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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
September 30,
2025
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 THERAPEUTICS, INC.
(Exact name of Registrant as specified in its Charter)
Delaware
81-3879991
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
One Main Street
Suite 1350
Cambridge
,
MA
02142
(Address of principal executive offices)
(Zip Code)
(
617
)
410-4650
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
YES
☒ NO ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
YES
☒ NO ☐
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☒
Accelerated filer
☐
Non-accelerated filer
☐
Smaller reporting company
☒
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO
☒
The number of shares of the Registrant’s common stock outstanding as of October 31, 2025 was
59,076,259
.
SPECIAL NOTE REGARDING FO
RWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would”, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed in our Annual Report on Form 10-K for the year ended December 31, 2024 (the "2024 10-K") and other filings with the Securities and Exchange Commission (the “SEC”), including the following:
•
the commercial success, cost of development, and timing of the approval of our clinical-stage product candidates;
•
the initiation, timing, progress, results, and cost of our research and development programs, and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or clinical trials and related preparatory work, and the period during which the results of the trials will become available;
•
our ability to submit, and obtain clearance of, any global regulatory filings, including investigational new drug applications, on our expected timelines, or at all;
•
our ability to initiate, recruit, and enroll patients in and conduct our clinical trials at the pace that we project;
•
our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations, or warnings in the label of any of our product candidates, if approved;
•
the impacts of governmental legislation and regulations, including adverse effects from the U.S. government shutdown;
•
the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics, on our business and operations, including our expenses, supply chain, manufacturing processes, preclinical studies, and clinical trials;
•
our ability to compete with companies currently marketing therapies or developing product candidates with targets or indications similar to our product candidates’ targets or indications;
•
our reliance on third parties to conduct our clinical trials and to manufacture drug substance and drug product for use in our clinical trials;
•
the size and growth potential of the markets for any of our current and future product candidates, and our ability to serve those markets;
•
our ability to identify and advance through clinical development any additional product candidates;
•
the commercialization of our current and future product candidates, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current and future product candidates;
•
our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop current and future product candidates;
•
our ability to retain and recruit key personnel;
•
our ability to obtain and maintain adequate intellectual property rights;
•
our expectations regarding government and third-party payor coverage, pricing, and reimbursement;
•
our estimates of our expenses, ongoing losses, capital requirements, the sufficiency of our current resources, and our needs for or ability to obtain additional financing;
•
the milestone payments that we may receive from Taiho Pharmaceutical Co., Ltd.;
•
potential investments in our pipeline and the potential for such product candidates;
ii
•
the potential benefits of strategic collaboration agreements, our ability to enter into additional strategic collaborations or arrangements, and our ability to attract collaborators with development, regulatory, and commercialization expertise; and
•
developments and projections relating to our competitors or our industry.
These factors are discussed more fully in our 2024 10-K and elsewhere in this Quarterly Report on Form 10-Q and other reports we file with the SEC. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and investors should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may make or collaborations or strategic partnerships we may enter into.
You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed or incorporated by reference as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
This Quarterly Report on Form 10-Q also contains estimates, projections, and other information concerning our industry, our business, and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research, or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research, as well as from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources. While we are not aware of any misstatements regarding any third-party information presented in this Quarterly Report on Form 10-Q, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors, including those discussed under the section titled “Risk Factors” in our 2024 10-K and elsewhere in this Quarterly Report on Form 10-Q.
iii
PART I—FINANCI
AL INFORMATION
Item 1. Financi
al Statements.
CULLINAN THERAPEUTICS, INC.
Consolidated B
alance Sheets
(unaudited)
(in thousands, except share amounts)
September 30, 2025
December 31, 2024
Assets
Current assets:
Cash and cash equivalents
$
103,335
$
83,005
Short-term investments
229,261
315,972
Prepaid expenses and other current assets
9,639
15,691
Total current assets
342,235
414,668
Property and equipment, net
489
683
Operating lease right-of-use assets
1,046
1,667
Other assets
361
366
Long-term investments
139,995
204,440
Total assets
$
484,126
$
621,824
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$
1,722
$
1,682
Accrued expenses and other current liabilities
29,847
27,663
Operating lease liabilities, current
1,188
1,302
Total current liabilities
32,757
30,647
Long-term liabilities:
Operating lease liabilities, net of current portion
—
849
Total liabilities
32,757
31,496
Commitments and contingencies (Note 9)
Stockholders' equity:
Preferred stock, $
0.0001
par value,
10,000,000
shares authorized as of September 30, 2025 and December 31, 2024;
647,500
shares issued and outstanding as of September 30, 2025 and December 31, 2024
—
—
Common stock, $
0.0001
par value,
150,000,000
shares authorized as of September 30, 2025 and December 31, 2024;
59,076,259
and
58,510,610
shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
6
6
Additional paid-in capital
987,796
958,695
Accumulated other comprehensive income (loss)
973
(
133
)
Accumulated deficit
(
537,406
)
(
368,240
)
Total Cullinan stockholders' equity
451,369
590,328
Noncontrolling interests
—
—
Total stockholders' equity
451,369
590,328
Total liabilities and stockholders' equity
$
484,126
$
621,824
See accompanying notes to the unaudited consolidated financial statements.
1
CULLINAN THERAPEUTICS, INC.
Consolidated Statements of Oper
ations and Comprehensive INCOME (LOSS)
(unaudited)
(in thousands, except per share amounts)
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Operating expenses:
Research and development
$
41,968
$
35,506
$
144,457
$
102,411
General and administrative
13,627
13,349
41,932
39,460
Total operating expenses
55,595
48,855
186,389
141,871
Loss from operations
(
55,595
)
(
48,855
)
(
186,389
)
(
141,871
)
Other income (expense):
Interest income
5,093
8,384
17,597
22,148
Other expense, net
(
108
)
(
89
)
(
374
)
(
205
)
Net loss
(
50,610
)
(
40,560
)
(
169,166
)
(
119,928
)
Net loss attributable to noncontrolling interests
—
—
—
(
192
)
Net loss attributable to Cullinan
$
(
50,610
)
$
(
40,560
)
$
(
169,166
)
$
(
119,736
)
Comprehensive income (loss):
Net loss
$
(
50,610
)
$
(
40,560
)
$
(
169,166
)
$
(
119,928
)
Unrealized gain on investments
366
1,446
1,106
1,099
Comprehensive loss
(
50,244
)
(
39,114
)
(
168,060
)
(
118,829
)
Comprehensive loss attributable to noncontrolling interests
—
—
—
(
192
)
Comprehensive loss attributable to Cullinan
$
(
50,244
)
$
(
39,114
)
$
(
168,060
)
$
(
118,637
)
Basic and diluted net loss per share attributable to Cullinan:
Common stock
$
(
0.77
)
$
(
0.63
)
$
(
2.58
)
$
(
2.04
)
Preferred stock
$
(
7.72
)
$
(
6.26
)
$
(
25.84
)
$
(
20.42
)
Weighted-average shares used in computing basic and diluted net loss per share attributable to Cullinan:
Common stock
59,075
58,337
58,999
52,157
Preferred stock
648
648
648
648
See accompanying notes to the unaudited consolidated financial statements.
