CTNM
Contineum TherapeuticsDDocument history
Earnings documents stored for CTNM.
Investor releaseQuarter not tagged2026-07-30Contineum Therapeutics Reports Second-Quarter 2026 Financial Results; Affirms Key Clinical Development Milestones
Business Wire
Contineum Therapeutics Reports Second-Quarter 2026 Financial Results; Affirms Key Clinical Development Milestones
SAN DIEGO, July 30, 2026--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated small molecule therapies for inflammatory and fibrotic diseases with significant unmet need, today reported its second-quarter 2026 financial results and affirmed its key clinical development milestones. "We continue to expand our footprint for PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for the treatment of patients with idiopathic pulmonary fibrosis (IPF), with more than 55 sites now online in eight countries to enable a steady pace of enrollment," said Carmine Stengone, CEO, Contineum Therapeutics. "In addition, Johnson & Johnson completed enrollment last month for its Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 in patients with major depressive disorder (MDD)." Research Updates Contineum has streamlined its discovery programs to focus on drug candidates for the treatment of inflammatory and fibrotic diseases. These actions have resulted in a limited workforce reduction for the Company’s research team, including Contineum’s Chief Scientific Officer, Daniel Lorrain, Ph.D. "We’re focused on advancing our highest potential and greatest probability-of-success clinical programs, led by our global Phase 2 PROPEL-IPF trial," said Carmine Stengone, CEO, Contineum Therapeutics. "We are dedicating our discovery, translational science and clinical development resources to align behind advancing potential treatments for inflammatory and fibrotic diseases. With a projected cash runway that extends through mid-2029, which is approximately one year past the estimated completion of our IPF trial, we are maintaining a disciplined approach to capital allocation." Stengone continued, "We’re grateful to Dan for his years of leadership, service and contributions in founding and helping build Contineum into the world-class organization it is today. I’m also thankful to our research team who work tirelessly to advance novel therapies for patients." Key Clinical Development Milestones The Company initiated patient dosing in PROPEL-IPF, a global Phase 2 clinical trial evaluating PIPE-791 for the treatment of patients with IPF, in the first quarter of 2026. PROPEL-IPF is a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy, safety, tolerability…Read full documentShow less
SAN DIEGO, July 30, 2026--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated small molecule therapies for inflammatory and fibrotic diseases with significant unmet need, today reported its second-quarter 2026 financial results and affirmed its key clinical development milestones. "We continue to expand our footprint for PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for the treatment of patients with idiopathic pulmonary fibrosis (IPF), with more than 55 sites now online in eight countries to enable a steady pace of enrollment," said Carmine Stengone, CEO, Contineum Therapeutics. "In addition, Johnson & Johnson completed enrollment last month for its Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 in patients with major depressive disorder (MDD)." Research Updates Contineum has streamlined its discovery programs to focus on drug candidates for the treatment of inflammatory and fibrotic diseases. These actions have resulted in a limited workforce reduction for the Company’s research team, including Contineum’s Chief Scientific Officer, Daniel Lorrain, Ph.D. "We’re focused on advancing our highest potential and greatest probability-of-success clinical programs, led by our global Phase 2 PROPEL-IPF trial," said Carmine Stengone, CEO, Contineum Therapeutics. "We are dedicating our discovery, translational science and clinical development resources to align behind advancing potential treatments for inflammatory and fibrotic diseases. With a projected cash runway that extends through mid-2029, which is approximately one year past the estimated completion of our IPF trial, we are maintaining a disciplined approach to capital allocation." Stengone continued, "We’re grateful to Dan for his years of leadership, service and contributions in founding and helping build Contineum into the world-class organization it is today. I’m also thankful to our research team who work tirelessly to advance novel therapies for patients." Key Clinical Development Milestones The Company initiated patient dosing in PROPEL-IPF, a global Phase 2 clinical trial evaluating PIPE-791 for the treatment of patients with IPF, in the first quarter of 2026. PROPEL-IPF is a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy, safety, tolerability and pharmacokinetics of once-daily, oral PIPE-791 in approximately 324 IPF patients. The primary efficacy endpoint is the change from baseline through week 26 in absolute forced vital capacity (FVC mL). More information on this trial can be found at https://clinicaltrials.gov (NCT07284459). Johnson & Johnson completed enrollment of 107 adult participants for its Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 in June 2026. This randomized, double-blind, multicenter, placebo-controlled, proof-of-concept trial is evaluating the efficacy, safety and tolerability of JNJ-5120/PIPE-307 as monotherapy in adult participants with major depressive disorder (MDD). More information on this trial can be found at https://clinicaltrials.gov (NCT06785012). On April 30, 2026, the Company reported positive topline data from its exploratory Phase 1b trial of PIPE-791 for the non-opioid treatment of chronic osteoarthritis pain or chronic low back pain. The trial met its primary objective of assessing safety and tolerability, demonstrating an adverse event profile generally consistent with previous PIPE-791 clinical trials. In addition, patients treated with PIPE-791 generally demonstrated improvements from baseline in pain that were numerically greater than the placebo arm. Contineum believes these data support further evaluation of PIPE-791 for the potential treatment of chronic pain. More information on this trial can be found at https://clinicaltrials.gov (NCT06810245). Second-Quarter 2026 Financial Results Cash, cash equivalents and marketable securities were $236.6 million as of June 30, 2026. Contineum believes its cash resources are sufficient to fund its