CORMEDIX THERAPEUTICS REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

On May 14, 2026 CorMedix Therapeutics (Nasdaq: CRMD) reported financial results for the first quarter ended March 31, 2026 and provided an update on its business.

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Recent Corporate Highlights:

CorMedix announces $127.4 million of net revenue for the first quarter of 2026, reflecting strong first quarter execution and positive underlying demand trends. The Company also recognized net income of $38.6 million and adjusted EBITDA of $70.0 million.(1) Basic and fully diluted EPS were $0.48 and $0.43 per share, respectively, for the quarter
DefenCath (taurolidine and heparin) sales contributed $97.5 million of net revenue in the quarter, bolstered by higher utilization of DefenCath by outpatient dialysis customers as well as a non-recurring $9.0 million favorable change in estimate related to certain sales allowances. The acquired Melinta portfolio contributed $29.9 million, reflecting typical, first quarter purchasing patterns for the anti-infective portfolio.
CorMedix updates previously established guidance for 2026 net revenue and adjusted EBITDA. The Company increases full-year 2026 net revenue guidance to a range of $325 to $345 million, and full-year adjusted EBITDA guidance to a range of $115 to $135 million.
On April 27, 2026, CorMedix announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic hematopoietic stem cell transplantation. CorMedix is actively working together with its global partner to prepare for FDA submission of the sNDA, expected in the second half of this year, and targeting for a potential commercial launch for the expanded indication in 2027.
The ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients and is currently trending to completion in 2028. The Company is taking appropriate steps to accelerate enrollment trajectory, including the opening of new study sites and the submission of a protocol amendment to FDA, which, if approved, would remove certain exclusion criteria and broaden patient enrollment.
Cash and short-term investments, excluding restricted cash, at March 31, 2026 totaled $178.1 million.
Joseph Todisco, CorMedix Chairman & CEO, commented, "CorMedix has entered 2026 with strong momentum across all areas of our business. DefenCath continues to exceed expectations despite pending TDAPA expiration and demonstrates strong underlying utilization demand. In addition, we are advancing a pipeline of late-stage opportunities, including REZZAYO for prophylaxis, which we expect will meaningfully expand our long-term revenue opportunity. Lastly, we have delivered significant profitability and cash generation, allowing us to reinvest in growth, as well as shareholder value creation through stock repurchases, while preserving financial flexibility for new business development initiatives."

(1) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expense, taxes and certain non-recurring items. See "Non-GAAP Financial Measures" on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure.

First Quarter 2026 Financial Highlights

For the first quarter of 2026, CorMedix recorded $127.4 million in net revenue, comprised of $97.5 million in sales of DefenCath and $29.9 million in revenue associated with the acquired Melinta portfolio, an increase from $39.1 million in net revenue in the comparable period of 2025. DefenCath sales in the quarter were positively impacted by a non-recurring $9.0 million change in estimate related to certain sales allowances. DefenCath sales increased year over year largely due to the onboarding of a large dialysis organization in mid-2025. As the Melinta acquisition occurred in August 2025, the first quarter of 2025 included net revenue from only sales of DefenCath

Total operating expenses in the first quarter of 2026 were $41.5 million, compared with $17.4 million in the first quarter of 2025, an increase of approximately 139%. The increase of $24.1 million over the prior period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter and reflects the larger combined company.

Research and development (R&D) expenses in the first quarter of 2026 were $7.2 million, compared with $3.2 million for the same period in 2025. The increase in R&D was primarily due to an increase in personnel and clinical trial services in support of the ongoing clinical programs, including pediatric studies for several of our brands and the continued investment in the development of DefenCath for the TPN indication.

Selling and marketing expense increased approximately 180% to $12.5 million in first quarter of 2026 from $4.5 million in the first quarter of 2025. The increase was primarily due to higher personnel cost associated with the larger product portfolio and related marketing programs.

General and administrative expenses increased approximately 124% to $21.7 million in the first quarter of 2026 from $9.7 million in the first quarter of 2025. The increase was primarily attributable to higher costs associated with operating as a combined company following the acquisition, including higher personnel, information technology, branded prescription drug, legal and facilities costs.

