Actinium Pharmaceuticals to Host KOL Webinar on ATNM-400, a First-in-Class HER3-Targeted Alpha Radiotherapy

On November 12, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or the "Company"), a pioneer in the development of targeted radiotherapies, reported that it will host a key opinion leader (KOL) webinar on Tuesday, December 1, 2026, at 8:00 a.m. ET to discuss the evolving treatment landscape in metastatic castration-resistant prostate cancer (mCRPC) and the potential of ATNM-400, its investigational, first-in-class, HER3-targeted Actinium-225 antibody radioconjugate.

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The event will feature Michael J. Morris, MD, Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center, who will join members of Actinium’s management team for the discussion. Participants can register for the webinar here.

The webinar will explore the applicability of a HER3-targeted radiotherapeutic across the broad mCRPC population, including those patients with low or negative PSMA expression and those who do not respond to or progress following PSMA-directed treatments. The discussion will also examine the role of HER3 in tumor progression and treatment resistance, the rationale for targeting HER3 with alpha radiotherapy, and the potential role of non-PSMA approaches in the evolving prostate cancer treatment paradigm.

Actinium management will review previously reported findings from ATNM-400’s ongoing first-in-human Phase 1 study, HERACT-PRO-1, including initial data presented at the 2026 European Association of Nuclear Medicine (EANM) Congress. HER3-targeted PET imaging demonstrated tumor uptake and retention through Day 7, with no dose-limiting toxicities, xerostomia or Grade 3/4 hematologic adverse events observed in the initial three-patient cohort at the 1.0 µCi/kg dose level. Dose escalation has advanced to the second dose level of 1.5 µCi/kg and is ongoing. Additionally, further detail on the RADIANZ (Radiolabeled Antibody Distribution In Advanced Neoplasms with Zirconium-89) imaging study to validate ATNM-400’s pan-tumor potential will be discussed. Management will also highlight preclinical findings demonstrating ATNM-400’s activity across prostate cancer models with varying PSMA expression and will review clinical plans for ATNM-400 in prostate cancer and additional solid tumors, including lung, breast, colorectal and ovarian cancers.

A live question-and-answer session will follow the presentations.

Webinar Details

Date: Tuesday, December 1, 2026
Time: 8:00 a.m. Eastern Time
Registration: Here

The live webcast will be accessible through the registration link above. A replay will be available following the event through the Events and Presentations section of Actinium’s website at www.actiniumpharma.com.

About Michael J. Morris, MD

Michael J. Morris, MD, is Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center and a leading investigator in the development of targeted radiopharmaceuticals for prostate cancer. He helped lead the pivotal Phase 3 VISION trial of lutetium-177–PSMA-617, which supported the initial FDA approval of Pluvicto, and is the lead author of the Phase 3 PSMAfore publication. His expertise spans clinical trial development, molecular imaging and the integration of radiopharmaceuticals into prostate cancer care.

About ATNM-400

ATNM-400 is an investigational antibody radioconjugate that pairs the HER3-targeting monoclonal antibody barecetamab with the alpha-emitting isotope Actinium-225. Its antibody-based design combines antigen-specific targeting with the potential for sustained tumor localization, supporting prolonged delivery of high-energy alpha radiation. Tumor uptake and retention observed through Day 7 with the ⁸⁹Zr-labeled imaging counterpart support this development rationale alongside the approximately 10-day half-life of ²²⁵Ac. The theranostic approach enables noninvasive visualization of antibody distribution to inform therapeutic development. The program is being evaluated in a first-in-human dose-escalation Phase 1 study of ATNM-400 in mCRPC, HERACT-PRO-1, which utlizes Zirconium-89-labeled barecetamab PET imaging to assess tumor targeting, biodistribution and dosimetry. Actinium is also conducting an imaging study, RADIANZ (Radiolabeled Antibody Distribution In Advanced Neoplasms with Zirconium-89) using PET to guide the pan-tumor development of ATNM-400 in various solid tumors outside of prostate cancer.

