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Item 2 — Management's Discussion and Analysis
Oruka Therapeutics, Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial
statements and the related notes included in Part I, Item 1 of this Quarterly Report on Form 10-Q for the quarterly period ended June
30, 2026 (this “Quarterly Report”) and with the audited consolidated financial statements and related notes included in our
Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”)
on March 12, 2026. This discussion contains forward-looking statements that involve risks and uncertainties, such as statements regarding
our plans, objectives, expectations, intentions, hopes, beliefs, strategies or projections regarding the future of our pipeline and business
and words such as “may,” “will,”, “should,” “could,” “would,” “expect,”
“plan,” “anticipate,” “believe,” “estimate,” “project,” “potential,”
“seek,” “target,” “goal,” “intend” and variations of such words and any statements that
refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, and
similar expressions are intended to identify forward-looking statements. You should not place undue reliance on these forward-looking
statements. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential
effects. There can be no assurance that future developments affecting us will be those that have been anticipated. These forward-looking
statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual
results or performance to be materially different from those expressed or implied by these forward-looking statements. Factors that could
cause or contribute to such differences include, but are not limited to, those discussed in the section of this Quarterly Report entitled
“Risk Factors” and elsewhere in this Quarterly Report. These and many other factors could affect our future financial and
operating results. We undertake no obligation to update any forward-looking statement to reflect events after the date of this Quarterly
Report. As used in this Quarterly Report, unless the context suggests otherwise, “we,” “us,” “our,”
“the Company,” “Oruka Therapeutics, Inc.,” and “Oruka,” refers to Oruka Therapeutics, Inc. and its
consolidated subsidiary, Oruka Therapeutics Operating Company LLC, taken as a whole.
Overview
We are a clinical-stage
biopharmaceutical company focused on developing novel monoclonal antibody therapeutics for psoriasis (“PsO”) and other inflammatory
and immunology (“I&I”) indications. Our name is derived from or, for “skin,” and arukah, for
“restoration,” and reflects our mission to deliver therapies for chronic skin diseases that provide patients the most
possible freedom from their condition. Our strategy is to apply antibody engineering and format innovations to validated modes of action,
which we believe will enable us to improve meaningfully upon the efficacy and dosing regimens of standard-of-care medicines while significantly
reducing technical and biological risk. Our programs aim to treat and potentially modify disease by targeting mechanisms with proven
efficacy and safety involved in disease pathology and the activity of pathogenic tissue-resident memory T cells (“TRMs”).
Our lead program,
ORKA-001, is designed to target the p19 subunit of interleukin-23 (“IL-23p19”) for the treatment of PsO. Our co-lead
program, ORKA-002, is designed to target interleukin-17A and interleukin-17F (“IL-17A/F”) for the treatment of PsO,
hidradenitis suppurativa (“HS”), psoriatic arthritis (“PsA”), and other conditions. These programs each bind
their respective targets at high affinity and incorporate half-life extension technology with the aim to increase exposure and
decrease dosing frequency. We are also developing ORKA-004, a novel, extended half-life antibody designed to target TNF-like ligand
1A (“TL1A”), which we plan to pursue in combination with ORKA-001 and ORKA-002 in a variety of diseases. We believe that
our focused strategy, differentiated portfolio, and deep expertise position us to set a new treatment standard in large I&I
markets with continued unmet need.
Since our inception in February
2024, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific
planning, conducting discovery and research activities, establishing and protecting our intellectual property portfolio, establishing
arrangements with third parties for the manufacture of our programs and component materials, developing and progressing our pipeline,
and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated
any revenue from product sales. To date, we have funded our operations primarily with proceeds from the issuance of convertible preferred
stock, common stock, a convertible note, and pre-funded warrants.
Since our inception, we have
incurred significant losses and negative cash flows from our operations. Our ability to generate product revenue sufficient to achieve
profitability will depend heavily on the successful development and eventual commercialization of any programs we may develop. As of June
30, 2026, we had an accumulated deficit of $262.2 million. For the three and six months ended June 30, 2026, we had net losses of $41.2
million and $73.0 million, respectively, and we used net cash of $56.7 million for our operating activities during the six months ended
June 30, 2026.
We had cash, cash equivalents,
and marketable securities of $1.1 billion as of June 30, 2026. In addition, in July 2026, we sold 1,499,500 shares of our common stock
pursuant to our existing ATM offering program for net proceeds of $122.5 million, after deducting sales agents’ commissions. We
expect that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operating plans for at least
twelve months from the date of filing of this Quarterly Report. We expect to continue to incur substantial losses for the foreseeable
future, and our transition to profitability will depend upon successful development, approval and commercialization of our product candidates
and upon achievement of sufficient revenues to support our cost structure.
