CNSP

Company reports approximately $20.0 million cash position and extended operating runway following oversubscribed $22.5 million financing, as it advances its pivot toward a diversified, high-value pipeline HOUSTON, TX / ACCESS Newswire / August 12, 2026 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company focused on building a pipeline of innovative therapies addressing significant unmet medical needs, today reported financial results for the second quarter ended June 30, 2026 and provided an update on the corporate strategy the company introduced in March 2026. "We are moving with speed and discipline to transform this company," said Rami Levin, President and Chief Executive Officer of CNS Pharmaceuticals. "In the second quarter, we significantly strengthened our balance sheet and added new expertise to our Board to enable us to build a differentiated, high-value pipeline of innovative therapies. We are executing with urgency and are confident that the actions we've taken this year strengthen CNS Pharmaceuticals ability to create meaningful value going forward." Strategic and Corporate Highlights New corporate strategy in motion. Since announcing its strategic pivot in March 2026 beyond a singular focus on glioblastoma multiforme, the Company has been leveraging its executive team's multi-functional experience across high-value therapeutic areas. As previously stated, the Company expects to in-license or acquire one or more assets by year end 2026. Oversubscribed $22.5 million financing closed. On May 5, 2026, the Company closed a private placement with institutional investors, including ADAR1 Capital, Ikarian Capital, Stonepine Capital Management and Nazare Partners, generating approximately $22.5 million in gross proceeds ($20.7 million net), significantly reinforcing the Company's capital and shareholder base in support of its new strategy. Board strengthened with dealmaking depth. The Company appointed Michal Fisher, a life sciences executive with a track record in business development, licensing and capital formation, including prior leadership roles in strategic alliances and corporate development to its Board of Directors in May 2026. Legacy programs advancing toward closure. The Company's global clinical trial of Berubicin for glioblastoma is complete. The Company is now focused on closing out the study while pursuing out-licensing discussions for both Berubicin and TPI 287. Since announcing its new corporate strategy in March 2026, the Company has focused on leveraging the experience of its leadership team to identify promising development-stage therapeutic assets that align with its strategy of building a diversified pipeline targeting serious diseases. Management is actively evaluating business development opportunities while maintaining financial discipline and preserving capital for future growth initiatives. "This quarter reflects the deliberate work of resetting CNS Pharmaceuticals for its next chapter," said Steve O'Loughlin, Chief Financial Officer. "With a fortified balance sheet, extended capital runway, and new shareholder base comprised of biotech focused institutional investors, we are well positioned to execute our strategy with an enhanced ability to transact." Second Quarter 2026 Financial Results Cash and cash equivalents were approximately $20.0 million as of June 30, 2026, compared to $7.2 million as of December 31, 2025. The increase primarily reflects the Company's previously announced private placement financing completed in May 2026. The Company believes its existing cash resources are sufficient to fund planned operations beyond the next twelve months as it continues executing its strategic business development initiatives. Research and development expenses were approximately $1.2 million for the second quarter of 2026, compared to $1.2 million for the same period in 2025. Research and development expenses included activities related to completing and closing out the Berubicin clinical trial, as enrollment and patient treatment have been completed. Future research and development expenses will depend on the timing and nature of any assets the Company acquires or licenses and the associated development activities. General and administrative expenses were approximately $1.5 million for the second quarter of 2026, compared to $1.2 million for the same period in 2025. The increase was primarily attributable to higher headcount-related expenses, partially offset by lower professional services costs. Net loss for the second quarter of 2026 was approximately $2.6 million, or $0.37 per basic and diluted share, compared to a net loss of approximately $2.4 million, or $6.42 per basic and diluted share, for the second quarter of 2025. As of August 14, 2025, the Company had 1,461,449 common shares of stock outstanding and 10,604,928 shares fully diluted including pre-funded warrants that were issued in its May 2026 financing. About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is a biotechnology company focused on developing innovative therapies for serious diseases. With