PLRZ
PolyrizonDDocument history
Earnings documents stored for PLRZ.
Investor releaseQuarter not tagged2026-07-02Polyrizon Announces Successful Results for NASARIX™ Biocompatibility Program, Supporting Advancement Towards First in Human Clinical Trial
GlobeNewswire
Polyrizon Announces Successful Results for NASARIX™ Biocompatibility Program, Supporting Advancement Towards First in Human Clinical Trial
Raanana, Israel, July 02, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development-stage biotech company specializing in the development of innovative intranasal hydrogels, today announced successful results from its biocompatibility evaluation program for its proprietary NASARIXTM Allergy Blocker nasal spray, with all required biological safety tests meeting their predetermined acceptance criteria. The comprehensive evaluation program was designed in accordance with internationally recognized standards for biological safety assessment of medical devices, including the ISO 10993 series, FDA guidance, and applicable European regulatory requirements. The program was developed to assess the safety and biocompatibility profile of NASARIXTM, a drug-free mucoadhesive nasal spray intended to help reduce exposure to airborne allergens associated with seasonal allergic rhinitis. The completed testing program evaluated key biological safety endpoints identified for the device, including: Cytotoxicity Sensitization Irritation / Intracutaneous Reactivity Material-Mediated Pyrogenicity Acute Systemic Toxicity In addition, long-term systemic toxicity was assessed through a toxicological risk assessment conducted in accordance with ISO 10993-17, demonstrating substantial safety margins across the product’s constituent materials under intended conditions of use. The biocompatibility evaluation was based on the final NASARIXTM product configuration and supported by extensive toxicological assessments of the formulation components, manufacturing processes, packaging materials, and intended patient exposure. According to the Biological Evaluation Plan, the product consists of well-characterized materials with established safety profiles and utilizes a manufacturing process designed to minimize biological risk. “We are pleased to report the successful completion of the NASARIXTM biocompatibility program,” said Tomer Izraeli, CEO of Polyrizon. “Achieving positive results across all required biological safety assessments represents a significant milestone in our development program and further supports the biocompatibility safety profile of NASARIXTM as we continue advancing its clinical and regulatory pathway.” The biocompatibility evaluation program was developed under a risk-management framework consistent with ISO 10993-1 and ISO 14…Read full documentShow less
Raanana, Israel, July 02, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development-stage biotech company specializing in the development of innovative intranasal hydrogels, today announced successful results from its biocompatibility evaluation program for its proprietary NASARIXTM Allergy Blocker nasal spray, with all required biological safety tests meeting their predetermined acceptance criteria. The comprehensive evaluation program was designed in accordance with internationally recognized standards for biological safety assessment of medical devices, including the ISO 10993 series, FDA guidance, and applicable European regulatory requirements. The program was developed to assess the safety and biocompatibility profile of NASARIXTM, a drug-free mucoadhesive nasal spray intended to help reduce exposure to airborne allergens associated with seasonal allergic rhinitis. The completed testing program evaluated key biological safety endpoints identified for the device, including: Cytotoxicity Sensitization Irritation / Intracutaneous Reactivity Material-Mediated Pyrogenicity Acute Systemic Toxicity In addition, long-term systemic toxicity was assessed through a toxicological risk assessment conducted in accordance with ISO 10993-17, demonstrating substantial safety margins across the product’s constituent materials under intended conditions of use. The biocompatibility evaluation was based on the final NASARIXTM product configuration and supported by extensive toxicological assessments of the formulation components, manufacturing processes, packaging materials, and intended patient exposure. According to the Biological Evaluation Plan, the product consists of well-characterized materials with established safety profiles and utilizes a manufacturing process designed to minimize biological risk. “We are pleased to report the successful completion of the NASARIXTM biocompatibility program,” said Tomer Izraeli, CEO of Polyrizon. “Achieving positive results across all required biological safety assessments represents a significant milestone in our development program and further supports the biocompatibility safety profile of NASARIXTM as we continue advancing its clinical and regulatory pathway.” The biocompatibility evaluation program was developed under a risk-management framework consistent with ISO 10993-1 and ISO 14971 and included assessment of physical and chemical characteristics, material safety data, toxicological literature, manufacturing controls, and endpoint-specific biological testing. The successful completion of the biocompatibility program further strengthens the non-clinical package supporting NASARIXTM and represents an important step toward potential commercialization of the product as a novel nasal barrier technology designed to help individuals suffering from seasonal allergies. About NASARIXTM NASARIXTM is Polyrizon’s proprietary nasal spray designed to create a protective barrier within the nasal cavity, helping to prevent contact between inhaled allergens and the nasal mucosa. The product is being developed as a non-drug approach for the management of seasonal allergic rhinitis. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target, or T&T. For more information, please visit https://polyrizon-biotech.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the the timing and progress of its clinical trials, advancing the clinical and regulatory pathway of NASARIXTM and the potential commercialization of NASARIXTM as a novel nasal barrier technology designed to help individuals suffering from seasonal allergies. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites. Contacts: Michal EfratyInvestor [email protected]
Investor releaseQuarter not tagged2026-03-26Polyrizon Ltd. Files Annual Report on Form 20-F for the Fiscal Year Ended December 31, 2025
GlobeNewswire
Polyrizon Ltd. Files Annual Report on Form 20-F for the Fiscal Year Ended December 31, 2025
Raanana, Israel, March 25, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal protective solutions, today announced that it has filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2025, with the U.S. Securities and Exchange Commission (the "SEC"). The report is available on the SEC's website, at www.sec.gov and Polyrizon’s Investor Relations website, at https://investor.polyrizon-biotech.com/. Shareholders can obtain copies of Polyrizon’s Annual Report on Form 20-F, free of charge, by making a request within a reasonable period of time to Polyrizon’s Investor Relations Department at [email protected]. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by thei…Read full documentShow less
Raanana, Israel, March 25, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal protective solutions, today announced that it has filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2025, with the U.S. Securities and Exchange Commission (the "SEC"). The report is available on the SEC's website, at www.sec.gov and Polyrizon’s Investor Relations website, at https://investor.polyrizon-biotech.com/. Shareholders can obtain copies of Polyrizon’s Annual Report on Form 20-F, free of charge, by making a request within a reasonable period of time to Polyrizon’s Investor Relations Department at [email protected]. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 24, 2026 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites. Contacts: Michal Efraty Investor Relations [email protected]
Investor releaseQuarter not tagged2026-01-05Polyrizon Announces New Pre-Clinical Results: PL-14 Demonstrates Significant Allergen-Blocking Performance Compared to a Standard Comparator
GlobeNewswire
Polyrizon Announces New Pre-Clinical Results: PL-14 Demonstrates Significant Allergen-Blocking Performance Compared to a Standard Comparator
Raanana, Israel, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal protective solutions today announced positive results from a new in-vitro pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation compared to hydroxypropyl methylcellulose (HPMC), an accepted and standard comparator used in nasal barrier products. The study, conducted using a validated in-vitro Transwell permeability system designed to mimic allergen transfer into the nasal mucosa, assessed PL-14’s ability to inhibit transfer of Der p 1, a major clinically relevant house dust mite allergen commonly associated with allergic rhinitis and asthma. Key findings demonstrated that PL-14 significantly reduced allergen transfer at all time points compared with HPMC, including early time points that are considered critical for preventing allergen-triggered immune activation. Statistical analysis showed that PL-14 significantly reduced Der p 1 transfer compared with HPMC at every tested time point (1, 2, 4, 6, and 24 hours), with p-values ≤ 0.0042. Highlights from the Study PL-14 showed markedly lower allergen transfer versus HPMC throughout the experiment, supporting a consistent barrier effect. At 1 hour, PL-14 demonstrated very low allergen penetration, with measured mean concentrations of ~20.6 ng compared with ~1354.4 ng for HPMC. HPMC exhibited substantial and time-dependent allergen permeation, rising to mean concentrations of ~5201.2 ng at 24 hours, consistent with limited barrier function. PL-14 maintained low mean allergen levels across all time points, reaching a maximum mean value of ~141.2 ng at 4 hours, supporting a sustained protective effect. “These results reinforce our belief that PL-14 can form an effective intranasal hydrogel barrier capable of reducing allergen exposure to nasal tissue,” said Tomer Izraeli, CEO of Polyrizon. “Importantly, this study benchmarked PL-14 against HPMC, an accepted comparator, and demonstrated statistically significant reduction in allergen transfer at all evaluated time points. From an R&D standpoint, we believe that this is an important confirmation of the performance of the PL-14 formulation using a rigorous quantitative permeation model. The data support continued advancement of…Read full documentShow less