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Our Portfolio and Development Plans
ORKA-001
ORKA-001 is a high affinity,
extended half-life monoclonal antibody (“mAb”) designed to target IL-23p19. IL-23 is a pro-inflammatory cytokine that plays
a critical role in the proliferation and development of T helper 17 (“Th17”) cells, which are the primary drivers of several
autoimmune and inflammatory disorders, including PsO. IL-23 is composed of two subunits: a p40 subunit that is shared with IL-12
and a p19 subunit that is specific to IL-23. First-generation IL-23 antibodies bound p40 and inhibited both IL-12 and IL-23 signaling,
while more recent IL-23 antibodies targeting the p19 subunit have shown improved efficacy and safety. Based on clinical evidence, we
believe that ORKA-001 could achieve higher response rates than established therapies in PsO while requiring less frequent dosing and
maintaining the favorable safety profile of therapies targeting IL-23p19.
ORKA-001 is engineered with
YTE half-life extension technology, a specific three amino acid change in the fragment crystallizable (“Fc”) domain to modify
the pH-dependent binding to the neonatal Fc receptor (“FcRn”). As a result, it has a pharmacokinetic profile designed to
support a subcutaneous (“SQ”) injection as infrequently as once or twice per year. In addition, emerging evidence suggests
that IL-23 blockade can modify the disease biology of PsO, possibly leading to durable remissions and preventing the development of PsA.
We believe that the expected characteristics of ORKA-001 increase its potential to deliver these disease-modifying benefits.
We initiated a Phase 1 trial
of ORKA-001 in the fourth quarter of 2024. In September 2025, we announced interim results and updated those results in April 2026. The
data showed that ORKA-001 has a human half-life of approximately 100 days and was well tolerated at all dose levels, with a favorable
safety profile consistent with the anti-IL-23 class. The Phase 1 trial data support that a single 600 mg dose maintained ORKA-001
concentrations well above effective trough levels through Week 52, the last timepoint evaluated, with sustained inhibition of IL-23 pathway
signaling observed throughout that time period.
In the third quarter of 2025,
we commenced dosing in a Phase 2a clinical trial of ORKA-001 in patients with moderate-to-severe PsO (also known as “EVERLAST-A”).
EVERLAST-A enrolled 84 patients randomized 3:1 to receive 600 mg of ORKA-001 at Weeks 0 and 4 or matching placebo. At Week 28, patients
who achieved PASI 100 were randomized 2:1 to an arm where either (1) they do not receive another dose until disease recurrence (to evaluate
the possibility of both yearly dosing and extended off-treatment remissions) or (2) they receive 300 mg ORKA-001 every six months. In
April 2026, we presented Week 16 data for all EVERLAST-A patients, showing that 40 of 63 participants (63.5%) treated with ORKA-001 achieved
the primary endpoint of PASI 100, representing a 100% reduction from baseline in the Psoriasis Area and Severity Index (“PASI”),
with identical results observed for Investigator’s Global Assessment (“IGA”) 0. Other key secondary endpoints included
PASI 90 at Week 16, achieved by 83% of participants, and IGA 0/1 at Week 16, achieved by 84% of participants. ORKA-001 was observed as
well tolerated with a safety profile consistent with prior IL-23p19 inhibitors. There were no serious treatment-emergent adverse events
(“TEAEs”) and only one severe TEAE, which occurred in the placebo group. Additionally, there were no injection site reactions.
Eligible patients initially randomized to ORKA-001 have the option to transition to the open-label extension study of ORKA-001 at Week
52, and eligible patients initially randomized to placebo have the option to transition to the open-label extension study at Week 28.
We plan to share Week 28 data from all patients at the end of the third quarter of 2026. We also plan to announce Week 52 data from all
patients by the end of 2026.
Additionally, we
commenced dosing in a Phase 2b clinical trial of ORKA-001 in patients with moderate-to-severe PsO (also known as
“EVERLAST-B”) in December 2025. EVERLAST-B enrolled 187 patients and is designed to evaluate three dose levels of
ORKA-001: 37.5 mg at Week 0, 300 mg at Weeks 0 and 4, and 600 mg at Weeks 0 and 4, versus placebo. The primary endpoint is PASI 100
at Week 16. Building on EVERLAST-A, this design is intended to further test the potential for ORKA-001 to achieve yearly dosing,
higher efficacy and extended off-treatment remissions. At Week 28, patients who have achieved PASI 100 will be re-randomized 1:1 to
either a 600 mg dose once yearly or placebo. Patients who have not achieved PASI 100 at Week 28 will receive a 300 mg dose every six
months. Eligible patients initially randomized to placebo have the option to roll over into the open-label extension study of
ORKA-001 at Week 28. We expect to announce Week 16 data from EVERLAST-B in the fourth quarter of 2026.
