Latest news with #pharmaceutical
Indian Express
12 hours ago
- Health
- Indian Express
Sumedha Pathak beats out ‘inspiration' Rubina Francis for Para World Cup shooting gold
Moments after 28-year-old Sumedha Pathak won her first WSPS World Cup individual gold in the women's P2 10m air pistol SH1 final in Changwon, Korea, she was hugged by Paris Paralympics bronze medallist and compatriot Rubina Francis, who finished seventh in the same category. For Sumedha, who edged out another Indian, Shrishti Arora, to win the gold with a score of 235.2, and many of her peers, Francis is an inspiration. 'Rubina mam has always been an inspiration for me and other shooters and whenever we compete at the shooting range, we see each other as inspiration as well motivating,' Sumedha told The Indian Express from Changwon, Korea. Daughter of pharmaceutical entrepreneur Brijesh Chandra Pathak, a young Sumedha would always be keen in her studies as well as listening about her father's social work in their hometown of Varanasi. In 2013, after complaining of fever and body pains, she was diagnosed with Multidrug-Resistant Tuberculosis resulting in spinal paralysis. The Pathak family would then spend months in hospitals in Delhi as well Kolkata before the youngster recovered, with her body movement below her chest being completely nil. 'After spending more than a year in recovery at different hospitals, when we returned home, the first thing I told Sumedha was to have belief that we will excel in whatever way we can. We live in a joint family and the entire family ensured that Sumedha always remained focussed on her goals whether it be studies or whatever field she chose,' says father Brijesh Chandra Pathak. Sumedha would top the CBSE 12th exam in commerce stream in specially abled division in India with 91.04 percent in 2016. It was in 2018 that her father, along with consultation with international shooters Asif and Ajit Singh Suryavanshi and coach Santosh Tiwari, got a makeshift shooting range built at their home. While Sumedha would start with pistol shooting, the coaches would face the problem of setting the right posture for the youngster. 'Sumedha's body movement is very restricted and hence we could not make her start in rifle shooting. Initially, when she started pistol shooting, her upper body would fall ahead. So we would start with the dry shooting part, working to increase her upper body and shoulder strength. Once we could achieve the right posture and balance on a wheelchair, we increased shots to 40-60 shots daily and she would train for 2-3 hours,' remembers coach Santosh Tiwari. Father Brijesh too talks about the initial struggles. 'While we had built the shooting range at the parking space of our home, Sumedha used to spend a lot of time for physiotherapy sessions too. During 2020-2021, early Covid-19 times, we got a new range built inside our home. We are lucky that the whole shooting community of Varanasi and UP would support her. (When the new) shooting range (came up) in Varanasi in 2024, it meant that the likes of Sumedha could dream of training at a world class facility one day in Varanasi,' says Pathak. In 2022, Sumedha made the Indian Para shooting team and was part of the Indian pistol team which won the silver medal in the WSPS World Cup in France and Korea respectively. In 2023, Sumedha finished seventh in women's P2 10m air pistol SH1 in the Hangzhou Asian Para Games. 'In shooters like Sumedha, the main challenge for coaches is to strike a balance between the upper body strength suited for their shooting style. While the technique can be tweaked based on the posture, the upper body strength has to be the strongest and she has been able to work on that,' says national para pistol coach Subash Rana. In Khelo India Para Games in March this year, Sumedha had scored a score of 237.5 to win the gold. On Monday, she qualified at the second spot with a score of 565 behind Francis, who shot 566. In the final, Sumedha was placed third after the second series before she made her way to the gold medal elimination round followed by her winning the gold with a score of 235.2. 'The Khelo India gold made Sumedha believe that she can win big in finals too and to edge out Rubina then also helped her confidence. While she has won team medals before, this Individual gold is a new beginning for her,' says Jaiprakash Nautiyal, chief coach Indian Para Shooting team. Nitin Sharma is an Assistant Editor with the sports team of The Indian Express. Based out of Chandigarh, Nitin works with the print sports desk while also breaking news stories for the online sports team. A Ramnath Goenka Excellence in Journalism Award recipient for the year 2017 for his story 'Harmans of Moga', Nitin has also been a two-time recipient of the UNFPA-supported Laadli Media Awards for Gender Sensitivity for the years 2022 and 2023 respectively. Nitin mainly covers Olympics sports disciplines with his main interests in shooting, boxing, wrestling, athletics and much more. The last 17 years with The Indian Express has seen him unearthing stories across India from as far as Andaman and Nicobar to the North East. Nitin also covers cricket apart from women's cricket with a keen interest. Nitin has covered events like the 2010 Commonwealth Games, the 2011 ODI World Cup, 2016 T20 World Cup and the 2017 AIBA World Youth Boxing Championships. An alumnus of School of Communication Studies, Panjab University, from where he completed his Masters in Mass Communications degree, Nitin has been an avid quizzer too. A Guru Nanak Dev University Colour holder, Nitin's interest in quizzing began in the town of Talwara Township, a small town near the Punjab-Himachal Pradesh border. When not reporting, Nitin's interests lie in discovering new treks in the mountains or spending time near the river Beas at his hometown. ... Read More
