come from a primary filing by the company, and this page publishes none.
The short position has nearly quadrupled in seven months, and the days-to-cover figure has tripled.
| Settlement date | Short interest | Average daily volume | Days to cover |
|---|---|---|---|
| September 15, 2026 | 9,773,562 | 600,596 | 16.27 |
| August 31, 2026 | 9,296,173 | 795,238 | 11.69 |
| August 14, 2026 | 8,673,787 | 1,500,713 | 5.78 |
| July 31, 2026 | 6,552,631 | 863,825 | 7.59 |
| June 30, 2026 | 5,396,019 | 1,007,329 | 5.36 |
| May 29, 2026 | 4,975,572 | 1,647,375 | 3.02 |
| April 30, 2026 | 4,407,012 | 1,368,047 | 3.22 |
| March 31, 2026 | 2,511,228 | 1,069,722 | 2.35 |
| February 27, 2026 | 2,459,826 | 521,313 | 4.72 |
At the September 15 settlement the position was about 22.6 per cent of the 43,295,767 shares outstanding, a calculation on the August cover count. The 16.27 days-to-cover figure is what makes it unusual: the position grew while the reported average daily volume in the same series fell by roughly 60 per cent from its August peak, so it would now take more than three trading weeks of normal volume to close. Short-interest data is published roughly on the eighth business day after settlement, so there is no September 30 figure.
No Form 4 has been filed in the last six months. The most recent is February 17, 2026, reporting a grant of 100,000 options to the chief operating officer at a zero price — an award, not a purchase. Across the whole period covered here, no insider has bought a single share on the open market. Four reports filed in September 2025 covered transactions dated the previous April, five months late against the two-business-day requirement. And the 398,353 restricted units and 25,000 options granted on July 28, 2026 do not appear in any Form 4 as of October 1, 2026.
The interim chief executive was made permanent on January 4, 2026, having held the role since October 2024 and having previously led the company until 2022; he is also chairman, and is paid through a consulting agreement at $0.6 million a year plus a target bonus of at least $0.3 million. A chief operating officer was engaged from December 2025 and formalised in January 2026, with 100,000 options at $2.39 carrying acceleration on a change in control. A first chief commercial officer was appointed in 2026. A director resigned effective December 31, 2025, having taken $371,000 in consulting fees and no salary during the year. Severance arrangements are individual rather than a general plan, capped at six months of salary for both the finance and operations officers. There is no securities class action against the company in the record, and no disclosed regulatory investigation.
One internal inconsistency is worth printing because a reader checking the filing will hit it. The litigation note states that “there are no material pending or threatened legal proceedings at this time” — and the same note, in the same document, describes the Kadima arbitration and lawsuit as pending. Both sentences are in the June quarterly report.
The useful thing about this map is the division running down the middle of it. One event has a date set by an agency. Everything else is a company statement, and several of those have already missed dates they set themselves.
| Window | Event | Status |
|---|---|---|
| November 10, 2026 | GDUFA goal date on the abbreviated application for preservative-free ketamine. Set by the acknowledgement letter after the remaining deficiency was cut from major to minor on September 15 | Agency-set. The only certified date in the file |
| By about November 14, 2026 | September-quarter report: the first September 30 cash figure, the first burn measured after the June raise, any at-the-market activity since June, and a restated runway statement | Statutory. The second-most-informative event of the year |
| Stated for 2026, no date | First commercial sales of the generic product. The company puts launch stock at five million doses and post-launch capacity at a million units a month | Company statement, conditional on the approval above |
| Stated, no date | Completion of the branded application for NRX-100, with approval “aiming for 2027” | Guided twice and missed twice: the second quarter of 2026 in the annual report, then the end of the third quarter of 2026 in the August filing. That quarter closed on September 30 with no submission announced. No PDUFA date can exist until it is filed |
| Stated, no date | Completion of the NRX-101 application in rolling review. Only the manufacturing module has been submitted | Company intention |
| Stated, no date | Signature of a DARPA contract worth more than $11.5 million. Selected for negotiation on July 21, 2026 | Not an award. No filing announces a signature |
| Overdue | Start of enrolment in SPARC-TMS (NCT07227103). Registered start date September 1, 2026 | Listed as not yet recruiting at the September 25 registry record — the start date has passed |
| Stated, no date | Outcome of the application to the national priority voucher programme, for which the broadened Fast Track letter supplies the qualifying finding | No outcome in the record |
| Announced since 2024, no date | Partial spin-off of 49 per cent of the clinic business | No registration statement of any kind. The annual report reserves the right to abandon it |
| Pending, unscheduled | Arbitration brought by the company and litigation brought against it over the terminated clinic acquisition | Both pending; no loss or range of loss recorded |
| December 31, 2027 | Estimated primary completion of SPARC-TMS | Registry estimate, and it has not started |
| July 2027 | Target first human dose for the antibody subsidiary’s lead programme | Company target |
The useful way to read this company is to sort its announcements by who issued them. One document in the file was written by the FDA and carries a date: the acknowledgement letter setting a GDUFA goal date of November 10, 2026 on the generic application for preservative-free intravenous ketamine. That application cleared its first review cycle with no major deficiency relating to the drug itself, and the single remaining objection — a twist-off cap on a luer lock vial — was downgraded from major to minor on September 15 after the company produced manufacturer certifications. The drug is on the shortage list. That is a legible, near, non-binary catalyst of a kind this sector rarely offers, and it is the reason the page exists.
