Invion (ASX:IVX) is a clinical-stage Australian life sciences company pioneering the next generation of photodynamic therapy (PDT) for the treatment of cancer and infectious diseases. Invion is advancing a transformative approach to disease treatment and diagnosis with a platform grounded in preclinical promise and growing clinical validation.
At the core of Invion’s platform is Photosoft, a proprietary suite of next-generation photosensitizers that selectively accumulate in diseased cells. Upon light activation, these compounds trigger a targeted oxidative stress response, leading to cell death with high precision. Unlike traditional PDT agents, Photosoft compounds are engineered to overcome the limitations of toxicity, off-target damage, and limited immune engagement. They are designed to deliver enhanced safety, selectivity, immune system activation, and theragnostic capabilities.
Invion is strategically expanding its clinical and commercial footprint through non-dilutive global partnerships that accelerate development while preserving shareholder value. In South Korea, Hanlim Pharm is fully funding the preclinical development of Photosoft for two high-need indications: glioblastoma multiforme (GBM) — one of the most aggressive and treatment-resistant brain cancers — and oesophageal cancer. Under the terms of the partnership, Hanlim covers all development costs, while Invion retains full ownership of the underlying intellectual property, positioning the company to benefit from future global opportunities.
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With a strong IP portfolio, deep clinical-stage pipeline, global collaborations and an experienced leadership team, Invion is poised for transformative value creation as it enters the next phase of clinical and commercial growth.
Invion Limited (ASX:IVX) is a clinical-stage Australian life sciences company focused on transforming photodynamic therapy (PDT) into a next-generation solution for treating cancer and infectious diseases. The company’s core value lies not just in preclinical promise, but in real-world clinical validation.
At the heart of Invion’s platform is Photosoft, a proprietary suite of next-generation photosensitizers that selectively target diseased cells and, upon light activation, induce a precise oxidative stress response to destroy them. Unlike conventional PDTs that suffer from toxicity and off-target effects, Photosoft compounds are engineered for enhanced safety, specificity, immune activation, and theragnostic utility. INV043, Invion’s lead cancer drug candidate, has demonstrated up to 80 percent tumor control in combination with immune checkpoint inhibitors, and is now in human trials.The company is actively progressing a broad pipeline across multiple indications, including:
These trials signal a critical shift for Invion from preclinical research to meaningful clinical validation, spanning both systemic and topical formulations. The safety data from the NMSC trial is expected to support accelerated development of the anogenital cancer program, given both use the same topical compound.
The clinical results so far have been consistent with the findings from the preclinical studies – showing INV043 to be very safe with promising efficacy signals. The next set of trials aim to further solidify the potential for the technology, where the one drug can treat multiple cancers, improve patient outcomes when using checkpoint inhibitors in combination with INV043 and demonstrate its diagnostic and theragnostic potential.
Beyond internally funded trials, Invion is strategically expanding its clinical and commercial footprint through non-dilutive, global partnerships. In South Korea, Hanlim Pharm is funding the preclinical development of Photosoft for glioblastoma multiforme — a highly aggressive brain cancer — and oesophageal cancer, both of which present major unmet needs. These programs are fully financed by Hanlim, with Invion retaining all intellectual property
Similarly, Dr. I&B Co. (Dr.inB), another South Korean group, is backing the development of Photosoft for human papillomavirus (HPV) in a new proof-of-concept trial. This collaboration not only funds a novel therapeutic area outside of oncology but underscores the versatility of Photosoft as a multi-indication, platform technology. Invion bears none of the clinical trial costs and maintains all rights to future commercialization.
In parallel, Invion is expanding the Photosoft platform into infectious diseases, where preclinical studies have demonstrated broad-spectrum antimicrobial activity. The compound has proven effective in vitro against:
These results reflect Invion’s long-term vision of developing a scalable, accessible and affordable therapy platform that addresses both high-burden cancers and the growing global threat of antimicrobial resistance. With Photosoft, the company is building a foundation not just for treating disease — but for reshaping therapeutic accessibility and patient outcomes worldwide.