In addition, we expect to initiate the ORKA-001 Phase 3 program in
the first half of 2027.
ORKA-002
ORKA-002 is a high affinity,
extended half-life mAb designed to target IL-17A and IL-17F (“IL-17A/F”). IL-17 inhibition has become central to the treatment
of psoriatic diseases, including PsO and PsA, and has also shown efficacy in other I&I indications, such as HS and axial spondyloarthritis
(“axSpA”). More recently, the importance of inhibiting the IL-17F isoform along with IL-17A has become appreciated, and dual
blockade with the recently approved therapy Bimzelx (bimekizumab) has led to higher response rates in patients than blockade of IL-17A
alone. ORKA-002 is designed to bind IL-17A/F at similar epitopes, or binding sites, and affinity ranges as bimekizumab, but incorporates
half-life extension technology that could enable more convenient dosing intervals.
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In January 2026, we announced interim findings from the Phase 1 trial
of ORKA-002 in healthy volunteers. The results showed that ORKA-002 has a half-life of approximately 75-80 days, which supports the potential
for twice-yearly maintenance dosing in PsO and quarterly maintenance dosing in HS. Single doses of ORKA-002 demonstrated potent and sustained
inhibition of IL-17 signaling in an ex vivo assay through 24 weeks. The data supports that ORKA-002 was well tolerated at all dose levels,
with a favorable safety profile consistent with the anti-IL-17 class. The trial remains blinded, and as of January 6, 2026, which was
the data cutoff date, all subjects remained on trial.
Based on these Phase 1 results,
we initiated ORCA-SURGE, a Phase 2 trial of ORKA-002 in patients with moderate-to-severe PsO, in February 2026. ORCA-SURGE is designed
to enroll approximately 160 patients randomized 1:1:1:1 to receive 40 mg, 160 mg or 320 mg of ORKA-002 at Weeks 0 and 4, or matching placebo.
The primary endpoint is PASI 100 at Week 16. Maintenance dosing will evaluate the potential for twice-yearly dosing with ORKA-002. We
expect to announce data from ORCA-SURGE in the first quarter of 2027.
In addition, we initiated
ORCA-SPLASH, a Phase 2 trial of ORKA-002 in patients with moderate-to-severe HS. ORCA-SPLASH is designed to enroll approximately 160 patients. Patients will be randomized
1:1 to receive 320 mg of ORKA-002 or placebo at Week 0, Week 4, Week 8, and Week 12. The primary endpoint is HiSCR75 (Hidradenitis Suppurativa
Clinical Response 75) at Week 16. Participants then enter an open-label maintenance period evaluating 320 mg of ORKA-002 every 12
weeks.
ORKA-004 and Additional Pipeline Program
ORKA-004 is a novel, subcutaneously administered, extended half-life mAb designed to target TL1A. We anticipate initiating clinical development
of ORKA-004 in the fourth quarter of 2026. We plan to pursue ORKA-004 in combination with ORKA-001 and ORKA-002, with Phase 2 combination
trials planned to begin in 2027.
In addition, we have a fourth program, ORKA-003, designed to target an undisclosed pathway. These additional programs provide the potential
for indication expansion beyond PsO while maintaining our strategic focus in I&I diseases, and especially inflammatory dermatology
conditions.
Option Agreements and License Agreements – Paragon Therapeutics
In March 2024, we entered
into two Antibody Discovery and Option Agreements with Paragon and Paruka (each, an “Option Agreement”), pursuant to which
we initiated certain research programs with Paragon focusing on discovering, generating, identifying and/or characterizing antibodies
directed to a particular target, including for IL-23 and IL-17A/F for ORKA-001 and ORKA-002, respectively. In September 2024, we exercised
our exclusive option to acquire certain rights to ORKA-001, and in December 2024, we entered into a corresponding license agreement with
Paragon pursuant to which Paragon granted us a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize or
otherwise exploit certain antibodies and products targeting IL-23 in all fields other than the field of inflammatory bowel disease. In
December 2024, we exercised our exclusive option to acquire certain rights to ORKA-002, and in February 2025, we entered into the corresponding
license agreement with Paragon pursuant to which Paragon granted us a royalty-bearing, world-wide, exclusive license to develop, manufacture,
commercialize or otherwise exploit certain antibodies and products targeting IL-17A/F in all fields (collectively, the “License
Agreements”). In May 2026, we amended our ORKA-001 License Agreement with Paragon to expand the definition of “ORKA-001 Field”
to include inflammatory bowel disease. The amendment expands the definition of ORKA-001 Field to encompass all therapeutic, prophylactic,
palliative and diagnostic uses, subject to the restriction that we will not dose a human patient in a clinical trial of ORKA-001 for inflammatory
bowel disease as part of a combination until June 1, 2028 or as a monotherapy until June 1, 2030 (the “Monotherapy Dosing Restriction”).
