Contineum Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Contineum Therapeutics (Nasdaq: CTNM) reported its Q3 2024 financial results and recent business highlights. The company continued enrolling patients in its Phase 2 VISTA trial of PIPE-307 for RRMS, achieving two-thirds enrollment. It expects full enrollment by H1 2025. Contineum submitted a CTA to the MHRA for a Phase 1b trial of PIPE-791, targeting healthy volunteers and patients with progressive multiple sclerosis and IPF, aiming to start in December 2024. Janssen Pharmaceutica remains on track to start a Phase 2 trial of PIPE-307 in depression. The company holds $214 million in cash, expected to support operations through 2027. Q3 R&D expenses rose to $9.7 million from $6.5 million YoY, driven by increased costs for ongoing trials and toxicology studies. General and administrative expenses also increased to $3.3 million from $1.6 million YoY, mainly due to higher stock-based compensation and consulting costs.
Contineum Therapeutics (Nasdaq: CTNM) ha riportato i risultati finanziari del terzo trimestre 2024 e i recenti punti salienti aziendali. L'azienda ha continuato a reclutare pazienti nel suo studio Fase 2 VISTA di PIPE-307 per la sclerosi multipla recidivante, raggiungendo i due terzi del reclutamento. Si aspetta il completamento del reclutamento entro la prima metà del 2025. Contineum ha presentato una CTA all'MHRA per uno studio Fase 1b di PIPE-791, rivolto a volontari sani e pazienti con sclerosi multipla progressiva e fibrosi polmonare idiopatica, con l'obiettivo di iniziare a dicembre 2024. Janssen Pharmaceutica è sulla buona strada per avviare uno studio Fase 2 di PIPE-307 nella depressione. L'azienda detiene 214 milioni di dollari in contante, previsti per sostenere le operazioni fino al 2027. Le spese di ricerca e sviluppo per il terzo trimestre sono aumentate a 9,7 milioni di dollari rispetto ai 6,5 milioni di dollari dell'anno precedente, principalmente a causa dell'aumento dei costi per studi in corso e studi di tossicologia. Anche le spese generali e amministrative sono aumentate a 3,3 milioni di dollari rispetto a 1,6 milioni di dollari dell'anno precedente, principalmente a causa di un aumento della compensazione azionaria e dei costi di consulenza.
Contineum Therapeutics (Nasdaq: CTNM) informó sus resultados financieros del tercer trimestre de 2024 y los recientes puntos destacados de la empresa. La compañía continuó reclutando pacientes en su ensayo Fase 2 VISTA de PIPE-307 para EMRR, logrando dos tercios de inscripción. Se espera completar el reclutamiento en la primera mitad de 2025. Contineum presentó una CTA a la MHRA para un ensayo Fase 1b de PIPE-791, dirigido a voluntarios sanos y pacientes con esclerosis múltiple progresiva e fibrosis pulmonar idiopática, con la intención de comenzar en diciembre de 2024. Janssen Pharmaceutica se mantiene en camino de iniciar un ensayo Fase 2 de PIPE-307 en depresión. La compañía posee 214 millones de dólares en efectivo, que se espera que respalden las operaciones hasta 2027. Los gastos de I+D del tercer trimestre aumentaron a 9,7 millones de dólares, desde 6,5 millones de dólares en el año anterior, impulsados por el aumento de los costos de ensayos en curso y estudios de toxicología. Los gastos generales y administrativos también aumentaron a 3,3 millones de dólares, desde 1,6 millones de dólares en el año anterior, principalmente debido a mayores compensaciones basadas en acciones y costos de consultoría.
Contineum Therapeutics (Nasdaq: CTNM)는 2024년 3분기 재무 결과와 최근 비즈니스 하이라이트를 보고했습니다. 이 회사는 RRMS에 대한 PIPE-307의 2상 VISTA 시험에 환자를 계속 등록하고 있으며, 현재 등록률은 2/3에 달합니다. 2025년 상반기까지 전체 등록이 완료될 것으로 기대하고 있습니다. Contineum은 건강한 자원봉사자 및 진행성 다발성 경화증과 IPF 환자를 대상으로 PIPE-791의 1b상 시험을 위해 MHRA에 CTA를 제출했으며, 2024년 12월에 시작할 계획입니다. Janssen Pharmaceutica는 우울증에 대한 PIPE-307의 2상 시험을 시작할 준비가 되어 있습니다. 이 회사는 214백만 달러의 현금을 보유하고 있으며, 이는 2027년까지 운영을 지원할 것으로 기대됩니다. 3분기 연구개발 비용은 6.5백만 달러에서 9.7백만 달러로 증가했으며, 이는 진행 중인 시험과 독성학 연구의 비용 증가로 인한 것입니다. 일반 및 관리 비용도 전년 대비 1.6백만 달러에서 3.3백만 달러로 증가했으며, 이는 주식 기반 보상 및 자문 비용 증가로 인한 것입니다.
