Oruka Therapeutics, Inc. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes included in Part 1, Item 1 of this Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 (this “Quarterly Report”) and with the audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on March 6, 2025. 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 its 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.,” “Oruka,” “ARCA biopharma, Inc.,” “ARCA,” refers to Oruka Therapeutics, Inc. and its consolidated subsidiaries, 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. 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, 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 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, pre-funded warrants, and the proceeds from the reverse recapitalization and merger, our Pre-Closing Financing and subsequent PIPE Financings (as defined and further described below). 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. During the three and nine months ended September 30, 2025, we generated net losses of $30.3 million and $75.9 million, respectively, and for the nine months ended September 30, 2025, we used net cash of $65.6 million for our operating activities. We had cash, cash equivalents, and marketable securities of $500.9 million as of September 30, 2025. 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. 22 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. As a result, it has a pharmacokinetic profile designed to support a subcutaneous 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 and in September 2025, we announced the interim results at the European Academy of Dermatology and Venereology (EADV) Congress. ORKA-001 showed a half-life of approximately 100 days. Single doses of ORKA-001 demonstrated complete and sustained inhibition of STAT3 signaling, a downstream marker of IL-23 activity, in an ex vivo assay through 24 weeks (the longest follow-up available). ORKA-001 was well tolerated at all dose levels, with a favorable safety profile consistent with the anti-IL-23 class. The trial remains blinded, and as of August 6, 2025, which was the data cutoff date, all subjects remained on trial. 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”). We expect to share efficacy and response duration data from this study in the second half of 2026. EVERLAST-A is expected to enroll approximately 80 patients randomized 3:1 to receive 600 mg of ORKA-001 at Weeks 0 and 4 or matching placebo. The primary endpoint is PASI 100 at Week 16. At Week 28, patients who have achieved PASI 100 will be 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. Additionally, in the third quarter of 2025, we announced our plans to initiate a dose-ranging Phase 2b trial of ORKA-001 in moderate-to-severe PsO patients (also known as “EVERLAST-B”) in the first half of 2026. EVERLAST-B will 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 will be PASI 100 at Week 16. To expedite development, EVERLAST-B dosing is projected to begin enrolling before the completion of EVERLAST-A. Based on recent precedent for PsO, we anticipate that the entire development program from first-in-human to biologics license application (“BLA”) filing could take as little as six to seven years based on the averages for recently approved medicines. However, we have no control over the length of time needed for the FDA review, and this timeline could vary. 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 hidradenitis suppurativa (“HS”) and axial spondyloarthritis. 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. We initiated the dosing of healthy volunteers in a Phase 1 trial of ORKA-002 in the second quarter of 2025 and plan to initiate a Phase 2 clinical trial of ORKA-002 in the first half of 2026. We expect to share interim data from the Phase 1 trial of ORKA-002, including initial pharmacokinetic data, around year end 2025. The Company is also planning for a Phase 2 trial in HS. We view ORKA-002 and ORKA-001 as highly complementary. Patients with moderate-to-severe PsO that have purely skin manifestations are most often treated with IL-23 inhibitors due to the high efficacy and tolerability of this mechanism. However, for patients who also have joint involvement, or signs and symptoms of PsA, an IL-17 inhibitor is typically used due to its efficacy in addressing both skin and joint symptoms. In addition, IL-17 inhibitors are often used in patients with highly resistant skin symptoms that do not adequately resolve through treatment with an IL-23 inhibitor. Furthermore, we plan to pursue a sequential combination regimen of ORKA-002 followed by ORKA-001, called ORKA-021. ORKA-021 has the potential to combine the rapid response of an IL-17 inhibitor with the ideal maintenance profile of an IL-23 inhibitor in a single regimen. We believe that ORKA-001 and ORKA-002 provide the potential to offer a highly compelling product profile for most patients with PsO and/or PsA, as well as the opportunity to address additional I&I indications. Additional Pipeline Program We have a third mAb program, ORKA-003, designed to target an undisclosed pathway. Our strategy as a company is to remain highly focused on I&I diseases, and specifically on inflammatory dermatology conditions. Our third program provides the potential for indication expansion beyond PsO and may create combination opportunities with our more advanced programs. 