In the event we or a licensee of Paragon’s retained rights under the ORKA-001 License Agreement consummates a material transaction,
including a change of control of the Company or such licensee, then any remaining restrictions outside of the initial definition of ORKA-001
Field set forth in the Monotherapy Dosing Restriction shall remain in effect only until June 1, 2028.
Pursuant to each of the
License Agreements, Paragon has agreed not to conduct any new campaigns that generate anti-IL-23 monospecific antibodies or anti-IL-17A/F
monospecific antibodies in the respective agreed-upon fields. Each of the ORKA-001 and ORKA-002 License Agreements may be terminated
on 60 days’ notice to Paragon, on material breach without cure, and on a party’s insolvency or bankruptcy to the extent permitted
by law.
Pursuant to the terms of
each of the License Agreements, we are obligated to pay Paragon non-refundable milestone payments of up to $12.0 million under each respective
agreement upon the achievement of certain clinical development milestones and up to $10.0 million under each respective agreement upon
the achievement of certain regulatory milestones. In addition, we are obligated to pay Paragon a low single-digit percentage royalty
for antibody products for each of ORKA-001 and ORKA-002. For each of the License Agreements, the royalty term ends on the later of (i)
the last-to-expire licensed patent or our patent directed to the manufacture, use or sale of a licensed antibody in the country at issue
or (ii) 12 years from the date of first sale of our product. There is also a royalty step-down if there is no Paragon patent in effect
during the royalty term for each program.
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In December 2025, we entered
into an additional option agreement for an antibody with Paragon and Paruka to enter into a license agreement, which we exercised in
December 2025. Per the terms of this option agreement, once we enter into the corresponding license agreement, we will be required to
make non-refundable milestone payments to Paragon of up to $12.0 million under the agreement upon the achievement of certain clinical
development milestones, up to $10.0 million under the agreement upon the achievement of a certain regulatory milestone, as well as a
low single-digit percentage royalty for antibody products beginning on the first commercial sale. As of June 30, 2026, we have not entered
into a license agreement with Paragon and Paruka related to this additional option agreement.
During the three and six
months ended June 30, 2026, we incurred and expensed a milestone of nil and $3.0 million for the ORKA-002 License Agreement, respectively.
Pursuant to the License Agreements, as of June 30, 2026, we have incurred and expensed milestone payments of $7.0 million for each of
ORKA-001 and ORKA-002.
Components of Results of Operations
Revenue
To date, we have not generated
revenue from any sources, including product sales, and do not expect to generate any revenue from the sale of products in the foreseeable
future. If our development efforts for our product candidates are successful and result in regulatory approval, we may generate revenue
in the future from product sales or payments from future collaboration or license agreements that we may enter into with third parties,
or any combination thereof. We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale
of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.
Operating Expenses
Research and Development
Research and development
expenses consist primarily of costs incurred in connection with the development and research of our programs. These expenses include:
● costs of funding research performed by third parties that conduct research and development activities on our behalf;
● costs incurred, and milestone payments under license and option agreements;
● expenses incurred in connection with continuing our current research programs and discovery-phase development of any programs we may identify, including under future agreements with third parties, such as consultants and contractors;
● expenses incurred under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and with clinical trial sites that conduct research and development activities on our behalf;
● the cost of development and validating our manufacturing process for use in our preclinical studies and current and future clinical trials;
● personnel-related expenses, including salaries, bonuses, employee benefits, travel, and stock-based compensation expense; and
● allocated human resource costs, information technology costs, and facility-related costs, including rent, maintenance, utilities, and depreciation for our leased office space.
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We expense research and development
costs as incurred. Non-refundable advance payments that we make for goods or services to be received in the future for use in research
and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the
services are performed, or when it is no longer expected that the goods will be delivered or the services rendered. Our primary focus
since inception has been the identification and development of our pipeline programs. Our research and development expenses primarily
consist of external costs. See Note 9 to the condensed consolidated financial statements included in Part I - Item 1 of this Quarterly
Report for further details on the Option Agreements and License Agreements.