an experienced executive team and a focus on high-value therapeutic opportunities, the Company is working to build a differentiated portfolio of assets addressing significant unmet medical needs. CNS is committed to advancing novel treatments that have the potential to improve patient outcomes while creating long-term value for patients and shareholders. For more information, please visit www.CNSPharma.com, and connect with the Company on X and LinkedIn. Forward-Looking Statements Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this release include, without limitation, statements regarding the Company's strategic transformation and pipeline development plans, the anticipated use of proceeds from the Company's recent $22.5 million financing, the Company's ability to identify and advance new therapeutic assets, expectations regarding the Company's ability to create long-term shareholder value, and key milestones related to the execution of the Company's strategy. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions and those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the SEC and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law. CONTACTS: Investor Relations ContactJTC Team, LLCJenene [email protected] Business Development ContactCNS Pharmaceuticals, Inc.Dylan Wenke, Chief Business [email protected] SOURCE: CNS Pharmaceuticals, Inc. View the original press release on ACCESS Newswire

Oversubscribed $22.5 million financing anticipated to enable CNS Pharmaceuticals to acquire differentiated, clinical-stage assets with identifiable near-term value-inflection catalysts, aligned with its recently announced corporate strategy Company actively evaluating multiple acquisition opportunities while advancing discussions to out-license its legacy glioblastoma multiforme programs, Berubicin and TPI-287 New executive leadership team assembled in the first quarter continues to demonstrate rapid execution against strategy HOUSTON, TX / ACCESS Newswire / May 14, 2026 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company focused on building a pipeline of innovative therapies addressing significant unmet medical needs, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update highlighting the Company's ongoing strategic transformation and execution progress. The first quarter of 2026 marked the beginning of a significant strategic shift for CNS Pharmaceuticals, including the appointment of a new Chief Executive Officer and executive leadership team, the launch of a new corporate strategy, the repositioning of the Company toward an acquisition-driven growth strategy focused on differentiated clinical-stage assets in neurology and oncology and the decision to seek out-licensing opportunities for its legacy glioblastoma multiforme programs, Berubicin and TPI-287. Subsequent to quarter end, CNS Pharmaceuticals completed a $22.5 million private placement with participation from several leading institutional healthcare investors. The proceeds from the private placement, together with existing cash, are intended to enable CNS Pharmaceuticals to identify, acquire, and advance differentiated assets with clear development and regulatory pathways that have clear inflection catalysts and the potential for near-term value creation. "We believe CNS Pharmaceuticals has entered a transformational new phase defined by strategic clarity, financial strength and disciplined execution," said Rami Levin, President and Chief Executive Officer of CNS Pharmaceuticals. "Over the past several months, we have rebuilt the foundation of the Company by assemblinga highly experienced executive team, completed a rigorous strategic review, strengthened our balance sheet through an oversubscribed financing, initiated an aggressive search for differentiated clinical-stage assets capable of generating meaningful near-term catalysts and long-term shareholder value, and advanced discussions to out-license our legacy glioblastoma multiforme programs, Berubicin and TPI-287." Mr. Levin continued, "The current biotechnology environment continues to create compelling acquisition opportunities, particularly for companies with capital, operational experience and strategic focus. We believe CNS Pharmaceuticals is now positioned to capitalize on this environment as we rapidly work to build and diversify our pipeline with high-value programs that have clear development pathways and the potential to drive substantial value creation." Summary of Financial Results for the First Quarter 2026 General and administrative expense was approximately $1,431,000 for the three months ended March 31, 2026 compared to approximately $1,095,000 for the comparable period in 2025. The increase in general and administrative expense was primarily attributable to increased professional expenses related to the Company's strategic review that was conducted in collaboration with a leading life science focused advisory firm and placement services related to the Company's new executive leadership team. Research and development expense was approximately $3,544,000 for the