Source: sec
Source ID: 0001193125-26-346884
URL: https://www.sec.gov/Archives/edgar/data/1422143/000119312526346884/kura-20260630.htm
Symbol: (KURA)
Published: 2026-08-12 16:15:38 EDT
Time precision: minute
Title: 10-Q 10-Q

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
10-Q
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
June 30,
2026
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:
001-37620
KURA ONCOLOGY, INC.
(Exact name of registrant as specified in its charter)
Delaware
61-1547851
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
4930 Directors Place
,
Suite 500
,
San Diego
,
CA
92121
(Address of principal executive offices)
(Zip Code)
(
858
)
500-8800
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
KURA
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
☒
As of the close of business on August 7, 2026, the registrant
had
88,960,619
s
hares of Common Stock, $0.0001 par value, outstanding.
KURA ONCOLOGY, INC.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Condensed Financial Statements (unaudited)
Condensed Balance Sheets − As of June 30, 2026 (unaudited) and December 31, 2025
1
Condensed Statements of Operations and Comprehensive Loss – Three and Six Months Ended June 30, 2026 and 2025 (unaudited)
2
Condensed Statements of Stockholders’ Equity – Three and Six Months Ended June 30, 2026 and 2025 (unaudited)
3
Condensed Statements of Cash Flows – Six Months Ended June 30, 2026 and 2025 (unaudited)
5
Notes to Condensed Financial Statements (unaudited)
6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
14
Item 3. Quantitative and Qualitative Disclosures about Market Risk
27
Item 4. Controls and Procedures
27
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
28
Item 1A. Risk Factors
28
Item 5. Other Information
77
Item 6. Exhibits
78
Signatures
PART I. FINAN
CIAL INFORMATION
I
TEM 1. FINANCIAL STATEMENTS
KURA ONCOLOGY, INC.
Condensed Bal
ance Sheets
(In thousands, except par value data)
June 30,
2026
December 31,
2025
(Unaudited)
Assets
Current assets
Cash and cash equivalents
$
70,242
$
149,099
Short-term investments
448,783
518,141
Accounts receivable, net
9,446
8,804
Inventory
2,485
413
Prepaid expenses and other current assets
28,483
32,206
Total current assets
559,439
708,663
Property and equipment, net
7,586
7,855
Operating lease right-of-use assets
7,038
7,302
Other long-term assets
13,728
14,543
Total assets
$
587,791
$
738,363
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable
$
2,392
$
5,017
Accrued expenses and other current liabilities
54,812
61,697
Current operating lease liabilities
1,291
1,277
Current portion of long-term debt
4,217
—
Current portion of contract liabilities
55,481
48,983
Total current liabilities
118,193
116,974
Long-term debt, net of current portion
5,573
9,711
Long-term operating lease liabilities
13,374
9,469
Other long-term liabilities
3,616
3,165
Long-term contract liabilities
398,604
424,909
Total liabilities
539,360
564,228
Stockholders’ equity
Preferred stock, $
0.0001
par value;
10,000
shares authorized;
no
shares issued and outstanding
—
—
Common stock, $
0.0001
par value;
200,000
shares authorized;
88,954
and
87,855
shares issued and outstanding as of
June 30, 2026 and December 31, 2025, respectively
9
9
Additional paid-in capital
1,365,383
1,347,190
Accumulated other comprehensive income (loss)
(
1,213
)
1,024
Accumulated deficit
(
1,315,748
)
(
1,174,088
)
Total stockholders’ equity
48,431
174,135
Total liabilities and stockholders’ equity
$
587,791
$
738,363
See accompanying notes to unaudited condensed financial statements.
1
KURA ONCOLOGY, INC.
Condensed Statements of Opera
tions and Comprehensive Loss
(In thousands, except per share data)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Revenue
Product revenue, net
$
9,122
$
—
$
14,888
$
—
Collaboration revenue
11,752
15,288
24,251
29,396
Total revenue
20,874
15,288
39,139
29,396
Operating Expenses
Cost of product sales
243
—
505
—
Research and development
61,891
62,785
127,154
118,758
Selling, general and administrative
31,750
25,169
63,305
48,004
Total operating expenses
93,884
87,954
190,964
166,762
Loss from operations
(
73,010
)
(
72,666
)
(
151,825
)
(
137,366
)
Other Income (Expense)
Interest and other income, net
5,033
6,935
10,859
14,814
Interest expense
(
345
)
(
391
)
(
681
)
(
773
)
Total other income, net
4,688
6,544
10,178
14,041
Loss before income taxes
(
68,322
)
(
66,122
)
(
141,647
)
(
123,325
)
Income tax expense
5
—
13
226
Net Loss
$
(
68,327
)
$
(
66,122
)
$
(
141,660
)
$
(
123,551
)
Net loss per share, basic and diluted
$
(
0.77
)
$
(
0.75
)
$
(
1.60
)
$
(
1.41
)
Weighted average number of shares used in computing net loss per share, basic and diluted
88,855
87,586
88,733
87,501
Comprehensive Loss
Net loss
$
(
68,327
)
$
(
66,122
)
$
(
141,660
)
$
(
123,551
)
Other comprehensive loss
Unrealized loss on short-term investments
(
833
)
(
263
)
(
2,237
)
(
53
)
Comprehensive loss
$
(
69,160
)
$
(
66,385
)
$
(
143,897
)
$
(
123,604
)
See accompanying notes to unaudited condensed financial statements.
2
KURA ONCOLOGY, INC.
Condensed Statements of Stockholders’ Equity
(In thousands)
(Unaudited)
Accumulated
Additional
Other
Total
Common Stock
Paid-In
Comprehensive
Accumulated
Stockholders’
Shares
Par Value
Capital
Income (Loss)
Deficit
Equity
Balance as of December 31, 2025
87,855
$
9
$
1,347,190
$
1,024
$
(
1,174,088
)
$
174,135
Share-based compensation expense
—
—
8,416
—
—
8,416
Issuance of common stock under equity plans
470
—
69
—
—
69
Exercise of pre-funded warrants
417
—
—
—
—
—
Exercise of warrants
21
—
—
—
—
—
Other comprehensive loss
—
—
—
(
1,404
)
—
(
1,404
)
Net loss
—
—
—
—
(
73,333
)
(
73,333
)
Balance as of March 31, 2026
88,763
9
1,355,675
(
380
)
(
1,247,421
)
107,883
Share-based compensation expense
—
—
8,209
—
—
8,209
Issuance of common stock under equity plans
191
—
1,499
—
—
1,499
Other comprehensive loss
—
—
—
(
833
)
—
(
833
)
Net loss
—
—
—
—
(
68,327
)
(
68,327
)
Balance as of June 30, 2026
88,954
$
9
$
1,365,383
$
(
1,213
)
$
(
1,315,748
)
$
48,431
See accompanying notes to unaudited condensed financial statements.
3
KURA ONCOLOGY, INC.
Condensed Statements of Stockholders’ Equity
(In thousands)
(Unaudited)
Accumulated
Additional
Other
Total
Common Stock
Paid-In
Comprehensive
Accumulated
Stockholders’
Shares
Par Value
Capital
Income (Loss)
Deficit
Equity
Balance as of December 31, 2024
78,229
$
8
$
1,308,290
$
764
$
(
895,422
)
$
413,640
Share-based compensation expense
—
—
7,842
—
—
7,842
Issuance of common stock under equity plans
375
—
143
—
—
143
Exercise of pre-funded warrants
2,174
—
—
—
—
—
Other comprehensive income
—
—
—
210
—
210
Net loss
—
—
—
—
(
57,429
)
(
57,429
)
Balance as of March 31, 2025
80,778
8
1,316,275
974
(
952,851
)
364,406
Share-based compensation expense
—
—
6,949
—
—
6,949
Issuance of common stock under equity plans
101
—
515
—
—
515
Exercise of pre-funded warrants
5,918
1
—
—
—
1
Other comprehensive loss
—
—
—
(
263
)
—
(
263
)
Net loss
—
—
—
—
(
66,122
)
(
66,122
)
Balance as of June 30, 2025
86,797
$
9
$
1,323,739
$
711
$
(
1,018,973
)
$
305,486
See accompanying notes to unaudited condensed financial statements.
4
KURA ONCOLOGY, INC.
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
Six Months Ended
June 30,
2026
2025
Operating Activities
Net loss
$
(
141,660
)
$
(
123,551
)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation expense
16,625
14,791
Amortization of premium and accretion of discounts on
short-term investments, net
(
1,641
)
(
5,182
)
Depreciation expense
724
465
Non-cash interest expense
217
271
Changes in operating assets and liabilities
Accounts receivable, net
(
642
)
(
2,514
)
Inventory
(
2,072
)
—
Prepaid expenses and other current assets
3,777
(
8,551
)
Operating lease right-of-use and other long-term assets
1,025
(
2,922
)
Accounts payable
(
2,624
)
235
Accrued expenses and other current liabilities
(
6,557
)
1,798
Operating lease liabilities
3,919
65
Other long-term liabilities
313
628
Contract liabilities
(
19,807
)
23,763
Net cash used in operating activities
(
148,403
)
(
100,704
)
Investing Activities
Maturities of short-term investments
259,998
342,596
Purchases of short-term investments
(
191,236
)
(
383,314
)
Purchases of property and equipment
(
784
)
(
1,750
)
Net cash provided by (used in) investing activities
67,978
(
42,468
)
Financing Activities
Proceeds from issuance of stock under equity plans
1,568
658
Net cash provided by financing activities
1,568
658
Net decrease in cash and cash equivalents
(
78,857
)
(
142,514
)
Cash and cash equivalents at beginning of period
149,099
224,462
Cash and cash equivalents at end of period
$
70,242
$
81,948
See accompanying notes to unaudited condensed financial statements.
5
KURA ONCOLOGY, INC.
Notes to Unaudited Condensed Financ
ial Statements
1. Organization and Basis of Presentation
Kura Oncology, Inc. is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Our diversified pipeline consists of small molecules designed to target cancer signaling pathways and address significant unmet needs in oncology and hematology.
References in these Notes to Unaudited Condensed Financial Statements to the “Company,” “we,” “our” or “us,” refer to Kura Oncology, Inc.
Basis of Presentation
The accompanying unaudited condensed financial statements should be read in conjunction with the audited financial statements and notes thereto in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 5, 2026, from which we derived our balance sheet as of December 31, 2025. The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited condensed financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year.
The preparation of the unaudited condensed financial statements in accordance with GAAP requires our management to make estimates and assumptions that affect the amounts reported on our unaudited condensed financial statements and accompanying notes. The amounts reported could differ under different estimates and assumptions. On an ongoing basis, we evaluate our estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates.
2. Summary of Significant Accounting Policies
Allowance for Credit Losses
For available-for-sale securities in an unrealized loss position, we first assess whether we intend to sell, or if it is more likely than not that we will be required to sell, the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through earnings. For available-for-sale securities that do not meet the aforementioned criteria, we evaluate whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, we consider the severity of the impairment, any changes in interest rates, market conditions, changes to the underlying credit ratings and forecasted recovery, among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in interest and other income, net on the unaudited condensed statements of operations and comprehensive loss through an allowance account. Any impairment that has not been recorded through an allowance for credit losses is included in other comprehensive income (loss) on the unaudited condensed statements of operations and comprehensive loss.
We elected the practical expedient to exclude the applicable accrued interest from both the fair value and amortized cost basis of our available-for-sale securities for purposes of identifying and measuring an impairment. Accrued interest receivable on available-for-sale securities is recorded in prepaid expenses and other current assets on our unaudited condensed balance sheets. Our accounting policy is to not measure an allowance for credit loss for accrued interest receivable and to write-off any uncollectible accrued interest receivable as a reversal of interest income in a timely manner, which we consider to be in the period in which we determine the accrued interest will not be collected by us.
6
Concentration of Credit Risk
Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. We maintain deposits in federally insured financial institutions in excess of federally insured limits. We have established guidelines to limit our exposure to credit risk by placing investments with high credit quality financial institutions, diversifying our investment portfolio and placing investments with maturities that maintain safety and liquidity. We periodically review and modify these guidelines to maximize trends in yields and interest rates without compromising safety and liquidity.
Our receivable from contracts with collaborators, included within accounts receivable, net, is derived from contracts with our collaborators. We do not typically require collateral from our collaborators. We continuously monitor payments from collaborators and consider various factors including historical experience, age of the receivable balances, and other current economic conditions or other factors that may affect our collaborators’ ability to pay.
