Braveheart Bio, Inc.

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited interim condensed financial statements and related notes and other financial information appearing elsewhere in this Quarterly Report and with our audited financial statements and related notes for the year ended December 31, 2025 included in our final prospectus dated August 5, 2026 filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended (the “Securities Act”). References to the "Company," “Braveheart,” "Braveheart Bio," “we,” “our,” “us,” or similar terms refer to Braveheart Bio, Inc. This discussion and analysis and other parts of this Quarterly Report contains forward-looking statements based upon our current plans and strategy for our business that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and beliefs. Our actual results and the timing of events could differ materially from those described in, anticipated in or implied by these forward-looking statements as a result of various factors, including those set forth under the headings “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” elsewhere in this Quarterly Report.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited interim condensed financial statements and related notes and other financial information appearing elsewhere in this Quarterly Report and with our audited financial statements and related notes for the year ended December 31, 2025 included in our IPO final prospectus dated August 5, 2026 filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended (the “Securities Act”). References to the "Company," “Braveheart,” "Braveheart Bio," “we,” “our,” “us,” or similar terms refer to Braveheart Bio, Inc. This discussion and analysis and other parts of this Quarterly Report contains forward-looking statements based upon our current plans and strategy for our business that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and beliefs. Our actual results and the timing of events could differ materially from those described in, anticipated in or implied by these forward-looking statements as a result of various factors, including those set forth under the headings “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” elsewhere in this Quarterly Report.

Previous wording

Cardiac myosin inhibition is a clinically validated therapeutic approach in symptomatic oHCM. However, currently approved therapies require complex dose titration and frequent echocardiographic monitoring, which can create operational burden and limit adoption. Based on preclinical and clinical data generated to date, we believe BHB-1893 has the potential to offer a differentiated product profile, including rapid onset of action, predictable pharmacokinetics, limited drug-drug interactions, and a low left ventricular ejection fraction cost.

Current wording

Cardiac myosin inhibition is a clinically validated therapeutic approach in symptomatic oHCM. However, currently approved therapies require complex dose titration and frequent echocardiographic monitoring, which can create operational burden and limit adoption. Based on nonclinical and clinical data generated to date, we believe BHB-1893 has the potential to offer a differentiated product profile, including rapid onset of action, predictable pharmacokinetics, limited drug-drug interactions, and a low left ventricular ejection fraction cost.

Previous wording

We plan to advance BHB-1893 through global Phase 3 development in both oHCM and nHCM. We have initiated LIONHEART-HCM, a Phase 3, multi-region, multi-center, randomized, double-blind, active-comparator-controlled trial to evaluate the efficacy and safety of BHB-1893 compared to metoprolol in adults with symptomatic obstructive hypertrophic cardiomyopathy. We plan to initiate NOBLEHEART-HCM, a global Phase 3 trial in nHCM in the first half of 2027. We hold exclusive rights to develop, manufacture and commercialize BHB-1893 worldwide, excluding Mainland China, Hong Kong, Macau and Taiwan, under an exclusive license agreement (the “Exclusive License Agreement”) with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui”).

Current wording

We plan to advance BHB-1893 through global Phase 3 development in both oHCM and nHCM. We have initiated LIONHEART-HCM, a Phase 3, multi-region, multi-center, randomized, double-blind, active-comparator-controlled trial to evaluate the efficacy and safety of BHB-1893 compared to metoprolol in adults with symptomatic obstructive hypertrophic cardiomyopathy. LIONHEART-HCM is currently enrolling patients, and we expect to conduct an interim analysis in the second half of 2027. We also plan to initiate TRUEHEART-HCM to evaluate a fixed 40 mg twice-daily dose of BHB-1893, with no titration visits, on top of standard of care in patients with symptomatic oHCM in the U.S. in the first half of 2027. We plan to initiate NOBLEHEART-HCM, a global Phase 3 trial in nHCM in the first half of 2027. Participants from our global studies will be candidates to enroll in HEARTSONG-LTE, our planned long-term extension study. We hold exclusive rights to develop, manufacture and commercialize BHB-1893 worldwide, excluding Mainland China, Hong Kong, Macau and Taiwan, under an exclusive license agreement (the “Exclusive License Agreement”) with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui”).