three months ended March 31, 2026 compared to approximately $3,243,000 for the comparable period in 2025. The change in research and development expense during the period is primarily attributable to an increase in placement services and headcount expense. The net loss for the three months ended March 31, 2026 was approximately $4,936,000 compared to approximately $4,301,000 for the comparable period in 2025. The change in net loss is primarily attributable to increased research and development costs and an increase in professional expenses. Cash and cash equivalents were $2,951,000 as of March 31, 2026. The cash balance on March 31, 2026 does not account for the gross proceeds from the $22.5 million private placement closed on May 5, 2026. The Company expects these proceeds, together with existing cash resources, to fund operations beyond twelve months. About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is a biotechnology company focused on developing innovative therapies for serious diseases. With an experienced executive team and a focus on high-value therapeutic opportunities, the Company is working to build a differentiated portfolio of assets addressing significant unmet medical needs. CNS is committed to advancing novel treatments that have the potential to improve patient outcomes while creating long-term value for patients and shareholders. For more information, please visit www.CNSPharma.com, and connect with the Company on X and LinkedIn. Forward-Looking Statements Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this release include, without limitation, statements regarding the expected gross proceeds and closing of the private placement, the Company's intended use of proceeds from the private placement together with existing cash, the Company's pipeline prioritization and strategic development, the anticipated contributions of the new management team to the Company's growth, expectations regarding clinical development and regulatory strategy, the Company's ability to deliver meaningful value to patients and shareholders, and the Company's plans to explore out-licensing or strategic sales of legacy assets. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions and those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the SEC and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law. CONTACTS: Investor Relations Contact JTC Team, LLC Jenene Thomas 908.824.0775 [email protected] Business Development Contact CNS Pharmaceuticals, Inc. Dylan Wenke, Chief Business Officer [email protected] SOURCE: CNS Pharmaceuticals, Inc. View the original press release on ACCESS Newswire

Cash expected to fund operations into the second half of 2026 Company focused on advancing next-generation anti-cancer therapies derived from well-established drug classes, now engineered to cross the blood-brain barrier, potentially enhancing efficacy for patients Lead program, TPI 287, progressing toward Phase 2 study for treatment of glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer, with a median survival of only around 15 months from the time of diagnosis HOUSTON, TX / ACCESS Newswire / November 17, 2025 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today reported its financial results for the third quarter ended September 30, 2025 and provided a corporate update. "As we head into the final quarter of the year, our mission remains centered on delivering meaningful developments for patients battling brain and CNS cancers. We continue to build momentum with our lead product candidate TPI 287 and work towards important, catalytic milestones. With Phase 1 data indicating potential blood-brain barrier penetration and tumor responses, we are aggressively advancing towards our Phase 2 study in GBM. We believe TPI 287 has the potential to be a meaningful new option for patients with brain tumors. Leveraging our established clinical data and team of experts, we are positioned to drive this program forward while creating value for our stakeholders. In the months ahead, we aim to concentrate on initiating the next chapter of TPI 287's development and delivering on our commitment to execute with urgency and precision," commented John Climaco, CEO of CNS Pharmaceuticals. TPI 287: Late Stage, Novel Blood Brain Barrier Permeable Abeotaxane for Treatment of Brain Malignancies TPI 287 is an abeotaxane and has the same mechanism of action as other taxanes, e.g. paclitaxel (Taxolﾮ) and docetaxel, in which it stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. While most taxanes are substrates for multi-drug resistant transporters, which maintain the blood brain barrier (BBB), TPI 287's clinical data suggests it has the potential to cross the BBB and treat CNS tumors. In a Phase 1 trial treating glioblastoma patients with TPI 287 in combination with bevacizumab (Avastinﾮ), the efficacy data included 3 Complete Responses and 9 Partial Responses out of 23 evaluable patients. These results are from an early-stage trial and may not be indicative of results in larger, controlled studies. CNS Pharmaceuticals plans to engage