23 Acquisition of Pre-Merger Oruka On August 29, 2024 (the “Closing”), we completed the acquisition (the “Merger”) of the private company, Oruka Therapeutics, Inc. (“Pre-Merger Oruka”), a pre-clinical stage biotechnology company that was incorporated on February 6, 2024 for the purposes of holding rights to certain intellectual property being developed by Paragon Therapeutics, Inc. (“Paragon”). On August 29, 2024, we changed our name from “ARCA biopharma, Inc.” to “Oruka Therapeutics, Inc.” and our Nasdaq ticker symbol from “ABIO” to “ORKA”. Following consummation of the Merger, we effected a 1-for-12 reverse stock split (the “Reverse Stock Split”) of the common stock, par value $0.001 per share, of the Company (“Company Common Stock”). The Company Common Stock commenced trading on a post-Reverse Stock Split, post-Merger basis at the opening of trading on September 3, 2024. Pre-Closing Financing and Closing In April 2024, certain new and existing investors of Pre-Merger Oruka entered into a subscription agreement with Pre-Merger Oruka (as amended, the “Subscription Agreement”), pursuant to which, and on the terms and subject to the conditions of which, immediately prior to the Closing, those investors purchased shares of common stock of Pre-Merger Oruka and Pre-Merger Oruka pre-funded warrants for gross proceeds of approximately $275.0 million. We incurred transaction costs of $20.5 million. At the Closing, those shares of common stock of Pre-Merger Oruka and the Pre-Merger Oruka pre-funded warrants were converted into shares of Company Common Stock and pre-funded warrants of Company Common Stock. PIPE Financings On September 11, 2024, we entered into a Securities Purchase Agreement (the “2024 Securities Purchase Agreement”) for a private placement (the “2024 PIPE Financing”) with certain institutional and accredited investors. The closing of the 2024 PIPE Financing occurred on September 13, 2024. Pursuant to the 2024 Securities Purchase Agreement, the investors purchased an aggregate of 5,600,000 shares of Company Common Stock at a purchase price of $23.00 per share, an aggregate of 2,439 shares of our Series A non-voting convertible preferred stock, par value $0.001 per share (“Company Series A Preferred Stock”), at a purchase price of $23,000.00 per share (each Company Series A Preferred Stock is convertible into 1,000 shares of Company Common Stock), and pre-funded warrants to purchase an aggregate of 680,000 shares of Company Common Stock at a purchase price of $22.999 per pre-funded warrant, for aggregate net proceeds of approximately $188.7 million (net of issuance costs of $11.9 million). On September 17, 2025, we entered into a Securities Purchase Agreement (the “2025 Securities Purchase Agreement”) for a private placement (the “2025 PIPE Financing”) with certain institutional and accredited investors. The closing of the 2025 PIPE Financing occurred on September 19, 2025. Pursuant to the 2025 Securities Purchase Agreement, the investors purchased an aggregate of 10,933,405 shares of Company Common Stock at a purchase price of $15.00 per share, and pre-funded warrants to purchase an aggregate of 1,066,666 shares of Company Common Stock at a purchase price of $14.999 per pre-funded warrant, for aggregate net proceeds of approximately $169.6 million (net of issuance costs of $10.4 million). Option Agreements and License Agreements – Paragon Therapeutics In March 2024, we entered into two Antibody Discovery and Option Agreements with Paragon and Paruka Holding, LLC (“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”). 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. 24 Pursuant to the License Agreements, as of September 30, 2025, we have incurred and expensed milestone payments of $7.0 million and $4.0 million for ORKA-001 and ORKA-002, respectively. 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. 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 10 to the condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report for further details on the Option 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; ● 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; 25 ● 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. 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; interest expense on the convertible note from a related party (see discussion herein); and foreign currency transactions gains and losses. Interest expense relates to a convertible note (the “Convertible Note”) issued to Fairmount Healthcare Fund II, L.P. (“Fairmount”), a related party, in March 2024. At the effective time of the Merger, the Convertible Note, along with the accrued interest, was automatically converted into Company Common Stock. Results of Operations Comparison of the Three Months Ended September 30, 2025 and 2024 The following table summarizes our results of operations and comprehensive loss for the periods presented (in thousands): Three Months Ended September 30, Three Months Ended September 30, Change 2025 2024 $ % Operating expenses Research and development (1) $ 28,988 $ 25,691 $ 3,297 13% General and administrative (2) 5,117 3,758 1,359 36% Total operating expenses 34,105 29,449 4,656 16% Loss from operations (34,105 ) (29,449 ) (4,656 ) 16% Other income (expense) Interest income 3,832 1,330 2,502 188% Interest expense (3) — (504 ) 504 (100)% Other expense, net (4 ) — (4 ) 100% Total other income (expense), net 3,828 826 3,002 * Net loss $ (30,277 ) $ (28,623 ) $ (1,654 ) 6% * Percentage not meaningful 26 (1) Includes related party