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GARLAND, Texas, Jan. 15, 2026 /PRNewswire/ -- Massimo Group (NASDAQ: MAMO), a manufacturer and distributor of powersports vehicles and emerging electric mobility solutions, today announced plans to debut its second-generation MVR HVAC Pro Series at the 2026 PGA Show, taking place January 20–23, 2026, at the Orange County Convention Center in Orlando, Florida.
The MVR HVAC Pro Series includes the MVR HVAC Pro, designed for golf course and neighborhood electric vehicle (NEV) applications, and the MVR HVAC Cargo Max Pro, a utility-focused model engineered for grounds maintenance and commercial fleet use. Both models feature fully enclosed cabins with integrated heating and air-conditioning systems, reflecting Massimo's continued investment in higher-value, all-weather electric vehicle platforms.
Addressing Operational and Seasonal Limitations
Traditional open-air golf carts and utility vehicles are often constrained by extreme heat, cold, rain, and humidity—conditions that can shorten golf seasons, reduce productivity, and limit year-round utilization. The MVR HVAC Pro Series is designed to address these challenges through:
- All-weather operation — Fully enclosed cabins help protect occupants from environmental exposure, supporting more consistent use across diverse climates.
- Extended duty cycles — Advanced 48-volt electric platforms, with AGM or lithium-ion battery configurations, are designed to support extended daily operation for golf, maintenance, and commercial fleet applications.
- Health, comfort, and accessibility considerations — Climate-controlled cabins may help reduce heat stress and fatigue, particularly for older golfers and users with mobility considerations, supporting longer and more frequent usage.
- Utility-focused versatility — The Cargo Max Pro configuration supports payloads and attachments commonly used by groundskeepers, resorts, security teams, municipalities, and commercial operators.
Large and Expanding Market Opportunity
Industry research firms estimate the global golf cart and electric utility vehicle market to be in the multi-billion-dollar range, with estimates generally ranging from approximately $2–$3.5 billion in 2026. The market is projected to continue growing over the next decade as electric vehicle adoption expands beyond traditional golf course use into resorts, campuses, airports, gated communities, municipalities, and commercial fleet environments. Published forecasts from firms such as Research Nester and Mordor Intelligence cite expected compound annual growth rates in the mid-single to high-single digits, driven by electrification trends, sustainability initiatives, and demand for more versatile, higher-comfort vehicles.
Management believes that the current global golf cart and electric utility vehicle market provides a meaningful long-term opportunity for differentiated, all-weather electric platforms that address the operational and seasonal limitations of traditional open-air vehicles.
Technology Roadmap, Artificial Intelligence Strategy, and Early Commercial Engagement
The second-generation MVR platform incorporates proprietary software-driven controls designed to support enhanced vehicle management, intelligent system optimization, and future fleet-level functionality. The Company is also advancing its use of artificial intelligence (AI) to support intelligent diagnostics, predictive maintenance, and future smart-vehicle applications. These initiatives reflect Massimo's broader strategy to combine hardware innovation with software intelligence, positioning the Company for the next phase of smart mobility and connected utility vehicles.
Following refinements to the second-generation design, Massimo reports receiving encouraging interest from U.S. dealers, golf courses, resorts, and commercial operators, including letters of intent and preliminary purchase discussions. Management believes this early engagement reflects growing demand for enclosed, climate-controlled electric vehicles capable of operating reliably across diverse geographic and weather conditions.
"The second-generation MVR HVAC Pro Series reflects the progress we are making as we expand into more advanced, higher-value electric platforms," said David Shan, Chief Executive Officer of Massimo Group. "By addressing weather-related limitations and operational inefficiencies, we believe this product line has the potential to enhance course utilization, fleet productivity, and overall user experience. The PGA Show provides an important opportunity to engage with industry partners as we continue executing our long-term growth strategy."
PGA Show Participation
PGA Show attendees are invited to visit the Massimo booth for product demonstrations, discussions regarding dealer and fleet programs, and an overview of customization and partnership opportunities. The PGA Show is a trade-only event; registration is required through the official PGA Show website.
