Pulmatrix Announces Year-End and Fourth Quarter 2024 Financial Results and Divestment Plan for Assets
Pulmatrix (PULM) announced its Q4 and full-year 2024 financial results, highlighting its planned merger with Cullgen expected to close in H1 2025. The company reported revenues of $7.8 million for 2024, up from $7.3 million in 2023. Research and development expenses decreased to $7.2 million from $15.5 million, while general and administrative expenses increased to $7.8 million from $6.5 million.
As part of the merger strategy, Pulmatrix plans to divest its clinical assets, including the Phase 2-ready PUR3100 for acute migraine, PUR1800 for AECOPD, and PUR1900 antifungal treatment. The company's cash position stands at $9.5 million as of December 31, 2024, deemed sufficient until the merger completion.
The company's iSPERSE™ technology portfolio includes 149 granted patents, with 19 U.S. patents expiring between 2024 and 2037, plus approximately 50 pending applications.
Pulmatrix (PULM) ha annunciato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando la fusione pianificata con Cullgen, prevista per la prima metà del 2025. L'azienda ha riportato ricavi di 7,8 milioni di dollari per il 2024, in aumento rispetto ai 7,3 milioni di dollari del 2023. Le spese per ricerca e sviluppo sono diminuite a 7,2 milioni di dollari rispetto ai 15,5 milioni, mentre le spese generali e amministrative sono aumentate a 7,8 milioni di dollari rispetto ai 6,5 milioni.
Come parte della strategia di fusione, Pulmatrix prevede di dismettere i suoi beni clinici, inclusi il PUR3100 pronto per la fase 2 per l'emicrania acuta, il PUR1800 per l'AECOPD e il trattamento antifungino PUR1900. La posizione di cassa dell'azienda ammonta a 9,5 milioni di dollari al 31 dicembre 2024, considerata sufficiente fino al completamento della fusione.
Il portafoglio tecnologico iSPERSE™ dell'azienda include 149 brevetti concessi, con 19 brevetti statunitensi in scadenza tra il 2024 e il 2037, oltre a circa 50 domande in attesa.
Pulmatrix (PULM) anunció sus resultados financieros del cuarto trimestre y del año completo 2024, destacando su fusión planificada con Cullgen que se espera cierre en la primera mitad de 2025. La compañía reportó ingresos de 7.8 millones de dólares para 2024, un aumento desde los 7.3 millones de dólares en 2023. Los gastos de investigación y desarrollo disminuyeron a 7.2 millones de dólares desde 15.5 millones, mientras que los gastos generales y administrativos aumentaron a 7.8 millones de dólares desde 6.5 millones.
Como parte de la estrategia de fusión, Pulmatrix planea desinvertir sus activos clínicos, incluidos el PUR3100 listo para fase 2 para migraña aguda, el PUR1800 para AECOPD y el tratamiento antifúngico PUR1900. La posición de efectivo de la compañía es de 9.5 millones de dólares a 31 de diciembre de 2024, considerada suficiente hasta la finalización de la fusión.
El portafolio de tecnología iSPERSE™ de la compañía incluye 149 patentes concedidas, con 19 patentes estadounidenses que expiran entre 2024 y 2037, además de aproximadamente 50 solicitudes pendientes.
Pulmatrix (PULM)는 2024년 4분기 및 연간 재무 결과를 발표하며 2025년 상반기 완료 예정인 Cullgen과의 계획된 합병을 강조했습니다. 회사는 2024년 매출이 780만 달러로, 2023년의 730만 달러에서 증가했다고 보고했습니다. 연구 및 개발 비용은 1550만 달러에서 720만 달러로 감소했으며, 일반 및 관리 비용은 650만 달러에서 780만 달러로 증가했습니다.
합병 전략의 일환으로 Pulmatrix는 급성 편두통을 위한 Phase 2 준비가 완료된 PUR3100, AECOPD를 위한 PUR1800 및 항진균 치료제 PUR1900을 포함한 임상 자산을 매각할 계획입니다. 회사의 현금 보유액은 2024년 12월 31일 기준 950만 달러로, 합병 완료까지 충분하다고 평가됩니다.
