Cardiff Oncology shares plunge after Q2 earnings miss
Theralase Technologies reported its first-quarter 2025 earnings, revealing a miss on both earnings per share (EPS) and revenue forecasts. The company posted an EPS of -0.006 against an expected -0.003, and revenue of $91,190, significantly below the forecast of $200,000. Following the announcement, the company’s stock fell by 9.52% in pre-market trading, closing at $0.19, near its 52-week low. According to InvestingPro data, the company’s financial health score stands at 2.71, indicating moderate concerns about its current position.
Key Takeaways
- Theralase Technologies missed EPS and revenue forecasts for Q1 2025.
- The company’s stock dropped by 9.52% following the earnings announcement.
- Despite financial challenges, the company reported progress in clinical trials and pipeline expansion.
- Operating expenses increased, particularly in research and development.
Company Performance
Theralase Technologies faced a challenging first quarter in 2025, with revenues dropping to $91,000 from $175,000 in the same quarter last year. The company’s focus on expanding its clinical pipeline and increasing research and development investments has yet to translate into improved financial results. InvestingPro analysis reveals that short-term obligations exceed liquid assets, and analysts anticipate continued sales decline in the current year. The broader market context shows that the company is struggling to meet investor expectations, which is reflected in its stock performance. For detailed insights into the company’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
Financial Highlights
- Revenue: $91,000, down from $175,000 YoY.
- Earnings per share: -0.006, missing the forecast of -0.003.
- Gross margin: $13,000, representing 15% of revenue.
- Operating expenses increased, with administrative expenses up by 9% and research and development costs up by 16%.
Earnings vs. Forecast
Theralase Technologies’ actual EPS of -0.006 fell short of the forecasted -0.003, marking a notable miss. The revenue of $91,190 was significantly below the anticipated $200,000, raising concerns about the company’s near-term growth prospects. This performance contrasts with previous quarters, highlighting ongoing financial challenges.
Market Reaction
The company’s stock reacted negatively to the earnings miss, dropping by 9.52% in pre-market trading to $0.19. This decline positions the stock near its 52-week low of $0.155, reflecting investor concerns about the company’s financial health and ability to meet growth targets. InvestingPro data shows the company is trading at high revenue and Price/Book multiples, suggesting potential overvaluation despite the recent price decline. Subscribers to InvestingPro can access additional valuation metrics and eight more exclusive ProTips to make more informed investment decisions.
Outlook & Guidance
Theralase Technologies is focused on completing its current clinical studies, with an estimated $8-10 million needed to achieve this goal. The company anticipates submitting marketing applications to the FDA and Health Canada by Q4 2026, with potential approval in early 2027. Efforts to secure non-dilutive funding and explore partnership opportunities are ongoing.
Executive Commentary
CEO Roger Dumoulin White emphasized the company’s commitment to becoming a leader in light-activated therapeutics, stating, "Ruvedar delivers high complete response rates with an ultra-high safety profile using a single intravesical treatment." He also highlighted efforts to pursue debt financing to reduce shareholder dilution.
Risks and Challenges
- Financial performance: Continued revenue shortfalls and increased expenses pose risks to profitability.
- Regulatory hurdles: Approval timelines for new treatments could impact market entry.
- Competition: The company faces challenges from established players in the oncology and antiviral markets.
- Funding needs: Securing adequate funding to complete clinical studies remains critical.
Q&A
During the earnings call, analysts focused on the progress of clinical studies, the strategy for a potential U.S. public listing, and the expansion of the company’s pipeline. CEO Roger Dumoulin White addressed questions on Ruvedar’s potential and the company’s approach to reducing shareholder dilution through debt financing.