Previous wording

To date, we have primarily funded our operations with proceeds from sales of shares of our common stock and redeemable convertible preferred stock in private placements. Through June 30, 2026, we had received aggregate gross proceeds of $185.1 million from sales of shares of our common stock and redeemable convertible preferred stock. On August 7, 2026, we completed our initial public offering (“IPO”), in which we sold 24,437,500 shares of our common stock, including the full exercise of the underwriters’ additional option, at a public offering price of $18.00 per share, resulting in aggregate net proceeds of approximately $404.5 million, after deducting underwriter discounts, commissions and other estimated offering expenses.

Current wording

To date, we have primarily funded our operations with proceeds from sales of shares of our common stock and redeemable convertible preferred stock in private placements and from our initial public offering (“IPO”), which closed in August 2026. As of September 30, 2026, we had $503.5 million in cash, cash equivalents, and investments.

Previous wording

We have incurred significant operating losses and negative cash flows from operations since our inception. Our net loss for the six months ended June 30, 2026 and 2025, was $29.3 million and $0.5 million, respectively. As of June 30, 2026, we had an accumulated deficit of $95.9 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and, to a lesser extent, from general and administrative costs associated with our operations. Our net losses and operating losses may fluctuate from quarter to quarter and year to year depending primarily on the timing of acquisition of any new product candidates, the timing of our preclinical studies and clinical trials, our other research and development expenses, and the timing and amount of any milestone or royalty payments due under the Exclusive License Agreement with Hengrui (as defined below) and future license agreements. In addition, following the closing of the IPO, we expect to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer liability insurance costs, investor and public relations costs, and other expenses that we did not incur as a private company. We anticipate that our expenses will increase significantly in connection with our ongoing activities, particularly if and as we:

Current wording

We have incurred significant operating losses and negative cash flows from operations since our inception. Our net loss for the nine months ended September 30, 2026 and 2025, was $55.8 million and $59.6 million, respectively. As of September 30, 2026, we had an accumulated deficit of $122.4 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and, to a lesser extent, from general and administrative costs associated with our operations. Our net losses and operating losses may fluctuate from quarter to quarter and year to year depending primarily on the timing of acquisition of any new product candidates, the timing of our nonclinical studies and clinical trials, our other research and development expenses, and the timing and amount of any milestone or royalty payments due under the Exclusive License Agreement with Hengrui (as defined below) and future license agreements. In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer liability insurance costs, investor and public relations costs, and other expenses that we did not incur as a private company. We anticipate that our expenses will increase significantly in connection with our ongoing activities, particularly if and as we:

Previous wording

•add operational, legal, financial, and management information systems and personnel to support our product development, clinical execution, and planned future commercialization efforts, as well as to support our transition to a public company.

Current wording

•add operational, legal, financial, and management information systems and personnel to support our product development, clinical execution, and planned future commercialization efforts.

Previous wording

As of June 30, 2026, we had $122.8 million in cash and cash equivalents. On August 7, 2026, we completed our IPO, resulting in aggregate net proceeds of approximately $404.5 million, after deducting underwriting discounts and commissions and offering expenses payable by us. Based on our current operating plan, we believe that our existing cash and cash equivalents, together with the net proceeds from our IPO , will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029. We have based this estimate on our current assumptions, which may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.

Current wording

As of September 30, 2026, we had $503.5 million in cash, cash equivalents and investments. Based on our current operating plan, we believe that our existing cash, cash equivalents and investments will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029. We have based this estimate on our current assumptions, which may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.

Previous wording

The acquisition of the exclusive license pursuant to the Exclusive License Agreement was accounted for as an in-process research and development asset acquisition. As the acquired technology did not have an alternative use, the total consideration of $58.2 million was recorded as in-process research and development expense in the statement of operations and comprehensive loss at the inception of the license agreements. Milestone payments are contingent consideration and are recognized in the period the obligation is resolved. Royalties will be recognized as cost of sales when products are sold and royalties are payable. The technology transfer milestone for $3.0 million was completed in December 2025, and recorded within accrued expenses and other current liabilities in the balance sheet as of December 31, 2025. As of June 30, 2026, this milestone has been paid. The manufacturing technology transfer milestone for $6.0 million was completed in March 2026, and has been paid as of June 30, 2026. For a more detailed description of the Exclusive License Agreement, see the section titled “Business—Hengrui License Agreement,” included in our IPO final prospectus dated August 5, 2026 filed with the SEC.