Invion’s leading active trial is a Phase I/II adaptive clinical study targeting non-melanoma skin cancer — a condition that represents 98 percent of all skin cancers and constitutes a substantial public health burden in Australia. Using a topical formulation of INV043, the trial is designed with a 3+3 structure allowing real-time protocol optimization for safety and efficacy. The formulation offers significant cosmetic and pain-reduction benefits over existing approved PDT treatments like Metvix (by Galderma S.A.) and excisional surgery, both of which have limitations related to scarring and pain. Dosing of the first patient commenced in December 2024, with ongoing recruitment and interim data expected in the second half 2025 or early 2026. The skin cancer program not only represents a potentially fast path to market but also supports downstream programs, such as the anogenital cancer study, through shared formulation and safety data.
The anogenital cancer program is a major upcoming milestone for Invion, developed in collaboration with the prestigious Peter MacCallum Cancer Centre in Melbourne, Australia, one of the leading oncology research centres in the world. Utilizing the same topical INV043 formulation as the non-melanoma skin cancer trial, this Phase I/II study will leverage safety data from the trial to accelerate approval timelines. The anogenital trial targets high-risk lesions and cancers with limited therapeutic options, and benefits from the scientific and operational expertise of Peter Mac. Preclinical data showed exceptional synergy when INV043 was used in combination with immune checkpoint inhibitors (anti-PD-1), achieving up to 80 percent tumor-free responses in models of anal squamous cell carcinoma, compared with a circa 12 percent response rate with aniti-PD-1 alone. This program exemplifies Invion’s theragnostic strength, where the compound also enables fluorescent visualization of tumor margins to aid surgical decision-making.
INV043 has completed a Phase II investigator-led clinical trial in prostate cancer, funded by the RMW Cho Group. The trial involved sublingual systemic administration of the compound followed by targeted light therapy. Following COVID-related disruptions, a second cohort of 16 patients was successfully treated and evaluated using PSMA-PET scans and RECIST criteria. Results were compelling: 44 percent of patients showed no detectable cancer via PSMA-PET scan three months post-treatment, while 40 percent demonstrated partial or stable response by MRI. The therapy was extremely well-tolerated, with no serious adverse events and only mild treatment-emergent side effects. These findings serve as clinical proof-of-concept for systemic delivery of INV043, highlighting its potential for deeper-seated cancers and reinforcing its safety and scalability.
Through a strategic partnership with South Korean pharmaceutical company Hanlim Pharma, Invion is advancing preclinical programs for two highly aggressive and deadly cancers: glioblastoma multiforme and oesophageal cancer. Hanlim is funding both programs entirely, allowing Invion to retain all IP and avoid capital outlay. These programs are exploring INV043’s efficacy in some of the most treatment-resistant solid tumors, with early-stage studies underway and updates expected in 2025. If successful, this collaboration could lead to regional licensing or joint ventures in Asia, significantly expanding Invion’s global footprint.
Dr.inB, a leading PDT innovator in South Korea, is partnering with Invion to develop Photosoft-based treatments for HPV-related conditions, including genital warts and potentially HPV-linked cancers. The program, which includes proof-of-concept human trials, is entirely funded by Dr.inB, and Invion retains all IP and commercialization rights. Beyond HPV, Photosoft has demonstrated broad-spectrum antimicrobial potential against antibiotic-resistant bacteria, fungi and viruses, including SARS-CoV-2. This opens the door to applications in periodontal disease, peri-implant mucositis, and other infectious conditions. PDT’s unique mechanism of action — using light to generate oxidative stress — renders it immune to resistance development, making it an ideal candidate for combatting antimicrobial resistance, one of the top 10 threats to humanity identified by the World Health Organization.