Collaboration Arrangements
We assess whether our licensing and other agreements are collaborative arrangements within the scope of Accounting Standards Codification, or ASC, Topic 808, Collaborative Arrangements, or Topic 808, based on whether they involve joint operating activities wherein both parties actively participate in the arrangement and are exposed to significant risks and rewards of the arrangement. For arrangements that we determine are collaborations under the Scope of Topic 808, we identify each unit of account by determining which promised goods or services are distinct in accordance with ASC Topic 606, Revenue from Contracts with Customers, or Topic 606, and then determine whether a customer relationship exists for that unit of account. If we determine a unit of account within the collaborative arrangement to be with a customer, we apply our revenue recognition accounting policy as further described below. For units of account within the collaborative arrangement under Topic 808 that are not with a customer in its entirety and are not within the scope of other relevant accounting topics, we apply recognition and measurement principles based on an analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational and consistently applied accounting policy election. See Note 7, Kyowa Kirin Collaboration and License Agreement, for more details.
Net Loss per Share
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, which includes the shares related to outstanding pre-funded warrants, but excludes other potential common stock equivalents. Pre-funded warrants are considered outstanding for the purposes of computing basic and diluted net loss per share because shares may be issued for little additional consideration, and are fully vested and exercisable. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period. As we have reported net loss for the three months ended June 30, 2026 and 2025, dilutive net loss per common share is the same as basic net loss per common share for those periods. Common stock equivalents outstanding are comprised of stock options, restricted stock units, or RSUs, performance-based restricted stock units, or PSUs, warrants and employee stock purchase plan rights and are only included in the calculation of diluted earnings per common share when net income is reported and their effect is dilutive. Common stock equivalents outstanding at June 30, 2026 and 2025
totaling approximately
21,667,000
and
18,213,000
, respectively, were excluded from the computation of dilutive weighted-average shares outstanding because their effect would be anti-dilutive.
Recent Accounting Pronouncements
Disaggregation of Income Statement Expenses
In November 2024, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2024-03 Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disaggregated disclosure of certain costs and expenses on an interim and annual basis. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The disclosure updates are required to be applied prospectively with the option for retrospective application. We are currently evaluating the impact of adopting ASU 2024-03.
Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40)
In September 2025, the FASB issued ASU 2025-06, Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. Under this guidance, software capitalization
7
will begin when management authorizes and commits to funding the software project and it is probable that the project will be completed and the software will be used for its intended purpose. ASU 2025-06 is effective for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those periods, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2025-06
.
3. Investments
We invest in available-for-sale securities consisting of U.S. Treasury securities, U.S. Agency bonds and money market funds. Available-for-sale securities are classified as either cash and cash equivalents or short-term investments on the unaudited condensed balance sheets.
The following tables summarize, by major security type, our short-term investments that are measured at fair value on a recurring basis, in thousands:
June 30, 2026
Maturities
(years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
Cash equivalents
Money market funds
1
or less
$
15,595
$
—
$
—
$
15,595
Short-term investments
U.S. Treasury securities
2
or less
400,000
102
(
976
)
399,126
U.S. Agency bonds
3
or less
49,996
—
(
339
)
49,657
Total short-term investments
449,996
102
(
1,315
)
448,783
Total
$
465,591
$
102
$
(
1,315
)
$
464,378
December 31, 2025
Maturities
(years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
Cash equivalents
Money market funds
1
or less
$
119,910
$
—
$
—
$
119,910
Short-term investments
U.S. Treasury securities
2
or less
464,623
1,042
—
465,665
U.S. Agency bonds
3
or less
52,494
11
(
29
)
52,476
Total short-term investments
517,117
1,053
(
29
)
518,141
Total
$
637,027
$
1,053
$
(
29
)
$
638,051
Short-term investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund our operations, as necessary.
As of
June 30, 2026 and December 31, 2025
, short-term investments of $
306.9
million and $
367.2
million, respectively, had maturities less than one year, short-term investments of $
124.5
million and $
135.9
million, respectively, had maturities between one to two years, and short-term investments of $
17.4
million and $
15.0
million, respectively, had maturities between two to three years.
Realized gains and losses were de minimis
for the three and six months ended June 30, 2026 and 2025.
As of June 30, 2026 and December 31, 2025,
55
av
ailable-for-sale securities with a fair market value of
$
406.3
million and
six
available-for-sale securities with a fair market value of $
22.5
million, respectively, were
in a gross unrealized loss po
sition.
None
of such securities were in a continuous unrealized loss position for greater than 12 months
. We do not intend to sell such available-for-sale securities, and it is not more likely than not that we will be required to sell such securities prior to recovery of their amortized cost basis.
Based on our review of these available-for-sale securities, the unrealized losses at June 30, 2026 were primarily due to changes in interest rates and not due to increased credit risks associated with specific securities. As such w
e have
no
allowance for credit losses as of
June 30, 2026 and December 31, 2025.
Unrealized gains and losses that are not credit-related are included in accumulated other comprehensive income (loss).
8
Accrued interest receivable on available-for-sale securities
was $
3.6
million and $
3.8
million as of
June 30, 2026 and December 31, 2025, respectively. We have not written off any accrued interest
receivables for the six months ended June 30, 2026 and 2025
.
4. Fair Value Measurements
As of June 30, 2026 and December 31, 2025, we had cash equivalents and short-term investments measured at fair value on a recurring basis.
Available-for-sale securities consist of U.S. Treasury securities and money market funds, which are measured at fair value using Level 1 inputs, and U.S. Agency bonds which are measured at fair value using Level 2 inputs. We determine the fair value of Level 2 related securities with the aid of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or prices for similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. We validate the fair values of Level 2 financial instruments by comparing these fair values to a third-party pricing source. We did not reclassify any investments between levels in the fair value hierarchy during the periods presented.
The following tables summarize, by major security type, our cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy, in thousands:
June 30, 2026
Total
Level 1
Level 2
Level 3
Cash equivalents
Money market funds
$
15,595
$
15,595
$
—
$
—
Short-term investments
U.S. Treasury securities
399,126
399,126
—
—
U.S. Agency bonds
49,657
—
49,657
—
Total short-term investments
448,783
399,126
49,657
—
Total
$
464,378
$
414,721
$
49,657
$
—
December 31, 2025
Total
Level 1
Level 2
Level 3
Cash equivalents
Money market funds
$
119,910
$
119,910
$
—
$
—
Short-term investments
U.S. Treasury securities
465,665
465,665
—
—
U.S. Agency bonds
52,476
—
52,476
—
Total short-term investments
518,141
465,665
52,476
—
Total
$
638,051
$
585,575
$
52,476
$
—
We believe that our term loan facility bears interest at a rate that approximates prevailing market rates for instruments with similar characteristics and, accordingly, the carrying value of the term loan facility approximates fair value. The fair value of our term loan facility is determined using Level 2 inputs in the fair value hierarchy.
9
5. Balance Sheet Detail
Property and equipment consisted of the following, in thousands:
June 30, 2026
December 31, 2025
Leasehold improvements
$
7,294
$
6,919
Furniture and fixtures
1,959
1,878
Laboratory and computer equipment
1,943
1,958
Property and equipment, gross
11,196
10,755
Less: accumulated depreciation
(
3,610
)
(
2,900
)
Property and equipment, net
$
7,586
$
7,855
Accrued expenses and other current liabilities consisted of the following, in thousands:
June 30, 2026
December 31, 2025
Product revenue allowances
$
2,170
$
377
Accrued clinical trial research and development expenses
20,086
23,276
Accrued other research and development expenses
14,655
12,041
Accrued compensation and benefits
14,344
22,372
Other accrued expenses
3,498
3,392
Income taxes payable
59
239
Total accrued expenses and other current liabilities
$
54,812
$
61,697
6. Leases
We currently have
two
operating leases for administrative and research and development office and lab space in San Diego, California and Boston, Massachusetts that expire between July 2031 and May 2033.
Under the terms of the operating leases, as each may be amended from time to time, we are required to pay our proportionate share of property taxes, insurance and normal maintenance costs. Both of our leases include renewal options for an additional
five years
, which were not included in the determination of the right-of-use, or ROU, asset or lease liability as the renewal was not reasonably certain at the inception of the lease. Our Boston lease provided for $
1.4
million in reimbursements for allowable tenant improvements and rent credits, which effectively reduced the total lease payments owed. Our San Diego research and development, lab, and principal executive office space lease entered into in January 2025 and amended in June 2025 provides (i) $
2.4
million in rent credits, and (ii) a $
6.2
million tenant improvement allowance expected to be fully received in the second half of 2026. The leases are also subject to additional variable charges for common area maintenance, property taxes, property insurance and other variable costs. Variable charges were not included in the measurement of our operating lease ROU assets.
Maturities of lease liabilities as of
June 30, 2026 are as follows, in thousands:
Year Ending December 31,
2026 (remaining)
$
867
2027
3,658
2028
3,755
2029
3,853
2030
3,954
Thereafter
7,214
Total lease payments
23,301
Less: imputed interest
(
7,426
)
Less: tenant improvement allowance reimbursements yet to be received
(
1,210
)
Total operating lease liabilities
$
14,665
As of June 30, 2026 and December 31, 2025, the weighted-average discoun
t rate was
12.3
% in both periods
, and the weighted-average remaining lease ter
m was
6.2
years and
6.4
years, respectively.
10
Total cash paid for amounts included in the measurement of operating lease liabilities, net of tenant improvement reimbursements, for the three months ended June 30, 2026 and 2025 were $
0.3
million and $
0.4
million, respectively. Tenant improvement reimbursements, net of cash paid for amounts included in the measurement of operating lease liabilities, was $
3.0
million for the six months ended June 30, 2026. Total cash paid for amounts included in the measurement of operating lease liabilities, net of tenant improvement reimbursements, was $
0.9
million for the six months ended June 30, 2025. For the six months ended June 30, 2026, there were
no
operating lease ROU assets obtained in exchange for operating lease liabilities compared to $
2.7
million for the
six months ended June 30, 2025.
Total operating lease and rent expense for the three months ended June 30, 2026 and 2025 were approximately $
0.6
million and $
0.8
million, respectively. Total operating lease and rent expense for the six months ended June 30, 2026 and 2025 were approximately $
1.2
million and $
1.6
million, respectively.
7. Kyowa Kirin Collaboration and License Agreement
On November 20, 2024, we and Kyowa Kirin Co., Ltd. and Kyowa Kirin, Inc., or together Kyowa Kirin, entered into a collaboration and license agreement, or the Kyowa License Agreement, to develop and commercialize ziftomenib globally. In addition, we are responsible for the global manufacture and supply of ziftomenib pursuant to a clinical supply agreement with Kyowa Kirin Co., Ltd., or Kyowa Supply Agreement. The Kyowa Supply Agreement was determined to be a separate contract from the Kyowa License Agreement for purposes of revenue recognition and reporting.
On June 27, 2025, we entered into a co-promotion and medical affairs agreement with Kyowa Kirin, Inc., which was determined to be a separate contract from the Kyowa License Agreement for purposes of revenue recognition and reporting.
The Kyowa License Agreement includes performance obligations for monotherapy development services, combination therapy development services, and commercialization services. We have the right and responsibility to lead all development, manufacturing, and commercialization activities for ziftomenib in the United States. We are responsible for funding the specified development activities set forth in the initial development plan and budget mutually agreed upon with Kyowa Kirin, or Development Plan, and we and Kyowa Kirin share equally (50/50) all other development costs in the United States. The parties share equally profits or losses from the commercialization of ziftomenib in the United States.
Through the Kyowa License Agreement, we granted Kyowa Kirin an exclusive license to develop, manufacture and commercialize ziftomenib outside of the United States, or ROW License, within the field of acute myeloid leukemia, or AML, and other hematologic malignancies.
As of June 30, 2026, we have received or expected to receive $
597.1
million under the Kyowa License Agreement, consisting of $
570.0
million in upfront and milestone payments and $
27.1
million in profit and loss and expense sharing. We are eligible to receive an additional $
693.0
million in development, regulatory, and commercial milestone payments for the existing field (i.e., AML and other hematologic malignancies) and, if Kyowa Kirin exercises its option to expand the ROW License, an additional $
228.0
million in upfront payments and development, regulatory, and commercial milestone payments for the expanded field (i.e., gastrointestinal stromal tumors and other solid tumor indications), totaling up to $
1.491
billion in upfront and milestone payments in the aggregate. We are also eligible to receive tiered double-digit royalties on sales of ziftomenib outside of the United States.