Raanana, Israel, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal protective solutions today announced positive results from a new in-vitro pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation compared to hydroxypropyl methylcellulose (HPMC), an accepted and standard comparator used in nasal barrier products. The study, conducted using a validated in-vitro Transwell permeability system designed to mimic allergen transfer into the nasal mucosa, assessed PL-14’s ability to inhibit transfer of Der p 1, a major clinically relevant house dust mite allergen commonly associated with allergic rhinitis and asthma. Key findings demonstrated that PL-14 significantly reduced allergen transfer at all time points compared with HPMC, including early time points that are considered critical for preventing allergen-triggered immune activation. Statistical analysis showed that PL-14 significantly reduced Der p 1 transfer compared with HPMC at every tested time point (1, 2, 4, 6, and 24 hours), with p-values ≤ 0.0042. Highlights from the Study PL-14 showed markedly lower allergen transfer versus HPMC throughout the experiment, supporting a consistent barrier effect. At 1 hour, PL-14 demonstrated very low allergen penetration, with measured mean concentrations of ~20.6 ng compared with ~1354.4 ng for HPMC. HPMC exhibited substantial and time-dependent allergen permeation, rising to mean concentrations of ~5201.2 ng at 24 hours, consistent with limited barrier function. PL-14 maintained low mean allergen levels across all time points, reaching a maximum mean value of ~141.2 ng at 4 hours, supporting a sustained protective effect. “These results reinforce our belief that PL-14 can form an effective intranasal hydrogel barrier capable of reducing allergen exposure to nasal tissue,” said Tomer Izraeli, CEO of Polyrizon. “Importantly, this study benchmarked PL-14 against HPMC, an accepted comparator, and demonstrated statistically significant reduction in allergen transfer at all evaluated time points. From an R&D standpoint, we believe that this is an important confirmation of the performance of the PL-14 formulation using a rigorous quantitative permeation model. The data support continued advancement of PL-14 as a potential preventive approach for allergic rhinitis by reducing allergen penetration through a synthetic surface.” Polyrizon continues to advance its preclinical development program and plans to support future clinical studies aimed at establishing PL-14’s regulatory pathway and real-world clinical benefit for allergy prevention. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses continued advancement of PL-14 as a potential preventive approach for allergic rhinitis by reducing allergen penetration through a synthetic surface and how the Company continues to advance its preclinical development program and plans to support future clinical studies aimed at establishing PL-14’s regulatory pathway and real-world clinical benefit for allergy prevention. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites. Contacts: Michal Efraty Investor Relations [email protected]
Investor releaseQuarter not tagged2025-12-03Polyrizon Reports Positive Mucoadhesion Results for Intranasal Naloxone Hydrogel Compared to Marketed Intranasal Naloxone product
GlobeNewswire
Polyrizon Reports Positive Mucoadhesion Results for Intranasal Naloxone Hydrogel Compared to Marketed Intranasal Naloxone product
Superior Mucoadhesion may potentially Translate into More Reliable Opioid Overdose Reversal in Real-World Emergencies Ra’anana, Israel, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced compelling new preclinical data showing its proprietary naloxone hydrogel adheres to nasal tissue longer than an approved and marketed intranasal naloxone spray product. Using an established ex-vivo rabbit nasal mucosa model, researchers evaluated the persistence of Polyrizon’s hydrogel formulation versus commercial product by applying each formulation to mucosal tissue and washing with Simulated Nasal Electrolyte Solution (SNES) over a 30-minute period. Quantification of residual fluorescence revealed that Polyrizon’s hydrogel maintained higher values of the fluorescence marker when compared to the commercial product, with differences reaching high statistical significance (p < 0.0001, two-way ANOVA), indicating notably stronger and more durable mucosal retention. The results showed that Polyrizon’s Trap and Target ™ (T&T) hydrogel exhibited significantly higher mucoadhesion levels compared to the commercial product, supporting potentially prolonged contact at the nasal deposition site and potentially enhancing bioavailability. Improved mucoadhesion is a critical factor for intranasal drug delivery - particularly for emergency treatments such as opioid overdose reversal - because enhanced residence time at the nasal deposition site can support more reliable absorption and potentially faster onset of action. “We believe that these outcomes further validate the potential of our T&T hydrogel platform and highlight its unique advantages in intranasal drug delivery,” said Tomer Izraeli, CEO of Polyrizon. “The ability to significantly outperform an existing marketed product in mucoadhesion is an important milestone as we continue advancing our Naloxone program.” This new dataset builds directly on the previously reported encouraging stability results, which demonstrated the robustness of Polyrizon’s formulation under various storage conditions. Collectively, stability plus mucoadhesion performance reinforce the potential of Polyrizon’s T&T technology to deliver a safer, more reliable, and more effective intranasal Naloxone product. About Polyriz…Read full documentShow less