Full transcript - Theralase Technologies Inc. (TLT) Q1 2025:
Matthew Perrittim, Investor Relations Manager, Theralase Technologies Inc: Good morning, everyone, and thank you for joining us today. I’m Matthew Perrittim, Perratim, Investor Relations Manager at Theralase Technologies Inc, and it’s a pleasure to welcome our shareholders and stakeholders to our first quarter twenty twenty five investor conference call. We appreciate your ongoing support as Theralase continues to advance through a pivotal phase of transformation. The February will mark a critical inflection point for our company. As after six years of hard work, including the trials and tribulations of running a clinical study through a global pandemic, we will finally complete enrollment in a registrational bladder cancer study.
Completion of this milestone will allow us to complete our obligatory fifteen month patient follow-up in the third quarter of twenty twenty six, which in turn allows us the opportunity to file a new drug application for marketing approval with Health Canada and the FDA for the fourth quarter of twenty twenty six. Assuming we achieve priority review for this new drug and meet all regulatory guidelines, we would be granted marketing approval for Canada and The United States in the beginning of twenty twenty seven. Completion of this clinical study allows the company the unique opportunity to embark in developing technologies for a whole new range of cancers and viruses. Most notably brain cancer, lung cancer, pancreatic cancer, colorectal cancer, muscle invasive bladder cancer, leukemia, lymphoma, multiple myeloma, and herpes simplex virus. To treat this plethora or new oncological conditions, Theraly’s plans to clinically develop powerful radiation activated therapeutics that can be offered to patients in a minimally invasive fashion but still deliver safe and effective treatment options for these conditions.
Therapies is in a transformational phase of its development financially, clinically and strategically. Today’s calls will provide insights into our first quarter twenty twenty five financial performance and current capital position. Interim clinical data from Study two for BCG, unresponsive bladder cancer, with some compelling new data patient durability data expansion of our pipeline into nine high value indications our strategic vision, including a potential U. S. Uplist with concurrent U.
S. Institutional financing. We believe the progress we’ve made over the last quarter and the steps we’re taking in the quarters ahead will set Theralase apart in the pharmaceutical world. Forward looking statement. Before we begin, I would like to remind everyone that today’s presentation may contain forward looking statements as defined under applicable Canadian securities laws.
Participants should not unduly rely on these forward looking statements. They are not a guarantee of future performance and there can be no assurance they will prove to be accurate in the future. These forward looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results or future events to differ materially. Although forward looking statements made today are based on what management believes to be reasonable assumptions, the company cannot assure investors that actual results will align with these expectations. All forward looking statements are made as of today’s date and are subject to change without notice, except as required by law.
The company assumes no obligation to update or revise them. This call will be posted on our corporate website next week. Now that we’ve covered the required disclosures, I’d like to introduce our chief financial officer, miss Christina Hachie.
Christina Hachie, Chief Financial Officer, Theralase Technologies Inc: Thank you, Matthew. Before we review the numbers, please note that all financial amounts I will be presenting today are rounded to the nearest thousand Canadian dollars for clarity and simplicity. For financial amounts accurate to the dollar, please refer to the first quarter financial statements available on SEDAR plus or on our website. Overall, Theralase continues to demonstrate strong financial discipline, advancing our clinical platforms on a shoestring budget, while continuing to invest in preclinical research that unlocks future shareholder value. Due to the fact that all of our oncological programs are pre revenue, nominal revenues for the first quarter twenty twenty five totaling $91,000 was derived from the business to business sales and service of our cool laser therapy systems.
This is down from $175,000 the year prior and reflects the company’s focus on allocating valuable financial resources strictly to our bladder cancer clinical study to allow completion. Now that this clinical study is completing enrollment, Theralase can now reinvest in both the drug and device divisions in 2025. With this investment, revenues in the device division are expected to grow, while investment in the drug division will allow the commencement of numerous new clinical study indications. Gross margin was approximately $13,000 or 15% of revenue and reflects reduced sales volume and fixed overhead costs. Operating expenses for the first quarter were comprised of selling expenses of 68,000, which were stable from the year prior, administrative expenses, which increased 9% to 555,000, and research and development expenses, increased 16% to $878,000 reflecting the ongoing cost of the bladder cancer study.