amounts of $9,595 and $13,537 for the three months ended September 30, 2025 and September 30, 2024, respectively (2) Includes related party amounts of $8 and $71 for the three months ended September 30, 2025 and September 30, 2024, respectively (3) Includes related party amounts of nil and $504 for the three months ended September 30, 2025 and September 30, 2024, respectively Research and Development Expenses The following table summarizes our research and development expenses for the periods presented (in thousands): Three Months Ended September 30, Three Months Ended September 30, Change 2025 2024 $ % External research and development expenses $ 15,581 $ 15,908 $ (327 ) (2)% Other research and development expenses: Personnel-related (excluding stock-based compensation) 3,774 1,304 2,470 189% Stock-based compensation 8,341 7,772 569 7% Other 1,292 707 585 83% Total research and development expenses $ 28,988 $ 25,691 $ 3,297 13% Research and development expenses increased by $3.3 million, from $25.7 million for the three months ended September 30, 2024 to $29.0 million for the three months ended September 30, 2025. External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses decreased by $0.3 million, from $15.9 million for the three months ended September 30, 2024 to $15.6 million for the three months ended September 30, 2025. The decrease is primarily related to the decrease in research expenses incurred by Paragon partially offset by increased CMO product development and manufacturing expenses and an increase in our CRO expenses related to our ongoing clinical trials and toxicology studies. Personnel-related expenses increased by $2.5 million, from $1.3 million for the three months ended September 30, 2024 to $3.8 million for the three months ended September 30, 2025, as we continue hiring employees in our research and development organization. Stock-based compensation expense increased by $0.6 million, from $7.8 million for the three months ended September 30, 2024 to $8.3 million for the three months ended September 30, 2025. The increase in stock-based compensation expense is primarily related to a $1.3 million increase in employee awards, partially offset by a $0.7 million decrease in Paruka warrant liability under the Option Agreements. Other research and development expenses increased by $0.6 million, from $0.7 million for the three months ended September 30, 2024 to $1.3 million for the three months ended September 30, 2025, primarily due to increases to facilities and allocated overhead expenses as we commenced using our leased Waltham office from April 2025, as well as an increase in our research and development employee count. 27 General and Administrative Expenses The following table summarizes our general and administrative expenses for the periods presented (in thousands): Three Months Ended September 30, Three Months Ended September 30, Change 2025 2024 $ % Personnel-related (including stock-based compensation) $ 3,769 $ 2,435 $ 1,334 55% Professional and consulting services 1,329 817 512 63% Other 19 506 (487 ) (96)% Total general and administrative expenses $ 5,117 $ 3,758 $ 1,359 36% General and administrative expenses increased by $1.4 million, from $3.8 million for the three months ended September 30, 2024 to $5.1 million for the three months ended September 30, 2025. Personnel-related expenses increased by $1.3 million, from $2.4 million for the three months ended September 30, 2024 to $3.8 million for the three months ended September 30, 2025, as a result of continued hiring of executives and administrative employees. Stock-based compensation expense increased by $0.6 million, from $1.2 million for the three months ended September 30, 2024 to $1.8 million for three months ended September 30, 2025. Expenses related to professional and consulting services increased by $0.5 million, from $0.8 million for the three months ended September 30, 2024 to $1.3 million for the three months ended September 30, 2025, due to higher spending on accounting, audit, and legal fees. Other general and administrative expenses decreased by $0.5 million primarily due to facilities and allocated overhead expenses being allocated to research and development expenses as a result of the increase in our research and development employee count. Total Other Income (Expense), Net Interest income from cash equivalents and marketable securities was $3.8 million for the three months ended September 30, 2025. Interest income from money market funds was $1.3 million for the three months ended September 30, 2024. No interest expense was recorded during the three months ended September 30, 2025. Interest expense of $0.5 million was incurred for the three months ended September 30, 2024 relating to the Convertible Note issued to Fairmount in March 2024. Comparison of the Nine Months Ended September 30, 2025, and the period from February 6 (inception) to September 30, 2024 The following table summarizes our results of operations and comprehensive loss for the periods presented (in thousands): Nine Months Ended September 30, Period from February 6, 2024 (inception) to September 30, Change 2025 2024 $ % Operating expenses Research and development (1) $ 73,000 $ 49,557 $ 23,443 47% General and administrative (2) 14,620 8,248 6,372 77% Total operating expenses 87,620 57,805 29,815 52% Loss from operations (87,620 ) (57,805 ) (29,815 ) 52% Other income (expense) Interest income 11,781 1,330 10,451 * Interest