Radiopharm Theranostics Reports Business Update

Quarter-end cash increased to $7.5 million, while operating activities used $10.7 million during the quarter.

Rhea-AI Summary

Radiopharm Theranostics (RADX) expects to initiate a Phase 3 imaging trial of RAD101 for recurrent brain metastases in 1Q27. An end-of-Phase 2 FDA meeting has been completed, and Siemens Healthineers will manufacture and distribute U.S. trial doses. Previously reported Phase 2b results showed 93% agreement with MRI across evaluable lesions, meeting the primary endpoint.

RAD301 Phase 1 imaging results supported further development in pancreatic cancer. RAD202 advanced to its fourth dosing cohort, while RAD204, RV-01 and RAD402 continued clinical development. Quarter-end cash rose to $7.5 million from $4.1 million; operating cash outflows were $10.7 million. Financing included an A$12.5 million institutional placement and share purchase plan. After September 30, Radiopharm received $8,000,000 through a facility secured against its anticipated FY26 research tax incentive.

18 points · 3 major

PositiveiHow this balance works

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2 major · 3 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointRAD101 Phase 2b imaging achieved 93% agreement with MRI across evaluable lesions, meeting its primary endpoint.
• Major pointInstitutional placement and share purchase plan raised A$12.5 million and A$6 million, respectively.
• Major pointPost-quarter funding facility provided $8,000,000 against the anticipated FY26 research tax incentive. 47% of market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.RAD101 Phase 3 imaging trial for recurrent brain metastases is expected to begin in 1Q27.
• Moderate pointRAD101 completed its end-of-Phase 2 FDA meeting in October 2026.
• Moderate pointSiemens Healthineers partnership provides manufacturing and distribution of RAD101 doses for the U.S. Phase 3 trial.
• Moderate point. Forward-looking: it has not happened yet and may not happen.RAD301 imaging results support advancement toward Phase 2 development in pancreatic ductal adenocarcinoma.
• Moderate pointFY2025 research tax refund provided A$5,885,131, including A$104,475 interest, in July.
• Moderate pointQuarter-end cash increased to $7.5 million from $4.1 million at the prior quarter-end.

9 minor points

• Minor pointRAD101 received FDA Fast Track Designation to distinguish recurrent brain metastases from treatment effects.
• Minor pointRAD301 Phase 1 results showed favorable safety in all evaluable participants, favorable distribution and tumor uptake.
• Minor pointRAD301 has received FDA Orphan Drug Designation.
• Minor pointRAD202 advanced to its 180mCi fourth cohort following a positive safety committee recommendation.
• Minor pointRAD202 demonstrated clinical proof-of-concept, with positive safety and distribution in the body.
• Minor point. Forward-looking: it has not happened yet and may not happen.RAD204 patient dosing progressed in the 90mCi third cohort; cohort data will inform the planned Phase 2 dose.
• Minor pointRV-01 dosed its first second-cohort patient at 70mCi in August 2026 following safety committee support.
• Minor pointRAD402 continued its first-in-human Phase 1 trial in advanced prostate cancer.
• Minor pointRadiopharm Ventures ownership increased from 87.5% to 93.75% after September 30.

Negative

• Major pointInstitutional placement and share purchase plan issued equity, diluting existing holders.
• Major pointRockford Capital funding adds a $8,000,000 secured financing obligation against the anticipated FY26 research tax incentive. 47% of market cap
• Moderate pointOperating activities used $10.7 million in cash during the quarter. 63% of market cap

News Explained

After September 30, Radiopharm increased its ownership in Radiopharm Ventures from 87.5% to 93.75% through continued participation, leaving it with a larger share of the joint venture than at quarter-end.

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On Nov 2, the day this news came out, the latest delayed price for RADX is 6.48% below the previous close. Our momentum scanner has recorded 4 alerts for this stock so far that day. The latest delayed price is $1.01.