Yahoo
18 hours ago
- Business
- Yahoo
Leading Independent Proxy Advisor ISS Recommends that Shareholders Vote the GREEN proxy FOR ALL MediPharm Director Nominees; REJECTS Apollo's Arguments and Director Slate
ISS concludes that Apollo 'has not presented a compelling case for change' TORONTO, June 02, 2025 (GLOBE NEWSWIRE) -- MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) ('MediPharm' or the 'Company'), a pharmaceutical company specialized in precision-based cannabinoids, today announced that Institutional Shareholder Services ('ISS') published a report on May 30, 2025 (the 'ISS Report') recommending that MediPharm shareholders vote the GREEN Proxy or voting instruction form FOR the Company's nominees for the Board of Directors (the 'Board') at the upcoming Annual and Special Meeting of Shareholders on June 16, 2025 (the 'Meeting'). ISS is a leading independent proxy voting and corporate governance advisory firm whose recommendations are trusted by pension funds, investment managers, mutual funds, and other institutional shareholders. The ISS Report concludes: 'As the dissident has not presented a compelling case for change, shareholders are recommended to vote FOR all management nominees.' The ISS Report further recommended that MediPharm shareholders DO NOT VOTE on the gold dissident proxy card as Apollo did not provide a compelling case for change. Chris Taves, Chair of MediPharm, commented, 'We are very pleased that an independent proxy advisory firm has taken the time to meet with both parties to hear our respective arguments, and has recommended voting in favour of management's director nominees. Shareholders have been subjected to a large volume of information from both the Company and the dissident in recent weeks, and we believe the ISS Report reinforces our consistent position that Apollo has been flooding the market with misinformation and unsupportable statements. It is also encouraging that ISS has recognized the turnaround of our business that has been facilitated under the leadership of CEO David Pidduck. The Board truly believes that there is momentum in our business and that once we can overcome the costly distraction of this proxy contest, we can return our complete focus to strategic growth opportunities.' Key Conclusions in the ISS Report In explaining the reasons for its recommendation, the ISS Report reviews each of Apollo's major claims and concludes that there is insufficient evidence to support any of them. Statements in the ISS Report that refute Apollo's claims include the following: 'Since Q2 2022, quarterly revenues have more than doubled, adjusted EBITDA has swung from a $6.3 million loss to a $0.1 million gain, gross margins have expanded 50.9 percentage points over Q2 2022, and the company's SG&A has remained fairly stable. Against this backdrop, it is challenging to validate the dissident's claims that the company's costs have 'ballooned' or that revenue is 'imploding'. In particular, it also seems incorrect to suggest the company has experienced poor post-acquisition integration over a period where revenues and gross margins have risen dramatically while SG&A expenses have remained relatively flat.' 'LABS has experienced multiple years of improving financial results, which overlap with Pidduck's tenure as CEO as well as a series of acquisitions and non-core asset divestitures. Management has communicated a logical strategy that focuses on higher margin, international markets where the company can leverage a competitive advantage. Moreover, there does not appear to be sufficient evidence that the company is in imminent danger of running out of cash.' '… the company has generally outperformed peers and experienced a clear operational turnaround. Meanwhile, the dissident's assertions about the company's peril are not able to be sufficiently validated with available information. As such, the dissident has not presented a case for board change.' '… a review of [Total Shareholder Return] over [Pidduck's] tenure shows that the company has outperformed its peer group and [the Global X Marijuana Life Sciences Index ETF HMMJ] … There is limited utility focusing on absolute performance as the entire sector has suffered tremendous losses. In this context, it can be recognized that since 2022, LABS has managed to reverse course and separate itself positively from most peers.' 'Based on the company's improving financial performance since the VIVO acquisition and the manner in which redundant assets are being monetized to improve balance sheet strength, it is difficult to conclude that the company has engaged in reckless M&A.' 'The dissident has presented serious claims about concerns with the board's management oversight capabilities and executive compensation practices. At this time, there does not appear to be a conclusive deficiency in corporate governance and the company has provided valid explanations for its compensation practices.' The ISS Report summarizes the high standard required of any dissident seeking to replace an entire board of directors: 'When analyzing proxy contests, ISS focuses on two central questions: Has the dissident made a compelling case that change is warranted? If so, are the dissident nominees more likely to effect that change than the incumbent directors?' 