About Massimo Group (NASDAQ: MAMO)
Massimo Group is a manufacturer and distributor of powersports and electric vehicles headquartered in Garland, Texas. The company's portfolio includes UTVs, ATVs, e-bikes, and electric utility vehicles known for performance, reliability and value.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws with respect to Massimo Group. All statements other than statements of historical facts contained in this press release, including statements regarding Massimo Group's future results of operations and financial position, Massimo Group's business strategy, prospective costs, timing and likelihood of success, plans and objectives of management for future operations, future results of current and anticipated operations of Massimo Group are forward-looking statements. In some cases, forward-looking statements can be identified because they contain words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "predict," "project," "target," "potential," "seek," "will," "would," "could," "should," "continue," "contemplate," "plan," and other words and terms of similar meaning. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to, risks relating to Massimo Group which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth economically and hire and retain key employees; costs; changes in applicable laws or regulations; the possibility that Massimo Group may be adversely affected by other economic, business, and/or competitive factors; and other risks and uncertainties, including those listed under "Risk Factors" in our Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Moreover, Massimo Group operates in very competitive and rapidly changing environments. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond Massimo Group's control, you should not rely on these forward-looking statements as predictions of future events. Forward-looking statements speak only as of the date they are made. No assurance can be given regarding the forward-looking statements, and actual results may differ materially from those as indicated. Massimo Group undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Company Contact
Quenton Petersen
Vice President
Massimo Group
Email: ir@massimomotor.com
GARLAND, Texas, Jan. 15, 2026 /PRNewswire/ -- Massimo Group (NASDAQ: MAMO), a manufacturer and distributor of powersports vehicles and emerging electric mobility solutions, today announced plans to debut its second-generation MVR HVAC Pro Series at the 2026 PGA Show, taking place January 20–23, 2026, at the Orange County Convention Center in Orlando, Florida.
The MVR HVAC Pro Series includes the MVR HVAC Pro, designed for golf course and neighborhood electric vehicle (NEV) applications, and the MVR HVAC Cargo Max Pro, a utility-focused model engineered for grounds maintenance and commercial fleet use. Both models feature fully enclosed cabins with integrated heating and air-conditioning systems, reflecting Massimo's continued investment in higher-value, all-weather electric vehicle platforms.
Addressing Operational and Seasonal Limitations
Traditional open-air golf carts and utility vehicles are often constrained by extreme heat, cold, rain, and humidity—conditions that can shorten golf seasons, reduce productivity, and limit year-round utilization. The MVR HVAC Pro Series is designed to address these challenges through:
- All-weather operation — Fully enclosed cabins help protect occupants from environmental exposure, supporting more consistent use across diverse climates.
- Extended duty cycles — Advanced 48-volt electric platforms, with AGM or lithium-ion battery configurations, are designed to support extended daily operation for golf, maintenance, and commercial fleet applications.
- Health, comfort, and accessibility considerations — Climate-controlled cabins may help reduce heat stress and fatigue, particularly for older golfers and users with mobility considerations, supporting longer and more frequent usage.
- Utility-focused versatility — The Cargo Max Pro configuration supports payloads and attachments commonly used by groundskeepers, resorts, security teams, municipalities, and commercial operators.
Large and Expanding Market Opportunity
Industry research firms estimate the global golf cart and electric utility vehicle market to be in the multi-billion-dollar range, with estimates generally ranging from approximately $2–$3.5 billion in 2026. The market is projected to continue growing over the next decade as electric vehicle adoption expands beyond traditional golf course use into resorts, campuses, airports, gated communities, municipalities, and commercial fleet environments. Published forecasts from firms such as Research Nester and Mordor Intelligence cite expected compound annual growth rates in the mid-single to high-single digits, driven by electrification trends, sustainability initiatives, and demand for more versatile, higher-comfort vehicles.
Management believes that the current global golf cart and electric utility vehicle market provides a meaningful long-term opportunity for differentiated, all-weather electric platforms that address the operational and seasonal limitations of traditional open-air vehicles.
Technology Roadmap, Artificial Intelligence Strategy, and Early Commercial Engagement
The second-generation MVR platform incorporates proprietary software-driven controls designed to support enhanced vehicle management, intelligent system optimization, and future fleet-level functionality. The Company is also advancing its use of artificial intelligence (AI) to support intelligent diagnostics, predictive maintenance, and future smart-vehicle applications. These initiatives reflect Massimo's broader strategy to combine hardware innovation with software intelligence, positioning the Company for the next phase of smart mobility and connected utility vehicles.
Following refinements to the second-generation design, Massimo reports receiving encouraging interest from U.S. dealers, golf courses, resorts, and commercial operators, including letters of intent and preliminary purchase discussions. Management believes this early engagement reflects growing demand for enclosed, climate-controlled electric vehicles capable of operating reliably across diverse geographic and weather conditions.