Superior Mucoadhesion may potentially Translate into More Reliable Opioid Overdose Reversal in Real-World Emergencies Ra’anana, Israel, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced compelling new preclinical data showing its proprietary naloxone hydrogel adheres to nasal tissue longer than an approved and marketed intranasal naloxone spray product. Using an established ex-vivo rabbit nasal mucosa model, researchers evaluated the persistence of Polyrizon’s hydrogel formulation versus commercial product by applying each formulation to mucosal tissue and washing with Simulated Nasal Electrolyte Solution (SNES) over a 30-minute period. Quantification of residual fluorescence revealed that Polyrizon’s hydrogel maintained higher values of the fluorescence marker when compared to the commercial product, with differences reaching high statistical significance (p < 0.0001, two-way ANOVA), indicating notably stronger and more durable mucosal retention. The results showed that Polyrizon’s Trap and Target ™ (T&T) hydrogel exhibited significantly higher mucoadhesion levels compared to the commercial product, supporting potentially prolonged contact at the nasal deposition site and potentially enhancing bioavailability. Improved mucoadhesion is a critical factor for intranasal drug delivery - particularly for emergency treatments such as opioid overdose reversal - because enhanced residence time at the nasal deposition site can support more reliable absorption and potentially faster onset of action. “We believe that these outcomes further validate the potential of our T&T hydrogel platform and highlight its unique advantages in intranasal drug delivery,” said Tomer Izraeli, CEO of Polyrizon. “The ability to significantly outperform an existing marketed product in mucoadhesion is an important milestone as we continue advancing our Naloxone program.” This new dataset builds directly on the previously reported encouraging stability results, which demonstrated the robustness of Polyrizon’s formulation under various storage conditions. Collectively, stability plus mucoadhesion performance reinforce the potential of Polyrizon’s T&T technology to deliver a safer, more reliable, and more effective intranasal Naloxone product. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses how superior mucoadhesion for its intranasal naloxone hydrogel may potentially translate into more reliable opioid overdose reversal in real-world emergencies, its belief that that the result further validate the potential of its T&T hydrogel platform and highlight its unique advantages in intranasal drug delivery, advancing its Naloxone program and the potential of Polyrizon’s T&T technology to deliver a safer, more reliable, and more effective intranasal Naloxone product . Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites. Contacts: Michal Efraty Investor Relations [email protected]
Investor releaseQuarter not tagged2025-10-06Polyrizon Announces Positive Pre-Clinical Results: PL-14 Demonstrates Encouraging Allergen-Blocking Efficacy
GlobeNewswire
Polyrizon Announces Positive Pre-Clinical Results: PL-14 Demonstrates Encouraging Allergen-Blocking Efficacy
Ra’anana, Israel, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company developing intranasal products based on its proprietary Capture & Contain (C&C) platform, today announced encouraging results from a recent pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation. The study was designed to simulate allergen exposure conditions and assess the ability of PL-14 to prevent allergen penetration through a hydrogel barrier. In the pre-clinical study, Der p 1 allergen, a major house dust mite allergen, was applied atop the PL-14 formulation. Samples were collected beneath the formulation at multiple time points to measure the quantity and pace of allergen penetration. The results demonstrated that PL-14 effectively limited allergen diffusion over time, forming an effective nasal barrier against the house dust mite allergen (Der p 1). Key results include: After one hour: Only 1.07% of the allergen passed through. After two hours: Penetration remained minimal at 1.14%. After four hours: Still highly effective, with just 13.6% diffusion. These findings emphasize the potentially strong barrier properties of PL-14, particularly during the critical early hours of exposure when allergen contact is most likely to trigger immune responses. Importantly, the allergen load used in this study was estimated to be tens of times higher than typical real-world exposure levels during allergy seasons, based on published clinical studies conducted in controlled allergen challenge chambers. This suggests that PL-14 may offer robust protection even under extreme allergen conditions. According to a Future Market Insights report, the Allergy Immunotherapy market is poised for substantial growth, with market valuation projected to increase from USD 1.9 billion in 2025 to USD 4.2 billion by 2035, expanding at a CAGR of 7.9% during the forecast period. This growth is primarily driven by the increasing prevalence of allergies worldwide, along with advancements in treatment methodologies and rising awareness of immunotherapy as an effective long-term solution. “Our innovative C&C platform is designed to form a protective hydrogel layer that captures and contains airborne allergens before they reach the nasal mucosa,” said Tomer Izraeli, CEO of Polyrizon. “We believe that these…Read full documentShow less