planned operations through mid-2029. Research and development expenses were $12.7 million, a 10 percent decrease from the second quarter of 2025. This decrease was primarily driven by a reduction in expenses related to the completion of the Company’s PIPE-307 VISTA trial and lower costs related to the PIPE-791 chronic pain trial, partially offset by increased expenses for the PIPE-791 IPF program and higher employee-related costs. General and administrative expenses were $4.7 million, a 23 percent increase from the second quarter of 2025. The increase was primarily driven by higher stock-based compensation and employee-related costs. Net loss was $15.2 million for the three months ended June 30, 2026, as compared to $16.0 million for the second quarter of 2025. About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for inflammatory and fibrotic diseases 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 and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for major depressive disorder. For more information, please visit www.contineum-tx.com. 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, implied or express statements regarding the pharmacological properties, safety, tolerability, clinical response and efficacy, and therapeutic potential of PIPE-791 and PIPE-307; the enrollment and estimated completion date of the Company’s global Phase 2 clinical trial in IPF; the Company’s cash runway; the indications, anticipated benefits of, and market opportunities for the Company’s drug candidates; the Company’s 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, events, 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 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; the FDA or comparable foreign regulatory authorities may disagree as to the design or implementation of our proposed clinical trials; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the Company may use its capital resources sooner than expected and they may be insufficient to allow the Company to achieve its anticipated milestones; 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; the Company’s reliance, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson company, to develop, in its sole discretion, PIPE-307 for MDD or for any other indication; the restrictions contained in the Company’s global license and development agreement with Janssen Pharmaceutica NV limiting the Company’s access to, and restricting the Company from disclosing, certain information regarding the development of PIPE-307; 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 ability to operate in a competitive industry and compete successfully against competitors that have greater resources than the Company does; 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 conflicts 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 www.contineum-tx.com under the Investor section and on the SEC’s website at www.sec.gov. 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 businesswire.com: https://www.businesswire.com/news/home/20260730847164/en/ Contacts Steve KunszaboContineum TherapeuticsSenior Director, Investor Relations & Corporate [email protected]
Investor releaseQuarter not tagged2026-05-06Contineum Therapeutics Reports First-Quarter 2026 Financial Results; Affirms Key Clinical Development Milestones
Business Wire
Contineum Therapeutics Reports First-Quarter 2026 Financial Results; Affirms Key Clinical Development Milestones
SAN DIEGO, May 05, 2026--(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 reported its first-quarter 2026 financial results and affirmed its key clinical development milestones. "We’re excited to have recently shared positive topline results from our chronic pain trial," said Carmine Stengone, CEO, Contineum Therapeutics. "We continue to steadily enroll PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for the treatment of patients with idiopathic pulmonary fibrosis (IPF). With a projected cash runway that extends through mid-2029, which is approximately one year past the estimated completion of our IPF trial, we are maintaining a disciplined approach to capital allocation that prioritizes our lead clinical indication, while thoughtfully considering the advancement of other programs." Key Clinical Development Milestones On April 30, 2026, the Company reported positive topline data from its exploratory Phase 1b trial of PIPE-791 for the non-opioid treatment of chronic osteoarthritis pain or chronic low back pain. The trial met its primary objective of assessing safety and tolerability, demonstrating an adverse event profile generally consistent with previous PIPE-791 clinical trials. In addition, patients treated with PIPE-791 generally demonstrated improvements from baseline in pain that were numerically greater than the placebo arm. Contineum believes these data support further evaluation and development of PIPE-791 for the potential treatment of chronic pain. More information on this trial can be found at https://clinicaltrials.gov (NCT06810245). The Company initiated patient dosing in PROPEL-IPF, a global Phase 2 clinical trial evaluating PIPE-791 for the treatment of patients with IPF, in the first quarter of 2026. PROPEL-IPF is a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy, safety, tolerability and pharmacokinetics of once-daily, oral PIPE-791 in approximately 324 IPF patients. The primary efficacy endpoint is the change from baseline through week 26 in absolute forced vital capacity (FVC mL). More information on this trial can be found at https://clinicaltrials.gov (NCT07284459). In December 202…Read full documentShow less
