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, 2022 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 ...

| --- | --- | --- | --- | |---------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | Mining for Tomorrow's Cures Cullinan Oncology Overview | | | | | Q3 2022 | | | | 2 Important notice and disclaimers This Presentation contains forward-looking statements and information. All statements other than statements of historical facts contained in this Presentation, including statements regarding our strategy, future financial condition, future operations, projected co ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of each exchange on which registered Common Stock, par value $0.0001 per share CGEM The Nasdaq Global Select Market 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 June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO ...

Product Development - The lead product candidate, CLN-081, has shown a 41% confirmed response rate in a Phase 1/2a trial for non-small cell lung cancer, with a median duration of response of 15 months and 12-month progression-free survival [112]. - CLN-617, a fusion protein in development, is expected to submit an IND by the first half of 2023 [115]. - The company has four partially-owned subsidiaries focused on advancing various product candidates, including CLN-081, CLN-049, CLN-619, and CLN-617 [118]. Financial Performance - The company has not generated any revenue from product sales and has incurred operating losses since inception [117]. - For the three months ended March 31, 2022, the company recognized $0 in license revenue, a decrease of $18.9 million compared to $18.9 million for the same period in 2021 [148]. - Total operating expenses for the three months ended March 31, 2022, were $32.7 million, an increase of $15.1 million from $17.6 million in the same period in 2021 [160]. - Research and development expenses increased to $24.5 million for the three months ended March 31, 2022, compared to $12.4 million for the same period in 2021, reflecting a rise of $12.1 million [161]. - The net loss attributable to common stockholders of Cullinan for the three months ended March 31, 2022, was $12.1 million, compared to a net loss of $0.07 million for the same period in 2021, reflecting an increase in loss of $12.0 million [160]. - The company reported a net loss of $21.9 million in operating activities for the three months ended March 31, 2022, compared to a net cash usage of $1.5 million in the same period of 2021 [172]. Cash and Investments - As of March 31, 2022, the company had cash, cash equivalents, and short-term investments totaling $314.9 million, with an accumulated deficit of $171 million [120]. - Cash, cash equivalents, and short-term investments totaled $314.9 million as of March 31, 2022, with long-term investments and interest receivable amounting to $95.4 million [168]. - The company anticipates that its current cash and investments will be sufficient to fund operations through 2024, based on current operational plans and assumptions [169]. Capital and Funding - The company will receive an upfront payment of $275 million from Taiho Pharmaceutical for the acquisition of Cullinan Pearl, along with an additional $130 million tied to regulatory milestones for CLN-081 [113]. - The company has raised $541.2 million from equity financings since inception, including $264.5 million from its IPO [119]. - The company expects to receive approximately $275.0 million from the sale of its subsidiary, Cullinan Pearl, which is anticipated to close in the second quarter of 2022 [170]. Operating Expenses - The increase in research and development expenses was primarily due to a $6.6 million rise in chemistry, manufacturing, and controls costs related to ongoing clinical trials for CLN-081 and CLN-619 [162]. - General and administrative expenses rose to $8.1 million for the three months ended March 31, 2022, up by $3.0 million from $5.2 million in the same period in 2021 [160]. - The company anticipates that general and administrative expenses will increase in the future as it increases headcount to support the development of its product candidates [156]. - General and administrative expenses increased to $8.1 million for the three months ended March 31, 2022, up from $5.2 million in the same period of 2021, primarily due to a $1.9 million rise in equity-based compensation expenses [164]. Risks and Future Outlook - The company is subject to risks common to early-stage biotechnology companies, including the need for significant additional capital for research and development [121]. - The impact of COVID-19 has not yet had a financial impact, but it may affect future operations and capital access [125]. - The company expects to continue generating operating losses for the foreseeable future, dependent on the success of its R&D efforts [120]. - The company plans to continue its research and development efforts, which will lead to increased expenses associated with clinical trials and regulatory approvals [178]. Tax and Accounting - A full valuation allowance was required to offset net deferred tax assets due to the lack of earnings history, but a tax benefit was recorded based on expected gains from the sale of Cullinan Pearl [198]. - The income tax benefit for the three months ended March 31, 2022, was $19.6 million, a significant increase from no provision for income taxes in the same period of 2021 [166]. - The company is classified as an "emerging growth company" and has elected to use the extended transition period for new accounting standards [199]. - The company qualifies as a "smaller reporting company," allowing it to present only the two most recent fiscal years of audited financial statements in its Annual Report [201]. - The company has not adopted any new accounting pronouncements that may materially impact its financial position and results of operations [202]. - The company is electing scaled disclosure requirements available to smaller reporting companies, which affects its market risk disclosures [203].

| --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------| | | | | | | | | | | | | Important notice and disclaimers This Presentation contains forward-looking statements and information. All statements other than statements of historical facts contained in this Presentation, including statements regarding our strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some c ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 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 jurisdictio ...

Mining for Tomorrow's Cures Cullinan Oncology Overview Q1 2022 Important notice and disclaimers This Presentation contains forward-looking statements and information. All statements other than statements of historical facts contained in this Presentation, including statements regarding our strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-look ...

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 ...

[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 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 ...