The Kyowa License Agreement will remain in effect in the United States until the latest of expiration of all valid claims of our patent rights, expiration of the last-to-expire regulatory exclusivity or ten years after first commercial sale. The Kyowa License Agreement will remain in effect outside of the United States until the expiration of the last-to-expire royalty term. Either party may terminate the Kyowa License Agreement for uncured material breach by or insolvency of the other party. Kyowa Kirin may terminate the Kyowa License Agreement for convenience upon twelve months’ prior written notice.
Based on our analysis of the key terms and activities required by the Kyowa License Agreement, we assessed the criteria under Topic 808 and concluded that both parties participate in a joint operating activity, are active participants, and are exposed to significant risks and rewards dependent on the commercial success of the activities. Therefore, the Kyowa License Agreement is within the scope of Topic 808.
11
We evaluated each of the promised goods and services and determined the Kyowa License Agreement contains multiple units of account, comprised of the ROW License, development services related to monotherapy, development services related to combination therapies and commercialization services. The ROW License is a unit of account under the scope of Topic 606, while the development services and commercialization services are under the scope of Topic 808. We determined that Topic 606 is the most appropriate accounting model to apply by analogy to the recognition and measurement of these units of account.
As of June 30, 2026, the transaction price of $
597.1
million includes fixed consideration and variable consideration to the extent that it is probable that a significant reversal of revenue recognized will not occur. The transaction price excludes variable consideration when uncertainties related to development, regulatory and commercial outcomes exist.
We allocated the transaction price to each performance obligation based on their relative stand-alone selling price. Transaction price allocated to the ROW License is recognized in collaboration revenue at a point in time as the performance obligation was completed upon transfer of the license. Transaction price allocated to development services for monotherapy and combination therapies is recognized in collaboration revenue over time using a cost-to-cost measure of progress.
For the three and six months ended June 30, 2026, we recognized $
6.2
million and $
13.4
million, respectively, of revenue from development services for monotherapy, and $
5.6
million and $
10.9
million, respectively, of revenue from development services in combination with other therapies. Collaboration revenue recognized for the three and six months ended June 30, 2026 was included in contract liabilities as of December 31, 2025.
As of June 30, 2026, the total contract liability was $
454.1
million, of which $
55.5
million was classified as current, and $
398.6
million was classified as long-term. As of June 30, 2026, the remaining unrecognized consideration allocated to the development services for monotherapy was $
20.9
million and to the development services in combination with other therapies was $
156.4
million. As of June 30, 2026, $
276.8
million of consideration allocated to commercialization services and profit and loss and expense sharing received or expected to be received was constrained and included in contract liabilities, of which $
8.7
million was classified as current, and $
268.1
million was classified as long-term.
8. Stockholders’ Equity
In November 2023, we entered into a Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $
150.0
million. We have not sold any shares of our common stock under the ATM Facility.
In November 2022, we entered into a loan and security agreement with several banks and other financial institutions or entities party thereto, or collectively the Lenders, and Hercules Capital, Inc., in its capacity as administrative agent and collateral agent for itself and the Lenders, which was amended in October 2023 and October 2025, or the Loan Agreement. In connection with the Loan Agreement, we issued warrants to certain of the Lenders to purchase up to
26,078
shares of our common stock at an exercise price of $
14.38
per share, which remained outstanding as of June 30, 2026.
9. Share-Based Compensation
The following table summarizes share-based compensation expense for all share-based compensation arrangements, in thousands:
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Research and development
$
3,238
$
2,714
$
6,453
$
6,041
Selling, general and administrative
4,971
4,235
10,172
8,750
Total share-based compensation expense
$
8,209
$
6,949
$
16,625
$
14,791
12
As of June 30, 2026, unrecognized estimated compensation expense related to stock options, RSUs and PSUs was approximate
ly $
48.7
million, $
19.5
million, and $
0.5
million, resp
ectively, which is expected to be recognized over a weighted average period of approxim
ately
2.7
years,
2.9
years, and
0.3
years
, respectively. As of June 30, 2026,
the vesting of PSUs covering
436,667
shares of common stock were determined to not be probable and have not been included in share-based compensation expense or unrecognized estimated compensation expense.
10. Segment Reporting
We operate in a
single
industry segment which is the discovery, development and commercialization of precision medicines for the treatment of cancer. Troy E. Wilson, Ph.D., J.D., our
president and chief executive officer
, who serves as the Chief Operating Decision-Maker, or CODM, reviews the operating results on an aggregate basis and manages the operations as a
single
operating segment in the United States. When
evaluating our financial performance, the CODM regularly reviews total revenues, total expenses, and research and development expenses by program and the CODM makes decisions using this information.
The table below is a summary of the segment profit or loss, including significant expenses, in thousands:
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Revenue
Product revenue, net
$
9,122
$
—
$
14,888
$
—
Collaboration revenue
11,752
15,288
24,251
29,396
Total revenue
20,874
15,288
39,139
29,396
Less:
Cost of product sales
243
—
505
—
Ziftomenib-related costs
34,938
37,584
71,818
67,531
Darlifarnib-related costs
5,985
6,141
12,553
11,376
Discovery stage program-related costs
1,901
1,490
3,301
3,579
Research and development personnel costs and other expenses
15,829
14,856
33,029
30,231
Share-based compensation expense
8,209
6,949
16,625
14,791
Other segment expenses
(1)
26,779
20,934
53,133
39,254
Total operating expenses
93,884
87,954
190,964
166,762
Other income (expenses)
Interest and other income, net
5,033
6,935
10,859
14,814
Interest expense
(
345
)
(
391
)
(
681
)
(
773
)
Income tax expense
(
5
)
—
(
13
)
(
226
)
Segment and net loss
$
(
68,327
)
$
(
66,122
)
$
(
141,660
)
$
(
123,551
)
(1)
Other segment expenses are comprised of selling, general and administrative expenses, excluding share-based compensation expense, which is shown separately.
13
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes included in this Quarterly Report on Form 10-Q, or Quarterly Report, and the audited financial statements and notes thereto as of and for the fiscal year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission, or SEC, on March 5, 2026.
This Quarterly Report includes forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections, that involve a number of risks, uncertainties and assumptions. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “seek,” “estimate,” “predict,” “potential,” “continue,” “likely,” or “opportunity,” the negative of these words or other similar words. Similarly, statements that describe our plans, strategies, intentions, expectations, objectives, goals or prospects and other statements that are not historical facts are also forward-looking statements. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Readers of this Quarterly Report are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the time this Quarterly Report was filed with the SEC. These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, without limitation, the risk factors identified in our SEC reports, including this Quarterly Report. In addition, past financial or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Except as required by law, we undertake no obligation to update publicly or revise our forward-looking statements.
References to “we,” “us” and “our” refer to Kura Oncology, Inc.
Overview
We are a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Since our founding in 2014, we have transformed from a research and development company to a fully-integrated commercial-stage organization with a diversified pipeline of product candidates. Our pipeline consists of small molecules designed to target cancer signaling pathways and address significant unmet needs in oncology and hematology.
Our Product and Pipeline
KOMZIFTI
®
(ziftomenib)
On November 13, 2025, the U.S. Food and Drug Administration, or FDA, approved our new drug application, or NDA, for ziftomenib, which is being marketed in the United States under the trade name KOMZIFTI, for the treatment of adults with relapsed or refractory acute myeloid leukemia, or AML, with a susceptible nucleophosmin 1, or NPM1, mutation who have no satisfactory alternative treatment options. KOMZIFTI is the first and only menin inhibitor approved by the FDA for once-daily oral administration. The FDA previously granted Breakthrough Therapy, Fast Track and Orphan Drug Designations as well as Priority Review to ziftomenib.
FDA approval of our NDA for KOMZIFTI was based upon positive data from our KOMET-001 trial, a global Phase 1/2 trial that evaluated KOMZIFTI’s safety and efficacy in 112 patients with relapsed or refractory NPM1-mutated AML.
We believe that KOMZIFTI is differentiated from other menin inhibitors based on its
efficacy
,
safety
,
compatibility
and
simplicity
, and our market research indicates that this differentiated profile aligns with the priorities of physicians, pharmacists and care teams who treat patients with AML as well as with third-party payors, including commercial insurers and government healthcare programs.
Efficacy
: The rate of complete remission, or CR, plus CR with partial hematologic recovery, or CRh, in the KOMET-001 trial was 21.4% (95% CI: 14.2, 30.2). The median duration of CR+CRh was five months (95% CI: 1.9, 8.1) and the
14
median time to first response in patients who achieved a CR or CRh was 2.7 months (range: 0.9 to 15 months). 88% of patients who achieved CR or CRh did so within six months of initiating KOMZIFTI. These data from the Prescribing Information for KOMZIFTI are generally consistent with the full results of the KOMET-001 trial published in the
Journal of Clinical Oncology
in September 2025.
Safety
:
KOMZIFTI demonstrated a manageable safety profile in the KOMET-001 trial, with most reported adverse events being Grade 1 or Grade 2. The most common adverse reactions, including laboratory abnormalities, reported in 20% or more of patients were aspartate aminotransferase increased, infection without an identified pathogen, potassium decreased, albumin decreased, alanine aminotransferase increased, sodium decreased, creatinine increased, alkaline phosphatase increased, hemorrhage, diarrhea, nausea, fatigue, edema, bacterial infection, musculoskeletal pain, bilirubin increased, potassium increased, differentiation syndrome, or DS, pruritus, febrile neutropenia and transaminases increased. Notably, no Grade 4 or Grade 5 QTc interval prolongation was reported. 12% of patients experienced QTc interval prolongation of ≤ Grade 3 and, of the 70 patients 65 years of age or older, 10% experienced QTc interval prolongation of any cause.
The Prescribing Information for KOMZIFTI includes a Black Box warning for DS, a well-studied mechanism-based risk in drugs that restore differentiation, and clear dose-modification guidelines for physicians to follow when DS is suspected. Unlike the other FDA-approved menin inhibitor, KOMZIFTI does not have a Black Box warning for QTc interval prolongations or Torsades de Pointes.
Compatibility
: In contrast with other therapies that require dose adjustments when co-administered with anti-infective medications or other strong or moderate CYP3A4 inhibitors or inducers, KOMZIFTI can be co-administered without dose modification, offering predictability to physicians and reducing complexity and risk.
Simplicity
: KOMZIFTI is the first and only menin inhibitor approved by the FDA for once-daily oral administration. KOMZIFTI’s once-daily dosing is beneficial to patients who are often elderly and on several concomitant medications.
We initiated commercial sales of KOMZIFTI in the United States on November 21, 2025. Under the terms of the collaboration and license agreement that we entered into with Kyowa Kirin Co., Ltd. and Kyowa Kirin, Inc., or together Kyowa Kirin, in November 2024, or the Kyowa License Agreement, we lead commercial strategy for and are responsible for manufacturing KOMZIFTI in the United States. We and Kyowa Kirin are jointly performing commercialization and medical affairs activities in accordance with a co-created U.S. territory commercialization plan and the co-promotion and medical affairs agreement that we entered into with Kyowa Kirin, Inc. in June 2025, or the Kyowa Co-Promotion Agreement. We record all U.S. sales of KOMZIFTI, and we and Kyowa Kirin share equally the profits and losses from the commercialization activities in the United States. Outside the United States, Kyowa Kirin is responsible for commercial strategy and for commercializing ziftomenib and booking sales.
For the six months ended June 30, 2026, we achieved $14.9 million in KOMZIFTI net product revenue.
Following the FDA’s November 2025 approval of KOMZIFTI, we announced that KOMZIFTI was added to the National Comprehensive Cancer Network
®
, or NCCN, Clinical Practice Guidelines in Oncology (NCCN Guidelines
®
) as a Category 2A recommended treatment option for adults with relapsed or refractory NPM1-mutated AML.
In addition, following FDA approval, we submitted patent information to our NDA regarding eight granted U.S. patents that claim the drug substance, drug product and/or methods of treatment for KOMZIFTI. These patents, which have been added to the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for KOMZIFTI, include two recently granted patents that share a base expiration date of July 16, 2044. We have submitted applications for patent term extension for two U.S. granted patents to the U.S. Patent and Trademark Office, or U.S. PTO, along with our assessment of the duration of applicable extensions.
We have made significant progress in securing insurance coverage and reimbursement for KOMZIFTI in the United States. We have secured parity coverage for more than 95% of covered lives in the United States. Among private payors, several published policies require patients with relapsed or refractory NPM1-mutated AML to step through KOMZIFTI first before receiving other available menin inhibitors.
15
Menin Inhibitor Development Programs
Clinical Development of Ziftomenib in AML
Together with Kyowa Kirin, we are advancing the global clinical development of ziftomenib across the treatment continuum for AML, including in combinations with standards of care for AML and in patients with frontline and relapsed or refractory disease.
