Latest news with #ContineumTherapeutics
Globe and Mail
06-08-2025
- Business
- Globe and Mail
Contineum (CTNM) Q2 R&D Jumps 78%
Key Points GAAP net loss per share widened to $(0.62) in Q2 2025, missing analyst GAAP EPS estimates by $0.18, driven by a sharp rise in research and development expenses. R&D expenses surged 78%, reflecting increased investment in clinical pipeline programs, while cash reserves stood at $175.5 million. These 10 stocks could mint the next wave of millionaires › Contineum Therapeutics (NASDAQ:CTNM), a clinical-stage biotechnology company focused on developing treatments for serious diseases such as pulmonary fibrosis, multiple sclerosis, and depression, released its second quarter fiscal 2025 results on August 5, 2025. The most notable news in the earnings release was a wider GAAP net loss per share of $(0.62), missing the estimate of $(0.44). Research and development expenses (GAAP) saw a sharp rise as the company continued to advance its clinical pipeline. Management reported a robust cash position of $175.5 million as of June 30, 2025. Overall, the period reflected ongoing progress in pipeline development, but came with significantly higher spending and a continued absence of commercial revenue. Metric Q2 2025 Q2 2025 Estimate Q2 2024 Y/Y Change EPS (GAAP) ($0.62) ($0.44) ($0.39) (-59.0%) Revenue N/A $7.5 million N/A — Research and Development Expense $14.1 million $7.9 million 78.5% General and Administrative Expense $3.8 million $3.0 million 26.7% Source: Analyst estimates for the quarter provided by FactSet. Business Overview and Key Success Factors Contineum Therapeutics develops small molecule therapies for diseases with high unmet medical need. Its clinical programs focus on two main drug candidates: PIPE-791, an oral treatment being studied for idiopathic pulmonary fibrosis (IPF), progressive multiple sclerosis (PrMS), and chronic pain; and PIPE-307, a selective M1R antagonist for use in depression and relapsing-remitting multiple sclerosis (RRMS). The company's pipeline also includes earlier-stage assets like CTX-343, a peripherally restricted LPA1R antagonist. Contineum has centered its business on advancing clinical trials for PIPE-791 and PIPE-307. Key success factors for the company include achieving positive clinical trial results, securing regulatory approvals, maintaining strategic partnerships (particularly with Johnson & Johnson for PIPE-307), and ensuring sufficient cash to fund ongoing development. A core part of its strategy relies on addressing conditions such as IPF and RRMS, where few effective therapies are available. Quarter Highlights and Financial Developments Contineum significantly increased its investment in research and development. This sharp rise was tied to the progression of clinical trials for both PIPE-791 and PIPE-307 and expanded workforce costs to support these activities. General and administrative expenses also increased, primarily due to higher stock-based compensation and salaries. GAAP net loss increased compared to the prior-year quarter. The absence of significant top-line revenue is typical for pre-commercial biotechnology companies at this stage. Management highlighted that all ongoing spending aligns with planned development milestones, focusing resources on advancing the pipeline rather than generating current sales. Operationally, the most notable achievements included advancing PIPE-791 in multiple indications. PIPE-791 is an oral drug designed to block LPA1R, a receptor implicated in the progression of fibrotic and neurodegenerative disorders. Management completed chronic toxicity studies for PIPE-791 and advanced plans for regulatory filings to begin a global Phase 2 trial for IPF later in 2025. Patient dosing started in a Phase 1b trial for chronic pain in March 2025, with results expected in the first half of 2026. The company postponed the planned Phase 2 study in progressive multiple sclerosis, choosing to concentrate resources on IPF instead. PIPE-307, intended for both RRMS and major depressive disorder (MDD), is in the VISTA Phase 2 proof-of-concept trial in RRMS. Top-line data are expected in the fourth quarter of 2025. Separately, Johnson & Johnson, through its Janssen business, launched recruitment in December 2024 for a Phase 2 trial testing PIPE-307 in adults with MDD. No new partnership deals or milestone payments were reported during the quarter. Strategic Focus, Program Prioritization, and Cash Updates Contineum made several program prioritization decisions during the period. It postponed starting clinical trials for PIPE-791 in PrMS and the first-in-human studies for CTX-343, focusing its resources on the largest near-term market opportunity in IPF. The company ended the quarter with $175.5 million in cash, cash equivalents, and marketable securities. This cash position should enable Contineum to fund operations through 2027, according to management. In July 2025, the company generated approximately $8.4 million in additional cash through an at-the-market stock offering, issuing 2,122,000 shares. The cash level reduces short-term financing risk, but ongoing operating losses and persistent