the FDA and obtain feedback on the design of a study potentially focused on the registration of TPI 287 in recurrent GBM in early 2026. Summary of Financial Results for the Third Quarter 2025 The net loss for the three months ended September 30, 2025 was approximately $3.3 million compared to approximately $5.6 million for the comparable period in 2024. The Company reported research and development expenses of $2.2 million for the three months ended September 30, 2025 compared to approximately $4.2 million for the comparable period in 2024. General and administrative expense was approximately $1.1 million for the three months ended September 30, 2025 compared to approximately $1.4 million for the comparable period in 2024. As of September 30, 2025, the Company had cash of approximately $9.9 million. While trial costs are difficult to estimate and the Company does not yet have firm estimates as the trial design for the upcoming trial of TPI 287 is not yet fixed, the Company believes that it has sufficient working capital to fund operations into the second half of 2026. About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's drug candidate TPI 287 is an abeotaxane, which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. The initial clinical efficacy data suggest TPI 287 has the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 also has been tested in over 350 patients in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of a range of diseases or conditions, including recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, advanced unresectable pancreatic cancer, metastatic melanoma, and breast cancer metastatic to the brain. To date TPI 287 appears to have both an excellent safety profile and high tolerability among patients. For more information, please visit www.CNSPharma.com, and connect with the Company on X, Facebook, and LinkedIn. Forward-Looking Statements Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this release include, without limitation, the timing of the start of a trial of TPI 287 and FDA engagement on the clinical trial for TPI 287, statements regarding potential of TPI 287 to treat brain tumors, and statements regarding the Company's cash runway. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions and those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law. CONTACTS: Investor Relations Contact JTC Team, LLC Jenene Thomas 908.824.0775 [email protected] SOURCE: CNS Pharmaceuticals, Inc. View the original press release on ACCESS Newswire

Strong cash position of $12.1 million expected to fund operations into the second half of 2026 Driving lead program, TPI 287, towards Phase 2 study for treatment of glioblastoma multiforme (GBM) HOUSTON, TX / ACCESS Newswire / August 15, 2025 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today reported its financial results for the second quarter ended June 30, 2025 and provided a corporate update. "Every decision we make is grounded in our science and driven by a sense of urgency and responsibility to the patients and families counting on us for better outcomes. We are making excellent progress in our development strategy for TPI 287, working rapidly toward commencing a Phase 2 study for the treatment of GBM in the first half of 2026. Looking ahead, we are continuing to leverage our operational experience and global infrastructure to support TPI 287 while working to get our trial up and running and begin dosing patients with this exciting drug candidate," commented John Climaco, CEO of CNS Pharmaceuticals. TPI 287: Late Stage, Novel Blood Brain Barrier Permeable Abeotaxane for Treatment of Brain Malignancies TPI 287 is an abeotaxane and has the same mechanism of action as other taxanes, e.g. paclitaxel (Taxol®) and docetaxel, in which it stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. While most taxanes are substrates for multi-drug resistant transporters, which maintain the blood brain barrier (BBB), TPI 287's clinical data suggest it has the potential to cross the BBB and treat CNS tumors. In a Phase 1 trial treating glioblastoma patients with TPI 287 in combination with bevacizumab (Avastin®), the efficacy data included 3 Complete Responses and 9 Partial Responses out of 23 patients evaluable. As previously announced, TPI 287 was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of gliomas, pediatric neuroblastoma, and progressive supranuclear palsy. CNS Pharmaceuticals plans to engage the FDA on the design of a study potentially focused on the registration of TPI 287 in recurrent GBM in 2025. Summary of Financial Results for the Second Quarter 2025 The net loss for the three months ended June 30, 2025 was approximately $2.4 million compared to approximately $2.5 million for the comparable period in 2024. The change in net loss is largely attributable to declining trial costs on the Berubicin trial. The Company reported research and development expenses of $1.2 million for the three months ended June 30, 2025 compared to approximately $1.1 million for the comparable period in 2024. The increase in research