2
CULLINAN THERAPEUTICS, INC.
Consolidated Statements
of STOCKHOLDERS’ EQUITY
(unaudited)
(in thousands, except share amounts)
Preferred Stock
Common Stock
Additional
Paid-In
Accumulated
Other
Comprehensive
Accumulated
Noncontrolling
Total Stockholders'
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Deficit
Interests
Equity
Balances at December 31, 2024
647,500
$
—
58,510,610
$
6
$
958,695
$
(
133
)
$
(
368,240
)
$
—
$
590,328
Issuance of common stock under equity-based compensation plans
—
—
188,309
—
—
—
—
—
—
Equity-based compensation
—
—
—
—
9,374
—
—
—
9,374
Unrealized gain on investments
—
—
—
—
—
638
—
—
638
Net loss
—
—
—
—
—
—
(
48,501
)
—
(
48,501
)
Balances at March 31, 2025
647,500
—
58,698,919
6
968,069
505
(
416,741
)
—
551,839
Issuance of common stock under equity-based compensation plans
—
—
59,724
—
373
—
—
—
373
Issuance of common stock upon exercise of pre-funded warrants
—
—
315,748
—
—
—
—
—
—
Equity-based compensation
—
—
—
—
9,887
—
—
—
9,887
Unrealized gain on investments
—
—
—
—
—
102
—
—
102
Net loss
—
—
—
—
—
—
(
70,055
)
—
(
70,055
)
Balances at June 30, 2025
647,500
—
59,074,391
6
978,329
607
(
486,796
)
—
492,146
Issuance of common stock under equity-based compensation plans
—
—
1,868
—
—
—
—
—
—
Equity-based compensation
—
—
—
—
9,467
—
—
—
9,467
Unrealized gain on investments
—
—
—
—
—
366
—
—
366
Net loss
—
—
—
—
—
—
(
50,610
)
—
(
50,610
)
Balances at September 30, 2025
647,500
$
—
59,076,259
$
6
$
987,796
$
973
$
(
537,406
)
$
—
$
451,369
See accompanying notes to the unaudited consolidated financial statements.
3
CULLINAN THERAPEUTICS, INC.
Consolidated Statements of STOCKHOLDERS’ EQUITY
(unaudited)
(in thousands, except share amounts)
Preferred Stock
Common Stock
Additional
Paid-In
Accumulated
Other
Comprehensive
Accumulated
Noncontrolling
Total Stockholders'
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Deficit
Interests
Equity
Balances at December 31, 2023
647,500
$
—
42,900,083
$
4
$
654,685
$
(
129
)
$
(
200,857
)
$
192
$
453,895
Issuance of common stock under equity-based compensation plans
—
—
165,562
—
1,085
—
—
—
1,085
Equity-based compensation
—
—
—
—
8,227
—
—
—
8,227
Unrealized loss on investments
—
—
—
—
—
(
202
)
—
—
(
202
)
Net loss
—
—
—
—
—
—
(
37,148
)
(
192
)
(
37,340
)
Balances at March 31, 2024
647,500
—
43,065,645
4
663,997
(
331
)
(
238,005
)
—
425,665
Issuance of common stock and pre-funded warrants, net of issuance costs
—
—
14,421,070
1
262,651
—
—
—
262,652
Issuance of common stock under equity-based compensation plans
—
—
384,923
1
3,335
—
—
—
3,336
Equity-based compensation
—
—
—
—
10,533
—
—
—
10,533
Acquisition of noncontrolling interests
—
—
—
—
(
3,792
)
—
—
—
(
3,792
)
Unrealized loss on investments
—
—
—
—
—
(
145
)
—
—
(
145
)
Net loss
—
—
—
—
—
—
(
42,028
)
—
(
42,028
)
Balances at June 30, 2024
647,500
—
57,871,638
6
936,724
(
476
)
(
280,033
)
—
656,221
Issuance of common stock under equity-based compensation plans
—
—
269,492
—
1,981
—
—
—
1,981
Equity-based compensation
—
—
—
—
9,430
—
—
—
9,430
Acquisition of noncontrolling interests
—
—
—
—
(
656
)
—
—
—
(
656
)
Unrealized gain on investments
—
—
—
—
—
1,446
—
—
1,446
Net loss
—
—
—
—
—
—
(
40,560
)
—
(
40,560
)
Balances at September 30, 2024
647,500
$
—
58,141,130
$
6
$
947,479
$
970
$
(
320,593
)
$
—
$
627,862
See accompanying notes to the unaudited consolidated financial statements.
4
CULLINAN THERAPEUTICS, INC.
CONSOLIDATED STATEM
ENTS OF CASH FLOWS
(unaudited)
(in thousands)
Nine Months Ended September 30,
2025
2024
Operating activities:
Net loss
$
(
169,166
)
$
(
119,928
)
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation expense
28,728
28,190
Accretion on marketable securities
(
5,375
)
(
11,958
)
Depreciation and amortization
232
229
Changes in operating assets and liabilities:
Prepaid expenses and other assets
6,057
(
837
)
Accounts payable
40
(
378
)
Accrued expenses and other liabilities
1,843
(
3,995
)
Net cash used in operating activities
(
137,641
)
(
108,677
)
Investing activities:
Maturities of marketable securities
374,572
400,817
Purchases of marketable securities
(
216,936
)
(
553,095
)
Purchases of property and equipment
(
38
)
—
Net cash provided by (used in) investing activities
157,598
(
152,278
)
Financing activities:
Issuance of common stock under equity-based compensation plans
373
6,402
Issuance of common stock and pre-funded warrants, net of issuance costs
—
262,652
Acquisition of noncontrolling interests
—
(
4,448
)
Net cash provided by financing activities
373
264,606
Net increase in cash and cash equivalents
20,330
3,651
Cash and cash equivalents at beginning of period
83,005
98,434
Cash and cash equivalents at end of period
$
103,335
$
102,085
SUPPLEMENTAL NONCASH DISCLOSURE
Non-cash investing and financing activities and supplemental cash flow information
Cash refunded for income taxes
$
(
2,970
)
$
(
2,274
)
See accompanying notes to the unaudited consolidated financial statements.
5
CULLINAN THERAPEUTICS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
(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 development, government regulation, potential commercialization, intellectual property, and our reliance on third parties, 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
$
332.6
million
, and long-term investments and interest receivable of
$
142.9
million
as of September 30, 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.
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”) 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 its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the "2024
10-K").
(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 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.