'When the dissident is seeking board control, ISS looks for a well-reasoned and detailed business plan (including the dissident's strategic initiatives), a transition plan that describes how the change in control of the company will be effected, and where management continuity may be an issue, the identification of a qualified and credible new management team.' The ISS Report then reaches a clear conclusion on its recommendation for the election of directors: 'As there is no case for change at this time, shareholders are recommended to vote FOR all management nominees.' The ISS Report further recommends that shareholders vote for the resolution to fix the number of directors at seven, and vote for the resolution to approve MNP LLP as auditors and authorize the Board to fix their remuneration. The ISS Report also recommends that shareholders vote against the resolution to approve all unallocated awards under the Company's equity incentive plan. The independent Compensation Committee of the Board will continue to regularly review the Company's compensation policies. Vote for the Highly Qualified MediPharm Nominees MediPharm urges shareholders to vote only using the GREEN proxy or GREEN voting instruction form in support of all of the Company's nominees and resolutions. To ensure your vote is counted, shareholders are encouraged to proactively contact their broker to obtain their 16-digit control number associated with the GREEN management proxy. Once received, you can cast your vote by visiting . You may receive materials or outreach from the dissident — please disregard any such communications and vote only using the GREEN proxy in support of the Company's nominees. About MediPharm Labs Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities for delivery of pure, trusted and precision-dosed cannabis products for its customers. MediPharm Labs develops, formulates, processes, packages and distributes cannabis and advanced cannabinoid-based products to domestic and international medical markets. In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment License from Health Canada, becoming the only company in North America to hold a commercial-scale domestic Good Manufacturing Practices License for the extraction of multiple natural cannabinoids. This GMP license was the first step in the Company's current foreign drug manufacturing site registration with the US FDA. In 2023, MediPharm acquired VIVO Cannabis Inc., which expanded MediPharm's reach to medical patients in Canada via Canna Farms medical ecommerce platform, and in Australia and Germany through Beacon Medical Australia PTY Ltd. and Beacon Medical Germany GMBH. This acquisition also included Harvest Medical Clinics in Canada which provides medical cannabis patients with Physician consultations for medical cannabis education and prescriptions. The Company carries out its operations in compliance with all applicable laws in the countries in which it operates. Shareholder Voting Assistance: If you have any questions or require any assistance in executing your GREEN proxy or voting instruction form, please call Sodali & Co at: North American Toll-Free Number: 1.888.777.2059Outside North America, Banks, Brokers and Collect Calls: 1.289.695.3075Email: assistance@ American Toll-Free Facsimile: 1.877.218.5372 For up-to-date information and assistance in voting please visit: Investor Contact: MediPharm Labs Investor RelationsTelephone: +1 416.913.7425Email: investors@ Media Contact: John VincicOakstrom Advisors+1 (647) 402-6375john@ Cautionary Note Regarding Forward-Looking Information: This news release contains 'forward-looking information' and 'forward-looking statements' (collectively, 'forward-looking statements') within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as 'expects', or 'does not expect', 'is expected', 'anticipates' or 'does not anticipate', 'plans', 'budget', 'scheduled', 'forecasts', 'estimates', 'believes' or 'intends' or variations of such words and phrases or stating that certain actions, events or results 'may' or 'could', 'would', 'might' or 'will' be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things: timing of the Annual and Special Meeting, any potential momentum in the Company's business, the ability of the Company to capitalize on strategic growth opportunities, and any outcomes resulting from the circumstances and information cited herein. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm Labs' continuous disclosure filings, available on the SEDAR+ website at There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.
Wall Street Journal
a day ago
- Business
- Wall Street Journal
Novartis's Cancer Treatment Pluvicto Shows Positive Results in Trial
Novartis said Pluvicto demonstrated positive results in patients with PSMA-positive metastatic hormone-sensitive prostate cancer. The Swiss pharmaceutical company on Monday said Pluvicto showed statistically significant and clinically meaningful benefits—including combined with hormone therapy versus hormone therapy alone—with positive trend in overall survival.