Thian Chew brings over two decades of executive and advisory experience in healthcare and finance. He is the co-founder of Chronic Airway Therapeutics and a board advisor at Stanford Medicine’s Center for Asian Health Research and Education (CARE). Formerly an executive director at Goldman Sachs and director at KPMG Consulting, Chew combines strategic vision with operational rigor. He is an adjunct professor at the University College London and associate professor at HKUST, holding dual an MBA from Wharton School (Palmer Scholar) and an MA from the Lauder Institute, University of Pennsylvania.
A world-renowned expert in immunotherapy and translational cancer biology, Robert Ramsay is a senior scientist at Peter MacCallum Cancer Centre and has over 30 years of oncology research experience. He was instrumental in demonstrating the synergy between INV043 and checkpoint inhibitors, leading to his appointment as a key advisor. Ramsay also served as president of the Australian Society for Medical Research.
Scott Carpenter brings cross-functional expertise in regulatory affairs, business development and stakeholder engagement. He previously held leadership roles at Starpharma, AusBiotech and Bayer CropScience and holds an MBA from Melbourne Business School.
The co-inventor of Invion’s PDT patents, Sebastian Marcuccio is the founder of Advanced Molecular Technologies and has a deep background in pharmaceutical R&D, including with CSIRO. He is currently adjunct professor at La Trobe University and holds a PhD in organic chemistry.
With more than 18 years of experience managing global Phase I-IV drug and device trials across 14 countries, Kim Steel has worked with Novotech and Pacific Clinical Research. She is managing director of SAPRO Consulting, leading operational delivery for Invion’s ongoing trials.
A veteran of scientific instrumentation development, Alexander Bennett brings 35+ years of experience designing medical and forensic light systems. He led PDT light source trials at Peter MacCallum Cancer Centre and ensures the clinical precision of INV043’s light activation protocol.
Revolutionizing Photodynamic Therapy (PDT) for cancer and infectious diseases
All financial results are reported in Canadian dollars unless otherwise stated.
Numinus Wellness Inc. (TSX: NUMI) (OTCQB: NUMIF) (FSE: LR23) ("Numinus" or the "Company") a mental health care company focused on innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, today announced its financial results for the three months ended May 31, 2025 ("Q3 2025 ").
"The progress we are making in fiscal 2025 demonstrates our success in shifting to a leaner operating model that will enable future growth," said Michael Tan, CEO of Numinus. "With a solid operational platform in place, Numinus is entering the next phase of its evolution: from direct care provider to the backbone of in-clinic delivery for approved psychedelic medicines."
"The Company is now up to date with its public company filing requirements and will be moving forward with its application to revoke the ongoing cease trade order," added Kelvin Yang, CFO of Numinus. "Once the cease trade order has been lifted, the Company will seek to relist on another reputable exchange."
Revenue from continuing operations
The Company's consolidated revenues increased by 81.6% in Q3 2025 to $1.8 million compared to $992,912 in Q3 2024.
Revenues from Cedar Clinical Research ("CCR") operations during Q3 2025 increased by 95.8% from $824,082 during Q3 2024 to $1.6 million, as a result of increased high-return clinical trials.
Revenues from Practitioner Training during Q3 2025 increased by 12.3% to $189,685 from $168,830 in Q3 2024. The continued increase in revenue was due to strategic contracts with research partners to help support the training efforts of various psychedelic clinical trials.
Gross Margin
Gross margin in Q3 2025 was 48.2%, compared to a gross margin loss of 4.6% in Q3 2024.
Operating expenditures
Operating expenditures and other items were $1.5 million in Q3 2025, compared to $3.8 million in Q3 2025. The decrease is a result of the Company's ongoing cost containment initiatives and operational optimization.
Balance Sheet and Liquidity
Numinus ended the quarter with a cash balance of $822,835.