회사의 iSPERSE™ 기술 포트폴리오는 149개의 특허가 부여되어 있으며, 2024년부터 2037년 사이에 만료되는 미국 특허가 19개 있으며, 약 50개의 신청이 대기 중입니다.
Pulmatrix (PULM) a annoncé ses résultats financiers du quatrième trimestre et de l'année complète 2024, mettant en avant sa fusion prévue avec Cullgen, qui devrait se conclure au premier semestre 2025. L'entreprise a rapporté des revenus de 7,8 millions de dollars pour 2024, en hausse par rapport à 7,3 millions de dollars en 2023. Les dépenses de recherche et développement ont diminué à 7,2 millions de dollars contre 15,5 millions, tandis que les dépenses générales et administratives ont augmenté à 7,8 millions de dollars contre 6,5 millions.
Dans le cadre de la stratégie de fusion, Pulmatrix prévoit de céder ses actifs cliniques, y compris le PUR3100 prêt pour la phase 2 pour la migraine aiguë, le PUR1800 pour l'AECOPD et le traitement antifongique PUR1900. La position de liquidités de l'entreprise s'élève à 9,5 millions de dollars au 31 décembre 2024, jugée suffisante jusqu'à l'achèvement de la fusion.
Le portefeuille technologique iSPERSE™ de l'entreprise comprend 149 brevets accordés, avec 19 brevets américains expirant entre 2024 et 2037, ainsi qu'environ 50 demandes en attente.
Pulmatrix (PULM) gab seine Finanzzahlen für das vierte Quartal und das gesamte Jahr 2024 bekannt und hob die geplante Fusion mit Cullgen hervor, die im ersten Halbjahr 2025 abgeschlossen werden soll. Das Unternehmen berichtete von Einnahmen in Höhe von 7,8 Millionen Dollar für 2024, ein Anstieg von 7,3 Millionen Dollar im Jahr 2023. Die Forschungs- und Entwicklungskosten sanken auf 7,2 Millionen Dollar von 15,5 Millionen, während die allgemeinen und administrativen Ausgaben auf 7,8 Millionen Dollar von 6,5 Millionen Dollar stiegen.
Im Rahmen der Fusionsstrategie plant Pulmatrix, seine klinischen Vermögenswerte zu veräußern, einschließlich des Phase-2-bereiten PUR3100 für akute Migräne, PUR1800 für AECOPD und PUR1900 als Antimykotikum. Die Liquiditätslage des Unternehmens beträgt zum 31. Dezember 2024 9,5 Millionen Dollar, was bis zum Abschluss der Fusion als ausreichend erachtet wird.
Das Technologieportfolio iSPERSE™ des Unternehmens umfasst 149 erteilte Patente, wobei 19 US-Patente zwischen 2024 und 2037 ablaufen und etwa 50 Anmeldungen noch ausstehen.
- Revenue increased to $7.8M in 2024 from $7.3M in 2023
- R&D expenses decreased significantly by $8.3M to $7.2M
- Cash position of $9.5M sufficient through planned merger completion
- Strong patent portfolio with 149 granted patents
- G&A expenses increased by $1.3M to $7.8M
- $2.6M loss recognized on MannKind transactions
- Stopped enrollment in PUR1900 Phase 2b study
- Company divesting all clinical assets as part of merger
Insights
The announcement reveals Pulmatrix's strategic pivot through its merger agreement with Cullgen, expected to close in H1 2025, and plans to divest its entire respiratory and migraine therapeutic portfolio. This represents a complete business transformation from Pulmatrix's inhaled drug delivery focus to Cullgen's protein degradation platform.
The financial picture shows modest revenue growth to
The
This transformation effectively means current PULM shareholders are investing in an entirely different business post-merger. Cullgen brings three Phase 1 or near-Phase 1 programs targeting cancer and pain treatment using protein degradation technology—a complete departure from Pulmatrix's respiratory focus. The divestiture of their Phase 2-ready migraine candidate (PUR3100) and proprietary iSPERSE technology signals abandonment of their original business model and intellectual property portfolio with 149 granted patents.