SAN DIEGO, May 05, 2026--(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 reported its first-quarter 2026 financial results and affirmed its key clinical development milestones. "We’re excited to have recently shared positive topline results from our chronic pain trial," said Carmine Stengone, CEO, Contineum Therapeutics. "We continue to steadily enroll PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for the treatment of patients with idiopathic pulmonary fibrosis (IPF). With a projected cash runway that extends through mid-2029, which is approximately one year past the estimated completion of our IPF trial, we are maintaining a disciplined approach to capital allocation that prioritizes our lead clinical indication, while thoughtfully considering the advancement of other programs." Key Clinical Development Milestones On April 30, 2026, the Company reported positive topline data from its exploratory Phase 1b trial of PIPE-791 for the non-opioid treatment of chronic osteoarthritis pain or chronic low back pain. The trial met its primary objective of assessing safety and tolerability, demonstrating an adverse event profile generally consistent with previous PIPE-791 clinical trials. In addition, patients treated with PIPE-791 generally demonstrated improvements from baseline in pain that were numerically greater than the placebo arm. Contineum believes these data support further evaluation and development of PIPE-791 for the potential treatment of chronic pain. More information on this trial can be found at https://clinicaltrials.gov (NCT06810245). The Company initiated patient dosing in PROPEL-IPF, a global Phase 2 clinical trial evaluating PIPE-791 for the treatment of patients with IPF, in the first quarter of 2026. PROPEL-IPF is a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy, safety, tolerability and pharmacokinetics of once-daily, oral PIPE-791 in approximately 324 IPF patients. The primary efficacy endpoint is the change from baseline through week 26 in absolute forced vital capacity (FVC mL). More information on this trial can be found at https://clinicaltrials.gov (NCT07284459). In December 2024, Johnson & Johnson began recruiting an estimated 124 adult participants for a Phase 2 Moonlight-1 trial of PIPE-307/JNJ-89495120. Estimated trial completion is June 2026. This randomized, double-blind, multicenter, placebo-controlled, proof-of-concept trial is evaluating the efficacy, safety and tolerability of PIPE-307/JNJ-89495120 as monotherapy in adult participants with major depressive disorder (MDD). More information on this trial can be found at https://clinicaltrials.gov (NCT06785012). First-Quarter 2026 Financial Results Cash, cash equivalents and marketable securities were $246.3 million as of March 31, 2026. Contineum believes its cash resources are sufficient to fund its planned operations through mid-2029. Research and development expenses were $11.6 million, a 15 percent decrease from the first quarter of 2025. This decrease was primarily driven by a reduction in expenses related to the completion of the Company’s PIPE-307 VISTA trial and lower costs related to the PIPE-791 PET trial, partially offset by increased expenses for the PIPE-791 IPF program and higher employee-related costs. General and administrative expenses were $5.3 million, a 20 percent increase from the first quarter of 2025. The increase was primarily driven by higher stock-based compensation and employee-related costs. Net loss was $14.5 million for the three months ended March 31, 2026, as compared to $16.0 million for the first quarter of 2025. 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 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 www.contineum-tx.com. 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, implied or express statements regarding the pharmacological properties, safety, tolerability, clinical response and efficacy, and therapeutic potential of PIPE-791 for the treatment of chronic pain or IPF; the potential of the data from the Company’s exploratory Phase 1b chronic pain trial to predict future clinical outcomes or results; the enrollment and estimated completion date of the Company’s global Phase 2 clinical trial in IPF; the estimated completion date of the Phase 2 Moonlight-1 trial of PIPE-307/JNJ-89495120; the Company’s cash runway; the indications, anticipated benefits of, and market opportunities for the Company’s drug candidates; the Company’s 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, events, 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 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; the FDA or comparable foreign regulatory authorities may disagree as to the design or implementation of our proposed clinical trials; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the Company may use its capital resources sooner than expected and they may be insufficient to allow the Company to achieve its anticipated milestones; 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; the Company’s reliance, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson company, to develop, in its sole discretion, PIPE-307 for relapsing-remitting multiple sclerosis, MDD or for any other indication; the restrictions contained in the Company’s global license and development agreement with Janssen Pharmaceutica NV limiting the Company’s access to, and restricting the Company from disclosing, certain information regarding the development of PIPE-307; 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 ability to operate in a competitive industry and compete successfully against competitors that have greater resources than the Company does; 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 conflicts 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 www.contineum-tx.com under the Investor section and on the SEC’s website at www.sec.gov. 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 businesswire.com: https://www.businesswire.com/news/home/20260505645392/en/ Contacts Steve Kunszabo Contineum Therapeutics Senior Director, Investor Relations & Corporate Communications 858-649-1158 [email protected]
Investor releaseQuarter not tagged2026-03-06Contineum Therapeutics Reports Fourth-Quarter 2025 Financial Results; Affirms Key Clinical Development Milestones
Business Wire
Contineum Therapeutics Reports Fourth-Quarter 2025 Financial Results; Affirms Key Clinical Development Milestones
- Patient dosing initiated in PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for the treatment of patients with idiopathic pulmonary fibrosis (IPF) - Topline data from the exploratory PIPE-791 Phase 1b trial in patients with chronic pain is expected in the second quarter of 2026 SAN DIEGO, March 05, 2026--(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 reported its fourth-quarter 2025 financial results and affirmed its key clinical development milestones. "We’re off to a strong start in 2026, having recently dosed the first patient in our global Phase 2 idiopathic pulmonary fibrosis (IPF) trial," said Carmine Stengone, CEO, Contineum Therapeutics. "IPF is a devastating disease that profoundly impacts patients and their families. We’re urgently advancing PIPE-791 with the goal of developing a transformative therapy that we believe could address the limitations of current treatments. PIPE-791 may potentially offer an improved dosing, efficacy and tolerability profile to enable sustainable management of this unrelenting disease." Stengone continued, "With a projected cash runway that