Cullinan Therapeutics Inc
For the period ended Mar 31, 2025. Filed May 8, 2025.
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Mar 31, 2025 · Filed May 8, 2025
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Notes to the Consolidated Financial Statements
(1)
Nature of Business and Basis of Presentation
Organization
Cullinan Therapeutics, Inc., together with its consolidated subsidiaries ("Cullinan" or the "Company"), is a clinical-stage biopharmaceutical company dedicated to creating new standards of care for patients that was incorporated in September 2016 and has a principal place of business in Cambridge, Massachusetts. In April 2024, the Company changed its name from Cullinan Oncology, Inc. to Cullinan Therapeutics, Inc.
Liquidity
The Company has a history of significant operating losses and has had negative cash flows from operations since its inception and expects to continue to generate operating losses for the foreseeable future. Cullinan’s ultimate success depends on the outcome of its research and development activities as well as its ability to commercialize the Company’s product candidates. Cullinan is subject to a number of risks including, but not limited to, the need to obtain adequate additional funding for the ongoing and planned clinical development of its product candidates. Due to the numerous risks and uncertainties associated with pharmaceutical products and development, the Company is unable to accurately predict the timing or amount of funds required to complete development of its product candidates, and costs could exceed Cullinan’s expectations for a number of reasons, including reasons beyond the Company’s control.
Since inception, Cullinan has funded its operations primarily through the sale of equity securities and from licensing or selling the rights to its product candidates. The Company expects that its cash, cash equivalents, and short-term investments of$303.8 million, and long-term investments and interest receivable of$263.6 million as of March 31, 2025, will be sufficient to fund its operating expenses and capital expenditure requirements through the next twelve months from the date of issuance of these consolidated financial statements.
(2)
Summary of Significant Accounting Policies
Cullinan’s significant accounting policies have not changed materially from those disclosed in its annual audited consolidated financial statements and accompanying notes in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “2024 10-K”).
Basis of Presentation
The accompanying unaudited consolidated financial statements of the Company have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) and in accordance with applicable rules and regulations of the Securities and Exchange Commission ("SEC") for interim financial reporting and include the accounts of Cullinan and its consolidated subsidiaries. Intercompany balances and transactions have been eliminated in consolidation.
In the opinion of Cullinan’s management, the unaudited consolidated financial statements reflect all adjustments, which are normal and recurring in nature, and necessary for fair financial statement presentation. The preparation of these unaudited consolidated financial statements and accompanying notes in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported. Actual results could differ materially from those estimates. These unaudited consolidated financial statements and accompanying notes should be read in conjunction with the Company’s annual audited consolidated financial statements and accompanying notes included in the 2024 10-K.
Recently Adopted Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board ("FASB") issued an accounting standards update to enhance transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The main provisions in this update will require companies to disclose, on an annual basis, specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. This update will also require companies to disclose, on an annual basis, the amount of income taxes paid, income (or loss) from continuing operations before income tax expense (or benefit), and income tax expense (or benefit) from continuing operations, disaggregated by federal, state and foreign jurisdictions. This new standard is effective for fiscal years beginning after December 15, 2024. Cullinan adopted this standard on January 1, 2025.
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued an accounting standards update to improve disclosures regarding the types of expenses included in commonly presented expense captions, including disaggregating the amounts of employee compensation, depreciation and amortization included within each income statement expense caption. This standard will be effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Cullinan is evaluating the impact of adopting this new standard on its consolidated financial statements and disclosures.