Q3 2025 Performance Metrics
| For the quarter ended: | |||
| May 31, 2025 (Q3 2025) | May 31, 2024 (Q3 2024) | % change | |
| Total Revenue | $1,802,942 | $992,912 | 81.6% |
| Cost of revenue | 932,842 | 1,038,887 | -10.2% |
| Gross Profit (Loss) | $870,100 | ($45,975) | -n/a |
| Gross profit margin (loss) | 48.2% | (4.6%) | 528 bps |
| Operating expenses and other items | 1,538,914 | 3,833,482 | -59.8% |
| Loss and comprehensive loss | ($741,575) | ($5,766,085) | n/a |
Numinus' unaudited condensed consolidated interim financial statements for the three months ended May 31, 2025, and related management's discussion and analysis are available on Numinus' Investor Relations website at www.investors.numinusnetwork.com and under the Company's profile on SEDAR+ at www.sedarplus.ca. These documents were prepared in accordance with IFRS.
Outlook
With strong relationships with leading drug sponsors and deep experience running late-stage clinical trials, Numinus is well-positioned as the bridge between regulatory approval and the rollout of thousands of clinics preparing to offer psychedelic-assisted therapy.
The company's focus going forward will be on building the infrastructure these clinics will need. Leveraging Numinus' operational expertise, extensive clinical dataset, and sector relationships, we are developing technology-enabled solutions to streamline insurance reimbursement, integrate measurement-based care, standardize therapist credentialing, and ensure compliance. These are essential capabilities for scaling psychedelic therapies safely and effectively, and Numinus is uniquely positioned to deliver them.
Numinus' foundation rests on two growing business units: Cedar Clinical Research and Numinus Practitioner Training. This, combined with valuable intellectual property and one of the most comprehensive sets of protocols and procedures in the sector, which was built through serving over 50,000 individuals and delivering 200,000 appointments, provides Numinus with unmatched insight into what it will take to operationalize psychedelic therapies at scale.
Momentum in the sector is accelerating. Multiple drug candidates are approaching regulatory submission, and supportive policy initiatives are gaining traction at both the federal and state levels. This growing demand, combined with Numinus' operational readiness, positions us to capitalize on the market opportunity as these treatments transition from trials to clinics.
Numinus is focused, growing, and strategically positioned to be a critical enabler of the psychedelic therapy rollout. The goal is to provide the systems, infrastructure, and expertise that will bring these treatments from approval to the patients who need them most.
Voting Results from the Annual General and Special Meeting Held on Thursday, August 28, 2025
A total of 65,684,359 common shares representing 20.49% of the 320,551,600 issued and outstanding common shares of the Company as at the record date of July 14, 2025, were represented either in person or by proxy at the Meeting.
The following four nominees proposed by Numinus were elected as directors of Numinus to serve until Numinus' next annual meeting of shareholders, or until their successors are elected or appointed. Below is a summary of the voting results for the directors elected:
| DIRECTOR | VOTES CAST FOR | % VOTES FOR | VOTES WITHHELD | % VOTES WITHHELD |
| Payton Nyquvest | 32,208,565 | 82.48% | 6,842,849 | 17.52% |
| Larry Timlick | 37,067,331 | 94.92% | 1,984,083 | 5.08% |
| Michael Tan | 33,515,358 | 85.82% | 5,536,056 | 14.18% |
| Donna Wilson | 37,305,639 | 95.53% | 1,745,775 | 4.47% |
In addition to the election of all nominees listed as directors in the management information circular, dated July 29, 2025 (the "Circular"), Numinus shareholders approved all other resolutions placed before the Meeting. More information about the resolutions voted on at the Meeting is available is available in Numinus' Management Information Circular, which can be found on the Company's profile on SEDAR+ at www.sedarplus.ca. Final voting results on all matters voted on at the Meeting are also filed on SEDAR+.
About Numinus
Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model - including psychedelic research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Learn more at www.numinusnetwork.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.
SOURCE Numinus Wellness Inc.
