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 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.

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 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.

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, 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.

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 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.

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. 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.

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 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.

Previous 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.

Current wording

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.

Previous wording

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 600mg 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.

Current wording

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.

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”). 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 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. We announced Week 16 data for all patients in April 2026. 40 of 63 participants (63.5%) treated with ORKA-001 achieved the primary endpoint of PASI 100, a 100% reduction from baseline in the Psoriasis Area and Severity Index (“PASI”), at Week 16 and identical results were 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 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. We plan to share longer-term data, including Week 28 for all patients and 52-week follow-up for a portion of the cohort, in the second half of 2026.

Current 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”). 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.

Previous 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.

Current wording

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.

Previous 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.

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. 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.

Previous wording

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 2027. Moreover, we also expect to initiate ORCA-SPLASH, a Phase 2 trial of ORKA-002 in patients with HS in the second half of 2026.

Current wording

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.

Previous 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.

Current wording

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.

Previous wording

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”).

Current wording

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.

Previous 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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous wording

Other research and development expenses increased by $0.3 million, from $0.8 million for the three months ended March 31, 2025 to $1.2 million for the three months ended March 31, 2026, 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

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

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 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.

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 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.

Previous 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.

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 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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous wording

For the three months ended March 31, 2025, net cash provided by investing activities was $42.9 million, which included $87.2 million in proceeds from maturities of marketable securities, partially offset by $44.3 million in purchases of marketable securities.

Current wording

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.

Previous 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.

Current wording

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.

Previous wording

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 March 31, 2026. 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.

Current wording

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.