Pulmatrix and Cullgen Announce Proposed Merger to Form Nasdaq-Listed Targeted Protein Degradation Company

On November 15, 2024, Pulmatrix (NASDAQ: PULM), a clinical-stage biopharmaceutical company, announced that it had entered into a merger agreement with Cullgen, a privately held clinical-stage biopharmaceutical company. The proposed merger aims to create a Nasdaq-listed company focused on targeted protein degradation technology, which boasts three degrader programs that are either about to initiate or are currently initiating Phase I clinical trials. Two of these programs are for the treatment of cancer, and one is for the treatment of acute and chronic pain.

The combined company is expected to have approximately $65 million in cash and cash equivalents upon completion of the merger, providing funding for multiple clinical milestones and supporting operations through 2026. Under the merger agreement, Pulmatrix plans to divest its assets, including its acute migraine candidate PUR3100 and other development candidates based on its iSPERSE™ technology.

Cullgen and Pulmatrix will jointly host a webcast regarding the proposed merger, which will be accessible at 12:00 p.m. Eastern Time on November 13, 2024.

November 13, 2024, Framingham, Massachusetts and San Diego, California—Pulmatrix (Pulmatrix, Inc., Nasdaq: PULM), a clinical-stage biopharmaceutical company, today announced that it has entered into a merger agreement with Cullgen (Cullgen Inc., a privately held clinical-stage biopharmaceutical company). Cullgen leverages its proprietary targeted protein degradation uSMITE™ platform to discover and advance the development of therapeutics for cancer and other diseases. Utilizing its proprietary uSMITE™ technology platform, which features novel E3 ligases, Cullgen builds next-generation targeted protein degraders and degrader-antibody conjugates (“DACs”). In 2023, Cullgen completed a Series C financing round led by the AstraZeneca-CICC Venture Capital Partnership and announced a strategic partnership with Astellas Pharma Inc.

The terms and conditions of the merger agreement stipulate that, upon completion of the merger, the pre-merger shareholders of Pulmatrix are expected to hold approximately 3.6% of the shares in the combined company, while the pre-merger shareholders of Cullgen are expected to hold approximately 96.4%. The combined company will operate under the name Cullgen, be headquartered in San Diego, California, and be listed on the Nasdaq Capital Market (Nasdaq). Pulmatrix shareholders will also receive a special cash dividend if the net cash at the time of the completion of the Pulmatrix merger exceeds $2.5 million, subject to certain adjustments. The transaction is expected to be completed by the end of March 2025, subject to approval by shareholders and regulatory authorities.

Upon the effectiveness of the merger, the executive management of the combined company will be led by Dr. Luo Ying, Chairman and Chief Executive Officer of Cullgen. The Cullgen Board of Directors will add one representative from Pulmatrix.

Dr. Luo Ying stated, “I am pleased to announce this merger plan with Pulmatrix. This is a pivotal moment for our company as we advance our targeted protein degrader pipeline into clinical development for cancer and other diseases. Listing on the Nasdaq will help drive our growth and enable us to fully realize the potential of our technology platform, including our plans to develop and advance degrader-antibody conjugates (DACs) and other targeted protein degraders into the clinic.”

Peter Ludlum, Interim CEO of Pulmatrix, added, “After a comprehensive evaluation of various strategic alternatives, Pulmatrix’s Board of Directors and management team believe that this anticipated transaction will create value for our shareholders. We expect that the merger will enable our shareholders to participate in Cullgen’s promising research and development activities and to receive benefits in the form of potential special dividends prior to the completion of the merger. Before the transaction closes, we will seek to increase the cash available for special dividends by divesting company assets, including the PUR1800 and PUR3100 programs and the iSPERSE™ patent portfolio.”