Forward-looking statements
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are "forward-looking statements". Forward-looking statements can be identified by the use of words such as "expects", "does not expect", "is expected", "believes", "intends", "anticipates", "does not anticipate", "believes" or variations of these words, expressions or statements, that certain actions, events or results "may", "could", "would", "might" or "will be" taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, ability of Numinus to maintain or increase earnings; ability of Numinus to achieve or maintain profitability; results of changes to operations from a financial or business perspective; the effect of cost containment measures on Numinus business and financial position; changes to cash burn rate, expenses, corporate programs or priorities, or unanticipated costs affecting cash runway or the pathway to positive cashflow or profitability, the effect of any transaction or other activity undertaken by the company in connection with the strategic review; interest in, uptake of and the ability to commercialize the Numinus Training; dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate the Company's facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal, state and provincial legalization, if any, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company's need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers; and other risk factors set forth in our annual information form dated July 25, 2025 and available on SEDAR+ at www.sedarplus.ca. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company's efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.
For more information:
Investor Contact
Craig MacPhail
invest@numinusnetwork.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/264825
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All financial results are reported in Canadian dollars unless otherwise stated.
Numinus Wellness Inc. (TSX: NUMI) (OTCQB: NUMIF) (FSE: LR23) ("Numinus" or the "Company"), a mental health care company focused on innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, today announced its financial results for the three months ended February 28, 2025 ("Q2 2025").
Q2 2025 Performance Metrics
| For the quarter ended: | |||||||||
| Feb 28, 2025 (Q2 2025) | Feb 28, 2024 (Q2 2024) | % change | |||||||
| Total Revenue | $ | 1,512,435 | $ | 822,973 | 83.8% | ||||
| Cost of revenue | 1,007,691 | 365,446 | 175.7% | ||||||
| Gross Profit (Loss) | $ | 504,744 | $ | 457,527 | 10.3% | ||||
| Gross profit margin (loss) | 33.4% | 55.6% | -400 bps | ||||||
| Operating expenses and other items | 9,886,497 | 5,306,523 | 86.31% | ||||||
| Loss and comprehensive loss | ($7,705,397 | ) | ($5,960,437 | ) | n/a | ||||
Balance Sheet and Liquidity
Numinus ended the quarter with cash and cash equivalents of $705,631.
Numinus' unaudited condensed consolidated interim financial statements for the three months ended February 28, 2025, and related management's discussion and analysis are available on Numinus' Investor Relations website at www.investors.numinusnetwork.com and under the Company's profile on SEDAR+ at www.sedarplus.ca. These documents were prepared in accordance with IFRS.
About Numinus
Numinus Wellness Inc. (TSX: NUMI) (OTCQB: NUMIF) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model — including psychedelic research and clinic care — is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Learn more at www.numinusnetwork.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.
SOURCE: Numinus Wellness Inc.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including, without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are "forward-looking statements". Forward-looking statements can be identified by the use of words such as "expects", "does not expect", "is expected", "believes", "intends", "anticipates", "does not anticipate", "believes" or variations of these words, expressions or statements, that certain actions, events or results "may", "could", "would", "might" or "will be" taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, ability of Numinus to maintain or increase earnings; ability of Numinus to achieve or maintain profitability; results of changes to operations from a financial or business perspective; the effect of cost containment measures on Numinus business and financial position; changes to cash burn rate, expenses, corporate programs or priorities, or unanticipated costs affecting cash runway or the pathway to positive cashflow or profitability, interest in, uptake of and the ability to commercialize the Numinus Training; availability of subjects and trainers for experiential opportunities in practitioners training, if approved; dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate the Company's facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal, state and provincial legalization, if any, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company's need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers; and other risk factors set forth in our annual information form dated July 25, 2025 and available on SEDAR+ at www.sedarplus.ca. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company's efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.
For more information:
Investor Contact
Craig MacPhail
invest@numinusnetwork.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/263266
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