6
(3)
Financial Instruments
Investments
Cullinan recognized its investments by security type at
September 30, 2025 as follows (in thousands):
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair Value
Short-term investments
U.S. government notes
$
119,144
$
208
$
—
$
119,352
Corporate notes
109,852
84
(
27
)
109,909
Total short-term investments
228,996
292
(
27
)
229,261
Long-term investments
U.S. government notes
90,009
565
—
$
90,574
Corporate notes
39,647
104
(
12
)
$
39,739
Asset-backed securities
9,631
51
—
$
9,682
Total long-term investments
139,287
720
(
12
)
139,995
Total investments
$
368,283
$
1,012
$
(
39
)
$
369,256
Cullinan recognized its investments by security type at December 31, 2024 as follows (in thousands):
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair 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
September 30, 2025 (in thousands):
Level 1
Level 2
Level 3
Total
Short-term investments
U.S. government notes
$
—
$
119,352
$
—
$
119,352
Corporate notes
—
109,909
—
109,909
Total short-term investments
—
229,261
—
229,261
Long-term investments
U.S. government notes
—
90,574
—
90,574
Corporate notes
—
39,739
—
39,739
Asset-backed securities
—
9,682
—
9,682
Total long-term investments
—
139,995
—
139,995
Total investments
$
—
$
369,256
$
—
$
369,256
7
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 September 30, 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
September 30, 2025 and December 31, 2024 (in thousands):
September 30, 2025
December 31, 2024
Contracted research and development expenses
$
15,719
$
10,297
Due to Taiho under collaboration agreement, net
5,240
5,994
Employee compensation
7,373
9,935
Other current liabilities
1,515
1,437
Total accrued expenses and other current liabilities
$
29,847
$
27,663
(5)
License and Collaboration Agreements
Genrix License Agreement
In June 2025, the Company and Chongqing Genrix Biopharmaceutical Co., Ltd. (“Genrix”) entered into a license agreement (the “Genrix License Agreement”), pursuant to which Genrix granted Cullinan a global (excluding mainland China, Hong Kong, Macau and Taiwan), exclusive license to develop and commercialize velinotamig, a BCMAxCD3 bispecific T cell engager, in all fields of use.
Under the terms of the Genrix License Agreement, Cullinan paid Genrix an upfront license fee of $
20.0
million. Genrix will be eligible to receive up to $
292.0
million in milestone payments based on the achievement of development and regulatory milestones. Genrix is also eligible to receive up to an additional $
400.0
million in net sales-based milestones as well as tiered royalties ranging from mid-single digit to mid-teens, as a percentage of net sales of licensed products.
Unless earlier terminated, the Genrix License Agreement will continue in effect on a country-by-country basis until the expiration of Cullinan’s royalty obligations in such country. The Genrix License Agreement may be terminated by either party for a material breach by the other party, subject to notice and cure provisions, or in the event of the other party’s insolvency. Additionally, subject to a notice period, Cullinan may terminate the Genrix License Agreement for convenience. In the Genrix License Agreement, each party made customary representations and warranties and agreed to customary covenants, including, without limitation, with respect to indemnification, for transactions of this type.
Cullinan evaluated the Genrix License Agreement and determined that the exclusive license to develop and commercialize velinotamig represented an asset acquisition of in-process research and development. The Company also determined that the asset had no alternative future use at the time of acquisition, and therefore, the upfront license fee of $
20.0
million was recorded within research and development expenses during the nine months ended September 30, 2025.
Harbour License Agreement
The Company and Harbour BioMed US Inc. (“Harbour”) were party to a license and collaboration agreement pursuant to which Harbour granted 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.
8
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. Amounts due to or from Taiho for zipalertinib development activities after the execution of the co-development agreement are recorded within research and development expenses or general and administrative expenses based on the nature of the activity.
The following table summarizes each party’s respective share of costs incurred by the other party for zipalertinib development activities for the
three and nine months ended September 30, 2025 and 2024 (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Cullinan's share of zipalertinib research and development costs incurred by Taiho
$
6,130
$
6,456
$
19,519
$
17,590
Cullinan’s share of general and administrative costs incurred by Taiho
$
836
$
706
$
1,899
$
706
Taiho’s share of research and development costs incurred by Cullinan
$
1,726
$
2,137
$
6,212
$
6,879
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 and nine months ended September 30, 2025 and 2024
, no milestone obligations were incurred 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
September 30, 2025.
2024 Private Placement
In April 2024, Cullinan completed a private placement (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 the
nine months ended September 30, 2025. Through September 30, 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
September 30, 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.
9
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 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.
The following table shows the Company’s ownership interest as of
September 30, 2025 and December 31, 2024, respectively, in product candidates in which the Company has a controlling interest:
Ownership Interest as of
Product Candidate
September 30, 2025
December 31, 2024
CLN-619
99
%
99
%
CLN-049
98
%
98
%
CLN-617
96
%
96
%
During the nine months ended September 30, 2024, Cullinan paid $
4.4
million to acquire shares of its CLN-619 development subsidiary that were held by noncontrolling interests.
Warrants
In April 2025, all outstanding pre-funded warrants were exercised on a cashless basis in exchange for
0.3
million shares of common stock.
Cullinan determined that the pre-funded warrants should be equity-classified when they were issued. 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 the
three and nine months ended September 30, 2025 and 2024 (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
General and administrative
$
5,568
$
5,503
$
16,734
$
17,274
Research and development
3,899
3,927
11,994
10,916
Total equity-based compensation
$
9,467
$
9,430
$
28,728
$
28,190
(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, has
no
t paid or incurred any royalties under these agreements as of
September 30, 2025. Given the early-stage nature of the underlying technologies and inherent risks associated with obtaining regulatory approval and achieving commercialization, the Company ascribed no value to the royalty transfer agreements as of September 30, 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.
10
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 has
no
t accrued any liabilities related to such obligations in its consolidated financial statements as of
September 30, 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 was scheduled to expire in July 2026. In October 2025, Cullinan extended its operating lease through September 2028. Refer to Note 13 for additional detail regarding the lease extension agreement. Lease expense consisted of operating lease costs of
$
0.3
million in each of the three months ended September 30, 2025 and 2024
. Lease expense consisted of operating lease costs of $
0.9
million in each of the
nine months ended September 30, 2025 and 2024.