ATNM-400 is differentiated from PSMA-targeted radiotherapies by its focus on HER3, an antigen implicated in tumor survival and treatment resistance. PSMA-directed approaches include Novartis’ Pluvicto and a broad pipeline of investigational therapies, including Telix Pharmaceuticals’ TLX591-Tx, Clarity Pharmaceuticals’ ⁶⁷Cu-SAR-bisPSMA, Convergent Therapeutics’ CONV01-α, AstraZeneca’s AZD2265 (formerly FPI-2265), Curium’s lutetium-177 zadavotide guraxetan (¹⁷⁷Lu-PSMA-I&T), ARTBIO’s AB001 and AdvanCell’s ADVC001. These programs span small-molecule and antibody-based therapies using beta- or alpha-emitting isotopes. ATNM-400 combines HER3 targeting with an Actinium-225 antibody radioconjugate, offering a distinct biological approach with the potential to expand radiotherapy across the broad mCRPC population, including patients with PSMA-low or PSMA-negative disease and those who do not respond to or progress following PSMA-directed treatment. Its HER3-directed mechanism also supports investigation beyond prostate cancer in other HER3-expressing solid tumors.

About HER3

HER3, also known as ERBB3, belongs to the epidermal growth factor receptor family and participates in signaling pathways that promote tumor growth, survival and treatment resistance. HER3-directed antibody-drug conjugates (ADCs) in clinical development include BioNTech and MediLink’s BNT326/YL202; Bristol Myers Squibb and SystImmune’s EGFR × HER3 bispecific ADC, izalontamab brengitecan (iza-bren); and Daiichi Sankyo and Merck’s patritumab deruxtecan (HER3-DXd). These programs highlight clinical development interest in HER3 as an oncology target. ATNM-400 takes a different payload approach, delivering alpha radiation rather than a conventional cytotoxic drug. Preclinical activity in prostate, non-small cell lung, breast, colorectal and ovarian cancer models supports investigating ATNM-400 as a potential pan-cancer radiotherapy, both as monotherapy and in rational combinations.

(Press release, Actinium Pharmaceuticals, NOV 12, 2026, View Source [SID1234674701])

Aktis Oncology Reports Third-Quarter Financial Results and Highlights Clinical Trial Progress

On November 12, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) ("Aktis" or the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, reported financial results for the third quarter ended September 30, 2026, and provided a business update, including progress with the Company’s two clinical-stage programs.

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"Aktis is on a trajectory to redefine radiopharmaceuticals as a major pillar of cancer treatment by expanding the modality to more targets, broader indications, and larger patient populations. In the third quarter, we continued to make tremendous progress operationalizing this vision," said Matthew Roden, Ph.D., President and Chief Executive Officer at Aktis Oncology. "With the initiation of the BActinium-2 trial of AKY-2519, we now have three clinical trials underway in the U.S. across two novel targets, Nectin-4 and B7-H3, which are both implicated in a range of solid tumor types. We also opened the first backfill cohorts in our ongoing NECTINIUM-2 and BActinium-1 trials to further characterize safety and preliminary antitumor activity at the selected doses, while dose escalation continues in both studies. This substantial clinical progress is a testament to our ability to execute rapidly with quality across multiple clinical trials and positions Aktis for a data-rich 2027."

Third quarter 2026 and recent business highlights

AKY-1189

AKY-1189 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver actinium-225 (225Ac) to tumors expressing Nectin-4, a clinically and commercially validated target expressed in several tumor types, including locally advanced or metastatic urothelial cancer (mUC) and breast cancer.

Dose escalation is ongoing in the Phase 1b NECTINIUM-2 trial evaluating AKY-1189 in patients with locally advanced or mUC and other Nectin-4 expressing solid tumors.
Aktis initiated backfill at the 6 MBq dose level to further characterize safety and preliminary antitumor activity in up to 30 patients. This is the first of up to two dose levels planned to be selected for backfill.
AKY-2519

AKY-2519 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver 225Ac to tumors expressing B7-H3, a clinically validated target expressed in prostate, lung, and other solid tumors.