Yahoo
3 days ago
- Business
- Yahoo
Pharma packaging meets tough regulations
In the highly regulated pharmaceutical industry, packaging plays a crucial role in ensuring the safety, efficacy, and compliance of medications. It is not just about containing the drug; it serves as a barrier between the product and external factors, such as contaminants, moisture, light, and air. But packaging in the pharmaceutical sector is far more than a protective covering—it must adhere to a stringent set of regulations that vary across countries. These regulations are designed to protect consumers, maintain product integrity, and prevent fraud. As the pharmaceutical sector grows, so too do the complexities surrounding its packaging requirements. Understanding the importance of pharma packaging is vital for manufacturers, suppliers, and consumers alike. For decades, packaging design, materials, and labelling have had to evolve to keep pace with increasing regulatory demands, new drug innovations, and changing consumer expectations. In this article, we'll explore the key regulations governing pharmaceutical packaging and examine how manufacturers are adapting to meet these tough standards. Pharmaceutical packaging is one of the most regulated areas in the entire manufacturing industry. The regulations that govern packaging are designed to ensure that products are safe for use and remain unaltered until they reach the consumer. These regulations focus on various aspects of packaging, including materials, labelling, and traceability. Most importantly, they protect against the risk of counterfeit drugs, a growing concern globally. In the European Union (EU), the regulations for pharmaceutical packaging are primarily governed by the EU's Good Manufacturing Practice (GMP) guidelines. These guidelines cover the entire lifecycle of a drug, from manufacturing to packaging, and require manufacturers to use packaging that maintains the drug's stability, safety, and efficacy. One of the most stringent regulations involves child-resistant packaging. This is required for products that could pose a poisoning risk, such as medicines containing high doses of analgesics, paracetamol, or opioids. In the United States, the Food and Drug Administration (FDA) plays a central role in overseeing pharmaceutical packaging regulations. The FDA enforces regulations concerning the packaging materials used in pharmaceuticals, ensuring that packaging does not interfere with the drug's quality. Similarly, the FDA's Drug Approval Process includes extensive testing for packaging to ensure that it meets requirements for tamper-evidence, labelling accuracy, and stability. Countries outside the EU and the US also have their own regulatory frameworks. Japan, for example, mandates that drug packaging must feature detailed instructions and warnings in both Japanese and English. Packaging regulations in China focus on the durability of materials, while India's packaging requirements include anti-counterfeit measures like holographic seals and track-and-trace systems. Navigating the complexity of these varying standards presents a challenge for global pharmaceutical companies. With the rise in global drug counterfeiting, pharmaceutical packaging has evolved to include several security features designed to protect consumers and ensure product authenticity. Packaging plays an instrumental role in preventing tampering, ensuring that medications reach consumers in their original, unaltered state. Tamper-evident features are a critical component of pharmaceutical packaging. These features make it apparent if a product has been opened or altered in any way. Common tamper-evident mechanisms include seals, shrink bands, breakable caps, and special adhesive labels. For instance, a bottle with a tamper-evident seal will show visible signs of damage if someone tries to open it. These features are essential to preventing fraud, which can lead to serious public health risks, including the distribution of counterfeit or substandard drugs. Beyond tamper evidence, the growing concern over counterfeiting has led to the incorporation of high-tech security features such as holograms, QR codes, and RFID (Radio Frequency Identification) tags. These innovations not only serve as a deterrent to counterfeiters but also allow for the traceability of medications from manufacturing to the point of sale. The track-and-trace system, mandated in some regions, enables regulators and pharmaceutical companies to trace a drug's path along the supply chain, ensuring that the product is authentic and has been stored and handled appropriately. As the pharmaceutical industry continues to face growing pressure to reduce its environmental impact, packaging is one area where significant improvements are being made. Pharmaceutical companies are increasingly exploring ways to reduce waste, lower carbon footprints, and use more sustainable materials while maintaining compliance with regulatory requirements. One of the primary concerns regarding the environmental impact of pharmaceutical packaging is the excessive use of plastic. Packaging waste, particularly from single-use plastic bottles and blister packs, contributes to environmental pollution. In response, many companies are now adopting eco-friendly alternatives, such as recyclable or biodegradable packaging materials. Some companies have even moved towards using plant-based plastics, which reduce reliance on fossil fuels and contribute less to pollution. In addition to choosing sustainable materials, manufacturers are focusing on improving packaging designs to minimise waste. For instance, reducing the size of packaging or opting for more compact designs