Contineum Therapeutics, Inc.(CTNM)

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Contineum Therapeutics Reports Positive Topline Data From Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791
Businesswire· 2025-09-18 12:05
Core Insights - Contineum Therapeutics, Inc. announced positive topline data from its PIPE-791 Phase 1b PET trial, achieving its primary objectives [1] Company Overview - Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for neuroscience, inflammation, and immunology indications [1]
Contineum Therapeutics (NasdaqGS:CTNM) 2025 Conference Transcript
2025-09-09 19:02
Summary of Contineum Therapeutics Conference Call Company Overview - **Company Name**: Contineum Therapeutics (NasdaqGS:CTNM) - **Focus Areas**: Neuroscience, Inflammation, and Immunology - **Clinical Stage Assets**: Two main assets PIPE-791 and PIPE-307, with multiple near-term readouts expected [3][6] Key Points on Clinical Development - **PIPE-791**: - A first-in-class brain-penetrant inhibitor of the LPA-1 receptor, currently advancing in Idiopathic Pulmonary Fibrosis (IPF) [4][5] - Phase 2 clinical proof-of-concept study expected to initiate before the end of 2025 [4] - Upcoming data on phase 1B PET receptor occupancy expected later this month [5] - Exploratory phase 1B study in chronic pain with a crossover design involving up to 40 patients [5][30] - **PIPE-307**: - A first-in-class selective inhibitor of the M1 receptor, currently in collaboration with Johnson & Johnson [5][36] - Two separate phase 2 clinical proof-of-concept studies ongoing, one for remyelination in relapsing-remitting MS and another for Major Depressive Disorder (MDD) [5][36] Mechanism and Efficacy - **LPA-1 Receptor**: - Increased LPA levels in IPF patients lead to fibroblast recruitment and collagen secretion, contributing to lung fibrosis [8][15] - Previous LPA-1 antagonists faced challenges, including off-target toxicity [9][10] - Contineum aims to differentiate PIPE-791 with a unique pharmacokinetic profile, allowing for once-daily dosing and potentially improved efficacy [10][11] - **IPF Treatment Landscape**: - Approximately 130,000 patients in the U.S. with IPF, with a high mortality rate post-diagnosis [15] - Current treatments (pirfenidone and nintedanib) have tolerability issues and do not significantly improve quality of life [16][17] - Contineum aims to stabilize forced vital capacity in IPF patients, addressing unmet needs in the treatment paradigm [16][17] Financial and Corporate Insights - **Cash Position**: - Company has sufficient cash to fund operations through the end of 2027, allowing focus on key clinical studies [6][33] - **Collaboration with Johnson & Johnson**: - Agreement valued at over $1.1 billion, with potential for co-funding registration studies to increase royalty rates [46][47] Upcoming Milestones - **Key Inflection Points**: - PET study results, relapse-remitting MS study data, and pain study results expected in the near future [49] - BMS's phase three study data release anticipated by the end of next year, which could impact Contineum's positioning [49] Intellectual Property - **Patent Coverage**: - PIPE-307 patent extends through 2040, with additional coverage extending to 2042; PIPE-791 similarly has coverage through 2042 to 2044 [47] Conclusion - Contineum Therapeutics is positioned to address significant unmet needs in IPF and MS with its innovative therapies PIPE-791 and PIPE-307, backed by a strong financial position and strategic collaborations. The upcoming clinical readouts and milestones will be critical for the company's future trajectory and investor interest [49][52]
Contineum Therapeutics (NasdaqGS:CTNM) FY Conference Transcript
2025-09-08 13:32
Summary of Contineum Therapeutics FY Conference Call Company Overview - **Company**: Contineum Therapeutics (NasdaqGS:CTNM) - **Focus Areas**: Neuroscience, Inflammation, Immunology (NINI) [3][4] - **Clinical Stage**: Running two clinical proof of concept studies: PIPE-307 (M1 receptor inhibitor) and PIPE-791 (LPA-1 antagonist) [3][4] Key Clinical Programs - **PIPE-307**: - First-in-class M1 receptor antagonist targeting remyelination in multiple sclerosis (MS) - Phase 2 study fully enrolled with data expected in Q4 2025 - Partnered with Johnson & Johnson, receiving $50 million upfront and potential milestones exceeding $1 billion [21][22] - **PIPE-791**: - LPA-1 antagonist with phase 1B PET data expected in Q3 2025 - Focused on idiopathic pulmonary fibrosis (IPF) and MS - Aims to differentiate from competitors by achieving high receptor occupancy and a unique pharmacokinetic profile [9][10][11][12] Market Context - **IPF Market**: - Approximately 130,000 patients in the U.S. with an annual incidence of 30,000 to 40,000 - Current treatments (pirfenidone and nintedanib) have significant tolerability issues, leading to high dropout rates [13][14][34] - Nintedanib generated over $4.5 billion in sales despite its drawbacks [34] - **MS Market**: - Over 20 approved drugs with a total market size of $27 billion [27] Competitive Landscape - **China's Biotech Innovation**: - Contineum does not see a need to change its R&D strategy but is open to collaborations in China [5] - **Comparison with Competitors**: - PIPE-791 aims to outperform BMS's drug by achieving higher receptor occupancy and a more favorable dosing regimen [16][17][18][19] Regulatory and Operational Considerations - **Regulatory Impact**: - Interactions with the FDA and global regulatory agencies are critical for clinical development strategy [8] - **Operational Focus**: - The company is prioritizing the IPF study, which resembles a phase 3 study in scale, before moving forward with other programs [11] Future Catalysts - **Upcoming Data Releases**: - PET receptor occupancy data for PIPE-791 and top-line data for PIPE-307 expected in the next 12 months [41][42] - **Market Penetration Strategy**: - Contineum plans to leverage its partnership with Johnson & Johnson for MS while independently managing the IPF program [39] Financial Considerations - **Pricing Strategy**: - Current therapies average around $135,000 annually; Contineum aims to improve upon existing treatments to justify pricing [40] Conclusion - **Investment Outlook**: - Contineum Therapeutics is positioned to capitalize on significant market opportunities in IPF and MS with a strong pipeline and favorable partnerships. The company emphasizes the importance of clinical validation and aims to mitigate risks through strategic R&D efforts [47][49]
Contineum Therapeutics (CTNM) 2025 Conference Transcript
2025-09-04 14:10