The net loss for the quarter was $1,470,000 which included $256,000 in non cash charges. This substantially reflects our investment in the bladder cancer clinical study, which will allow enrollment to be completed in the summer of twenty twenty five. In terms of capital, we successfully closed private placements totaling 730,000 in the first and second quarter of twenty twenty five. Altogether, we’ve raised nearly $7,500,000 over the past twenty four months through non brokered private placements, with significant participation from insiders and long term shareholders. This capital has been strategically deployed to complete enrollment in our bladder cancer clinical study.
Looking forward, we are planning to invest in both the drug and device division to increase current revenue and future revenue. To this end, we are exploring the potential for a US institutional raise in collaboration with a possible US listing, steps that can significantly broader our investor base, improve stock liquidity, and provide the company with the much needed capital required to expand our pipeline.
Matthew Perrittim, Investor Relations Manager, Theralase Technologies Inc: Thank you, Christina, for Therabliz’s Q1 twenty twenty five financial update. Now I will provide an update on our Study two from non muscle invasive bladder cancer. As could be expected, Study two remains our top strategic objective. This multi center single arm phase two registrational clinical study is being used to evaluate the efficacy and safety of Ruvedar, a light activated small molecule in patients with BCG unresponsive non muscle invasive bladder cancer carcinoma in situ. To date, we have enrolled and successfully treated eighty two out of our total ninety patients scheduled to be enrolled, representing ninety one percent of our target enrollment.
As previously mentioned, we are on track to complete enrollment by the summer of twenty twenty five. ’60 ’9 patients have completed the clinical study assessment leaving thirteen patients of the eighty two currently pending assessment. Study two has achieved a sixty two percent complete response at any time with patients assessed with no detectable cancer. Seventy percent total response, which includes patients who have achieved a complete response as well as patients who exhibit positive or suspicious urine cytology suggesting upper tract disease which is outside the design of our clinical study. Forty two percent of patients who achieved a complete response continue to show a durability of that response at fifteen months and beyond.
There will be no serious adverse events directly related to Ruvedar or to the TLC 3,200 medical laser system used to activate it confirming an exceptional safety and tolerability profile. In assessing patients outside of the defined endpoints of the study, the company has demonstrated a duration response of twenty three percent at two years, twenty one percent at three years and two percent at seven years with additional clinical data still to be being collected. This level of safety, efficacy and durability particularly from a single intravesical treatment places Ruvanar in a coveted position as one of the most promising emerging therapies in bladder cancer. Our next milestones include enrolling and treating the remaining eight patients by the summer of twenty twenty five, completing follow-up on all patients until study completion expected in September 2026, Completing soft and hard data lock by third quarter two thousand twenty six. Submitting a new drug application to Health Canada and the FDA for marketing approval expected in six months if prior review is obtained and in ten months otherwise.
With strong interim clinical results, a growing shareholder base, interest for partnerships for larger pharmaceutical companies and new clinical locations in oncology and virology on the horizon. The company is undertaking a number of strategic initiatives for long term growth as a publicly listed pharmaceutical company. Specifically, separating reporting and funding for the drug and device divisions. Potential US public company up list concurrent with The US institutional initial public offering raise. Capitalizing an expansion and partnering of new clinical indications.
These strategic initiatives should help position Theralase for breakout growth in A US public listing would provide a number of clear advantages including much larger potential shareholder base that could provide increased daily trading volume and hence increased shareholder liquidity. Visibility and positioning of our company amongst US based investors. Equal footing with competitive biotech names who trade at significantly higher valuations with substantially less effective technology. Ability to raise funds from US based institutional investors who solely invest in pharmaceutical and biotech companies.