extends into mid-2029, which is approximately one year past the estimated completion of our IPF trial, we are maintaining a disciplined approach to capital allocation that prioritizes our lead clinical program, while thoughtfully advancing select discovery programs." Key Clinical Development Milestones Contineum has initiated patient dosing in PROPEL-IPF, a global Phase 2 clinical trial evaluating PIPE-791 for the treatment of patients with IPF. PROPEL-IPF is a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy, safety, tolerability and pharmacokinetics of once-daily, oral PIPE-791 in approximately 324 IPF patients. The primary efficacy endpoint is the change from baseline through week 26 in absolute forced vital capacity (FVC mL). More information on this trial can be found at https://clinicaltrials.gov (NCT07284459). The Company anticipates reporting topline data from its exploratory PIPE-791 Phase 1b trial in patients with chronic osteoarthritis pain or chronic lower back pain in the second quarter of 2026. This randomized,…Read full documentShow less
- Patient dosing initiated in PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for the treatment of patients with idiopathic pulmonary fibrosis (IPF) - Topline data from the exploratory PIPE-791 Phase 1b trial in patients with chronic pain is expected in the second quarter of 2026 SAN DIEGO, March 05, 2026--(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 reported its fourth-quarter 2025 financial results and affirmed its key clinical development milestones. "We’re off to a strong start in 2026, having recently dosed the first patient in our global Phase 2 idiopathic pulmonary fibrosis (IPF) trial," said Carmine Stengone, CEO, Contineum Therapeutics. "IPF is a devastating disease that profoundly impacts patients and their families. We’re urgently advancing PIPE-791 with the goal of developing a transformative therapy that we believe could address the limitations of current treatments. PIPE-791 may potentially offer an improved dosing, efficacy and tolerability profile to enable sustainable management of this unrelenting disease." Stengone continued, "With a projected cash runway that extends into mid-2029, which is approximately one year past the estimated completion of our IPF trial, we are maintaining a disciplined approach to capital allocation that prioritizes our lead clinical program, while thoughtfully advancing select discovery programs." Key Clinical Development Milestones Contineum has initiated patient dosing in PROPEL-IPF, a global Phase 2 clinical trial evaluating PIPE-791 for the treatment of patients with IPF. PROPEL-IPF is a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy, safety, tolerability and pharmacokinetics of once-daily, oral PIPE-791 in approximately 324 IPF patients. The primary efficacy endpoint is the change from baseline through week 26 in absolute forced vital capacity (FVC mL). More information on this trial can be found at https://clinicaltrials.gov (NCT07284459). The Company anticipates reporting topline data from its exploratory PIPE-791 Phase 1b trial in patients with chronic osteoarthritis pain or chronic lower back pain in the second quarter of 2026. This randomized, double-blind, placebo-controlled, crossover trial initiated patient dosing in March 2025. More information on this trial can be found at https://clinicaltrials.gov (NCT06810245). In December 2024, Johnson & Johnson began recruiting an estimated 124 adult participants for a Phase 2 Moonlight-1 trial of PIPE-307/JNJ-89495120. This randomized, double-blind, multicenter, placebo-controlled, proof-of-concept trial is evaluating the efficacy, safety and tolerability of PIPE-307/JNJ-89495120 as monotherapy in adult participants with major depressive disorder (MDD). More information on this trial can be found at https://clinicaltrials.gov (NCT06785012). Fourth-Quarter 2025 Financial Results Cash, cash equivalents and marketable securities were $262.9 million as of December 31, 2025. Contineum believes its cash resources are sufficient to fund its planned operations through mid-2029. During the fourth quarter, the Company completed an upsized public offering that generated net proceeds of $93.0 million from the issuance of approximately 8.1 million shares of Class A common stock at a price of $12.25. Research and development expenses were $12.8 million, a 2 percent decrease from the fourth quarter of 2024. This decrease was primarily driven by a reduction in expenses related to the completion of the Company’s PIPE-307 VISTA trial and lower costs for the CTX-343 program, partially offset by increased expenses for the PIPE-791 programs and higher employee-related costs. General and administrative expenses were $4.4 million, an 8 percent increase from the fourth quarter of 2024. The increase was primarily driven by higher stock-based compensation and employee-related costs. Net loss was $15.2 million for the three months ended December 31, 2025, as compared to $14.6 million for the prior-year quarter. 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 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 www.contineum-tx.com. 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 potential for PIPE-791 to be a transformative therapy and the pharmacological properties, safety, efficacy, tolerability and therapeutic potential of PIPE-791; the expected timing of topline data from the exploratory Phase 1b chronic pain trial; the estimated completion date of the Company’s global Phase 2 clinical trial in IPF; the Company’s cash runway; the indications, anticipated benefits of, and market opportunities for the Company’s drug candidates; the Company’s 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, events, 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; the FDA or comparable foreign regulatory authorities may disagree as to the design or implementation of our proposed clinical trials; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the Company may use its capital resources sooner than expected and they may be insufficient to allow the Company to achieve its anticipated milestones; 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; the Company’s reliance, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson company, to develop, in its sole discretion, PIPE-307 for relapsing-remitting multiple sclerosis, MDD or for any other indication; the restrictions contained in the Company’s global license and development agreement with Janssen Pharmaceutica NV limiting the Company’s access to, and restricting the Company from disclosing, certain information regarding the development of PIPE-307; 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 ability to operate in a competitive industry and compete successfully against competitors that have greater resources than the Company does; 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 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 www.contineum-tx.com under the Investor section and on the SEC’s website at www.sec.gov. 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 businesswire.com: https://www.businesswire.com/news/home/20260305029664/en/ Contacts Steve Kunszabo Contineum Therapeutics Senior Director, Investor Relations & Corporate Communications 858-649-1158 [email protected]