(3)
Financial Instruments
Investments
Cullinan recognized its investments by security type at March 31, 2025 as follows (in thousands):
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | EstimatedFair Value | |
|---|---|---|---|---|
| Short-term investments | ||||
| Corporate notes | $148,703 | $64 | $(49) | $148,718 |
| U.S. government notes | 78,380 | 78 | (2) | 78,456 |
| Total short-term investments | 227,083 | 142 | (51) | 227,174 |
| Long-term investments | ||||
| U.S. government notes | 149,244 | 577 | (16) | 149,805 |
| Corporate notes | 70,261 | 37 | (209) | 70,089 |
| Asset-backed securities | 39,465 | 44 | (19) | 39,490 |
| Total long-term investments | 258,970 | 658 | (244) | 259,384 |
| Total investments | $486,053 | $800 | $(295) | $486,558 |
Cullinan recognized its investments by security type at December 31, 2024 as follows (in thousands):
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | EstimatedFair Value | |
|---|---|---|---|---|
| Short-term investments | ||||
| Corporate notes | $211,584 | $343 | $(6) | $211,921 |
| U.S. government notes | 78,874 | 81 | — | 78,955 |
| Asset-backed securities | 25,084 | 12 | — | 25,096 |
| Total short-term investments | 315,542 | 436 | (6) | 315,972 |
| Long-term investments | ||||
| U.S. government notes | 118,423 | 88 | (188) | 118,323 |
| Corporate notes | 77,196 | 9 | (472) | 76,733 |
| Asset-backed securities | 9,384 | — | — | 9,384 |
| Total long-term investments | 205,003 | 97 | (660) | 204,440 |
| Total investments | $520,545 | $533 | $(666) | $520,412 |
Fair Value of Financial Instruments
The following table sets forth the fair value of Cullinan’s financial assets that were measured at fair value on a recurring basis as of March 31, 2025 (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Short-term investments | ||||
| Corporate notes | $— | $148,718 | $— | $148,718 |
| U.S. government notes | — | 78,456 | — | 78,456 |
| Total short-term investments | — | 227,174 | — | 227,174 |
| Long-term investments | ||||
| U.S. government notes | — | 149,805 | — | 149,805 |
| Corporate notes | — | 70,089 | — | 70,089 |
| Asset-backed securities | — | 39,490 | — | 39,490 |
| Total long-term investments | — | 259,384 | — | 259,384 |
| Total investments | $— | $486,558 | $— | $486,558 |
The following table sets forth the fair value of the Company’s financial assets that were measured at fair value on a recurring basis as of December 31, 2024 (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Short-term investments | ||||
| Corporate notes | $— | $211,921 | $— | $211,921 |
| U.S. government notes | — | 78,955 | — | 78,955 |
| Asset-backed securities | — | 25,096 | — | 25,096 |
| Total short-term investments | — | 315,972 | — | 315,972 |
| Long-term investments | ||||
| U.S. government notes | — | 118,323 | — | 118,323 |
| Corporate notes | — | 76,733 | — | 76,733 |
| Asset-backed securities | — | 9,384 | — | 9,384 |
| Total long-term investments | — | 204,440 | — | 204,440 |
| Total investments | $— | $520,412 | $— | $520,412 |
As of March 31, 2025 and December 31, 2024, the fair values of Cullinan's cash and cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities approximated their carrying values due to the short-term nature of these instruments.
(4)
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following as of March 31, 2025 and December 31, 2024 (in thousands):
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Contracted research and development expenses | $12,395 | $10,297 |
| Due to Taiho under collaboration agreement, net | 4,715 | 5,994 |
| Employee compensation | 2,696 | 9,935 |
| Other current liabilities | 2,795 | 1,437 |
| Total accrued expenses and other current liabilities | $22,601 | $27,663 |
(5)
License and Collaboration Agreements
Harbour License Agreement
The Company and Harbour BioMed US Inc. (“Harbour”) were party to a license and collaboration agreement pursuant to which Harbour granted to Cullinan an exclusive license for the development, manufacturing and commercialization of HBM7008 (CLN-418) in the U.S. In August 2024, following a review of the data from the Phase 1 clinical trial of CLN-418, the Company notified Harbour of its decision to terminate the license and collaboration agreement, effective November 2024. In connection with the termination, the Company discontinued development of CLN-418 and returned development and commercial rights for CLN-418 to Harbour.
Taiho Agreements
Cullinan has a co-development agreement with an affiliate of Taiho Pharmaceutical Co., Ltd ("Taiho"), pursuant to which the Company is collaborating to develop zipalertinib and has the option to co-commercialize zipalertinib in the U.S. Development costs for zipalertinib are shared equally between Taiho and the Company with each party receiving 50% of any future pre-tax profits from potential U.S. sales of zipalertinib.
