PART I [Business](index=6&type=section&id=Item%201.%20Business) Cullinan Oncology is a biopharmaceutical company developing a diversified pipeline of targeted oncology and immuno-oncology therapies using a hub-and-spoke model - The company operates on a unique **hub-and-spoke business model**, with a central operating company providing services to separate subsidiaries that advance individual therapeutic candidates[14](index=14&type=chunk)[28](index=28&type=chunk) - Cullinan's strategy focuses on building a **diversified pipeline** of uncorrelated therapeutic candidates, prioritizing novel technology and differentiated mechanisms[12](index=12&type=chunk)[25](index=25&type=chunk) Cullinan Oncology Pipeline Overview | Program (Project) | Description | Target Indication | Preclinical | Phase 1 | Phase 2 | Next Milestone | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **CLN-081 (Pearl)** | Oral small molecule irreversible EGFR inhibitor | NSCLC EGFRex20ins | | ■ | ■ | Clinical update in 1H21 | | **CLN-049 (Florentine)** | Bispecific mAb targeting FLT3 and CD3 | R/R AML | ■ | | | Program update in 2021 | | **CLN-619 (MICA)** | Anti-MICA/B IgG1 mAb engaging NK cells | Solid Tumors | ■ | | | Submit IND in 2Q21 | | **CLN-978 (NexGem)** | Half-life extended bispecific mAb targeting CD19 and CD3 | B-cell ALL | ■ | | | Submit IND in 2022 | | **CLN-617 (Amber)** | Tumor retained cytokine fusion protein (IL-2 & IL-12) | Pan-cancer | ■ | | | Submit IND in 2022 | | **Opal** | Bispecific fusion protein (PD-1 block & 4-1BB activation) | Pan-cancer | ■ | | | IND-enabling studies in 2H21 | | **Jade** | TCR-based therapy targeting novel senescence/cancer protein | HPV+ / RB- | ■ | | | IND-enabling studies in 2H21 | [Our Programs](index=11&type=section&id=Our%20Programs) The company's portfolio is led by CLN-081 for NSCLC, with key immuno-oncology candidates CLN-049, CLN-619, CLN-617, and CLN-978 - **CLN-081:** An orally available, irreversible EGFR inhibitor for NSCLC with EGFRex20ins mutations, showing **partial responses in 10 of 25 patients** in Phase 1/2a with a manageable safety profile[41](index=41&type=chunk)[42](index=42&type=chunk)[70](index=70&type=chunk) - **CLN-049:** A humanized bispecific antibody targeting FLT3 and CD3 for AML, demonstrating **potent antitumor activity** in preclinical studies[78](index=78&type=chunk) - **CLN-619:** A MICA/B-targeted monoclonal antibody designed to stimulate NK and T cell responses against solid tumors, with an **IND submission planned for Q2 2021**[100](index=100&type=chunk)[101](index=101&type=chunk) - **CLN-617 (AMBER platform):** A tumor-retained cytokine fusion protein designed to minimize systemic toxicity, with an **IND submission expected in 2022**[134](index=134&type=chunk)[135](index=135&type=chunk) - **CLN-978:** A half-life extended, single-chain bispecific antibody engaging CD19 and CD3 for B-cell malignancies[155](index=155&type=chunk) [Competition](index=35&type=section&id=Competition) The company faces substantial competition from major pharmaceutical and biotechnology companies across its pipeline, including for CLN-081, CLN-049, and CLN-619 - The biotechnology and pharmaceutical industries are characterized by **rapid technological evolution**, intense competition, and a strong emphasis on intellectual property[168](index=168&type=chunk) - Competitors for **CLN-081** in NSCLC with EGFRex20ins mutations include Spectrum's poziotinib, Takeda's mobocertinib, and Johnson & Johnson's amivantamab[171](index=171&type=chunk) - Competitors for **CLN-049** in AML include companies developing bispecifics targeting CD3/CD33, CD123, and FLT3[173](index=173&type=chunk) - Competitors for **CLN-619** (MICA/B target) include Innate Pharma, CanCure LLC, Genentech, Novartis, and Bristol-Myers Squibb, with none known to be in clinical development[172](index=172&type=chunk) [License Agreements](index=37&type=section&id=License%20Agreements) The company holds key license agreements for CLN-081 (Taiho, Zai Lab), CLN-049 (DKFZ/Tübingen), and CLN-617 (MIT) - **Taiho License (CLN-081):** Cullinan Pearl obtained exclusive worldwide rights (excluding Japan) from Taiho Pharma, involving a **$2.5 million upfront fee** and potential milestones up to **$154.5 million** plus royalties[178](index=178&type=chunk)[180](index=180&type=chunk) - **Zai Lab Sublicense (CLN-081):** Cullinan Pearl granted Zai Lab exclusive Greater China rights for a **$20.0 million upfront fee** and potential milestones up to **$211.0 million** plus royalties[185](index=185&type=chunk)[188](index=188&type=chunk) - **DKFZ/Tübingen License (CLN-049):** Cullinan Florentine obtained an exclusive worldwide license for a **$600,000 upfront fee** and potential milestones up to **$28 million** plus royalties[192](index=192&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk) - **MIT License (CLN-617/AMBER):** Cullinan Amber obtained an exclusive worldwide license from MIT for a **$50,000 upfront fee** and potential milestones up to **$7 million** for the first product plus royalties[199](index=199&type=chunk)[200](index=200&type=chunk)[201](index=201&type=chunk) [Intellectual Property](index=41&type=section&id=Intellectual%20Property) Cullinan's patent portfolio, as of February 2021, includes 12 patent families with patents expiring between 2034 and 2041 - The patent