Investor releaseQuarter not tagged2025-10-31Contineum Therapeutics Reports Third-Quarter 2025 Financial Results; Affirms Key Clinical Development Milestones
Business Wire
Contineum Therapeutics Reports Third-Quarter 2025 Financial Results; Affirms Key Clinical Development Milestones
- Topline data from the PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) is anticipated in the fourth quarter of 2025 - Initiation of a global Phase 2 clinical trial of PIPE-791 in idiopathic pulmonary fibrosis (IPF) in the fourth quarter of 2025 - Projected cash runway extended to fund planned operations through 2028 SAN DIEGO, October 30, 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 reported its third-quarter 2025 financial results and affirmed its key clinical development milestones. "We have several important catalysts on the horizon during the next 12 months for our key programs," said Carmine Stengone, CEO, Contineum Therapeutics. "First, we expect to report topline data from our PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) before the end of the year. We’re also on the cusp of initiating a comprehensive global Phase 2 clinical trial in idiopathic pulmonary fibrosis (IPF). Finally, we anticipate our PIPE-791 Phase 1b chronic pain trial will read out topline data in the first half of 2026." Key Clinical Development Milestones In September 2025, Contineum announced positive topline data from its PIPE-791 Phase 1b positron emission tomography (PET) trial. The trial met its primary objectives by demonstrating PIPE-791 achieved high brain receptor occupancy in healthy volunteers and progressive multiple sclerosis (PrMS) patients with a clear pharmacokinetic correlation between drug exposure and receptor engagement. PIPE-791 also demonstrated a safety and tolerability profile consistent with the Company’s previous clinical studies. The Company expects to report topline data from its ongoing PIPE-307 Phase 2 VISTA RRMS trial in the fourth quarter of 2025. This randomized, double-blind, placebo-controlled, multi-center, proof-of-concept trial is evaluating safety and efficacy in RRMS patients including clinical and imaging endpoints sensitive to remyelination. More information on this trial can be found at https://clinicaltrials.gov (NCT06083753). Contineum is proceeding with activities supporting the launch of its planned global PIPE-791 Phase 2 clin…Read full documentShow less
- Topline data from the PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) is anticipated in the fourth quarter of 2025 - Initiation of a global Phase 2 clinical trial of PIPE-791 in idiopathic pulmonary fibrosis (IPF) in the fourth quarter of 2025 - Projected cash runway extended to fund planned operations through 2028 SAN DIEGO, October 30, 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 reported its third-quarter 2025 financial results and affirmed its key clinical development milestones. "We have several important catalysts on the horizon during the next 12 months for our key programs," said Carmine Stengone, CEO, Contineum Therapeutics. "First, we expect to report topline data from our PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) before the end of the year. We’re also on the cusp of initiating a comprehensive global Phase 2 clinical trial in idiopathic pulmonary fibrosis (IPF). Finally, we anticipate our PIPE-791 Phase 1b chronic pain trial will read out topline data in the first half of 2026." Key Clinical Development Milestones In September 2025, Contineum announced positive topline data from its PIPE-791 Phase 1b positron emission tomography (PET) trial. The trial met its primary objectives by demonstrating PIPE-791 achieved high brain receptor occupancy in healthy volunteers and progressive multiple sclerosis (PrMS) patients with a clear pharmacokinetic correlation between drug exposure and receptor engagement. PIPE-791 also demonstrated a safety and tolerability profile consistent with the Company’s previous clinical studies. The Company expects to report topline data from its ongoing PIPE-307 Phase 2 VISTA RRMS trial in the fourth quarter of 2025. This randomized, double-blind, placebo-controlled, multi-center, proof-of-concept trial is evaluating safety and efficacy in RRMS patients including clinical and imaging endpoints sensitive to remyelination. More information on this trial can be found at https://clinicaltrials.gov (NCT06083753). Contineum is proceeding with activities supporting the launch of its planned global PIPE-791 Phase 2 clinical trial in IPF. This trial is expected to be initiated in the fourth quarter of 2025. The Company anticipates reporting topline data from its exploratory PIPE-791 Phase 1b trial in patients with chronic pain in the first half of 2026. This randomized, double-blind, placebo-controlled, crossover trial initiated patient dosing in March 2025. PIPE-791 is being evaluated for the treatment of patients with chronic osteoarthritis pain and chronic lower back pain. More information on this trial can be found at https://clinicaltrials.gov (NCT06810245). In December 2024, Johnson & Johnson began recruiting an estimated 124 adult participants for a Phase 2 Moonlight-1 trial of PIPE-307/JNJ-89495120. This trial is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety and tolerability of PIPE-307/JNJ-89495120 as monotherapy in adult participants with major depressive disorder (MDD). More information on this trial can be found at https://clinicaltrials.gov (NCT06785012). Operational Update The Company has made a strategic decision to defer initiation of its PIPE-791 PrMS and CTX-343 clinical development efforts. As a result, the Company has extended its projected cash runway to fund planned operations through 2028. Peter Slover, Chief Financial Officer, Contineum Therapeutics, stated, "With a cash runway that is now