CorMedix recorded net income of $38.6 million, or $0.48 and $0.43 per basic and diluted share, respectively, in the first quarter of 2026, compared with net income of $20.6 million, or $0.32 and $0.30 per basic and diluted share, respectively, in the first quarter of 2025. Also for the first quarter of 2026, CorMedix reported adjusted EBITDA of $70.0 million, compared to adjusted EBITDA of $23.6 million in the first quarter of 2025.

The Company reported cash and cash equivalents of $178.1 million at March 31, 2026, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 14, 2026, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

May 14, 2026 @ 8:30am ET

Domestic: 1-844-676-2922

International: 1-412-634-6840

Webcast: Webcast Link

(Press release, CorMedix, MAY 14, 2026, View Source [SID1234665701])

Cellectar Biosciences Reports First Quarter 2026 Financial Results and Provides Corporate Updates

On May 14, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the quarter ended March 31, 2026, and provided a corporate update.

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"The first part of 2026 was a pivotal period for Cellectar as we executed across our pipeline and capital strategies to position the company for value creation," said James Caruso, president and chief executive officer of Cellectar. "With the support of industry-leading healthcare focused investors, we successfully completed a financing of up to $140 million, providing the necessary resources to advance iopofosine through key U.S. regulatory milestones and potential commercialization. The recently reported positive 12-month follow-on data from our CLOVER WaM study reinforce our confidence that iopofosine can provide meaningful patient benefits and meet regulatory expectations, supporting our plans to initiate a Phase 3 confirmatory study and file for accelerated approval with the FDA," Mr. Caruso continued.

"In parallel, we expanded our radio-conjugate pipeline with the enrollment of the first patients in our Phase 1b study of CLR 125 in triple negative breast cancer, a challenging solid tumor cancer with a substantial unmet medical need. Together, these advances underscore the strength of our radiopharmaceutical platform and potential to deliver meaningful new treatment options to patients battling a variety of difficult-to-treat cancers," concluded Mr. Caruso.

First Quarter 2026 and Recent Corporate Highlights

Iopofosine I 131, the company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope)
Reported positive 12-month follow-up data from all patients in the Phase 2b CLOVER WaM study evaluating iopofosine I 131 in relapsed/refractory Waldenström Macroglobulinemia, which demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients. The minimum 12-month follow-up data aligns with the expectations set by the U.S. Food and Drug Administration (FDA) and positions the company for accelerated approval submission and the initiation of the confirmatory study.
Notably, the primary and secondary endpoints were both achieved in the protocol study population (n=55), with 61.8% achieving a major response rate (MRR) and a median duration of response (DoR) of 17.8 months. Additional data points included:
Overall response rate (ORR): 83.6%
Median progression-free survival (PFS): 13.5 months
Very good partial response/complete response rate (VGPR/CR): 14.5%
Disease control rate (DCR):98.2
Selected to present data from the CLOVER WaM study of iopofosine I 131 in r/r WM patients at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) taking place May 29 – June 2, 2026. The poster presentation will highlight efficacy results from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy. Details of the poster presentation are as follows:
Title: "Iopofosine I-131 after BTK inhibitors in Waldenström macroglobulinemia: CLOVER-WaM subgroup efficacy and safety"
Poster: 592
Date/Time: June 1, 2026, 9:00 AM – 12:00pm CDT
Presenter: Jarrod Longcor
Advancing plans to initiate a Phase 3 confirmatory trial of iopofosine I 131 as a treatment for WM and file for accelerated approval with the U.S. FDA in alignment with the FDA requirements. This Phase 3 study will be a comparator, randomized controlled study with approximately 100 WM patients per arm, with full patient enrollment projected within 18-24 months of the first patient admitted to the study.
Continuing to work with the European Medicines Agency (EMA) to file for a Conditional Marketing Approval (CMA) for iopofosine I 131 as a treatment option for post-BTKi refractory patients with WM.
CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors
Announced the enrollment of the first patient in the Phase 1b trial evaluating CLR 125 in refractory triple negative breast cancer (TNBC). The Company anticipates activating additional study sites throughout the second quarter and will provide dosimetry, safety and efficacy updates in the second quarter and throughout the balance of 2026.
Corporate
In May 2026, the Company entered into a securities purchase agreement with certain institutional investors to issue and sell an aggregate of approximately $35 million upfront and up to $105 million of milestone-based securities in a registered direct offering of common stock and a concurrent private placement of common stock, pre-funded warrants and milestone-based warrants.
The oversubscribed financing was led by Nantahala Capital, with participation from Balyasny Asset Management, Caligan Partners, Janus Henderson Investors, SilverArc Capital Management and other dedicated healthcare funds. In connection with the Offering, Andrew Gu of Nantahala Capital Management, LLC will join Cellectar’s Board of Directors.
2026 Financial Highlights