Everything else in the file was written by the company, and several of those items are not what they are usually called. The DARPA letter is a selection for negotiation, and the filing itself says it is not an award, not a commitment and not an authorisation to incur costs — a distinction the previous version of this page lost, which is why the headline has changed. The branded application for the same molecule was guided for the second quarter of 2026 and has not been filed. The defence trial is past its own registered start date and not recruiting. The clinic spin-off has been announced since 2024 with no registration statement, no date, and a risk factor reserving the right to abandon it. None of that makes the generic application less real; all of it is relevant to how much weight to put on the next announcement.
The balance sheet is where a reader should be most careful, because it is the constraint on everything above. The company itself says substantial doubt exists about going concern. At June 30 liabilities of $34.330 million exceeded assets, leaving a stockholders’ deficit and negative working capital of $4.7 million, on $26.686 million of cash and a burn near $3.0 million a month. The real debt is trivial — a $412 thousand insurance loan, with the old lender debt converted away in December 2025 — and most of the liability total is a non-cash warrant derivative of $18.550 million, so the balance sheet is less alarming than the headline total suggests. But the share count rose 36 per cent in under eight months, and the at-the-market programme is open against a $150 million shelf whose remaining capacity is not disclosed — having already sold 4,812,972 shares over the half at an implied average gross price near $2.51, well under the $3.50 of the June underwritten offering. The two runway sentences published three days apart do not agree with each other.
Which sets up the only question that matters between now and mid-November, and it is not a scientific one. Does the approval arrive before the company needs to raise again, or after? An approval reached with the current share count is a different outcome for existing holders than the same approval reached after further issuance at these levels — and with short interest at 22.6 per cent of the count and 16.27 days to cover, the market has taken a large position on that sequencing. The two documents that will answer it are the FDA’s decision and the September-quarter report, and they are due within days of each other.
None of the above is a recommendation, a target, or a view on the share price. It is a description of what is documented, what is guided, what is calculated and labelled as such, and what the record does not say.
Method, and what is not verified. Balance-sheet, cash-flow and expense figures, the share counts, the warrant and option tables, the going-concern conclusion and the runway sentence come from the Form 10-Q for the quarter ended June 30, 2026, filed August 14, 2026; prior-year figures from the annual report filed March 23, 2026. Regulatory facts come from the Forms 8-K read with their exhibits rather than their cover pages, which matters here because the limiting language on the DARPA selection is in the body of the filing and the goal date is in the exhibit. Market figures come from the exchange’s own daily series at the September 30, 2026 close, cross-checked against an independent end-of-day provider. The market value, the fully diluted count, the June-quarter burn, the share-count increase, the short interest as a percentage of shares outstanding and the implied current size of the unamended B Group stake are calculations from published data and are labelled as calculations where they appear.