Summary of Continuum Therapeutics (CTNM) 2025 Conference Call Company Overview - Continuum Therapeutics is a San Diego-based biotech company focused on neuroscience, inflammation, and immunology [3][4] - The company has two clinical-stage assets and is pursuing multiple therapeutic areas with important clinical proof of concept readouts expected [4] Key Programs PIPE-791 - PIPE-791 is a first-in-class selective inhibitor of the LPA1 receptor, currently in development for idiopathic pulmonary fibrosis (IPF) [5][16] - The unmet need in IPF is significant, with approximately 130,000 patients in the US and 3 million worldwide, and existing treatments are considered suboptimal [7][8] - Current treatments, such as Nintendonib and Prophenidone, have tolerability issues leading to high dropout rates [15] - The LPA1 receptor is linked to fibrosis and inflammation, making it a critical target for IPF treatment [16][17] - Continuum believes that PIPE-791 has a unique pharmacokinetic (PK) profile that allows for high target coverage and improved tolerability compared to existing therapies [21][25] PIPE-307 - PIPE-307 is a muscarinic receptor antagonist being evaluated in relapse and remitting multiple sclerosis (MS) [49] - The program is based on prior studies that demonstrated the potential for muscarinic receptor antagonism to improve remyelination [51] - The Phase II study is designed to measure low contrast letter acuity and other functional biomarkers [57] Clinical Development and Strategy - Continuum plans to initiate a global Phase II proof of concept study for PIPE-791 in the fourth quarter, with a focus on safety, tolerability, and efficacy [30][31] - The company is also conducting a PET receptor occupancy study to validate dosing for PIPE-791 [34][36] - The chronic pain program is exploratory, focusing on osteoarthritis and chronic lower back pain, with a small Phase Ib study planned [39][45] Market Landscape - The IPF treatment market is viewed as an untapped opportunity, with existing therapies generating significant sales despite their limitations [29] - Continuum anticipates that a safer and more effective drug could carve out a significant space in the IPF treatment landscape, which is currently lacking in effective options [27][28] Upcoming Catalysts - Key upcoming catalysts include the pain study readout in the first half of next year and the initiation of the IPF study [47] - The company is also monitoring BMS' top-line data, expected in the second half of next year, as a benchmark for its own programs [48] Conclusion - Continuum Therapeutics is positioned to address significant unmet needs in IPF and MS with its innovative drug candidates, backed by a robust clinical development strategy and a focus on improving patient outcomes through enhanced tolerability and efficacy [64]
Wall Street Analysts Think Contineum Therapeutics, Inc. (CTNM) Could Surge 235.81%: Read This Before Placing a Bet
ZACKS· 2025-08-08 14:56
Core Viewpoint - Contineum Therapeutics, Inc. (CTNM) has shown a significant price increase of 67% over the past four weeks, with analysts projecting a mean price target of $22.6, indicating a potential upside of 235.8% from the current price of $6.73 [1] Price Targets and Analyst Estimates - The mean estimate consists of five short-term price targets with a standard deviation of $4.93, where the lowest estimate is $16.00 (137.7% increase) and the highest is $29.00 (330.9% increase) [2] - A low standard deviation among price targets suggests a strong agreement among analysts regarding the stock's price movement, which can serve as a starting point for further research [9] Earnings Estimates and Analyst Agreement - Analysts have shown strong agreement in revising CTNM's earnings estimates higher, which correlates with potential stock price increases [11] - The Zacks Consensus Estimate for the current year has risen by 2.7% over the past month, with two estimates increasing and no negative revisions [12] - CTNM holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - While price targets are often sought after by investors, they can be misleading and should not be the sole basis for investment decisions [3][10] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8]
Contineum (CTNM) Q2 R&D Jumps 78%
The Motley Fool· 2025-08-06 03:34
Core Viewpoint - Contineum Therapeutics reported a wider GAAP net loss per share of $(0.62) for Q2 2025, missing the estimate of $(0.44), while continuing to advance its clinical pipeline with significant increases in research and development expenses [1][2][5] Financial Performance - GAAP EPS for Q2 2025 was $(0.62), a 59.0% decrease from $(0.39) in Q2 2024 [2] - Research and Development Expense rose to $14.1 million, a 78.5% increase from $7.9 million in Q2 2024 [2] - General and Administrative Expense increased to $3.8 million, up 26.7% from $3.0 million in Q2 2024 [2] - The company ended the quarter with a cash position of $175.5 million, sufficient to fund operations through 2027 [10] Business Overview - Contineum focuses on developing small molecule therapies for diseases with high unmet medical needs, particularly through its main drug candidates PIPE-791 and PIPE-307 [3][4] - PIPE-791 is being studied for idiopathic pulmonary fibrosis (IPF), progressive multiple sclerosis (PrMS), and chronic pain, while PIPE-307 targets depression and relapsing-remitting multiple sclerosis (RRMS) [3][4] Operational Highlights - The company advanced PIPE-791 in multiple indications and completed chronic toxicity studies, with plans for a global Phase 2 trial for IPF later in 2025 [7] - Patient dosing for PIPE-791 in a Phase 1b trial for chronic pain began in March 2025, with results expected in the first half of 2026 [7] - PIPE-307 is currently in the VISTA Phase 2 proof-of-concept trial for RRMS, with top-line data expected in Q4 2025 [8] Strategic Focus - Contineum has prioritized its resources on PIPE-791 for IPF, postponing trials for PIPE-791 in PrMS and first-in-human studies for CTX-343 [9] - The company maintains strategic partnerships, particularly with Johnson & Johnson for PIPE-307, to support its development efforts [4][8] Future Outlook - Management did not provide explicit guidance for the next quarter or fiscal 2025 but indicated that the strong cash position supports planned development activities [12] - Investors will monitor the timing and outcomes of clinical milestones for PIPE-791 and PIPE-307, as well as enrollment trends and potential partnership developments [13]
Contineum Therapeutics, Inc.(CTNM) - 2025 Q2 - Quarterly Report
2025-08-05 20:13