Cash and Cash Equivalents: As of March 31, 2026, the company had cash and cash equivalents of $8.3 million, compared to $13.2 million as of December 31, 2025, which does not reflect net proceeds of approximately $31 million from the May 2026 offering. The company believes its cash balance as of March 31, 2026, along with funds from the May 2026 financing, are adequate to fund its budgeted operations into the second quarter of 2027, including the initiation costs for the iopofosine I 131 confirmatory study in WM.
Research and Development Expenses: R&D expenses for the three months ended March 31, 2026, were approximately $3.0 million, compared to approximately $3.4 million for the three months ended March 31, 2025. The overall decrease was primarily a result of reduced clinical and preclinical study costs, partially offset by increased spending for product manufacturing processes.
General and Administrative Expenses: G&A expenses for the three months ended March 31, 2026, were approximately $2.8 million, compared to approximately $3.0 million for the same period in 2025. The decrease was primarily a result of reduced personnel costs.
Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2026, was $5.7 million, or $1.33 per share, compared to $6.6 million, or $4.30 per share, in the three months ended March 31, 2025.
Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, May 14, 2026, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.

(Press release, Cellectar Biosciences, MAY 14, 2026, View Source [SID1234665700])

Celcuity Inc. Reports Release of First Quarter 2026 Financial Results and Provides Corporate Update

On May 14, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, reported financial results for the first quarter ended March 31, 2026 and other recent business developments.

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"With positive results in both cohorts of the pivotal VIKTORIA-1 study, we believe gedatolisib regimens have the potential to advance the standard of care in the second-line setting for a significant number of patients with HR+/HER2- advanced breast cancer, regardless of PIK3CA status," said Brian Sullivan, CEO and co-founder of Celcuity. "We are on track to launch gedatolisib commercially in anticipation of its potential FDA approval in the third quarter of 2026, and we look forward to bringing this important therapy to physicians treating patients with advanced breast cancer."

Mr. Sullivan added, "Our positive Phase 3 results, combined with our promising Phase 1b clinical trial results in treatment-naive late-stage patients, provide a strong scientific rationale to evaluate gedatolisib combinations as first-line therapy. By expanding our VIKTORIA-2 study to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, we are positioning gedatolisib regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status."

First Quarter 2026 Business Highlights and Other Recent Developments

● Celcuity reported positive topline results from the PIK3CA mutant-type ("MT") cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-") ("HR+/HER2-"), PIK3CA MT locally advanced or metastatic breast cancer ("ABC").

○ The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib ("gedatolisib triplet") demonstrated a statistically significant and clinically meaningful improvement in progression-free survival ("PFS") compared with alpelisib, a PI3Kα inhibitor, and fulvestrant.

○ The secondary endpoint comparing gedatolisib in combination with fulvestrant ("gedatolisib doublet") versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS.

○ Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety signals.

○ Detailed data for the gedatolisib triplet and doublet regimens will be presented in a late-breaking abstract ("LBA") oral session on June 2, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, Illinois.

○ Celcuity intends to submit these data to the FDA in the third quarter as a supplemental New Drug Application ("sNDA") and to submit VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission.

● The Phase 3 VIKTORIA-2 clinical trial now includes two studies, Study 1 and Study 2, each with independent statistical analysis plans that include primary endpoints for their respective intent-to-treat populations. Study 1, which is ongoing, is evaluating the efficacy and safety of gedatolisib in combination with palbociclib and fulvestrant in approximately 440 patients with endocrine-resistant HR+/HER2- ABC. Study 2, which was added in conjunction with a VIKTORIA-2 protocol amendment, is evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in approximately 740 patients with treatment-naive endocrine-sensitive HR+/HER2- ABC. Eligible patients include those whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. Approximately 60,000 adults are newly diagnosed each year in the United States with endocrine-sensitive HR+/HER2- ABC.1

● To support its long-term lifecycle development plan, Celcuity submitted its first patent application to the United States Patent and Trademark Office ("USPTO") for a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. Development of the subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.