Ziftomenib Combinations with Standards of Care for AML
Newly Diagnosed AML
In September 2025, we initiated KOMET-017, a single protocol comprised of two independent, global, randomized, double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive regimens in patients with newly diagnosed NPM1-mutated or KMT2A-rearranged AML. The KOMET-017 protocol was informed by the clinical data and findings generated in our Phase 1 KOMET-007 trial. The single protocol design of KOMET-017 has streamlined the study start-up process, resulting in site activation at a pace that has exceeded our expectations. Patients have been dosed in both trials and enrollment continues to progress.
Combination with Non-Intensive Chemotherapy (Venetoclax/Azacitidine) in NPM1-Mutated AML
The registrational KOMET-017-NIC (Non-Intensive Chemotherapy) trial is evaluating the combination of ziftomenib with venetoclax plus azacitidine in patients with newly diagnosed NPM1-mutated AML who are unfit to receive intensive chemotherapy. The KOMET-017-NIC trial will assess CR and overall survival, or OS, as dual-primary endpoints to support potential U.S. accelerated approval and full approval, respectively. Patients in this trial are randomized to receive ziftomenib or placebo, in combination with venetoclax and azacitidine.
We previously evaluated ziftomenib in combination with venetoclax and azacitidine in patients with newly diagnosed NPM1-mutated AML in the Phase 1 KOMET-007 trial, and we delivered an oral presentation of preliminary data from the Phase 1b expansion cohort evaluating this regimen at the 67th Annual Meeting of the American Society of Hematology, or ASH, in December 2025. As presented at ASH, 40 patients with newly diagnosed NPM1-mutated AML had been enrolled in the cohort as of the September 24, 2025 data cutoff date, 58% (23/40) of whom had an ECOG performance status of two and 37 of whom were response evaluable. High rates of durable morphologic complete responses (composite complete remission, or CRc, 86%; CR 73%) were observed, with 68% of CRc responders having achieved molecular measurable residual disease, or MRD, negativity by central next-generation sequencing.
As of the data cutoff for the ASH presentation, median duration of CR and median OS were not reached at median follow-up of 26.1 weeks (range 1.6–54.1). 68% of patients remained alive and on treatment or in long-term follow-up as of the data cutoff. The triplet combination was generally well tolerated, with a safety profile consistent with that reported for venetoclax and azacitidine alone. Rates of ziftomenib-related myelosuppression were low, and the median times to neutrophil and platelet recovery were also consistent with those expected for venetoclax and azacitidine alone. One case each of Grade 2 DS and Grade 3 investigator-assessed QTc prolongation were successfully managed without treatment discontinuation.
We anticipate presenting updated long-term data from the KOMET-007 Phase 1b trial, including durability, survival, and MRD outcomes, in the second half of 2026.
Combination with Intensive Chemotherapy (7+3) in NPM1-Mutated or KMT2A-Rearranged AML
The registrational KOMET-017-IC (Intensive Chemotherapy) trial is evaluating the combination of ziftomenib with induction chemotherapy (7+3) in patients with newly diagnosed NPM1-mutated or KMT2A-rearranged AML. Patients in this trial are randomized to receive ziftomenib or placebo in combination with standard induction, consolidation chemotherapy and post-consolidation maintenance. The KOMET-017-IC trial will assess MRD-negative CR and event-free survival as dual-primary endpoints to support potential U.S. accelerated approval and full approval, respectively. Based on our current assumptions, we anticipate topline results from the MRD-negative CR accelerated endpoint in the intensive chemotherapy setting in 2028.
16
On June 14, 2026, we shared long-term results from our evaluation of ziftomenib with 7+3 in newly diagnosed NPM1-mutated or KMT2A-rearranged AML from the KOMET-007 trial in an oral presentation at the European Hematology Association Congress. The presentation featured results from 99 patients treated with ziftomenib in combination with 7+3 as of the data cutoff of April 10, 2026. Among all 99 response-evaluable patients, CRc rates were 96% (47/49) and 90% (45/50), with local CRc MRD-negativity rates of 85% (40/47) and 82% (32/39), in patients with NPM1 mutations and KMT2A rearrangements, respectively. Median OS was not reached, with median follow-up of 17.6 months for patients with NPM1-mutated AML and 11.0 months for patients with KMT2A-rearranged AML. At 12 months, OS rates were 94% for NPM1-mutated AML and 71% for KMT2A-rearranged AML. At data cutoff, median CR duration had not been reached for NPM1-mutated AML and was 12.0 months for KMT2A-rearranged AML. Treatment-emergent adverse events were similar between the two patient subgroups, and low rates of additive myelosuppression were observed. No Grade 4 DS or QTc prolongation events were reported. Four patients (4%) experienced Grade 3 DS; all cases successfully resolved with protocol-specified mitigation and three continued on ziftomenib treatment. Three patients (3%) experienced Grade 3 investigator-assessed QTc prolongation (all three on azole antifungals, fluoroquinolones, or other medications at time of assessment; one with ongoing hypokalemia and hypomagnesemia); none were assessed as ziftomenib-related and all QTc events successfully resolved with all patients continuing on ziftomenib treatment.
Combination with Intensive Chemotherapy (7+3) and Quizartinib in NPM1/FLT3-ITD
Co-Mutated AML
In October 2025, we and Kyowa Kirin announced dosing of the first patient in a cohort of the KOMET-007 trial evaluating the safety, tolerability and activity of ziftomenib in combination with 7+3 plus quizartinib in patients with newly diagnosed NPM1/FLT3-ITD co-mutated AML. We continue to advance the enrollment of patients in this cohort and anticipate presenting preliminary data in the second half of 2026.
Relapsed or Refractory AML
Combination with Non-Intensive Chemotherapy (Venetoclax/Azacitidine) in NPM1-Mutated or KMT2A-Rearranged AML
We are evaluating ziftomenib in combination with venetoclax and azacitidine in patients with relapsed or refractory NPM1-mutated or KMT2A-rearranged AML in our Phase 1 KOMET-007 trial.
We have completed enrollment of patients with relapsed or refractory NPM1-mutated AML in the dose expansion cohort evaluating the combination of ziftomenib with venetoclax and azacitidine. On June 2, 2026, we announced the publication in
Blood
of updated results from our evaluation of this combination. The publication reports data from 64 response-evaluable patients, 27 of whom were treated in Phase 1a dose escalation and 37 of whom were treated in Phase 1b expansion, as of the January 16, 2026 data cutoff date. Patients had received 1 to 8 prior lines of therapy (median of 1), and 37 patients (55%) had prior venetoclax exposure. Robust clinical activity was observed in patients with relapsed or refractory NPM1-mutated AML across all ziftomenib dose levels, with nearly two-thirds of all patients experiencing clinically meaningful, deep, and durable responses. In addition, rapid responses were observed, with a median time to CRc of 3.9 weeks.
In venetoclax-naïve patients treated with the recommended once-daily dose of 600 mg of ziftomenib in combination with venetoclax and azacitidine, the ORR was 87% and the CRc rate was 70%, with 75% central MRD negativity. The median duration of CRc response was 9.2 months (95% CI, 5.8-NE). Median OS was not reached after median follow-up of 10.7 months in this population.
In venetoclax-experienced patients treated with a once-daily dose of 600 mg of ziftomenib in combination with venetoclax and azacitidine, the ORR was 48% and the CRc rate was 24%, with 50% central MRD negativity. The median duration of CRc response was 8.6 months (95% CI, 1.6-NE). After median follow-up of 9.9 months, this population experienced median OS of 7.4 months.
The triplet combination was well tolerated, with a safety profile consistent with that reported for the venetoclax and azacitidine combination alone. Two patients treated with the triplet experienced DS, and both events resolved with protocol-specified mitigation. One case of ziftomenib-related QTc prolongation was observed, and
the event resolved without a change or interruption in dose.
Combination with Gilteritinib in NPM1/FLT3
Co-Mutated AML
We are evaluating ziftomenib in combination with gilteritinib in patients with relapsed or refractory NPM1 and FLT3 co-mutated AML in our Phase 1 KOMET-008 trial. We have completed patient enrollment in the dose expansion portion of this cohort and anticipate presenting preliminary data in the second half of 2026.
17
Combination with FLAG-IDA or LDAC in NPM1-Mutated or KMT2A-Rearranged AML
We also are evaluating ziftomenib in combination with fludarabine, cytarabine, granulocyte-colony stimulating factor, and idarubicin, or FLAG-IDA, or low-dose cytarabine, or LDAC, in patients with relapsed or refractory NPM1-mutated or KMT2A-rearranged AML as part of our KOMET-008 trial.
Ziftomenib Monotherapy
On April 24, 2026, we and Kyowa Kirin announced the dosing of the first patient in a Japanese Phase 2 registrational clinical trial evaluating ziftomenib for the treatment of relapsed or refractory NPM1-mutated AML. The trial is a multicenter, single-arm, open-label clinical trial evaluating the efficacy and safety of ziftomenib in adult patients with relapsed or refractory NPM1-mutated AML. As the primary endpoint, the trial will assess CR plus CRh. Following completion of this clinical trial, Kyowa Kirin plans to file for regulatory approval in Japan.
While the FDA approval of KOMZIFTI marked the completion of our clinical evaluation of ziftomenib as a monotherapy for adult patients with relapsed or refractory NPM1-mutated AML in the United States, we continue to evaluate ziftomenib as a monotherapy in patients with non-NPM1-mutated and non-KMT2A-rearranged AML and in patients with KMT2A-rearranged acute lymphoblastic leukemia under the KOMET-001 protocol. We anticipate presenting an exploratory analysis from our evaluation of ziftomenib monotherapy activity in molecularly defined, MEIS1-associated non-NPM1-mutated and non-KMT2A-rearranged AML in the second half of 2026.
We are supporting an investigator-sponsored trial, and may initiate a company-sponsored trial, evaluating the ability of ziftomenib to improve outcomes when administered as a maintenance therapy to patients with NPM1-mutated or KMT2A-rearranged AML following HSCT.
In December 2023, we announced a clinical collaboration with Blood Cancer United, or BCU, formerly known as The Leukemia & Lymphoma Society, to evaluate ziftomenib in combination with chemotherapy in pediatric patients with relapsed or refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutated acute leukemia. Under the terms of the collaboration agreement, BCU serves as the coordinating sponsor of a Phase 1 trial of ziftomenib in pediatric patients with acute leukemias in North America, the Princess Máxima Center for Pediatric Oncology in Utrecht, Netherlands serves as the coordinating sponsor of the trial in Europe, and we supply BCU and the Princess Máxima Center with ziftomenib for the trial.
Finally, several investigator-sponsored clinical trials of ziftomenib in acute leukemias are either open for enrollment or in development, in addition to the clinical trials described above.
Clinical Development of Ziftomenib in Gastrointestinal Stromal Tumors
In April 2025, we dosed the first patients in a Phase 1 trial evaluating ziftomenib in combination with imatinib in patients with advanced gastrointestinal stromal tumors after imatinib failure, which we refer to as the KOMET-015 trial. We are advancing the combination in dose escalation and have reached a range of dose levels with encouraging safety and tolerability.
Next-Generation Menin Inhibitors
We continue to make progress toward multiple next-generation menin inhibitor drug candidates. We have nominated our first next-generation menin inhibitor, KO-7246, which we expect to advance into investigational new drug application, or IND, -enabling studies in diabetes and cardiometabolic diseases in 2026 with external investment or through a collaboration. We anticipate the presentation of preclinical data on the use of menin inhibitors in diabetes in 2026.
We also expect to advance preclinical development of an additional next-generation menin inhibitor development candidate for use in combination therapy for solid tumors in 2026.
18
Farnesyl Transferase Inhibitor Development Program
Darlifarnib
Darlifarnib is our next-generation farnesyl transferase inhibitor. Darlifarnib inhibits farnesylation of the RHEB protein, resulting in selective mTORC1 inhibition while sparing mTORC2. This mechanism has potential to enhance the activity of multiple targeted therapies where complementary inhibition of oncogenic pathways may improve clinical outcomes. We are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of darlifarnib in a Phase 1 first-in-human trial, which we call the FIT-001 trial. The FIT-001 trial includes multiple cohorts to evaluate darlifarnib in combination with other targeted therapies in large solid tumor indications.