We expect our research and
development expenses will increase substantially for the foreseeable future as we continue to invest in research and development activities
related to the continued development of our programs, developing any future programs, including investments in manufacturing, as we advance
any program we may identify and continue to conduct clinical trials. The success of programs we may identify and develop will depend
on many factors, including the following:
● timely and successful completion of preclinical studies and clinical trials;
● effective investigational new drug (“IND”) or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for any programs we may develop;
● successful enrollment and completion of clinical trials;
● positive results from our clinical trials that support a finding of safety and effectiveness, acceptable pharmacokinetics profile, and an acceptable risk-benefit profile in the intended populations;
● receipt of marketing approvals from applicable regulatory authorities;
● establishment of arrangements through our own facilities or with third-party manufacturers for clinical supply and, where applicable, commercial manufacturing capabilities; and
● maintenance of a continued acceptable safety, tolerability, and efficacy profile of any programs we may develop following approval.
Any changes in the outcome
of any of these variables with respect to the development of programs that we may identify could mean a significant change in the costs
and possible delays in timing associated with the development of such programs. For example, if the FDA or another regulatory authority
were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical
development of a program, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we
would be required to expend significant additional financial resources and time on the completion of clinical development. We may never
obtain regulatory approval for any of our programs.
General and Administrative
General and administrative
expenses consist primarily of personnel-related expenses, including salaries, bonuses, employee benefits, travel, and stock-based compensation,
for our executive and other administrative personnel. Other significant general and administrative expenses include legal services, including
intellectual property and corporate matters; professional fees for accounting, auditing, tax, insurance, and allocated human resource
costs, information technology costs, and facility-related costs, including rent, utilities, maintenance, and depreciation for our leased
office space.
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We expect our general and
administrative expenses will increase substantially for the foreseeable future as we anticipate an increase in our personnel headcount
to support the expansion of research and development activities, as well as to support our operations generally. We also expect to continue
to incur significant expenses associated with being a public company, including costs related to accounting, audit, legal, regulatory,
and tax-related services associated with maintaining compliance with applicable Nasdaq and SEC requirements; director and officer
insurance costs; and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as
we file patent applications to protect innovations arising from our research and development activities.
Other Income (Expense), Net
Total other income (expense),
net, consists of interest earned on our cash, cash equivalents, and marketable securities, and foreign currency transactions gains and
losses.
Results of Operations
Comparison of the Three Months Ended June
30, 2026 and 2025
The following table summarizes
our results of operations for the periods presented (in thousands):
Three Months Ended June 30, Change
2026 2025 $ %
Operating expenses
Research and development(1) $ 43,257 $ 24,087 $ 19,170 80 %
General and administrative(2) 6,850 4,342 2,508 58 %
Total operating expenses 50,107 28,429 21,678 76 %
Loss from operations (50,107 ) (28,429 ) (21,678 ) 76 %
Other income (expense)
Interest income 8,897 3,857 5,040 131 %
Other income (expense), net 4 (2 ) 6 *
Total other income, net 8,901 3,855 5,046 131 %
Net loss $ (41,206 ) $ (24,574 ) $ (16,632 ) 68 %
* Percentage not meaningful
(1) Includes related party amounts of nil and $4,281 for the three months ended June 30, 2026 and 2025, respectively.
(2) Includes related party amounts of nil and $12 for the three months ended June 30, 2026 and 2025, respectively.
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Research and Development Expenses
The following table summarizes our research and
development expenses for the periods presented (in thousands):
Three Months Ended June 30, Change
2026 2025 $ %
External research and development expenses $ 30,924 $ 16,416 $ 14,508 88 %
Other research and development expenses:
Personnel-related (excluding stock-based compensation) 6,786 3,301 3,485 106 %
Stock-based compensation 3,913 3,368 545 16 %
Other 1,634 1,002 632 63 %
Total research and development expenses $ 43,257 $ 24,087 $ 19,170 80 %
Research and development
expenses increased by $19.2 million, from $24.1 million for the three months ended June 30, 2025 to $43.3 million for the three months
ended June 30, 2026.
External research and development
expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $14.5 million, from
$16.4 million for the three months ended June 30, 2025 to $30.9 million for the three months ended June 30, 2026. The increase is primarily
related to increased CRO expenses related to our ongoing clinical trials, a $5.0 million expense related to a non-refundable upfront payment
made to Halozyme Hypercon, Inc. (“Halozyme”) pursuant to our collaboration and license agreement, and increased CMO product
development and manufacturing expenses. These increases were partially offset by the absence of a $2.5 million milestone pursuant to ORKA-002
License Agreement with Paragon related to dosing of the first patient in a Phase 1 trial during the prior year.