projected to extend through 2028, we’re fostering a disciplined approach to capital allocation that prioritizes our key programs and clinical development inflection points across our portfolio." Third-Quarter 2025 Financial Results Cash, cash equivalents and marketable securities were $182.4 million as of September 30, 2025. Contineum believes it should have sufficient cash resources to fund its planned operations through 2028. During the third quarter, the Company generated net proceeds of $19.0 million from the issuance of approximately 3.2 million shares of Class A common stock in at-the-market (ATM) offerings at a weighted average price of $6.04 per share. Research and development expenses were $11.0 million, a 13 percent increase from the third quarter of 2024, largely due to higher clinical development expenses related to the advancement of the Company’s PIPE-791 and PIPE-307 programs and higher employee-related costs. General and administrative expenses were $3.9 million, a 21 percent increase from the third quarter of 2024. The increase was primarily driven by higher stock-based compensation and employee-related costs. Net loss was $12.8 million for the three months ended September 30, 2025, as compared to $10.3 million for the prior-year quarter. 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 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 www.contineum-tx.com. 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, statements regarding the Company’s expectations related to the regulatory submission process and expected timing of the initiation of the Company’s global Phase 2 clinical trial in IPF; the expected timing of topline data from the PIPE-307 Phase 2 VISTA RRMS trial, or from the exploratory Phase 1b chronic pain trial; the pharmacological properties, safety, tolerability and therapeutic potential of PIPE-791; the Company’s cash runway; the indications, anticipated benefits of, and market opportunities for the Company’s drug candidates; the Company’s 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, events, 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; the FDA or comparable foreign regulatory authorities may disagree as to the design or implementation of our proposed clinical trials; 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 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; the restrictions contained in the Company’s global license and development agreement with Janssen Pharmaceutica NV limiting the Company’s access to, and restricting the Company from disclosing, certain information regarding the development of PIPE-307; 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 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 www.contineum-tx.com under the Investor section and on the SEC’s website at www.sec.gov. 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 businesswire.com: https://www.businesswire.com/news/home/20251030221332/en/ Contacts Steve Kunszabo Contineum Therapeutics Senior Director, Investor Relations & Corporate Communications 858-649-1158 [email protected]
Investor releaseQuarter not tagged2025-08-06Contineum Therapeutics Reports Second-Quarter 2025 Financial Results; Updates Key Clinical Development Milestones
Business Wire
Contineum Therapeutics Reports Second-Quarter 2025 Financial Results; Updates Key Clinical Development Milestones
- Topline data from the PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) is anticipated in the fourth quarter of 2025 - Initiation of a global Phase 2 proof-of-concept clinical trial of PIPE-791 in idiopathic pulmonary fibrosis (IPF) in the fourth quarter of 2025 - Cash runway projected to fund operations through 2027 SAN DIEGO, August 05, 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 reported its second-quarter 2025 financial results and updated its key clinical development milestones. Key Clinical Development Milestones The Company expects to report topline data from its ongoing PIPE-307 Phase 2 VISTA relapsing-remitting multiple sclerosis (RRMS) trial in the fourth quarter of 2025. This randomized, double-blind, placebo-controlled, multi-center, proof-of-concept trial is evaluating safety and efficacy in RRMS patients including clinical and imaging endpoints sensitive to remyelination. More information on this trial can be found at https://clinicaltrials.gov (NCT06083753). Contineum expects to report topline data from its PIPE-791 Phase 1b Positron Emission Tomography (PET) trial in the third quarter of 2025. This open-label, single-center trial is designed to assess the correlation between pharmacokinetics and lysophosphatidic acid 1 (LPA1) receptor occupancy using PET imaging to help guide dose selection in the next stages of clinical development. More information on this trial can be found at https://clinicaltrials.gov (NCT06683612). The Company is proceeding with activities related to the submission of regulatory applications with foreign regulatory authorities, and with the U.S. Food & Drug Administration (FDA), in support of its planned global PIPE-791 Phase 2 proof-of-concept clinical trial in IPF. This trial is expected to be initiated in the fourth quarter of 2025. In order to focus internal clinical resources on the PIPE-791 IPF program, the Company has postponed the initiation of its planned PIPE-791 Phase 2 clinical trial in progressive multiple sclerosis (PrMS) and the advancement of CTX-343 to first-in-human studies. The Company anticipates reporting topline data from its explorator…Read full documentShow less
- Topline data from the PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) is anticipated in the fourth quarter of 2025 - Initiation of a global Phase 2 proof-of-concept clinical trial of PIPE-791 in idiopathic pulmonary fibrosis (IPF) in the fourth quarter of 2025 - Cash runway projected to fund operations through 2027 SAN DIEGO, August 05, 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 reported its second-quarter 2025 financial results and updated its key clinical development milestones. Key Clinical Development Milestones The Company expects to report topline data from its ongoing PIPE-307 Phase 2 VISTA relapsing-remitting multiple sclerosis (RRMS) trial in the fourth quarter of 2025. This randomized, double-blind, placebo-controlled, multi-center, proof-of-concept trial is evaluating safety and efficacy in RRMS patients including clinical and imaging endpoints sensitive to remyelination. More information on this trial can be found at https://clinicaltrials.gov (NCT06083753). Contineum expects to report topline