Tarsus Pharmaceuticals, Inc.

Previous wording

•our ability to integrate iRenix Medical, Inc. (“iRenix”) and realize the anticipated benefits of the acquisition;

Current wording

•our ability to integrate Alkeus Pharmaceuticals, Inc. (“Alkeus”) and iRenix Medical, Inc. (“iRenix”) and realize the anticipated benefits of the acquisitions;

Previous wording

•our anticipated use of our existing resources and the proceeds from our initial public offering (“IPO”), our subsequent follow-on public offerings in May 2022 (the “May 2022 Public Offering”), August 2023 (the “August 2023 Public Offering”), March 2024 (the “March 2024 Public Offering”), and March 2025 (the “March 2025 Public Offering”), collectively the “Follow-On Public Offerings”, as well as proceeds from our sales agreement prospectus (the “2023 ATM Prospectus”), drawdowns from our loan and security agreement (the “2024 Credit Facility”) with funds associated with Pharmakon Advisors, LP (“Pharmakon”), and a private placement of 2,098,519 shares of our common stock at a purchase price of $56.00 per share and pre-funded warrants to purchase 133,625 shares of our common stock at a purchase price per pre-funded warrant of $55.9999 (the purchase price per share less $0.0001, the exercise price of the pre-funded warrants), which is expected to result in gross proceeds of $125.0 million, before deducting placement agent fees and offering expenses (the “PIPE Transaction”). The PIPE Transaction is expected to close on August 7, 2026, subject to the satisfaction of customary closing conditions.

Current wording

•our anticipated use of our existing resources and the proceeds from our initial public offering (“IPO”), our subsequent follow-on public offerings in May 2022 (the “May 2022 Public Offering”), August 2023 (the “August 2023 Public Offering”), March 2024 (the “March 2024 Public Offering”), and March 2025 (the “March 2025 Public Offering”), collectively the “Follow-On Public Offerings”, as well as proceeds from our sales agreement prospectus (the “2023 ATM Prospectus”), drawdowns from our loan and security agreement (the “2024 Credit Facility”) with funds associated with Pharmakon Advisors, LP (“Pharmakon”), and a private placement of shares of our common stock and pre-funded warrants to purchase shares of our common stock in August 2026.

Previous wording

References in this Quarterly Report on Form 10-Q to the terms, “Tarsus,” the “Company,” “we,” “our,” and “us” refer to Tarsus Pharmaceuticals, Inc., unless the context otherwise indicates.

Current wording

References in this Quarterly Report on Form 10-Q to the terms, “Tarsus,” the “Company,” “we,” “our,” and “us” refer to Tarsus Pharmaceuticals, Inc., and its consolidated subsidiaries, unless the context otherwise indicates.

Previous wording

In March 2026, we initiated and have since completed enrollment in a Phase 2 clinical trial (the “Calliope Trial”) evaluating TP-05, a novel investigational lotilaner-based oral prophylactic designed to kill ticks before potential disease transmission. Topline results are expected in the first half of 2027, which we believe could support a Phase 3-ready package by the end of 2027.

Current wording

In March 2026, we initiated and have since completed enrollment in a Phase 2 clinical trial (the “Calliope Trial”) evaluating TP-05, a novel investigational lotilaner-based oral prophylactic designed to kill ticks before potential disease transmission. Enrollment was completed in June 2026 and topline results are expected in the first half of 2027, which we believe could support a Phase 3-ready package by the end of 2027.

Previous wording

In July 2026, as part of our strategic entry into the retina market, we acquired IRX-101 in connection with the acquisition of iRenix (the “iRenix Acquisition”). IRX-101 is an investigational ocular antiseptic based on a stable aqueous chlorine dioxide solution that is being developed for the potential to reduce post-procedural pain and corneal toxicity in patients receiving intravitreal therapy. Based on data from a Phase 2b/3 trial and in alignment with feedback from the FDA, we plan to initiate a Phase 3 trial (the “COMFORT Trial”) of IRX-101, an investigational ocular antiseptic designed to evaluate the tolerability and safety of IRX-101 compared to povidone-iodine. The COMFORT Trial is expected to begin enrolling in the first half of 2027 with topline results expected in 2028.

