Contineum Therapeutics Reports Fourth-Quarter 2024 Financial Results; Affirms Key Clinical Development Milestones

Rhea-AI Summary

Contineum Therapeutics (NASDAQ: CTNM) has reported its Q4 2024 financial results and clinical development milestones. The company ended Q4 2024 with $204.8 million in cash and equivalents, projecting runway through 2027.

Key upcoming milestones include:

• PIPE-791 Phase 1b PET trial topline data expected in Q2 2025
• PIPE-307 Phase 2 VISTA trial data for RRMS treatment anticipated in H2 2025
• Phase 2 proof-of-concept trials for IPF and PrMS planned for H2 2025
• PIPE-791 Phase 1b chronic pain trial topline data expected in early 2026

Financial highlights show R&D expenses at $13.0 million (62% increase YoY), G&A expenses at $4.0 million, and a net loss of $14.6 million for Q4 2024.

Positive

• Strong cash position of $204.8M with runway through 2027
• Multiple clinical trial milestones expected in 2025
• Johnson & Johnson partnership advancing with Phase 2 trial
• Expanding clinical pipeline with up to 6 trials in 2025

Negative

• Net loss increased to $14.6M from $7.8M YoY
• R&D expenses up 62% YoY
• G&A expenses increased by $2.4M YoY
• Higher expenses expected in 2025 due to increased clinical activity

Insights

Financial Analyst

Contineum's Q4 2024 results present a typical biotech investment profile with increasing R&D expenses reflected in their widening net loss of $14.6 million (compared to $7.8 million year-over-year). This spending acceleration is strategic rather than concerning, supporting their ambitious clinical pipeline expansion to potentially six concurrent trials in 2025.

The company's $204.8 million cash position is particularly noteworthy, providing runway through 2027 – a substantial operational cushion that covers multiple clinical readouts and potential value-creating events. This cash strength eliminates near-term dilution concerns, allowing management to focus on execution rather than fundraising.

Investor focus should remain on the two key catalysts: PIPE-791 PET trial results (Q2 2025) and PIPE-307 Phase 2 RRMS data (H2 2025). These represent potential valuation inflection points typical in biotech development. The Johnson & Johnson partnership adds validation to their platform, reducing development risk for the PIPE-307 program.

With a market cap of approximately $161 million against $204.8 million in cash, Contineum currently trades below cash value – suggesting the market is assigning minimal value to their clinical pipeline despite multiple shots on goal across neuroscience, inflammation and immunology indications. This conservative valuation provides potential asymmetric risk-reward if any of their clinical programs demonstrate positive efficacy signals.

Neuroscience Specialist

Contineum's clinical pipeline demonstrates strategic targeting of high-unmet-need neurological indications. Their PIPE-307 program for relapsing-remitting multiple sclerosis represents a novel approach in this space, with their Phase 2 VISTA trial measuring not just standard endpoints but specifically assessing remyelination – a key mechanism that could potentially modify disease progression rather than just managing symptoms.

The expansion of PIPE-307 into major depressive disorder through Johnson & Johnson's Phase 2 trial highlights the compound's potential mechanistic versatility across different CNS conditions. This neuropsychiatric application suggests broader platform potential that could significantly expand the addressable market.

Their PIPE-791 program spans an impressive range of indications from idiopathic pulmonary fibrosis to progressive MS and chronic pain. The initiation of the chronic pain trial targeting both osteoarthritis and low back pain is particularly noteworthy given the need for non-opioid pain management alternatives. The planned Phase 2 trials in IPF and progressive MS following toxicity studies completion suggests confidence in the safety profile and mechanism.

The PET imaging approach to correlate pharmacokinetics with receptor occupancy across both healthy volunteers and patients represents sophisticated clinical trial design that should provide valuable mechanistic insights beyond standard safety/efficacy measures. This translational approach to clinical development indicates scientific rigor in their development strategy and could potentially de-risk subsequent larger trials.

- 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--(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 https://clinicaltrials.gov (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 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.

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 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 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 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.

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 Ended December 31,								Years Ended December 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 businesswire.com: https://www.businesswire.com/news/home/20250306364028/en/

Steve Kunszabo

Contineum Therapeutics

Senior Director, Investor Relations & Corporate Communications

858-649-1158

skunszabo@contineum-tx.com

Source: Contineum Therapeutics, Inc.

FAQ

What are the key clinical trial milestones for CTNM stock in 2025?

CTNM expects PIPE-791 Phase 1b PET trial data in Q2 2025 and PIPE-307 Phase 2 VISTA trial results for RRMS in H2 2025. The company plans to initiate Phase 2 trials for IPF and PrMS in H2 2025.

How much cash does CTNM have and how long will it last?

CTNM has $204.8 million in cash and equivalents as of December 31, 2024, with projected runway through 2027.

What was CTNM's net loss in Q4 2024?

CTNM reported a net loss of $14.6 million for Q4 2024, compared to $7.8 million in Q4 2023.

How much did CTNM's R&D expenses increase in Q4 2024?

R&D expenses were $13.0 million, representing a 62% increase from Q4 2023, due to higher clinical development costs.

What is the status of CTNM's partnership with Johnson & Johnson?

Johnson & Johnson began recruiting 124 participants for a Phase 2 trial of PIPE-307/JNJ-89495120 for major depressive disorder in December 2024.