Contineum Therapeutics (Nasdaq: CTNM) a publié ses résultats financiers du troisième trimestre 2024 et ses récents points saillants d'activité. La société a poursuivi le recrutement de patients dans son essai de Phase 2 VISTA de PIPE-307 pour la SEP récurrente, atteignant les deux tiers du recrutement. Elle prévoit un recrutement complet d'ici la première moitié de 2025. Contineum a soumis une CTA à la MHRA pour un essai de Phase 1b de PIPE-791, ciblant des volontaires en bonne santé et des patients atteints de sclérose en plaques progressive et de fibrose pulmonaire idiopathique, visant à commencer en décembre 2024. Janssen Pharmaceutica est sur la bonne voie pour commencer un essai de Phase 2 de PIPE-307 sur la dépression. La société dispose de 214 millions de dollars en liquidités, prévus pour soutenir ses opérations jusqu'en 2027. Les dépenses de R&D du troisième trimestre ont augmenté à 9,7 millions de dollars contre 6,5 millions de dollars l'année précédente, en raison de l'augmentation des coûts des essais en cours et des études de toxicologie. Les dépenses générales et administratives ont également augmenté à 3,3 millions de dollars contre 1,6 million de dollars l'année précédente, principalement en raison d'une compensation basée sur des actions et des coûts de consulting accrus.
Contineum Therapeutics (Nasdaq: CTNM) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und die aktuellen Unternehmenshighlights. Das Unternehmen setzte die Rekrutierung von Patienten für die Phase-2-Studie VISTA zu PIPE-307 für RRMS fort und erreichte zwei Drittel der Rekrutierung. Es erwartet, dass die vollständige Rekrutierung bis zur ersten Hälfte von 2025 abgeschlossen ist. Contineum hat eine CTA bei der MHRA für eine Phase-1b-Studie zu PIPE-791 eingereicht, die sich an gesunde Freiwillige und Patienten mit fortschreitender Multipler Sklerose und IPF richtet und die im Dezember 2024 beginnen soll. Janssen Pharmaceutica liegt im Zeitplan, um eine Phase-2-Studie zu PIPE-307 bei Depressionen zu starten. Das Unternehmen verfügt über 214 Millionen Dollar an Bargeld, das voraussichtlich die Operationen bis 2027 unterstützen wird. Die Forschungs- und Entwicklungsausgaben für das dritte Quartal stiegen im Jahresvergleich von 6,5 Millionen Dollar auf 9,7 Millionen Dollar, was auf gestiegene Kosten für laufende Studien und toxikologische Untersuchungen zurückzuführen ist. Auch die allgemeinen und administrativen Ausgaben stiegen im Jahresvergleich von 1,6 Millionen Dollar auf 3,3 Millionen Dollar, hauptsächlich aufgrund höherer aktienbasierter Vergütungen und Beratungskosten.
- Strong cash position of $214 million to support operations through 2027.
- Two-thirds enrollment in the VISTA trial, ahead of projections.
- Multiple potential clinical readouts in 2025.
- Janssen Pharmaceutica on track for Phase 2 trial of PIPE-307 in depression.
- Increased R&D expenses to $9.7 million from $6.5 million YoY.
- General and administrative expenses rose to $3.3 million from $1.6 million YoY.
-Enrollment for PIPE-307 VISTA trial on track-
-Strong cash position of
-Multiple potential clinical readouts in 2025-
“The third quarter of 2024 was focused on clinical execution for our lead assets PIPE-307 and PIPE-791, where we have multiple potential opportunities in sizeable markets in IPF, depression and multiple sclerosis. During the quarter, we continued to enroll patients in our Phase 2 VISTA trial of PIPE-307 for RRMS, and we remain on track to initiate our Phase 1b open-label PET trial of PIPE-791 in the fourth quarter of 2024,” said Carmine Stengone, Contineum’s Chief Executive Officer. “In addition, we believe our strong cash balance of
Third Quarter 2024 and Recent Business Highlights
- As of September 30, 2024, Contineum had achieved two-thirds enrollment in its VISTA clinical trial, a multi-center randomized, double blinded, placebo-controlled Phase 2 clinical proof-of-concept trial of PIPE-307 in relapsing-remitting multiple sclerosis, ahead of Contineum’s initial projections. Contineum now expects the VISTA trial to be fully enrolled in the first half of 2025.
