Moderna or BioNTech, but focused on developing cancer therapies instead of vaccines.

A specialized Bristol Myers Squibb (BMS) or Merck, entirely dedicated to developing new cancer drugs.

• CLDN6 Program (CG-0140 / BI 764532): A T-cell engaging bispecific antibody in clinical development for solid tumors, partnered with Boehringer Ingelheim.
• FLT3 x CD3 Program (CG-0238): A T-cell engaging bispecific antibody in clinical development for relapsed/refractory acute myeloid leukemia (AML).
• MYC Degrader Program (CG-0014): A small molecule degrader targeting the MYC oncogene, currently in preclinical development for various cancers.

Cullinan Therapeutics (symbol: CGEM) is a clinical-stage biopharmaceutical company focused on developing novel cancer therapies. As such, it does not have commercial products widely available for sale to individuals or healthcare providers directly. Instead, its revenue is primarily generated through collaboration and licensing agreements with other pharmaceutical companies.

Therefore, the company sells primarily to other companies, and its major "customers" (in the context of revenue generation through partnerships) are:

• Taiho Pharmaceutical Co., Ltd. (a subsidiary of Otsuka Holdings Co., Ltd.
  Symbols: 4578.T (Tokyo Stock Exchange), TYHOF (OTC)
• AstraZeneca plc
  Symbols: AZN (NASDAQ), AZN.L (London Stock Exchange)

null

Nadim Ahmed, President and Chief Executive Officer. Mr. Ahmed was appointed CEO in October 2021. He has been cited for his strategic insight and experience in scaling organizations.

Mary Kay Fenton, Chief Financial Officer and Principal Accounting Officer. Ms. Fenton was appointed CFO effective April 29, 2024, and brings over thirty years of financial and operational experience within the biotech sector. She previously served as Interim Chief Executive Officer and Chief Financial Officer of Talaris Therapeutics, Inc. Ms. Fenton was also the Chief Financial Officer and Chief Operating Officer at Semma Therapeutics, which was acquired by Vertex Pharmaceuticals, and served as CFO of Achillion Pharmaceuticals prior to its acquisition by AstraZeneca. Her experience includes leading financial operations, managing capital raises, and overseeing mergers and acquisitions.

Jacquelyn L. Sumer, Chief Legal Officer, Chief Compliance Officer and Secretary.

Dr. Jennifer Michaelson, PhD, Chief Scientific Officer. Dr. Michaelson is a biotech executive with over 20 years of industry experience in oncology, immunology, and immuno-oncology drug development, and participated in the launch of Jounce Therapeutics.

Dr. Jeffrey Alan Jones, M.D., Chief Medical Officer.

The key risks to Cullinan Therapeutics (CGEM) primarily revolve around the inherent challenges of drug development in the biopharmaceutical industry, its financial sustainability as a clinical-stage company, and the successful commercialization and protection of its intellectual property.

1. Clinical Development and Regulatory Approval Risks: As a clinical-stage biopharmaceutical company, Cullinan Therapeutics' business success is highly dependent on the timely and successful progression of its product candidates through clinical trials and obtaining regulatory approvals. There is significant uncertainty regarding the timing and results of regulatory submissions (e.g., INDs, NDAs), and the risk that these submissions may not be cleared on expected timelines, or at all. The success of preclinical studies and clinical trials is not guaranteed, and results may not be predictive of future outcomes. The discontinuation of programs like CLN-619 and CLN-617 exemplifies the challenges and risks associated with drug development.
2. Financial Risks: Lack of Revenue, Operating Losses, and Need for Additional Capital: Cullinan Therapeutics currently generates no product revenue and consistently reports significant net losses and negative cash flow from operations, with increasing research and development expenses. While the company projects a cash runway into 2028 or 2029 based on its current operating plan, there is an ongoing risk that current cash, cash equivalents, and investments may become insufficient, necessitating the need to raise additional capital. This financial profile is typical for early-stage biotech firms, but it inherently carries a high-risk, high-reward dynamic for investors due to the speculative nature of potential future earnings.
3. Commercialization, Intellectual Property, and Competition Risks: Even if product candidates successfully complete clinical trials and receive regulatory approval, there is a risk that they may not be successfully commercialized. This encompasses challenges related to manufacturing, supply, and distribution. Furthermore, protecting and maintaining its intellectual property position is critical for Cullinan Therapeutics to realize value from its drug candidates. The competitive landscape, particularly for lead assets like zipalertinib, poses a significant risk as it faces strong competition and potentially limited market potential. Additionally, dependence on collaborations and partnerships for critical pipeline assets, such as zipalertinib with Taiho Pharmaceutical, introduces risks related to co-development agreements, milestone payments, and shared intellectual property.