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Key Figures

RAD101 Phase 3 initiation: 1Q27 RAD101 MRI concordance: 93% RAD202 dose level: 180mCi +5 more

RAD101 Phase 3 initiation

1Q27

Expected start of the imaging trial

RAD101 MRI concordance

93%

Previously reported Phase 2b data across evaluable lesions

RAD202 dose level

180mCi

Fourth cohort of the Phase 1 HEAT trial

Institutional placement

A$12.5 million

Completed during the quarter

R&D tax refund

A$5,885,131

Received in July for the 2025 financial year, including A$104,475 interest

R&D advance

$8,000,000

Received after September 30 under a facility secured against the anticipated FY26 R&D tax incentive

Quarter-end cash

$7.5 million

Compared with $4.1 million at the end of the prior quarter

Net operating cash outflows

$10.7 million

During the quarter

Historical Context

4 past events · Latest: Oct 05

4 events

1. Oct 05

   FDA meeting

   24h Move

   -10.6%

   Completed the FDA End-of-Phase 2 meeting for RAD101 and described ongoing Phase 3 planning.

2. Sep 14

   Phase 2b data

   24h Move

   +1.5%

   Reported 93% PET-MRI concordance, met the primary endpoint, and cited preliminary sensitivity data.

3. Sep 09

   Phase 1 data

   24h Move

   -1.9%

   Reported favorable safety and significant tumor uptake in pancreatic cancer metastases.

4. Aug 20

   Dose escalation

   24h Move

   -8.4%

   The DSMC recommended advancing RAD202 to cohort four at 180mCi in the Phase 1 HEAT trial.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

end-of-phase 2, fast track designation, biodistribution, orphan drug designation, +1 more

5 terms

end-of-phase 2 regulatory

"following a productive End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration"

End-of-phase 2 is the development milestone when a drug or medical treatment completes its mid-stage human testing and the sponsor and regulators review the results to decide whether and how to proceed to larger late-stage trials. It matters to investors because this review signals whether the product showed enough benefit and acceptable safety to justify expensive Phase 3 studies, much like passing a major exam before committing to the final, costly year of a degree, and can materially affect a company’s value and funding needs.

fast track designation regulatory

"RAD101 has received FDA Fast Track Designation"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

biodistribution medical

"RAD202 has demonstrated clinical proof-of-concept with positive safety and biodistribution"

Biodistribution is the map of where a drug, vaccine, or diagnostic agent travels and accumulates inside the body after administration. Investors care because where a product ends up affects how well it works, what side effects it may cause, and whether regulators will approve it—similar to tracking dye in a plumbing system to find leaks or blockages; unexpected destinations can raise safety, cost, and market-adoption risks.

orphan drug designation regulatory

"RAD301 has previously received Orphan Drug Designation (ODD) from the FDA"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

radiation dosimetry medical

"designed to evaluate the safety, biodistribution, radiation dosimetry and preliminary anti-tumor activity"

Radiation dosimetry is the measurement and calculation of the amount of ionizing radiation absorbed by people, biological tissues, or materials. It matters to investors because accurate dosimetry determines safety, regulatory approval, product labeling and liability, and the effectiveness of medical treatments or industrial processes—much like measuring how long you can safely stay in the sun to avoid a burn, it helps companies manage risk, costs, and marketability.

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Phase 3 imaging trial of RAD101 in recurrent brain metastases from solid tumors expected to initiate in 1Q27 following successful end-of-phase 2 meeting with U.S. Food and Drug Administration

Reported positive Phase 1 imaging data for RAD301, supporting advancement toward Phase 2 development in pancreatic ductal adenocarcinoma

Advanced to fourth dosing cohort in ongoing Phase 1 ‘HEAT’ study of RAD202 in HER2+ solid tumors

SYDNEY, Nov. 02, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced financial results for the quarter ended September 30, 2026, and provided a corporate update.