This announcement marks a fundamental redirection in Pulmatrix's business focus, abandoning years of investment in their proprietary iSPERSE™ dry powder inhalation platform in favor of Cullgen's protein degradation technology (uSMITE™).
The divestment of PUR3100, their most advanced clinical candidate, is particularly significant. This inhaled dihydroergotamine for acute migraine had shown promising pharmacokinetics in Phase 1, achieving therapeutic plasma concentrations within just 5 minutes of administration with reduced nausea compared to IV administration. The product was Phase 2-ready with FDA acceptance of the IND and "study may proceed" authorization already secured—representing substantial development value that will now be sold off.
Similarly, PUR1800 (an inhaled narrow spectrum kinase inhibitor for COPD exacerbations) showed positive safety data in Phase 1b, and their antifungal candidate PUR1900 remains under development by partner Cipla outside the US, with Pulmatrix retaining a minimal
The pivot to Cullgen's platform represents an entry into the competitive protein degradation space, with programs targeting cancer and pain that are just entering clinical development. While this field has significant potential, it's a crowded space with multiple approaches from well-capitalized competitors. Post-merger, the company will have three early clinical-stage degrader programs—two in oncology and one in pain management—all at or approaching Phase 1, essentially resetting Pulmatrix's clinical development timeline back several years versus their current portfolio.
Announced merger agreement with Cullgen in November, anticipated to close in the first half of 2025
As part of proposed merger, Pulmatrix intends to divest its assets including its Phase 2-ready acute migraine candidate, PUR3100, and other development candidates based on its iSPERSE™ technology
Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the fourth quarter has been to advance the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE™ platform to discover and advance therapeutics for the treatment of cancer and other diseases. If successful, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in or about to initiate Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain. As part of the proposed merger, Pulmatrix is in a process to divest its clinical assets, including iSPERSE™ and our Phase 2 ready acute migraine product."
Proposed Merger with Cullgen
As previously reported, on November 13, 2024, following a review of strategic alternatives, the Company announced it had entered into an agreement and plan of merger (the "Merger Agreement" and such transaction, the "Merger") with Cullgen Inc. ("Cullgen"). The Merger is anticipated to close in the first half of 2025, subject to the satisfaction of certain closing conditions, among others, however the exact timing of the consummation of the Merger cannot be predicted.
Additional information about the Merger Agreement was previously disclosed on a Current Report on Form 8-K filed with the SEC on November 13, 2024, and in a registration statement on Form S-4 filed with the SEC on February 14, 2025.
Pulmatrix Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology
PUR3100
- PUR3100 is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE dry powder inhalation technology for the treatment of acute migraine.
- In 2023, Pulmatrix announced the Food and Drug Administration's acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study, positioning PUR3100 as Phase 2-ready. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine.
- The planned Phase 2 trial builds on the Phase 1 trial results of PUR3100, which were published in 2024 in a peer-reviewed publication, Headache: The Journal of Head and Face Pain.
- The study showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting compared to observations of nausea and vomiting in the intravenously ("IV") administered DHE dose group.
PUR1800
- PUR1800 is a Narrow Spectrum Kinase Inhibitor ("NSKI"), engineered with our iSPERSE™ technology, for the treatment of acute exacerbations in chronic obstructive pulmonary disease ("AECOPD"). In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for AECOPD, indicating PUR1800 was safe and well tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases.
PUR1900
- PUR1900 is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. Per an updated agreement with its partner Cipla, Pulmatrix has stopped patient enrollment for the Phase 2b study of PUR1900 while Cipla has continued their Phae 2 trial outside
the United States . The decision to stop the study was unrelated to any safety concerns. The Phase 2b study had been ongoing since the first quarter of 2023. The Company completed all Phase 2b wind down activities within the third quarter of 2024 as planned. - With the study wind down complete, Pulmatrix bears no further financial responsibility for the development of PUR1900 and will receive
2% royalties on any potential future net sales by Cipla outsidethe United States . Withinthe United States , Pulmatrix and Cipla will seek to monetize PUR1900.
iSPERSE™ Technology
- iSPERSE™ particles are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases.