Personnel-related expenses,
excluding stock-based compensation, increased by $3.5 million, from $3.3 million for the three months ended June 30, 2025 to $6.8 million
for the three months ended June 30, 2026. This increase was primarily attributable to the growth in our research and development headcount
to support our growing portfolio of clinical trials. Stock-based compensation expense increased by $0.5 million, from $3.4 million for
the three months ended June 30, 2025 to $3.9 million for the three months ended June 30, 2026. The increase in stock-based compensation
expense is primarily related to a $2.2 million increase related to employee awards due to an increase in research and development headcount,
partially offset by a $1.7 million decrease due to the absence of expense related to the Paruka warrant liability under the Option Agreements,
which was recorded in the prior year.
Other research and development
expenses increased by $0.6 million, from $1.0 million for the three months ended June 30, 2025 to $1.6 million for the three months ended
June 30, 2026, primarily due to an increase in our research and development employee count.
General and Administrative Expenses
The following table summarizes our general and
administrative expenses for the periods presented (in thousands):
Three Months Ended June 30, Change
2026 2025 $ %
Personnel-related (including stock-based compensation) $ 5,492 $ 3,426 $ 2,066 60 %
Professional and consulting services 1,208 758 450 59 %
Other 150 158 (8 ) (5 )%
Total general and administrative expenses $ 6,850 $ 4,342 $ 2,508 58 %
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General and administrative
expenses increased by $2.5 million, from $4.3 million for the three months ended June 30, 2025 to $6.9 million for the three months ended
June 30, 2026.
Personnel-related expenses,
including stock-based compensation, increased by $2.1 million, from $3.4 million for the three months ended June 30, 2025 to
$5.5 million for the three months ended June 30, 2026. This increase was primarily attributable to a $1.7 million increase in
stock-based compensation expense due to additional equity awards issued to existing employees and new equity awards granted to new hires,
and an increase in headcount to support our growing operations as a public company.
Expenses related to professional and consulting services increased
by $0.5 million, from $0.8 million for the three months ended June 30, 2025 to $1.2 million for the three months ended
June 30, 2026, due to higher spending on legal and other professional services to support our growing operations as a public company.
Other general and administrative
expenses remained relatively consistent year over year.
Total Other Income (Expense), Net
Interest income from cash
equivalents and marketable securities was $8.9 million and $3.9 million for the three months ended June 30, 2026 and 2025, respectively.
The increase was primarily due to interest earned on higher cash and marketable securities balances.
Comparison of the Six Months Ended June
30, 2026 and 2025
The following table summarizes
our results of operations for the periods presented (in thousands):
Six Months Ended June 30, Change
2026 2025 $ %
Operating expenses
Research and development(1) $ 72,402 $ 44,012 $ 28,390 65 %
General and administrative(2) 14,139 9,503 4,636 49 %
Total operating expenses 86,541 53,515 33,026 62 %
Loss from operations (86,541 ) (53,515 ) (33,026 ) 62 %
Other income (expense)
Interest income 13,503 7,949 5,554 70 %
Other income (expense), net 12 (7 ) 19 *
Total other income, net 13,515 7,942 5,573 70 %
Net loss $ (73,026 ) $ (45,573 ) $ (27,453 ) 60 %
* Percentage not meaningful
(1) Includes related party amounts of $3,000 and $6,403 for the six months ended June 30, 2026 and 2025, respectively.
(2) Includes related party amounts of $4 and $122 for the six months ended June 30, 2026 and 2025, respectively.
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Research and Development Expenses
The following table summarizes our research and
development expenses for the periods presented (in thousands):
Six Months Ended June 30, Change
2026 2025 $ %
External research and development expenses $ 49,253 $ 30,026 $ 19,227 64 %
Other research and development expenses:
Personnel-related (excluding stock-based compensation) 12,863 5,764 7,099 123 %
Stock-based compensation 7,492 6,371 1,121 18 %
Other 2,794 1,851 943 51 %
Total research and development expenses $ 72,402 $ 44,012 $ 28,390 65 %
Research and development
expenses increased by $28.4 million, from $44.0 million for the six months ended June 30, 2025 to $72.4 million for the six months
ended June 30, 2026.