The following table summarizes supplemental cash flow information for the
nine months ended September 30, 2025 and 2024 (in thousands):
Nine Months Ended September 30,
2025
2024
Cash paid for amounts included in measurement of lease liabilities:
Operating cash flows from operating leases
$
1,095
$
1,381
The following table summarizes the Company’s future minimum lease payments as of
September 30, 2025 (in thousands):
September 30, 2025
Remainder of 2025
$
366
2026
872
Total future minimum lease payments
1,238
Less: imputed interest
(
50
)
Total lease liabilities at present value
$
1,188
The following table summarizes the weighted-average remaining lease term and discount rate as of
September 30, 2025 and December 31, 2024:
September 30, 2025
December 31, 2024
Weighted-average remaining lease term (in years)
0.8
1.6
Weighted-average discount rate
11.0
%
11.0
%
11
(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 tables set forth the calculation of basic and diluted net loss per share attributable to Cullinan for the
three and nine months ended September 30, 2025 and 2024 (in thousands, except per share data):
Three Months Ended September 30,
2025
2024
Common Stock
Preferred Stock
Common Stock
Preferred Stock
Numerator:
Net loss attributable to Cullinan - basic and diluted
$
(
45,611
)
$
(
4,999
)
$
(
36,508
)
$
(
4,052
)
Denominator:
Weighted-average shares outstanding — basic and diluted
59,075
648
58,337
648
Net loss per share attributable to Cullinan:
Basic and diluted
$
(
0.77
)
$
(
7.72
)
$
(
0.63
)
$
(
6.26
)
Nine Months Ended September 30,
2025
2024
Common Stock
Preferred Stock
Common Stock
Preferred Stock
Numerator:
Net loss attributable to Cullinan - basic and diluted
$
(
152,436
)
$
(
16,730
)
$
(
106,513
)
$
(
13,223
)
Denominator:
Weighted-average shares outstanding — basic and diluted
58,999
648
52,157
648
Net loss per share attributable to Cullinan:
Basic and diluted
$
(
2.58
)
$
(
25.84
)
$
(
2.04
)
$
(
20.42
)
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.
The following table sets forth potential common shares that were excluded from the diluted weighted-average common shares outstanding for the
nine months ended September 30, 2025 and 2024 because their effect would have been anti-dilutive (in thousands):
Nine Months Ended September 30,
2025
2024
Stock options
12,836
8,411
Preferred stock
6,475
6,475
Restricted stock units
1,656
328
Employee stock purchase plan
7
9
Total
20,974
15,223
12
(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 the
three and nine months ended September 30, 2025 and 2024 are as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Research and development ("R&D") programs:
CLN-049
$
4,532
$
2,041
$
13,325
$
5,203
CLN-418
—
927
—
6,036
CLN-617
1,757
1,637
4,953
3,602
CLN-619
6,209
5,472
19,644
17,087
CLN-978
5,329
4,888
15,395
10,849
Early-stage programs
2,112
1,281
5,120
4,097
Velinotamig
763
—
773
—
Zipalertinib
7,575
7,596
23,736
23,110
Total R&D program expense
28,277
23,842
82,946
69,984
Equity-based compensation
9,467
9,430
28,728
28,190
R&D personnel and operations
9,717
7,712
29,289
21,436
General and administrative personnel
3,317
3,332
10,141
10,885
License agreement obligations
75
25
20,228
75
Other segment expenses
(1)
4,742
4,514
15,057
11,301
Loss from operations
(
55,595
)
(
48,855
)
(
186,389
)
(
141,871
)
Other income (expense):
Interest income
5,093
8,384
17,597
22,148
Other income (expense), net
(
108
)
(
89
)
(
374
)
(
205
)
Net loss
(
50,610
)
(
40,560
)
(
169,166
)
(
119,928
)
Net loss attributable to noncontrolling interests
—
—
—
(
192
)
Net loss attributable to Cullinan
$
(
50,610
)
$
(
40,560
)
$
(
169,166
)
$
(
119,736
)
(1)
Other segment expenses for
the three and nine months ended September 30, 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 September 30, 2025 and 2024. Expenditures for additions to long-lived assets included purchases of property and equipment for the nine months ended September 30, 2025.
There were
no
expenditures for long-lived assets in the
three and nine months ended September 30, 2025 or the three and nine months ended September 30, 2024
.
(13)
Subsequent Event
In October 2025, the Company extended its operating lease for approximately
14,000
square feet of office space in a multi-tenant building in Cambridge, Massachusetts through September 2028. Cullinan’s future minimum lease payments will increase by $
2.4
million as a result of this operating lease extension.
In November 2025, after a review of the emerging clinical data, the Company decided not to pursue further development of CLN-619 or CLN-617.
13
Item 2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 10-K”), filed with the Securities and Exchange Commission (the “SEC”) on February 27, 2025. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Please also refer to those factors described in “Part I, Item 1A. Risk Factors” of our 2024 10-K and "Part II. Item 1A. Risk Factors" in this Quarterly Report on Form 10-Q for important factors that we believe could cause actual results to differ materially from those in our forward-looking statements.
Overview
We are a clinical-stage biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. Our strategy is to identify high-impact targets, which we define as those that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer, and then select what we believe is the optimal therapeutic modality for those targets. We source innovation both internally and externally, focusing on product candidates with novel technology or differentiated mechanisms. Before we advance a product candidate into clinical development, we evaluate its potential for activity as a single agent as well as its ability to generate an immune response or to inhibit disease processes. Using this strategy, we have built a pipeline of targeted immunology and oncology product candidates that aim to maximize therapeutic potential for patients.
Immunology
•
CLN-978 is a CD19xCD3 bispecific T cell engager that we are developing for autoimmune diseases. In the Phase 1 OUTRACE Program, CLN-978 is being investigated in patients with systemic lupus erythematosus (“SLE”), rheumatoid arthritis (“RA”) and Sjögren’s disease (“SjD”). The OUTRACE SLE Study is an ongoing global Phase 1 clinical trial in patients with moderate to severe SLE. The OUTRACE RA Study is a Phase 1 clinical trial in patients with active, difficult-to-treat RA, which is ongoing in Europe. We plan to share initial safety and B cell depletion data in SLE and RA in the first half of 2026. The OUTRACE SjD Study is an ongoing global Phase 1 clinical trial in patients with active, moderate to severe Sjögren’s disease. Separately, we were issued a composition of matter patent by the United States Patent and Trademark Office, which is expected to extend patent protection until at least 2042, excluding possible patent term extension.
•
Velinotamig is a BCMAxCD3 bispecific T cell engager that we are developing for autoimmune diseases. Chongqing Genrix Biopharmaceutical Co., Ltd. ("Genrix"), from whom we licensed velinotamig, plans to initiate a Phase 1 clinical trial in China in patients with autoimmune diseases by the end of 2025. We intend to use the data generated from this Phase 1 clinical trial to accelerate global clinical development of the program. Following the completion of the Genrix Phase 1 clinical trial, we will conduct all further development of velinotamig in autoimmune diseases.