Darlifarnib in Combination with Cabozantinib in RCC
As part of our FIT-001 trial, we are evaluating darlifarnib in combination with cabozantinib in patients with clear cell renal cell carcinoma, or ccRCC, and patients with non-clear cell renal cell carcinoma, or RCC. In February 2026, we initiated a global, randomized Phase 1b dose expansion study evaluating darlifarnib plus cabozantinib against cabozantinib alone to establish the recommended Phase 3 dose for the combination in cabozantinib-naïve patients with advanced or metastatic ccRCC.
On April 17, 2026, we announced new preliminary data from a subset analysis of FIT-001 patients with ccRCC who were previously treated with cabozantinib, a population that typically derives limited benefit from subsequent therapy. Results were presented at the 2026 International Kidney Cancer Symposium (IKCS): Europe in Paris, France. In 16 patients with ccRCC who had previously received cabozantinib, the ORR was 44% and the disease control rate was 94%. Tumor shrinkage was observed in 75% of patients, with reductions ranging from 32% to 47% among responders. A manageable safety profile was demonstrated across all RCC patients at multiple dose levels, including the full FDA-approved dose of cabozantinib.
On July 24, 2026, we shared updated Phase 1a dose-escalation data from the combination of darlifarnib and cabozantinib in an oral presentation at the 2026 Kidney Cancer Research Summit, or KCRS. The presentation highlighted long-term follow-up results in heavily pretreated cabozantinib-naïve patients with advanced ccRCC. Across the dose levels evaluated, the ORR ranged from 33% to 50% and median progression-free survival was 13 months. Median duration of response was not estimable at most dose levels assessed because multiple responses remained ongoing at the time of data cutoff. Durable clinical benefit was observed across all evaluated dose levels, with more than half of the 34 cabozantinib-naïve patients remaining on treatment at data cutoff. As reported at KCRS, the safety and tolerability profile of the combination was manageable and generally consistent with reported safety profiles of the individual agents.
We expect to complete enrollment in the FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib in cabozantinib-naïve ccRCC in the first half of 2027 and to report initial clinical data in the second half of 2027.
Darlifarnib in Combination with Adagrasib in KRAS-Mutant Cancers
Preclinical studies of darlifarnib have shown enhanced anti-tumor activity across multiple classes of RAS inhibitors, including mutant-selective and multi-selective RAS(ON) inhibitors, as well as pan-KRAS and pan-RAS approaches, and demonstrated tumor regressions in models previously exposed to KRAS inhibitor therapy. These data support darlifarnib’s broad applicability across the evolving RAS inhibitor landscape, including mutant-selective, pan-KRAS and RAS(ON) multiselective inhibitors.
We are evaluating darlifarnib in combination with adagrasib in patients with KRAS
G12C
-mutated non-small cell lung cancer, or NSCLC, colorectal cancer, or CRC, and pancreatic ductal adenocarcinoma, or PDAC, as part of our FIT-001 trial. Under the terms of a clinical collaboration agreement with Mirati Therapeutics, Inc., or Mirati, a wholly owned subsidiary of Bristol Myers Squibb, we sponsor the trial and Mirati supplies us with adagrasib, a KRAS
G12C
inhibitor, for use in the trial. On May 30, 2026, we presented preliminary clinical data from the dose escalation portion of the FIT-001 trial evaluating the combination of darlifarnib and adagrasib at the 2026 American Society of Clinical Oncology Annual Meeting, or ASCO. Among 26 response-evaluable patients, tumor shrinkage was observed in 77% of patients overall and in 94% of KRAS inhibitor-naïve patients. Confirmed objective response rates included 67% in PDAC, 50% in NSCLC, and 29% in KRAS inhibitor-naïve CRC. Clinical activity was also observed in patients previously treated with KRAS inhibitors. The combination of darlifarnib with adagrasib demonstrated a manageable safety profile, with observed adverse events consistent with expected on-target effects.
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Darlifarnib Combination Platform Study
On June 3, 2026, we announced a new platform study designed to evaluate darlifarnib across multiple targeted therapy combinations and disease settings. The flexible design is intended to allow combinations with both approved and investigational targeted therapies in multiple tumor types, add new arms over time, and advance successful combinations into dedicated registrational studies. We anticipate initiation of a Phase 1a study in the first planned platform combination — darlifarnib with daraxonrasib in KRAS-mutant pancreatic cancer — in the first half of 2027.
Darlifarnib as a Monotherapy
Preliminary data from the FIT-001 trial evaluating darlifarnib as a monotherapy in RAS-altered advanced solid tumors were presented at the European Society for Medical Oncology, or ESMO, in October 2025. The data presented at ESMO indicate that darlifarnib has a manageable safety and tolerability profile when administered at doses from 3 to 10 mg per day. Encouraging antitumor activity was observed in advanced HRAS-mutated solid tumors across multiple dose levels, demonstrating on-target activity and a broad therapeutic window.
Tipifarnib
Tipifarnib in Combination with Alpelisib in HNSCC
In 2021, we initiated a Phase 1/2 open-label, biomarker-defined cohort trial, called the KURRENT-HN trial, to evaluate the combination of tipifarnib and alpelisib, a PI3K alpha inhibitor, in patients with head and neck squamous cell carcinoma, or HNSCC, whose tumors have HRAS overexpression and/or PIK3CA mutation and/or amplification. We completed the KURRENT-HN trial in the third quarter of 2025 and presented data from the trial at ESMO in October 2025. The combination of tipifarnib and alpelisib demonstrated a manageable safety profile in HNSCC patients across multiple doses. Robust antitumor activity was observed in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations. An ORR of 47% was observed at a daily dose of tipifarnib 1200 mg with alpelisib 250 mg.
Based on the data from the KURRENT-HN trial, we are evaluating data generation options for the combination of darlifarnib and a PI3K alpha inhibitor in HNSCC and other PI3K alpha-driven solid tumors.
Liquidity Overview
As of June 30, 2026, we had cash, cash equivalents and short-term investments of $519.0 million.
In November 2024, we entered into the Kyowa License Agreement to develop and commercialize globally ziftomenib for the treatment of patients with AML and other hematologic malignancies, which may be expanded into other oncology indications at the option of Kyowa Kirin, subject to certain conditions. As of June 30, 2026, we have received or expected to receive $597.1 million under the Kyowa License Agreement, consisting of $570.0 million in upfront and milestone payments and $27.1 million in profit and loss and expense sharing.
In November 2023, we entered into a Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.
In November 2022, we entered into a loan and security agreement with several banks and other financial institutions or entities party thereto, or collectively the Lenders, and Hercules Capital, Inc., or Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders, which was amended in October 2023 and October 2025, or the Loan Agreement, providing for up to $125.0 million in a series of term loans, or Term Loans. Under the terms of the Loan Agreement, we borrowed $10.0 million of an initial $25.0 million tranche of Term Loans. The remaining tranches of Term Loans expired without us drawing down such additional loans. The Term Loans have a maturity date of November 2, 2027, or the Maturity Date. Repayment of the Term Loans is interest only until May 1, 2027. After the interest-only payment period, borrowings under the Loan Agreement are repayable in monthly payments of principal and accrued interest until the Maturity Date. The per annum interest rate for the Term Loans is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of June 30, 2026, the interest rate on the Term Loans was 9.15%.
In November 2025, we began to generate revenues from product sales. Since our inception and prior to such product revenues, we have funded our operations primarily through equity and debt financings and payments received under the Kyowa License Agreement. We anticipate that we will require significant additional financing in the future to continue to fund our operations as discussed more fully below under the heading “Liquidity and Capital Resources.”
20
Financial Operations Overview
Product Revenue, Net
Our first commercial product, KOMZIFTI, was approved by the FDA for sale in the United States on November 13, 2025. In accordance with U.S. generally accepted accounting principles, we determine net product revenue for KOMZIFTI, with specific assumptions for variable consideration components including, but not limited to, trade discounts and allowances, co-pay assistance programs and payor rebates.
Revenue from Collaborations and Licenses
We generate revenue primarily through collaboration and license agreements, such as the Kyowa License Agreement. Such agreements may require us to deliver various rights and/or services, including intellectual property rights or licenses and research, development and other services. Under such agreements, we are generally eligible to receive non-refundable upfront payments, funding for research, development and other services, milestone payments and royalties.
Cost of Product Sales
Cost of product sales consists primarily of direct and indirect costs related to the manufacture of KOMZIFTI for commercial sale, including internal manufacturing related staff costs, third-party manufacturing and packaging costs, raw material and component costs, freight-in, storage costs and royalties on product sales. Prior to the FDA approval of KOMZIFTI in November 2025, costs incurred for the manufacture of KOMZIFTI were recorded as research and development expenses, which resulted in zero-cost inventory. As a result, the cost of product sales related to KOMZIFTI will initially reflect a lower average per unit cost of materials, as previously expensed zero-cost inventory is utilized for commercial production and sold to customers. We expect the cost of product sales for KOMZIFTI to increase in relation to product revenues as we deplete these inventories.
Research and Development Expenses
We focus on the research and development of our pipeline programs. Our research and development expenses consist of costs associated with our research and development activities including salaries, benefits, share-based compensation and other personnel costs, clinical trial costs, manufacturing costs for non-commercial products, fees paid to external service providers and consultants, facilities costs and supplies, equipment and materials used in clinical and preclinical studies and research and development. All such costs are charged to research and development expense as incurred. Payments that we make in connection with in-licensed technology for a particular research and development project that have no alternative future uses in other research and development projects or otherwise and therefore, no separate economic values, are expensed as research and development costs at the time such costs are incurred. As of June 30, 2026, we had no in-licensed technologies that had alternative future uses in research and development projects or otherwise.
We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we are unable to estimate with any certainty the costs we will incur and the timelines we will require in the continued development of our product candidates and our other pipeline programs. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. Our future research and development expenses will depend on the preclinical and clinical success of each product candidate that we develop, as well as ongoing assessments of the commercial potential of such product candidates. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
Completion of clinical trials may take several years or more, and the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate. The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others:
•
per patient clinical trial costs;
•
the number of clinical trials required for approval;
•
the number of sites included in the clinical trials;
•
the length of time required to enroll suitable patients;
21
•
the number of doses that patients receive;
•
the number of patients that participate in the clinical trials;
•
the drop-out or discontinuation rates of patients;
•
the duration of patient follow-up;
•
potential additional safety monitoring or other studies requested by regulatory agencies;
•
the number and complexity of analyses and tests performed during the clinical trial;
•
the phase of development of the product candidate; and
•
the efficacy and safety profile of the product candidate.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of salaries, benefits, share-based compensation and other personnel costs for employees in sales and marketing, executive, finance, business development and support functions. Other significant selling, general and administrative expenses include the costs associated with obtaining and maintaining our patent portfolio, professional services for audit, legal, sales and marketing, investor and public relations, director and officer insurance premiums, corporate activities and allocated facilities.
Other Income, Net
Other income, net consists primarily of interest income and interest expense.
Results of Operations
The following table sets forth our results of operations for the periods presented, in thousands:
Three Months Ended
Six Months Ended
June 30,
June 30,
2026
2025
Change
2026
2025
Change
Product revenue, net
$
9,122
$
—
$
9,122
$
14,888
$
—
$
14,888
Collaboration revenue
11,752
15,288
(3,536
)
24,251
29,396
(5,145
)
Cost of product sales
243
—
243
505
—
505
Research and development expenses
61,891
62,785
(894
)
127,154
118,758
8,396
Selling, general and administrative expenses
31,750
25,169
6,581
63,305
48,004
15,301
Other income, net
4,688
6,544
(1,856
)
10,178
14,041
(3,863
)
Comparison of the Three Months Ended June 30, 2026 and 2025
Product Revenue, net.
We recognized product revenue, net, of $9.1 million for the three months ended June 30, 2026 related to sales of KOMZIFTI in the United States, following FDA approval in November 2025. We generated no product revenue during the three months ended June 30, 2025.
Collaboration Revenue.
For the three months ended June 30, 2026 and 2025, we recognized $11.8 million and $15.3 million, respectively, of collaboration revenue related to services performed under the Kyowa License Agreement.
22
Research and Development Expenses.
The following table illustrates the components of our research and development expenses for the periods presented, in thousands:
Three Months Ended
June 30,
2026
2025
Change
Ziftomenib-related costs
$
34,938
$
37,584
$
(2,646
)
Darlifarnib-related costs
5,985
6,141
(156
)
Discovery stage program-related costs
1,901
1,490
411
Personnel costs and other expenses
15,829
14,856
973
Share-based compensation expense
3,238
2,714
524
Total research and development expenses
$
61,891
$
62,785
$
(894
)
The decrease in ziftomenib-related research and development expenses for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to the timing of clinical development activities. The increase in personnel costs and other expenses for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in headcount costs to support our ongoing clinical trials. We expect our research and development expenses to increase in future periods as we continue clinical development activities for our ziftomenib and darlifarnib programs.