● In January 2026, the FDA accepted the submission of Celcuity’s New Drug Application ("NDA") for gedatolisib in HR+/HER2- PIK3CA wild-type ("WT") ABC. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026.

First Quarter 2026 Financial Results

Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2026, compared to the first quarter ended March 31, 2025.

Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share, compared to a net loss of $37.0 million, or $0.86 per share, for the first quarter of 2025. Non-GAAP adjusted net loss for the first quarter of 2026 was $46.8 million, or $0.86 per share, compared to non-GAAP adjusted net loss of $34.7 million, or $0.81 per share, for the first quarter of 2025. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Total operating expenses were $50.5 million for the first quarter of 2026, compared to $36.1 million for the first quarter of 2025.

Research and development ("R&D") expenses were $33.1 million for the first quarter of 2026, compared to $29.8 million for the prior year period. The $3.3 million increase in R&D expenses was primarily due to a $3.0 million increase in employee-related and consulting expenses. The remaining increase was primarily due to a $5.4 million increase in manufacturing and other costs, partially offset by a $5.1 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial.

Selling, general and administrative ("SG&A") expenses were $17.4 million for the first quarter of 2026, compared to $6.3 million for the prior year period. The $11.1 million increase in SG&A expenses was primarily due to an $8.7 million increase in employee-related and consulting expenses, of which $6.6 million was due to commercial headcount additions and other launch-related activities, and a $2.4 million increase primarily due to software costs, professional fees and other costs.

Net cash used in operating activities for the first quarter of 2026 was $55.1 million, compared to $35.9 million for the prior year period. Cash, cash equivalents and short-term investments were $387.1 million at the end of the first quarter of 2026. We expect cash, cash equivalents, investments and drawdowns on our debt facility to finance our operations through 2027.

Webcast and Conference Call Information

To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865.

A live webcast presentation can also be accessed using this weblink: View Source;tp_key=2f73ec65ba. A replay of the webcast will be available on the Celcuity website following the live event.

(Press release, Celcuity, MAY 14, 2026, View Source [SID1234665699])

Candel Therapeutics Reports First Quarter 2026 Financial Results and Recent Corporate Highlights

On May 14, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for patients with cancer, reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

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"The quarter was marked by strong execution across our lead clinical programs, commercial readiness efforts, and further strengthening of our balance sheet," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. "Our primary focus remains on preparing for our planned BLA submission in Q4 2026 for aglatimagene in localized, intermediate- to high-risk prostate cancer. In parallel, we continue to follow patients from our phase 3 localized prostate cancer trial, with extended follow up data to be presented in a plenary oral presentation in May 2026 at AUA and additional biomarker data to be announced in Q3 2026. We are also encouraged by the persistent survival tail observed after extended follow-up from our phase 2a NSCLC trial and look forward to the planned initiation of a pivotal NSCLC phase 3 trial in June 2026."

Dr. Tak continued, "On the commercial readiness front, we are encouraged by our progress in building a differentiated, partnership-driven model that leverages the expertise of world-class organizations EVERSANA and IDEA Pharma. We believe this approach can enhance speed, flexibility, and scalability, positioning Candel for a successful and timely commercial launch of aglatimagene, if approved, for patients with localized prostate cancer."

First Quarter 2026 & Recent Highlights


Aglatimagene besadenovec (CAN-2409) – Prostate Cancer

The Company continues to advance its pre-BLA readiness initiative, including its Chemistry, Manufacturing, and Controls (CMC) activities, and preparation of clinical study reports and BLA modules.

The Company will report follow-up clinical data from its phase 3 trial of aglatimagene in prostate cancer in an oral presentation at the American Urological Association (AUA) 2026 Annual Meeting Plenary Program being held in Washington D.C. from May 15-18, 2026. In Q3 2026, the Company expects to present additional biomarker data.