and development expenses during the period were mainly attributed to declining trial costs on the Berubicin trial offset by expenditures preparing for a TPI 287 trial including drug manufacturing. General and administrative expense was approximately $1.2 million for the three months ended June 30, 2025 compared to approximately $1.4 million for the comparable period in 2024. The decrease in general and administrative expense is attributable to decreases of approximately $36,000 in legal and professional expenses, $19,000 in travel expenses, $195,000 in stock-based compensation, which were offset by increases of approximately $51,000 in compensation expense and $29,000 in insurance expense. As of June 30, 2025, the Company had cash of approximately $12.1 million. The Company believes that the cash on hand as of June 30, 2025 is sufficient to fund planned operations into the second half of 2026. About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's drug candidate TPI 287 is an abeotaxane, which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. The initial clinical efficacy data suggest TPI 287 has the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 also has been tested in over 350 patients in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of a range of diseases or conditions, including recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, advanced unresectable pancreatic cancer, metastatic melanoma, and breast cancer metastatic to the brain. To date TPI 287 appears have both an excellent safety profile and high tolerability among patients. For more information, please visit www.CNSPharma.com, and connect with the Company on X, Facebook, and LinkedIn. Forward-Looking Statements Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this release include, without limitation, the timing of the start of a trial of TPI 287and the Company's cash runway. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions and those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law. CONTACTS: Investor Relations Contact JTC Team, LLC Jenene Thomas 908.824.0775 [email protected] SOURCE: CNS Pharmaceuticals, Inc. View the original press release on ACCESS Newswire

Cash expected to fund operations into the second half of 2026 Advancing development strategy for lead program TPI 287 to commence Phase 2 study around year end 2025 for treatment of glioblastoma multiforme (GBM) HOUSTON, TX / ACCESS Newswire / May 16, 2025 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today reported its financial results for the first quarter ended March 31, 2025 and provided a corporate update. "Our company remains focused as tightly as ever on neuro-oncology drug development. We are off to a very rapid start on our lead program, TPI 287, for the treatment of GBM. With the encouraging published body of data established and anticipation of productive discussions with FDA, we remain confident in our ability to drive this program towards the start of our Phase 2 study around year end 2025. Importantly, we have further solidified our financial security with a cash runway into the second half of 2026 which we believe will fund the Company and our operational execution through much of the next planned study of TPI 287," commented John Climaco, CEO of CNS Pharmaceuticals. TPI 287 Update TPI 287 is an abeotaxane and has the same mechanism of action as other taxanes, e.g. paclitaxel (Taxol®) and docetaxel, in which it stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. While most taxanes are substrates for multi-drug resistant transporters, which maintain the blood brain barrier (BBB), TPI 287's clinical data suggest it has the potential to cross the BBB and treat CNS tumors. In a Phase 1 trial treating glioblastoma patients with TPI 287 in combination with bevacizumab (Avastin®), the efficacy data included 3 Complete Responses and 9 Partial Responses out of 23 patients evaluable. The Company recently announced the successful transfer of the previously granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for TPI 287 from Cortice Biosciences, Inc. The granted Orphan Drug Designations for TPI 287 include use as treatments of gliomas, pediatric neuroblastoma, and progressive supranuclear palsy. CNS Pharmaceuticals plans to engage the FDA and obtain feedback on the design of a study potentially focused on the registration of TPI 287 in recurrent GBM in 2025. Summary of Financial Results for the First Quarter 2025 The net loss for the three months ended March 31, 2025 was approximately $4.3 million compared to approximately $3.5 million for the comparable period in 2024. The change in net loss is largely attributable to the costs of data clean-up, preparation and analysis for the topline primary data release on the Berubicin trial. The Company reported research and development expenses of $3.2 million for the three months ended March 31, 2025 compared to approximately $2.5 million for the comparable period in 2024. The increase in research and development expenses during the period were mainly attributed to the costs of data