Radiopharm Theranostics Reports Half-Year Financial Results and Business Updates

Rhea-AI Summary

Radiopharm Theranostics (Nasdaq: RADX) reported H1 fiscal 2026 results and pipeline updates highlighting clinical progress and funding. Interim Phase 2b RAD 101 imaging data showed 92% MRI concordance in 12 evaluable patients. Cash and equivalents were $34.52 million, with net operating outflows of $22.67 million.

Key milestones include FDA Fast Track for RAD 101, DSMC dose-escalation clearance for RAD 202 and RAD 204, IND clearance for RV 01, Bellberry ethics approval for RAD 402, and expected cohort data in mid-2026.

Positive

• Phase 2b RAD 101 interim MRI concordance of 92%
• Cash balance of $34.52M as of Dec 31, 2025
• Firm commitments to raise approximately $35M via private placement
• DSMC approvals to escalate dosing for RAD 202 and RAD 204
• Regulatory progress: FDA Fast Track for RAD 101 and IND clearance for RV 01

Negative

• Net cash outflow of $22.67M for the six months ended Dec 31, 2025
• RAD 101 interim result based on only 12 evaluable patients, a small sample

News Market Reaction

+2.24%

2 alerts

+2.24% News Effect

+$1M Valuation Impact

$59M Market Cap

0.8x Rel. Volume

On the day this news was published, RADX gained 2.24%, reflecting a moderate positive market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $59M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

RAD 101 primary endpoint: 92% of evaluable participants Cash and equivalents: $34.52M Prior cash balance: $29.12M +5 more

8 metrics

RAD 101 primary endpoint 92% of evaluable participants Phase 2b trial in brain metastases, MRI concordance primary endpoint

Cash and equivalents $34.52M Half-year closing balance as of Dec 31, 2025; runway into 2027

Prior cash balance $29.12M Year-end balance referenced in half-year financial update

Operating cash outflow $22.67M Net cash outflows from operating activities, 6 months ended Dec 31, 2025

Private placement size $35M Firm commitments from investors announced in October 2025

RAD 202 dose level 75 mCi Next dose level in Phase 1 'HEAT' trial for HER2-positive tumors

RAD 204 higher dose 90 mCi Third cohort dose in Phase 1 PD-L1-driven cancer study

Stable disease duration 5.5 vs 3.5 months PFS 2/3 patients in 30 mCi RAD 204 cohort vs historical SOC in metastatic NSCLC

Market Reality Check

Price: $5.05 Vol: Volume 15,057 versus 20-d...

low vol

$5.05 Last Close

Volume Volume 15,057 versus 20-day average of 52,532 indicates relatively light trading ahead of this update. low

Technical Shares at $4.92, trading slightly below the 200-day MA of $5.02 and well under the 52-week high of $16.25.

Peers on Argus

RADX slipped 0.81% while peers were mixed: PSTV fell 3.4%, but TPST, BRNS, RENB,...

RADX slipped 0.81% while peers were mixed: PSTV fell 3.4%, but TPST, BRNS, RENB, and ACRV gained between 1.25% and 19.33%, pointing to stock-specific factors.

Previous Earnings Reports

1 past event · Latest: Jul 29 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	Move	Catalyst
Jul 29	Earnings and pipeline	Positive	+1.3%	FY2025 results with stronger cash position and multiple trial advances.

Pattern Detected

Prior earnings-related disclosure saw a modest positive move, suggesting historically balanced reactions to financial updates.

Recent Company History

Over the past six months, Radiopharm reported steady pipeline advances and strengthening finances. A prior earnings update on Jul 29, 2025 highlighted Fast Track status for RAD101, dose escalation for RAD204, and a cash balance of $29.12M supporting runway through mid-2026, with shares rising 1.27%. Subsequent clinical updates on RAD101, RAD204 and RAD402 reaffirmed trial progress. Today’s half-year results and cash of $34.52M extend that trajectory with additional clinical detail and updated runway.

Historical Comparison

earnings

+1.3 %

Average Historical Move

Historical Analysis

In the past year, RADX had one prior earnings-style update, which moved the stock about 1.27%. Today’s half-year results follow a similar pattern of cash runway extension and pipeline progress.

Typical Pattern

Across earnings updates, Radiopharm has moved from a cash balance of $29.12M with runway to mid‑2026 to $34.52M supporting runway into 2027, alongside advancing multiple radiopharmaceutical trials.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-12-17

An effective Form F‑3 dated Dec 17, 2025 registers up to 940,000 ADSs (representing 281,999,998 ordinary shares) for resale by existing investors. Proceeds from any ADS sales would go to selling shareholders; Radiopharm would only receive cash if related options are exercised.

Market Pulse Summary

This announcement combines encouraging clinical signals with a detailed cash update. Interim RAD 101...