Based on new rules, if the company did decide to pursue a US listing, the company would pursue use of a vehicle that does not not require a common share reverse split to meet US listing criteria. This simplifies our path forward and preserves continuity for our shareholders. As we approach late stage development in bladder cancer, we are simultaneously advancing robust pipeline across oncology and infectious disease indications including glioblastoma multiforme, a deadly form of brain cancer. Non small cell lung cancer, the leading cause of deaths worldwide. Pancreatic cancer, a cancer which is often diagnosed late leading to a low survival rates.
Muscle invasive bladder cancer, a disease where the standard of care is bladder removal. Colorectal cancer, the second leading cause of cancer deaths in The United States. Hematologic Cancers such as leukemia, leukemia, lymphoma, multiple myeloma, all deadly forms of blood cancers. Herpes simplex virus cold sores, a condition with no cures that affects sixty four percent of the world’s population 50. Good laboratory practice or GLP toxicology studies for these indications are expected to be completed by the end of twenty twenty five.
Pending completion of GLP toxicology studies, we anticipate initiating adaptive phase one two clinical studies in the first quarter of twenty twenty six. These studies will be designed to provide early validation of safety and efficacy positioning Theralase to efficiently move from preclinical research to clinical development in high need therapeutic areas. The strength of our technology platform lies in its versatility, target approach, minimally invasive administration, ultra high safety profile, high efficacy and broad therapeutic application. Theralase is building a multifaceted clinical engine capable of addressing major oncology and virology challenges. Now I’d like to transition us to the question and answer portion of today’s call.
To answer your questions, I would like to now introduce our president and chief executive officer, Roger Dumoulin White. Roger, welcome, and thank you for joining us today.
Roger Dumoulin White, President and Chief Executive Officer, Theralase Technologies Inc: Thank you, Matthew, and it’s a pleasure being here. Hello, everyone, and thank you for joining us today. We sincerely appreciate your time, your questions, and your continued support of Theralase as we commence a turning point in the evolution of our company. We’ve received a number of questions in advance of today’s call and have taken the liberty of combining them based on their theme. I would now like to take some time to address some of the most commonly asked questions from shareholders.
Question one, when will study two be complete? Enrollment and delivery of the primary study procedure is expected to be completed by the summer of twenty twenty five. This will allow us to complete our fifteen month follow-up by September 2026 and allow us to be in a position to submit a marketing submission to Health Canada and the FDA by fourth quarter twenty twenty six. Health Canada and the FDA take a minimum of six months to render a decision. So if we meet all of their guidelines, then marketing approval would be granted the beginning of twenty twenty seven.
Question two. What is the estimated cost to complete study two? We estimate approximately 8,000,000 to $10,000,000 Canadian is needed to complete enrollment, follow-up, data lock, and regulatory submissions over the next eighteen months. Question number three. Will Ferrales pursue a US listing this year?
Properly funding the drug and device divisions is the company’s priority this year. As such, a US listing remains a strategic objective of the company if it is able to help us accomplish this objective. Question four. How does Ruvedar compare to other bladder cancer therapies? Ruvedar delivers high complete response rates with an ultra high safety profile using a single intravesical treatment.
No directly related serious adverse events have been reported, which differentiates it significantly from other more expensive and complex multi dose immunotherapeutic approaches. Question five. What value does a US listing bring to shareholders? It increases access to US Institutional Investors, allowing funding from specialized funds that focus solely on the pharmaceutical and biotech world. As a result, it potentially improves trading volumes and, hence, liquidity, which helps the company align with US biotech peers that trade at significantly higher valuations despite less compelling data.
Question six. Are you seeing increased interest from US Investors? Yes. As our interim clinical data matures, we are seeing increased interest from US based investors. We associate this with our pending FDA marketing submission, which could bring significant value to shareholders.
Question seven. What non dilutive funding sources are you pursuing? We are pursuing debt financing support from a couple of Canadian based institutions to help reduce shareholder dilution. We will provide more guidance on these vehicles if and when they become material. Question eight.