helps to lower material consumption and the energy needed for production and transport. The growing use of minimalist packaging also aligns with broader sustainability trends and consumer demand for greener products. Regulations governing the environmental impact of packaging are already in place in many regions. The EU, for example, has introduced the Waste Framework Directive, which aims to reduce packaging waste and encourage the use of recycled materials. The directive is part of a broader effort to transition towards a circular economy, where resources are reused and recycled rather than disposed of. Pharmaceutical companies must navigate these regulations while ensuring that their packaging continues to meet safety and compliance standards. Pharmaceutical packaging is a critical part of ensuring the safety, effectiveness, and compliance of medications. From tamper-evident features to sustainable packaging solutions, pharmaceutical companies must adhere to an array of regulations that vary by region and product. These regulations are designed not only to protect consumers but also to ensure that drugs maintain their integrity from the manufacturer to the patient. As the global demand for medicines continues to grow, the pharmaceutical industry will face new challenges in packaging. However, with innovations in materials, security features, and sustainability, the industry is likely to evolve in ways that continue to prioritise both consumer safety and environmental responsibility. With regulatory bodies remaining vigilant and the rise of technology offering new solutions, pharmaceutical packaging will undoubtedly continue to meet tough regulations for years to come. "Pharma packaging meets tough regulations" was originally created and published by Packaging Gateway, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
4 days ago
- Business
- Globe and Mail
Theralase(R) 1Q2025 Financial Statements
Toronto, Ontario--(Newsfile Corp. - May 30, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) (" Theralase®" or the " Company"), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses has released the Company's unaudited interim consolidated 1Q2025 financial statements (" Financial Statements"). Theralase® will be hosting a conference call on Monday June 9 th, 2025 at 11:00 am ET, which will include a presentation of the financial and operational results for the fiscal quarter ending March 31 st, 2025. Questions are welcome; however, to ensure we have time to review and properly address them during the call, please send them in advance to mperraton@ An archived version will be available on the website following the conference call. 1 Other represents foreign exchange, interest accretion on lease liabilities and / or interest income To view an enhanced version of this graphic, please visit: Financial Highlights For the three-month period ended March 31, 2025: Total revenue was $91,190, compared to $175,554 in Q1 2024, a 48% year-over-year decrease. Cost of sales was $77,896 (85% of revenue), resulting in a gross margin of $13,294 (15% of revenue), down from $62,114 (35% of revenue) in Q1 2024. Selling expenses were $68,143, essentially flat compared to $67,552 in the prior year. Administrative expenses rose to $555,074 from $511,495, a 9% increase driven primarily by professional fees and stock-based compensation. Research and development expenses were $877,670, up from $756,380, reflecting increased activity to support Study II progress. Net loss for the period was $1,471,250, compared to $1,266,711 in Q1 2024. This includes $220,538 in non-cash charges such as amortization and stock-based compensation. Operational Highlights Private Placements On March 10, 2025, the Company closed a non-brokered private placement of 1,034,002 units at $0.30 per unit for gross proceeds of $310,201. Each unit consisted of one common share and one non-transferable common share purchase warrant exercisable at $0.45 for five years. Net proceeds were $304,633, after transaction costs. On April 22, 2025, the Company completed another non-brokered private placement, issuing 1,995,829 units at $0.21 per unit for gross proceeds of $419,124. Each unit included one common share and one non-transferable common share purchase warrant exercisable at $0.32 for five years. The Company has raised approximately $CAN 6.3 million over the last 2 years through non-brokered private placements in support of its research and development programs. It is currently investigating the use of a full-service investment bank in the United States to advise on potential financings and US listing opportunities. Information on any future financings will be released once available in accordance with applicable securities laws. Herpes Simplex Virus ("HSV") Treatment Program Theralase® continues preclinical development of its HSV treatment using non-light activated and light-activated small molecules. The Company is actively working on in-vitro, and in the near future, in-vivo HSV preclinical models to finalize a formulation for optimal dermal penetration to increase patient safety and efficacy. Good Laboratory Practice (" GLP") toxicology studies will commence once a formulation has been finalized. Additional details will be announced as strategic objectives are achieved. Phase II Bladder Cancer Study Update ("Study II") 82 patients have been treated with the Study Procedure, representing approximately 91% of the total targeted enrollment of 90 evaluable patients. 69 patients have completed their 90-day assessment and are considered evaluable for interim efficacy analysis. 