[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides unaudited condensed financial statements and management's discussion and analysis for the reporting period [Item 1. Condensed Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(Unaudited)) This section presents Contineum Therapeutics, Inc.'s unaudited condensed financial statements and accompanying notes for the periods ended June 30, 2025, and December 31, 2024 [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) The condensed balance sheets reflect a decrease in total assets and stockholders' equity from December 2024 to June 2025, mainly due to reduced marketable securities and an accumulated deficit Condensed Balance Sheets (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $20,784 | $21,943 | | Marketable securities | $154,700 | $182,817 | | Total current assets | $176,839 | $206,388 | | Total assets | $182,888 | $212,847 | | Total current liabilities | $7,214 | $9,974 | | Total liabilities | $11,498 | $14,781 | | Total stockholders' equity | $171,390 | $198,066 | | Accumulated deficit | $(149,432) | $(117,402) | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses increased for both three and six months ended June 30, 2025, driven by higher research and development and general and administrative expenses Condensed Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $14,063 | $7,901 | $27,775 | $15,679 | | General and administrative | $3,839 | $3,043 | $8,237 | $5,195 | | Total operating expenses | $17,902 | $10,944 | $36,012 | $20,874 | | Net loss | $(16,040) | $(9,009) | $(32,030) | $(17,426) | | Net loss per share, basic and diluted | $(0.62) | $(0.39) | $(1.24) | $(1.35) | [Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity decreased from December 2024 to June 2025 due to net loss, partially offset by stock-based compensation, after convertible preferred stock converted to common stock in the 2024 IPO Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (in thousands) | Metric (in thousands) | Balance at Dec 31, 2024 | Balance at Mar 31, 2025 | Balance at Jun 30, 2025 | | :-------------------- | :---------------------- | :---------------------- | :---------------------- | | Total Stockholders' Equity | $198,066 | $184,768 | $171,390 | | Accumulated Deficit | $(117,402) | $(133,392) | $(149,432) | | Stock-based compensation | $2,569 (Q1 2025) | $2,418 (Q2 2025) | $4,987 (6M 2025) | [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, significant cash used in operating activities was largely offset by cash from investing activities, resulting in a net decrease in cash and cash equivalents Condensed Statements of Cash Flows (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(30,073) | $(16,474) | | Net cash provided by (used in) investing activities | $28,799 | $(30,168) | | Net cash provided by financing activities | $115 | $108,346 | | Net increase (decrease) in cash and cash equivalents | $(1,159) | $61,704 | | Cash and cash equivalents at end of period | $20,784 | $77,230 | [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) These notes provide detailed explanations of the company's organization, accounting policies, financial instruments, equity, the J&J License Agreement, and other financial reporting specifics [Note 1. Organization and Basis of Presentation](index=10&type=section&id=Note%201.%20Organization%20and%20Basis%20of%20Presentation) Contineum Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on NI&I indications, which completed an IPO in April 2024 and maintains sufficient liquidity for at least 12 months - Contineum Therapeutics, Inc. is a clinical-stage biopharmaceutical company specializing in neuroscience, inflammation, and immunology (NI&I) indications[29](index=29&type=chunk) - The company completed its Initial Public Offering (IPO) on April 9, 2024, issuing 6,875,000 shares at **$16.00 per share**, with an additional 548,682 shares sold to underwriters, resulting in net proceeds of approximately **$107.9 million**[31](index=31&type=chunk) - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling **$175.5 million**, which management expects to be sufficient to fund operations for at least 12 months[34](index=34&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=11&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) Significant accounting policies remained consistent with the 2024 Annual Report, with retrospective adoption of ASU 2023-07 having no material impact, while ASU 2023-09 and ASU 2024-03 are under evaluation - No significant changes to accounting policies occurred during the six months ended June 30, 2025, compared to the Annual Report on Form 10-K for December 31, 2024[38](index=38&type=chunk) - The company adopted ASU 2023-07, Segment Reporting, retrospectively for the fiscal year ended December 31, 2024, and subsequent interim periods, with no material impact on financial position or results[41](index=41&type=chunk) - The company is currently evaluating the impact of ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation) on its financial statements[42](index=42&type=chunk)[43](index=43&type=chunk) [Note 3. Marketable Securities](index=11&type=section&id=Note%203.%20Marketable%20Securities) Marketable securities decreased to **$154.7 million** by June 30, 2025, from **$182.8 million** at December 31, 2024, with some in an unrealized loss position but not intended for early sale Marketable Securities Fair Value (in thousands) | Investment Category | June 30, 2025 Fair Value (in thousands) | December 31, 2024 Fair Value (in thousands) | | :------------------ | :-------------------------------------- | :---------------------------------------- | | U.S. Government agency securities | $55,804 | $57,155 | | Corporate debt securities | $67,370 | $80,822 | | Commercial paper | $10,612 | $22,275 | | Total | $154,700 | $182,817 | - As of June 30, 2025, 62 out of 237 available-for-sale debt securities were in an aggregate gross unrealized loss position of **$(43) thousand**, compared to 86 out of 252 securities with **$(175) thousand** in unrealized losses as of December 31, 2024[45](index=45&type=chunk)[46](index=46&type=chunk) [Note 4. Fair Value Measurements](index=13&type=section&id=Note%204.%20Fair%20Value%20Measurements) Financial assets are measured at fair value using a three-tier hierarchy, totaling **$174.5 million** as of June 30, 2025, with **$75.7 million** in Level 1 and **$98.9 million** in Level 2 Financial Asset Fair Value Measurements (in thousands) | Financial Asset Category (in thousands) | Total Fair Value (June 30, 2025) | Level 1 (June 30, 2025) | Level 2 (June 30, 2025) | | :-------------------------------------- | :------------------------------- | :---------------------- | :---------------------- | | Cash equivalents | $19,848 | $19,848 | $— | | U.S. Government agency securities | $55,804 | $55,804 | $— | | Certificates of deposits | $6,200 | $— | $6,200 | | Corporate debt securities | $67,370 | $— | $67,370 | | Commercial paper | $10,612 | $— | $10,612 | | Yankee debt | $2,336 | $— | $2,336 | | Asset-backed securities | $12,378 | $— | $12,378 | | **Total financial assets** | **$174,548** | **$75,652** | **$98,896** | [Note 5. Accrued Expenses](index=14&type=section&id=Note%205.%20Accrued%20Expenses) Total accrued expenses decreased from **$6.7 million** at December 31, 2024, to **$3.7 million** at June 30, 2025, mainly due to reduced compensation and R&D accruals Accrued Expense Categories (in thousands) | Accrued Expense Category (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------------- | :------------ | :---------------- | | Accrued compensation expenses | $1,770 | $3,338 | | Accrued research and development expenses | $1,686 | $3,151 | | Total accrued expenses | $3,747 | $6,711 | [Note 6. Stockholders' Equity (Deficit)](index=14&type=section&id=Note%206.