data from its PIPE-791 Phase 1b Positron Emission Tomography (PET) trial in the third quarter of 2025. This open-label, single-center trial is designed to assess the correlation between pharmacokinetics and lysophosphatidic acid 1 (LPA1) receptor occupancy using PET imaging to help guide dose selection in the next stages of clinical development. More information on this trial can be found at https://clinicaltrials.gov (NCT06683612). The Company is proceeding with activities related to the submission of regulatory applications with foreign regulatory authorities, and with the U.S. Food & Drug Administration (FDA), in support of its planned global PIPE-791 Phase 2 proof-of-concept clinical trial in IPF. This trial is expected to be initiated in the fourth quarter of 2025. In order to focus internal clinical resources on the PIPE-791 IPF program, the Company has postponed the initiation of its planned PIPE-791 Phase 2 clinical trial in progressive multiple sclerosis (PrMS) and the advancement of CTX-343 to first-in-human studies. The Company anticipates reporting topline data from its exploratory PIPE-791 Phase 1b trial in patients with chronic pain in the first half of 2026. This randomized, double-blind, placebo-controlled, crossover trial initiated patient dosing in March 2025. PIPE-791 is being evaluated for the treatment of patients with chronic osteoarthritis pain and chronic lower back pain. More information on this trial can be found at https://clincialtrials.gov (NCT06810245). In December 2024, Johnson & Johnson began recruiting an estimated 124 adult participants for a Phase 2 Moonlight-1 trial of PIPE-307/JNJ-89495120. This trial is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety and tolerability of PIPE-307/JNJ-89495120 as monotherapy in adult participants with major depressive disorder (MDD). More information on this trial can be found at https://clinicaltrials.gov (NCT06785012). "We continue to make significant progress with our lead programs and have taken several important steps to focus our key clinical development efforts," said Carmine Stengone, CEO, Contineum Therapeutics. "We’re focused on initiating a comprehensive, well-designed global Phase 2 proof-of-concept trial in IPF by year-end. In parallel, we elected to postpone the initiation of our planned PIPE-791 PrMS and CTX-343 clinical trials in order to concentrate internal clinical resources on our IPF trial. We also expect to report topline data from our PIPE-307 Phase 2 VISTA trial for the treatment of RRMS in the fourth quarter of 2025. This topline data readout could provide the first evidence of remyelination in this challenging disease setting, while representing a critical step in delivering a novel therapy for patients in need." Stengone continued, "With a cash runway that is projected to extend through 2027, our near-term objectives are advancing the PIPE-307 partnered programs and PIPE-791 IPF program through critical milestones." Second-Quarter 2025 Financial Results Cash, cash equivalents and marketable securities were $175.5 million as of June 30, 2025. Contineum believes it should have sufficient cash resources to fund its planned operations through 2027. During July 2025, the Company generated net proceeds of approximately $8.4 million from the issuance of 2,122,000 shares of Class A common stock in an at-the-market (ATM) offering at a weighted average price of $4.03 per share. Research and development expenses were $14.1 million, a 78 percent increase from the second quarter of 2024, largely due to higher clinical development expenses related to the advancement of the Company’s PIPE-791 and PIPE-307 programs and higher employee-related costs. General and administrative expenses were $3.8 million, a 26 percent increase from the second quarter of 2024. The increase was primarily driven by higher stock-based compensation expense and employee-related costs. Net loss was $16.0 million for the three months ended June 30, 2025, as compared to $9.0 million for the prior-year quarter. 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 www.contineum-tx.com. 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, the Company’s expectations related to the regulatory submission process and expected timing of the initiation of the Company’s Phase 2 proof-of-concept clinical trial in IPF; the expected timing of topline data from the PIPE-307 Phase 2 VISTA RRMS trial, the PIPE-791 Phase 1b PET trial or from the exploratory Phase 1b chronic pain trial; the Company’s cash runway; the indications, anticipated benefits of, and market opportunities for the Company’s drug candidates; the Company’s 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; the FDA or comparable foreign regulatory authorities may disagree as to the design or implementation of our proposed clinical trials; 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 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; 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 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 www.contineum-tx.com under the Investor section and on the SEC’s website at www.sec.gov. 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 businesswire.com: https://www.businesswire.com/news/home/20250805005342/en/ Contacts Steve Kunszabo Contineum Therapeutics Senior Director, Investor Relations & Corporate Communications 858-649-1158 [email protected]
Investor releaseQuarter not tagged2025-05-15Contineum Therapeutics Reports First-Quarter 2025 Financial Results; Affirms Key Clinical Development Milestones
Business Wire
Contineum Therapeutics Reports First-Quarter 2025 Financial Results; Affirms Key Clinical Development Milestones