The Company plans to conduct process validation with its Contract Development and Manufacturing Organization in Q2 2026 to enable its anticipated submission of a BLA in Q4 2026. Clinical material from the new process has been manufactured and filled into vials. Candel intends to use this material in the pivotal phase 3 clinical trial in NSCLC.

The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of localized prostate cancer. The phase 3 clinical trial of aglatimagene in localized prostate cancer was conducted under a Special Protocol Assessment with respect to certain aspects of the study design, agreed with the FDA.

Aglatimagene besadenovec (CAN-2409) – Non-Small Cell Lung Cancer (NSCLC)

The Company reported an additional 12 months of extended follow-up from its clinical trial of aglatimagene plus valacyclovir in combination with continued ICI therapy in patients with advanced NSCLC, who had an inadequate response to prior ICI treatment. The reported data included:

Extended long-term survival observed after an additional year of follow-up in an ongoing phase 2a clinical trial, with 50% of the 46 patients with advanced NSCLC treated per-protocol with aglatimagene surviving beyond 24 months, despite prior inadequate response to ICI and multiple adverse baseline prognostic factors.

Among the patients surviving beyond 24 months and with PD-L1 status available, 85% (17/20) had baseline PD-L1 tumor proportion scores (TPS) below 50% (a population typically less responsive to ICI), supporting the potential of aglatimagene to upregulate PD-L1 in the tumor microenvironment and convert non-responders to ICI into responders.

Median overall survival (mOS) was 25.4 months in the evaluable patients with inadequate response to ICI in cohorts 1 and 2 (per-protocol population), 21.5 months among evaluable patients exhibiting progressive disease at baseline despite prior ICI therapy (cohort 2), and 25.4 months in the subgroup of patients with non-squamous histology within cohort 2, supporting the rationale for a precision medicine-based design for the phase 3 pivotal trial planned for initiation in June 2026.

Post-treatment tumor biopsies demonstrated an increase in pro-inflammatory gene expression, which was significantly associated with long-term survival, supporting activation of inflammatory pathways within the tumor microenvironment following aglatimagene treatment.

Expansion of T-cell receptor (TCR) repertoire diversity was observed after treatment both within the tumor and in peripheral blood, consistent with broad activation of anti-tumor immunity through enhanced exposure of tumor antigens following aglatimagene therapy.

Following a positive end-of-phase 2 meeting with the FDA in July 2025, the Company is preparing to initiate a pivotal phase 3 clinical trial of aglatimagene in NSCLC in June 2026.

The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.

Linoserpaturev (CAN-3110) – Recurrent High-Grade Glioma (rHGG)

In February 2026, at the 7th Annual Glioblastoma Drug Development Summit, the Company shared insights from its herpes simplex virus (HSV)-based platform and its linoserpaturev program through workshop presentations and panel discussions focused on advancing biomarker-driven clinical development in glioblastoma.

The Company submitted an IND for linoserpaturev to advance the ongoing development of this asset in rHGG in Q4 2025 and received clearance to proceed from the FDA in Q1 2026.

The FDA previously granted Fast Track Designation and Orphan Drug Designation to linoserpaturev in rHGG.•
Recent Corporate Events

In April 2026, the Company announced a commercialization agreement with EVERSANA to support the potential U.S. launch of aglatimagene in localized prostate cancer. EVERSANA joins IDEA Pharma, a division of SAI MedPartners, who has been providing path-to-market strategies and strategic positioning for aglatimagene. This operating model gives Candel immediate access to leading commercial capabilities, while maintaining financial flexibility, capital efficiency, and scientific focus that has driven the Company’s progress to date.

On February 23, 2026, Candel issued and sold 18,348,624 shares of common stock at a price to the public of $5.45 per share for aggregate gross proceeds of approximately $100 million, which will be used to complete critical launch readiness, medical affairs, pre-commercialization, and commercial activities for aglatimagene in early, localized prostate cancer, ongoing development costs related to the phase 3 trial of aglatimagene in NSCLC, and for general corporate purposes.

