Regeneron Announces Investor Conference Presentation

On March 5, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported it will webcast management participation at the Barclays 28th Annual Global Healthcare Conference at 9:00 a.m. ET on Tuesday, March 10, 2026.

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The session may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay and transcript of the webcast will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, MAR 5, 2026, View Source [SID1234663304])

Atavistik Bio Closes $40 Million Series B Extension for Advancement of its Pipeline Bringing Total Round Proceeds to $160 Million

On March 5, 2026 Atavistik Bio, a biotechnology company discovering the next generation of selective allosteric therapeutics, reported the closing of a $40 million extension to its Series B financing from new investor RA Capital Management, bringing the total round proceeds to $160 million. RA Capital joins other top-tier investors who participated in the Series B round, including Nextech Invest, The Column Group, Lux Capital and Regeneron Ventures, as previously announced in December 2025. Atavistik Bio will use the proceeds from the upsized Series B financing to fund clinical development of ATV-1601, a potential best-in-class AKT1-selective oral inhibitor for HHT, and its JAK2 V617F mutant-selective inhibitor program for MPNs through clinical proof of concept.

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"We’re excited to welcome RA Capital as an investor in Atavistik Bio. Our Series B round, backed by a highly respected syndicate, reflects strong belief in our selective allosteric programs and our focus to advance meaningful therapies for patients with severe diseases," said Bryan Stuart, Chief Executive Officer at Atavistik Bio. "This additional funding further strengthens our ability to accelerate the development of best-in-class therapies designed to deliver superior efficacy, improved tolerability profiles, and potentially transformative outcomes for patients."

"We are pleased to support Atavistik Bio in this next phase of growth as the company is at the forefront of developing transformative therapies for HHT and MPNs," said Nandita Shangari, PhD, Managing Director at RA Capital Management. "Atavistik Bio’s highly experienced team and a pipeline of high-quality programs targeting significant unmet need, position the company to create meaningful value."

About Hereditary Hemorrhagic Telangiectasia (HHT), AKT1 Inhibition and ATV-1601

HHT is a severe inherited bleeding disorder that affects more than 1.6 million people globally, with no approved therapies currently available. This condition often leads to frequent bleeding episodes and vascular shunts, resulting in chronic anemia, multiorgan damage, and life-threatening complications. AKT1 hyperactivation is a hallmark of HHT and has been shown to drive the vascular pathology of HHT. Selectively inhibiting AKT1, the primary AKT isoform and driver of abnormal endothelial growth implicated in HHT, offers a novel and potentially disease-modifying therapeutic approach for this difficult disease. Although there has been substantial investment in pan-AKT inhibitors, their use is limited by AKT2-driven toxicities, most notably hyperglycemia, which impact tolerability and restrict their use for chronic dosing. ATV-1601 is an oral allosteric inhibitor that selectively inhibits AKT1.

ATV-1601 was evaluated in a Phase 1 oncology study, and demonstrated a favorable safety profile, validating its differentiated selectivity profile that addresses key limitations of pan-AKT inhibitors. Development efforts will now focus on advancing ATV-1601 in HHT.

About Myeloproliferative Neoplasms (MPNs) and Selective Targeting of the JAK2 V617F Mutation

MPNs are a group of rare chronic blood cancers for which current treatment options are limited. The JAK2 V617F mutation is the most common driver mutation in patients living with MPNs, affecting approximately 95% of patients with polycythemia vera, 60% of patients with essential thrombocythemia, and 55% of patients with myelofibrosis. Approved pan-JAK inhibitors, such as ruxolitinib, provide symptom relief, but non-selectively inhibit both mutant and wild-type JAK2. This limits the ability to reduce JAK2 V617F mutant allele burden and can disrupt normal blood cell production regulated by wild-type JAK2, contributing to adverse events and treatment discontinuation. Selectively targeting the JAK2 V617F mutation has the potential to reduce mutant allele burden, preserve normal bone marrow function, and have a disease modifying impact that will substantially improve long term outcomes for patients with MPNs.