R&D investment mean further funding might be required if programs take longer or cost more than anticipated. Management reaffirmed its focus on advancing the most promising pipeline programs and signaled no change in strategic partnerships or cash material events aside from the ATM offering. The pipeline's pace and development depend heavily on positive results from ongoing and upcoming clinical trials, particularly for PIPE-791 in IPF and PIPE-307 in RRMS and MDD. The company did not announce or adjust any dividend. Outlook and Guidance Contineum did not provide explicit guidance or financial forecasts for the next quarter or the remainder of fiscal 2025. Management referenced its strong cash position as sufficient to support planned development activities through 2027 but did not give revenue, expense, or earnings targets. Looking ahead, investors will likely track the timing and outcomes of the planned clinical milestones for PIPE-791 and PIPE-307, enrollment trends, and any updates on delayed programs or additional partnership deals. Risks remain tied to clinical trial outcomes, future cash burn trends, and the company's ability to access additional non-dilutive funding if needed. Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted. Where to invest $1,000 right now When our analyst team has a stock tip, it can pay to listen. After all, Stock Advisor's total average return is 1,039%* — a market-crushing outperformance compared to 181% for the S&P 500. They just revealed what they believe are the 10 best stocks for investors to buy right now, available when you join Stock Advisor. See the stocks » *Stock Advisor returns as of August 4, 2025
Yahoo
25-06-2025
- Business
- Yahoo
Contineum Therapeutics Provides Update on Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791
SAN DIEGO, June 25, 2025--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced an update on its Phase 1b positron emission tomography (PET) trial of PIPE-791, a selective antagonist of the lysophosphatidic acid 1 (LPA1) receptor. The Company has completed enrollment of the healthy volunteer and progressive multiple sclerosis (PrMS) cohorts of this trial. The screening and enrollment of idiopathic pulmonary fibrosis (IPF) patients to participate in this trial is ongoing. "In early June, consistent with our protocol, we enrolled two additional PrMS patients to assess PET imaging of the brain," said Timothy Watkins, M.D., Chief Medical Officer and Head of Development, Contineum Therapeutics. "While adding these additional patients to the trial has led to a modest delay in reporting our topline data, we believe the enhanced clinical understanding of PIPE-791 in patients is important to the program. This trial builds on our compelling preclinical data and improves our understanding of receptor occupancy in healthy volunteers and patients, helping guide our dose selection in the next stages of clinical development. We now anticipate reporting topline data from these fully enrolled cohorts in the third quarter of 2025." The Phase 1b, open label, single-center trial is designed to assess the correlation between pharmacokinetics and LPA1 receptor occupancy using PET imaging in healthy volunteers, as well as IPF and PrMS patients. To date, 12 healthy volunteers and four PrMS patients have participated in this trial. More information on this trial can be found at (NCT06683612). About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis, progressive multiple sclerosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit Forward-Looking Statements Certain statements contained in this press release, other than historical information, constitute forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include, but are not limited to, statements regarding the Company's clinical trial and product development plans and timelines, including, but not limited to, those regarding the anticipated timing and results of topline data from the healthy volunteer and PrMS cohorts from the Company's ongoing Phase 1b PET trial; the potential of the Company's Phase 1b PET trial to improve the Company's understanding of target occupancy of PIPE-791 or to guide dose selection for further clinical development, or to predict future clinical outcomes or results; the indications, anticipated benefits of, and market opportunities for its drug candidates; its business strategies and plans; and the quotations of the Company's management. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond the Company's control and may cause its actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties, include, but are not limited to, the following: the Company is heavily dependent on the success of PIPE-791 and PIPE-307, both of which are in the early stages of clinical development, and neither of these drug candidates may progress through clinical development or receive regulatory approval; the results of earlier preclinical studies and clinical trials, including those conducted by third parties, may not be predictive of future results and unexpected adverse side effects or inadequate efficacy of the Company's drug candidates may limit their development, regulatory approval and/or commercialization; the timing and outcome of research, development and regulatory review is uncertain; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the potential for the Company's programs and prospects to be negatively impacted by developments relating to the Company's competitors, including the results of studies or regulatory determinations relating to the Company's competitors; risks associated with reliance on third parties to successfully conduct clinical trials and, in the case of PIPE-307, the Company's reliance, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson Company, to develop PIPE-307 for any other indication other than relapsing-remitting multiple sclerosis (RRMS) and, after completion of the Company's PIPE-307 Phase 2 VISTA trial, Janssen Pharmaceutica NV's decision, in its sole discretion, whether or not to further develop PIPE-307 for relapsing-remitting multiple sclerosis (RRMS); the Company has incurred significant operating expenses since inception and it expects that its operating expenses will continue to significantly increase for the foreseeable future; the Company's license agreement with Janssen Pharmaceutica NV may not result in the successful development of PIPE-307; the Company may be unable to obtain, maintain and enforce intellectual property protection for its technology and drug candidates; and unstable macroeconomic and market and economic conditions and uncertainty caused by, among other things, geopolitical conditions, tariffs or threatened tariffs, inflation volatility, and military conflict may adversely affect the Company's business and financial condition and the broader economy and biotechnology industry. Additional risks and uncertainties that could affect the Company's business, operations and results are included under the captions, "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's periodic filings and in other filings that the Company makes with the Securities and Exchange Commission (SEC) from time to time, which are available on the Company's website at under the Investor section and on the SEC's website at Accordingly, readers should not rely upon forward-looking statements as predictions of future events. Except as required by applicable law, the Company undertakes no obligation to update publicly or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. View source version on Contacts Steve KunszaboContineum TherapeuticsSenior Director, Investor Relations & Corporate Communications858-649-1158skunszabo@
Business Wire
25-06-2025
- Business
- Business Wire
Contineum Therapeutics Provides Update on Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791
SAN DIEGO--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced an update on its Phase 1b positron emission tomography (PET) trial of PIPE-791, a selective antagonist of the lysophosphatidic acid 1 (LPA1) receptor. The Company has completed enrollment of the healthy volunteer and progressive multiple sclerosis (PrMS) cohorts of this trial. The screening and enrollment of idiopathic pulmonary fibrosis (IPF) patients to participate in this trial is ongoing. 'In early June, consistent with our protocol, we enrolled two additional PrMS patients to assess PET imaging of the brain,' said Timothy Watkins, M.D., Chief Medical Officer and Head of Development, Contineum Therapeutics. 'While adding these additional patients to the trial has led to a modest delay in reporting our topline data, we believe the enhanced clinical understanding of PIPE-791 in patients is important to the program. This trial builds on our compelling preclinical data and improves our understanding of receptor occupancy in healthy volunteers and patients, helping guide our dose selection in the next stages of clinical development. We now anticipate reporting topline data from these fully enrolled cohorts in the third quarter of 2025.' The Phase 1b, open label, single-center trial is designed to assess the correlation between pharmacokinetics and LPA1 receptor occupancy using PET imaging in healthy volunteers, as well as IPF and PrMS patients. To date, 12 healthy volunteers and four PrMS patients have participated in this trial. More information on this trial can be found at (NCT06683612). About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis, progressive multiple sclerosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit Forward-Looking Statements Certain statements contained in this press release, other than historical information, constitute forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include, but are not limited to, statements regarding the Company's clinical trial and product development plans and timelines, including, but not limited to, those regarding the anticipated timing and results of topline data from the healthy volunteer and PrMS cohorts from the Company's ongoing Phase 1b PET trial; the potential of the Company's Phase 1b PET trial to improve the Company's understanding of target occupancy of PIPE-791 or to guide dose selection for further clinical development, or to predict future clinical outcomes or results; the indications, anticipated benefits of, and market opportunities for its drug candidates; its business strategies and plans; and the quotations of the Company's management. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond the Company's control and may cause its actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties, include, but are not limited to, the following: the Company is heavily dependent on the success of PIPE-791 and PIPE-307, both of which are in the early stages of clinical development, and neither of these drug candidates may progress through clinical development or receive regulatory approval; the results of earlier preclinical studies and clinical trials, including those conducted by third parties, may not be predictive of future results and unexpected adverse side effects or inadequate efficacy of the Company's drug candidates may limit their development, regulatory approval and/or commercialization; the timing and outcome of research, development and regulatory review is uncertain; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the potential for the Company's programs and prospects to be negatively impacted by developments relating to the Company's competitors, including the results of studies or regulatory determinations relating to the Company's competitors; risks associated with reliance on third parties to successfully conduct clinical trials and, in the case of PIPE-307, the Company's reliance, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson Company, to develop PIPE-307 for any other indication other than relapsing-remitting multiple sclerosis (RRMS) and, after completion of the Company's PIPE-307 Phase 2 VISTA trial, Janssen Pharmaceutica NV's decision, in its sole discretion, whether or not to further develop PIPE-307 for relapsing-remitting multiple sclerosis (RRMS); the Company has incurred significant operating expenses since inception and it expects that its operating expenses will continue to significantly increase for the foreseeable future; the Company's license agreement with Janssen Pharmaceutica NV may not result in the successful development of PIPE-307; the Company may be unable to obtain, maintain and enforce intellectual property protection for its technology and drug candidates; and unstable macroeconomic and market and economic conditions and uncertainty caused by, among other things, geopolitical conditions, tariffs or threatened tariffs, inflation volatility, and military conflict may adversely affect the Company's business and financial condition and the broader economy and biotechnology industry. Additional risks and uncertainties that could affect the Company's business, operations and results are included under the captions, 'Risk Factors' and "Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's periodic filings and in other filings that the Company makes with the Securities and Exchange Commission (SEC) from time to time, which are available on the Company's website at under the Investor section and on the SEC's website at Accordingly, readers should not rely upon forward-looking statements as predictions of future events. Except as required by applicable law, the Company undertakes no obligation to update publicly or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Yahoo
17-03-2025
- Business
- Yahoo
Contineum Therapeutics Announces Appointment of Diego Miralles, M.D. to Its Board of Directors
SAN DIEGO, March 17, 2025--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced the appointment of Diego Miralles, M.D. as a member of its board of directors, effective March 14, 2025. "We are excited to welcome Diego to our board," commented Eef Schimmelpennink, Contineum's Chairperson. "He has successfully led the development of novel therapies throughout his distinguished career and has an extensive track record in both early stage research and all stages of clinical development. During his time at Janssen Research, Dr. Miralles was engaged in the development and approval of several important medicines. He is an accomplished life sciences executive and his perspective in guiding life sciences companies will provide our board with valuable insights as we look ahead to key clinical development and operating milestones." Dr. Miralles has served as Chief Executive Officer at AZURNA Therapeutics, Inc., a private pharmaceutical development company, since January 2024. From December 2020 to September 2022, Dr. Miralles was Chief Executive Officer at Laronde Inc., an early-stage biotechnology company. From August 2017 to September 2020, Dr. Miralles served as Chief Executive Officer at Vividion Therapeutics, Inc., a private biopharmaceutical company. From October 2007 to March 2016, Dr. Miralles held executive positions of increasing responsibility leading various research and clinical development programs at Johnson & Johnson. Dr. Miralles has served on the board of directors of Artiva Biotherapeutics, Inc., a publicly traded biotechnology company, since May 2024 and in January 2025, he was appointed as chair of the Clinical Strategy Committee. Dr. Miralles has also been a member of the board of directors at Rady Children's