Selling, General and Administrative Expenses
. The increase in selling, general and administrative expenses for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in personnel costs and professional services expenses. We expect our selling, general and administrative expenses to increase in future periods to support our planned increases in research and development and commercialization activities.
Other income, net.
The decrease in other income, net for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to a decrease in interest income.
Comparison of the Six Months Ended June 30, 2026 and 2025
Product Revenue, net.
We recognized product revenue, net, of $14.9 million for the six months ended June 30, 2026 related to sales of KOMZIFTI in the United States, following FDA approval in November 2025. We generated no product revenue during the six months ended June 30, 2025.
Collaboration Revenue.
For the six months ended June 30, 2026 and 2025, we recognized $24.3 million and $29.4 million, respectively, of collaboration revenue related to services performed under the Kyowa License Agreement.
Research and Development Expenses.
The following table illustrates the components of our research and development expenses for the periods presented, in thousands:
Six Months Ended
June 30,
2026
2025
Change
Ziftomenib-related costs
$
71,818
$
67,531
$
4,287
Darlifarnib-related costs
12,553
11,376
1,177
Discovery stage program-related costs
3,301
3,579
(278
)
Personnel costs and other expenses
33,029
30,231
2,798
Share-based compensation expense
6,453
6,041
412
Total research and development expenses
$
127,154
$
118,758
$
8,396
23
The increase in ziftomenib-related research and development expenses for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in costs related to ziftomenib combination trials, including our registration-directed frontline clinical trials. The increase in darlifarnib-related research and development expenses for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increased costs related to our Phase 1 clinical trial. The increase in personnel costs and other expenses for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in headcount costs to support our ongoing clinical trials.
Selling, General and Administrative Expenses
. The increase in selling, general and administrative expenses for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in personnel costs, professional services expenses, travel expenses and non-cash share-based compensation expense.
Other income, net.
The decrease in other income, net for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to a decrease in interest income.
Liquidity and Capital Resources
Since our inception, we have funded our operations primarily through equity and debt financings and payments received under the Kyowa License Agreement. We have devoted our resources to funding research and development programs, including discovery research, preclinical and clinical development activities and, more recently, to building out our commercial capabilities and infrastructure.
In November 2024, we entered into the Kyowa License Agreement to develop and commercialize globally ziftomenib for the treatment of patients with AML and other hematologic malignancies, which may be expanded into other oncology indications at the option of Kyowa Kirin, subject to certain conditions. As of June 30, 2026, in exchange for the licenses and rights granted to Kyowa Kirin to participate in the development and commercialization of ziftomenib, we received or expected to receive $597.1 million.
In November 2023, we entered into the ATM Facility under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.
In November 2022, we entered into the Loan Agreement with the Lenders and Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders, providing for up to $125.0 million in a series of Term Loans. Under the terms of the Loan Agreement, we borrowed $10.0 million of an initial $25.0 million tranche of Term Loans. The remaining tranches of Term Loans expired without us drawing down such additional loans. The Maturity Date for the Term Loans is November 2, 2027. Repayment of the Term Loans is interest only until May 1, 2027. After the interest-only payment period, borrowings under the Loan Agreement are repayable in monthly payments of principal and accrued interest until the Maturity Date. The per annum interest rate for the Term Loans is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of June 30, 2026, the interest rate on the Term Loans was 9.15%.
At our option, we may prepay all or any portion of the outstanding Term Loans at any time. The Loan Agreement also contains an end of term fee in an amount equal to approximately $1.5 million (which is 6.05% of the maximum amount of the first tranche of loans), which is due and payable on the earliest to occur of (i) the Maturity Date, (ii) the date we prepay the outstanding loans in full, and (iii) the date that the secured obligations become due and payable. Our obligations under the Loan Agreement are secured by substantially all of our assets other than our intellectual property, but including proceeds from the sale, licensing or other disposition of our intellectual property. As part of the Loan Agreement, we are subject to certain negative covenants, which, among other things, prohibit us from selling, transferring, assigning, mortgaging, pledging, leasing, granting a security interest in or otherwise encumbering our intellectual property, subject to limited exceptions.
We have incurred operating losses and negative cash flows from operating activities since inception. As of June 30, 2026, we had an accumulated deficit of $1.3 billion. Although we have recorded product revenue related to KOMZIFTI, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution of KOMZIFTI and, following regulatory approval, other products, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of collaborators or potential collaborators. In addition, we expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue and initiate clinical trials of, and seek marketing approval for, our product candidates. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or commercialization efforts.
24
As of June 30, 2026, we had cash, cash equivalents and short-term investments of $519.0 million. We believe that our cash, cash equivalents and short-term investments as of June 30, 2026 will be sufficient to fund our current operating plan into the fourth quarter of 2027. In addition, when combined with the anticipated $180.0 million in payments under the Kyowa License Agreement, we expect to have sufficient capital to advance our ziftomenib AML program through the first topline results from KOMET-017, anticipated in 2028. Our future capital requirements will depend on many factors, including:
•
the level of sales and market acceptance of KOMZIFTI;
•
the ability of KOMZIFTI to generate revenue;
•
the availability of coverage and adequate third-party reimbursement for KOMZIFTI;
•
the costs of product sales, medical affairs, marketing, manufacturing and distribution for KOMZIFTI;
•
the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our product candidates;
•
the costs, timing and outcome of regulatory review of our product candidates;
•
the costs of fully developing our sales, marketing and distribution capabilities for our approved products;
•
the costs of securing and producing drug substance and drug product material for use in preclinical studies and clinical trials and for use as commercial supply;
•
the costs of securing manufacturing arrangements for development activities and commercial production;
•
the scope, prioritization and number of our research and development programs;
•
the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under current or any future collaboration agreements;
•
the extent to which we acquire or in-license other product candidates and technologies;
•
the success of our current or future companion diagnostic test collaborations for companion diagnostic tests; and
•
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims.
We are subject to all of the risks incident to the development and commercialization of new therapeutic products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We may need substantial additional funding in connection with our continuing operations.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of stock offerings, debt financings, collaborations, strategic partnerships or licensing arrangements, such as the Kyowa License Agreement. Additional capital may not be available on reasonable terms, if at all. Subject to limited exceptions, our term loan facility also prohibits us from incurring indebtedness without the prior written consent of the Lenders. To the extent that we raise additional capital through the sale of stock or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include increased fixed payment obligations and covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, selling or licensing intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through collaborations, strategic partnerships or licensing arrangements with third parties, such as the Kyowa License Agreement, we may have to relinquish valuable rights to our product candidates, other technologies, future revenue streams or research programs, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be unable to carry out our business plan. As a result, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and commercialize our product candidates even if we would otherwise prefer to develop and commercialize such product candidates ourselves, and our business, financial condition and results of operations would be materially adversely affected.
25
The following table provides a summary of our net cash flow activities for the periods presented, in thousands:
Six Months Ended
June 30,
2026
2025
Change
Net cash used in operating activities
$
(148,403
)
$
(100,704
)
$
(47,699
)
Net cash provided by (used in) investing activities
67,978
(42,468
)
110,446
Net cash provided by financing activities
1,568
658
910
Operating Activities.
The increase of $47.7 million in net cash used in operating activities for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases of $18.1 million in net loss and changes in operating assets and liabilities of $35.2 million, offset by increases of $3.5 million in amortization of premiums and accretion of discounts on short-term investments and $1.8 million in non-cash share-based compensation.
Investing Activities.
The increase of $110.5 million in net cash provided by investing activities for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to decreases of $192.1 million in purchases of short-term investments and $1.0 million in purchases of property and equipment, offset by a decrease of $82.6 million in maturities of short-term investments.
Financing Activities.
Net cash provided by financing activities for both the six months ended June 30, 2026 and 2025 related to proceeds from the issuance of shares of common stock under our equity plans.
Contractual Obligations and Commitments
We have borrowed $10.0 million of Term Loans under our Loan Agreement, which requires us to make principal and interest payments. The Term Loans are subject to variable changes in the per annum interest rate, which is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of June 30, 2026, the interest rate on the Term Loans was 9.15%. In addition, an end of term fee will be due in an amount equal to approximately $1.5 million (which is 6.05% of the maximum amount of the first tranche of loans), payable on the earliest of the Maturity Date, acceleration or prepayment of the Term Loans.
We lease certain office and laboratory space under non-cancelable operating leases. The leases are also subject to additional variable charges for common area maintenance, property taxes, property insurance and other variable costs. See Note 6 of the unaudited condensed financial statements for additional detail related to our lease obligations.
We enter into short-term and cancellable agreements in the normal course of operations with clinical sites and contract research organizations, or CROs, for clinical research studies, professional consultants and various third parties for preclinical research studies, clinical supply manufacturing and other services through purchase orders or other documentation. Such short-term agreements are generally outstanding for periods less than one year and are settled by cash payments upon delivery of goods and services. The nature of the work being conducted under these agreements is such that, in most cases, the services may be cancelled upon prior notice of 90 days or less. Payments due upon cancellation generally consist only of payments for services provided and expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation.
Pursuant to our in-license agreements, we have milestone and contractual payment obligations contingent upon the achievement of certain milestones or events. We may be required to pay up to approximately $76.8 million in milestone payments, plus additional sales royalties and sublicense fees, in the event that regulatory and commercial milestones under the in-license agreements are achieved. Our in-license agreements are cancelable by us with written notice within 180 days or less.
Under the Kyowa License Agreement, we are responsible for funding the specified development activities set forth in the initial development plan and budget mutually agreed upon with Kyowa Kirin, or Development Plan, that are planned to be conducted prior to the end of 2028, and we will share equally (50/50) with Kyowa Kirin all development costs for all other development activities in the United States included in the Development Plan (including the costs of future trials conducted under the Development Plan in the United States). We will share equally with Kyowa Kirin in any potential profits and losses arising from the commercialization of KOMZIFTI and any other approved products containing ziftomenib in the United States for the existing field and, if Kyowa Kirin exercises its option to expand the licensed field, the expanded field.
26
Critical Accounting Policies and Management Estimates
The SEC defines critical accounting policies as those that are, in management’s view, important to the portrayal of our financial condition and results of operations and demanding of management’s judgment. Management’s discussion and analysis of our financial condition and results of operations are based on our unaudited condensed financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these unaudited condensed financial statements required estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in the unaudited condensed financial statements. On an ongoing basis, we evaluate our critical accounting estimates and judgments, including those related to revenue from product sales, collaborations and licenses, and clinical trial costs and accruals. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes to our critical accounting policies and estimates from the information provided in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Management Estimates,” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
ITEM 3. QUANTITATIVE AND QUALITATI
VE DISCLOSURES ABOUT MARKET RISK
Not required for smaller reporting companies.
ITEM 4. CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports required by the Exchange Act is recorded, processed, summarized and reported within the timelines specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive and financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report. Based on the foregoing, our principal executive and financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of the end of the quarter covered by this Quarterly Report.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting identified in connection with management’s evaluation of such internal control that occurred during our most recent quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
27
PART II – OT
HER INFORMATION
IT
EM 1. LEGAL PROCEEDINGS
We are not currently a party to, nor is our property the subject of, any material legal proceedings.
ITEM 1A. RISK F
ACTORS
Risk Factor Summary
We face many risks and uncertainties, as more fully described in this section under the heading “Risk Factors.” Some of these risks and uncertainties are summarized below. The summary below does not contain all of the information that may be important to you, and you should read this summary together with the more detailed discussion of these risks and uncertainties contained in “Risk Factors.”
•
Our ability to generate revenue is highly dependent on the successful commercialization of KOMZIFTI in the United States and continued global development of ziftomenib. If we are unable to successfully commercialize KOMZIFTI in the United States, or to expand ziftomenib’s indications of use or market opportunity, our ability to generate meaningful revenue or achieve profitability will be materially and adversely affected.
•
KOMZIFTI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
•
If the market opportunities for KOMZIFTI are smaller than we believe, our revenue may be adversely affected, and our business may suffer.
•
If we are unable to execute on our sales, marketing and distribution plans to commercialize KOMZIFTI, we may be unable to generate meaningful product revenue.
•
If competitors develop products, product candidates or technologies that are superior to or more favorable than KOMZIFTI or our product candidates, such development would significantly impact the development and commercial viability of KOMZIFTI and our product candidates, which would severely and adversely affect our financial results, business and business prospects, and might cause us to cease operations.