Aktis initiated the Phase 1b BActinium-2 trial evaluating AKY-2519 in patients with non-small cell lung cancer (NSCLC) and other B7-H3 expressing solid tumors.
Dose escalation is ongoing in the Phase 1b BActinium-1 trial evaluating AKY-2519 in patients with metastatic castration-resistant prostate cancer (mCRPC), including PLUVICTO-naïve and PLUVICTO-experienced patients.
In the Phase 1b BActinium-1 trial, Aktis initiated backfill at the 9 MBq dose level for both the PLUVICTO-naïve and PLUVICTO-experienced cohorts to further characterize safety and preliminary antitumor activity in up to 30 patients per cohort. This is the first of up to two planned dose levels that will be backfilled in each of the mCRPC patient populations.
Dr. Roden added, "With our robust end-to-end supply chain supported by multiple contract manufacturing organizations and isotope suppliers, we are successfully delivering clinical supply for our clinical trials nationally. In the quarter, we operationalized our in-house GMP facility at 17 Drydock in Boston, where we expect to begin supplying drug product for our clinical trials in the first half of 2027, further expanding manufacturing capacity for clinical supply. The 17 Drydock facility progresses our strategy to build capabilities to support potential Phase 3 trials and commercial product supply in a capital-efficient manner."

Manufacturing

Aktis began manufacturing drug product in its in-house GMP facility, as part of the Company’s hybrid sourcing manufacturing strategy. Aktis intends to amend the INDs for AKY-2519 and AKY-1189 to include the in-house facility as a manufacturer of clinical supply for its ongoing clinical trials.
Anticipated milestones for the next 12 months

AKY-1189: Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 trial in the first quarter of 2027.
AKY-2519: Expect preliminary data from the ongoing Phase 1b BActinium-1 trial in 2027.
Early pipeline: Two programs tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
Corporate: Expect to expand drug supply to include our in-house GMP facility to support ongoing clinical trials in the first half of 2027.
Third quarter 2026 financial results

Cash position: Cash, cash equivalents, and marketable securities were $492.9 million as of September 30, 2026, compared with $226.8 million as of December 31, 2025. The increase in cash, cash equivalents, and marketable securities reflects net proceeds from the Company’s initial public offering in January 2026, primarily offset by cash used in operations. The Company’s cash, cash equivalents, and marketable securities as of September 30, 2026, are expected to fund the Company’s operating plan into 2029.
Collaboration revenue: Collaboration revenue was $3.9 million for the quarter ended September 30, 2026, compared with $1.6 million for the comparable prior-year period. The increase of $2.3 million was attributable to continued advancement of the Company’s research collaboration with Eli Lilly and Company, with revenue recognized over time using the cost incurred input method.
R&D expenses: Research and development expenses were $32.1 million for the quarter ended September 30, 2026, compared with $16.5 million for the comparable prior-year period. The increase of $15.6 million was primarily driven by the advancement of clinical trials for AKY-1189 and AKY-2519 and increased headcount primarily in clinical development and manufacturing to support the advancement of the clinical pipeline.
G&A expenses: General and administrative expenses were $6.5 million for the quarter ended September 30, 2026, compared with $3.3 million for the comparable prior-year period. The increase of $3.2 million was primarily due to increased headcount to support company growth and increased activities associated with operating as a public company.
Net loss: Net loss was $29.9 million for the quarter ended September 30, 2026, compared with $15.5 million for the comparable prior-year period. The increase of $14.4 million was primarily driven by higher operating expenses, partially offset by increased collaboration revenue recognized and interest income, net.
PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a registered trademark of Novartis Pharmaceuticals Corporation.

About NECTINIUM-2
The Phase 1b multicenter, open-label clinical trial is evaluating AKY-1189 in patients with locally advanced or mUC, breast cancer and other Nectin-4 expressing tumors. The trial will explore up to 5 dose levels in the dose escalation. Per protocol, Aktis has the ability to expand enrollment in backfill cohorts at selected dose levels and tumor types to generate additional clinical data while dose escalation continues. The trial is being conducted in the U.S. Additional information about the trial is available at clinicaltrials.gov using the identifier NCT07020117.

About BActinium-1
The Phase 1b multicenter, open-label clinical trial is evaluating AKY-2519 in patients with mCRPC, including PLUVICTO-naïve and PLUVICTO-experienced cohorts. The study will explore up to 3 dose levels in the dose escalation. Per protocol, Aktis has the ability to expand enrollment in backfill cohorts at selected dose levels to generate additional clinical data while dose escalation continues. The trial is being conducted in the U.S. Additional information about the trial is available at clinicaltrials.gov using the identifier NCT07581184.