Oncology
•
Zipalertinib (CLN-081/TAS6417), which we are co-developing with an affiliate of Taiho Pharmaceutical Co., Ltd. ("Taiho"), is an orally-available small-molecule, irreversible epidermal growth factor receptor ("EGFR") inhibitor that is designed to selectively target cells expressing EGFR exon 20 insertion mutations (“EGFR ex20ins”) with relative sparing of cells expressing wild-type EGFR.
o
We are evaluating zipalertinib in a pivotal Phase 2b portion of the REZILIENT1 clinical trial in patients with EGFR ex20ins non-small cell lung cancer ("NSCLC") who progressed after prior systemic therapy. In January 2025, we announced the Phase 2b portion of the REZILIENT1 trial met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who have received prior therapy. The results were shared at the 2025 American Society of Clinical Oncology Annual Meeting and published simultaneously in the Journal of Clinical Oncology. We also shared updated efficacy and safety data demonstrating responses in patients previously treated with amivantamab during a mini oral abstract session at the International Association for the Study of Lung Cancer ("IASLC") 2025 World Conference on Lung Cancer ("WCLC"). Following a positive Type B pre-NDA meeting with the U.S. Food and Drug Administration (“FDA”) in October 2025, Taiho plans to initiate a rolling submission of a new drug application (“NDA”) in relapsed EGFR ex20ins NSCLC by the end of 2025.
o
Taiho is evaluating zipalertinib in a global Phase 3 clinical trial (“REZILIENT3”) in combination with chemotherapy as a potential first-line treatment for EGFR ex20ins NSCLC adult patients. Taiho expects to complete enrollment of the trial in the first half of 2026.
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o
Taiho is also evaluating zipalertinib in a Phase 2 parallel cohort study (“REZILIENT2”). Taiho shared initial data from the REZILIENT2 cohort demonstrating the clinical activity of zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC. Taiho also shared initial data from the REZILIENT2 cohort demonstrating intracranial responses with zipalertinib in patients with active brain metastases at the European Society for Medical Oncology Congress 2025.
•
CLN-049 is a FLT3xCD3 bispecific T cell engager. CLN-049 is being investigated in an ongoing Phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia ("AML") or myelodysplastic syndrome. We recently shared clinical data in a published American Society of Hematology (“ASH”) abstract demonstrating anti-leukemic activity at clinically active target doses in patients with relapsed/refractory AML and updated results will be shared in an oral presentation at the 2025 ASH Annual Meeting in December 2025. CLN-049 is also being evaluated in a Phase 1 clinical trial in patients with AML and measurable residual disease immediately following induction therapy.
Preclinical Programs
In addition to the product candidates described above, we are actively developing several preclinical programs by leveraging our own internal expertise and through partnerships with external collaborators.
Recently Discontinued Programs
CLN-619 is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis mediated by both cytotoxic innate and adaptive immune cells that we were evaluating in Phase 1 clinical trials. In May 2025, following a review of the CLN-619 data from the disease-specific expansion cohorts for endometrial and cervical cancers, we announced discontinuation of further development of CLN-619 in patients with gynecological cancers as preliminary results did not meet our internal threshold for advancement. In November 2025, after a review of the emerging clinical data in patients with NSCLC and multiple myeloma, we decided not to pursue further development of CLN-619.
CLN-617 is a fusion protein combining two potent antitumor cytokines, interleukin-2 and interleukin-12, with tumor retention domains for the treatment of solid tumors that we were evaluating in a Phase 1 clinical trial. In November 2025, after a review of the emerging clinical data in patients with advanced solid tumors, we decided not to pursue further development of CLN-617.
Previously, we were evaluating CLN-418, a fully human bispecific immune activator targeting B7H4 and 4-1BB that we licensed from Harbour BioMed US Inc. (“Harbour”), in a Phase 1 clinical trial. In August 2024, following a review of the data from the Phase 1 clinical trial, we notified Harbour of our decision to terminate the license and collaboration agreement for CLN-418 (the “Harbour License Agreement”), effective November 2024. In connection with the termination of the Harbour License Agreement, we discontinued development of CLN-418 and returned development and commercial rights for CLN-418 to Harbour to focus our resources on our other product candidates.
Intellectual Property
We hold the worldwide intellectual property rights for CLN-978 and the worldwide, excluding mainland China, Hong Kong, Macau and Taiwan (collectively referred to as "greater China"), intellectual property rights for velinotamig. We also hold the worldwide intellectual property rights or exclusive options for worldwide intellectual property for our early-stage programs. We have a controlling interest in the worldwide intellectual property rights for CLN-619, CLN-049, and CLN-617. We are co-developing zipalertinib, for which Taiho holds the intellectual property rights, with an affiliate of Taiho. The following table shows our ownership interest as of September 30, 2025 in product candidates in which we have a controlling interest in the worldwide intellectual property rights:
Product Candidate
Ownership Interest as of
September 30, 2025
CLN-619
99%
CLN-049
98%
CLN-617
96%
Financing and Business Operations
Since our inception in 2016, we have focused all of our efforts and financial resources on raising capital, organizing and staffing our company, identifying, acquiring or in-licensing and developing product and technology rights, establishing and protecting our intellectual property portfolio, and developing and advancing our programs. We do not have any products approved for sale and have not generated any revenue from product sales.
We have funded our operations primarily through the sale of equity securities and from licensing or selling the rights to our product candidates. As of September 30, 2025, we have received net proceeds of $842.2 million from equity financings. We have received $18.9 million in revenue from a previous license agreement and cash proceeds of $275.0 million from the sale of our equity interest in our former zipalertinib development subsidiary to Taiho.
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As of September 30, 2025, we had cash, cash equivalents, and short-term investments of $332.6 million, and long-term investments and interest receivable of $142.9 million. Interest receivable is included in prepaid expenses and other current assets on the consolidated balance sheets and represents accrued and unpaid interest on our marketable securities. We have a history of significant operating losses and have had negative cash flows from operations since our inception. As of September 30, 2025, we had an accumulated deficit of $537.4 million. We expect to continue to generate operating losses for the foreseeable future. Our future viability is dependent on the success of our research and development and our ability to access additional capital to fund our operations. There can be no assurance that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.
In June 2025, we entered into a license and collaboration agreement (the “Genrix License Agreement”) with Genrix, pursuant to which Genrix granted us a global (excluding greater China), exclusive license to develop and commercialize velinotamig, a BCMAxCD3 bispecific T cell engager, in all fields of use. Under the terms of the Genrix License Agreement, we paid Genrix an upfront license fee of $20.0 million in June 2025. Refer to Note 5 of our notes to the consolidated financial statements in this Quarterly Report on Form 10-Q for additional detail regarding the Genrix License Agreement.
We are subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, reliance on third parties, compliance with government regulations, and the ability to obtain additional capital to fund operations. Our current and future product candidates will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require additional capital, adequate personnel and extensive compliance-reporting capabilities. There can be no assurance that our research and development will be successfully completed, that adequate protection for our intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval, or that any approved products will be commercially viable.