Ra’anana, Israel, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company developing intranasal products based on its proprietary Capture & Contain (C&C) platform, today announced encouraging results from a recent pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation. The study was designed to simulate allergen exposure conditions and assess the ability of PL-14 to prevent allergen penetration through a hydrogel barrier. In the pre-clinical study, Der p 1 allergen, a major house dust mite allergen, was applied atop the PL-14 formulation. Samples were collected beneath the formulation at multiple time points to measure the quantity and pace of allergen penetration. The results demonstrated that PL-14 effectively limited allergen diffusion over time, forming an effective nasal barrier against the house dust mite allergen (Der p 1). Key results include: After one hour: Only 1.07% of the allergen passed through. After two hours: Penetration remained minimal at 1.14%. After four hours: Still highly effective, with just 13.6% diffusion. These findings emphasize the potentially strong barrier properties of PL-14, particularly during the critical early hours of exposure when allergen contact is most likely to trigger immune responses. Importantly, the allergen load used in this study was estimated to be tens of times higher than typical real-world exposure levels during allergy seasons, based on published clinical studies conducted in controlled allergen challenge chambers. This suggests that PL-14 may offer robust protection even under extreme allergen conditions. According to a Future Market Insights report, the Allergy Immunotherapy market is poised for substantial growth, with market valuation projected to increase from USD 1.9 billion in 2025 to USD 4.2 billion by 2035, expanding at a CAGR of 7.9% during the forecast period. This growth is primarily driven by the increasing prevalence of allergies worldwide, along with advancements in treatment methodologies and rising awareness of immunotherapy as an effective long-term solution. “Our innovative C&C platform is designed to form a protective hydrogel layer that captures and contains airborne allergens before they reach the nasal mucosa,” said Tomer Izraeli, CEO of Polyrizon. “We believe that these results reinforce the potential of PL-14 as a frontline preventive solution for allergic rhinitis and other nasal allergies.” Polyrizon continues to advance its preclinical development program and plans to initiate clinical studies to support regulatory and clinical pathways for PL-14 and other candidates within the C&C platform. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the potentially strong barrier properties of PL-14, the growth of the Allergy Immunotherapy market, its belief that the pre-clinical study results reinforce the potential of PL-14 as a frontline preventive solution for allergic rhinitis and other nasal allergies, the advancement of its its preclinical development program and its plans to initiate clinical studies to support regulatory and clinical pathways for PL-14 and other candidates within the C&C platform.. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites. Contacts: Michal Efraty Investor Relations [email protected]
Investor releaseQuarter not tagged2025-06-12Polyrizon Reports Promising Results Demonstrating Successful Internasal Delivery of its Innovative Hydrogel Formulation for CNS Therapeutics
GlobeNewswire
Polyrizon Reports Promising Results Demonstrating Successful Internasal Delivery of its Innovative Hydrogel Formulation for CNS Therapeutics
Ra’anana, Israel, June 12, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a biotechnology company developing intranasal drug delivery systems, today announced encouraging preclinical results from a recent study evaluating its proprietary hydrogel-based Trap & Target (T&T) platform. The study, conducted in collaboration with the University of Parma (Italy), demonstrated that Polyrizon’s hydrogel formulation achieves targeted deposition in the upper regions of the nasal cavity—critical for central nervous system (CNS) drug delivery. The promising results are part of a collaborative study between the Company and the Department of Food and Drug of the University of Parma (Italy), led and conducted by Professor Fabio Sonvico, a leading expert in the development of intranasal and pulmonary drug delivery solutions and a member of the Company’s Scientific Advisory Board. Using a silicone-based human nasal cast and fluorescein-traced imaging, the Polyrizon hydrogel formulation was shown to exhibit a preferential accumulation of over 60% in the middle and upper turbinates, the