%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity decreased to **$171.4 million** by June 30, 2025, primarily due to net losses, with **$4.987 million** in stock-based compensation for the six-month period - In May 2025, the company entered into a Sales Agreement for an at-the-market (ATM) offering of up to **$75.0 million** in Class A common stock, but no shares were sold under this agreement during the three months ended June 30, 2025[53](index=53&type=chunk) Common Stock Outstanding and Reserved | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------------- | :------------ | :---------------- | | Class A common stock outstanding | 19,190,723 | 19,125,377 | | Class B common stock outstanding | 6,729,172 | 6,729,172 | | Total common stock reserved for future issuance | 7,769,503 | 5,997,577 | - The company recorded **$4.987 million** in total stock-based compensation for the six months ended June 30, 2025, with **$2.8 million** in general and administrative and **$2.2 million** in research and development[26](index=26&type=chunk)[67](index=67&type=chunk) [Note 7. License Agreement](index=17&type=section&id=Note%207.%20License%20Agreement) The J&J license agreement for PIPE-307, with a **$50.0 million** upfront payment and potential **$1.0 billion** in milestones, saw no revenue recognized from a Phase 2 trial modification as of June 30, 2025 - The company granted J&J an exclusive, worldwide license for PIPE-307 in February 2023, receiving a **$50.0 million** upfront payment[72](index=72&type=chunk)[74](index=74&type=chunk) - The company is eligible to receive approximately **$1.0 billion** in non-refundable, non-creditable milestone payments and tiered royalties (low-double digit to high-teen percent range) on net sales of products containing PIPE-307[72](index=72&type=chunk) - In August 2023, the company elected to conduct a Phase 2 trial for PIPE-307 in multiple sclerosis, which was treated as a contract modification. No revenue related to this modification had been recognized as of June 30, 2025[75](index=75&type=chunk) [Note 8. Commitments and Contingencies](index=17&type=section&id=Note%208.%20Commitments%20and%20Contingencies) Primary commitments are **$5.75 million** in operating lease liabilities for office and lab space, with **$6.89 million** in future minimum payments, and no material legal proceedings as of June 30, 2025 Operating Lease Metrics (in thousands) | Operating Lease Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Operating lease right-of-use assets | $5,007 | $5,467 | | Total lease liability obligations | $5,750 | $6,259 | | Weighted-average remaining lease term | 4.3 years | 4.4 years | | Weighted-average discount rate | 9.0% | 9.0% | Future Minimum Lease Payments (in thousands) | Future Minimum Lease Payments (in thousands) | Amount | | :------------------------------------------- | :----- | | 2025 | $763 | | 2026 | $1,564 | | 2027 | $1,611 | | 2028 | $1,660 | | 2029 | $1,292 | | Total minimum lease payments | $6,890 | - The company is not currently a party to any material legal proceedings[83](index=83&type=chunk) [Note 9. Net Loss Per Share](index=18&type=section&id=Note%209.%20Net%20Loss%20Per%20Share) Basic and diluted net loss per share were **$(0.62)** for three months and **$(1.24)** for six months ended June 30, 2025, with dilutive securities excluded due to anti-dilutive effects Net Loss Per Share Calculation (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss applicable to common stockholders (in thousands) | $(16,040) | $(9,009) | $(32,030) | $(17,426) | | Weighted average shares outstanding (basic and diluted) | 25,895,996 | 23,355,588 | 25,882,540 | 12,862,328 | | Net loss per share (basic and diluted) | $(0.62) | $(0.39) | $(1.24) | $(1.35) | - Potentially dilutive securities (common stock options and warrants) were excluded from diluted EPS calculations for all periods presented because their inclusion would be anti-dilutive[87](index=87&type=chunk) [Note 10. Segment Reporting](index=19&type=section&id=Note%2010.%20Segment%20Reporting) The company operates as a single reportable segment focused on NI&I therapies, with the CODM assessing performance and allocating resources based on operating expenses and net loss - The company operates in one reportable segment, focusing on differentiated therapies for neuroscience, inflammation, and immunology (NI&I) indications[89](index=89&type=chunk) - The CODM (President and CEO) uses operating expenses and net loss to make decisions on resource allocation and assess business performance[90](index=90&type=chunk) Significant Segment Expenses (in thousands) | Significant Segment Expenses (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | | | | | | PIPE-791 | $6,178 | $2,028 | $11,732 | $4,889 | | PIPE-307 | $2,160 | $2,258 | $4,775 | $4,333 | | CTX-343 | $1,059 | $574 | $2,437 | $886 | | Discovery programs | $1,328 | $1,244 | $2,710 | $2,348 | | Unallocated internal costs | $3,338 | $1,797 | $6,121 | $3,223 | | General and administrative | $3,839 | $3,043 | $8,237 | $5,195 | | Interest income | $2,029 | $2,001 | $4,279 | $3,637 | | Net loss | $(16,040) | $(9,009) | $(32,030) | $(17,426) | [Note 11. Subsequent Events](index=19&type=section&id=Note%2011.%20Subsequent%20Events) In July 2025, an ATM offering sold **2,122,000** Class A common shares at **$4.03** per share, generating **$8.4 million** in net proceeds - In July 2025, the company closed an ATM offering, selling **2,122,000** shares of Class A common stock at a weighted average price of **$4.03 per share**[94](index=94&type=chunk) - The ATM offering resulted in gross proceeds of **$8.6 million** and net proceeds of **$8.4 million** after deducting sales agent commissions[94](index=94&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of financial condition and operations, focusing on NI&I therapies, clinical trial progress, financial performance, liquidity, and future funding requirements [Overview](index=20&type=section&id=Overview) Contineum Therapeutics is a clinical-stage biopharmaceutical company developing small molecule drug candidates for NI&I indications, with key programs PIPE-791 and PIPE-307, expecting increased operating expenses - Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for neuroscience, inflammation, and immunology (NI&I) indications[99](index=99&type=chunk) - Lead asset PIPE-791 (LPA1R inhibitor) is in development for idiopathic pulmonary fibrosis (IPF), progressive multiple sclerosis (PrMS), and chronic pain, with Phase 1b PET trial topline data expected in Q3 2025 and a Phase 2 IPF trial planned for Q4 2025[101](index=101&type=chunk) - PIPE-307 (M1R inhibitor), partnered with J&J, is in Phase 2 trials for relapse-remitting multiple sclerosis (RRMS) (topline data expected Q4 2025) and major depressive disorder (MDD) (J&J initiated Phase 2 recruitment)[102](index=102&type=chunk) [Collaboration](index=21&type=section&id=Collaboration) The J&J collaboration grants exclusive worldwide rights for PIPE-307, with Contineum