Global Economic Conditions
As we continue to pursue commercial opportunities in both U.S. and international markets, we remain attentive to evolving global economic conditions, including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Although these factors have not had a material impact on our business to date, future changes in trade regulations or tariff structures could have an impact on our business and operations, including our expenses, supply chain, manufacturing processes, preclinical studies and clinical trials. We continue to monitor these developments closely.
U.S. Government Shutdown
During the ongoing government shutdown in the U.S., the FDA has retained the majority of its staff and continues most of its typical operations. However, during the government shutdown, the FDA is not accepting new marketing applications that require a user fee, including NDAs. Taiho intends to initiate a rolling submission of an NDA for zipalertinib in relapsed EGFR ex20ins NSCLC by the end of 2025. If the government shutdown continues, acceptance and review of the NDA submission for zipalertinib may be delayed. Additionally, even when the government shutdown ends, the FDA may face a backlog of marketing submissions that it had not accepted for review during the shutdown, which may further delay acceptance and review of the planned NDA for zipalertinib.
Components of Our Results of Operations
Revenue
We have not generated any revenue from the sale of products since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all.
Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with the research and development of our product candidates and programs. These expenses include:
•
compensation costs for employees engaged in research and development functions;
•
expenses incurred under agreements with organizations that support our drug discovery and development activities;
•
expenses incurred in connection with the preclinical and clinical development of our product candidates and programs, including under agreements with contract research organizations ("CROs");
•
costs related to contract manufacturing organizations that are primarily engaged to provide drug substance, raw materials, and drug product for our clinical trials, research and development programs, as well as investigative sites and consultants that conduct our clinical trials, nonclinical studies, and other scientific development services;
•
the costs of acquiring and manufacturing nonclinical and clinical trial materials, including manufacturing registration and validation batches;
•
costs related to compliance with quality and regulatory requirements;
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•
payments made under third-party licensing agreements; and
•
direct and allocated costs related to facilities, information technology, personnel and other overhead.
Development costs and any future potential pre-tax profits from U.S. sales of zipalertinib are shared equally between us and Taiho.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation costs for personnel in executive management, finance, legal, corporate and business development, and other administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax, and administrative consulting services; insurance costs; administrative travel expenses; marketing expenses; and other operating costs.
Other Income
Other income consists primarily of interest income earned on our cash, cash equivalents, and investments.
Income Taxes
In July 2025, the U.S enacted the budget reconciliation bill H.R. 1 into law, which included significant changes to U.S. income tax laws. We have assessed the impacts of H.R. 1 in the current quarter and have determined that there is no expected impact on our 2025 effective tax rate.
Results of Operations
Comparison of the
Three and Nine Months Ended September 30, 2025 and 2024
The following table presents our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Operating expenses:
Research and development
$
41,968
$
35,506
$
144,457
$
102,411
General and administrative
13,627
13,349
41,932
39,460
Total operating expenses
55,595
48,855
186,389
141,871
Loss from operations
(55,595
)
(48,855
)
(186,389
)
(141,871
)
Other income (expense):
Interest income
5,093
8,384
17,597
22,148
Other expense, net
(108
)
(89
)
(374
)
(205
)
Net loss
(50,610
)
(40,560
)
(169,166
)
(119,928
)
Net loss attributable to noncontrolling interests
—
—
—
(192
)
Net loss attributable to Cullinan
$
(50,610
)
$
(40,560
)
$
(169,166
)
$
(119,736
)
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Research and Development Expenses
In the fourth quarter of 2024, we began disclosing research and development personnel costs without the effect of intercompany allocations to product candidates held by our development subsidiaries and also began disclosing license agreement obligations separately from the related product candidate. We have recast prior period financial information to conform to the new presentation. The following table summarizes our research and development expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
CLN-049
$
4,532
$
2,041
$
13,325
$
5,203
CLN-418
—
927
—
6,036
CLN-617
1,757
1,637
4,953
3,602
CLN-619
6,209
5,472
19,644
17,087
CLN-978
5,329
4,888
15,395
10,849
Velinotamig
763
—
773
—
Zipalertinib
7,575
7,596
23,736
23,110
Clinical-stage product candidates
26,165
22,561
77,826
65,887
Early-stage programs
2,112
1,281
5,120
4,097
Research and development personnel and operations
9,717
7,712
29,289
21,436
License agreement obligations
75
25
20,228
75
Equity-based compensation
3,899
3,927
11,994
10,916
Total research and development expenses
$
41,968
$
35,506
$
144,457
$
102,411
The $6.5 million increase in research and development expenses in the three months ended September 30, 2025 compared to the same period in 2024 was primarily due to increases in clinical development costs ($4.2 million), personnel costs relating to additional headcount ($2.0 million), and chemistry, manufacturing and controls costs ($0.8 million), offset partially by a decrease in preclinical costs ($0.5 million).
The $42.0 million increase in research and development expenses in the nine months ended September 30, 2025 compared to the same period in 2024 was primarily due to the one-time upfront in-licensing fee for velinotamig ($20.0 million), and increases in clinical development costs ($13.8 million), personnel costs relating to additional headcount ($7.6 million), chemistry, manufacturing and controls costs ($1.6 million), and equity-based compensation expense ($1.1 million), offset partially by a decrease in preclinical costs ($2.3 million).
General and Administrative Expenses
The $0.3 million increase in general and administrative expenses in the three months ended September 30, 2025 compared to the same period in 2024 was primarily due to an increase in other professional fees ($0.3 million).
The $2.5 million increase in general and administrative expenses in the nine months ended September 30, 2025 compared to the same period in 2024 was primarily due to increases in other professional fees ($2.1 million) and legal costs ($1.4 million), partially offset by decreases in personnel costs ($0.7 million) and equity-based compensation costs ($0.5 million).
Other Income
The $3.3 million and $4.7 million decreases in other income for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024 were primarily related to lower investment income.
Net Loss Attributable to Noncontrolling Interests
Net loss attributable to noncontrolling interests is the difference in the noncontrolling interests in the consolidated balance sheets between the start and end of each reporting period, after taking into account any capital transactions between our development subsidiaries and third parties.
Liquidity and Capital Resources
Overview
We have a history of significant operating losses and have had negative cash flows from operations since our inception and expect to continue to generate operating losses for the foreseeable future. We have not yet commercialized any products, and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have funded our operations primarily with proceeds from the sale of equity securities and from licensing or selling the rights to our product candidates. As of September 30, 2025, we had cash, cash equivalents, and short-term investments of $332.6 million, and long-term investments and interest receivable of $142.9 million.
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Based on our current operational plans and assumptions, we expect that our current cash, cash equivalents, investments, and interest receivable, will be sufficient to fund operations through at least twelve months from the date of issuance of our consolidated financial statements. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We cannot guarantee that we will be able to raise additional capital on reasonable terms or at all.