Current wording

The acquisition of the exclusive license pursuant to the Exclusive License Agreement was accounted for as an in-process research and development asset acquisition. As the acquired technology did not have an alternative use, the total consideration of $58.2 million was recorded as in-process research and development expense in the statement of operations and comprehensive loss at the inception of the license agreements. Milestone payments are contingent consideration and are recognized in the period the obligation is resolved. Royalties will be recognized as cost of sales when products are sold and royalties are payable. The technology transfer milestone for $3.0 million was completed in December 2025, and recorded within accrued expenses and other current liabilities in the balance sheet as of December 31, 2025. As of September 30, 2026, this milestone has been paid. The manufacturing technology transfer milestone for $6.0 million was completed in March 2026, and has been paid as of September 30, 2026. The initial echo data transfer milestone for $1.0 million was completed in August 2026, and was recorded within accrued expenses on the condensed balance sheet as of September 30, 2026. For a more detailed description of the Exclusive License Agreement, see the section titled “Business—Hengrui License Agreement,” included in our IPO final prospectus dated August 5, 2026 filed with the SEC.

Previous wording

•the scope, timing, progress, costs, and results of our ongoing development of BHB-1893 as well as for potential discovery, preclinical, and clinical development activities for future product candidates;

Current wording

•the scope, timing, progress, costs, and results of our ongoing development of BHB-1893 as well as for potential discovery, nonclinical, and clinical development activities for future product candidates;

Previous wording

Our general and administrative expenses consist primarily of personnel-related costs, legal and consulting services, including those relating to intellectual property and corporate matters, and allocated overhead, including software, computer supplies and accessories, insurance, and other miscellaneous expenses. Personnel-related costs include salaries, annual bonuses, benefits, recruiting fees, travel and meal expenses, and stock-based compensation for our general and administrative personnel.

Current wording

Our general and administrative expenses consist primarily of personnel-related costs, legal and consulting services, including those relating to intellectual property and corporate matters, and allocated overhead, including software, computer supplies and accessories, insurance, and other miscellaneous expenses. Personnel-related costs include salaries, annual bonuses, benefits, recruiting fees, travel and meal expenses, and stock-based compensation for our general and administrative personnel, including expenses related to the executive modified restricted stock award.

Previous wording

Other income (expense), net consists primarily of interest income and gains or losses from exchange rate changes on transactions denominated in currencies other than the U.S. dollar. Interest income consists of interest earned on money market funds.

Current wording

Other income (expense), net consists primarily of interest income and gains or losses from exchange rate changes on transactions denominated in currencies other than the U.S. dollar. Interest income consists of interest earned on money market funds and U.S. Treasury securities.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of the Three and Nine Months Ended September 30, 2026 and 2025

Previous wording

The following table summarizes our results of operations for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our results of operations for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

The following table summarizes our research and development expenses for the three and six months ended June 30, 2026, and 2025 (in thousands):

Current wording

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2026, and 2025 (in thousands):

Previous wording

Research and development expense for the three and six months ended June 30, 2026 was $11.1 million and $22.0 million, respectively. The six-month expense was comprised of $6.0 million in Hengrui license milestone expenses incurred during the first quarter of 2026, $5.0 million in personnel-related costs, $7.7 million in clinical and manufacturing expenses to support BHB-1893 oHCM Phase 3 study start-up activities, $3.0 million in outside research and development support services, and $0.3 million in other research and development expenses primarily related to allocated rent, software subscriptions and other IT-related matters. The three-month expense was comprised of $6.1 million in clinical and manufacturing expenses to support BHB-1893 oHCM Phase 3 study start-up activities, $3.0 million in personnel-related costs, $1.8 million in outside research and development support services, and $0.2 million in other research and development expenses primarily related to allocated rent, software subscriptions and other IT-related matters. There was no research and development expense incurred during the three or six months ended June 30, 2025, as the Company’s research and development efforts did not begin until late 2025.