"The second-generation MVR HVAC Pro Series reflects the progress we are making as we expand into more advanced, higher-value electric platforms," said David Shan, Chief Executive Officer of Massimo Group. "By addressing weather-related limitations and operational inefficiencies, we believe this product line has the potential to enhance course utilization, fleet productivity, and overall user experience. The PGA Show provides an important opportunity to engage with industry partners as we continue executing our long-term growth strategy."
PGA Show Participation
PGA Show attendees are invited to visit the Massimo booth for product demonstrations, discussions regarding dealer and fleet programs, and an overview of customization and partnership opportunities. The PGA Show is a trade-only event; registration is required through the official PGA Show website.
About Massimo Group (NASDAQ: MAMO)
Massimo Group is a manufacturer and distributor of powersports and electric vehicles headquartered in Garland, Texas. The company's portfolio includes UTVs, ATVs, e-bikes, and electric utility vehicles known for performance, reliability and value.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws with respect to Massimo Group. All statements other than statements of historical facts contained in this press release, including statements regarding Massimo Group's future results of operations and financial position, Massimo Group's business strategy, prospective costs, timing and likelihood of success, plans and objectives of management for future operations, future results of current and anticipated operations of Massimo Group are forward-looking statements. In some cases, forward-looking statements can be identified because they contain words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "predict," "project," "target," "potential," "seek," "will," "would," "could," "should," "continue," "contemplate," "plan," and other words and terms of similar meaning. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to, risks relating to Massimo Group which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth economically and hire and retain key employees; costs; changes in applicable laws or regulations; the possibility that Massimo Group may be adversely affected by other economic, business, and/or competitive factors; and other risks and uncertainties, including those listed under "Risk Factors" in our Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Moreover, Massimo Group operates in very competitive and rapidly changing environments. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond Massimo Group's control, you should not rely on these forward-looking statements as predictions of future events. Forward-looking statements speak only as of the date they are made. No assurance can be given regarding the forward-looking statements, and actual results may differ materially from those as indicated. Massimo Group undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Company Contact
Quenton Petersen
Vice President
Massimo Group
Email: ir@massimomotor.com
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Massimo Group to Debut Second-Generation MVR HVAC Pro Series at 2026 PGA Show
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HIGHLIGHTS
- Following an interim data review of the Cohort Expansion Phase (Phase II) of the SECuRE trial, the Safety Review Committee (SRC) confirms the trial will continue with no modifications to the protocol.
Patient population
- With the SECuRE trial continuing to recruit, a total of nine participants who had evaluable data by the 25th of November 2025 were included in the interim assessment by the SRC, with the majority of participants receiving at least two cycles of 8 GBq of 67Cu-SAR-bisPSMA each by the data cut-off date.
- Seven participants received 67Cu-SAR-bisPSMA and two participants were treated with a combination of 67Cu-SAR-bisPSMA with enzalutamide.
- Most participants were heavily pre-treated (with 55.6% having received more than 5 previous anti-cancer regimens) and had bone metastasis (66.7%).
Safety
- The safety profile of 67Cu-SAR-bisPSMA remains favourable with most related adverse events (AEs) in the Cohort Expansion to date being Grade 1 or 2. The most common AEs were nausea and lymphopenia (observed in 33.3% of participants, for each AE).
Efficacy
- Six participants had at least two prostate specific antigen (PSA) results following 67Cu-SAR-bisPSMA administration, with all showing a decrease in PSA. Of those, four participants (66.7%) thus far had a reduction of more than 50% in PSA (PSA50) and two participants (33.3%) had a reduction of more than 80% (PSA80).
- One participant who presented with bone metastasis at enrolment achieved undetectable PSA with no prostate cancer detected by computed tomography (CT) or bone scan following 67Cu-SAR-bisPSMA treatment. The participant reported having excellent quality of life following the treatment.
Next Steps
- The SECuRE trial will continue enrolment into the Cohort Expansion Phase with planned completion of recruitment in 2026. Phase III registrational trial planning ongoing based on data generated to date.
SYDNEY, Jan. 15, 2026 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to share a number of updates on the SECuRE trial following an SRC meeting. The SRC has recommended that the trial continue with the Cohort Expansion Phase (Phase II) as planned with no modifications to the protocol. The interim results assessed by the SRC were collected from nine participants enrolled in the cohort that had evaluable data by the cut-off date of the 25th of November 2025 and continue to show promising efficacy and a favourable safety profile of 67Cu-SAR-bisPSMA.