In June 2025, we entered into the Genrix License Agreement with Genrix, pursuant to which Genrix granted us a global (excluding greater China), exclusive license to develop and commercialize velinotamig, a BCMAxCD3 bispecific T cell engager, in all fields of use. Under the terms of the Genrix License Agreement, we paid Genrix an upfront license fee of $20.0 million in June 2025. Refer to Note 5 of our notes to the consolidated financial statements in this Quarterly Report on Form 10-Q for additional detail regarding the Genrix License Agreement.
In April 2024, we completed the 2024 Private Placement, in which we issued approximately 14.4 million shares of our common stock and pre-funded warrants to purchase approximately 0.3 million additional shares of our common stock. We received net proceeds of $262.7 million from the 2024 Private Placement, after deducting offering costs of $17.3 million.
We have an at-the-market equity offering program (the "ATM") through an agreement with Cowen and Company, LLC (“Cowen”), pursuant to which we may offer and sell up to $125.0 million of our common stock from time to time through Cowen, acting as our sales agent. We made no sales under the ATM in the nine months ended September 30, 2025. Through September 30, 2025, we have sold approximately 3.3 million shares under the ATM and received net proceeds of $38.4 million, after deducting commissions. As of September 30, 2025, we had $85.6 million in shares of our common stock remaining under the ATM.
Comparison of Cash Flows for the Nine Months Ended September 30, 2025 and 2024
The following table summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024 (in thousands):
Nine Months Ended September 30,
2025
2024
Net cash used in operating activities
$
(137,641
)
$
(108,677
)
Net cash provided by (used in) investing activities
157,598
(152,278
)
Net cash provided by financing activities
373
264,606
Net increase in cash and cash equivalents
$
20,330
$
3,651
Cash Flow from Operating Activities
For the nine months ended September 30, 2025, our operating activities used $137.6 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $157.4 million, partially offset by interest income, excluding accretion on marketable securities, of $12.2 million, a $5.0 million net change in our non-tax operating assets and liabilities, and an income tax refund of $3.0 million related to the utilization of federal research and development credits generated during 2023 that were carried back to tax year 2022. The non-cash operating expenses primarily consisted of equity-based compensation expense.
For the nine months ended September 30, 2024, our operating activities used $108.7 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $113.5 million and a $7.5 million net change in our non-tax operating assets and liabilities, partially offset by interest income, excluding accretion on marketable securities, of $10.2 million, and a net income tax refund of $2.3 million. The non-cash operating expenses primarily consisted of equity-based compensation expense.
Cash Flow from Investing Activities
For the nine months ended September 30, 2025, our investing activities provided $157.6 million of cash, which consisted of $374.6 million of proceeds from the maturities of marketable securities, partially offset by $216.9 million of purchases of marketable securities.
For the nine months ended September 30, 2024, our investing activities used $152.3 million of cash, which primarily consisted of $553.1 million of purchases of marketable securities, partially offset by $400.8 million of proceeds from the maturities of marketable securities.
Cash Flow from Financing Activities
For the nine months ended September 30, 2025, our financing activities provided $0.3 million of cash, which consisted of net proceeds from the issuance of common stock under equity-based compensation plans.
For the nine months ended September 30, 2024, our financing activities provided $264.6 million of cash, which consisted of $262.7 million of net proceeds from the issuance of common stock under a private placement and $6.4 million in net proceeds from the issuance of common stock under equity-based compensation plans, partially offset by $4.4 million paid to acquire shares of our CLN-619 development subsidiary that were held by noncontrolling interests.
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Future Funding Requirements
We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we:
•
continue our research and development of our current and future product candidates and programs;
•
conduct preclinical studies and clinical trials for our current and future product candidates;
•
experience any delays or encounter any issues with any of the above, including but not limited to failed studies, or trials, complex results, safety issues, or other regulatory challenges;
•
develop the necessary processes, controls, and manufacturing capabilities to obtain marketing approval for our current and future product candidates and to support manufacturing on a commercial scale;
•
develop and implement plans to establish and operate in-house manufacturing operations and facilities, if deemed appropriate;
•
seek regulatory approvals for our current and future product candidates that successfully complete clinical trials;
•
hire and retain additional personnel, such as nonclinical, clinical, pharmacovigilance, quality assurance, regulatory affairs, manufacturing, distribution, legal, compliance, medical affairs, finance, general and administrative, commercial, and scientific personnel; and
•
develop, maintain, expand, and protect our intellectual property portfolio.
Based on our current operational plans and assumptions, we expect that our current cash, cash equivalents, investments, and interest receivable will be sufficient to fund operations through at least twelve months from the date of issuance of our consolidated financial statements. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. As we progress with our development programs and the regulatory review process, we expect to incur significant expenses related to product manufacturing, pre-commercial activities and commercialization. We may also require additional capital to pursue in-licenses or acquisitions of other programs to further expand our pipeline.
Because of the numerous risks and uncertainties associated with research, development and commercialization of our product candidates and programs, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
•
the scope, progress, results, and costs of drug discovery, laboratory testing, and preclinical and clinical development for our current and future product candidates;
•
timely completion of our preclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors;
•
the prevalence, duration, and severity of potential side effects or other safety issues experienced by patients receiving our current and future product candidates;
•
our ability to establish and maintain collaborations and license agreements on favorable terms, if at all, and the extent to which we acquire or in-license technologies or programs, if at all;
•
our ability to enroll clinical trials in a timely manner and to quickly resolve any delays or clinical holds that may be imposed on our development programs;
•
the costs of expanding our facilities to accommodate our expected growth in personnel;
•
our ability and the ability of third parties with whom we contract to manufacture adequate clinical and commercial supplies of our current and future product candidates, remain in good standing with regulatory authorities and develop, validate, and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices;
•
the costs of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property rights, and defending intellectual property-related claims;
•
the extent to which we acquire or in-license technologies or programs;
•
the sales price and availability of adequate third-party coverage and reimbursement for our product candidates, if and when approved; and
•
the ongoing costs of operating as a public company.
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Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through equity offerings, debt financings, government or other third-party funding, marketing and distribution arrangements, and other collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity, current ownership interests will be diluted. If we raise additional funds through government or third-party funding, collaboration agreements, strategic alliances, licensing arrangements, or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Other Commitments
We have certain payment obligations that are contingent upon future events under various license and collaboration agreements. Under these agreements, we will be required to make milestone payments upon successful completion and achievement of certain intellectual property, clinical, regulatory, and sales milestones, and we will be required to make royalty payments in connection with the sale of products developed under these agreements. As the achievement and timing of these future payment obligations are not probable or estimable, such amounts have not been included in our consolidated balance sheets as of September 30, 2025 and December 31, 2024.
As of September 30, 2025, total future minimum lease payments of $1.2 million were all payable within twelve months. See Note 10 to our consolidated financial statements included in this Quarterly Report on Form 10-Q for further detail on our lease obligations and the timing of expected future payments.