conducting a Phase 2 RRMS trial (topline data Q3 2025) and J&J recruiting for a Phase 2 MDD trial - The J&J License Agreement grants J&J an exclusive, worldwide license to develop, manufacture, and commercialize PIPE-307 in all indications[109](index=109&type=chunk) - Contineum is conducting a Phase 2 clinical trial of PIPE-307 in RRMS patients, with enrollment completed in December 2024 and topline data expected in Q3 2025[111](index=111&type=chunk) - J&J began recruiting for a Phase 2 trial of PIPE-307/JNJ-89495120 for the potential treatment of major depressive disorder (MDD) in December 2024[111](index=111&type=chunk) [Financial Operations Overview](index=22&type=section&id=Financial%20Operations%20Overview) No revenue was recognized for the periods ended June 30, 2025 or 2024, due to constrained J&J License Agreement milestones, while operating expenses, especially R&D, are expected to increase significantly - The company did not recognize any revenue for the three and six months ended June 30, 2025 or 2024, as all variable consideration under the J&J License Agreement was fully constrained[114](index=114&type=chunk) - Research and development expenses are expensed as incurred and include direct costs (e.g., clinical trials, manufacturing) and unallocated internal costs (e.g., personnel, stock-based compensation, facilities)[115](index=115&type=chunk)[116](index=116&type=chunk)[120](index=120&type=chunk) - General and administrative expenses are expected to increase due to expanded R&D, business growth, increased headcount, and costs associated with operating as a public company[124](index=124&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Net losses increased for both three and six months ended June 30, 2025, driven by substantial increases in research and development and general and administrative expenses, partially offset by higher interest income [Comparison of the Three Months Ended June 30, 2025 and 2024](index=24&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) Net loss increased to **$(16.0) million** for the three months ended June 30, 2025, from **$(9.0) million** in 2024, primarily due to higher R&D and G&A expenses Three Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development | $14,063 | $7,901 | $6,162 | | General and administrative | $3,839 | $3,043 | $796 | | Net loss | $(16,040) | $(9,009) | $(7,031) | - Research and development expenses increased by **$6.1 million**, primarily due to a **$4.3 million** increase in CRO costs for PIPE-791 trials (IPF, chronic pain, PET) and a **$1.5 million** increase in personnel-related expenses[128](index=128&type=chunk)[135](index=135&type=chunk) - General and administrative expenses increased by **$0.8 million**, driven by a **$0.5 million** increase in non-cash stock-based compensation and a **$0.5 million** increase in personnel-related expenses[129](index=129&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=24&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Net loss increased to **$(32.0) million** for the six months ended June 30, 2025, from **$(17.4) million** in 2024, driven by higher R&D and G&A expenses, partially offset by increased interest income Six Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development | $27,775 | $15,679 | $12,096 | | General and administrative | $8,237 | $5,195 | $3,042 | | Interest income | $4,279 | $3,637 | $642 | | Net loss | $(32,030) | $(17,426) | $(14,604) | - Research and development expenses increased by **$12.1 million**, primarily due to an **$8.1 million** increase in CRO costs for PIPE-791 and PIPE-307 trials, a **$2.3 million** increase in personnel-related expenses, and a **$1.2 million** increase in non-cash stock-based compensation[130](index=130&type=chunk)[136](index=136&type=chunk) - General and administrative expenses increased by **$3.0 million**, mainly from a **$1.6 million** increase in non-cash stock-based compensation and a **$1.2 million** increase in personnel-related expenses[130](index=130&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company, historically incurring net losses, funds operations through various sources, holding **$175.5 million** in liquidity as of June 30, 2025, sufficient for 12 months, with future funding dependent on drug development needs - The company has incurred net losses and negative cash flows from operations since inception and expects this trend to continue[133](index=133&type=chunk) - As of June 30, 2025, the company had **$175.5 million** in cash, cash equivalents, and marketable securities, which management believes will be sufficient to meet operating expenses and capital expenditure requirements for at least the next 12 months[137](index=137&type=chunk) - Future capital requirements are substantial and depend on factors such as clinical trial progress, regulatory approvals, manufacturing costs, and the expansion of operations and intellectual property[145](index=145&type=chunk)[146](index=146&type=chunk)[159](index=159&type=chunk) [Sources of Liquidity](index=24&type=section&id=Sources%20of%20Liquidity) Liquidity sources include convertible notes, preferred stock, the **$50.0 million** J&J License Agreement, **$107.9 million** IPO proceeds, and **$8.4 million** from a July 2025 ATM offering, totaling **$175.5 million** as of June 30, 2025 - The company has funded operations primarily through convertible promissory notes, convertible preferred stock financings, the J&J License Agreement (**$50.0 million** upfront payment), and **$107.9 million** net proceeds from its April 2024 IPO[33](index=33&type=chunk)[134](index=134&type=chunk) - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled **$175.5 million**, expected to be sufficient for at least 12 months of operations[34](index=34&type=chunk)[137](index=137&type=chunk) - In July 2025, the company completed an ATM offering, raising **$8.4 million** in net proceeds from the sale of **2,122,000** shares of Class A common stock[94](index=94&type=chunk)[139](index=139&type=chunk) [Cash Flows](index=26&type=section&id=Cash%20Flows) Net cash used in operating activities was **$(30.1) million** for the six months ended June 30, 2025, largely offset by **$28.8 million** from investing activities, resulting in a **$1.2 million** net decrease in cash Cash Flow Activities (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(30,073) | $(16,474) | | Net cash provided by (used in) investing activities | $28,799 | $(30,168) | | Net cash provided by financing activities | $115 | $108,346 | | Net increase (decrease) in cash and cash equivalents | $(1,159) | $61,704 | - Net cash used in operating activities increased to **$(30.1) million** for the six months ended June 30, 2025, from **$(16.5) million** in the prior year, primarily due to higher net loss[142](index=142&type=chunk) - Net cash provided by investing activities was **$28.8 million** in 2025, a significant change from **$(30.2) million** used in 2024, driven by increased sales and maturities of marketable