“We continue to execute on multiple value-driving catalysts across our portfolio, with the successful End-of-Phase 2 meeting for RAD101 representing a particularly important milestone as we prepare to enter a pivotal Phase 3 study,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “The progress achieved this quarter reflects both the growing maturity of our pipeline and the differentiated potential of our radiopharmaceutical platform. From advancing RAD202, RAD204 and RV-01 in the clinic to reporting positive Phase 1 imaging data for RAD301, we are steadily building a robust body of clinical evidence across several high-value oncology targets. With multiple upcoming clinical, regulatory and scientific milestones anticipated over the coming months, we believe Radiopharm is well positioned to continue generating momentum as we work to develop the next generation of precision cancer therapies for patients with significant unmet needs.”

Program and Business Updates

18F-RAD101 – Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18

RAD101 is currently being prepared for a pivotal, multi-center, global Phase 3 imaging trial following a productive End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) in individuals with confirmed recurrent brain metastases from solid tumors of different origins. RAD101 has received FDA Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 registrational trial in the U.S.

• In October 2026, the Company announced the successful completion of an EOP2 meeting with the FDA for RAD101 for the detection of brain metastases. Previously reported Phase 2b clinical data showed that RAD101 demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial’s primary endpoint.
  

• RAD101 was selected for a late-breaking oral presentation of interim Phase 2b imaging data for its trial in participants with suspected recurrent brain metastases from solid tumors at the 31^st Annual Meeting of the Society of Neuro-Oncology (SNO26) taking place from November 12-15, 2026, in Philadelphia, Pennsylvania. The data from these findings are supportive for the initiation of the Phase 3 imaging trial.
  

177Lu-RAD204 – Nanobody targeting PD-L1 radiolabeled with Lutetium 177

RAD204 is being evaluated in a Phase 1 study in PD-L1-driven cancers, including Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial Cancer.

• The Company continues to make progress in dosing patients in the 90mCi third cohort of the Phase 1 study. Data from each of the cohorts of the Phase 1 study will be used to inform the recommended dose for the planned Phase 2 trial.
  

177Lu-RAD202 – Nanobody targeting HER2 radiolabeled with Lutetium 177

The Company continues to evaluate RAD202 in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. RAD202 has demonstrated clinical proof-of-concept with positive safety and biodistribution.

• In August 2026, the Company received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance RAD202 to the next dose level of 180mCi in the fourth cohort of the Phase 1 ‘HEAT’ clinical trial in patients with HER2-positive advanced solid tumors.
  

Lu177-RV 01 – monoclonal antibody targeting 4Ig isoform of B7H3 radiolabeled with Lutetium 177

RV-01 (Betabart) is a monoclonal antibody targeting the 4Ig isoform of B7H3, an immune checkpoint protein that is highly expressed in tumors and not in healthy tissue. In multiple preclinical studies, RV-01 has shown tumor shrinkage and prolonged survival. This is the first radiopharmaceutical therapeutic developed by Radiopharm Ventures, a joint venture between Radiopharm Theranostics and the MD Anderson Cancer Center.

• In August 2026, the Company dosed the first patient in the second cohort of its First-In-Human (FIH) Phase 1/2 clinical trial of RV-01 in patients with B7-H3 expressing tumors. The dosing of the first patient came following a positive recommendation from the Safety and Monitoring Committee (SMC) to advance to the 70mCi dose.
  
• The Phase 1/2a clinical trial of RV-01 is a dose escalation and expansion trial designed to evaluate the safety, biodistribution, radiation dosimetry and preliminary anti-tumor activity of RV-01 in B7-H3 expressing tumors. The trial will determine the recommended dose of RV-01 to move forward in future studies. The Phase 1/2a study is currently being conducted at clinical centers across the U.S.

Tb161-RAD 402 – Monoclonal antibody targeting KLK3 radiolabeled with Terbium 161

RAD402 is a monoclonal antibody targeting Kallikrein Related Peptidase 3 (KLK3) radiolabeled with the radionuclide 161Tb for the treatment of prostate cancer. In preclinical mouse models, RAD 402 showed strong tumor targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.

• The Company continues to progress its First-In-Human (FIH) Phase 1 clinical trial of RAD402, designed to evaluate the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD402 in patients with advanced prostate cancer. The dose escalation Phase 1 study is designed to determine the Maximum Tolerated Dose and recommended Phase 2 dose for expansion.
  

