Pulmatrix and Cullgen Announce Proposed Merger
Pulmatrix (NASDAQ: PULM) announced a merger agreement with privately-held Cullgen, creating a Nasdaq-listed company focused on targeted protein degradation technology. The combined entity will have approximately $65 million in cash, providing funding through multiple clinical milestones and runway through 2026. The merger includes three degrader programs approaching or in Phase 1 clinical trials - two for cancer treatment and one for acute and chronic pain. As part of the agreement, Pulmatrix will divest its assets, including PUR3100 for acute migraine and other iSPERSE™ technology-based candidates. Cullgen brings its proprietary uSMITE™ platform for developing targeted protein degraders and degrader-antibody conjugates (DACs).
Pulmatrix (NASDAQ: PULM) ha annunciato un accordo di fusione con la società privata Cullgen, creando una società quotata al Nasdaq focalizzata sulla tecnologia di degradazione mirata delle proteine. L'entità combinata avrà circa 65 milioni di dollari in contanti, fornendo finanziamenti attraverso molteplici traguardi clinici e risorse fino al 2026. La fusione include tre programmi di degradazione che si avvicinano o sono in fase 1 di trial clinici - due per il trattamento del cancro e uno per il dolore acuto e cronico. Come parte dell'accordo, Pulmatrix cederà i suoi beni, inclusi PUR3100 per l'emicrania acuta e altri candidati basati su tecnologia iSPERSE™. Cullgen porta la sua piattaforma proprietaria uSMITE™ per lo sviluppo di degradatori di proteine mirati e coniugati di anticorpi degradatori (DACs).
Pulmatrix (NASDAQ: PULM) anunció un acuerdo de fusión con la empresa privada Cullgen, creando una compañía cotizada en Nasdaq enfocada en la tecnología de degradación de proteínas dirigida. La entidad combinada tendrá aproximadamente 65 millones de dólares en efectivo, proporcionando financiación a través de múltiples hitos clínicos y recursos hasta 2026. La fusión incluye tres programas de degradadores que se acercan o están en ensayos clínicos de fase 1 - dos para el tratamiento del cáncer y uno para el dolor agudo y crónico. Como parte del acuerdo, Pulmatrix desinvertirá sus activos, incluidos PUR3100 para la migraña aguda y otros candidatos basados en la tecnología iSPERSE™. Cullgen aporta su plataforma propietaria uSMITE™ para el desarrollo de degradadores de proteínas dirigidos y conjugados de anticuerpos degradadores (DACs).
Pulmatrix (NASDAQ: PULM)는 비상장 회사 Cullgen과의 합병 계약을 발표하며 표적 단백질 분해 기술에 중점을 둔 나스닥 상장 회사를 설립했습니다. 결합된 법인은 약 6,500만 달러의 현금을 보유하게 되며, 이는 여러 임상 마일스톤을 통한 자금 조달과 2026년까지의 운영 자금을 제공합니다. 합병에는 암 치료를 위한 두 가지와 급성과 만성 통증을 위한 하나의 임상 1상 시험에 접근 중인 세 가지 분해 프로그램이 포함됩니다. 계약의 일환으로 Pulmatrix는 급성 편두통을 위한 PUR3100과 iSPERSE™ 기술을 기반으로 한 기타 후보 물질을 포함한 자산을 매각하게 됩니다. Cullgen은 표적 단백질 분해제 및 분해제-항체 접합체(DAC)를 개발하기 위한 전유 uSMITE™ 플랫폼을 제공합니다.