- As of December 31, 2024, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 149 granted patents, 19 of which are granted
U.S. patents, with expiration dates from 2024 to 2037, and approximately 50 additional pending patent applications in theU.S. and other jurisdictions.
Fourth Quarter and Year-End 2024 Financial Results
Revenues increased approximately
Research and development expenses decreased approximately
General and administrative expenses increased approximately
The Company recognized a
The Company's total cash and cash equivalents balance as of December 31, 2024, was
PULMATRIX, INC. | ||||||||
December 31, 2024 | December 31, 2023 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 9,521 | $ | 19,173 | ||||
Accounts receivable | - | 928 | ||||||
Prepaid expenses and other current assets | 399 | 742 | ||||||
Total current assets | 9,920 | 20,843 | ||||||
Property and equipment, net | - | 1,158 | ||||||
Operating lease right-of-use asset | - | 10,309 | ||||||
Long-term restricted cash | 10 | 1,472 | ||||||
Other long-term assets | 13 | 176 | ||||||
Total assets | $ | 9,943 | $ | 33,958 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 809 | $ | 1,915 | ||||
Accrued expenses and other current liabilities | 120 | 947 | ||||||
Operating lease liability | - | 429 | ||||||
Deferred revenue | - | 618 | ||||||
Total current liabilities | 929 | 3,909 | ||||||
Warrant liability | 67 | - | ||||||
Deferred revenue, net of current portion | - | 3,727 | ||||||
Operating lease liability, net of current portion | - | 8,327 | ||||||
Total liabilities | 996 | 15,963 | ||||||
Stockholders' equity: | ||||||||
Preferred stock, | - | - | ||||||
Common stock, | - | - | ||||||
Additional paid-in capital | 306,103 | 305,592 | ||||||
Accumulated deficit | (297,156) | (287,597) | ||||||
Total stockholders' equity | 8,947 | 17,995 | ||||||
Total liabilities and stockholders' equity | $ | 9,943 | $ | 33,958 | ||||
PULMATRIX, INC. | ||||||||
Year Ended December 31, | ||||||||
2024 | 2023 | |||||||
Revenues | $ | 7,806 | $ | 7,298 | ||||
Operating expenses: | ||||||||
Research and development | 7,166 | 15,518 | ||||||
General and administrative | 7,785 | 6,520 | ||||||
Loss on MannKind Transaction | 2,618 | - | ||||||
Total operating expenses | 17,569 | 22,038 | ||||||
Loss from operations | (9,763) | (14,740) | ||||||
Other income (expense): | ||||||||
Interest income | 467 | 867 | ||||||
Fair value adjustment of warrants | (67) | - | ||||||
Other expense, net | (196) | (248) | ||||||
Total other income, net | 204 | 619 | ||||||
Net loss | $ | (9,559) | $ | (14,121) | ||||
Net loss per share attributable to common stockholders – basic and | $ | (2.62) | $ | (3.87) | ||||
Weighted average common shares outstanding – basic and diluted | 3,652,285 | 3,651,911 | ||||||
About Pulmatrix, Inc.
Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for central nervous system ("CNS") disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease ("COPD") and allergic bronchopulmonary aspergillosis ("ABPA"). Pulmatrix's product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes.
About iSPERSE™ Technology
Pulmatrix's innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE™ is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs. iSPERSE™ can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases.
For more on the Company's inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html.
Forward-Looking Statements
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the consummation of the proposed Merger with Cullgen and satisfaction of closing conditions thereunder, among others, the Company's ability to maintain compliance with the listing standards of the Nasdaq Capital Market, the Company's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company's products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, including the proposed Merger with Cullgen, is set forth in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Chuck Padala
Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-announces-year-end-and-fourth-quarter-2024-financial-results-and-divestment-plan-for-assets-302407628.html
SOURCE Pulmatrix Inc.
FAQ
What are the key financial results for Pulmatrix (PULM) in 2024?
What is the status of Pulmatrix's (PULM) merger with Cullgen?
What are the main assets Pulmatrix (PULM) is planning to divest?
What is the current patent position of Pulmatrix's (PULM) iSPERSE technology?