About BActinium-2
The Phase 1b multicenter, open-label trial is evaluating AKY-2519 in patients with NSCLC and other B7-H3 expressing solid tumors. The study will explore up to 3 dose levels in the dose escalation. Per protocol, Aktis has the ability to expand enrollment at selected dose levels and tumor types to generate additional clinical data while dose escalation continues. The trial is being conducted in the U.S. Additional information about the trial is available at clinicaltrials.gov using the identifier NCT07887971.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anticancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end clinical supply chain built for resiliency and scalability, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, NOV 12, 2026, View Source [SID1234674700])

Azitra, Inc. Announces Q3 2026 Results and Provides Business Updates

On November 12, 2026 Azitra, Inc. ("Azitra" or the "Company") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and high value cosmetic proteins and peptides, reported financial results for the quarter ended September 30, 2026, and provided a business update.

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Q3 2026 and Recent Business Highlights

Announced revitalizing results from ex vivo study of ATR-COSF demonstrating ability to reduce fine lines and improve elasticity in human skin
Reported breakthrough repeat dose and anti-wrinkle ex vivo results for ATR-COSF program, demonstrating increased distribution and elasticity
Announced completion of Cohort 1 of the ATR-04 Phase 1/2 trial and the safety review committee’s recommendation to proceed to Cohort 2
Expanded ATR-04 trial eligibility to include patients with KRAS and MEK inhibitor-associated rash, including patients with neurofibromatosis type 1 with rash associated with receiving MEK inhibitors
"During the third quarter and recent weeks, we made substantial progress with our two priority programs, generating encouraging results for ATR-COSF and advancing ATR-04 forward in the clinic while broadening its potential to benefit more patients," said Francisco Salva, Chief Executive Officer of Azitra. "We were very pleased to report research involving ATR-COSF demonstrating a single application of the product was able to reduce the appearance of fine lines and wrinkles by approximately 50% after 48 hours in laboratory studies, while our optimized formulation improved skin elasticity across every measure tested in a separate study. These results strengthen our confidence in ATR-COSF’s potential as a differentiated cosmetic ingredient and set the stage for a first-in-human cosmetic study, with initial results anticipated by year-end."

Salva continued: "The recommendation to advance ATR-04 to Cohort 2 brings us closer to our goal of providing a new treatment option for patients whose debilitating skin rash can disrupt essential therapy. Additionally, by expanding the trial to address rash associated with KRAS and MEK inhibitors, including in patients with neurofibromatosis type 1 with MEK inhibitor-associated rash, we are broadening ATR-04’s potential reach and expanding the eligible patient pool to support enrollment. We believe ATR-04 has the potential to become the first live biotherapeutic developed for skin rashes associated with cancer and MEK inhibitor treatment for neurofibromatosis treatments. We are encouraged by the potential to reach additional patient populations and look forward to reporting topline data from Cohort 1, which we anticipate in the fourth quarter of 2026."

Salva concluded: "The remainder of 2026 has the potential to be a defining period for Azitra as we expect to report initial results from our first in-human cosmetic study of ATR-COSF and topline data from Cohort 1 of our ATR-04 Phase 1/2 trial. Importantly, once we announce the ATR-COSF results, institutional investors who participated in our financing earlier this year will have the opportunity to invest an additional $5.25 million to $10.5 million through certain financial instruments issued in that transaction."