On February 19, 2026, Candel announced a $100 million royalty funding agreement with funds managed by RTW Investments, LP (RTW), subject to FDA approval of aglatimagene in localized, intermediate- to high-risk, prostate cancer. Under the terms of the agreement, RTW will receive a tiered single digit percentage of annual net sales of aglatimagene in the U.S., subject to a cap. Funds will strengthen the Company’s balance sheet for potential U.S. commercial launch of aglatimagene in intermediate- to high-risk localized prostate cancer.
Anticipated Milestones


Updated extended follow-up data from the positive phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk localized prostate cancer, will be reported in an oral presentation at the AUA 2026 Annual Meeting Plenary Program being held in Washington D.C. from May 15-18, 2026.

The Company plans to initiate a pivotal phase 3 clinical trial of aglatimagene in patients with metastatic, non-squamous, NSCLC, and progressive disease despite ICI treatment in June 2026.

Biomarker data related to the effects of aglatimagene in patients with localized prostate cancer is expected in Q3 2026.

The Company expects to present mature mOS data and an update on long-term survivors from arm C of its phase 1b clinical trial of linoserpaturev in patients with rHGG in Q4 2026.

Submission of BLA for aglatimagene in prostate cancer is planned for Q4 2026.

Financial Results for the First Quarter Ended March 31, 2026

Research and Development Expenses: Research and development expenses were $9.8 million for the first quarter of 2026 compared to $4.0 million for the first quarter of 2025. The increase was primarily due to higher clinical trial and manufacturing costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $0.6 million for the first quarter of 2026, as compared to a non-cash stock compensation expense of ($0.1) million for the first quarter of 2025.

General and Administrative Expenses: General and administrative expenses were $6.4 million for the first quarter of 2026, compared to $4.1 million for the first quarter of 2025. The increase was primarily due to higher commercial readiness costs and an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $0.8 million for the first quarter of 2026, as compared to a non-cash stock compensation expense of $0.4 million for the first quarter of 2025.

Net Income/Loss: Net loss for the first quarter of 2026 was $8.9 million compared to net income of $7.4 million for the first quarter of 2025 and included net other income of $7.4 million and $15.5 million, respectively. The decrease in net other income was primarily related to the change in the fair value of the Company’s warrant liabilities.

Cash Position: Cash and cash equivalents, as of March 31, 2026, were $194.8 million compared to $119.7 million as of December 31, 2025. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of March 31, 2026, will be sufficient to fund operations into Q1 2028.

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use.

About linoserpaturev (CAN-3110)

Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of rHGG from the U.S. Food and Drug Administration (FDA).

(Press release, Candel Therapeutics, MAY 14, 2026, View Source [SID1234665698])

Biogen Completes Acquisition of Apellis Pharmaceuticals

On May 14, 2026 Biogen Inc. (Nasdaq: BIIB) reported the successful completion of the acquisition of Apellis Pharmaceuticals, Inc. (Nasdaq: APLS). Apellis, a leader in advancing treatments for serious, complement-driven diseases, is now a wholly owned subsidiary of Biogen.

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The acquisition adds two best-in-class commercialized products, EMPAVELI and SYFOVRE, significantly bolstering Biogen’s near-term growth outlook and accelerating the Company’s expansion into nephrology. Together, the products recorded $689 million in net product revenue in 2025. This transaction will strengthen Biogen’s revenue and EPS growth potential by being accretive to Biogen’s Non-GAAP diluted EPS in 2027 and is expected to materially increase Biogen’s non-GAAP EPS compound annual growth rate (CAGR) through the end of the decade. Updated financial guidance will be provided in conjunction with the Q2 earnings report in July.

Apellis also brings an established nephrology commercial and medical infrastructure to accelerate Biogen’s launch readiness for felzartamab, with a first Phase 3 readout in antibody-mediated rejection in kidney transplant patients anticipated in the first half of 2027.

Biogen’s tender offer, to acquire all of the outstanding shares of Apellis common stock for $41 per share in cash and one contractual, non-transferable contingent value right per share representing the right to receive contingent cash payments of up to an aggregate of $4 in cash upon the achievement of certain annual global net sales thresholds for SYFOVRE, expired one minute after 11:59 p.m., Eastern Time, on May 13, 2026. Equiniti Trust Company, LLC, the depositary for the tender offer, has advised Biogen that approximately 105,687,831 shares were validly tendered and not validly withdrawn in the tender offer, representing approximately 82.4% of the total outstanding shares as of the expiration time. All conditions to the tender offer having been satisfied or waived on May 14, 2026, Aspen Purchaser Sub, Inc. (Aspen), a wholly owned subsidiary of Biogen, accepted for payment all shares that were validly tendered and not validly withdrawn pursuant to the tender offer.