The following are not established on the public record and are not asserted here: any September 30, 2026 cash figure or burn rate; any approval, tentative approval or refusal on the abbreviated application, November 10 being a goal date rather than a decision; any formal acceptance of the manufacturer certifications requested on August 6, the September 15 reclassification being strong evidence but not a statement of acceptance; any signed DARPA contract, the July 21 letter being a selection for negotiation that the filing says is not an award; any filed branded application or PDUFA date for NRX-100 or NRX-101; any registration statement, date or structure for the clinic spin-off, and the clinic subsidiary is not an SEC registrant; any valuation figure for the clinic business, although its revenue and operating result are disclosed in the segment note; any completion of the second announced clinic acquisition or of the January 2025 preferred-funding term sheet; the remaining at-the-market capacity, which the company does not disclose — the share counts sold are disclosed, so the average price quoted here is a calculation from them; the non-affiliate float at any 2026 date; any written Nasdaq confirmation that compliance was regained for the 2026 deficiency; any aggregate institutional-ownership percentage, which cannot be sourced from the issuer’s own filings; any current position for The B Group after August 2025; and any analyst rating, consensus or price target, none of which is verifiable from a primary source and none of which this page publishes. There is also no securities class action against the company and no disclosed regulatory investigation in the record. Third-party screen data for float, short float and retail sentiment has not been re-verified and is not reproduced.
Educational and editorial content only. This report is not personalised financial advice, a solicitation, or a recommendation to buy, sell or hold any security. Biotech and small and mid-cap stocks can be extremely volatile and may result in partial or total loss of capital. Regulatory outcomes, manufacturing and container-closure reviews, litigation, financing availability, dilution and commercial execution all remain uncertain, and this company states that substantial doubt exists about its ability to continue as a going concern.
Balance-sheet and income-statement figures are those reported for the quarter ended June 30, 2026 and are historical. Price, range and volume figures are at the September 30, 2026 close. A 1-for-10 reverse share combination took effect on April 2, 2024, and per-share data in the filings is restated retroactively, so prices and per-share figures from before that date are on a different basis unless adjusted. Short-interest figures are as of the September 15, 2026 settlement date and are published with a lag. Ownership figures derive from lagged filings, one of which has not been amended since August 2025. Market prices are indicative and may differ materially from the opening or closing price on any given day.
It is the GDUFA goal date on NRx’s abbreviated application for preservative-free intravenous ketamine, set by the FDA’s acknowledgement letter after the agency reclassified the one remaining deficiency from major to minor on September 15, 2026. It is the only date in this company’s file set by an agency rather than announced by the company. A goal date is a target the agency works to, not a guarantee and not a decision.
A container closure, not the drug. The first review cycle on July 30, 2026 found no major deficiency relating to the drug’s components, required a label update to match the reference listed drug, and raised one major deficiency: the twist-off cap on the luer lock vial, on a concern that the vial tip could deform in clinical use. A clarification meeting on August 6 asked for signed manufacturer certifications that the product runs on the same lines, machinery and plastics as three already-approved applications. On September 15 the amendment was downgraded to minor, which keeps the review clock short instead of restarting it.
No. On July 21, 2026 a subsidiary received a letter saying its proposal for the SPARC-TMS trial had been selected for negotiation of a potential award. The filing states in its own words that this “does not constitute a notice of award, a commitment by DARPA to make an award or an authorization for the Company to incur costs.” The expected budget is more than $11.5 million of non-dilutive funding. No filing since then announces a signed contract, and the trial, NCT07227103, was still listed as not yet recruiting at the September 25 registry record despite a registered start date of September 1, 2026.
$26.686 million at June 30, 2026, with no marketable securities, and yes. The filing states that the company “has concluded that substantial doubt exists” about continuing as a going concern for at least twelve months, and the auditor added the same paragraph to the 2025 annual accounts. Total liabilities of $34.330 million exceeded total assets, leaving a stockholders’ deficit and negative working capital of $4.7 million. Operating cash use was $13.170 million over the half, of which the June quarter was $8.875 million, about $3.0 million a month.
Almost none. The only financial debt is a $412 thousand insurance loan — no notes, no convertibles, no bank borrowings. The residual $5.4 million owed to the former lender was converted to equity in December 2025. The reason the liability total looks large is a non-cash warrant derivative of $18.550 million, which is a fair-value measurement rather than money owed, plus a $5.8 million Alvogen repayment obligation sitting in accrued expenses at about 10.8 per cent.
They do not match, and they were published three days apart. The filing says the cash is “sufficient to fund its drug development operations through at least the first quarter of 2027 solely from existing cash on hand.” The press release on the same results says sufficient “to support operations for at least one year.” The filing is narrower in both scope and horizon, and it is the document that carries legal weight. No September 30 cash figure exists; the quarterly report is due in mid-November.