(Press release, Atavistik Bio, MAR 5, 2026, View Source [SID1234663321])

Shattuck Labs Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Business Highlights

On March 5, 2026 Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, reported financial results for the fourth quarter and full year ended December 31, 2025 and provided recent business highlights.

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"SL-325 is now the first DR3 blocking antibody to generate human clinical data, and we are very pleased with the progress we have made in our Phase 1 clinical trial, which is nearly complete. We look forward to sharing the data from this trial in the second quarter, and anticipate initiating our Phase 2 clinical trial in Crohn’s disease in the third quarter," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck.
DR3 Program Development in 2025

Shattuck’s lead product candidate, SL-325, is a potentially first-in-class and best-in-mechanism DR3 blocking antibody for the treatment of Crohn’s disease, ulcerative colitis, and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325, and Shattuck’s other DR3 blocking antibodies, include:

•The Phase 1 trial evaluating the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of SL-325 in healthy volunteers is ongoing and progressing as planned, and will determine the recommended Phase 2 dose and dosing schedule.

▪Enrollment of all six single-ascending dose (SAD) cohorts is now complete, and full enrollment in the final multiple-ascending dose (MAD) cohort of the trial is expected to be completed in the second quarter of 2026.
•Shattuck expects to disclose safety and tolerability, PK, receptor occupancy, duration of receptor occupancy, and immunogenicity data from this trial in the second quarter of 2026.

•Subject to positive Phase 1 data and regulatory alignment, Shattuck expects to initiate a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease in the third quarter of 2026.

•Shattuck continues to develop multiple DR3-based bispecific antibodies. Shattuck’s lead bispecific antibody has entered IND-enabling activities. This bispecific antibody was designed to inhibit both the DR3/TL1A axis and another biologically relevant target for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck plans to disclose the targets of its lead bispecific product candidate, supporting preclinical data, and expected development timelines in the first half of 2026.

Appointment to Management Team

•Michael Choi, M.D., joined Shattuck Labs as Vice President of Clinical Development in November 2025. Dr. Choi brings extensive experience advancing inflammatory bowel disease programs, including as clinical lead at Morphic Therapeutic, where he led the development of MORF-057, its oral α4β7 antagonist. Earlier in his career, Dr. Choi served as Assistant Professor of Medicine at Harvard Medical School and Affiliated Faculty at the Harvard Stem Cell Institute. Dr. Choi received his medical degree from Cornell University, trained in Internal Medicine at UCSF, and completed his Gastroenterology Fellowship at Massachusetts General Hospital.

Recent Events
•Shattuck participated in the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025. Dr. Schreiber presented at the conference and management participated in one-on-one meetings.
•Shattuck participated in the Evercore ISI 8th Annual HealthCONx Conference on December 3-4, 2025. Dr. Schreiber participated in a fireside chat and management participated in one-on-one meetings.
•Shattuck participated in the Piper Sandler Virtual Novel Targets in Immunology Symposium on February 12-13, 2026. Dr. Schreiber, Andrew R. Neill, Chief Financial Officer, and Michael Choi, M.D., Vice President of Clinical Development participated in a fireside chat.
•Shattuck participated in the TD Cowen 46th Annual Health Care Conference on March 2-4, 2026. Dr. Schreiber presented at the conference and management participated in one-on-one meetings.
Upcoming Events
•Shattuck plans to attend the following investor conference. Details will be included on the Events & Presentations section of the Company’s website.
•Leerink Global Healthcare Conference 2026 (Miami, FL), March 8-11, 2026. Dr. Schreiber will present at the conference and participate in one-on-one meetings.
Capital Markets Update
•In the first quarter of 2026, Shattuck sold shares of its common stock under its at-the-market offering facility for aggregate gross proceeds of $21.4 million. As a result of these sales, accounts advised by T. Rowe Price Investment Management, Inc. reported beneficial ownership of more than 10% of the Company’s outstanding common stock.
•As of February 28, 2026, cash and cash equivalents and short-term investments were approximately $94.5 million (unaudited), which includes the gross proceeds of $21.4 million from sales of Shattuck’s common stock under its at-the-market offering facility, as described above. This amount is preliminary, has not been audited or reviewed by the Company’s independent registered public accounting firm, and is subject to change upon completion of the Company’s financial closing procedures.