Current wording

Research and development expense for the three and nine months ended September 30, 2026 was $17.5 million and $39.6 million, respectively. The nine-month expense was comprised of $17.2 million in clinical and manufacturing expenses to support BHB-1893 oHCM Phase 3 study start-up activities, $9.9 million in personnel-related costs, $7.0 million in Hengrui license milestone expenses, $4.9 million in outside research and development support services, and $0.6 million in other research and development expenses primarily related to allocated rent, software subscriptions and other IT-related matters. The three-month expense was comprised of $9.5 million in clinical and manufacturing expenses to support BHB-1893 oHCM Phase 3 study start-up activities, $4.8 million in personnel-related costs, $1.9 million in outside research and development support services, $1.0 million in Hengrui license milestone expenses, and $0.3 million in other research and development expenses primarily related to allocated rent, software subscriptions and other IT-related matters. There was nominal research and development expense incurred during the three and nine months ended September 30, 2025, as the Company’s research and development efforts did not begin until late 2025.

Previous wording

In-process research and development expense was zero for the three and six months ended June 30, 2026, as the Hengrui license acquisition occurred in 2025. In-process research and development expense was $0.4 million for the three and six months ended June 30, 2025, which related to transaction costs incurred in connection with that license.

Current wording

In-process research and development expense was zero for the three and nine months ended September 30, 2026, as the Hengrui license acquisition occurred in 2025. In-process research and development expense was $58.8 million and $59.2 million for the three and nine months ended September 30, 2025, respectively, which related to $32.5 million of cash consideration and $0.2 million in VAT taxes, $25.7 million in non-cash consideration, and transaction costs incurred in connection with that license.

Previous wording

General and administrative expense for the three and six months ended June 30, 2026 was $4.8 million and $8.9 million, respectively. During both the three and six months ended June 30, 2026, expenses were comprised primarily of personnel-related costs, consultant costs to support the Company’s increased operations and business development, legal costs for general counsel and patent services, and other general and administrative expenses primarily related to allocated rent, insurance and software subscriptions. General and administrative expense for the three and six months ended June 30, 2025 was nominal, related to legal costs as the Company’s operations did not begin until late 2025.

Current wording

General and administrative expense for the three and nine months ended September 30, 2026 was $12.6 million and $21.5 million, respectively. During both the three and nine months ended September 30, 2026, expenses were comprised primarily of personnel-related costs, consultant costs to support the Company’s increased operations and business development, legal costs for general counsel and patent services, and other general and administrative expenses primarily related to allocated rent, insurance and software subscriptions. General and administrative expense for the three and nine months ended September 30, 2026 included stock-based compensation expense of $7.8 million and $10.1 million, respectively, of which $6.1 million in each period related to the liability-classified modified executive restricted stock awards described in Note 9 to our unaudited interim condensed financial statements. Because this award is remeasured to fair value at each reporting date until it vests or is settled, the related expense will fluctuate with the trading price of our common stock and may cause general and administrative expense to vary significantly from period to period. General and administrative expense for the three and nine months ended September 30, 2025 was $0.5 million, primarily related to legal costs and nominal personnel and consultant costs, as the Company’s operations did not begin until late 2025.

Previous wording

Total other income for the three and six months ended June 30, 2026 was $0.9 million and $1.7 million, respectively, from the recognition of interest income from our cash invested in money market funds. There was no other income or other expense for the three or six months ended June 30, 2025.

Current wording

Total other income for the three and nine months ended September 30, 2026 was $3.7 million and $5.3 million, respectively, from the recognition of interest income from our cash invested in money market funds and US treasuries, increasing from the total other income for the three and nine months ended September 30, 2025 of $0.2 million, as the accounts were opened during the three months ended September 30, 2025.

Previous wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. From inception, we have primarily funded our operations from sales of shares of our common stock and redeemable convertible preferred stock in private placements.

Current wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. From inception, we have primarily funded our operations from sales of shares of our common stock and redeemable convertible preferred stock in private placements and through our IPO.

Previous wording

As of June 30, 2026, we had $122.8 million in cash and cash equivalents. On August 7, 2026, we completed our IPO, resulting in aggregate net proceeds of approximately $404.5 million, after deducting underwriting discounts and commissions and offering expenses payable by us. On a pro forma basis, giving effect to the receipt of those net proceeds as if the IPO had closed on June 30, 2026, we would have had approximately $527.3 million in cash and cash equivalents as of that date. Based on our current operating plan, we estimate that our existing cash and cash equivalents, together with the net proceeds from our IPO completed during the third quarter of 2026, will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029. We have based this estimate on our current assumptions which may prove to be wrong, and we may exhaust our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with therapeutic product development, we may never achieve or maintain profitability and, unless and until we are able to commercialize our product candidate, if ever, we will continue to be dependent upon equity financing, debt financing, and other forms of capital raises. If we are unable to raise capital as and when needed or on attractive terms, we may have to significantly delay, reduce, or discontinue the development and commercialization of our product candidate or scale back or terminate our pursuit of new in-licenses and acquisitions.