The majority of the nine participants had bone metastasis at enrolment (66.7%) and received multiple lines of previous treatments (more than 5 previous anti-cancer regimens, 55.6%). Median PSA prior to 67Cu-SAR-bisPSMA treatment was 18.9 ng/mL (range 1.5-30.2 ng/mL). Six out of these nine participants received at least 2 cycles of 8 GBq of 67Cu-SAR-bisPSMA each, with two of them also receiving concomitant enzalutamide.
Of the nine participants included in this SRC analysis, six had at least two PSA results following their 67Cu-SAR-bisPSMA treatment by the data cut-off date. Of these six participants, thus far four (66.7%) showed reductions in PSA of 50% or more (PSA50) and two (33.3%) showed reductions of 80% or more (PSA80).
The safety profile of 67Cu-SAR-bisPSMA remains favourable in the Cohort Expansion, with the majority of related AEs being Grade 1 or 2. The most common related AEs were nausea and lymphopenia (observed in three out of nine participants [33.3%], for each AE). The only AE that was Grade 3 or above was lymphopenia observed in three participants, some of whom had bone metastasis at baseline and/or had received multiple lines of therapy, including taxane and an investigational agent, prior to enrolment in the SECuRE study. There have been no overall renal toxicity or electrocardiogram (ECG) changes observed in these participants. In the combination enzalutamide arm, no new AEs (or worsening of AEs) related to 67Cu-SAR-bisPSMA have been observed to date.
Trial participant with no detectable disease after 3 cycles of 67Cu-SAR-bisPSMA
One of the participants in the Cohort Expansion was a 64-year-old man with bone metastases and baseline PSA of 5.4 ng/mL prior to entering the SECuRE study. Following his first cycle of 67Cu-SAR-bisPSMA, this participant showed a dramatic 95.2% reduction in PSA. He went on to receive 2 more cycles of 67Cu-SAR-bisPSMA and achieved undetectable PSA levels. In a follow-up bone scan and CT no metastatic disease was observed. This participant only exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs observed. The participant reported having excellent quality of life following the treatment.
The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of the SECuRE trial[1] and supports the continuation of the trial with the aim to progress to a registrational Phase III study.
Clarity's Executive Chairperson, Dr Alan Taylor, commented, "SAR-bisPSMA continues generating world-class data in both theranostic and diagnostic trials. The combination of the optimised dimer 'bis' structure with the benefits of copper isotopes, enabled by the proprietary sarcophagine technology, is proving to have created a product that is here to challenge the current treatment and diagnostic paradigms in radiopharmaceuticals.
"We have already seen a glimpse of the effects of 67Cu-SAR-bisPSMA through our Dose Escalation cohorts with additional and similar data being generated in the Cohort Expansion phase, demonstrating once again excellent efficacy and safety results of 67Cu-SAR-bisPSMA.
"All of the participants with evaluable data treated in the Phase II to date have shown declines in PSA, with the majority showing PSA decreases of more than 50% and mostly having only mild or moderate AEs. Most of these patients have been treated with more than 5 systemic treatment regiments and had bone metastasis prior to entering the SECuRE study. Although the number of participants with evaluable data to date is small, it is incredible to see yet another extraordinary case where a patient who had bone metastasis prior to entering the study achieved undetectable PSA following 67Cu-SAR-bisPSMA treatment, with no disease observed by anatomical and molecular imaging at the last assessments. This participant only experienced mild, transient AEs, most being gastrointestinal, and has reported having excellent quality of life following the treatment.
"Importantly, the work we have undertaken during the Dose Escalation Phase is now continuing to provide a strong foundation for us as we look ahead at protocol development and dosing for our Phase III clinical trial and commercialisation. As the participant numbers continue to increase with the trial enrollment, we continue to see very promising responses over and over again, giving us more confidence about the future of this product and its potential for commercialisation in metastatic castration-resistant prostate cancer (mCRPC). With three Fast Track Designations for the SAR-bisPSMA product and positive interactions with the US Food and Drug Administration (FDA) to date, we are working towards bringing this agent to clinicians and their patients around the world through the entirety of the prostate cancer journey, from first diagnosis to late-stage disease. All of these indications, being imaging in pre-definitive therapy and biochemical recurrence, as well as therapy in mCRPC, are blockbuster markets individually for prostate-specific membrane antigen (PSMA) targeted products, with an estimated combined market value of approximately US$10-15 billion by 2030. We are committed to continuing the development of this product, aiming to bring improved diagnostic and treatment options for prostate cancer in various stages of their disease."
About the SECuRE trial
The SECuRE trial (NCT04868604)[2] is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.