In addition, we enter into agreements in the normal course of business with CROs for clinical trials and with other vendors for preclinical studies, manufacturing services, and other services and products for operating purposes, which are generally cancelable upon written notice.
Critical Accounting Policies and Estimates
Our critical accounting policies have not materially changed from those described in the 2024 10-K.
Recently Issued and Adopted Accounting Pronouncements
A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 of our consolidated financial statements included in this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitati
ve Disclosures About Market Risk.
Information required by this Item is not applicable as we are electing scaled disclosure requirements available to smaller reporting companies with respect to this Item.
Item 4. Controls
and Procedures.
Evaluation of Disclosure Controls and Procedures
Based on an evaluation under the supervision and with the participation of our management, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (as amended, the "Exchange Act") were effective as of September 30, 2025 to provide reasonable assurance that information required to be disclosed by us in reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms and (ii) accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER
INFORMATION
Item 1. Legal
Proceedings.
From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Ris
k Factors.
In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 10-K"), which could materially affect our business, financial condition or future results. The risk factors disclosure in our 2024 10-K is qualified by the information that is described in this Quarterly Report on Form 10-Q. The risks described in our 2024 10-K are not our only risks. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial also may materially adversely affect our business, financial condition or future results. There have been no material changes to our risk factors as previously disclosed in the 2024 10-K except as follows:
Commencing on December 31, 2025, we will be a smaller reporting company due to our qualification at June 30, 2025. We cannot be certain if the reduced reporting requirements applicable to smaller reporting companies could make our common stock less attractive to investors.
As of January 1, 2025, we were a large accelerated filer and were subject to all of the related compliance or disclosure requirements applicable to a large accelerated filer. Based on the market value of our common stock that was held by non-affiliates as of June 30, 2025 and our annual revenues for the fiscal year ended December 31, 2024, we will be a smaller reporting company effective December 31, 2025 and are able to immediately avail ourselves of the reduced disclosure requirements permitted for smaller reporting companies. As a smaller reporting company, we will be permitted and intend to rely on exemptions from certain compliance and disclosure requirements that are applicable to other public companies that are not smaller reporting companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We may take advantage of scaled disclosures available to smaller reporting companies until the fiscal year following the determination that either (i) the market value of our voting and non-voting common stock held by non-affiliates is greater than $700 million, as measured on the last business day of the most recently completed second fiscal quarter, or (ii) the market value of our voting and non-voting common stock held by non-affiliates, as measured on the last business day of our most recently completed second fiscal quarter, is less than $700 million but greater than $250 million and our annual revenues during our most recently completed fiscal year are greater than $100 million. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
Difficulty in enrolling patients has delayed, and in the future could delay or prevent, clinical trials of our product candidates and ultimately delay or prevent regulatory approval.
Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of completion of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates, and we have experienced delays in the past and may experience delays in the future in our clinical trials if we encounter difficulties in enrollment. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll enough eligible patients to participate in these clinical trials as required by the FDA or similar regulatory authorities outside the U.S., or as needed to provide appropriate statistical power for a given clinical trial. For example, in early phase autoimmune disease development, identification of patients with appropriate disease severity and/or willingness to accept the potential risks associated with a novel approach to treating their disease could impair enrollment.
In addition to the potentially small populations, the eligibility criteria of our planned clinical trials for some of our product candidates will further limit the pool of available clinical trial participants as we require that patients have specific characteristics, such as a certain severity or stage of disease progression, to include them in a clinical trial. For example, in the ongoing Phase 1 clinical trial for CLN-978 in patients with moderate to severe SLE in the U.S., we experienced more screening failures than anticipated due to our initial eligibility criteria, leading to a delay in enrollment in the clinical trial.
Additionally, the process of finding eligible patients may prove costly. We also may not be able to identify, recruit, and enroll a sufficient number of patients to complete our clinical studies because of the perceived risks and benefits of the product candidate under clinical trial, the availability and efficacy of competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective patients, the availability of patients with appropriate disease severity and extent of prior therapy in autoimmune disease indications, the availability of genetic sequencing information for patient tumors so that we can identify patients with the targeted genetic mutations for our oncology studies, and the patient referral practices of physicians. If patients are unwilling to participate in our studies for any reason, the timeline for recruiting patients, conducting studies, and obtaining regulatory approval of potential products may be delayed.
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The enrollment of patients further depends on many factors, including:
•
the proximity of patients to clinical trial sites;
•
the design of the clinical trial;
•
our ability to recruit clinical trial investigators with the appropriate competencies and experience;
•
our ability to obtain and maintain patient consents;
•
our ability to enroll a diverse patient base in our clinical trials to meet FDA recommended guidance;
•
reporting of the preliminary results of any of our clinical trials;
•
availability of investigational medicinal product(s);
•
the risk that patients enrolled in clinical trials will drop out of the clinical trials before clinical trial completion; and
•
factors we may not be able to control, such as future pandemics that may limit patients, principal investigators or staff or clinical site availability.
In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us because some patients who might have opted to enroll in our clinical trials may instead opt to enroll in a clinical trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites. Moreover, because certain of our product candidates represent a departure from more commonly used methods for autoimmune diseases or cancer treatment and because certain of our product candidates have not been tested in humans before, potential patients and their doctors may be inclined to use conventional therapies, such as conventional immune suppressing medications in autoimmune diseases or chemotherapy in oncology, rather than enroll patients in any future clinical trial of our product candidates.
If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenue from any of these product candidates could be delayed or prevented.
Item 2. Unregistered Sales of Equit
y Securities and Use of Proceeds.
Not applicable.
Item 3.
Defaults Upon Senior Securities
.
Not applicable.
Item 4.
Mine Safety Disclosures
.
Not applicable.
Item 5.
Other Information
.
Rule 10b5-1 Trading Plans
During the fiscal quarter ended September 30, 2025, an officer (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified, or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408(a) of Regulation S-K. The trading plan is intended to satisfy the affirmative defense in Rule 10b5-1(c). The material terms of such trading arrangement are described below.
Jennifer Michaelson, Ph.D., Chief Scientific Officer
On
August 7, 2025
,
Jennifer Michaelson, Ph.D
., our
Chief Scientific Officer
, entered into a Rule
10b5-1
trading arrangement that provides that Dr. Michaelson, acting through a broker, may sell up to an aggregate of
83,606
shares of our common stock.
Sales of shares under the trading arrangement will not begin until the applicable Rule 10b5-1 “cooling-off” period has expired and are scheduled to end by
May 1, 2027
,
subject to earlier termination upon the sale of all shares subject to the plan, upon termination by Dr. Michaelson or the broker, or as otherwise provided in the arrangement.
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH
Inline XBRL Taxonomy Extension Schema Document With Embedded Linkbase Documents.
104
Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101).
* Filed herewith.
** Furnished herewith.
24
SIGNAT
URES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
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