The Company concluded that the co-development agreement with Taiho is a collaborative arrangement because Cullinan is an active participant in the development of zipalertinib. Payments made to or received from Taiho for zipalertinib development activities after the execution of the co-development agreement are recorded within research and development expenses and general and administrative expenses. For the three months ended March 31, 2025 and 2024, the Company recorded $5.6 million and $6.0 million, respectively, related to its share of research and development costs incurred by Taiho. The Company recorded $0.5 million for thethree months ended March 31, 2025 related to its share of general and administrative costs incurred by Taiho. Cullinan incurred $1.4 million and $1.9 million of costs that were reimbursable by Taiho for thethree months ended March 31, 2025 and 2024, respectively, which were recorded as a reduction to research and development expenses. The net amounts of $4.7 million and $6.0 million due to Taiho as of March 31, 2025 and December 31, 2024, respectively, were recorded within accrued expenses and other current liabilities.
Cullinan is also eligible to receive up to $130.0 million from Taiho tied to epidermal growth factor receptor exon 20 non-small-cell lung cancer U.S. regulatory milestones.
Other License and Collaboration Agreements
The Company has certain payment obligations that are contingent upon future events under various other license and collaboration agreements. Under these agreements, Cullinan will be required to make milestone payments upon successful completion and achievement of certain intellectual property, clinical, regulatory, and sales milestones and will be required to make royalty payments in connection with the sale of products developed under these agreements. During each of the three months ended March 31, 2025 and 2024, no milestones were achieved under the Company’s other license and collaboration agreements.
(6)
Stockholders' Equity
Common Stock
Each share of common stock entitles the holder to one vote and to receive dividends when and if declared by the board of directors of the Company. No dividends have been declared through March 31, 2025.
2024 Private Placement
In April 2024, Cullinan completed the 2024 Private Placement in which Cullinan issued approximately 14.4 million shares of its common stock and pre-funded warrants to purchase approximately 0.3 million additional shares of its common stock. Cullinan received net proceeds of$262.7 million from the 2024 Private Placement, after deducting offering costs of$17.3 million. Refer to the discussion under the heading “Warrants” below for further detail regarding the pre-funded warrants.
At-the-Market Equity Offering Program
Cullinan has an at-the-market equity offering program (the “ATM") through an agreement with Cowen and Company, LLC ("Cowen") pursuant to which the Company may offer and sell up to $125.0 million of its common stock from time to time through Cowen, acting as its sales agent. The Company made no sales under the ATM in thethree months ended March 31, 2025. Through March 31, 2025, the Company has sold approximately 3.3 million shares under the ATM and received net proceeds of $38.4 million after deducting commissions. As of March 31, 2025, Cullinan had $85.6 million in shares of its common stock remaining under the ATM.
Preferred Stock
Each share of preferred stock is convertible into ten shares of common stock at the option of the holder at any time, subject to certain limitations, including that the holder is prohibited from converting preferred stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock more than 9.99% of the total common stock then issued and outstanding immediately following the conversion of such shares of preferred stock. Holders of the preferred stock are permitted to increase this percentage to an amount not to exceed 19.99% upon 60 days notice.
Shares of preferred stock generally have no voting rights, except as required by law and except that the consent of a majority of the holders of the outstanding preferred stock will be required to amend the terms of the preferred stock. In the event of the Company’s liquidation, dissolution or winding up, holders of preferred stock will participate pari passu with any distribution of proceeds to holders of common stock. Holders of preferred stock are entitled to receive when, as, and if dividends are declared and paid on the common stock, an equivalent dividend, calculated on an as-converted basis. Shares of preferred stock are otherwise not entitled to dividends.
The preferred stock ranks (i) senior to any class or series of capital stock of Cullinan hereafter created specifically ranking by its terms junior to the preferred stock; (ii) on parity with the common stock and any class or series of capital stock of the Company created specifically ranking by its terms on parity with the preferred stock; and (iii) junior to any class or series of capital stock of Cullinan created specifically ranking by its terms senior to any preferred stock, in each case, as to distributions of assets upon liquidation, dissolution or winding up of the Company, whether voluntarily or involuntarily.
The Company determined that the preferred stock should be classified as permanent equity.