- In September 2024, Contineum submitted a Clinical Trial Authorization (CTA) to the Medicines and Healthcare projects Regulatory Agency (MHRA) to commence a Phase 1b open-label clinical trial of PIPE-791 to measure the relationship of pharmacokinetics to receptor occupancy by PET imaging in healthy volunteers, as well as progressive multiple sclerosis and idiopathic pulmonary fibrosis (IPF) patients. Assuming near-term MHRA authorization of Contineum’s CTA submission, Contineum plans to enroll the first two healthy volunteers in this trial in December 2024 and to have the full dataset from this trial in the first half of 2025.
- Janssen Pharmaceutica NV, a Johnson & Johnson company, has confirmed to Contineum that it remains on track to initiate a Phase 2 clinical trial of PIPE-307 in depression.
- Contineum anticipates nominating a development candidate from its discovery portfolio against a new target by the end of 2024.
Third Quarter 2024 Financial Results
-
Cash, Cash Equivalents and Marketable Securities. As of September 30, 2024, Contineum had cash, cash equivalents and marketable securities of
$213.9 million $125.2 million -
Research and Development Expenses. Research and development expenses were
$9.7 million $6.5 million $3.2 million $1.1 million $1.5 million $0.6 million $0.7 million $0.7 million -
General and Administrative Expenses. General and administrative expenses were
$3.3 million $1.6 million $1.7 million $0.2 million $1.1 million $0.3 million
About Contineum Therapeutics
Contineum Therapeutics (Nasdaq: CTNM) is a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule therapies for NI&I indications with high unmet need. Contineum is focused on targeting biological pathways associated with specific clinical impairments, that Contineum believes, once modulated, may demonstrably impact the course of disease. Contineum has a pipeline of internally-developed programs to address multiple NI&I disorders. Contineum has two drug candidates in clinical trials, PIPE-791, an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and progressive multiple sclerosis, and PIPE-307, a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis. PIPE-307 is being developed pursuant to a global license and development agreement between Contineum and Janssen Pharmaceutica NV, a Johnson & Johnson company, who has also announced plans to initiate a Phase 2 trial of PIPE-307 in depression in 2024.
Contineum is headquartered in
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 the timing and outcome of the MHRA’s assessment of our CTA submission to initiate a Phase 1b open-label PET clinical trial of PIPE-791, the timing and outcome of any assessment by the FDA of an IND submission to initiate the Company’s planned Phase 2 study clinical trial of PIPE-791 for the treatment of IPF as well as the Company’s ability to generate meaningful clinical readouts from either clinical trial in 2025; the indications, anticipated benefits of, and market opportunities for its drug candidates; its cash runway; 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 studies 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 upon Johnson & Johnson to develop PIPE-307 for depression or any other indication other than RRMS and, after completion of the VISTA trial, Johnson and Johnson’s decision, in its sole discretion, whether or not 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 Johnson & Johnson 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-Q 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. Condensed Balance Sheets (Unaudited) |
||||||||
| (in thousands) | September 30, 2024 | December 31, 2023 | ||||||
| Assets | ||||||||
| Cash, cash equivalents and marketable securities | $ |
213,911 |
$ |
125,190 |
|
|||
| Prepaid expenses and other current assets |
|
1,232 |
|
2,516 |
|
|||
| Property and equipment, net |
|
888 |
|
678 |
|
|||
| Other long-term assets |
|
3 |
|
1,283 |
|
|||
| Operating lease right-of-use assets |
|
- |
|
719 |
|
|||
| Total assets | $ |
216,034 |
$ |
130,386 |
|
|||
| Liabilities, convertible preferred stock and stockholders' equity (deficit) | ||||||||
| Current liabilities | $ |
5,806 |
$ |
5,484 |
|
|||
| Long-term liabilities |
|
- |
|
218 |
|
|||
| Convertible preferred stock |
|
- |
|
192,620 |
|
|||
| Total stockholders' equity (deficit) |
|
210,228 |
|
(67,936 |
) |
|||
| Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ |
216,034 |
$ |
130,386 |
|
|||
Contineum Therapeutics, Inc.