Fourth Quarter and Full-Year 2025 Financial Results

•Cash and Cash Equivalents and Investments: As of December 31, 2025, cash and cash equivalents and short-term investments were approximately $78.1 million, as compared to $73.0 million as of December 31, 2024.
•Research and Development (R&D) Expenses: R&D expenses were $9.1 million for the quarter ended December 31, 2025, as compared to $15.4 million for the quarter ended December 31, 2024. R&D expenses for the year ended December 31, 2025 were $35.3 million, as compared to $67.2 million for the year ended December 31, 2024. This full year decrease was a result of the discontinuation of the SL-172154 program and related workforce reductions and other pipeline compound costs, partially offset by an increase in SL-325 expenses primarily as a result of moving SL-325 into clinical development in 2025.
•General and Administrative (G&A) Expenses: G&A expenses were $4.3 million for the quarter ended December 31, 2025, as compared to $4.2 million for the quarter ended December 31, 2024. General and administrative expenses for the year ended December 31, 2025 were $17.2 million, as compared to $19.1 million for the year ended December 31, 2024. This full year decrease was primarily the result of a decrease in compensation and related benefit expenses as a result of workforce reductions in 2024 as well as a decrease in legal fees.
•Net Loss: Net loss was $12.6 million for the quarter ended December 31, 2025, or $0.12 per basic and diluted share, as compared to a net loss of $18.7 million for the quarter ended December 31, 2024, or $0.37 per basic and diluted share. Net loss for the year ended December 31, 2025 was $48.8 million, or $0.70 per basic and diluted share, as compared to $75.4 million, or $1.49 per basic and diluted share, for the year ended December 31, 2024.

Financial Guidance

As of December 31, 2025, cash and cash equivalents and short-term investments were approximately $78.1 million. Shattuck’s current cash and cash equivalents and short-term investments, including the gross proceeds from its sale of common stock under its at-the-market offering facility of $21.4 million in the first quarter of 2026, and assuming the full exercise of the outstanding common stock warrants, are expected to fund operations into 2029. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken.

About SL-325
SL-325 is a potential first-in-class Death Receptor 3 (DR3) blocking antibody designed to achieve a complete and durable blockade of the clinically validated DR3/TL1A pathway. Shattuck’s preclinical studies demonstrate high affinity binding and superior activity over TL1A antibodies, and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. SL-325 is a fully Fc-silenced, humanized immunoglobulin G monoclonal antibody with a favorable safety profile in non-human primates, currently being evaluated in a Phase 1 clinical trial.

(Press release, Shattuck Labs, MAR 5, 2026, View Source [SID1234663305])

ITM Announces Phase 3 COMPETE Trial Post-Hoc Subgroup Analyses with n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Patients with Pancreatic Neuroendocrine Tumors at ENETS 2026 Conference

On March 5, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported post-hoc subgroup analyses of the ITM-11 Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In patients with pancreatic neuroendocrine tumors (P-NETs), data showed that n.c.a. 177Lu-edotreotide (ITM-11) prolonged progression-free survival (PFS) and achieved higher objective response rates (ORR) when compared to everolimus. Data were presented by Thomas Walter, MD, PhD, professor of gastroenterology, Hospices Civil of Lyon, France, in a mini-oral presentation and in an accompanying poster at the 23rd Annual Meeting of the European Neuroendocrine Tumor Society (ENETS), held March 4-6, 2026 in Krakow, Poland.

