Cellectar Biosciences INC NEW 2026 Q2 Earnings Call

Please go ahead. Thank you, operator.

Good morning, and welcome to Cellectar Biosciences' second quarter 2026 financial results and business update conference call. Joining us today from Cellectar are James Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Kolean, CFO, for a financial review of the quarter. Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Cellectar issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of Cellectar's corporate website. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements.

Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 13, 2026. The company undertakes no obligation to revise or update any firm forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line to your questions. I'll now turn the call over to James Caruso.

Jim? Thank you, Anne Marie, and thank you all for joining us this morning.

The second quarter marked an especially productive period for Cellectar as we continued making meaningful progress across every area of our business, including clinical development, regulatory action, pipeline advancement, platform expansion, and strengthening of our financials. Our near-term priority remains clear. Advancing iopofosine I 131 for patients with relaxed or refractory Waldenstrom's macroglobulinemia, or WM. Particularly those patients whose disease has progressed following earlier lines of treatment, including BTK inhibitor therapy. We believe this represents a significant unmet medical need and an attractive opportunity to bring a differentiated treatment option to patients who currently face limited therapeutic alternatives. During the quarter, we took several important steps to move this strategy forward. First, we reported the full 12-month follow-up results from the CLOVER-WaM study.

These data further reinforced both the depth and durability of response achieved with iopofosine and demonstrated that the study successfully met both its primary and secondary endpoints. Taken together, we believe the totality of evidence generated to date continues to support iopofosine's potential to become an important treatment option for WM patients. Second, we continued to build an increasingly compelling clinical data set for iopofosine. We presented new data at ASCO 2026 from the CLOVER-WaM study highlighting outcomes in patients treated immediately following BTKI therapy, a challenging patient population. These results demonstrated a 79.2% major response rate, an 87.5% overall response rate, a 100% clinical benefit rate, and encouraging durability with a median duration of response of 16 months. Most importantly, we have now initiated site activation activities for our planned confirmatory phase III study.

This represents a critical milestone in our regulatory strategy. Once necessary site activation and ongoing patient enrollment is achieved, we expect to be in a position to submit our new drug application under the FDA's Accelerated Approval Program in mid-2027. Based upon the breakthrough designation awarded to iopofosine I 131 for relapsed refractory WM, an approximate 6-month review is anticipated. To support these efforts, we were pleased to complete an oversubscribed financing in May that has the potential to provide up to $140 million in capital, including $35 million upfront and up to $105 million tied to future milestones. This financing significantly strengthens our balance sheet and provides the resources needed to execute our WM strategy, advance our regulatory initiatives, and continue investing in our broader radiopharmaceutical pipeline.

Beyond WM, we continue to advance the broader opportunity represented by our phospholipid drug conjugate or PDC platform. The PDC platform is a highly differentiated targeting technology designed to selectively deliver therapeutic payloads to cancer cells, including primary tumors, metastatic lesions, and cancer stem cells. Importantly, the platform is highly versatile and can be combined with a variety of payloads and isotopes, including beta emitting, Auger-emitting, and alpha emitting radiotherapeutics. We believe the success we are seeing with iopofosine is validating the platform and creating a strong foundation for future pipeline expansion. Today, in addition to discussing our progress with iopofosine, we will also review advancements in CLR 125, our Auger-emitting program in solid tumors, and discuss how we plan to leverage the platform to build a next generation radiopharmaceutical franchise. With that overview, I'll turn the call over to Chad for the financial review.

Thank you, Jim, and good morning, everyone. First, I will spend a couple of minutes on the financing that Jim mentioned. As he stated, the transaction provided the company with the current and anticipated future funding to support our strategy to obtain approval for iopofosine I 131. The company received $35 million gross upfront, or approximately $31.7 million net, for common shares and pre-funded warrants. Additionally, we issued three tranches of approximately 13.2 million warrants each, all of which are currently exercisable with a strike price of $2.65. Furthermore, these warrants are callable for cash by the company if the respective milestone and related criteria are met. Each tranche of warrants, A, B, and C, has a milestone associated with it. The tranche A warrants, which expire on July 7, 2027, have a milestone of first patient enrolled in the confirmatory study for iopofosine I 131 in Waldenstrom's macroglobulinemia, or WM, patients.

The tranche B warrants, which expire July 7, 2028, have the milestone of the FDA's acceptance of a new drug application for iopofosine. The tranche C warrants, which expire July 7, 2031, have the milestone of approval by the FDA of iopofosine for marketing. In addition to achieving the milestones, two additional criteria must be met for the warrants to be callable. First, the volume-weighted average price, or VWAP, for the company stock must be at least $3.45 for 20 consecutive trading days. Second, the trading liquidity based upon the VWAP must average a minimum of $500,000 for those same 20 trading days. The milestone timing is designed to provide the necessary funding through the anticipated study initiation, submission to FDA, and approval. We believe this structure, provided it occurs as designed, supports the company's capital needs through initial commercialization of iopofosine.

Now for our financial results for the period ended June 30, 2026. We ended the second quarter with cash and cash equivalents of approximately $34.0 million, compared to $13.2 million as of December 31, 2025, which reflects the cash generated from the initial portion of the May financing. Turning now to our operating results. Research and development expenses for the three months ended June 30, 2026, were approximately $4.6 million, compared to approximately $2.4 million for the three months ended June 30, 2025. The overall increase in R&D largely reflected increased clinical study activity to support our CLR 125 study in triple-negative breast cancer and initiation of the confirmatory study of iopofosine I 131 in WM. General and administrative expenses for the three months ended June 30, 2026, were $2.6 million, compared to $3.6 million for the same period in 2025.

The decrease in G&A was driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs. Net loss for the three months ended June 30, 2026, was $6.9 million, or $0.57 per share, compared with $5.4 million, or $3.39 per share during the three months ended June 30, 2025. The enhanced strength of our balance sheet enables our ability to effectively advance our clinical and regulatory programs. Now I will turn the call over to Jarrod to discuss the regulatory and clinical advancements we have been making during the first half of 2026.

Thank you, Chad, and good morning, everyone. As Jim noted, we continue to make meaningful progress across our clinical, regulatory, and development initiatives and believe Cellectar is entering an important phase of execution with multiple value-driving milestones ahead. Our primary focus remains advancing iopofosine I 131 to potential registration in WM, where we have generated a compelling body of clinical evidence and established a clear regulatory path forward. We have been encouraged by the consistency of the data emerging from the CLOVER-WaM study, which continues to demonstrate meaningful and durable responses in a patient population with significant unmet medical need. During the quarter, we expanded that clinical evidence base with two important data updates. First, we presented new analyses at ASCO highlighting outcomes in patients treated immediately following BTK inhibitor therapy, a particularly challenging setting where treatment options remain limited.