portfolio for the lead candidate, **CLN-081**, includes five patent families covering composition of matter and methods of use, with the primary composition patent expected to expire in **2034**[215](index=215&type=chunk) - The portfolio for **CLN-619** includes three owned patent families, with patents, if issued, expected to expire in **2039 or later**[216](index=216&type=chunk) - The portfolio for **CLN-049** includes one in-licensed patent family, with patent applications that, if issued, are expected to expire in **2039**[217](index=217&type=chunk) [Manufacturing](index=43&type=section&id=Manufacturing) Cullinan employs a virtual manufacturing model, relying entirely on third-party CMOs for all supply, including single-source providers for CLN-049 and CLN-619 - The company does not own or operate any GMP manufacturing facilities and relies on **third-party CMOs** for all manufacturing, packaging, and distribution[221](index=221&type=chunk) - Drug substance for **CLN-049** and **CLN-619** is sourced from WuXi Biologics and Abzena, with sufficient supply obtained to begin planned clinical trials[224](index=224&type=chunk) [Governmental Regulation](index=44&type=section&id=Governmental%20Regulation) The company's products are subject to extensive regulation by the FDA and international authorities, requiring comprehensive data for approval via NDA or BLA, with potential for expedited pathways - Product candidates require **FDA approval** via an NDA (for drugs like CLN-081) or a BLA (for biologics like CLN-049 and CLN-619) before U.S. marketing[229](index=229&type=chunk) - The development process involves extensive **preclinical studies (GLP)**, IND submission, and **multi-phase clinical trials (GCP)** to establish safety and efficacy[229](index=229&type=chunk)[231](index=231&type=chunk) - The company may seek **expedited development pathways** such as Fast Track, Breakthrough Therapy, and Accelerated Approval to potentially speed up review for serious conditions[260](index=260&type=chunk) - In the European Union, medicinal products require a **marketing authorization (MA)** via centralized or national procedures, with Brexit impacting the UK regulatory framework[317](index=317&type=chunk)[318](index=318&type=chunk)[328](index=328&type=chunk) [Risk Factors](index=63&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, development, operational, and external risks, including limited operating history, reliance on lead candidates, and third-party dependencies - **Financial Risks:** The company has a limited operating history, incurred **$59.5 million in losses in 2020**, and requires substantial additional funding[339](index=339&type=chunk)[344](index=344&type=chunk)[352](index=352&type=chunk) - **Development Risks:** The business is substantially dependent on its lead candidates **CLN-081, CLN-049, and CLN-619**, with failure or delays materially harming the company[408](index=408&type=chunk) - **Operational Risks:** The company relies on a novel **hub-and-spoke model** and outsources nearly all functions to third parties, creating management and disruption risks[362](index=362&type=chunk)[385](index=385&type=chunk) - **Commercial Risks:** The company faces substantial competition, and approved products may not gain market acceptance or secure adequate reimbursement[448](index=448&type=chunk)[452](index=452&type=chunk) - **External Risks:** The **COVID-19 pandemic** may adversely impact business operations, including preclinical studies and clinical trial timelines[662](index=662&type=chunk)[663](index=663&type=chunk) [Unresolved Staff Comments](index=125&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments - None[725](index=725&type=chunk) [Properties](index=125&type=section&id=Item%202.%20Properties) The company's corporate headquarters is in Cambridge, MA, subleasing 7,531 square feet of office space until June 2024 - The company subleases **7,531 square feet** of office space in Cambridge, MA, with the lease expiring **June 30, 2024**[726](index=726&type=chunk) [Legal Proceedings](index=125&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[727](index=727&type=chunk) [Mine Safety Disclosures](index=125&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[729](index=729&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=126&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock began trading on Nasdaq in January 2021, and it does not anticipate paying dividends, with its IPO raising approximately $264.7 million in net proceeds - The company's common stock began trading on Nasdaq under the symbol **"CGEM" on January 8, 2021**[732](index=732&type=chunk) - The company does not anticipate paying any cash dividends in the foreseeable future, intending to retain earnings for business development[734](index=734&type=chunk) - The initial public offering in January 2021 generated net proceeds of approximately **$264.7 million**[747](index=747&type=chunk) [Reserved](index=127&type=section&id=Item%206.