The primary clear emerging threat to Cullinan Therapeutics (CGEM) stems from the highly competitive landscape for its lead clinical asset, zipalertinib (CLN-081). Zipalertinib is an investigational oral EGFR inhibitor designed to treat non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations.

While Cullinan aims to demonstrate superior efficacy and tolerability for zipalertinib compared to currently approved therapies (such as Takeda's Exkivity (mobocertinib) and Johnson & Johnson's Rybrevant (amivantamab)), there are several other companies actively developing next-generation oral EGFR exon 20 insertion inhibitors. These competing investigational drugs, some of which are in advanced clinical stages, represent a direct and potent emerging threat.

For example, companies like Dizal Pharmaceutical with sunvozertinib (DZD9008) have reported positive clinical data and are progressing through trials, potentially aiming for market entry around a similar timeframe as zipalertinib or even earlier. If any of these competing therapies demonstrate a superior efficacy, safety, or convenience profile (e.g., higher response rates, longer duration of response, better tolerability, or more favorable dosing) in their clinical trials, it could significantly erode zipalertinib's potential market share and commercial success, even if zipalertinib itself proves effective. This dynamic is analogous to new, superior technology or product offerings directly challenging an existing or developing product in a niche market.

1. Commercialization of Zipalertinib: Cullinan's partner, Taiho Pharmaceutical Co., Ltd., plans to initiate a rolling New Drug Application (NDA) submission for zipalertinib by the end of 2025 for the treatment of relapsed EGFR ex20ins non-small cell lung cancer (NSCLC). Successful approval and launch of zipalertinib would mark Cullinan's first potential product on the market, generating revenue through collaboration agreements.
2. Advancement of CLN-049: Cullinan is concentrating resources on its lead T cell engager programs, including CLN-049, a FLT3xCD3 bispecific T cell engager for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Promising Phase 1 data for CLN-049 will be presented at the 2025 ASH Annual Meeting. Continued positive clinical development and progression through later-stage trials are crucial for its eventual market potential and future revenue.
3. Development of CLN-978 in Autoimmune Diseases: The company is strategically focusing on CLN-978, a CD19xCD3 bispecific T cell engager, for various autoimmune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren's disease. Cullinan plans to share initial clinical data for CLN-978 in autoimmune diseases in the first half of 2026. Expansion into these autoimmune indications represents a significant market opportunity and potential future revenue stream.
4. Progression of In-licensed Velinotamig: Cullinan in-licensed velinotamig, a BCMA-directed bispecific T cell engager, from Genrix Bio. Genrix Bio is expected to initiate a Phase 1 study in patients with autoimmune diseases in China by the end of 2025, with Cullinan intending to use this data to accelerate global clinical development. This program further strengthens Cullinan's pipeline in autoimmune diseases and adds another potential product candidate for future revenue generation.

Share Issuance

• Cullinan Therapeutics completed its Initial Public Offering (IPO) in January 2021, offering 11,900,000 shares at $21.00 per share, raising $249,900,000.
• As of October 31, 2025, the company had 59,076,259 common shares outstanding.
• As of Q3 2025, Cullinan Therapeutics had $85.6 million remaining capacity under an at-the-market (ATM) program.

Inbound Investments

• Lynx1 Capital Management Lp, a major shareholder, acquired over 1.7 million shares of Cullinan Therapeutics stock in October 2025 through multiple transactions, with a total value exceeding $8 million.
• As of September 30, 2025, Cullinan Therapeutics maintained a strong liquidity position with $475.5 million in cash and investments, which management expects to fund operations into 2029.
• Institutional investors hold 86.31% of the company's stock.

Outbound Investments

• In June 2025, Cullinan licensed velinotamig from Genrix, which included a $20.0 million upfront fee expensed in research and development.
• Cullinan has a co-development agreement with Taiho Pharmaceutical Co., Ltd for zipalertinib.
• In June 2021, Cullinan invested in its partially-owned operating subsidiary, Cullinan MICA, by purchasing 5.4 million shares of Series A senior preferred stock.

Capital Expenditures

• Research and development expenses increased to $42.0 million for the third quarter of 2025, up from $35.5 million for the same period in 2024, reflecting intensified investment in clinical programs.
• Cullinan strategically discontinued the CLN-619 and CLN-617 programs in November 2025 to focus resources and development efforts on select, high-conviction clinical stage programs.
• The company's capital allocation in R&D is focused on advancing its pipeline of targeted immunology and oncology product candidates, including CLN-049 and CLN-978.