Institute for Genomic Medicine since 2008 and served as a member of the board of directors at NeuBase Therapeutics, Inc., a public biopharmaceutical company, from April 2019 to April 2021. Dr. Miralles received his M.D. degree from the University of Buenos Aires, his residency in Internal Medicine at the Mayo Clinic and fellowship in Infectious Diseases at The New York Hospital/Cornell University and was on the faculty at Duke University. "I am impressed with Contineum's progress as it works to meet the significant unmet needs in several NI&I indications," stated Dr. Miralles. "The Company's robust pipeline enables multiple opportunities with de-risked, clinically-validated targets. I am thrilled to join a passionate board of directors with a unified vision to help guide the Company as it initiates multiple proof-of-concept clinical trials." About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis, progressive multiple sclerosis and chronic pain, and PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit Forward-Looking Statements Certain statements contained in this press release, other than historical information, constitute forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include, but are not limited to, statements regarding the Company's plans for, and the anticipated benefits of, and market opportunities for its drug candidates, including PIPE-791 and PIPE-307; its business strategies and plans; and the quotations of the Company's management and board members. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond the Company's control and may cause its actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties, include, but are not limited to, the following: the Company is heavily dependent on the success of PIPE-791 and PIPE-307, both of which are in the early stages of clinical development, and neither of these drug candidates may progress through clinical development or receive regulatory approval; the results of earlier preclinical studies and clinical trials, including those conducted by third parties, may not be predictive of future results and unexpected adverse side effects or inadequate efficacy of the Company's drug candidates may limit their development, regulatory approval and/or commercialization; the timing and outcome of research, development and regulatory review is uncertain; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; risks associated with reliance on third parties to successfully conduct clinical trials and, in the case of PIPE-307, the Company's reliance, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson company, to develop PIPE-307 for any other indication other than RRMS and, after completion of the Company's PIPE-307 Phase 2 VISTA trial, Janssen Pharmaceutica NV's decision, in its sole discretion, whether or not to further develop PIPE-307 for RRMS; the Company has incurred significant operating expenses since inception and it expects that its operating expenses will continue to significantly increase for the foreseeable future; the Company's license agreement with Janssen Pharmaceutica NV may not result in the successful development of PIPE-307; the Company may be unable to obtain, maintain and enforce intellectual property protection for its technology and drug candidates; and unstable market and economic conditions and military conflict may adversely affect our business and financial condition and the broader economy and biotechnology industry. Additional risks and uncertainties that could affect the Company's business, operations and results are included under the captions, "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in its most recent filing on Form 10-K and in other filings that it makes with the SEC from time to time. These documents are available on the Company's website at under the Investor section and on the SEC's website at Accordingly, readers should not rely upon forward-looking statements as predictions of future events. Except as required by applicable law, the Company undertakes no obligation to update publicly or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. View source version on Contacts Steve KunszaboContineum TherapeuticsSenior Director, Investor Relations & Corporate Communications858-649-1158skunszabo@
Yahoo
03-03-2025
- Business
- Yahoo
Contineum Therapeutics to Present at the 2025 Leerink Partners Global Healthcare Conference
SAN DIEGO, March 03, 2025--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced that management is scheduled to present at the 2025 Leerink Partners Global Healthcare Conference on Tuesday, March 11th at 3:00 p.m. ET. An audio webcast of the presentation can be accessed on the Investors section of Contineum's website. A webcast replay will also be available. About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis, progressive multiple sclerosis and chronic pain, and PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and depression. For more information, please visit View source version on Contacts Steve KunszaboContineum TherapeuticsSenior Director, Investor Relations & Corporate Communications858-649-1158skunszabo@ Sign in to access your portfolio