clean-up, preparation and analysis for the topline primary data release on the Berubicin trial. General and administrative expense was approximately $1.09 million for the three months ended March 31, 2025 compared to approximately $1.11 million for the comparable period in 2024. The decrease in general and administrative expense was mainly attributable to increases of approximately $76,000 in legal and professional expenses, $54,000 in compensation expense, $80,000 in travel expenses, and $13,000 in other expenses, which were offset by decreases of approximately $120,000 in stock-based compensation, $103,000 in marketing, advertising expenses and $19,000 in insurance expense. As of March 31, 2025, the Company had cash of approximately $13.1 million. Subsequent to the end of the quarter, in May 2025, the Company completed a public offering with a single healthcare focused institutional investor for gross proceeds of approximately $5 million, before deducting placement agent fees and other estimated offering expenses. The Company believes that the cash on hand as of March 31, 2025 in addition to the $5 million public offering, is sufficient to fund planned operations into the second half of 2026. About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's drug candidate TPI 287 is an abeotaxane, which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. The initial clinical efficacy data suggest TPI 287 has the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 also has been tested in over 350 patients in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of a range of diseases or conditions, including recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, progressive neoplastic disease, advanced unresectable pancreatic cancer, metastatic melanoma, and breast cancer metastatic to the brain. To date TPI 287 appears have both an excellent safety profile and high tolerability among patients. For more information, please visit www.CNSPharma.com, and connect with the Company on X, Facebook, and LinkedIn. Forward-Looking Statements Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this release include, without limitation, the timing of the start of a trial of TPI 287, the timing of the release of further analysis data on Berubicin's performance and the Company's cash runway. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions and those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law. CONTACTS: Investor Relations Contact JTC Team, LLCJenene [email protected] SOURCE: CNS Pharmaceuticals, Inc. View the original press release on ACCESS Newswire

Company has one year of cash to fund operations Company advancing plans to develop TPI 287, a novel, late stage abeotaxane that is potentially blood brain barrier permeable with published clinical efficacy data in glioblastoma multiforme (GBM) for treatment of brain malignancies HOUSTON, TX / ACCESS Newswire / April 1, 2025 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today reported its financial results for the full year ended December 31, 2024 and outlined recent corporate and clinical development highlights. "Oncology drug development can be complex and challenging, but the GBM patients who live with this devastating condition in the shadow of a significant unmet medical need keep us motivated and determined to succeed. Although our recently announced findings from the primary analysis of our Berubicin study did not meet its primary target, it provided valuable insight and proof in a large dataset that Berubicin is safe, well-tolerated and has activity against GBM, attributes that few compounds have ever shown in the last 30 years. As a result, the coming months will be spent in part making preparations to discuss the future of this program with regulatory authorities. Simultaneously we have seamlessly pivoted our scientific, CMC and clinical operations toward the development of TPI 287 to promptly bring this program back to the clinic. Importantly for both efforts, we are in a fundamentally secure position as a company, with a year of cash to focus our resources on the advancement of our entire pipeline," commented John Climaco, CEO of CNS Pharmaceuticals. "Looking ahead, we strongly believe in the potential of TPI 287 to be an important candidate for the treatment of GBM. The published body of data are highly compelling, and we look forward to productive discussions with FDA to best advance its development in the near term." Clinical Programs Update TPI 287 In July 2024, the Company entered into an exclusive license agreement with Cortice Biosciences, Inc. for drug candidate TPI 287, which was previously awarded Orphan Drug Designation and studied in over 350 patients to date, including clinical trials as monotherapy and in combination with bevacizumab showing an encouraging clinical efficacy and safety profile at target therapeutic doses. CNS Pharmaceuticals plans to engage the FDA and obtain feedback on the design of a study potentially focused on the registration of TPI 287 in recurrent GBM in 2025. Berubicin The Company recently reported results