region’s most favorable for nose-to-brain transport. This region-specific delivery has the potential to be particularly promising for CNS indications, such as opioid overdose (e.g., naloxone) and benzodiazepine for epileptic seizures, where rapid and direct access to the brain can be lifesaving. “The results validate the unique capabilities of our T&T technology in achieving localized deposition in anatomically favorable zones of the nasal cavity,” said Tomer Izraeli, CEO at Polyrizon. “We believe that this has the potential to open a strategic path forward for leveraging our intranasal platform in the development of therapies for acute neurological and psychiatric conditions.” Polyrizon’s hydrogel demonstrated consistent, concentrated delivery to the upper nasal segments while maintaining favorable handling characteristics. These findings support the continued preclinical development of the T&T platform for CNS-targeted applications. Polyrizon intends to further validate these results in animal models and initiate safety studies as part of its translational roadmap for the T&T technology. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sp…Read full documentShow less
Ra’anana, Israel, June 12, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a biotechnology company developing intranasal drug delivery systems, today announced encouraging preclinical results from a recent study evaluating its proprietary hydrogel-based Trap & Target (T&T) platform. The study, conducted in collaboration with the University of Parma (Italy), demonstrated that Polyrizon’s hydrogel formulation achieves targeted deposition in the upper regions of the nasal cavity—critical for central nervous system (CNS) drug delivery. The promising results are part of a collaborative study between the Company and the Department of Food and Drug of the University of Parma (Italy), led and conducted by Professor Fabio Sonvico, a leading expert in the development of intranasal and pulmonary drug delivery solutions and a member of the Company’s Scientific Advisory Board. Using a silicone-based human nasal cast and fluorescein-traced imaging, the Polyrizon hydrogel formulation was shown to exhibit a preferential accumulation of over 60% in the middle and upper turbinates, the region’s most favorable for nose-to-brain transport. This region-specific delivery has the potential to be particularly promising for CNS indications, such as opioid overdose (e.g., naloxone) and benzodiazepine for epileptic seizures, where rapid and direct access to the brain can be lifesaving. “The results validate the unique capabilities of our T&T technology in achieving localized deposition in anatomically favorable zones of the nasal cavity,” said Tomer Izraeli, CEO at Polyrizon. “We believe that this has the potential to open a strategic path forward for leveraging our intranasal platform in the development of therapies for acute neurological and psychiatric conditions.” Polyrizon’s hydrogel demonstrated consistent, concentrated delivery to the upper nasal segments while maintaining favorable handling characteristics. These findings support the continued preclinical development of the T&T platform for CNS-targeted applications. Polyrizon intends to further validate these results in animal models and initiate safety studies as part of its translational roadmap for the T&T technology. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its belief that its Trap and Target™ (T&T) platform has the potential to opens a strategic path forward for leveraging its intranasal platform in the development of therapies for acute neurological and psychiatric conditions, the continued preclinical development of the T&T platform for CNS-targeted applications and its intention to further validate these results in animal models and initiate safety studies as part of its translational roadmap for the T&T technology. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites. Contacts: Michal Efraty Investor Relations [email protected]
Investor releaseQuarter not tagged2025-03-21Psychedelic: atai Life Sciences, NRx report quarterly results
TipRanks
Psychedelic: atai Life Sciences, NRx report quarterly results
In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a collaboration LOI and a study publication. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. EARNINGS: On Monday, atai Life Sciences (ATAI) reported a fourth quarter loss per share of (24c) on revenue loss of ($5,000), which compared to analyst estimates of a loss per share of (15c) and revenue of $18,000 for the same period last year. As of December 31, the company had cash, cash equivalents, restricted cash and short-term securities of $72.3M compared to $154.2M as of December 31, 2023. In February, the company completed an equity offering with net proceeds of $59.2M and now expects its cash, short-term securities, and public equity holdings to be sufficient to fund operations into 2027. “We are beginning the year in a strong financial position, thanks to the recent capital raise, which extends our runway into 2027, beyond when we expect the topline data readouts from the Phase 2 clinical trials of our two core programs, VLS-01 and EMP-01, in 1Q26” stated Srinivas Rao, CEO. “Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health. We also look forward to several key milestones