•
Post-approval results for KOMZIFTI in larger numbers of patients, broader populations or real world clinical practice may not be consistent with the results from our clinical trials.
•
We have limited experience as a commercial company and our sales, marketing and distribution of KOMZIFTI may be unsuccessful or less successful than anticipated.
•
We may be unable to maintain FDA approval of KOMZIFTI for adult patients with relapsed or refractory NPM1-mutated AML, which would severely and adversely affect our business and business prospects.
•
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals in some or all planned regions, whether due to actual or perceived deficiencies in our applications, changes in regulatory requirements, evolving agency guidance or interpretation, resource constraints at regulatory authorities, or other factors, we will not be able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
•
Our marketing approval for KOMZIFTI in the United States for adult patients with relapsed or refractory NPM1-mutated AML is subject to post-approval regulatory requirements and commitments, and we may be subject to penalties, restrictions or withdrawal from the market if we fail to comply with these requirements and commitments or if we experience unanticipated problems with KOMZIFTI.
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We are highly dependent on the success of the continued development of ziftomenib and darlifarnib, and we cannot give any assurance that ziftomenib, darlifarnib or any of our other product candidates will receive regulatory approval in any indications, which is necessary before they can be commercialized in such indications. Even if our product candidates receive regulatory approval and are commercialized in such indications, they may be less competitive and generate less revenue than we anticipate.
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Our discovery, preclinical and clinical development activities are primarily focused on the development of targeted therapeutics for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may not lead to new marketable products or new approved disease indications.
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Clinical drug development involves a lengthy and expensive process with an uncertain outcome. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of subsequent clinical trials, and preliminary or interim results of a clinical trial do not necessarily predict final results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
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We anticipate that our current product candidates and any future product candidates may be used in combination with third-party drugs or biologics, some of which may still be in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs or biologics.
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Our product candidates may cause serious adverse events or have unacceptable side effects that could delay, limit or prevent their development.
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Failure by us or our third-party collaborators to develop, validate and obtain regulatory approval for a diagnostic testing platform could harm our drug development strategy and operational results.
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We have incurred losses since our inception, expect to incur losses over the next several years and may never achieve or maintain profitability.
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We have limited historical product revenue, and we expect that our financial and operating results will vary significantly from period to period.
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We may need to obtain substantial additional capital in connection with our continuing operations. If we are required to raise additional capital, doing so may cause dilution to our stockholders, restrict our operations or require us to relinquish certain rights to our technologies or product candidates.
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Our collaboration with Kyowa Kirin is important to our business. If Kyowa Kirin ceases development efforts under the Kyowa License Agreement, or if the Kyowa License Agreement is terminated, we may not receive future milestone payments or royalties under the Kyowa License Agreement and our business could be adversely affected. If Kyowa Kirin does not fulfill its obligations under the Kyowa Co-Promotion Agreement, our business could be adversely affected.
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We rely on third-party contractors and organizations to conduct, and/or to supply materials to conduct, our clinical trials and provide commercial supply, and those third parties may not perform satisfactorily, including failing to meet deadlines for the supply of materials and/or the completion of such clinical trials or to meet the demands of our commercial supply.
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We depend on third parties for the manufacture of our product candidates for preclinical and clinical testing and for the manufacture of commercial supplies of KOMZIFTI. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or KOMZIFTI at an acceptable cost and quality, which could delay, prevent or impair our development or commercialization efforts.
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If we are unable to, or if we do not, obtain and maintain intellectual property protection for our product and product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product and product candidates may be impaired.
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We depend on our licensors to prosecute and maintain patents and patent applications that are material to our business. Any failure by our licensors to effectively protect these intellectual property rights could adversely impact our business and operations.
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Patent terms may be inadequate to protect our competitive position on our product and product candidates for a commercially meaningful length of time.
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We may not be successful in obtaining or maintaining necessary third-party intellectual property rights for our development pipeline through acquisitions and in-licenses.
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If we are unable to maintain the confidentiality of our trade secrets or other confidential information, our business and competitive position would be harmed.
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We are highly dependent on our Chief Executive Officer. Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
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If our information technology systems, or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
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Our stock price may fluctuate significantly and you may have difficulty selling your shares based on current trading volumes of our stock.
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The price of our common stock may be volatile and may be influenced by numerous factors, some of which are beyond our control.
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Risk Factors
Investing in our common stock involves a high degree of risk. In addition to the information included or incorporated by reference in this Quarterly Report and in our other public filings, you should carefully consider the risks described below in evaluating our company. Our business, financial condition or results of operations could be harmed by any of these risks. The risks and uncertainties described below are not the only ones we face. Additional risks not currently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations. We have marked with an asterisk (*) those risk factors that reflect changes from the risk factors previously disclosed in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 5, 2026.
Risks Related to the Commercialization of KOMZIFTI and Our Product Candidates
Our ability to generate revenue is highly dependent on the successful commercialization of KOMZIFTI in the United States and continued global development of ziftomenib. If we are unable to successfully commercialize KOMZIFTI in the United States, or to expand ziftomenib’s indications of use or market opportunity, our ability to generate meaningful revenue or achieve profitability will be materially and adversely affected.
KOMZIFTI is our only approved product and it has been approved solely as a monotherapy for the treatment of adult patients with relapsed or refractory NPM1-mutated AML. Prior to KOMZIFTI, we have not, as an organization, launched or commercialized a product, and there is no guarantee that we will be able to do so successfully with KOMZIFTI. Our ability to generate revenue and achieve profitability is wholly dependent on our ability to successfully commercialize KOMZIFTI in the United States and to expand ziftomenib’s indications for use beyond monotherapy in adult patients with relapsed or refractory NPM1-mutated AML.
The success of KOMZIFTI and ziftomenib will depend on several factors, including the following:
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KOMZIFTI’s ability to achieve market acceptance by physicians, patients, third-party payors and others in the medical community;
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the willingness of physicians to prescribe KOMZIFTI as a monotherapy;
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the length of time that patients who are prescribed KOMZIFTI remain on treatment, which may be shorter than we anticipate;
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our lack of experience in marketing, selling and distributing KOMZIFTI or, as an organization, any other approved product;
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our ability to obtain and maintain third-party payor coverage and adequate reimbursement in both public and private payor spaces;
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the reimbursement and coverage policies of government and private payors such as Medicare, Medicaid, insurance companies, health maintenance organizations and other plan administrators;
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effectively competing with other existing and future therapies;
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the relative price of KOMZIFTI as compared to alternative treatment options;
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the relatively low incidence and prevalence of patients in KOMZIFTI’s approved indication;
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the high unmet need and relatively poor prognosis for patients in KOMZIFTI’s approved indication;
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future competitive or other market factors that may adversely affect the commercial potential of KOMZIFTI;
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timely and successful enrollment of patients in, and completion of, clinical trials of ziftomenib with favorable results;
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our ability to obtain and maintain regulatory approvals for ziftomenib for any other indications;
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changed or increased regulatory restrictions;
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changes to the label for KOMZIFTI that could restrict how we market and sell KOMZIFTI, including as a result of new data from spontaneous adverse event reports, post-marketing studies, or ongoing or future clinical trials of ziftomenib;
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our ability to maintain adequate commercial supplies of KOMZIFTI and clinical supplies of ziftomenib to meet demand;
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our ability, or that of our collaborators, to develop and obtain clearance or approval of companion diagnostics on a timely basis, or at all, and an adequate supply of these diagnostics and access to these diagnostics that outpaces demand;
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the successful completion of any required or committed post-marketing studies and available funding to perform any such post-marketing requirements or post-marketing commitments; and
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our ability to obtain and maintain patent, trade secret and other intellectual property protection and statutory exclusivities for KOMZIFTI and ziftomenib, and to protect and enforce our intellectual property rights.
Many of these factors are beyond our control, and if we cannot address any of them in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize KOMZIFTI and continue to develop ziftomenib, which would materially harm our business. Moreover, successful commercialization of KOMZIFTI may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all. If we are unable to successfully commercialize KOMZIFTI, our ability to generate meaningful revenue from product sales and achieve profitability will be materially and adversely affected, which in turn would severely and adversely affect our financial results, business and business prospects.
KOMZIFTI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
While KOMZIFTI has received marketing approval in the United States for the treatment of adult patients with relapsed or refractory NPM1-mutated AML, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. For example, current cancer treatments like immunotherapy, chemotherapy, targeted therapy and radiation therapy are well established in the medical community, and doctors may continue to rely on these treatments to the exclusion of KOMZIFTI. If KOMZIFTI does not achieve an adequate level of market acceptance, we may not generate significant product revenues and we may not become profitable. The degree of KOMZIFTI’s market acceptance will depend on a number of factors, including:
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KOMZIFTI's efficacy, safety and potential advantages and disadvantages compared to alternative available treatments;
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our ability to offer KOMZIFTI for sale at a price reflective of its value to the market;
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the convenience and ease of administration compared to alternative treatments;
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the willingness of the target patient population to try KOMZIFTI and of physicians to prescribe KOMZIFTI;
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the willingness of physicians to keep patients of the target patient population on therapy for a duration of time;
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the strength of our marketing and distribution support;
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the availability of third-party coverage and adequate reimbursement, including patient cost-sharing programs such as copays and deductibles;
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the ability of our third-party collaborators to develop companion diagnostics;
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the acceptance and utilization of companion diagnostics to identify appropriate patients;
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the prevalence and severity of any side effects; and
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any restrictions on the use of KOMZIFTI together with other medications.
If the market opportunities for KOMZIFTI are smaller than we believe, our revenue may be adversely affected, and our business may suffer.
We are commercializing KOMZIFTI as a monotherapy for the treatment of adult patients with relapsed or refractory NPM1-mutated AML in the United States. We also intend to seek to expand ziftomenib’s indications of use into combination therapy in the frontline setting. Our estimates of the size of the patient populations with relapsed or refractory AML and newly diagnosed AML in the United States are based on a variety of sources, including scientific literature, government databases, industry reports and internal analyses. These estimates involve assumptions and uncertainties and may prove to be incorrect. Further, new data generated by us or others could change the estimated incidence or prevalence of relapsed or refractory AML or newly diagnosed AML in the United States.
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The potentially addressable patient population for KOMZIFTI may be smaller than we expect. Patients within the eligible population may not be eligible for, or amenable to, treatment with KOMZIFTI, and we may be unable to successfully identify and reach appropriate patients or achieve a significant market share in the approved indication. In addition, initial sales of KOMZIFTI may deplete the prevalence pool of patients in KOMZIFTI’s approved indication more quickly than expected, which would have a negative impact on sales of KOMZIFTI in the future.
Our commercialization of KOMZIFTI in the United States currently is limited to relapsed or refractory NPM1-mutated AML. Any future potential commercialization will be limited to the therapeutic indications examined in our clinical trials and approved by the FDA and other applicable regulatory authorities. We are not permitted to market KOMZIFTI for any unapproved indications. Future regulatory approvals for KOMZIFTI, if any, could be conditioned upon label restrictions that materially limit the addressable patient population.
Our market opportunity may also be limited by the pricing we are able to achieve, the quality and expiration of our intellectual property rights and regulatory exclusivity, duration of treatment and future competitor treatments that enter the market. If any of our estimates prove to be inaccurate, our market opportunity
could be significantly diminished, which would have a material adverse impact on our business and business prospects, and would adversely affect our ability to achieve profitability.
If we are unable to execute on our sales, marketing and distribution plans to commercialize KOMZIFTI, we may be unable to generate meaningful product revenue.
To successfully commercialize KOMZIFTI, we need to execute on our sales, marketing and distribution plans. The execution of our sales, marketing and distribution plans is, and will continue to be, expensive and time-consuming and we cannot be certain that we will be able to execute on these plans successfully.
We may compete with companies that have more extensive, experienced or well-funded sales and marketing operations to recruit, hire, train and retain marketing and sales personnel. If we are unable to retain and effectively train marketing and sales personnel and equip them with compliant and effective materials, our efforts to successfully commercialize KOMZIFTI could be adversely affected. In addition, under the Kyowa Co-Promotion Agreement, Kyowa Kirin has the right and responsibility to co-promote ziftomenib in the United States and is obligated to meet minimum detailing requirements using sales representatives meeting specific qualifications. If Kyowa Kirin does not perform in the manner we expect or fulfill its responsibilities in a timely manner, or at all, the commercialization efforts related to KOMZIFTI could be adversely impacted. Any of the foregoing would negatively impact our business and business prospects, severely and adversely affect our financial results, and might cause us to cease operations.