Pipeline, Platform and Corporate Updates

ATR-COSF – Consumer Initiative to Improve the Appearance of Fine Lines and Wrinkles

Announced positive repeat-dose results demonstrating increased delivery and distribution of recombinant filaggrin domains and improved elasticity in ex vivo human skin.
Reported additional ex vivo results showing reduced appearance of fine lines and wrinkles following a single application, with continued improvement through 48 hours, and improved elasticity with an optimized formulation.
First-in-human cosmetic study planned with initial results expected by year-end 2026.
ATR-04 – Advancing a Potential Treatment for Targeted Therapy-Associated Rash

Completed Cohort 1 of the ongoing Phase 1/2 trial and received safety review committee’s recommendation to proceed to Cohort 2.
Expanded trial eligibility to include patients with KRAS and MEK inhibitor-associated rash, including patients with neurofibromatosis type 1 with rash associated with MEK inhibitors.
Modified trial requirements to facilitate recruitment, with Cohort 2 expected to enroll approximately 24 patients receiving once-daily treatment for 28 days.
Topline data from first cohort of Phase 1/2 trial expected in Q4 2026.
Financial Results for the Quarter Ended September 30, 2026

Research and Development (R&D) expenses: R&D expenses for the quarter ended September 30, 2026, were $1.3 million compared to $1.2 million for the comparable period in 2025.
General and Administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2026, were $1.6 million compared to $1.6 million for the comparable period in 2025.
Net Loss was $3.0 million for the quarter ended September 30, 2026, compared to $2.8 million for the comparable period in 2025.
Cash and cash equivalents: As of September 30, 2026, Azitra had cash and cash equivalents of $3.8 million.

(Press release, Azitra, NOV 12, 2026, View Source [SID1234674699])

Immuneering to Collaborate with Astellas on Clinical Studies of Investigational CLDN18.2 Programs in Combination with Atebimetinib for Pancreatic Cancer Patients

On November 12, 2026 Immuneering Corporation (Nasdaq: IMRX) reported it has entered into a clinical trial collaboration and supply agreement with Astellas Pharma Global Development, Inc., a subsidiary of Astellas Pharma Inc. (TSE: 4503). Under the agreement, Immuneering will supply its investigational MEK inhibitor, atebimetinib, for two Astellas-sponsored studies targeting the subset of pancreatic cancer patients whose tumors express CLDN18.2. One trial will evaluate an Astellas investigational CLDN18.2-targeted program added to atebimetinib plus modified gemcitabine/nab-paclitaxel (mGnP) in first-line metastatic pancreatic cancer patients. A second trial will evaluate a chemotherapy-free regimen combining a different Astellas investigational CLDN18.2-targeted program with atebimetinib in previously-treated metastatic pancreatic cancer patients. Further trial details will be forthcoming.

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"This collaboration reflects our conviction that atebimetinib has the potential to become an essential backbone therapy in a broad range of combinations across MAPK-driven cancers," said Ben Zeskind, Immuneering CEO and co-founder. "Atebimetinib’s unique tolerability profile and broad activity make it well suited to combine with a wide range of innovative medicines targeted to specific subsets of patients, including the CLDN18.2-targeted therapies that Astellas is developing."

"Claudin 18.2 has emerged as a promising target in gastrointestinal cancers," said Igor Matushansky, MD, PhD, Chief Medical Officer of Immuneering. "By combining CLDN18.2 targeted therapy with atebimetinib, these studies will evaluate the extent to which there is synergy between these distinct yet complementary mechanisms that can benefit patients with CLDN18.2-expressing pancreatic cancer."

Under the terms of the collaboration, Astellas will sponsor and conduct the planned studies and Immuneering will supply atebimetinib. Immuneering maintains global development and commercialization rights to atebimetinib, and Astellas maintains global development and commercialization rights to its CLDN18.2-targeted programs.

(Press release, Immuneering, NOV 12, 2026, View Source [SID1234674698])

Cerenome to Review REYOBIQ ReSPECT-LM Data Presented at SNO Conference and Provide CNSide Commercial Update on November 16

On November 12, 2026 Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), a CNS oncology company integrating diagnostics, therapeutics, and artificial intelligence, reported it will host a conference call on Monday, November 16, 2026, at 8:30 a.m. Eastern Time to review REYOBIQ ReSPECT-LM clinical data scheduled for presentation at SNO on November 13 and provide a CNSide commercial update. The Company will also report its third quarter 2026 financial results that day.

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Webcast and Conference Call
Date/Time: Monday, November 16, 2026, at 8:30 AM ET
Webcast: View Source
Dial-in: U.S.: 833-862-0853
International: 412-365-5147
Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days.

(Press release, Cerenome, NOV 12, 2026, View Source [SID1234674697])