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Business Wire
10 hours ago
- 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
06-03-2025
- Business
- Yahoo
Contineum Therapeutics Reports Fourth-Quarter 2024 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 - 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, March 06, 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 fourth-quarter 2024 financial results and affirmed its key clinical development milestones. "2025 is shaping up to be a pivotal year, as we have several important clinical data readouts and trial initiations on the horizon," said Carmine Stengone, CEO, Contineum Therapeutics. "We expect to be sponsoring up to six clinical trials during the course of the year, with key 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 capital that takes us through our critical milestones in 2027, we remain focused on executing against our key clinical development objectives." Key Clinical Development Milestones & Outlook 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 (NCT06683612). The Company anticipates completing its PIPE-791 long-term chronic toxicity studies in the first half of 2025. Upon successful completion of the PIPE-791 chronic toxicity studies, 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 (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 (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. Fourth-Quarter 2024 Financial Results Cash, cash equivalents and marketable securities were $204.8 million as of December 31, 2024. Contineum believes it should have sufficient cash resources to fund its planned operations through 2027. Research and development expenses were $13.0 million, a 62 percent increase from the fourth quarter of 2023, 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 believes 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 $4.0 million, a $2.4 million increase from the fourth quarter of 2023. The increase was primarily driven by higher stock-based compensation expense and employee-related costs. Net loss was $14.6 million for the three months ended December 31, 2024, as compared to $7.8 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, 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 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 or not the PIPE-791 long-term chronic toxicity studies will be successfully completed or the expected timing for completion; 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 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. CONTINEUM THERAPEUTICS, INC. BALANCE SHEETS (in thousands, except share and par value data) December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $ 21,943 $ 15,526 Marketable securities 182,817 109,664 Prepaid expenses and other current assets 1,628 2,516 Total current assets 206,388 127,706 Property and equipment, net 989 678 Other long-term assets 3 1,283 Operating lease right-of-use assets 5,467 719 Total assets $ 212,847 $ 130,386 Liabilities, convertible preferred stock and stockholders' equity (deficit) Current liabilities: Accounts payable $ 1,811 $ 635 Accrued expenses 6,711 4,385 Current portion of operating lease liabilities 1,452 464 Total current liabilities 9,974 5,484 Other long-term liabilities — 110 Operating lease liabilities, net of current portion 4,807 108 Total liabilities 14,781 5,702 Commitments and contingencies (Note 11) Convertible preferred stock, $0.001 par value; no shares authorized, issued, or outstanding at December 31, 2024; authorized shares—16,940,594 at December 31, 2023; issued and outstanding shares—15,906,236 shares at December 31, 2023. — 192,620 Stockholders' equity (deficit): Class A common stock, $0.001 par value; authorized shares—200,000,000 and 39,630,511 at December 31, 2024 and December 31, 2023, respectively; issued and outstanding shares—19,125,377 and 2,349,554 at December 31, 2024 and December 31, 2023, respectively. 19 2 Class B common stock, $0.001 par value; authorized shares—20,000,000 at December 31, 2024; issued and outstanding shares—6,729,172 at December 31, 2024; no shares authorized, issued, or outstanding at December 31, 2023. 7 — Preferred stock, $0.001 par value; authorized shares—10,000,000 at December 31, 2024; no shares issued or outstanding at December 31, 2024; no shares authorized, issued, or outstanding at December 31, 2023 — — Additional paid-in-capital 315,371 7,098 Accumulated deficit (117,402 ) (75,144 ) Accumulated other comprehensive income 71 108 Total stockholders' equity (deficit) 198,066 (67,936 ) Total liabilities, convertible preferred stock and stockholders' equity (deficit) $ 212,847 $ 130,386 CONTINEUM THERAPEUTICS, INC. STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (in thousands, except share and per share data) Three Months EndedDecember 31, Years EndedDecember 31, 2024 2023 2024 2023 Revenue: License revenue $ — $ — $ — $ 50,000 Operating expenses: Research and development 13,014 8,012 38,422 27,603 General and administrative 4,033 1,664 12,472 6,320 Total operating expenses 17,047 9,676 50,894 33,923 Income (loss) from operations (17,047 ) (9,676 ) (50,894 ) 16,077 Other income (expense): Interest income 2,528 1,790 8,905 4,606 Interest expense — — — (208 ) Change in fair value of warrant liability — 3 (106 ) 5 Change in fair value of investor rights and obligations liability — — — 2,867 Other expense, net (46 ) (47 ) (163 ) (177 ) Total other income 2,482 1,746 8,636 7,093 Income (loss) before income taxes (14,565 ) (7,930 ) (42,258 ) 23,170 Provision for (benefit from) income taxes — (161 ) — 450 Net income (loss) $ (14,565 ) $ (7,769 ) $ (42,258 ) $ 22,720 Other comprehensive income (loss): Unrealized gain (loss) on marketable securities (490 ) 197 (37 ) 184 Comprehensive income (loss) $ (15,055 ) $ (7,572 ) $ (42,295 ) $ 22,904 Net income (loss) attributable to common stockholders, basic $ (14,565 ) $ (7,769 ) $ (42,258 ) $ 3,146 Net income (loss) attributable to common stockholders, diluted $ (14,565 ) $ (7,769 ) $ (42,258 ) $ 274 Net income (loss) per share, basic (a) $ (0.56 ) $ (3.32 ) $ (2.18 ) $ 1.36 Net income (loss) per share, diluted (a) $ (0.56 ) $ (3.32 ) $ (2.18 ) $ 0.08 Weighted-average shares of common stock outstanding, basic 25,815,670 2,337,436 19,352,859 2,308,972 Weighted-average shares of common stock outstanding, diluted 25,815,670 2,337,436 19,352,859 3,395,514 _____________ (a) Basic and diluted per share amounts are the same for Class A and Class B shares. View source version on Contacts Steve KunszaboContineum TherapeuticsSenior Director, Investor Relations & Corporate Communications858-649-1158skunszabo@ Sign in to access your portfolio