%20Reserved) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=128&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of $59.5 million in 2020, driven by increased R&D and G&A expenses, but expects sufficient capital to fund operations through 2024 with IPO proceeds Results of Operations (2019 vs. 2020) | (in thousands) | Year Ended 2019 | Year Ended 2020 | | :--- | :--- | :--- | | Research and development | $16,788 | $43,211 | | General and administrative | $5,482 | $17,124 | | **Total operating expenses** | **$22,270** | **$60,335** | | **Net loss** | **($21,654)** | **($59,458)** | Research & Development Expenses by Program (2019 vs. 2020) | (in thousands) | Year Ended 2019 | Year Ended 2020 | | :--- | :--- | :--- | | Cullinan Mica (CLN-619) | $0 | $10,352 | | Cullinan Florentine (CLN-049) | $909 | $9,659 | | Cullinan Pearl (CLN-081) | $7,002 | $8,253 | | Cullinan Apollo (VK-2019) | $4,133 | $2,166 | | Cullinan Amber (CLN-617) | $281 | $720 | | **Total Asset Subsidiaries expenses** | **$12,325** | **$31,150** | - The increase in R&D expenses was primarily due to the acquisition of **CLN-619**, increased pre-clinical and CMC costs for **CLN-049**, and increased trial enrollment for **CLN-081**[791](index=791&type=chunk) - The increase in G&A expenses was primarily due to increased headcount and **equity-based compensation** granted in Q4 2020[794](index=794&type=chunk) - As of December 31, 2020, the company had **$210.2 million** in cash and investments, expected to fund operations through **2024** with IPO proceeds[797](index=797&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=143&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Cullinan Oncology is not required to provide this information - The company is a smaller reporting company and is not required to provide this information[842](index=842&type=chunk) [Financial Statements and Supplementary Data](index=143&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for 2019 and 2020, including balance sheets, statements of operations, and cash flows Consolidated Balance Sheet Highlights (as of Dec 31) | (in thousands) | 2019 | 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $63,250 | $168,198 | | Short term investments | $35,380 | $42,008 | | **Total Assets** | **$100,461** | **$214,708** | | Total liabilities | $2,596 | $14,394 | | Total members' deficit | ($39,909) | ($76,338) | Consolidated Statements of Cash Flows Highlights (Year Ended Dec 31) | (in thousands) | 2019 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($20,897) | ($29,772) | | Net cash used in investing activities | ($35,400) | ($5,420) | | Net cash provided by financing activities | $85,715 | $140,140 | | **Net increase in cash and cash equivalents** | **$29,418** | **$104,948** | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=143&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There have been no changes in or disagreements with the company's accountants on accounting or financial disclosure - There has been no change of accountants nor any disagreements with accountants[844](index=844&type=chunk) [Controls and Procedures](index=143&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of December 31, 2020, with no material changes reported - Management concluded that disclosure controls and procedures were **effective as of December 31, 2020**[846](index=846&type=chunk) - A management report on internal control over financial reporting is not included due to the **transition period for newly public companies**[847](index=847&type=chunk) [Other Information](index=143&type=section&id=Item%209B.%20Other%20Information) There is no other information to report - None[850](index=850&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=144&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is incorporated by reference from the company's 2021 definitive Proxy Statement - Information is incorporated by reference from the **2021 Proxy Statement**[853](index=853&type=chunk) [Executive Compensation](index=144&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item is incorporated by reference from the company's 2021 definitive Proxy Statement - Information is incorporated by reference from the **2021 Proxy Statement**[854](index=854&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=144&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item is incorporated by reference from the company's 2021 definitive Proxy Statement - Information is incorporated by reference from the **2021 Proxy Statement**[855](index=855&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=144&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item is incorporated by reference from the company's 2021 definitive Proxy Statement - Information is incorporated by reference from the **2021 Proxy Statement**[856](index=856&type=chunk) [Principal Accounting Fees and Services](index=144&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information for this item is incorporated by reference from the company's 2021 definitive Proxy Statement - Information is incorporated by reference from the **2021 Proxy Statement**[857](index=857&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=145&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements and provides an index of exhibits filed as part of the Annual Report - This item provides an index to the consolidated financial statements and a list of exhibits filed with the report[860](index=860&type=chunk)[861](index=861&type=chunk) [Form 10-K Summary](index=145&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has elected not to include a summary - The Company has elected not to include summary information[862](index=862&type=chunk)