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Cullinan Oncology(CGEM) - 2021 Q3 - Quarterly Report
2021-11-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39856 CULLINAN ONCOLOGY, INC. (Exact name of Registrant as specified in its Charter) Delaware 81-3879991 (State or other ju ...
Cullinan Oncology(CGEM) - 2021 Q2 - Quarterly Report
2021-08-09 16:00
[PART I FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) This section presents the unaudited consolidated financial statements for the quarterly period ended June 30, 2021, highlighting total assets of **$464.4 million** and a net loss of **$15.0 million** for the six months ended June 30, 2021 Consolidated Balance Sheet Highlights (as of June 30, 2021 vs. Dec 31, 2020) | Metric | December 31, 2020 (in thousands) | June 30, 2021 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $168,198 | $123,670 | | Short-term investments | $42,008 | $213,035 | | Long-term investments | $0 | $119,637 | | **Total Assets** | **$214,708** | **$464,353** | | Total Liabilities | $5,813 | $14,394 | | **Total Stockholders' Equity** | **$200,314** | **$458,540** | Consolidated Statement of Operations Highlights (Six Months Ended June 30) | Metric | 2020 (in thousands) | 2021 (in thousands) | | :--- | :--- | :--- | | License revenue | $0 | $18,943 | | Research and development | $16,669 | $24,193 | | General and administrative | $2,994 | $9,982 | | Loss from operations | ($19,663) | ($15,232) | | **Net loss** | **($19,038)** | **($15,020)** | | Net loss per share | ($0.71) | ($0.37) | - In January 2021, the company completed its IPO, issuing **13,685,000 shares** of common stock and receiving net proceeds of **$264.5 million** after deducting expenses[38](index=38&type=chunk) - In January 2021, Pearl recognized **$18.9 million** in revenue from an upfront, non-refundable license fee from its agreement with Zai Lab, resulting in a **$3.0 million** R&D expense paid to Taiho Pharma[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - The company's liquidity is strong, with cash, cash equivalents, and investments expected to fund operating expenses and capital expenditure requirements through at least the next twelve months from the report's issuance date[42](index=42&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, highlighting the impact of its hub-and-spoke business model and the IPO, with R&D expenses increasing to **$24.2 million** and G&A expenses rising to **$10.0 million** for the six months ended June 30, 2021 - The company operates a hub-and-spoke business model with a central operating company and five partially-owned development subsidiaries advancing individual therapeutic candidates, including CLN-081, CLN-619, and CLN-049[156](index=156&type=chunk)[158](index=158&type=chunk) Comparison of Operating Expenses (Six Months Ended June 30) | Expense Category | 2020 (in thousands) | 2021 (in thousands) | Change (in thousands) | Key Drivers | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $16,669 | $24,193 | $7,524 | Increased activity for CLN-081, CLN-049, CLN-619; equity-based compensation | | General & Administrative | $2,994 | $9,982 | $6,988 | Public company costs (D&O insurance), equity-based compensation, increased headcount | - The company's liquidity position is strong, with cash, cash equivalents, and investments totaling **$456.3 million** as of June 30, 2021, expected to support operations through 2024[216](index=216&type=chunk)[217](index=217&type=chunk)[227](index=227&type=chunk) - Future funding requirements are substantial and depend on the progress of clinical trials for key candidates like CLN-081, CLN-049, and CLN-619, as well as public company operating costs and potential in-licensing activities[226](index=226&type=chunk)[227](index=227&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has elected to use the scaled disclosure requirements available to Smaller Reporting Companies and, as a result, is not required to provide the information for this item - As a Smaller Reporting Company, the company has elected to omit disclosures regarding market risk[253](index=253&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with the participation of the CEO and CFO, evaluated the company's disclosure controls and procedures as of June 30, 2021, concluding they were effective with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2021[256](index=256&type=chunk) - There were no material changes to the company's internal control over financial reporting during the fiscal quarter ended June 30, 2021[257](index=257&type=chunk) [PART II OTHER INFORMATION](index=44&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any litigation or legal proceedings that, in management's opinion, are probable to have a material adverse effect on its