The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion (Phase II) at an 8 GBq dose level as per the SRC recommendation (up to 6 cycles per patient in total)[3].
Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)[1]. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants[1]. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.
Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), in line with the positive results from the Enza-p trial[4] and previous discussions with and advice from key global medical experts in the field of prostate cancer, including the Company's Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.
About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.
67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[5]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease[6].
About Clarity Pharmaceuticals
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing TCTs based on its SAR Technology Platform for the treatment of cancers.
www.claritypharmaceuticals.com
For more information, please contact:
References
- Clarity Pharmaceuticals. SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences. https://www.claritypharmaceuticals.com/news/secure-update/
- ClinicalTrials.gov Identifier: NCT04868604, https://clinicaltrials.gov/ct2/show/NCT04868604
- Clarity Pharmaceuticals. SECuRE trial update: First patient treated in the Phase II Cohort Expansion. https://www.claritypharmaceuticals.com/news/secure-fp-phase2/
- Emmett L et al. ENZA-p Trial Investigators; Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Overall survival and quality of life with [177Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Mar;26(3):291-299. doi: 10.1016/S1470-2045(25)00009-9.
- Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834
- American Cancer Society: Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
This announcement has been authorised for release by the Executive Chairperson.
HIGHLIGHTS
- Following an interim data review of the Cohort Expansion Phase (Phase II) of the SECuRE trial, the Safety Review Committee (SRC) confirms the trial will continue with no modifications to the protocol.
Patient population
- With the SECuRE trial continuing to recruit, a total of nine participants who had evaluable data by the 25th of November 2025 were included in the interim assessment by the SRC, with the majority of participants receiving at least two cycles of 8 GBq of 67Cu-SAR-bisPSMA each by the data cut-off date.
- Seven participants received 67Cu-SAR-bisPSMA and two participants were treated with a combination of 67Cu-SAR-bisPSMA with enzalutamide.
- Most participants were heavily pre-treated (with 55.6% having received more than 5 previous anti-cancer regimens) and had bone metastasis (66.7%).
Safety
- The safety profile of 67Cu-SAR-bisPSMA remains favourable with most related adverse events (AEs) in the Cohort Expansion to date being Grade 1 or 2. The most common AEs were nausea and lymphopenia (observed in 33.3% of participants, for each AE).
Efficacy
- Six participants had at least two prostate specific antigen (PSA) results following 67Cu-SAR-bisPSMA administration, with all showing a decrease in PSA. Of those, four participants (66.7%) thus far had a reduction of more than 50% in PSA (PSA50) and two participants (33.3%) had a reduction of more than 80% (PSA80).
- One participant who presented with bone metastasis at enrolment achieved undetectable PSA with no prostate cancer detected by computed tomography (CT) or bone scan following 67Cu-SAR-bisPSMA treatment. The participant reported having excellent quality of life following the treatment.
Next Steps
- The SECuRE trial will continue enrolment into the Cohort Expansion Phase with planned completion of recruitment in 2026. Phase III registrational trial planning ongoing based on data generated to date.
SYDNEY, Jan. 15, 2026 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to share a number of updates on the SECuRE trial following an SRC meeting. The SRC has recommended that the trial continue with the Cohort Expansion Phase (Phase II) as planned with no modifications to the protocol. The interim results assessed by the SRC were collected from nine participants enrolled in the cohort that had evaluable data by the cut-off date of the 25th of November 2025 and continue to show promising efficacy and a favourable safety profile of 67Cu-SAR-bisPSMA.
The majority of the nine participants had bone metastasis at enrolment (66.7%) and received multiple lines of previous treatments (more than 5 previous anti-cancer regimens, 55.6%). Median PSA prior to 67Cu-SAR-bisPSMA treatment was 18.9 ng/mL (range 1.5-30.2 ng/mL). Six out of these nine participants received at least 2 cycles of 8 GBq of 67Cu-SAR-bisPSMA each, with two of them also receiving concomitant enzalutamide.
Of the nine participants included in this SRC analysis, six had at least two PSA results following their 67Cu-SAR-bisPSMA treatment by the data cut-off date. Of these six participants, thus far four (66.7%) showed reductions in PSA of 50% or more (PSA50) and two (33.3%) showed reductions of 80% or more (PSA80).