External research and development
expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $19.2 million, from
$30.0 million for the six months ended June 30, 2025 to $49.3 million for the six months ended June 30, 2026. The increase is primarily
related to an increase in our CRO expenses related to our ongoing clinical trials and a $5.0 million expense related to a non-refundable
upfront payment made to Halozyme pursuant to our collaboration and license agreement. These increases were partially offset by lower research
related expenses incurred during the current year.
Personnel-related expenses,
excluding stock-based compensation, increased by $7.1 million, from $5.8 million for the six months ended June 30, 2025 to $12.9 million
for the six months ended June 30, 2026. This increase was primarily attributable to the growth in our research and development headcount
to support our growing portfolio of clinical trials. Stock-based compensation expense increased by $1.1 million, from $6.4 million for
the six months ended June 30, 2025 to $7.5 million for the six months ended June 30, 2026. The increase in stock-based compensation expense
is primarily related to a $4.2 million increase related to employee awards due to an increase in research and development headcount, partially
offset by a $3.1 million decrease due to the absence of expense related to the Paruka warrant liability under the Option Agreements, which
was recorded in the prior year.
Other research and development
expenses increased by $0.9 million, from $1.9 million for the six months ended June 30, 2025 to $2.8 million for the six months ended
June 30, 2026, primarily due to an increase in our research and development employee count.
General and Administrative Expenses
The following table summarizes our general and
administrative expenses for the periods presented (in thousands):
Six Months Ended June 30, Change
2026 2025 $ %
Personnel-related (including stock-based compensation) $ 10,998 $ 7,000 $ 3,998 57 %
Professional and consulting services 2,796 2,120 676 32 %
Other 345 383 (38 ) (10 )%
Total general and administrative expenses $ 14,139 $ 9,503 $ 4,636 49 %
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General and administrative
expenses increased by $4.6 million, from $9.5 million for the six months ended June 30, 2025 to $14.1 million for the six months ended
June 30, 2026.
Personnel-related expenses, including stock-based compensation, increased
by $4.0 million, from $7.0 million for the six months ended June 30, 2025 to $11.0 million for the six months ended
June 30, 2026. This increase was primarily attributable to a $3.2 million increase in stock-based compensation expense due to additional
equity awards issued to existing employees and new equity awards granted to new hires, and an increase in cash personnel costs due to
additional headcount to support our growing operations as a public company.
Expenses related to professional and consulting services increased
by $0.7 million, from $2.1 million for the six months ended June 30, 2025 to $2.8 million for the six months ended
June 30, 2026, due to higher spending on legal and other professional services to support our growing operations as a public company.
Other general and administrative
expenses remained relatively consistent year over year.
Total Other Income (Expense), Net
Interest income from cash
equivalents and marketable securities was $13.5 million and $7.9 million for the six months ended June 30, 2026 and 2025, respectively.
The increase was primarily due to interest earned on higher cash and marketable securities balances.
Liquidity and Capital Resources
As of June 30, 2026, we had
$1.1 billion of cash, cash equivalents, and marketable securities.
Since our inception, we have
incurred significant operating losses and negative cash flow from operations. We expect to incur significant expenses and operating losses
for the foreseeable future as we continue the preclinical and clinical development of our programs and our early-stage research activities.
We have not yet commercialized any products, and we do not expect to generate revenue from sales of products for several years, if
at all. Through June 30, 2026, we have funded our operations primarily with proceeds from issuances of convertible preferred stock, common
stock, a convertible note, and pre-funded warrants.
In October 2025, we entered
into a Sales Agreement with TD Securities (USA) LLC (the “Sales Agreement”), as our sales agent, pursuant to which we may
issue and sell, from time to time, shares of common stock for aggregate gross proceeds of up to $200.0 million under an at-the-market
(“ATM”) equity offering program. We are not obligated to make any sales of shares under the Sales Agreement. During the three
months ended March 31, 2026, we issued and sold an aggregate of 1,167,895 shares of the Company’s common stock pursuant to the ATM
offering program for total net proceeds of $38.9 million after deducting sales agents’ commissions. In addition, in July 2026, we
sold 1,499,500 shares of our common stock pursuant to the ATM offering program for net proceeds of $122.5 million, after deducting sales
agents’ commissions. In April 2026, we sold 9,660,000 shares of our common stock in an underwritten public offering for net proceeds
of $658.3 million, after deducting underwriting discounts and commissions and related issuance expenses.