Pulmatrix (NASDAQ: PULM) a annoncé un accord de fusion avec Cullgen, une société privée, créant une entreprise cotée au Nasdaq axée sur la technologie de dégradation ciblée des protéines. L'entité combinée disposera de déjà 65 millions de dollars en espèces, fournissant un financement à travers plusieurs étapes cliniques et un soutien jusqu'en 2026. La fusion inclut trois programmes de dégradateurs approchant ou en phase 1 des essais cliniques - deux pour le traitement du cancer et un pour la douleur aiguë et chronique. Dans le cadre de l'accord, Pulmatrix cèdera ses actifs, y compris PUR3100 pour la migraine aiguë et d'autres candidats basés sur la technologie iSPERSE™. Cullgen apporte sa plateforme propriétaire uSMITE™ pour développer des dégradateurs de protéines ciblés et des conjugués anticorps-dégradateurs (DAC).
Pulmatrix (NASDAQ: PULM) gab eine Fusionsvereinbarung mit dem privat gehaltenen Unternehmen Cullgen bekannt, die eine an der Nasdaq gelistete Firma schaffen, die sich auf zielgerichtete Proteinabbau-Technologie konzentriert. Die kombinierte Einheit wird ungefähr 65 Millionen Dollar in bar haben, was eine Finanzierung durch mehrere klinische Meilensteine und einen finanziellen Spielraum bis 2026 ermöglicht. Die Fusion umfasst drei Abbau-Programme, die sich in Phase 1 klinischen Studien befinden oder sich nähern - zwei zur Behandlung von Krebs und eines für akute und chronische Schmerzen. Im Rahmen der Vereinbarung wird Pulmatrix seine Vermögenswerte veräußern, einschließlich PUR3100 zur Behandlung akuter Migräne und anderer Kandidaten auf Basis der iSPERSE™-Technologie. Cullgen bringt seine proprietäre uSMITE™-Plattform zur Entwicklung von zielgerichteten Proteinabbauprodukten und Abbau-Antikörper-Konjugaten (DACs) ein.
- Combined company to have $65M cash position with runway through 2026
- Three Phase 1 clinical trial programs in pipeline
- Strategic partnership with Astellas Pharma
- Successful Series C financing led by AstraZeneca-CICC
- Pulmatrix required to divest all current assets and development candidates
- Complete shift in business strategy and technology focus
Insights
The merger between Pulmatrix and Cullgen represents a significant strategic shift with substantial financial implications. The combined entity will have approximately
The deal structure involves Pulmatrix divesting its current assets, including PUR3100 and iSPERSE™ technology, to focus on Cullgen's three clinical-stage programs. Cullgen's recent Series C funding from AstraZeneca-CICC and partnership with Astellas adds credibility to their technology platform. The combined company's focus on targeted protein degradation, particularly with three Phase 1 programs, positions it in a high-value therapeutic space with significant market potential.
This merger brings significant therapeutic potential through Cullgen's uSMITE™ platform and novel E3 ligase technology. The combined pipeline includes two oncology programs and one pain management candidate in or near Phase 1 trials, representing diverse therapeutic applications of protein degradation technology. The development of degrader-antibody conjugates (DACs) is particularly noteworthy as it represents a novel approach in the protein degradation field.
Cullgen's strategic partnerships with major pharmaceutical companies like Astellas and investment from AstraZeneca-CICC validate their technology platform. The focus on protein degradation aligns with current industry trends, as this modality has shown promise in addressing previously "undruggable" targets in cancer and other diseases.
Merger to 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
Combined company expected to have approximately
provide funding through multiple clinical milestones and expected runway through 2026
As part of merger agreement, Pulmatrix intends to divest its assets including its acute migraine candidate,
PUR3100, and other development candidates based on its iSPERSE™ technology
Cullgen and Pulmatrix will host an informational webcast about the proposed merger that will be made
available to access at 12:00 pm ET today
In 2023 Cullgen completed a Series C financing led by AstraZeneca-CICC Venture Capital Partnership, and also announced a strategic partnership with Astellas Pharma Inc.
About the Proposed Transaction
Subject to the terms and conditions of the merger agreement, and upon the closing of the merger, pre-merger Pulmatrix stockholders are expected to own approximately
The transaction is expected to close by the end of March 2025, subject to obtaining stockholder and CSRC approval.