Analysis

This announcement combines encouraging clinical signals with a detailed cash update. Interim RAD 101 data show 92% of evaluable patients met the primary MRI concordance endpoint, while RAD 202, RAD 204, RV 01, RAD 402 and RAD 301 all advanced along early-stage pathways. Cash of $34.52M and recent $35M private placement support runway into 2027. Investors may watch upcoming 2026 cohort readouts, enrollment milestones and use of the existing F‑3 shelf for future capital needs.

Key Terms

phase 2b, phase 1, fast track designation, her2-positive, +4 more

8 terms

phase 2b medical

"Phase 2b clinical trial of RAD 101 showed 92% of evaluable participants..."

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

phase 1 medical

"Phase 1 clinical trial of RAD 202 and RAD 204 in advanced solid tumors..."

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

fast track designation regulatory

"RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation..."

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

her2-positive medical

"HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors."

HER2-positive describes cancer cells that have too many copies of the HER2 gene or make too much of the HER2 protein, which acts like an overactive growth switch that drives tumor growth. For investors, HER2 status matters because it determines whether patients can receive specific, often expensive targeted therapies and diagnostic tests, so trial results, approvals, or competing drugs tied to HER2 can strongly affect drug sales and company value.

pd-l1 medical

"RAD 204 is continuing to be evaluated in a Phase 1 study in PD-L1-driven cancers..."

PD-L1 is a protein found on the surface of some cells that acts like a stop sign for the immune system, telling certain immune cells to back off. It matters to investors because many cancer drugs and diagnostic tests target or measure PD-L1 to unlock immune responses or predict which patients will benefit, affecting clinical success, regulatory approval, and potential sales in the oncology market.

nsclc medical

"including Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC)..."

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

pfs medical

"compared to historical data of 3.5 months PFS with standard of care (SOC)."

Progression-free survival (PFS) is a clinical-trial measure that records how long, on average, patients live without their disease getting worse after starting a treatment. For investors, PFS acts like a stopwatch of a drug’s effectiveness: longer PFS can signal meaningful patient benefit, improve chances of regulatory approval or label strength, and raise a drug’s commercial value, while shorter or unchanged PFS can weigh on a company’s prospects.

orphan drug designation regulatory

"RAD 301 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.

AI-generated analysis. Not financial advice.

Interim results from Phase 2b clinical trial of RAD 101 showed 92% of evaluable participants met the primary endpoint of MRI concordance in imaging study of patients with brain metastases 

Interim data from additional Cohorts of the Phase 1 clinical trial of RAD 202 and RAD 204 in advanced solid tumors are expected in mid-2026

Cash and cash equivalents of approximately $34.52 million provide runway into 2027 to advance pipeline of high value radiotherapeutic programs through key clinical and regulatory milestones

SYDNEY, Jan. 28, 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 first six months of fiscal 2026 ended December 31, 2025 and provided an update on its clinical pipeline with an outline of its expected milestones for 2026.

“2025 was a year of strong execution across our pipeline, as we presented unprecedented imaging data from our RAD 101 diagnostic program, received Data Safety Monitoring Committee approval to escalate dosing in both RAD 204 and RAD 202 programs and secured clearance to advance both RV 01 and RAD 402 into Phase 1 clinical trials,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “As we enter 2026, we remain laser-focused on advancing our radiopharmaceutical assets and taking a deliberate approach to pipeline prioritization. This year, we aim to deliver meaningful data from across multiple programs, expand treatment and diagnostic options for patients with solid tumors, and create long-term value for all stakeholders.”

Program and Business Updates

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

RAD 101 is being evaluated in a single-arm U.S. Phase 2b clinical trial for the diagnostic performance of the molecule in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to expedite the review process and help bring the novel imaging small molecule to the over 300,000 patients diagnosed annually in the U.S. with cerebral metastases. The study is currently enrolling patients and anticipates completing enrollment in the first quarter of 2026.

• In December 2025, Radiopharm Theranostics announced interim data from the first twelve patients in the Phase 2b trial of RAD 101, with 92% of evaluable patients achieving concordance with MRI imaging, the primary endpoint.
• These promising interim results are in line with the Phase 2a results and, if confirmed, will trigger the preparation of a multi-center, multi-country Phase 3 registrational trial.

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

The Company continues to evaluate RAD 202 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. RAD 202 has demonstrated clinical proof-of-concept with positive safety and biodistribution and was recently recommended by the Data Safety and Monitoring Committee (DSMC) to progress to the next dose level of 75mCi in the ‘HEAT’ trial.

• Recently completed dosing at the 30mCi dosing level and is moving to the next dose level of 75mCi following recommendation from the DSMC.
• Data available from the first three patients in the first cohort of the study show significant tumor uptake in HER2 positive tumors.
• RAD 202’s has shown a favorable safety profile with no drug-related adverse events reported.
• The Company expects to complete enrollment in the higher dose Cohort 2 and to have data from both the first and second cohorts in the first half of 2026.