Ga68-RAD301 – Peptide targeting αvB-integrin radiolabeled with Gallium 68

RAD301 is being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The αvB-integrin is a cellular marker for tumor invasion and metastatic growth, which correlates with decreased survival in several carcinomas, particularly pancreatic. RAD301 has previously received Orphan Drug Designation (ODD) from the FDA and data from the Phase 1 trial is supportive of continuing its development.

• In September 2026, the Company announced positive data from the Phase 1 trial of RAD301 in patients with pancreatic ductal adenocarcinoma. RAD301 demonstrated a favorable safety profile in all evaluable participants as well as favorable biodistribution and significant tumor uptake in pancreatic cancer metastases, which supports the potential of αvβ6-integrin as a target for future therapeutic development and potentially as a theranostic pair.
  

Radiopharm Ventures

Subsequent to 30 September, Radiopharm increased its ownership In Radiopharm Ventures from 87.5% to 93.75% as the result of continuous participation in the program.

Financial Updates

COMPLETION OF A$12.5 MILLION INSTITUTIONAL OFFER AND A$6 MILLION SHARE PURCHASE PLAN

During the quarter, Radiopharm completed a A$12.5 million institutional placement and a A$3 million Share Purchase Plan (SPP) to strengthen its financial position to support the preparation and readiness to commence the RAD101 registrational Phase 3 study, the completion of RAD204 dose escalation, while progressing RAD202, RAD402 and RV01 therapeutic programs and supporting ongoing strategic partnering initiatives.

R&D TAX REFUND

In July, Radiopharm received its research and development (R&D) tax refund for the 2025 financial year, totaling to A$5,885,131, including A$104,475 interest. The refund is received as part of the Australian Government’s R&D tax incentive, which provides companies engaging in appropriate and eligible activities with a refundable tax offset of up to 43.5%.

R&D ADVANCE

Subsequent to 30 September, Radiopharm received $8,000,000 from Rockford Capital under a funding facility secured against Radiopharm’s anticipated FY26 Research and Development Tax Incentive (RDTI).

QUARTERLY RESULTS

Closing cash at the end of the quarter was $7.5 million, increasing from $4.1 million at the end of the prior quarter. Net cash outflows from operating activities during the period was $10.7 million with direct Research and Development expenditure and staff costs accounting for 93% of the operating expenditure for the quarter, excluding receipt of the R&D tax refund.

In compliance with Listing Rule 4.7C, payments to related parties and their associates, as detailed in item 6.1 of Appendix 4C, encompass remuneration for director fees to executive and non-executive directors, conducted in the ordinary course of business at commercial rates, excluding reimbursements for out-of-pocket expenses.

About Radiopharm Theranostics

Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and five Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com.

Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.

For more information:

Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com

Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com

Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au

Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
Investor Hub – https://investorhub.radiopharmtheranostics.com/

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Radiopharm Theranostics expect to start the RAD101 Phase 3 trial?

Radiopharm expects the RAD101 Phase 3 imaging trial to begin in 1Q27. The planned global, multi-center trial concerns confirmed recurrent brain metastases from solid tumors. The company completed its end-of-Phase 2 FDA meeting in October 2026.

What did Radiopharm Theranostics report from the RAD301 Phase 1 trial?

RAD301 showed a favorable safety profile in all evaluable participants, favorable distribution in the body and tumor uptake in pancreatic cancer metastases. Radiopharm considers the imaging results supportive of advancement toward Phase 2 development in pancreatic ductal adenocarcinoma.

What will Radiopharm Theranostics use its equity financing to support?

The financing supports RAD101 Phase 3 preparation and readiness and completion of RAD204 dose escalation. It also supports progression of the RAD202, RAD402 and RV01 therapeutic programs and ongoing partnering initiatives.

What share of Radiopharm Theranostics' operating expenditure went to research and staff?

Direct research and development expenditure and staff costs accounted for 93% of operating expenditure for the quarter ended September 30, 2026, excluding receipt of the research and development tax refund.