From 31,734,333 at December 31, 2025 to 43,295,767 at August 14, 2026 — up 36 per cent in under eight months. The sources were an underwritten offering of 5,714,286 shares at $3.50 in June, of which 664,656 of the 857,142-share option was taken — about 78 per cent, not all of it, for 6,378,942 shares in all and $20.716 million net; and an at-the-market programme that sold 4,812,972 shares over the half for $11.828 million net, an implied average gross price near $2.51. Fully diluted, counting 8,986,823 warrants at a weighted $3.50 plus options and the July grants, is about 53.4 million — a calculation, since no filing states it.
9,773,562 shares at the September 15, 2026 settlement date — about 22.6 per cent of the 43,295,767 shares outstanding, with 16.27 days to cover. At the February 27 settlement it was 2,459,826, so the position has nearly quadrupled in seven months, and the days-to-cover figure has tripled because the reported average daily volume in that series fell while the position grew. There is no September 30 figure: short-interest data is published roughly on the eighth business day after settlement.
Yes, and it was narrower than it sounds. The notice of January 12, 2026 was for failure to hold an annual meeting within twelve months of the financial year end — not a bid price, equity, market value or late-filing deficiency. A remediation plan was accepted, an extension ran to March 23, 2026, and the meeting was held that day, so the condition is satisfied. What is missing is the paperwork: no filing records a written Nasdaq confirmation that compliance was regained. Separately the company’s warrants were delisted on May 22, 2026 because they expired on May 31 — housekeeping, not enforcement. The common stock remains listed.
The audit committee appointed Weinberg & Company on November 20, 2025 and dismissed Salberg & Company days later. There were no disagreements and no reportable events over the two prior years and the interim period, stated for both firms, and the departing auditor confirmed agreement in its own letter. Two things to know anyway: Salberg’s opinions on both 2024 and 2023 already carried going-concern paragraphs, so that language did not arrive with the new firm, and the incoming firm was already the auditor of the clinic business NRx acquired. There is no restatement and no non-reliance determination anywhere in the record.
Yes, from clinics rather than drugs. Net patient service revenue was $1.101 million in the June quarter and $2.169 million over the half, against zero in both 2025 comparatives, from six sites in Florida held through the majority-owned HOPE Therapeutics. Cost of patient services was $675 thousand in the quarter. The quarterly report does report it as a segment of its own, and on that basis the clinic business was profitable at the operating line: operating income of $98 thousand in the quarter and $182 thousand over the half. What does not exist is any valuation figure for it.
It has been announced since 2024 and has not happened. The stated plan is a partial distribution of 49 per cent of HOPE to NRx shareholders. HOPE is not an SEC registrant — no registration statement of any kind exists in its name — and no date has ever been announced. The annual report carries it as a risk factor reserving the right to “pursue, modify or abandon such spin-off at any time.” Of three clinic transactions, one closed in September 2025, one announced in October 2025 has no completion filing, and one was terminated for cause on August 12, 2026 and is now in arbitration and litigation.
No. No Form 4 has been filed in the last six months, and no insider has bought a single share on the open market at any point in the period covered here. The most recent report, dated February 17, 2026, is a grant of 100,000 options at a zero price. The 398,353 restricted units and 25,000 options granted to executives on July 28, 2026 do not appear in any Form 4 as of October 1, 2026.
No. This Stock Hub is informational and educational. It sets out dated facts, their sources, the calculations it makes and labels as calculations, and the scenarios they leave open, and it says plainly where the record is silent. It does not recommend any action, and the outcome of a regulatory review is not knowable in advance.
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Figures are taken from public filings with the U.S. Securities and Exchange Commission, company press releases, official trial registries and market-data providers, and are stated with their reference dates. Data can change without notice, and figures published before a results release become outdated the moment that release is issued. Merlintrader makes no representation that the information is complete or current at the time of reading. Readers should verify every figure against the primary source before acting on it.
Biotechnology and healthcare companies carry binary risk. Clinical trials fail, regulatory decisions go against the applicant, approval does not guarantee commercial uptake, and development-stage companies frequently raise equity at whatever price the market will bear. A single decision can change the value of the business overnight in either direction, and companies at this stage can lose all of their value. This company states that substantial doubt exists about its ability to continue as a going concern. Every reader is responsible for their own decisions and should consult a licensed financial adviser where appropriate.
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