this year, notably Beckley Psytech’s BPL-003 Phase 2b topline results in patients with treatment-resistant depression as well as RL-007 in patients with cognitive impairment associated with schizophrenia, both expected mid-2025.” Additionally on Monday, NRx Pharmaceuticals (NRXP) reported a FY24 loss per share of ($2.36), which compared to a loss per share of ($3.98) for the same period last year. As of December 31, the company had approximately $1.4M in cash and cash equivalents. In January, the company completed two financings with aggregate gross proceeds of approximately $8.5M. Management believes that current available cash resources will be sufficient to support ongoing operations through at least the end of 2025. “Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors. We have retired debt that was impeding the launch of HOPE Therapeutics and brought new investors into the Company who are aligned with our objectives. We launched the…Read full documentShow less
In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a collaboration LOI and a study publication. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. EARNINGS: On Monday, atai Life Sciences (ATAI) reported a fourth quarter loss per share of (24c) on revenue loss of ($5,000), which compared to analyst estimates of a loss per share of (15c) and revenue of $18,000 for the same period last year. As of December 31, the company had cash, cash equivalents, restricted cash and short-term securities of $72.3M compared to $154.2M as of December 31, 2023. In February, the company completed an equity offering with net proceeds of $59.2M and now expects its cash, short-term securities, and public equity holdings to be sufficient to fund operations into 2027. “We are beginning the year in a strong financial position, thanks to the recent capital raise, which extends our runway into 2027, beyond when we expect the topline data readouts from the Phase 2 clinical trials of our two core programs, VLS-01 and EMP-01, in 1Q26” stated Srinivas Rao, CEO. “Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health. We also look forward to several key milestones this year, notably Beckley Psytech’s BPL-003 Phase 2b topline results in patients with treatment-resistant depression as well as RL-007 in patients with cognitive impairment associated with schizophrenia, both expected mid-2025.” Additionally on Monday, NRx Pharmaceuticals (NRXP) reported a FY24 loss per share of ($2.36), which compared to a loss per share of ($3.98) for the same period last year. As of December 31, the company had approximately $1.4M in cash and cash equivalents. In January, the company completed two financings with aggregate gross proceeds of approximately $8.5M. Management believes that current available cash resources will be sufficient to support ongoing operations through at least the end of 2025. “Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors. We have retired debt that was impeding the launch of HOPE Therapeutics and brought new investors into the Company who are aligned with our objectives. We launched the filing of a New Drug Application for NRX-100 for the treatment of Suicidal Depression: a major milestone for NRx. We also moved NRX-101 toward it’s NDA for Accelerated Approval in bipolar depression in patients at risk of akathisia, and made meaningful progress building HOPE’s best-in-class network of Interventional Psychiatry Clinics. Additionally, two potential strategic transactions that are under negotiation could further accelerate our progress. These accomplishments advance our mission of preventing and treating suicide: work that is critical to our patients, their families and our country,” said Jonathan Javitt, CEO. CLEARMIND SIGNS LOI WITH POLYRIZON: Clearmind Medicine (CMND) announced Wednesday that it has (PLRZ) to develop a novel intranasal formulation for its psychedelic-based treatment applications. The collaboration will explore the potential of Clearmind’s proprietary drug candidate, 5-Methoxy-2-aminoindane, alone or in combination with Palmitoylethanolamide, through intranasal administration. This initiative aims to enhance bioavailability and optimize the therapeutic effect of Clearmind’s psychedelic-based treatments. Under the terms of the LOI, Clearmind and Polyrizon will conduct research and development efforts to achieve a proof of concept for an intranasal formulation of MEAI and MEAI-PEA combinations. The companies will assess the feasibility of intranasal drug delivery, which offers several potential advantages over traditional administration methods, including faster absorption and onset of action, high bioavailability for increased therapeutic effects and enhanced patient compliance due to non-invasive administration. “This collaboration represents an exciting step forward in our efforts to continue innovating psychedelic-based treatments,” said Adi Zuloff-Shani, CEO. “We believe intranasal administration has the potential to improve patient outcomes by providing a faster-acting, more efficient, and user-friendly treatment option. This agreement aligns with our commitment to developing innovative and accessible solutions for mental health and addiction treatment.” Additionally on Tuesday, Clearmind Medicine announced that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile of its