When will new indications move into the clinic? GLP toxicology should conclude by the end of this year, enabling Phase zero, one, two adaptive clinical studies to commence for multiple cancer and viral indications beginning in the first quarter twenty twenty six. Question nine. Will Ruvedar be commercialized in house or through partnerships? Various options are being discussed at the moment.
As our discussion and negotiations continue, Theralys will decide between what technologies to partner and what technologies to advance in house, with the primary decision based on what provides the greatest shareholder value. Question 10. What is the shelf life and logistical advantage of Ruvedar? Ruvedar has demonstrated a ten year shelf life at room temperature, which offers significant logistical and cost advantages for global distribution, especially since the biologically proposed solutions of our competitors require complex drug preparation and administration along with expensive and time consuming cold storage management. Question 11.
How long do you expect complete response durability to last based on current data? We’ve seen complete response durability extend beyond fifteen months in many cases, with twenty one percent of patients who achieved a complete response still exhibiting this duration of response at three years, and one patient demonstrating a complete response over seven years after only one treatment. As our clinical data continues to mature, these numbers are expected to rise. Question number 12: Why expand into new indications now? Our small molecule platform has shown potential across numerous tumor types.
Diversifying the pipeline reduces overall risks and expands our target markets and our market revenue potential. Question 13. Are you in discussions with regulators? Yes. We continue to engage proactively with Health Canada and the FDA to ensure alignment as we move towards submission readiness.
Question 14. What is your long term strategic vision? To be a global leader in light and radiation activated therapeutics, delivering innovative, safe, effective, accessible oncology and antiviral solutions to patients worldwide. Question 15. Will Ferrolase require a share consolidation to list in The US?
No. We are pleased to confirm that we’ve identified a pathway to list in The US that does not require a share consolidation. This removes a major hurdle and simplifies our road map to listing. It also reflects the strength of our current structure and supports shareholder continuity and confidence. Question 16.
Are you pursuing any partnership opportunities? Yes. We are always pursuing potential partnership opportunities with some discussions more advanced than others. As outlined in our most recent corporate update, we are engaged in multiple ongoing partnership discussions, both for potential out licensing opportunities and clinical collaborations. These span various geographic and therapeutic areas and reflect growing recognition of the value in our lead program and platform technologies.
Question 17. Is there an update regarding bird flu? Yes. We continue to pursue this opportunity with a Canadian federal research institution, but there’s nothing materially to report at this time. Question 18.
Is there an update regarding your preclinical research at the University of Manitoba? Yes. As part of our broader infectious disease strategy, Fairleigh’s continues to collaborate with researchers at the University of Manitoba on herpes simplex research and development. This preclinical work is ongoing and designed to more fully uncover the antiviral potential of Ruvedar. We look forward to sharing this preclinical data as it becomes available and in exploring how this approach may address emerging viral threats.
That seems to be all the questions the company has received to date. I look forward to answering additional questions in the future. Thank you.
Matthew Perrittim, Investor Relations Manager, Theralase Technologies Inc: Thank you, Roger, for your detailed responses and thank you to all the shareholders for your thoughtful questions and continued engagement throughout today’s discussion. We appreciate your interest and continued support as Theralase makes advances on its clinical, financial and strategic objectives. As we move through this pivotal phase of our development, the progress that we have achieved to date reflects a strong momentum achieved across our organization. This is reflected by the strengthening of our capital position, reaching key milestones in our pivotal bladder cancer clinical study and in clinical development of our new oncological conditions, which will ultimately lead to increased shareholder value. With an expanding pipeline that now spans additional nine indications, the potential for a US listing and concurrent US institutional financing, Theralase is well positioned to become the next up and coming pharmaceutical company.
The steps we’ve taken over the past quarter and those that we are focused on in the quarters ahead continue to differentiate Theralase within the biotech and pharmaceutical landscape. Thank you again for your time today. A replay of this call will be available in due course on our website. We invite you to stay connected with us as we host our annual general and special meeting this Wednesday, June 11. Have a great day.
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