Current wording

As of September 30, 2026, we had $503.5 million in cash, cash equivalents and investments. Based on our current operating plan, we estimate that our existing cash, cash equivalents, and investments will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029. We have based this estimate on our current assumptions which may prove to be wrong, and we may exhaust our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with therapeutic product development, we may never achieve or maintain profitability and, unless and until we are able to commercialize our product candidate, if ever, we will continue to be dependent upon equity financing, debt financing, and other forms of capital raises. If we are unable to raise capital as and when needed or on attractive terms, we may have to significantly delay, reduce, or discontinue the development and commercialization of our product candidate or scale back or terminate our pursuit of new in-licenses and acquisitions.

Previous wording

•the timing, scope, progress, and results of our preclinical studies and clinical trials for our current or future product candidates;

Current wording

•the timing, scope, progress, and results of our nonclinical studies and clinical trials for our current or future product candidates;

Previous wording

•the outcome, timing, and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities for our current or future product candidates, including any requirement to conduct more studies or generate additional data beyond that which we currently expect would be required to support an NDA;

Current wording

•the outcome, timing, and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities for our current or future product candidates, including any requirement to conduct more studies or generate additional data beyond that which we currently expect would be required to support a new drug application;

Previous wording

Net cash used in operating activities for the six months ended June 30, 2026 of $22.1 million was primarily due to our net loss for the period of $29.3 million, offset by $2.9 million in non-cash items, including $2.8 million of non-cash stock-based compensation expense and $0.1 million of depreciation and amortization, and $4.3 million of changes in operating assets and liabilities. The changes in operating assets and liabilities include a $0.4 million increase in prepaid expenses and other current assets, partially offset by a $0.9 million increase in accounts payable, a $3.9 million increase in accrued expenses and other current liabilities, and a $0.1 million decrease in operating lease right-of-use asset and lease liabilities. The operating cash activity during the six months ended June 30, 2025 was comprised of a $0.5 million net loss, offset by $0.4 million in non-cash in-process research and development expense and $0.1 million net increase in operating liabilities.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026 of $46.5 million was primarily due to our net loss for the period of $55.8 million and $2.0 million of changes in operating assets and liabilities, partially offset by $11.3 million in net non-cash items. Non-cash items include $6.1 million of non-cash stock-based compensation expense related to the liability-classified awards and $5.6 million of non-cash stock-based compensation expense, partially offset by $0.5 million of accretion on investments. The changes in operating assets and liabilities include a $10.2 million increase in prepaid expenses and other current assets, primarily reflecting prepayments to our CROs and CDMOs for LIONHEART-HCM, partially offset by a $7.1 million increase in accrued expenses and a $1.1 million increase in accounts payable. The operating cash activity during the nine months ended September 30, 2025 was comprised of a $59.6 million net loss and a $0.3 million net decrease in operating liabilities, partially offset by $59.2 million in non-cash in-process research and development expense.

Previous wording

Cash used in investing activities for the six months ended June 30, 2026 was $3.0 million related to the cash payment of the Hengrui license technology transfer milestone that had been accrued as of December 31, 2025. There was no investing activity for the six months ended June 30, 2025.

Current wording

Cash used in investing activities for the nine months ended September 30, 2026 was $385.5 million, $382.5 million from the purchases of investments and $3.0 million from the cash payment of the Hengrui license technology transfer milestone that had been accrued as of December 31, 2025. Cash used in investing activities for the nine months ended September 30, 2025 consisted of $32.7 million from the purchase of the license from Hengrui.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2026 was $58.8 million, primarily related to net proceeds from our Series A redeemable convertible preferred stock financing of $59.6 million, partially offset by $0.8 million in payments of deferred offering costs. Cash provided by financing activities for the six months ended June 30, 2025 was nominal, from proceeds from the issuance of founders stock.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2026 was $464.1 million, primarily related to net cash proceeds received in the period from our IPO of $404.5 million, and net proceeds from our Series A redeemable convertible preferred stock financing of $59.6 million. Cash provided by financing activities for the nine months ended September 30, 2025 was $101.0 million, from net proceeds of our Series A redeemable convertible preferred stock financing.