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As previously announced at ENETS 2025, the COMPETE trial met its primary endpoint of PFS (23.9 vs. 14.1 months; p=0.022; HR 0.67, 95% CI [0.48, 0.95]). At ESMO (Free ESMO Whitepaper) 2025, ITM announced that COMPETE also met a key secondary endpoint of ORR (21.9% vs 4.2%, p<0.0001) in patients with GEP-NETs.

The COMPETE study enrolled a total of 309 GEP-NET patients, including 178 (57.6%) patients with P-NETs randomized 2:1 to either 177Lu-edotreotide (n=119) or everolimus (n=59). Of the 178 P-NET patients, 150 (84.3%) had non-functional tumors, meaning they did not produce hormones causing clinical symptoms, and 28 (15.7%) had functional tumors, in which excess hormone production can cause symptoms such as hypoglycemia (insulinoma), or diarrhea and peptic ulcer (Zollinger Elison syndrome).

Key findings in the P-NETs population showed:

Median PFS was longer in the 177Lu-edotreotide arm compared to everolimus (24.5 months vs. 14.7 months; p=0.114; HR 0.70, 95% CI [0.45, 1.09]) and ORR in the 177Lu-edotreotide arm was 33.3% vs. 3.6% in everolimus arm.
ORR in the 177Lu-edotreotide arm was ≥ 30% in P-NET patients with non-functional disease, across all patients regardless of line of therapy and Ki-67 index. This includes 38.1% ORR in P-NET patients with non-functional disease and 34.2% ORR in patients with a Ki-67 index ≥10%.
Median overall survival was numerically longer in the 177Lu-edotreotide arm compared to everolimus (65.7 months vs. 49.3 months) at the time of analyses; data continue to mature with ongoing five-year follow up.
The overall safety profile in P-NET patients receiving 177Lu-edotreotide compared to everolimus was similar or potentially improved, and included fewer serious adverse events (SAEs) (29.1% vs. 43.1%). Lower incidence of adverse events suspected to be related to the study drug was seen in the 177Lu-edotreotide arm vs. everolimus arm (83.8% vs. 96.6%).
"Given that the data on peptide receptor radionuclide therapy in pancreatic NETs has been limited to date, we are encouraged by the activity of 177Lu-edotreotide observed in this prespecified exploratory subgroup of patients with Grade 1 or 2 pancreatic NETs, who represented approximately 58% of trial participants," said Thomas Walter, MD, PhD, professor of gastroenterology, Hospices Civil of Lyon, France.

"These additional results from our Phase 3 COMPETE trial provide important insights into treatment options for patients with pancreatic NETs, and further enhance the robust clinical data of 177Lu-edotreotide," said Dr. Celine Wilke, chief medical officer of ITM.

177Lu-edotreotide (ITM-11) is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.

ENETS Oral Presentation Details
Title: 177Lu-edotreotide for the Treatment of Pancreatic Neuroendocrine Tumours: A Subgroup Analysis from the COMPETE Study
Date and Time: March 5, 2026, 11:00 am-12:30 pm CET Session; 11:50-11:57 am CET Oral Presentation
Session and Room Number: Clinical Science, Session 2B: Abstract session; Theatre Hall (S2)
Presenter: Thomas Walter, PhD, MD, Professor of Gastroenterology, Hospices Civil of Lyon, France

The e-poster will be accessible to registered participants during the event and available on www.enets.org after the conference.

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular standard-of-care therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors.

(Press release, ITM Isotopen Technologien Munchen, MAR 5, 2026, View Source [SID1234663322])

Cellectar Biosciences Reports Financial Results for Year Ended 2025 and Provides Corporate Updates

On March 4, 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 year ended December 31, 2025, and provided a corporate update.

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"2025 was a productive year for Cellectar, marked by disciplined execution across our pipeline and meaningful clinical, regulatory, and operational achievements," said James Caruso, president and CEO of Cellectar. "We advanced iopofosine I-131 toward its planned mid-2026 Conditional Marketing Authorization (CMA) submission in Europe, supported by a strong clinical dataset and productive dialogue with both the European and U.S. regulatory agencies. In parallel, we continued to shape the future of our radiotherapeutic platform with the initiation of our Phase 1b CLR 125 study in triple negative breast cancer and strengthened our supply chain and intellectual property estate."