securities[143](index=143&type=chunk) [Funding Requirements](index=26&type=section&id=Funding%20Requirements) Operating expenses are expected to increase significantly for drug development and commercialization, with future capital requirements dependent on clinical outcomes and intellectual property, likely financed through equity, debt, or commercial arrangements - Operating expenses are expected to increase significantly due to ongoing drug development, regulatory approvals, expansion of drug candidate pipeline, and potential commercialization activities[145](index=145&type=chunk) - Future capital requirements are uncertain and depend on factors such as the type, scope, progress, and costs of clinical trials, regulatory review, manufacturing, and intellectual property protection[146](index=146&type=chunk)[159](index=159&type=chunk) - The company expects to finance future cash needs through public or private equity/debt financings or commercial arrangements, which may involve dilution, restrictive covenants, or relinquishing valuable rights[147](index=147&type=chunk) [Contractual Obligations and Commitments](index=27&type=section&id=Contractual%20Obligations%20and%20Commitments) Total contractual commitments for operating lease agreements were approximately **$6.9 million** as of June 30, 2025, with other service contracts generally terminable with notice and not classified as long-term obligations - Total contractual commitments for operating lease agreements amounted to approximately **$6.9 million** as of June 30, 2025[149](index=149&type=chunk) - Contracts for research, manufacturing, and professional services are generally terminable with advanced written notice and payment for services received, and thus are not included in long-term contractual obligations[150](index=150&type=chunk) [Off-Balance Sheet Arrangements](index=27&type=section&id=Off-Balance%20Sheet%20Arrangements) The company did not have any off-balance sheet arrangements during the periods presented - The company did not have any off-balance sheet arrangements during the periods presented[152](index=152&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Financial statements rely on estimates for R&D accruals, lease rates, common stock fair value, and stock-based compensation, with no material changes since the 2024 Annual Report on Form 10-K - Key accounting estimates and judgments include accrual of research and development expenses, incremental borrowing rate for lease liabilities, fair value of common stock, and stock-based compensation[154](index=154&type=chunk) - There have been no material changes to the company's critical accounting estimates from those described in its Annual Report on Form 10-K for the year ended December 31, 2024[155](index=155&type=chunk) [Emerging growth company and smaller reporting company status](index=27&type=section&id=Emerging%20growth%20company%20and%20smaller%20reporting%20company%20status) The company qualifies as an "emerging growth company" and "smaller reporting company," utilizing extended transition periods for accounting standards and scaled disclosures, which may affect comparability - The company is an "emerging growth company" under the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards[157](index=157&type=chunk) - The company is also a "smaller reporting company" and takes advantage of scaled disclosures, which may affect comparability with other public companies[158](index=158&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Contineum Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk[160](index=160&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=28&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management, including principal executive and financial officers, concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025 - As of June 30, 2025, the company's disclosure controls and procedures were evaluated and deemed effective at the reasonable assurance level by management, including the principal executive and financial officers[161](index=161&type=chunk) [Changes in Internal Control over Financial Reporting](index=28&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025 - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[162](index=162&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, other information, and exhibits for the reporting period [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though ordinary course claims may arise - The company is not currently a party to any material legal proceedings[165](index=165&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) Investing in the company's common stock involves high risk, including potential adverse effects from tax law changes and unstable global economic conditions impacting operations and financing - Investing in the company's common stock involves a high degree of risk, and additional risks not currently known may also adversely affect the business[166](index=166&type=chunk) - Changes in tax laws, such as the OBBB Act, could affect the company, though no material impact on its effective tax rate or cash flows is expected in the current fiscal year[167](index=167&type=chunk) - Unstable global economic conditions and geopolitical instability could adversely affect the company's business, financial condition, and ability to advance drug candidates, potentially making financing more difficult and costly[169](index=169&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred, and the **$107.9 million** net IPO proceeds from April 2024 saw no material change in planned use - No unregistered sales of equity securities occurred during the period[170](index=170&type=chunk) - The company received approximately **$107.9 million** in aggregate net proceeds from its IPO in April 2024[171](index=171&type=chunk) - There has been no material change in the planned use of proceeds from the IPO[172](index=172&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - The company reported no defaults upon senior securities[173](index=173&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[174](index=174&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025 - None of the company's directors or officers adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[175](index=175&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, agreements, executive certifications, and Inline XBRL files - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, Offer Letters for Tim Watkins, and a Sales Agreement with Leerink Partners[177](index=177&type=chunk)[178](index=178&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer (pursuant to Sarbanes-Oxley Act Sections 302 and 906) are included[178](index=178&type=chunk)[180](index=180&type=chunk) - Inline XBRL Instance Document, Taxonomy Extension Schema, and Cover Page Interactive Data File are also filed as exhibits[178](index=178&type=chunk) [Signatures](index=33&type=section&id=Signatures) The report was duly signed by Carmine Stengone, President, CEO, and Director, and Peter Slover, CFO, on August 5, 2025 - The report was signed by Carmine Stengone, President, Chief Executive Officer and Director, and Peter Slover, Chief Financial Officer, on August 5, 2025[185](index=185&type=chunk)
