Key Highlights

  • Net loss for the third quarter rose to USD 7.97 million, or USD 0.46 per share, from USD 4.44 million, or USD 1.41, in the third quarter of 2025.
  • Research and development expense jumped 115% to USD 5.44 million, mainly clinical project costs of USD 3.60 million tied to the Phase 3 confirmatory trial and the CLR 125 breast cancer study.
  • Cash and cash equivalents were USD 24.6 million on September 30, 2026, against USD 13.2 million at the end of 2025, after a May 2026 financing of up to USD 140 million.
  • Management said the first patient dose in the Phase 3 confirmatory trial is on track for the first quarter of 2027, with an NDA targeted for the first half of 2027.

Phase 3 Preparation Drives the Wider Quarterly Loss

Cellectar Biosciences (NASDAQ:CLRB) filed its Quarterly Report and held its call on November 10, 2026. The company develops radiopharmaceuticals built on a phospholipid drug conjugate platform that delivers radiation directly to cancer cells. Net loss was USD 7.97 million, compared with USD 4.44 million, and the nine-month net loss reached USD 20.6 million, or USD 1.81 per share, versus USD 16.5 million, or USD 7.82. Research and Development rose USD 2.9 million as the Phase 3 confirmatory trial of iopofosine I-131 started up. General and administrative expense increased 15% to USD 2.67 million on professional fees and personnel costs. Other income fell to USD 129,000 from USD 407,000, largely non-cash Warrant revaluation.

Waldenstrom Data and the Path to Accelerated Approval

Management said the lead program, iopofosine I-131, targets relapsed or refractory Waldenstrom's macroglobulinemia after exposure to BTK inhibitors. On the call, it cited a subgroup analysis from the CLOVER-WaM study showing a major response rate of 79.2% and a median duration of response of 16 months in patients treated right after BTK inhibitor therapy. It said approval could come as early as late 2027 or early 2028 if the plan holds. Management also said it will defer a European submission by about nine months, because of United States most-favored-nation pricing concerns. A 20 to 30 patient dosimetry study has also begun.

Going Concern Language Contrasts With Management's Runway View

The filing says available Liquidity over the next twelve months was limited to about USD 21 million of unrestricted cash at the issuance date, and that the company may be unable to fund operations beyond the second quarter of 2027 without further action. It states substantial doubt about continuing as a going concern. Management on the call also placed the runway into the second quarter of 2027. The May financing brought USD 35 million upfront and up to USD 105 million more through milestone-based warrants, which depend on exercises. Cash used in operations was USD 20.3 million for nine months. The filing also reports material weaknesses in internal control, which management said it is remediating. With a small share count, a few trades can move the price, spreads can be wide and quoted moves can reverse.

Where Things Stand

It can reach the key milestones, by management's account, but not much beyond them. Cellectar Biosciences (NASDAQ:CLRB) held USD 24.6 million and said the runway extends into the second quarter of 2027, covering the first Phase 3 dose and a planned NDA filing in the first half of 2027. The filing, however, raises Going Concern doubt and notes reliance on milestone-based warrants and new capital. The loss is widening as trial work scales. Next markers are the upcoming hematology meeting presentations, initial CLR 125 data, first Phase 3 dosing in the first quarter of 2027 and any new financing.