Noncontrolling Interests
Certain of the Company's clinical-stage product candidates are held through development subsidiaries in which the Company has controlling interests. These development subsidiaries have issued common stock and preferred stock to the Company and to third parties. The holders of subsidiary common stock and preferred stock are generally entitled to one vote per share. The holders of subsidiary common stock are entitled to receive dividends when and if declared by the subsidiaries’ board of directors and distributions in either case only after the payment of all preferential amounts required to be paid to the holders of shares of preferred stock of the respective subsidiary. The following table shows the Company’s ownership interest as of March 31, 2025 and December 31, 2024, respectively, in product candidates in which the Company has a controlling interest:
| Ownership Interest as of | ||
|---|---|---|
| Product Candidate | March 31, 2025 | December 31, 2024 |
| CLN-619 | 99% | 99% |
| CLN-049 | 98% | 98% |
| CLN-617 | 96% | 96% |
Warrants
As of March 31, 2025, the Company had potentially issuable shares of common stock related to unexercised pre-funded warrants to purchase 0.3 million shares of the Company’s common stock at an exercise price of $0.001 per share. The pre-funded warrants may be exercised at the option of the holder at any time, subject to certain limitations. The exercise price and the number of shares are subject to adjustment for certain dividend payments and upon reclassification, exchange, combination or substitution of the shares of common stock. The pre-funded warrants expire in April 2054 if they have not been exercised by that time.
Cullinan determined that the pre-funded warrants should be equity-classified. The Company also determined that the pre-funded warrants should be included in the weighted-average shares used in computing basic net loss per share attributable to common stockholders of Cullinan.
(7)
Equity-Based Compensation
Cullinan recorded equity-based compensation in the following expense categories in the consolidated statements of operations and comprehensive income (loss) for thethree months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| General and administrative | $5,445 | $5,092 |
| Research and development | 3,929 | 3,135 |
| Total equity-based compensation | $9,374 | $8,227 |
(8)
Royalty Transfer Agreements
The Company's CLN-619, CLN-049, and CLN-617 development subsidiaries are each party to royalty transfer agreements with two charitable foundations. Under these royalty transfer agreements, the charitable foundations are collectively entitled to receive a low single digit royalty percentage of all global net sales of any products developed by the applicable subsidiary, subject to limitations after patent expirations and on intellectual property developed after a change of control. Cullinan has deemed these royalty transfer agreements to be freestanding financial instruments that should be accounted for at fair value. The Company concluded that these instruments had no value at the inception of the agreements.
Cullinan has not had any applicable net sales from its products and as a result, hasnot paid or incurred any royalties under these agreements as of March 31, 2025. Given the early-stage nature of the underlying technologies and inherent technical, regulatory and competitive risks associated with achieving approval and commercialization, the Company ascribed no value to the royalty transfer agreements as of March 31, 2025 and December 31, 2024.
(9)
Commitments and Contingencies
The Company enters into contracts in the normal course of business with contract research organizations, contract manufacturing organizations, and other third parties for preclinical research studies, clinical trials and testing and manufacturing services. These agreements generally include cancellation clauses.
Indemnification Agreements
In the ordinary course of business, Cullinan may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and executive officers that will require Cullinan, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in certain cases, unlimited. To date, Cullinan has not incurred any material costs as a result of such indemnifications. The Company is not aware of any indemnification arrangements that could have a material effect on its financial position, results of operations or cash flows, and it hasnot accrued any liabilities related to such obligations in its consolidated financial statements as of March 31, 2025 and December 31, 2024.
Legal Proceedings
Cullinan is not currently party to, or aware of, any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. Cullinan expenses as incurred the costs related to such legal proceedings.
(10)
Leases
Cullinan has an operating lease for approximately 14,000 square feet of office space in a multi-tenant building in Cambridge, Massachusetts, which commenced in August 2022 and goes through July 2026. The Company also had an operating lease for approximately 8,000 square feet of office space in a multi-tenant building in Cambridge, Massachusetts, which commenced in February 2018 and expired in June 2024. Lease expense consisted of operating lease costs of $0.3 million for each of thethree months ended March 31, 2025 and 2024, respectively.