"As we look ahead to 2026, our momentum is building. We expect important clinical readouts, continued regulatory progress, and expansion of our next-generation Phospholipid Drug Conjugate (PDC) programs. We remain focused on executing with excellence, communicating transparently, and delivering meaningful therapeutic advances for patients with difficult-to-treat cancers," added Mr. Caruso.

2025 and Recent Corporate Highlights

Iopofosine I 131, the Company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope)
Following advice from the European Medicines Agency’s (EMA) Scientific Advice Working Party (SAWP), the Company plans to submit a CMA for iopofosine I 131 as a treatment for in Waldenström Macroglobulinemia (WM). The CMA submission will be supported by data from the CLOVER WaM study, including 12-month follow-up on all patients, updated overall and major response rates, progression-free survival, duration of response, and compelling subset analyses on post-BTKi patients.
Received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for iopofosine I 131 in relapsed/refractory WM.
Received recommendation from the FDA to investigate iopofosine I 131 as a treatment option in post-BTKi indications as early as the second line, substantially expanding the available patients in the U.S. market.
CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors
Initiated a Phase 1b study of CLR 125 in Triple Negative Breast Cancer (TNBC).
CLR 125 has been well tolerated in vivo with no signs of end-organ toxicity, including hematologic toxicity, and has also demonstrated reduction or inhibition of solid tumors in preclinical studies.
Enrollment is ongoing in the Phase 1b dose finding study of CLR 125, which will evaluate three doses of 32.75 mCi/m2/dose for up to 4 cycles, 62.5 mCi/m2/dose for up to 3 cycles and 95 mCi/m2/dose for up to 2 cycles in patients with relapsed TNBC.
The study’s primary endpoint is to determine a recommended Phase 2 dose and to evaluate safety, tolerability and initial response assessment (RECIST v1.1 and PFS).
Secured a supply agreement with Ionetix to provide commercial-scale supply of cGMP-grade Actinium-225 (Ac-225) and Astatine-211 (At-211) to support ongoing CLR 225 clinical development programs.
Corporate
Strengthened and expanded the Company’s global intellectual property estate with newly issued patents across Europe, Asia-Pacific, the Middle East and the Americas. The expanded IP coverage protects both iopofosine I 131 as well as the broader radiotherapeutic pipeline, including CLR 125.

2025 Financial Highlights

Cash and Cash Equivalents: As of December 31, 2025, the company had cash and cash equivalents of $13.2 million, compared to $23.3 million as of December 31, 2024. The company believes its cash balance as of December 31, 2025, is adequate to fund its basic budgeted operations into the third quarter of 2026.
Research and Development Expenses: R&D expenses for the year ended December 31, 2025, were approximately $11.5 million, compared to approximately $26.1 million for the year ended December 31, 2024. The decrease was primarily a result of reduced activity in our CLOVER WaM clinical study, as we were exclusively in patient follow-up during 2025. Additionally, manufacturing costs declined as we completed development of a fully redundant production and logistics pipeline.
General and Administrative Expenses: G&A expenses for the year ended December 31, 2025, were approximately $11.5 million, compared to approximately $25.6 million for the same period in 2024. The decrease was primarily a result of reduced pre-commercialization efforts and related personnel.
Other income and expense: Other income and expense, net, was approximately $1.2 million of income in 2025, as compared to approximately $7.3 million of income in the prior year. These amounts are almost exclusively a result of non-cash impacts from the cost to issue and in the valuation of certain warrants that are considered liabilities.
Net Loss: Net loss for the full year ending December 31, 2025, was $21.8 million or $8.35 per basic and diluted share, compared with $44.6 million or $36.52 per basic share and $41.89 per diluted share during 2024.

Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, March 4, 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, MAR 4, 2026, View Source [SID1234663242])