business - The company is not currently involved in any material legal proceedings[260](index=260&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks to the company's business, categorized into areas such as product development, financial condition, corporate structure, intellectual property, and third-party reliance [Risks Related to the Development of Our Product Candidates](index=44&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) The company's development efforts are early-stage and substantially dependent on its lead candidates, CLN-081, CLN-049, and CLN-619, facing risks of clinical trial failures, patient enrollment difficulties, and challenges with companion diagnostics - The business is substantially dependent on the success of its lead candidates: CLN-081, CLN-049, and CLN-619, where failure to advance them would materially harm the business[283](index=283&type=chunk) - Preclinical and clinical trials may fail to demonstrate adequate safety and efficacy, which would prevent or delay regulatory approval and commercialization, with undesirable side effects potentially leading to trial suspension or termination[262](index=262&type=chunk)[263](index=263&type=chunk)[305](index=305&type=chunk) - Difficulty in enrolling patients, particularly for genetically defined populations, could delay or prevent clinical trials and ultimate regulatory approval[288](index=288&type=chunk)[289](index=289&type=chunk) [Risks Related to Our Financial Condition and Capital Requirements](index=52&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) The company has a limited operating history and has incurred significant losses since inception, with an accumulated deficit of **$109.0 million** as of June 30, 2021, requiring substantial additional funding to advance its product candidates - The company has a limited operating history, making it difficult to evaluate its success to date and assess future viability[316](index=316&type=chunk) - Significant losses have been incurred since inception (**$109.0 million** accumulated deficit as of June 30, 2021), and these are expected to continue for the foreseeable future[320](index=320&type=chunk)[322](index=322&type=chunk) - Substantial additional funding is required for development and commercialization, and inability to raise capital would force the company to delay, reduce, or eliminate programs[328](index=328&type=chunk)[329](index=329&type=chunk) [Risks Related to Our Corporate Structure](index=57&type=section&id=Risks%20Related%20to%20Our%20Corporate%20Structure) The company's novel hub-and-spoke business model is unproven and may not succeed in building a valuable product pipeline, concentrating risk in single subsidiaries and presenting operational challenges due to reliance on a small central team - The differentiated hub-and-spoke business model is unproven and may not be successful in building a pipeline of commercially valuable product candidates[338](index=338&type=chunk)[339](index=339&type=chunk) - A large portion of the company's value may be concentrated in one or a few subsidiaries, making the overall business vulnerable to setbacks in those specific programs[350](index=350&type=chunk) - Reliance on a small central team for administrative and R&D services across the organization presents operational challenges and may not sufficiently incentivize value maximization at the subsidiary level[354](index=354&type=chunk)[355](index=355&type=chunk) [Risks Related to Our Intellectual Property](index=75&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success is highly dependent on obtaining and maintaining robust intellectual property protection, facing risks of failing to secure broad patents, losing rights under in-licensing agreements, and costly infringement lawsuits - Failure to obtain and maintain adequate patent and other IP protection could allow competitors to develop similar products, eroding the company's competitive advantage[461](index=461&type=chunk) - The company is party to license agreements and could lose important rights if it fails to comply with obligations such as diligence, milestone payments, and royalties[475](index=475&type=chunk)[476](index=476&type=chunk) - The company may face costly and time-consuming litigation if third parties claim infringement of their intellectual property rights, which could delay or prevent product development[487](index=487&type=chunk) [Risks Related to Our Reliance on Third Parties](index=88&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) The company outsources most development and manufacturing to third parties, creating risks of non-performance, delays, and non-compliance with regulations, particularly for complex biologic manufacturing - The company relies heavily on third-party CROs and