The safety profile of 67Cu-SAR-bisPSMA remains favourable in the Cohort Expansion, with the majority of related AEs being Grade 1 or 2. The most common related AEs were nausea and lymphopenia (observed in three out of nine participants [33.3%], for each AE). The only AE that was Grade 3 or above was lymphopenia observed in three participants, some of whom had bone metastasis at baseline and/or had received multiple lines of therapy, including taxane and an investigational agent, prior to enrolment in the SECuRE study. There have been no overall renal toxicity or electrocardiogram (ECG) changes observed in these participants. In the combination enzalutamide arm, no new AEs (or worsening of AEs) related to 67Cu-SAR-bisPSMA have been observed to date.
Trial participant with no detectable disease after 3 cycles of 67Cu-SAR-bisPSMA
One of the participants in the Cohort Expansion was a 64-year-old man with bone metastases and baseline PSA of 5.4 ng/mL prior to entering the SECuRE study. Following his first cycle of 67Cu-SAR-bisPSMA, this participant showed a dramatic 95.2% reduction in PSA. He went on to receive 2 more cycles of 67Cu-SAR-bisPSMA and achieved undetectable PSA levels. In a follow-up bone scan and CT no metastatic disease was observed. This participant only exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs observed. The participant reported having excellent quality of life following the treatment.
The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of the SECuRE trial[1] and supports the continuation of the trial with the aim to progress to a registrational Phase III study.
Clarity's Executive Chairperson, Dr Alan Taylor, commented, "SAR-bisPSMA continues generating world-class data in both theranostic and diagnostic trials. The combination of the optimised dimer 'bis' structure with the benefits of copper isotopes, enabled by the proprietary sarcophagine technology, is proving to have created a product that is here to challenge the current treatment and diagnostic paradigms in radiopharmaceuticals.
"We have already seen a glimpse of the effects of 67Cu-SAR-bisPSMA through our Dose Escalation cohorts with additional and similar data being generated in the Cohort Expansion phase, demonstrating once again excellent efficacy and safety results of 67Cu-SAR-bisPSMA.
"All of the participants with evaluable data treated in the Phase II to date have shown declines in PSA, with the majority showing PSA decreases of more than 50% and mostly having only mild or moderate AEs. Most of these patients have been treated with more than 5 systemic treatment regiments and had bone metastasis prior to entering the SECuRE study. Although the number of participants with evaluable data to date is small, it is incredible to see yet another extraordinary case where a patient who had bone metastasis prior to entering the study achieved undetectable PSA following 67Cu-SAR-bisPSMA treatment, with no disease observed by anatomical and molecular imaging at the last assessments. This participant only experienced mild, transient AEs, most being gastrointestinal, and has reported having excellent quality of life following the treatment.
"Importantly, the work we have undertaken during the Dose Escalation Phase is now continuing to provide a strong foundation for us as we look ahead at protocol development and dosing for our Phase III clinical trial and commercialisation. As the participant numbers continue to increase with the trial enrollment, we continue to see very promising responses over and over again, giving us more confidence about the future of this product and its potential for commercialisation in metastatic castration-resistant prostate cancer (mCRPC). With three Fast Track Designations for the SAR-bisPSMA product and positive interactions with the US Food and Drug Administration (FDA) to date, we are working towards bringing this agent to clinicians and their patients around the world through the entirety of the prostate cancer journey, from first diagnosis to late-stage disease. All of these indications, being imaging in pre-definitive therapy and biochemical recurrence, as well as therapy in mCRPC, are blockbuster markets individually for prostate-specific membrane antigen (PSMA) targeted products, with an estimated combined market value of approximately US$10-15 billion by 2030. We are committed to continuing the development of this product, aiming to bring improved diagnostic and treatment options for prostate cancer in various stages of their disease."
About the SECuRE trial
The SECuRE trial (NCT04868604)[2] is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.
The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion (Phase II) at an 8 GBq dose level as per the SRC recommendation (up to 6 cycles per patient in total)[3].
Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)[1]. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants[1]. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.
Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), in line with the positive results from the Enza-p trial[4] and previous discussions with and advice from key global medical experts in the field of prostate cancer, including the Company's Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.
About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.
67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[5]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease[6].
About Clarity Pharmaceuticals
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing TCTs based on its SAR Technology Platform for the treatment of cancers.
www.claritypharmaceuticals.com
For more information, please contact:
Clarity Pharmaceuticals
Dr Alan Taylor
Lisa Sadetskaya
Executive Chairperson
Director, Corporate Communications
ataylor@claritypharm.com
lisa@claritypharm.com
References
This announcement has been authorised for release by the Executive Chairperson.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
SECuRE trial to continue with no modifications to protocol following Safety Review Committee meeting