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

RAD 204 is continuing to be 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. Previous Phase 1 imaging data of 16 NSCLC patients treated with RAD 204 demonstrated that the diagnostic compound is safe and is associated with acceptable dosimetry.

• The Company completed enrollment of the second Cohort of the Phase 1 study of RAD 204 and can proceed with dosing patients in the third Cohort with an updated dose of 90mCi of Lu177 as approved by the Data and Safety Monitoring Committee.
• Two out of three patients in the 30mCi cohort exhibited stable disease for 5.5 months in metastatic NSCLC, compared to historical data of 3.5 months PFS with standard of care (SOC).
• Initial data from the first six patients across the first two cohorts show tumor uptake in the PD-L1-positive lesions, in line with published results of the previously conducted imaging study.
• RAD 204’s safety profile is reassuring and there have been no drug-related adverse events reported.

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 January 2026, the Company increased its ownership in Radiopharm Ventures from 75% to 87.5% as the joint venture continues to show promising progress in its cancer therapeutic pipeline, including the advancement of its leading B7H3 candidate and other preclinical assets.
• In July 2025, RV 01 received Investigational New Drug clearance from the FDA to initiate the first-in-human Phase 1 clinical trial. The Company expects to dose the first patients in the Phase 1 trial in the first quarter of 2026.

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

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

• In November 2025, RAD 402 was granted Bellberry Human Research Ethics Committee approval in Australia to initiate a First-In-Human (FIH) Phase 1 clinical trial of RAD 402 for the treatment of metastatic or locally advanced prostate cancer.
• The Company anticipates initiating a Phase 1 trial of RAD 402 in adults with metastatic or locally advanced prostate cancer in Q1 2026.

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

RAD 301 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. RAD 301 has previously received Orphan Drug Designation (ODD) from the FDA and data from the Phase 1 trial is supportive of the Company’s decision to move to a Phase 2 imaging trial in patients with loco-regional pancreatic cancer.

• Enrollment in the Phase 1 imaging trial in metastatic pancreatic cancer continues, having dosed 8 patients out of 9, with last patient expected in Q1 2026
• Initial data from the first six patients demonstrated confirmed safety and significant uptake in the AvB6 positive lesions.

The unmet medical need in the earlier stage of disease and the larger disease prevalence compared to the patient population of the current Phase 1 trial have influenced the decision to evaluate RAD 301 in loco-regional pancreatic cancer.

Financial Update

The following is a summary of the Appendix 4C Cash Flow Report:

• The half-year closing cash balance was $34,52 million, a rise from $29.12 million at the close of the year-end balance.
• Net cash outflows from operating activities for the 6 months ended December 31, 2025 totaled $22.67 million.
• In October 2025, Radiopharm Theranostics announced that it had received firm commitments from international and Australian institutional and industry investors to raise approximately $35 million by way of private placement.
  

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 four 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/
InvestorHub – https://investorhub.radiopharmtheranostics.com/

FAQ

What did Radiopharm Theranostics (RADX) report for RAD 101 interim Phase 2b results on January 28, 2026?

Interim data showed 92% MRI concordance among 12 evaluable patients, a positive diagnostic signal. According to the company, these results align with Phase 2a and could trigger planning for a multi-center Phase 3 registrational trial.

How much cash runway did Radiopharm Theranostics (RADX) report on Jan 28, 2026 and what does it imply?

The company reported $34.52 million in cash and equivalents as of Dec 31, 2025. According to the company, this balance plus committed funding is expected to provide runway into 2027 to advance clinical and regulatory milestones.

What clinical progress did Radiopharm say about RAD 202 and RAD 204 dosing on January 28, 2026?

The Data Safety and Monitoring Committee recommended escalation to higher dose cohorts for both programs. According to the company, RAD 202 moved toward 75 mCi dosing and RAD 204 progressed to a 90 mCi cohort following DSMC approval.

When will Radiopharm Theranostics (RADX) dose first patients in RV 01 and RAD 402 trials according to the Jan 28, 2026 update?

The company expects to dose the first RV 01 patients in Q1 2026 and to initiate RAD 402 Phase 1 in Q1 2026. According to the company, RV 01 has FDA IND clearance and RAD 402 has Bellberry ethics approval.

When does Radiopharm (RADX) expect additional RAD 202 and RAD 204 data in 2026?

Radiopharm expects data from RAD 202 and RAD 204 cohorts in the first half of 2026. According to the company, enrollment and DSMC-recommended escalations aim to deliver cohort readouts by mid-2026.

What funding did Radiopharm Theranostics (RADX) secure in late 2025 and how large was it?

In October 2025, the company announced firm commitments to raise approximately $35 million via private placement. According to the company, commitments came from international and Australian institutional and industry investors.