expense (3) — (1,468 ) 1,468 (100)% Other expense, net (11 ) — (11 ) 100% Total other income (expense), net 11,770 (138 ) 11,908 * Net loss $ (75,850 ) $ (57,943 ) $ (17,907 ) 31% * Percentage not meaningful (1) Includes related party amounts of $15,998 and $33,967 for the nine months ended September 30, 2025 and the period from February 6, 2024 (inception) to September 30, 2024, respectively 28 (2) Includes related party amounts of $130 and $1,339 for the nine months ended September 30, 2025 and the period from February 6, 2024 (inception) to September 30, 2024, respectively (3) Includes related party amounts of nil and $1,468 for the nine months ended September 30, 2025 and the period from February 6, 2024 (inception) to September 30, 2024, respectively Research and Development Expenses The following table summarizes our research and development expenses for the periods presented (in thousands): Nine Months Ended September 30, Period from February 6, 2024 (inception) to September 30, Change 2025 2024 $ % External research and development expenses $ 45,607 $ 37,926 $ 7,681 20% Other research and development expenses: Personnel-related (excluding stock-based compensation) 9,538 2,374 7,164 * Stock-based compensation 14,712 8,310 6,402 77% Other 3,143 947 2,196 * Total research and development expenses $ 73,000 $ 49,557 $ 23,443 47% * Percentage not meaningful Research and development expenses increased by $23.4 million, from $49.6 million for the period from February 6, 2024 (inception) to September 30, 2024 to $73.0 million for the nine months ended September 30, 2025. External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $7.7 million, from $37.9 million for the period from February 6, 2024 (inception) to September 30, 2024 to $45.6 million for the nine months ended September 30, 2025. The increase is primarily related to increased CMO product development and manufacturing expenses, an increase in our CRO expenses related to our ongoing clinical trials and toxicology studies, partially offset by a reduction of research expenses incurred by Paragon. Personnel-related expenses increased by $7.2 million, from $2.4 million for the period from February 6, 2024 (inception) to September 30, 2024 to $9.5 million for the nine months ended September 30, 2025, as we continue hiring employees in our research and development organization. Stock-based compensation expense increased by $6.4 million, from $8.3 million for the period from February 6, 2024 (inception) to September 30, 2024 to $14.7 million for the nine months ended September 30, 2025. Stock-based compensation expense increased by $4.4 million due to the increase in employee awards and $2.0 million due to an increase in Paruka warrant liability under the Option Agreements. Other research and development expenses increased by $2.2 million, from $0.9 million for the period from February 6, 2024 (inception) to September 30, 2024 to $3.1 million for the nine months ended September 30, 2025, primarily due to facilities and allocated overhead expenses as we commenced using our leased Menlo Park office space from June 2024 and Waltham office from April 2025, as well as 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): Nine Months Ended September 30, Period from February 6, 2024 (inception) to September 30, Change 2025 2024 $ % Personnel-related (including stock-based compensation) $ 10,769 $ 4,590 $ 6,179 135% Professional and consulting services 3,449 2,936 513 17% Other 402 722 (320 ) (44)% Total general and administrative expenses $ 14,620 $ 8,248 $ 6,372 77% General and administrative expenses increased by $6.4 million, from $8.2 million for the period from February 6, 2024 (inception) to September 30, 2024 to $14.6 million for the nine months ended September 30, 2025. 29 Personnel-related expenses increased by $6.2 million, from $4.6 million for the period from February 6, 2024 (inception) to September 30, 2024 to $10.8 million for the nine months ended September 30, 2025, as a result of continued hiring of executives and administrative employees. Stock-based compensation expense was $1.5 million and $5.4 million for the period from February 6, 2024 (inception) to September 30, 2024 and for the nine months ended September 30, 2025, respectively. Expenses related to professional and consulting services increased by $0.5 million, from $2.9 million for the period from February 6, 2024 (inception) to September 30, 2024 compared to $3.4 million for the nine months ended September 30, 2025, due to higher spending on accounting, audit, and legal fees. Other general and administrative expenses decreased by $0.3 million primarily due to facilities and allocated overhead expenses being allocated to research and development expenses as a result of the increase in our research and development employee count. Total Other Income (Expense), Net Interest income from cash equivalents and marketable securities was $11.8 million for the nine months ended September 30, 2025. Interest income from money market funds was $1.3 million for the period from February 6, 2024 (inception) to September 30, 2024. No interest expense was recorded during the nine months ended September 30, 2025. Interest expense was $1.5 million for the period from February 6, 2024 (inception) to September 30, 2024 relating to the Convertible Note issued to Fairmount in March 2024. Liquidity and Capital Resources As of September 30, 2025, we had $500.9 million 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 pre-clinical 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 September 30, 2025, we had 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 its sales agent, pursuant to which we may issue and sell, from time to time, shares of Company Common Stock for aggregate gross proceeds of up to $200.0 million under an at-the-market equity offering program. We are not obligated to make any sales of shares under the Sales Agreement. 