Management and Board of Directors
At the effective time of the merger, the executive officers of the combined company will be led by Ying Luo, Ph.D. Cullgen's Chairman and CEO. The Cullgen Board of Directors will be supplemented by one representative of Pulmatrix.
Ying Luo, Ph.D., commented, "I'm delighted to announce this planned merger with Pulmatrix, which comes at a pivotal moment in the evolution of our company as we advance our pipeline of targeted protein degraders into clinical development for cancer and other diseases. Listing on Nasdaq will help fuel our growth and enable us to unlock the full potential of our technology platform, including our plans to develop and advance degrader-antibody conjugates and additional targeted protein degraders into the clinic."
Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, added, "Following a thorough evaluation of strategic alternatives, the Pulmatrix board of directors and management team believe that this anticipated transaction represents an opportunity to deliver value to our stockholders. We anticipate that this merger will allow our stockholders to participate in Cullgen's promising research and development activities and also provide a benefit in the form of a potential dividend component immediately prior to the close of the merger. Prior to transaction closing, we will attempt to increase cash available for the special dividend by divesting corporate assets including PUR1800, PUR3100, and the patent portfolio for iSPERSE™."
Cullgen Pipeline Overview and Development Milestones
Cullgen currently has three degrader programs that are in or about to initiate Phase 1 clinical testing. CG001419 is a first-in-class, selective, clinically active, oral pan-TRK degrader that is being studied in two separate clinical trials—one for solid tumors, and the other for the treatment of acute and chronic pain. With respect to the cancer trial, Cullgen has dosed ten patients thus far with no observed dose-limiting toxicity, treatment-related serious adverse events or grade ≥ 3 treatment related adverse events. Regarding the pain trial, Cullgen recently received HREC (
Cullgen is also evaluating CG009301, a GSPT1 degrader for the treatment of blood cancers including relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and acute lymphoblastic leukemia (ALL). Cullgen has received IND allowance from the China CDE for this product candidate and Cullgen anticipates dosing the first patient in the first quarter of 2025. CG009301 also has the potential to be used for the treatment of solid tumors harboring MYC amplification.
In addition to these three clinical programs, Cullgen is also advancing several other targeted protein degraders and DACs, predominantly for the treatment of cancer and autoimmune disease, including a program targeting a cell cycle protein that has been partnered with Astellas Pharma Inc.
Webcast Information
Management will host an informational webcast that will be made available to access at 12:00 pm ET today. A link to the webcast can be found in the Investor Events and Presentations section of the Pulmatrix website at www.pulmatrix.com and in the News & Events section of Cullgen's website at www.cullgen.com.
About Cullgen Inc.
Cullgen is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class new chemical entities (NCEs) for the treatment of diseases lacking effective therapeutic approaches. The Company applies its proprietary uSMITE™ (ubiquitin-mediated, small molecule-induced target elimination) platform to expand the drug design paradigm beyond functional site inhibition, enabling the targeting of historically "undruggable" proteins for selective destruction. Leveraging years of work by its founders on the proteasome system and key discoveries regarding its functionality, Cullgen has successfully generated multiple highly active, selective, and bioavailable targeted protein degrader compounds that utilize proprietary, novel E3 ligands. Cullgen is also actively advancing several of its highly active degraders as payloads for use in degrader-antibody conjugates (DACs). For more information, visit www.cullgen.com.
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and treat central nervous system ("CNS"), respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for 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 maximizing local concentrations 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 Pulmatrix's inhaled product candidates please visit:
https://www.pulmatrix.com/pipeline.html.
Advisory and Legal Counsel
Wedbush PacGrow is serving as exclusive strategic financial advisor to Cullgen in the
Pulmatrix is advised by MTS Health Partners, L.P. and its legal counsel is Haynes and Boone, LLP. Lucid Capital Markets, LLC is providing a fairness opinion to Pulmatrix's Board of Directors.