|
||||||||||||||||
| (in thousands) | Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|||||
| Revenue: | ||||||||||||||||
| License revenue | $ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
50,000 |
|
||||
| Operating expenses: | ||||||||||||||||
| Research and development |
|
9,728 |
|
|
6,499 |
|
|
25,407 |
|
|
19,591 |
|
||||
| General and administrative |
|
3,246 |
|
|
1,570 |
|
|
8,440 |
|
|
4,656 |
|
||||
| Total operating expenses |
|
12,974 |
|
|
8,069 |
|
|
33,847 |
|
|
24,247 |
|
||||
| Income (loss) from operations |
|
(12,974 |
) |
|
(8,069 |
) |
|
(33,847 |
) |
|
25,753 |
|
||||
| Other income (expense): | ||||||||||||||||
| Interest income |
|
2,741 |
|
|
1,736 |
|
|
6,377 |
|
|
2,816 |
|
||||
| Interest expense |
|
- |
|
|
- |
|
|
- |
|
|
(208 |
) |
||||
| Change in fair value of warrant liability |
|
- |
|
|
- |
|
|
(107 |
) |
|
2 |
|
||||
| Change in fair value of investor rights and obligations liability |
|
- |
|
|
- |
|
|
- |
|
|
2,867 |
|
||||
| Other expense, net |
|
(34 |
) |
|
(36 |
) |
|
(116 |
) |
|
(130 |
) |
||||
| Total other income |
|
2,707 |
|
|
1,700 |
|
|
6,154 |
|
|
5,347 |
|
||||
| Income (loss) before income taxes |
|
(10,267 |
) |
|
(6,369 |
) |
|
(27,693 |
) |
|
31,100 |
|
||||
| Provision for (benefit from) income taxes |
|
- |
|
|
(118 |
) |
|
- |
|
|
611 |
|
||||
| Net income (loss) | $ |
(10,267 |
) |
$ |
(6,251 |
) |
$ |
(27,693 |
) |
$ |
30,489 |
|
||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain (loss) on marketable securities |
|
688 |
|
|
(24 |
) |
|
453 |
|
|
(13 |
) |
||||
| Comprehensive income (loss) | $ |
(9,579 |
) |
$ |
(6,275 |
) |
$ |
(27,240 |
) |
$ |
30,476 |
|
||||
| Net income (loss) attributable to common stockholders, basic | $ |
(10,267 |
) |
$ |
(6,251 |
) |
$ |
(27,693 |
) |
$ |
4,340 |
|
||||
| Net income (loss) attributable to common stockholders, diluted | $ |
(10,267 |
) |
$ |
(6,251 |
) |
$ |
(27,693 |
) |
$ |
1,471 |
|
||||
| Net income (loss) per share, basic (a) | $ |
(0.40 |
) |
$ |
(2.69 |
) |
$ |
(1.61 |
) |
$ |
1.89 |
|
||||
| Net income (loss) per share, diluted (a) | $ |
(0.40 |
) |
$ |
(2.69 |
) |
$ |
(1.61 |
) |
$ |
0.43 |
|
||||
| Weighted-average shares of common stock outstanding, basic |
|
25,730,014 |
|
|
2,324,588 |
|
|
17,182,865 |
|
|
2,298,175 |
|
||||
| Weighted-average shares of common stock outstanding, diluted |
|
25,730,014 |
|
|
2,324,588 |
|
|
17,182,865 |
|
|
3,445,978 |
|
||||
| _____________ | ||||||||||||||||
| (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/20241106662946/en/
Peter Slover
CFO
pslover@contineum-tx.com
IR@contineum-tx.com
Source: Contineum Therapeutics, Inc.
FAQ
What are the key financial highlights for Contineum Therapeutics (CTNM) in Q3 2024?
What is the enrollment status of Contineum Therapeutics' (CTNM) VISTA trial?
When will Contineum Therapeutics (CTNM) begin its Phase 1b trial of PIPE-791?
Is Janssen Pharmaceutica on track with its Phase 2 trial of PIPE-307 in depression?
What are the research and development expenses for Contineum Therapeutics (CTNM) in Q3 2024?