13 additional patients are pending their 90-day assessment and will be included in future efficacy updates once evaluations are complete. Interim Clinical Results For the primary endpoint of Study II (Complete Response (" CR") at any point in time) 62% of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a CR. Including patients, who demonstrated an Indeterminate Response (" IR") (negative cystoscopy and positive or suspicious urine cytology), the Total Response ("TR") increases to 70%. This represents that approximately 2 out of 3 BCG-Unresponsive NMIBC CIS patients treated with Theralase®'s unique Study Procedure are demonstrating complete destruction of their bladder cancer. For the secondary endpoint of Study II (duration of CR) 42% of treated patients who achieved a CR, maintained their CR response for at least 12 months (450 days from date of Study Procedure). For the tertiary endpoint of Study II (safety of Study Procedure) 100% (69/69) experienced no Serious Adverse Events (" SAEs") directly related to the Study Drug or Study Device. Outside of the defined endpoints of Study II, Theralase® has demonstrated a duration of CR at extended time points of 23% at 2 years, 21% at 3 years and 2% at 7 years. Note: Not all patients have been assessed at these extended time points. As more clinical data is collected, the duration of CR at 2, 3 and 7 years may increase. Theralase® is on track to complete enrollment in Study II by the summer of 2025. This will allow the Company to report on 75 patients who have completed Study II in December 2025 and to report on all 90 patients by September 2026. Upon follow-up of all patients, the Company plans to submit a New Drug Application ("NDA") to Health Canada and the FDA in 4Q2026, with a decision expected by the respective regulatory authorities on a marketing approval in 2027. As Theralase® completes enrollment in Study II, it is actively searching for commercialization partners for international marketing and sales of Ruvidar®. To this end, Theralase® is in various stages of initial and advanced discussions with international pharmaceutical companies for various geographical territories concerning: Licensing of the light-activated Ruvidar® for BCG-Unresponsive NMIBC CIS Collaborative research focused on investigating light-activated Ruvidar® in the treatment of NMIBC Collaborative research focused on combining Ruvidar® with other FDA approved drugs In recent discussions with the FDA, the Company has decided that since Study II is 91% complete, the best course of action is not to pursue Break Through Designation, but to complete Study II and submit the clinical data to the FDA in a formal NDA. At the end of the meeting, the FDA made a comment that they were impressed that the interim clinical data obtained to date was able to be achieved with only one clinical treatment, in the majority of cases. Ruvidar® has demonstrated 10 years of shelf life, strongly supporting the stability of the molecule and the ability of clinics to store the small molecule for extended periods of time. Additional Oncology Targets Theralase® has combined Ruvidar® with transferrin (human glycoprotein) to form Rutherrin®. Rutherrin® is a strong candidate for the systemic treatment of recurrent, deep seated and/or progressive cancers. Due to the limitations of using laser light to activate Rutherrin® in deep oncological targets, Theralase® plans to activate Rutherrin® with radiation therapy to increase the "tumour's damage zone" and the effectiveness of Theralase®'s small molecule beyond the reach of light in the body. Rutherrin®, if clinically proven, will be able to "hunt" and "localize" into cancer cells and when activated by radiation "destroy" them; wherever, they may reside in the body. The Company expects to complete Good Laboratory Practice toxicology analysis in 4Q2025 to allow commencement of a Phase 0/I/II adaptive clinical study in 1Q2026 for the following indications: 1) Glio Blastoma Multiforme (" GBM") Brain Cancer Treatment 2) Non-Small Cell Lung Cancer (" NSCLC") Treatment 3) Pancreatic Cancer 4) Colorectal Cancer 5) Muscle Invasive Bladder Cancer (" MIBC") Treatment 6) Herpes Simplex Virus (" HSV-1") Topical Treatment for Cold Sore Lesions For additional information, please refer to the Company's Management's Discussion and Analysis ("MD&A") available at About Ruvidar®: Ruvidar®(TLD-1433) is a small molecule, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses. About Theralase® Technologies Inc.: Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecule compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses. Additional information is available at and Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Statements: This news release contains Forward-Looking Statements (" FLS") within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words " may, " should", " will", " anticipates", " believes", " plans", " expects", " estimate", " potential for" and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals. These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure the regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; the risk that access to sufficient capital to fund the Company's operations may not be available on terms that are commercially favorable to the Company or at all; the risk that the Company's small molecule and drug formulations may not be effective against the diseases tested in its clinical studies; the risk that the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict. Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS. Although the FLS contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these FLS. All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS. For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies.