In addition, we rely on a select network of third-party distributors, specialty pharmacies and other vendors to distribute KOMZIFTI in the United States. We rely on such vendors to effectively distribute KOMZIFTI in a timely manner, provide certain patient support services, manage prescription intake, collect accurate patient and inventory data and collect payments from payors. While we have entered into agreements with these third parties, they may not perform as agreed, our strategic priorities may change, they may terminate their agreements with us or they may experience business disruption or failure, and any of these circumstances could adversely affect our revenues, financial condition or results of operations. Further, an inability by our distributors or specialty pharmacies to meet our patients’ needs may lead to reputational harm or patient loss. In the event that such network fails to properly meet our or our patients’ needs, we may need to partner with other distributors, specialty pharmacies or vendors to replace or supplement our current network and there is no guarantee that we will be able to do so on commercially reasonable terms or at all.
If competitors develop products, product candidates or technologies that are superior to or more favorable than KOMZIFTI or our product candidates, such development would significantly impact the development and commercial viability of KOMZIFTI and our product candidates, which would severely and adversely affect our financial results, business and business prospects, and might cause us to cease operations.
The development and commercialization of new drug products is highly competitive. We face competition with respect to KOMZIFTI and our current product candidates, and we will face competition with respect to any other product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Specifically, there are a large number of companies developing or marketing treatments for cancer, including many major pharmaceutical and biotechnology companies. Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to our approach, and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and
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other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.
KOMZIFTI competes with a number of widely accepted treatments for relapsed or refractory AML, including intensive and non-intensive chemotherapy, and other targeted therapies that target specific mutations that can be co-mutated with NPM1 mutations, including IDH1, IDH2 or FLT3 inhibitors. KOMZIFTI also competes with revumenib (REVUFORJ®), another FDA-approved menin inhibitor targeting relapsed or refractory NPM1-mutated AML as well as relapsed or refractory KMT2A-rearranged acute leukemia. In addition, KOMZIFTI may face future competition from treatments, including other menin inhibitors, that are currently under development.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, are more effective, have fewer or less severe side effects, are more convenient or are less expensive than KOMZIFTI. Our competitors may price their products below our price for KOMZIFTI, or may receive better third-party payor coverage and/or reimbursement. Such competitive practices may limit the commercial potential of KOMZIFTI.
Many of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
If we are unable to compete effectively as a result of the factors described above, our financial results, business and business prospects could be severely and adversely affected, and might cause us to cease operations.
Post-approval results for KOMZIFTI in larger numbers of patients, broader populations or real world clinical practice may not be consistent with the results from our clinical trials.
Prior to approval, KOMZIFTI had been administered only to a limited number of patients and in limited populations in clinical trials. We do not know whether the results when a larger number of patients and a broader population are exposed to KOMZIFTI, including results related to safety and efficacy, will be consistent with the results from earlier clinical trials that served as the basis for the approval. New data, including from spontaneous adverse event reports and post-marketing studies in the United States, and other ongoing clinical trials to evaluate real world experience and outcomes of patients in the United States may result in changes to the product label and may adversely affect sales or reimbursement decisions by payors, or result in withdrawal of KOMZIFTI from the market. The FDA and regulatory authorities in other jurisdictions may also consider the new data in reviewing potential marketing applications or imposing post-approval requirements. If any of these actions were to occur, it could result in significant expense and delay or limit our ability to generate sales revenues.
We have limited experience as a commercial company and our sales, marketing and distribution of KOMZIFTI may be unsuccessful or less successful than anticipated.*
As a company, prior to KOMZIFTI, we had no experience in selling, marketing or commercializing an approved drug product. The success of our commercialization efforts of KOMZIFTI is difficult to predict and subject to, among other things, continued development of our internal sales, marketing and distribution capabilities and our ability to navigate the significant expenses and risks involved with the development and management of such capabilities. For example, our commercial launch may not develop as planned or anticipated, which may require us to, among other things, adjust or amend our commercialization plan and incur significant expenses. Further, given our lack of historical experience commercializing drug products as an organization, we do not have a track record of successfully executing a commercial launch. If we are unsuccessful in accomplishing our objectives or if our commercialization efforts do not proceed as planned, we may not be able to successfully commercialize KOMZIFTI in adult patients with relapsed or refractory NPM1-mutated AML, we may require significant additional capital and financial resources, we may not become profitable, and we may not be able to compete against more established companies in our industry, any of which would severely and adversely affect our financial results, business and business prospects, and might cause us to cease operations.
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The insurance coverage and reimbursement status of newly-approved products are uncertain. Failure to obtain or maintain coverage and adequate reimbursement for KOMZIFTI or any product candidates for which we receive marketing approval could limit our ability to market those products and decrease our ability to generate revenue.*
The availability and extent of coverage and reimbursement by governmental and private payors is essential for most patients to be able to afford expensive treatments. Sales of KOMZIFTI and any product candidates for which we receive marketing approval will depend substantially, both domestically and abroad, on the extent to which the costs of KOMZIFTI and such product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize KOMZIFTI or any product candidates for which we receive marketing approval. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment. Further, coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for KOMZIFTI or any product candidates for which we receive marketing approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Further, any companion diagnostic that we or our collaborators develop will be subject to separate coverage and reimbursement determinations by third-party payors.
There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, the principal decisions about government-funded reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, or HHS, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private payors often, but not always, follow CMS’s decisions regarding coverage and reimbursement. It is difficult to predict what CMS will decide with respect to coverage and reimbursement for fundamentally novel products such as ours, as there is no body of established practices and precedents for these new products. One payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product. Further, a payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. We or our collaborators may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain FDA approvals. Nonetheless, our products may not be considered medically necessary or cost-effective.
Reimbursement agencies in countries other than the United States may be more conservative than CMS. For example, a number of cancer drugs have been approved for reimbursement in the United States and have not been approved for reimbursement in certain European countries. Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe, Canada, and other countries has and will continue to put pressure on the pricing and usage of our products. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. In general, the prices of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for medicines but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our products. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits.
Moreover, increasing efforts by governmental and third-party payors, in the United States and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement for new products approved and, as a result, they may not cover or provide adequate payment for our products. In addition, drug-pricing by pharmaceutical companies has come under increased scrutiny. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing by requiring drug companies to notify insurers and government regulators of price increases and provide an explanation of the reasons for the increase, reduce the out-of-pocket cost of prescription drugs, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drugs. Further, HHS imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation. In addition, HHS has been empowered to negotiate the price of certain single-source drugs that have been on the market for at least seven years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to 20 products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our current and any future product candidates that we develop, which could have an adverse effect on our operating results and our overall financial condition. We expect to experience pricing pressures in connection
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with the sale of our products, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products into the healthcare market.
In addition to CMS and private payors, professional organizations such as the NCCN and American Society of Clinical Oncology can influence decisions about reimbursement for new medicines by determining standards for care. Also, many private payors contract with commercial vendors who sell software that provide guidelines that attempt to limit utilization of, and therefore reimbursement for, certain products deemed to provide limited benefit to existing alternatives. Such organizations may set guidelines that limit reimbursement or utilization of our products.
Further, we or our collaborators will be required to obtain coverage and reimbursement for companion diagnostic tests separate and apart from the coverage and reimbursement we seek for KOMZIFTI and any product candidates for which we receive marketing approval. There is significant uncertainty regarding our and our collaborators’ ability to obtain coverage and adequate reimbursement for any companion diagnostic test for the same reasons applicable to KOMZIFTI and our product candidates. If insurance coverage and reimbursement for companion diagnostic tests for our products is inadequate, utilization may be low, and patients may not be comprehensively screened for the presence of the genetic markers that predict response to our products.
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of KOMZIFTI or any other approved products.*
We face an inherent risk of product liability exposure related to the commercialization of KOMZIFTI and testing of our product candidates in human clinical trials. If we cannot successfully defend ourselves against claims that KOMZIFTI or any of our product candidates caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
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FDA or other regulatory authority investigations, which could lead to a product recall or more serious enforcement action, limitations on approved indications or suspension or withdrawal of approvals;
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decreased demand for KOMZIFTI or any other approved products;
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injury to our reputation and significant negative media attention;
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withdrawal of clinical trial participants;
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significant costs to defend the related litigation;
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substantial monetary awards to clinical trial participants or patients;
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loss of revenue;
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reduced resources of our management to pursue our business strategy; and
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the inability to commercialize KOMZIFTI or any other approved products.
We currently have product liability and clinical trial liability insurance coverage that we believe is sufficient, but such coverage may not be adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage related to the commercialization of KOMZIFTI and each time we commence or expand a clinical trial. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
Risks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
We may be unable to maintain FDA approval of KOMZIFTI for adult patients with relapsed or refractory NPM1-mutated AML, which would severely and adversely affect our business and business prospects.
In November 2025, we received regulatory approval from the FDA to commercialize ziftomenib under the trade name KOMZIFTI in the United States for adult patients with relapsed or refractory NPM1-mutated AML. Ziftomenib does not yet have regulatory approval for any other indication. Failure to maintain FDA approval for KOMZIFTI for adult patients with relapsed or refractory NPM1-mutated AML, or delays in obtaining, failure to obtain, or limitations in the scope of any obtained approvals for ziftomenib for any other indications, could:
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result in a withdrawal of KOMZIFTI from the market or otherwise delay, limit or preclude any revenue we may receive from the commercialization of KOMZIFTI in the United States;
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significantly harm the commercial potential of KOMZIFTI; or
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impede, halt or increase the costs of our activities and plans for further clinical development of ziftomenib.
In addition, approved products and their manufacturers are subject to continual review, and discovery of previously unknown problems with a product or its manufacturer may result in restrictions on the product or manufacturer, including import restrictions, seizure and withdrawal of the product from the market. Commercialization and sales of KOMZIFTI are subject to government regulations related to numerous matters, including the processes of manufacturing, advertising and promotion, sales and marketing, medical information, labeling and distribution. If, and to the extent that, we are unable to comply with these regulations, our ability to earn revenue from the commercialization of KOMZIFTI will be materially and adversely impacted.
Further, if KOMZIFTI causes serious or unexpected side effects, or if other safety risks are observed as a result of our commercialization efforts for KOMZIFTI in the United States in relapsed or refractory NPM1-mutated AML or in current or potential future clinical trials of ziftomenib, a number of potential significant negative consequences could result, including:
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the FDA may withdraw its approval of KOMZIFTI;
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we may be required to recall KOMZIFTI, seek to change the way it is administered or conduct additional clinical trials;
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the FDA may require revisions to the labeling of KOMZIFTI, including limitations on approved uses or the addition of further warnings, contraindications or other safety information, or may impose restrictions on distribution in the form of risk evaluation and mitigation strategies;
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we may experience manufacturing delays and supply disruptions if regulatory inspectors identify regulatory noncompliance by third-party manufacturers requiring remediation;
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KOMZIFTI may be rendered less competitive and sales, if any, may decrease;
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our reputation may suffer generally both among clinicians and patients;
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we may be exposed to lawsuits and associated legal expenses, including costs of resolving claims;
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the FDA or similar international regulatory authorities may refuse to approve pending applications, or may suspend or revoke license approvals; or
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we may be required to change or stop ongoing clinical trials of ziftomenib, which would negatively impact the development of ziftomenib for other potential indications.
Any of these events could prevent us from achieving or maintaining market acceptance for KOMZIFTI, could substantially increase the costs and expenses of commercializing KOMZIFTI, or could limit its commercial potential, which in turn could delay or prevent us from generating any meaningful revenues from the sale of the KOMZIFTI.
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals in some or all planned regions, whether due to actual or perceived deficiencies in our applications, changes in regulatory requirements, evolving agency guidance or interpretation, resource constraints at regulatory authorities, or other factors, we will not be able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
Our product candidates must be approved by the FDA in the United States and similar regulatory authorities outside the United States prior to commercialization.
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The process of obtaining marketing approvals, both in the United States and abroad, is expensive and takes many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities, among other requirements. Our product candidates may not be effective, may be only moderately effective, may not have an acceptable durability of response, may not have an acceptable risk-benefit profile or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude us from obtaining marketing approval or prevent or limit commercial use.
Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical studies, clinical trials or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Moreover, the regulatory environment for new drug development is dynamic and subject to change, and the FDA and other regulatory agencies may modify their policies, guidance, review processes, or approval standards in ways that are difficult to predict. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in or prevent the approval of an application.
The ability of the FDA to review and approve new products or review other regulatory submissions can be affected by a variety of factors, including statutory, regulatory and policy changes, inadequate government budget and funding levels, a reduction in the FDA’s workforce and its ability to hi