The following table summarizes supplemental cash flow information for thethree months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Cash paid for amounts included in measurement of lease liabilities: | ||
| Operating cash flows from operating leases | $363 | $510 |
The following table summarizes the Company’s future minimum lease payments as of March 31, 2025 (in thousands):
| Remainder of 2025 | $1,098 |
| 2026 | 872 |
| Total future minimum lease payments | 1,970 |
| Less: imputed interest | (130) |
| Total lease liabilities at present value | $1,840 |
The following table summarizes the weighted-average remaining lease term and discount rate as of March 31, 2025 and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Weighted-average remaining lease term (in years) | 1.3 | 1.6 |
| Weighted-average discount rate | 11.0% | 11.0% |
(11)
Net Loss per Share Attributable to Cullinan
The Company computes net loss per share attributable to Cullinan for its common stock and preferred stock using the two-class method required for multiple classes of common stock. The two-class method is an earnings (loss) allocation method under which earnings (loss) per share is calculated for each class of common stock.
The following table sets forth the calculation of basic and diluted net loss per share attributable to Cullinan for the three months ended March 31, 2025 and 2024 (in thousands, except per share data):
| Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | |||
|---|---|---|---|---|
| Common Stock | Preferred Stock | Common Stock | Preferred Stock | |
| Numerator: | ||||
| Net loss attributable to Cullinan - basic and diluted | $(43,698) | $(4,803) | $(32,287) | $(4,861) |
| Denominator: | ||||
| Weighted-average shares outstanding — basic and diluted | 58,905 | 648 | 43,011 | 648 |
| Net loss per share attributable to Cullinan: | ||||
| Basic and diluted | $(0.74) | $(7.42) | $(0.75) | $(7.51) |
Cullinan used the treasury stock method for equity awards and the if converted method for preferred stock to determine the number of dilutive shares outstanding in each period. There were no securities that were potentially dilutive to the preferred stockholders of Cullinan during each of the three months ended March 31, 2025 and 2024. The following table sets forth potential common shares that were excluded from the computation of diluted net loss per share attributable to common stockholders of Cullinanfor thethree months ended March 31, 2025 and 2024 because their effect would have been anti-dilutive (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options | 12,076 | 10,155 |
| Preferred stock | 6,475 | 6,475 |
| Restricted stock units | 986 | 520 |
| Employee stock purchase plan | 10 | 4 |
| Total | 19,547 | 17,154 |
(12)
Segment Reporting
The Company operates and manages the business as one reporting and one operating segment, which is the business of developing immunology and oncology therapies. Cullinan has determined that its Chief Executive Officer is the chief operating decision maker (“CODM”). Cullinan’s CODM reviews financial information on an aggregate basis and uses net loss attributable to Cullinan as presented in the consolidated statement of operations and comprehensive income (loss) for purposes of allocating resources and evaluating financial performance.
Financial information of the Company’s reportable segment for thethree months ended March 31, 2025 and 2024 are as follows (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development ("R&D") programs: | ||
| CLN-978 | $4,673 | $1,503 |
| CLN-619 | 6,118 | 4,286 |
| Zipalertinib | 10,160 | 8,288 |
| CLN-049 | 3,895 | 1,476 |
| CLN-617 | 1,793 | 1,012 |
| CLN-418 | — | 3,072 |
| Early-stage programs | 1,022 | 1,361 |
| Total R&D program expense | 27,661 | 20,998 |
| Equity-based compensation | 9,374 | 8,227 |
| R&D personnel and operations | 9,831 | 6,488 |
| G&A personnel | 3,489 | 3,952 |
| License agreement obligations | 38 | 25 |
| Other segment expenses(1) | 4,603 | 3,299 |
| Loss from operations | (54,996) | (42,989) |
| Other income (expense): | ||
| Interest income | 6,580 | 5,693 |
| Other income (expense), net | (85) | (44) |
| Net loss | (48,501) | (37,340) |
| Net loss attributable to noncontrolling interests | — | (192) |
| Net loss attributable to Cullinan | $(48,501) | $(37,148) |
(1)
Other segment expenses forthe three months ended March 31, 2025 and 2024 include legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax, and administrative consulting services; insurance costs; marketing expenses; depreciation; and other operating costs.
All of the Company’s long-lived assets were located in the U.S. as of each of March 31, 2025 and 2024. There wereno expenditures for long-lived assets in each of thethree months ended March 31, 2025 and 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.