Our primary use of cash
is to fund the development of our product candidates and advance our pipeline. This includes both the research and development costs
and the general and administrative expenses required to support those operations. Since we are a clinical stage biopharmaceutical company,
we have incurred significant operating losses since our inception and we anticipate such losses, in absolute dollar terms, to increase
as we continue to pursue clinical development of our product candidates, prepare for the potential commercialization of our product candidates,
and expand our development efforts in our pipeline of nonclinical candidates. We expect that our existing cash, cash equivalents, and
marketable securities will be sufficient to fund our operating plans for at least twelve months from the date of filing of this Quarterly
Report. We will need to secure additional financing in the future to fund additional research and development, and before a commercial
drug can be produced, marketed, and sold. If we are unable to obtain additional financing or generate license or product revenue, the
lack of liquidity could have a material adverse effect on our company.
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Cash Flows
The following table summarizes
our cash flows for the periods presented (in thousands):
Six Months Ended June 30,
2026 2025
Net cash used in operating activities $ (56,723 ) $ (44,014 )
Net cash (used in) provided by investing activities (425,384 ) 47,726
Net cash provided by financing activities 703,642 109
Net increase in cash and cash equivalents $ 221,535 $ 3,821
Operating Activities
For the six months ended June 30, 2026, net cash used in operating
activities was $56.7 million, which was primarily attributable to a net loss of $73.0 million, partially offset by net non-cash charges
of $13.2 million and net cash provided by changes in our operating assets and liabilities of $3.1 million. Net cash provided by changes
in our operating assets and liabilities were primarily comprised of an increase of $3.8 million in accounts payable and an increase of
$3.8 million in accrued expenses and other liabilities, partially offset by an increase of $4.2 million in prepaid expenses and other
current assets and a decrease of $0.3 million in operating lease liability. Net non-cash charges primarily comprised of $14.3 million
in stock-based compensation expense, partially offset by $1.4 million in net accretion of premiums and discounts on marketable securities.
For the six months ended
June 30, 2025, net cash used in operating activities was $44.0 million, which was primarily attributable to a net loss of $45.6 million
and net changes in our operating assets and liabilities of $5.3 million, partially offset by net non-cash charges of $6.9 million. Net
changes in our operating assets and liabilities were primarily comprised of a decrease of $5.9 million in related party accounts payable
and other current liabilities and an increase of $1.2 million in accounts payable. Net non-cash charges primarily comprised of an increase
of $10.0 million in stock-based compensation expense, partially offset by $3.3 million in net accretion of premiums and discounts on
marketable securities.
Investing Activities
For the six months ended
June 30, 2026, net cash used in investing activities was $425.4 million, which included $581.4 million in purchases of marketable securities,
$0.1 million in purchases of property and equipment, partially offset by $156.1 million in proceeds from maturities of marketable securities.
For the six months ended
June 30, 2025, net cash provided by investing activities was $47.7 million, which included $200.1 million in proceeds from maturities
of marketable securities, partially offset by $152.3 million in purchases of marketable securities.
Financing Activities
For the six months ended June 30, 2026, net cash provided by financing
activities was $703.6 million due to $658.3 million of net proceeds from the April 2026 underwritten public offering, $38.9 million of
net proceeds from the ATM offering program, $6.1 million of proceeds from the issuance of shares of common stock in connection with exercises
of stock options and employee warrants, and $0.3 million of proceeds from the issuance of common stock under the employee stock purchase
plan.
For the six months ended
June 30, 2025, net cash provided by financing activities was $0.1 million due to proceeds from the issuance of shares of common stock
in connection with purchases under our employee stock purchase plan.
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Contractual Obligations and Commitments
We enter into contracts in
the normal course of business with CROs, CMOs and with other vendors for preclinical research studies, clinical trials, manufacturing,
and other services and products for operating purposes. These contracts generally provide for termination on notice or may have a
potential termination fee if the contract is cancelled within a specified time, and therefore, are cancelable contracts. We do not expect
any such contract terminations and did not have any non-cancellable obligations under these agreements as of June 30, 2026. See Notes
9 and 10 to the condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report for further information
on our contractual lease obligations for our headquarters in Menlo Park, California, and our office in Waltham, Massachusetts, and other
commitments, including the commitments under the Option and License Agreements.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion
and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance
with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions
that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the
financial statements, as well as the reported revenues recognized and expenses incurred during the reporting periods. Our estimates are
based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of
which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates under different assumptions or conditions.
Our significant accounting
policies are described in more detail in Note 2 to our condensed consolidated financial statements included in Part I - Item 1 of
this Quarterly Report. During the three months ended June 30, 2026, there were no changes to our critical accounting policies and significant
judgments and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.
Off-Balance Sheet Arrangements
As of June 30, 2026, we
did not have any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.