Oruka Therapeutics, Inc.

Previous wording

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.

Current wording

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 March 31, 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.,” “Oruka,” “ARCA biopharma, Inc.,” “ARCA,” refers to Oruka Therapeutics, Inc. and its consolidated subsidiary, Oruka Therapeutics Operating Company LLC, taken as a whole.

Previous wording

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 fromor, for “skin,” andarukah, 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.

Current wording

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 fromor, for “skin,” andarukah, 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”).

Previous wording

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.

Current wording

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 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.

Previous wording

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).

Current wording

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.

Previous wording

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.

Current wording

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 March 31, 2026, we had an accumulated deficit of $221.0 million. For the three months ended March 31, 2026, we had net losses of $31.8 million, and we used net cash of $23.6 million for our operating activities.

Previous wording

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.

Current wording

We had cash, cash equivalents, and marketable securities of $496.0 million as of March 31, 2026. In addition, in April 2026, we sold 9,660,000 shares of our common stock in an underwritten public offering for gross proceeds of $700.4 million before any underwriting discounts and commissions and related issuance expenses. 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.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

Additionally, the first patients were dosed in EVERLAST-B in December 2025. EVERLAST-B is designed to enroll approximately 160 patients into a dose-ranging Phase 2b trial of ORKA-001 in patients with moderate-to-severe PsO and 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 is PASI 100 at Week 16. 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. Building on EVERLAST-A, this design will further test the potential for ORKA-001 to achieve yearly dosing, higher efficacy and extended off-treatment remissions. We expect to announce data from EVERLAST-B in 2027.

Previous wording

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.

Current wording

Based on recent precedent in PsO, we anticipate that the overall development program, from first-in-human studies through biologics license application (“BLA”) submission, could take as little as six to seven years, based on averages observed for recently approved medicines. However, we have no control over the duration of the United States Food and Drug Administration (“FDA”) review process, and the actual timeline may vary.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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. 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.

Previous wording

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.

Current wording

We have a third 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.

Previous wording

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.

Current wording

During the quarter ended March 31, 2026, we incurred and expensed a milestone of $3.0 million related to the dosing of the first patient in a Phase 2 trial for the ORKA-002 License Agreement. Pursuant to the License Agreements, as of March 31, 2026, we have incurred and expensed milestone payments of $7.0 million for each of ORKA-001 and ORKA-002.

Previous wording

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.

Current wording

Total other income (expense), net, consists of interest earned on our cash, cash equivalents, and marketable securities, and foreign currency transactions gains and losses.

Previous wording

The following table summarizes our results of operations and comprehensive loss for the periods presented (in thousands):

Current wording

The following table summarizes our results of operations for the periods presented (in thousands):

Previous wording

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.

Current wording

External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $4.7 million, from $13.6 million for the three months ended March 31, 2025 to $18.3 million for the three months ended March 31, 2026. 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 $3.0 million milestone pursuant to ORKA-002 License Agreement with Paragon related to the dosing of the first patient in a Phase 2 trial during the three months ended March 31, 2026.

Previous wording

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.

Current wording

Personnel-related expenses, excluding stock-based compensation, increased by $3.6 million, from $2.5 million for the three months ended March 31, 2025 to $6.1 million for the three months ended March 31, 2026, as we continue hiring employees in our research and development organization. Stock-based compensation expense increased by $0.6 million, from $3.0 million for the three months ended March 31, 2025 to $3.6 million for the three months ended March 31, 2026. The increase in stock-based compensation expense is primarily related to a $2.0 million increase related to employee awards due to an increase in research and development headcount, partially offset by a $1.4 million decrease in Paruka warrant liability under the Option Agreements.

Previous wording

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.

Current wording

Personnel-related expenses increased by $1.9 million, from $3.6 million for the three months ended March 31, 2025 to $5.5 million for the three months ended March 31, 2026, as a result of continued hiring of executives and administrative employees. Stock-based compensation expense increased by $1.5 million, from $1.9 million for the three months ended March 31, 2025 to $3.4 million for the three months ended March 31, 2026 due to additional general and administrative headcount.

Previous wording

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.

Current wording

Expenses related to professional and consulting services increased by $0.2 million, from $1.4 million for the three months ended March 31, 2025 to $1.6 million for the three months ended March 31, 2026, due to higher spending on legal and other professional services.

Previous wording

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.

Current wording

Interest income from cash equivalents and marketable securities was $4.6 million and $4.1 million for the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to interest earned on higher cash and marketable securities balances.

Previous wording

As of September 30, 2025, we had $500.9 million of cash, cash equivalents, and marketable securities.

Current wording

As of March 31, 2026, we had $496.0 million of cash, cash equivalents, and marketable securities.

Previous wording

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.

Current wording

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 March 31, 2026, we had funded our operations primarily with proceeds from issuances of convertible preferred stock, common stock, a convertible note, and pre-funded warrants.

Previous wording

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.

Current wording

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 April 2026, we sold 9,660,000 shares of our common stock in an underwritten public offering for gross proceeds of $700.4 million before any underwriting discounts and commissions and related issuance expenses.

Previous wording

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

Current wording

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.

Previous wording

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.

Current wording

For the three months ended March 31, 2026, net cash used in operating activities was $23.6 million, which was primarily attributable to a net loss of $31.8 million, partially offset by net non-cash charges of $6.7 million and net cash used by changes in our operating assets and liabilities of $1.5 million. Net cash used by changes in our operating assets and liabilities were primarily comprised of an increase of $3.0 million in related party accounts payable and other current liabilities and an increase of $0.5 million in prepaid expenses and other current assets, partially offset by a decrease of $1.3 million in accrued expenses and other liabilities and a decrease of $0.5 million in accounts payable. Net non-cash charges primarily comprised of $7.0 million in stock-based compensation expense, partially offset by $0.4 million in net accretion of premiums and discounts on marketable securities.

Previous wording

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.

Current wording

For the three months ended March 31, 2025, net cash used in operating activities was $20.9 million, which was primarily attributable to a net loss of $21.0 million and net changes in our operating assets and liabilities of $3.0 million, partially offset by net non-cash charges of $3.1 million. Net changes in our operating assets and liabilities were primarily comprised of a decrease of $5.2 million in related party accounts payable and other current liabilities and an increase of $2.3 million in accrued expenses and other current liabilities. Net non-cash charges primarily comprised of $4.9 million in stock-based compensation expense, partially offset by $1.8 million in net accretion of premiums and discounts on marketable securities.

Previous wording

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.

Current wording

For the three months ended March 31, 2026, net cash used in investing activities was $14.4 million, which included $90.8 million in purchases of marketable securities, $0.1 million in purchases of property and equipment, partially offset by $76.5 million in proceeds from maturities of marketable securities.

Previous wording

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.

Current wording

For the three months ended March 31, 2026, net cash provided by financing activities was $40.6 million due to $38.9 million of net proceeds from the ATM offering program and $1.7 million of proceeds from the issuance of shares of common stock in connection with exercises of stock options and employee warrants.

Previous wording

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.

Current wording

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 March 31, 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.