Contineum Therapeutics Reports Fourth-Quarter 2024 Financial Results; Affirms Key Clinical Development Milestones
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--(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.
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.
Contacts
Steve Kunszabo Contineum Therapeutics Senior Director, Investor Relations & Corporate Communications 858-649-1158 [email protected]