Contineum Therapeutics, Inc.(CTNM) - 2025 Q2 - Quarterly Results
2025-08-05 20:08
[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview) Contineum Therapeutics, a clinical-stage biopharma, provided Q2 2025 updates on PIPE-307 and PIPE-791 trials, projecting cash runway into 2027 [About Contineum Therapeutics](index=2&type=section&id=About%20Contineum%20Therapeutics) Contineum Therapeutics is a clinical-stage biopharmaceutical company developing oral small molecule therapies for neuroscience, inflammation, and immunology - Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on oral small molecule therapies in **neuroscience, inflammation, and immunology (NI&I)**[7](index=7&type=chunk) - Key drug candidates include **PIPE-791** (LPA1 receptor antagonist for idiopathic pulmonary fibrosis, progressive multiple sclerosis, and chronic pain) and **PIPE-307** (M1 receptor selective inhibitor for relapsing-remitting multiple sclerosis and major depressive disorder)[7](index=7&type=chunk) [Q2 2025 Key Highlights](index=1&type=section&id=Q2%202025%20Highlights) Contineum Therapeutics reported Q2 2025 financial results and clinical updates, with key data readouts and trial initiations expected in Q4 2025 and cash runway into 2027 - Topline data from the **PIPE-307** Phase 2 VISTA trial for relapsing-remitting multiple sclerosis (RRMS) is anticipated in **Q4 2025**[1](index=1&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) - A global Phase 2 proof-of-concept clinical trial for **PIPE-791** in idiopathic pulmonary fibrosis (IPF) is planned to commence in **Q4 2025**[1](index=1&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) - The company's cash runway is projected to support operations into **2027**[1](index=1&type=chunk)[4](index=4&type=chunk)[9](index=9&type=chunk) [Key Clinical Development Milestones](index=1&type=section&id=Key%20Clinical%20Development%20Milestones) This section details progress for PIPE-307 and PIPE-791 programs, outlining expected data readouts and strategic adjustments to clinical development [PIPE-307 Program Updates](index=1&type=section&id=PIPE-307%20Program%20Updates) PIPE-307 shows progress in RRMS and MDD, with VISTA Phase 2 RRMS data expected in Q4 2025 and J&J initiating a Phase 2 MDD trial - Topline data from the **PIPE-307** Phase 2 VISTA RRMS trial, evaluating safety, efficacy, and myelin regeneration endpoints, is anticipated in **Q4 2025**[4](index=4&type=chunk)[5](index=5&type=chunk) - Johnson & Johnson initiated the Phase 2 Moonlight-1 trial for **PIPE-307/JNJ-89495120** in major depressive disorder (MDD) in **December 2024**, assessing efficacy, safety, and tolerability as a monotherapy[5](index=5&type=chunk) [PIPE-791 Program Updates](index=1&type=section&id=PIPE-791%20Program%20Updates) PIPE-791 advances in IPF, PrMS, and chronic pain, with a global Phase 2 IPF trial planned for Q4 2025 and data readouts expected in Q3 2025 and H1 2026 - Regulatory submissions are underway for a global Phase 2 proof-of-concept clinical trial of **PIPE-791** in idiopathic pulmonary fibrosis (IPF), with initiation expected in **Q4 2025**[4](index=4&type=chunk)[5](index=5&type=chunk) - Topline data from the **PIPE-791** Phase 1b PET trial, correlating pharmacokinetics with LPA1 receptor occupancy, is anticipated in **Q3 2025**[5](index=5&type=chunk) - Topline data from the exploratory Phase 1b trial of **PIPE-791** for chronic pain (chronic osteoarthritis pain and chronic low back pain), which began patient dosing in March 2025, is expected in **H1 2026**[5](index=5&type=chunk) [Strategic Program Prioritization](index=1&type=section&id=Strategic%20Program%20Prioritization) The company has deferred the PIPE-791 PrMS Phase 2 trial and CTX-343's first-in-human study to focus internal clinical resources on the PIPE-791 IPF program - The initiation of the **PIPE-791** Phase 2 clinical trial for progressive multiple sclerosis (PrMS) and the advancement of **CTX-343** into first-in-human studies have been deferred[4](index=4&type=chunk)[5](index=5&type=chunk) - This strategic decision aims to concentrate internal clinical resources on the **PIPE-791 IPF** program[4](index=4&type=chunk)[5](index=5&type=chunk) [Second-Quarter 2025 Financial Results](index=2&type=section&id=Second-Quarter%202025%20Financial%20Results) This section presents Contineum Therapeutics' Q2 2025 financial performance, detailing cash position, increased R&D and G&A expenses, and expanded net loss [Financial Highlights](index=2&type=section&id=Financial%20Highlights) As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $175.5 million, supporting operations into 2027, while R&D and G&A expenses increased, leading to a $16 million net loss Q2 2025 Financial Highlights | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | YoY Change | Change Rate | Notes | | :--- | :---: | :---: | :---: | :---: | :--- | | Cash, Cash Equivalents, and Marketable Securities (as of June 30) | 175.5 | N/A | N/A | N/A | Projected to support operations into 2027 | | Research & Development Expenses | 14.1 | 7.9 | +6.2 | +78% | Primarily due to PIPE-791 and PIPE-307 program advancements and increased personnel costs | | General & Administrative Expenses | 3.8 | 3.0 | +0.8 | +26% | Primarily due to stock-based compensation and increased personnel costs | | Net Loss | (16.0) | (9.0) | (7.0) | +78% | | - In **July 2025**, the company issued **2,122,000** shares of Class A common stock through an At-The-Market (ATM) offering, raising approximately **$8.4 million** in net proceeds at a weighted average price of **$4.03 per share**[9](index=9&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=CONDENSED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) Contineum Therapeutics' total operating expenses significantly increased to $17.902 million in Q2 2025, resulting in an expanded net loss of $16.04 million and a basic and diluted net loss per share of $0.62 Condensed Statements of Operations and Comprehensive Loss (For the Three and Six Months Ended) | Metric (thousand USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :---: | :---: | :---: | :---: | | Research & Development Expenses | 14,063 | 7,901 | 27,775 | 15,679 | | General & Administrative Expenses | 3,839 | 3,043 | 8,237 | 5,195 | | **Total Operating Expenses** | **17,902** | **10,944** | **36,012** | **20,874** | | Loss from Operations | (17,902) | (10,944) | (36,012) | (20,874) | | Interest Income | 2,029 | 2,001 | 4,279 | 3,637 | | **Net Loss** | **(16,040)** | **(9,009)** | **(32,030)** | **(17,426)** | | Comprehensive Loss | (16,063) | (9,078) | (31,954) | (17,661) | | Net Loss Per Share (Basic and Diluted) | (0.62) | (0.39) | (1.24) | (1.35) | | Weighted-Average Common Shares Outstanding | 25,895,996 | 23,355,588 | 25,882,540 | 12,862,328 | [Condensed