CMOs to conduct preclinical studies, clinical trials, and manufacturing, where poor performance could delay or prevent regulatory approval[533](index=533&type=chunk)[534](index=534&type=chunk) - Switching or adding new third-party contractors is costly and time-consuming, and can materially impact development timelines[538](index=538&type=chunk) - Manufacturing of biologics is complex and subject to strict cGMP regulations, where any failure by third-party manufacturers to comply could result in production delays, recalls, or suspension of approvals[553](index=553&type=chunk)[554](index=554&type=chunk)[557](index=557&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=102&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details unregistered equity transactions, including the issuance of **34,434,262 shares** of common stock in January 2021 as part of a pre-IPO reorganization and the granting of over **2.1 million** stock options, confirming the use of **$264.5 million** net IPO proceeds as planned - In January 2021, the company issued **34,434,262 shares** of common stock in exchange for units of its predecessor LLC as part of its reorganization, exempt from registration under Section 4(a)(2) of the Securities Act[615](index=615&type=chunk)[620](index=620&type=chunk) - During the six months ended June 30, 2021, the company granted options to purchase an aggregate of over **2.1 million shares** of common stock under its 2021 Stock Plan, deemed exempt from registration under Rule 701 of the Securities Act[622](index=622&type=chunk) - The company received approximately **$264.5 million** in net proceeds from its IPO in January 2021, with no material change in the planned use of these proceeds from what was disclosed in the final prospectus[626](index=626&type=chunk)[627](index=627&type=chunk) [Defaults Upon Senior Securities](index=103&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[629](index=629&type=chunk) [Mine Safety Disclosures](index=103&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[631](index=631&type=chunk) [Other Information](index=103&type=section&id=Item%205.%20Other%20Information) This item is not applicable to the company - Not applicable[633](index=633&type=chunk) [Exhibits](index=103&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including a consulting agreement and required certifications by the Principal Executive Officer and Principal Financial Officer - The report includes several exhibits, notably a consulting agreement dated May 20, 2021, and certifications from the CEO and CFO as required by Sections 302 and 906 of the Sarbanes-Oxley Act[634](index=634&type=chunk)
Cullinan Oncology (CGEM) Presents At 2021 ASCO Annual Virtual Meeting - Slideshow
2021-06-05 04:04
| --- | --- | --- | --- | --- | --- | --- | |-----------------------------|-------|-------|-------|-------|-------|-------| | | | | | | | | | Cullinan Pearl | | | | | | | | 2021 ASCO Update on CLN-081 | | | | | | | | June 4, 2021 | | | | | | | Important Notice and Disclaimers This presentation contains forward-looking statements of Cullinan Oncology, Inc. ("Cullinan," "we" or "our") within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are ...
Cullinan Oncology(CGEM) - 2021 Q1 - Quarterly Report
2021-05-13 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39856 CULLINAN ONCOLOGY, INC. (Exact name of Registrant as specified in its Charter) Delaware 81-3879991 (State or other jurisd ...
Cullinan Oncology (CEGM) Investor Presentation - Slideshow
2021-04-13 20:17
Company Overview - Cullinan has a well-capitalized position with approximately $490 million in cash and investments as of December 31, 2020[6] - The company employs a differentiated hub-and-spoke model with a robust pipeline of 7 novel oncology programs[6] Clinical Programs - CLN-081 (Pearl): A selective EGFR inhibitor targeting Exon 20 insertion mutant NSCLC, with Phase 2a expansion initiated in February 2021 and plans for a potentially registrational Phase 2b study in 2021[8, 10, 18] - Preliminary data for CLN-081 shows promising responses across several mutations, with one DLT observed at 150 mg BID as of November 10, 2020[15, 18] - CLN-619 (MICA): An anti-MICA/B IgG1 antibody with IND submission anticipated in 2Q21, showing single-agent tumor regression in a PLC/PRF/5 liver cancer model[8, 24] - CLN-049 (Florentine): A FLT3 x CD3 bispecific antibody for r/r AML, with program updates expected in 2021[8] - CLN-978 (NexGem): A CD19 and CD3 trispecific antibody for B-cell ALL, with IND submission planned for 2022[8] - CLN-617 (Amber): An IL2 x IL12 x CBD therapeutic for pan-cancer, with IND submission anticipated in 2022[8]
Cullinan Oncology(CGEM) - 2020 Q4 - Annual Report
2021-03-29 16:00
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)