Following the consummation of the tender offer, Aspen merged with and into Apellis in accordance with Section 251(h) of the General Corporation Law of the State of Delaware without a vote of Apellis shareholders, with Apellis continuing as the surviving corporation of the merger and a wholly owned subsidiary of Biogen. In connection with the merger, the shares that were not tendered in the tender offer were acquired by Biogen and converted into the right to receive the offer price. In connection with the completion of the transaction, the Apellis shares ceased trading on Nasdaq.

About SYFOVRE (pegcetacoplan injection)

SYFOVRE (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA) secondary to AMD. By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States and Australia for the treatment of GA secondary to age-related macular degeneration.

About Geographic Atrophy

Geographic atrophy is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide.1,2 It is a progressive and irreversible disease caused by the growth of lesions, which destroys the retinal cells responsible for vision. Vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. While rates of progression vary between patients, on average, it takes 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3

About EMPAVELI/Aspaveli (pegcetacoplan)

EMPAVELI (Aspaveli in the EU) (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is the first treatment approved in the United States for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age or older, to reduce proteinuria. EMPAVELI/Aspaveli is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally, and for the treatment of C3G and primary IC-MPGN in the European Union and other countries globally. EMPAVELI is being evaluated for the treatment of additional rare diseases. Sobi has commercial rights to EMPAVELI/Aspaveli outside the U.S.

About C3 Glomerulopathy (C3G) and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring lifelong dialysis therapy or a burdensome kidney transplant.4-6 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.7

About Paroxysmal Nocturnal Hemoglobinuria (PNH)

Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired, rare, chronic, and potentially life-threatening blood disease that is associated with persistently low (below normal) hemoglobin levels, thrombosis, and debilitating symptoms. PNH can appear at any age and in any race or gender, and is most often diagnosed in people in their early 30s.8,9

U.S. Important Safety Information for SYFOVRE (pegcetacoplan injection)

CONTRAINDICATIONS


SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred.

WARNINGS AND PRECAUTIONS


Endophthalmitis and Retinal Detachments


Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. •
Retinal Vasculitis and/or Retinal Vascular Occlusion


Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay.


Neovascular Age-related Macular Degeneration (AMD)


In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration.


Intraocular Inflammation


In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.


Increased Intraocular Pressure


Acute increase in intraocular pressure may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.

ADVERSE REACTIONS


Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.

Please see full Prescribing Information for more information.

U.S. Important Safety Information for EMPAVELI (pegcetacoplan)

BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.


Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.


Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.

Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS.

CONTRAINDICATIONS


Hypersensitivity to pegcetacoplan or to any of the excipients


For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B

WARNINGS AND PRECAUTIONS

Serious Infections Caused by Encapsulated Bacteria

EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria.

Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.

Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections.

EMPAVELI is available only through a restricted program under a REMS.EMPAVELI REMS

EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following:

Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients’ vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified.

Further information is available at www.empavelirems.com or 1-888-343-7073.

Infusion-Related Reactions

Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved.

Monitoring Paroxysmal Nocturnal Hemoglobinuria (PNH) Manifestations after Discontinuation of EMPAVELI

After discontinuing treatment with EMPAVELI, closely monitor for signs and symptoms of hemolysis, identified by elevated Lactate Dehydrogenase (LDH) levels along with sudden decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues EMPAVELI for at least 8 weeks to detect hemolysis and other reactions. If hemolysis, including elevated LDH, occurs after discontinuation of EMPAVELI, consider restarting treatment with EMPAVELI.

Interference with Laboratory Tests

There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels.

ADVERSE REACTIONS

Most common adverse reactions in adult patients with PNH (incidence ≥10%) were injection site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, pain in extremity, hypokalemia, fatigue, viral infection, cough, arthralgia, dizziness, headache, and rash.

Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) (incidence ≥10%) were injection-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea.

USE IN SPECIFIC POPULATIONS

Females of Reproductive Potential

EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose.

(Press release, Biogen, MAY 14, 2026, View Source [SID1234665697])