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. These forward-looking statements include express or implied statements relating to the structure, timing and completion of the proposed merger; the combined company's listing on Nasdaq after closing of the proposed merger; expectations regarding the ownership structure of the combined company; the expected executive officers and directors of the combined company; each company's and the combined company's expected cash position at the closing of the proposed merger and cash runway of the combined company; Pulmatrix's ability to divest its assets; the expected contribution and potential payment of dividends in connection with the merger, including the timing thereof; the future operations of the combined company; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of any product candidates of the combined company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for enrollment, data and other clinical results; the combined company having sufficient resources to advance its pipeline candidates; and other statements that are not historical fact. 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 possible failure to satisfy the conditions to the closing or consummation of the merger, including Pulmatrix's failure to obtain stockholder approval for the merger, risks associated with the uncertainty as to the timing of the consummation of the merger and the ability of each of Pulmatrix and Cullgen to consummate the transactions contemplated by the merger, risks associated with Pulmatrix's continued listing on Nasdaq until closing of the merger, the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the merger; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger prior to the closing or consummation of the merger, risks associated with the possible failure to realize certain anticipated benefits of the merger, including, with respect to future financial and operating results; the effect of the completion of the merger on the combined company's business relationships, operating results and business generally; risks associated with the combined company's ability to manage expenses and unanticipated spending and costs that could reduce the combined company's cash resources; risks related to the combined company's ability to correctly estimate its operating expenses and other events; changes in capital resource requirements; risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance its product candidates or its preclinical programs; the outcome of any legal proceedings that may be instituted against the combined company or any of its directors or officers related to the merger agreement or the transactions contemplated thereby; the ability of the combined company to obtain, maintain and protect its intellectual property rights, in particular those related to its product candidates; the combined company's ability to advance the development of its product candidates or preclinical activities under the timelines it anticipates in planned and future clinical trials; the combined company's ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; the combined company's ability to realize the anticipated benefits of its research and development programs, strategic partnerships, licensing programs or other collaborations; regulatory requirements or developments and the combined company's ability to obtain necessary approvals from the
No Offer or Solicitation
This communication and the information contained herein is not intended to and does not constitute (i) a solicitation of a proxy, consent or approval with respect to any securities or in respect of the proposed transaction or (ii) an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, or an exemption therefrom. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.
NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THE SECURITIES OR DETERMINED IF THIS COMMUNICATION IS TRUTHFUL OR COMPLETE.
Important Additional Information about the Proposed Transaction Will be Filed with the SEC
This communication is not a substitute for the registration statement or for any other document that Pulmatrix may file with the SEC in connection with the proposed transaction. In connection with the proposed transaction between Pulmatrix and Cullgen, Pulmatrix intends to file relevant materials with the SEC, including a registration statement on Form S-4 that will contain a proxy statement/prospectus of Pulmatrix. PULMATRIX URGES INVESTORS AND STOCKHOLDERS TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT PULMATRIX, CULLGEN, THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and stockholders will be able to obtain free copies of the proxy statement/prospectus and other documents filed by Pulmatrix with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. Stockholders are urged to read the proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. In addition, investors and stockholders should note that Pulmatrix communicates with investors and the public using its website www.pulmatrix.com.
Participants in the Solicitation
Pulmatrix, Cullgen and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from stockholders in connection with the proposed transaction. Information about Pulmatrix's directors and executive officers, including a description of their interests in Pulmatrix, is included in Pulmatrix's most recent Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 28, 2024, subsequent Quarterly Reports on Form 10-Q filed with the SEC, including any information incorporated therein by reference, as filed with the SEC, and other documents that may be filed from time to time with the SEC. Additional information regarding these persons and their interests in the transaction will be included in the proxy statement/prospectus relating to the proposed transaction when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated above.
Pulmatrix, Inc. Investor Contact:
Timothy McCarthy, CFA
917-679-9282
tim@lifesciadvisors.com
Cullgen Inc. Investor Contact :
Cullgen Inc.
Thomas Eastling, CFO
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SOURCE Pulmatrix Inc.
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