treatment, CMND-100, in Alcohol Use Disorder patients. This study is the first clinical application of the company’s proprietary CMND-100 platform. The first site to be initiated is IMCA in Israel and will be led by Prof. Mark Weiser, head of the Psychiatric Division at the Sheba Medical Center. “Transitioning to a clinical stage pharmaceutical company is a major milestone for our Company, enabling us to evaluate whether the promising results from our animal studies will translate to human clinical trial participants with AUD,” said Zuloff-Shani. “Previously announced preclinical data on alcohol curb supports the potential ofCMND-100 as a novel and effective treatment approach for alcoholism, addressing a significant unmet medical need.” COMPASS REPORTS PUBLICATION OF COMP004 RESULTS: Compass Pathways (CMPS) announced Tuesday the publication of results from the COMP004 study, an observational 52-week follow-up from the Phase 2 COMP001 and COMP003 trials of COMP360 psilocybin treatment in patients with treatment-resistant depression. The COMP004 study’s findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of antidepressant effects compared to the 1 mg and 10 mg doses. The results of COMP004 build upon previous findings from the Phase 2b trial COMP001, which showed that a single 25mg dose of COMP360 psilocybin was associated with a rapid and highly statistically significant reduction in depressive symptoms compared to COMP360 1mg dose after three weeks, with durable response for up to 12 weeks. “Treatment-resistant depression is a major public health challenge, affecting approximately 100 million people worldwide, and it is well understood that there is an urgent need for differentiated treatment options,” said Guy Goodwin, CMO. “This study together with the Phase 2b suggest the potential of COMP360 to provide rapid and durable clinical benefits from a single administration. We continue to explore the full profile of COMP360 in our ongoing Phase 3 clinical development program and we look forward to seeing the first phase 3 data from our COMP005 trial in the second quarter.” FILAMENT REPORTS PHASE 2 PEX010 DATA: Filament Health (FLHLF) announced Monday data from an open-label phase 2 clinical trial studying the effects of its botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder at Psychiatric Centre Copenhagen. The results were published in the Journal of Psychopharmacology and found that a single 25mg dose of PEX010 was safe and effective in reducing alcohol consumption in AUD patients. The open-label phase 2 study investigated single-dose psilocybin therapy in 10 treatment-seeking adults with severe AUD. The treatment involved two preparation sessions, a high-dose psilocybin session, and two integration sessions. Alcohol consumption significantly decreased over the 12 weeks following the administration of PEX010. The percentage of heavy drinking days was reduced from 53.6% before receiving PEX010 to 16.1% at week 12 and drinks per day decreased by an average of 3.4 drinks over the 12-week follow up period. This was corroborated by reports of rapid and sustained reductions in craving and temptation and significant increases in self-efficacy. All participants completed the therapy course, and the safety profile was favourable with no serious adverse events. “We are thrilled to announce positive results which support the efficacy of PEX010,” said Benjamin Lightburn, CEO. “These data reinforce our confidence in the potential of botanical psilocybin to help the millions of people suffering from substance use disorders like AUD. We look forward to advancing to the next stage of development.” NUMINUS RECEIVES STATE CERTIFICATION APPROVAL: Numinus Wellness (NUMIF) announced Thursday that its Psychedelic-Assisted Therapy Training Program has been officially approved by the state of Colorado. This approval comes as part of Colorado’s Natural Medicine Health Act, which establishes a legal framework for the facilitation of psilocybin services by trained and licensed professionals. Numinus’ state-approved certification pathway includes coursework in psychedelic-assisted therapy fundamentals, psilocybin-specific training, trauma-informed care, and practical applications, along with clinical practicum placements to ensure hands-on experience. “This is an exciting step forward for both Numinus and for the future of psychedelic-assisted therapy in Colorado,” said Michael Tan, CEO of Numinus Wellness. “We are committed to ensuring that practitioners receive the highest standard of training so they can provide safe, ethical, and transformative psilocybin-assisted therapy in accordance with Colorado’s regulations.” OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Incannex Healthcare (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today’s best-performing stocks on TipRanks >> Read More on ATAI: Questions or Comments about the article? Write to [email protected] ATAI Life Sciences Diversifies Treasury with Bitcoin Investment ATAI Life Sciences: Positioned for Growth in Psychedelic and Neuropsychiatric Treatments with Strong Pipeline and Upcoming Catalysts ATAI Life Sciences: Strong Financial Position and Promising Pipeline Drive Buy Rating Atai Life Sciences reports Q4 EPS (24c), consensus (15c) Psychedelic: atai reports dosing of first patient in Phase 2 VLS-01 trial