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. At this time, due to the inherently unpredictable nature of clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval, and commercialize our current product candidate or any future product candidates. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or our current or any future license agreements which we may enter into or whether, or when, if ever, we may achieve profitability. In addition, with a change in the presidential administration in 2025, there has been an economic policy shift towards increasing tariffs, which in turn has led and could lead to further retaliatory tariffs. These may have the potential to impact expenses as well as our ability to, if ever, generate revenue or achieve profitability. 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 Cash Flows The following table summarizes our cash flows for the periods presented (in thousands): Nine Months Ended September 30, 2025 Period from February 6, 2024 (inception) to September 30, 2024 Net cash used in operating activities $ (65,616 ) $ (39,019 ) Net cash used in investing activities (74,723 ) (171 ) Net cash provided by financing activities 170,017 450,065 Net increase in cash and cash equivalents $ 29,678 $ 410,875 30 Operating Activities For the nine months ended September 30, 2025, net cash used in operating activities was $65.6 million, which was primarily attributable to a net loss of $75.9 million and net cash used by changes in our operating assets and liabilities of $5.9 million, partially offset by net non-cash charges of $16.2 million. Net cash used by changes in our operating assets and liabilities were primarily comprised of a decrease of $6.0 million in related party accounts payable and other current liabilities, an increase of $3.2 million in prepaid expenses and other current assets, partly offset by an increase of $5.0 million in accrued expenses and other current liabilities. Net non-cash charges primarily comprised of $20.1 million in stock-based compensation expense (includes $9.7 million from Paruka Warrant Obligation), partially offset by $4.3 million in net accretion of premiums and discounts on marketable securities. From February 6, 2024 (inception) to September 30, 2024, net cash used in operating activities was $39.0 million, which was primarily attributable to a net loss of $57.9 million, offset by non-cash charges of $11.3 million and net cash provided by changes in operating activities of $7.6 million. Non-cash charges primarily consisted of a $9.8 million increase in stock-based compensation expense (primarily from the Paruka Warrant Obligation) and $1.5 million of non-cash interest expense. Net cash provided by changes in our operating activities primarily consisted of a $1.6 million increase in accounts payable, $1.7 million increase in accrued expenses and other current liabilities, $6.4 million increase in related parties accounts payable and other current liabilities, partially offset by a $2.0 million increase in prepaid expenses and other current assets. Investing Activities For the nine months ended September 30, 2025, net cash used in investing activities was $74.7 million, which included $420.0 million in purchases of marketable securities, $0.1 million in purchases of property and equipment, partially offset by $345.4 million in proceeds from maturities of marketable securities. From February 6, 2024 (inception) to September 30, 2024, net cash used in investing activities was $0.2 million, which was attributable to purchases of property and equipment. Financing Activities For the nine months ended September 30, 2025, net cash provided by financing activities was $170.0 million due to $169.9 million of net proceeds from the 2025 PIPE Financing and $0.1 million proceeds from the issuance of shares of common stock in connection with purchases under our employee stock purchase plan. From February 6, 2024 (inception) to September 30, 2024, net cash provided by financing activities was $450.1 million, consisting of $228.1 million of net proceeds from the Pre-Closing Financing, $189.1 million of net proceeds from the 2024 PIPE Financing, $25.0 million of net proceeds from the issuance of the Convertible Note, $4.9 million of cash acquired in connection with the reverse recapitalization, and $2.9 million of net proceeds from the issuance of Series B Preferred Stock 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 September 30, 2025. See Notes 10 and 11 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 September 30, 2025, 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 period from February 6 (inception) to December 31, 2024. Off-Balance Sheet Arrangements As of September 30, 2025, we did not have any off-balance sheet arrangements, as defined in the rules and regulations of the SEC. 31 Item 3. Quantitative and Qualitative Disclosures About Market Risk We are a smaller reporting company, as defined by Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.