Cullgen currently has three degrader programs in or approaching Phase I clinical trials. CG001419 is a first-in-class, selective, and clinically active oral pan-TRK degrader being investigated in two separate clinical trials—one for solid tumors and the other for the treatment of acute and chronic pain. In the oncology trial, Cullgen has dosed ten patients to date, with no observed dose-limiting toxicities, treatment-related serious adverse events, or treatment-related adverse events of Grade ≥3. In the pain trial, Cullgen recently received approval from the Australian Human Research Ethics Committee (HREC) to begin enrolling patients to evaluate the safety and pharmacokinetic profile of CG001419 in healthy volunteers. Cullgen expects to enroll the first patient in early 2025. This program aims to provide a novel non-opioid, non-steroidal anti-inflammatory drug (NSAID) analgesic to address unmet medical needs in pain management.

Cullgen is also evaluating CG009301, a GSPT1 degrader for the treatment of hematologic cancers, including relapsed/refractory acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (HR-MDS), and acute lymphoblastic leukemia (ALL). Cullgen has obtained approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for this candidate compound and expects to administer the first dose to a patient in the first quarter of 2025. CG009301 also holds potential for treating solid tumors harboring MYC amplification.

In addition to these three clinical programs, Cullgen is advancing the development of several other targeted protein degraders and DACs, primarily for the treatment of cancer and autoimmune diseases, including a cyclin-targeting program in collaboration with Astellas Pharma.

Management will host a live webcast, which will be accessible at 12:00 p.m. Eastern Time on November 13, 2024. Links to the live broadcast are available in the “Investor Events & Presentations” section of the Pulmatrix website (http://www.pulmatrix.com) and the “News & Events” section of the Cullgen website (www.cullgen.com).

Cullgen is a clinical-stage biopharmaceutical company focused on addressing unmet clinical needs and dedicated to developing first-in-class new chemical entity (NCE) therapies. Leveraging its proprietary uSMITE™ (ubiquitin-mediated, small molecule-induced target elimination) platform, the company degrades target proteins through small molecule-induced, ubiquitination-mediated mechanisms, thereby enabling the targeted degradation of proteins that are traditionally considered “undruggable” via functional site inhibition. Building on the founders’ research in the proteasome system, Cullgen has successfully developed multiple highly potent, selective, and bioavailable target protein degraders. These compounds utilize proprietary novel E3 ligases. Furthermore, Cullgen is actively advancing the development of degrader-antibody conjugates (DACs) by employing various high-potency degraders as payloads. For more information, please visit www.cullgen.com.

Pulmatrix is a clinical-stage biopharmaceutical company that leverages its proprietary iSPERSE™ technology to focus on the development of novel inhaled therapeutics aimed at preventing and treating central nervous system disorders, respiratory diseases, and other conditions with significant unmet medical needs. The company’s product pipeline includes candidates for the treatment of central nervous system disorders such as acute migraine, as well as serious pulmonary 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 is designed to improve therapeutic outcomes by maximizing local drug concentration in the lungs and reducing systemic side effects through targeted pulmonary delivery.

iSPERSE™ is Pulmatrix’s innovative particle engineering technology. This technology generates drugs in dry powder form, addresses the limitations of traditional inhalation technologies, and expands the scope of inhalable drug therapies. iSPERSE™ is a proprietary technology that formulates various drugs into small, dense, and dispersible particles, thereby enabling efficient drug delivery and deep lung penetration. iSPERSE™ can effectively deliver small molecules, combination drugs, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases. For more information on Pulmatrix’s inhaled product candidates, please visit: https://www.pulmatrix.com/pipeline.html.

Wedbush PacGrow served as Cullgen’s exclusive strategic financial advisor in the United States. Gibson, Dunn & Crutcher LLP and DeHeng Law Offices acted as legal counsel to Cullgen.

Pulmatrix was advised by MTS Health Partners, L.P., with Haynes and Boone, LLP serving as its legal counsel. Lucid Capital Markets, LLC provided a fairness opinion to the Board of Directors of Pulmatrix.