Previous wording

We have milestones, royalties, and/or other payments due under our Exclusive License Agreement with Hengrui. See Note 3 to our unaudited interim condensed financial statements. The technology transfer milestone for $3.0 million was completed in 2025 and recorded within accrued expenses and other current liabilities in the balance sheet as of December 31, 2025, and was paid as of June 30, 2026. The manufacturing technology transfer milestone for $6.0 million was completed in March 2026, and has been paid as of June 30, 2026.

Current wording

We have milestones, royalties, and/or other payments due under our Exclusive License Agreement with Hengrui. See Note 3 to our unaudited interim condensed financial statements. The technology transfer milestone for $3.0 million was completed in 2025 and recorded within accrued expenses and other current liabilities in the balance sheet as of December 31, 2025, and was paid as of September 30, 2026. The manufacturing technology transfer milestone for $6.0 million was completed in March 2026, and has been paid as of September 30, 2026. The initial echo data transfer milestone for $1.0 million was completed in August 2026, and was recorded within accrued expenses on the condensed balance sheet as of September 30, 2026.

Previous wording

As of December 31, 2025, we had no lease obligations. As of June 30, 2026, we have one operating lease agreement for subleased office space located in San Francisco, California. The sublease, which commenced in January 2026, has a term of 24 months, and our total remaining rent commitments under the sublease agreement are $0.6 million throughout the lease term. In addition to base rent, we pay our share of operating expenses and taxes.

Current wording

As of December 31, 2025, we had no lease obligations. As of September 30, 2026, we have one operating lease agreement for subleased office space located in San Francisco, California. The sublease, which commenced in January 2026, has a term of 24 months, and our total remaining rent commitments under the sublease agreement are $0.5 million throughout the lease term. In addition to base rent, we pay our share of operating expenses and taxes.

Previous wording

•CMOs in connection with the process development and scale-up activities and the production of preclinical and clinical trial materials.

Current wording

•CMOs in connection with the process development and scale-up activities and the production of nonclinical and clinical trial materials.

Previous wording

Stock-based compensation expense related to the stock-based awards granted to employees, consultants and Board members is measured at the grant date based on the fair value of the award. Compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period. We use the straight-line method to record the expense of awards with service-based vesting conditions. We account for forfeitures of stock-based awards as they occur rather than applying an estimated forfeiture rate to stock-based compensation expense. We recognize share-based compensation expense for awards with performance conditions when it is probable that the condition will be met, and the award will vest.

Current wording

Stock-based compensation expense related to the stock-based awards granted to employees, consultants and Board members is measured at the grant date based on the fair value of the award. Compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period. We use the straight-line method to record the expense of awards with service-based vesting conditions. We account for forfeitures of stock-based awards as they occur rather than applying an estimated forfeiture rate to stock-based compensation expense. We recognize share-based compensation expense for awards with performance conditions when it is probable that the condition will be met, and the award will vest. For the three and nine months ended September 30, 2026, the majority of our stock-based compensation expense related to restricted stock awards, primarily due to the executive restricted stock awards modified in July 2026. These awards are liability-classified, valued using a Monte Carlo simulation model, and remeasured to fair value at each reporting date until reclassified to equity or settled.

Previous wording

•Fair value of common stock. See the subsection titled “—Determination of Fair Value of Common Stock” below.

Current wording

•Fair value of common stock. Prior to our IPO, the fair value of our common stock was determined as described in the subsection titled “—Determination of Fair Value of Common Stock” below. Following our IPO, the fair value of our common stock is based on its quoted market price.

Previous wording

•Expected volatility. Since we are not yet a public company and do not have any trading history for our common stock, the expected volatility was estimated based on the average historical volatilities of common stock of comparable publicly traded entities over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their size, stage of their life cycle, or area of specialty. We will continue to apply this process until enough historical information regarding the volatility of our stock price becomes available.

Current wording

•Expected volatility. Because we have limited trading history for our common stock, the expected volatility was estimated based on the average historical volatilities of common stock of comparable publicly traded entities over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their size, stage of their life cycle, or area of specialty. We will continue to apply this process until enough historical information regarding the volatility of our stock price becomes available.