from the primary analysis of Berubicin in second line treatment of glioblastoma multiforme (GBM). The trial compared Berubicin to Lomustine, a current standard of care in GBM. The analysis did not demonstrate statistically significant superiority in overall survival, the primary endpoint. However, although the trial was not powered to determine non-inferiority, the data appear comparable in clinically important endpoints, including overall survival (OS) and progression free survival (PFS), in all patients treated with Berubicin, including those with the most unfavorable tumor markers. Additionally, patients experienced no cardiotoxicity, a risk that curtails the use of other anthracyclines, and the safety profile continues to be favorable in this patient population. Further, the aggregate data facilitate multiple additional clinical analyses for informed hypothesis generation for the Berubicin program as well as for TPI 287 and other future pipeline opportunities. This study of Berubicin is a multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV - IDH Wild-Type), comparing Berubicin to Lomustine, an accepted treatment for second line therapy in this disease. The study has included 252 patients across North America and Europe, randomizing Berubicin to Lomustine 2:1. Continuation of patients on treatment and their follow-up for overall survival is proceeding. Further data will be included in a future analysis. For more information about the Berubicin clinical trial, visit clinicaltrials.gov and reference identifier NCT04762069. Summary of Financial Results for the Full Year 2024 The net loss for the year ended December 31, 2024 was approximately $14.9 million compared to approximately $18.9 million for the comparable period in 2023. The change in net loss is primarily attributable to decreased research and development costs. The Company reported research and development expenses of $9.3 million for the year ended December 31, 2024 compared to approximately $14.1 million for the comparable period in 2024. The decrease in research and development expenses during the period was mainly attributed to a decline in clinical research organization (CRO) expenses and patient treatment costs related to continued progress with our clinical trial for Berubicin. General and administrative expenses were approximately $5.6 million for the year ended December 31, 2024 compared to approximately $4.8 million for the comparable period in 2023. The increase in general and administrative expense was mainly attributable to increase of approximately $756,000 in professional expenses and $440,000 in employee compensation. These changes were offset by decrease of approximately $104,000 in stock-based compensation, $49,000 in insurance expenses, advertising and marketing of $119,000 and other general and administrative expenses of $52,000. As of December 31, 2024, the Company had cash of approximately $6.5 million. Subsequent to December 31, 2024, the Company has sold 1,530,985 shares of common stock for net proceeds of approximately $9.9 million. Management anticipates that its cash on hand as of December 31, 2024 combined with capital raised subsequent to year-end is sufficient to fund operations into the first quarter of 2026. About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's drug candidate Berubicin is the first anthracycline to appear to cross the blood-brain barrier. Berubicin is the subject of the Company's late-stage, fully-enrolled, global clinical trial for the treatment of glioblastoma multiforme (GBM), an aggressive and currently incurable form of brain cancer. Results of the primary analysis for the study did not demonstrate statistically significant superiority in overall survival, the primary endpoint. However, although the trial was not powered to determine non-inferiority, the data appear comparable in clinically important endpoints in all patients, including those with the most unfavorable tumor markers. The Company's drug candidate TPI 287 is an abeotaxane which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. TPI 287 has shown the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 has been well tolerated in over 350 patients to date, including in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, progressive neoplastic disease, advanced unresectable pancreatic cancer, metastatic melanoma as well as breast cancer metastatic to the brain. For more information, please visit www.CNSPharma.com, and connect with the Company on X, Facebook, and LinkedIn. Forward-Looking Statements Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this release include, without limitation, the timing of the start of a trial of TPI 287, the timing of the release of further analysis data on Berubicin's performance and the Company's cash runway. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions and those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law. CONTACTS: Investor Relations ContactJTC Team, LLCJenene [email protected] SOURCE: CNS Pharmaceuticals, Inc. View the original press release on ACCESS Newswire