- Topline data from PIPE-791 Phase 1b positron emission tomography (PET) trial expected in the second quarter of 2025 - PIPE-791 chronic toxicity studies completed to support future Phase 2 trials - Topline data from PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) anticipated in the second half of 2025 - Cash runway projected through 2027 SAN DIEGO, May 14, 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 reported its first-quarter 2025 financial results and affirmed its key clinical development milestones. "We remain on track to achieve all of our clinical operations milestones and significant clinical data readouts," said Carmine Stengone, CEO, Contineum Therapeutics. "We expect to report topline data from our PIPE-791 Phase 1b positron emission tomography (PET) trial in the second quarter of 2025 and from our PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the second half of 2025." Stengone continued, "Our potentially best-in-class/first-in-class LPA1 and M1 receptor antagonists support our vision of seeking better and new therapies for patients that have limited options today. With a solid balance sheet that carries us through 2027, we remain focused on executing against our clinical development objectives." Key Clinical Development Milestones Contineum expects topline data from its PIPE-791 Phase 1b PET trial in the second quarter of 2025. This Phase 1b, open label, single-center trial is designed to measure the correlation of pharmacokinetics to receptor occupancy by PET imaging in healthy volunteers, as well as idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (PrMS) patients. More information on this trial can be found at https://clinicaltrials.gov (NCT06683612). The Company completed the PIPE-791 chronic toxicity studies required to support future Phase 2 trials. Contineum plans to initiate Phase 2 proof-of-concept clinical trials in IPF and PrMS in the second half of 2025. The Company anticipates topline data from its PIPE-791 Phase 1b chronic pain trial in early 2026. This Phase 1b, randomized, double-blind, plac…Read full documentShow less
- Topline data from PIPE-791 Phase 1b positron emission tomography (PET) trial expected in the second quarter of 2025 - PIPE-791 chronic toxicity studies completed to support future Phase 2 trials - Topline data from PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) anticipated in the second half of 2025 - Cash runway projected through 2027 SAN DIEGO, May 14, 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 reported its first-quarter 2025 financial results and affirmed its key clinical development milestones. "We remain on track to achieve all of our clinical operations milestones and significant clinical data readouts," said Carmine Stengone, CEO, Contineum Therapeutics. "We expect to report topline data from our PIPE-791 Phase 1b positron emission tomography (PET) trial in the second quarter of 2025 and from our PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the second half of 2025." Stengone continued, "Our potentially best-in-class/first-in-class LPA1 and M1 receptor antagonists support our vision of seeking better and new therapies for patients that have limited options today. With a solid balance sheet that carries us through 2027, we remain focused on executing against our clinical development objectives." Key Clinical Development Milestones Contineum expects topline data from its PIPE-791 Phase 1b PET trial in the second quarter of 2025. This Phase 1b, open label, single-center trial is designed to measure the correlation of pharmacokinetics to receptor occupancy by PET imaging in healthy volunteers, as well as idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (PrMS) patients. More information on this trial can be found at https://clinicaltrials.gov (NCT06683612). The Company completed the PIPE-791 chronic toxicity studies required to support future Phase 2 trials. Contineum plans to initiate Phase 2 proof-of-concept clinical trials in IPF and PrMS in the second half of 2025. The Company anticipates topline data from its PIPE-791 Phase 1b chronic pain trial in early 2026. This Phase 1b, randomized, double-blind, placebo-controlled, crossover trial initiated patient dosing in March 2025. PIPE-791 is being evaluated for the treatment of chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP). Contineum expects topline data from its PIPE-307 Phase 2 VISTA RRMS trial in the second half of 2025. This Phase 2, randomized, double-blind, placebo-controlled, multi-center, proof-of-concept trial is designed to assess safety and efficacy in RRMS patients and to measure multiple clinical and imaging endpoints sensitive to changes in remyelination in RRMS. More information on this trial can be found at https://clinicaltrials.gov (NCT06083753). In December 2024, Johnson & Johnson began recruiting an estimated 124 adult participants for a Phase 2 trial of PIPE-307/JNJ-89495120. This trial is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety and tolerability of PIPE-307/JNJ-89495120 as monotherapy in adult participants with major depressive disorder (MDD). More information on this trial can be found at https://clinicaltrials.gov (NCT06785012). The Company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CTX-343 in the second half of 2025. First-Quarter 2025 Financial Results Cash, cash equivalents and marketable securities were $190.7 million as of March 31, 2025. Contineum believes it should have sufficient cash resources to fund its planned operations through 2027. Research and development expenses were $13.7 million, a 76 percent increase from the first quarter of 2024, largely due to higher clinical development expenses related to the advancement of the Company’s PIPE-791 and PIPE-307 programs and higher employee-related costs. The Company continues to believe its full-year 2025 research and development expenses will be significantly higher when compared to the full-year 2024 due to a meaningful increase in clinical development activity across its pipeline. General and administrative expenses were $4.4 million, a $2.2 million increase from the first quarter of 2024. The increase was primarily driven by higher stock-based compensation expense and employee-related costs. Net loss was $16.0 million for the three months ended March 31, 2025, as compared to $8.4 million for the prior-year quarter. 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 www.contineum-tx.com. 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, the expected timing of the topline data from the PIPE-791 Phase 1b PET trial or from the PIPE-307 Phase 2 VISTA RRMS trial; whether the results of the completed toxicology studies will be sufficient to support the initiation of the Company’s Phase 2 proof-of-concept clinical trials in IPF and PrMS; the Company’s expectations related to the FDA submission process and timelines for CTX-343; its cash runway; 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 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; 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 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 www.contineum-tx.com under the Investor section and on the SEC’s website at www.sec.gov. 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 businesswire.com: https://www.businesswire.com/news/home/20250514693739/en/ Contacts Steve KunszaboContineum TherapeuticsSenior Director, Investor Relations & Corporate [email protected]