Previous wording

Stock-based compensation expense for employees and non-employees is reflected in the statements of operations and comprehensive loss as follows:

Current wording

Stock-based compensation expense for employees and non-employees is reflected in the statements of operations and comprehensive loss as follows (in thousands):

Previous wording

As of June 30, 2026 there was $4.6 million of total unrecognized stock-based compensation expense related to our granted options, which we expect to recognize over a remaining weighted-average period of 3.7 years. As of June 30, 2026 there was $7.5 million, of total unrecognized stock-based compensation expense related to outstanding RSAs, which we expect to recognize over a remaining weighted-average period of 3.0 years. We expect to continue to grant equity-based awards in the future, and to the extent that we do, our stock-based compensation expense recognized in future periods will likely increase.

Current wording

As of September 30, 2026 there was $45.4 million of total unrecognized stock-based compensation expense related to our granted options, which we expect to recognize over a remaining weighted-average period of 3.7 years. As of September 30, 2026 there was $6.4 million, of total unrecognized stock-based compensation expense related to outstanding RSAs, which we expect to recognize over a remaining weighted-average period of 2.9 years, in addition to $21.9 million of total unrecognized stock-based compensation expense related to the modified executive RSAs, which we expect to recognize over a remaining weighted-average period of 0.8 years. We expect to continue to grant equity-based awards in the future, and to the extent that we do, our stock-based compensation expense recognized in future periods will likely increase.

Previous wording

As there has been no public market for our common stock prior to the IPO, the estimated fair value of our common stock underlying our stock-based awards has been determined by our board of directors as of each option grant date with input from management, considering our most recently available third-party valuations of common stock and our board of directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant. These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the Practice Aid).

Current wording

As there had been no public market for our common stock prior to the IPO, the estimated fair value of our common stock underlying our stock-based awards has been determined by our board of directors as of each option grant date with input from management, considering our most recently available third-party valuations of common stock and our board of directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant. These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the Practice Aid).

Previous wording

We had a third-party valuation performed as of September 3, 2025, which resulted in a valuation of our common stock of $1.93 per share. Given our recent financing transactions and progress toward an IPO, we further utilized a hybrid approach to value our equity on January 15, 2026, February 25, 2026 and May 27, 2026, which resulted in valuations of our common stock of $2.28 per share, $2.41 per share, and$3.07 per share, respectively. All per share values presented reflect the 1-for-4.38 reverse stock split of our issued and outstanding shares of common stock effected on July 29, 2026.

Current wording

We had a third-party valuation performed as of September 3, 2025, which resulted in a valuation of our common stock of $1.93 per share. Given our recent financing transactions and progress at the time toward an IPO, we further utilized a hybrid approach to value our equity on January 15, 2026, February 25, 2026 and May 27, 2026, which resulted in valuations of our common stock of $2.28 per share, $2.41 per share, and $3.07 per share, respectively. All per share values presented reflect the 1-for-4.38 reverse stock split of our issued and outstanding shares of common stock effected on July 29, 2026.

Previous wording

In addition to considering the results of independent third party valuations, our board of directors considered various objective and subjective factors to determine the fair value of common stock as of each grant date, including:

Current wording

In addition to considering the results of independent third party valuations prior to our IPO, our board of directors considered various objective and subjective factors to determine the fair value of common stock as of each grant date, including:

Previous wording

•the prices at which we sold shares of our preferred stock and the superior rights, preferences and privileges of our preferred stock relative;

Current wording

•the prices at which we sold shares of our preferred stock and the superior rights, preferences and privileges of our preferred stock relative to those of our common stock at the time of each grant;

Previous wording

•the progress of our research and development programs, including the status of preclinical studies and clinical trials for our product candidate;

Current wording

•the progress of our research and development programs, including the status of nonclinical studies and clinical trials for our product candidate;

Previous wording

•the likelihood of achieving a liquidity event, such as an initial public offering (IPO) or a sale of our company, given prevailing market conditions; and

Current wording

•the likelihood of achieving a liquidity event, such as an initial public offering or a sale of our company, given prevailing market conditions; and

Previous wording

Once a public trading market for our common stock has been established in connection with the completion of the IPO, it will no longer be necessary for our board of directors to estimate the fair value of our common stock in connection with our accounting for granted stock options and other such awards we may grant, as the fair value of our common stock will be based on the quoted market price of our common stock.

Current wording

Following our IPO, the fair value of our common stock is based on the quoted market price of our common stock.