Balance Sheets](index=5&type=section&id=CONDENSED%20BALANCE%20SHEETS) As of June 30, 2025, Contineum Therapeutics' total assets decreased to $182.888 million, with declines in cash, marketable securities, total liabilities, and stockholders' equity Condensed Balance Sheets (As of) | Metric (thousand USD) | June 30, 2025 | December 31, 2024 | | :--- | :---: | :---: | | Cash and cash equivalents | 20,784 | 21,943 | | Marketable securities | 154,700 | 182,817 | | **Total current assets** | **176,839** | **206,388** | | **Total assets** | **182,888** | **212,847** | | Accounts payable | 2,001 | 1,811 | | Accrued expenses | 3,747 | 6,711 | | **Total current liabilities** | **7,214** | **9,974** | | **Total liabilities** | **11,498** | **14,781** | | Additional paid-in capital | 320,649 | 315,371 | | Accumulated deficit | (149,432) | (117,402) | | **Total stockholders' equity** | **171,390** | **198,066** | | **Total liabilities and stockholders' equity** | **182,888** | **212,847** | [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding clinical trials, product development, cash flow, and market opportunities, subject to risks including trial success, regulatory uncertainty, and economic conditions, with no obligation to update - Forward-looking statements cover clinical trials, product development plans, timelines, regulatory submissions, data release dates, cash runway, drug candidate indications, anticipated benefits, and market opportunities[8](index=8&type=chunk) - Key risks include high dependence on the success of **PIPE-791** and **PIPE-307**, unpredictability of early clinical results, uncertainties in clinical trials and regulatory review, reliance on third parties for trials, and unstable market and economic conditions[8](index=8&type=chunk) - The company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law[8](index=8&type=chunk)
Contineum Therapeutics (CTNM) 2025 Conference Transcript
2025-05-20 13:30
Summary of Contineum Therapeutics (CTNM) 2025 Conference Call Company Overview - **Company**: Contineum Therapeutics (CTNM) - **Focus**: Development of LPA1 receptor antagonists for indications including Idiopathic Pulmonary Fibrosis (IPF) and Multiple Sclerosis (MS) Key Points Industry and Product Development - **LPA1 Receptor Antagonists**: The company is developing a molecule, referred to as type 791, which has a unique pharmacokinetic profile allowing for prolonged target coverage and high receptor occupancy [4][6][10] - **Clinical Trials**: The company plans to initiate a Phase II study for IPF and MS, with a focus on receptor occupancy data expected to be released by the end of the current quarter [7][11] - **Market Position**: CTNM aims to differentiate itself in a competitive market with multiple LPA receptor antagonists by demonstrating superior receptor occupancy and safety profiles [15][16] Clinical Data and Results - **Phase II Study Results**: Previous studies indicated a 46-47% change in FPC in Phase II, but the lowest dose tested showed no difference from placebo [2][3] - **Receptor Occupancy Studies**: The company is set to release data on receptor occupancy, which is critical for determining effective dosing for upcoming Phase II and III studies [5][7] - **Challenges in Interpretation**: Differences in receptor occupancy between brain and lung tissues are acknowledged, with a focus on maximizing receptor occupancy in both areas [8][9] Leadership and Strategy - **New Chief Medical Officer**: The recruitment of Tim Watkins, with extensive experience in IPF and immunology, is expected to enhance the company's clinical strategy and regulatory approach [11][12] - **Regulatory Path**: The company is cautious about the design of its studies, preferring longer study durations to ensure data reliability [13][14] Future Directions - **Multiple Indications**: The company is exploring the use of type 791 in MS, focusing on its potential to impact remyelination and inflammation [17][18] - **Chronic Pain Studies**: CTNM is also investigating the role of LPA1 antagonism in chronic pain, with a Phase Ib study currently underway [19][20][21] - **Pipeline Programs**: The company is advancing other programs, including type 307 for relapsing remitting MS, with a focus on remyelination [27][28] Financial Position - **Funding**: As of the end of the last quarter, the company reported $191 million in cash, which is expected to fund operations through the end of 2027 [42] Intellectual Property - **Patent Status**: All compounds in development are internally generated, with specific patents covering the composition and polymorphs of type 307 and type 791 [40][41] Market Outlook - **Unmet Needs**: The company acknowledges the presence of existing treatments but emphasizes the unmet medical needs in the IPF and MS markets, positioning itself to address these gaps [15][16] Additional Insights - **Exploratory Studies**: The company is conducting exploratory studies in chronic pain, emphasizing the importance of both central and peripheral mechanisms in pain management [22][24][26] - **Collaboration with J&J**: CTNM has partnered with Johnson & Johnson for the development of type 307, which is being explored for its potential in treating major depressive disorder [33][35] This summary encapsulates the key discussions and insights from the conference call, highlighting the strategic direction, clinical developments, and market positioning of Contineum Therapeutics.
Contineum Therapeutics, Inc.(CTNM) - 2025 Q1 - Earnings Call Presentation
2025-05-14 21:48
Pipeline Overview - Contineum Therapeutics is advancing internally-developed treatments for neuroscience, inflammation, and immunology indications[6] - The company's pipeline includes PIPE-791 (LPA1R antagonist) for IPF, PrMS, and chronic pain, CTX-343 (LPA1R antagonist) for peripheral indications, and PIPE-307 (M1R antagonist) for RRMS and MDD[8] - Contineum expects to have cash runway through 2027 to support key milestones[6] PIPE-791 (LPA1R Antagonist) - PIPE-791 is being developed for Idiopathic Pulmonary Fibrosis (IPF), a disease affecting over 130,000 patients in the US and 3 million patients globally[13] - In a bleomycin-induced in vivo lung fibrosis model, PIPE-791 at 03 mg/kg showed maximal effect with once-daily dosing, reducing lung collagen[28] - Phase 1 healthy volunteer trials showed no dose-limiting adverse events or toxicity[34] - PIPE-791 achieved EC50 and EC90 receptor occupancy at 24-hour trough after a single 1 mg dose[37] - PIPE-791 is also being developed for Progressive Multiple Sclerosis (PrMS), which affects over 750,000 patients globally[45] PIPE-307 (M1R Antagonist) - Contineum has a partnering agreement with J&J for PIPE-307, potentially worth over $1 billion, for all indications[73, 75] - Phase 2 VISTA trial enrollment in RRMS was completed in December 2024, with topline data expected in 2H25[75, 95] - Phase 1 PET trial established brain receptor uptake and PK relationship at pharmacologically active doses for CNS indications[91]