Current wording

In connection with the iRenix Acquisition, we acquired IRX-101, an investigational ocular antiseptic based on a stable aqueous chlorine dioxide solution that is being developed for the potential to reduce post-procedural pain and corneal toxicity in patients receiving repeated intravitreal therapy. Based on data from a Phase 2b/3 trial and in alignment with feedback from the FDA, we plan to initiate a Phase 3 trial (the “Comfort Trial”) of IRX-101, an investigational ocular antiseptic designed to evaluate the tolerability and safety of IRX-101 compared to povidone-iodine. We plan to initiate the Comfort Trial in the first half of 2027, with topline results expected in 2028.

Previous wording

Definitive Agreement to Acquire Alkeus: On July 31, 2026, we entered into an Agreement and Plan of Merger (the “Alkeus Merger Agreement”), by and among the Company, Apex 2026 Merger Sub, Inc., Alkeus and Shareholder Representative Services LLC, pursuant to which we have agreed to acquire (the “Alkeus Acquisition”) Alkeus, a privately held ophthalmology-focused biotechnology company developing gildeuretinol (ALK-001), an investigational once-daily oral therapy with a differentiated approach designed to reduce toxic Vitamin A dimer formation in the retina, targeting the underlying biology of Stargardt disease, an inherited retinal disease affecting more than 36,000 diagnosed patients and an estimated 86,000 total patients in the U.S., that can lead to blindness. The Alkeus Acquisition adds a Phase 3 clinical program and is expected to further expand our presence in retina, one of the largest and fastest-growing specialties and is an important advancement in our strategy to become a leading eye care company. The Alkeus Acquisition is expected to close in 2026, subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the satisfaction of other customary closing conditions. The closing of the Alkeus Acquisition is not conditioned upon the closing of the PIPE Transaction or the receipt of any minimum amount of gross proceeds in the PIPE Transaction. There can be no assurances that the Alkeus Acquisition will be consummated on the terms and in the timing described herein or at all.

Current wording

In connection with the Alkeus Acquisition we acquired ALK-001, an investigational once-daily oral medicine with a differentiated approach designed to reduce toxic Vitamin A dimer formation in the retina, targeting the underlying biology of Stargardt disease. Stargardt disease is an inherited retinal disease affecting more than 36,000 diagnosed patients and an estimated 86,000 total patients in the U.S., which can lead to blindness. The Alkeus Acquisition added an ongoing Phase 3 clinical program (the “Northstar Trial”), evaluating ALK-001 for the potential treatment of Stargardt disease with enrollment continuing to progress and topline results expected in 2029.

Previous wording

Interim Chief Commercial Officer: In July 2026, we appointed Neera Clase, Interim Chief Commercial Officer, as we enter the next phase of growth. Ms. Clase has been instrumental in the development and execution of our successful commercial strategy. Her extensive knowledge of the business and established leadership across the organization position her well to support continued commercial execution.

Current wording

In October 2026 we appointed Neera Clase, formerly Interim Chief Commercial Officer, as Chief Commercial Officer. Ms. Clase has been instrumental in creating a new market for XDEMVY, building our commercial team, and securing broad coverage for patients. Her extensive knowledge of the business and established leadership across the organization position her well to lead commercial execution.

Previous wording

•Generated $173.9 million of net product sales in the second quarter of 2026, a year-over-year increase of more than 69%.

Current wording

•Generated $194.6 million of net product sales of XDEMVY in the U.S. in the third quarter of 2026, a year-over-year increase of approximately 64%.

Previous wording

In December 2023, we announced positive topline results of the Ersa Trial evaluating XDEMVY administered twice daily (“BID”) or three times a day (“TID”) for 6 weeks and 12 weeks for the treatment of MGD in patients with Demodex mites. XDEMVY demonstrated statistically significant and clinically meaningful improvements compared to baseline in two objective measures of the disease: the presence and quality of liquid secretion as measured by the Meibomian Gland Secretion Score; and the number of glands secreting normal or clear liquid. In November 2024, additional positive data was presented from the Ersa Trial as well as data from the Rhea Trial, a pilot study evaluating XDEMVY vehicle for the treatment of MGD in patients with Demodex mites, at the American Academy of Optometry (“AAOpt”) Annual Meeting 2024, and in April 2025 at the American Society of Cataract and Refractive Surgery (“ASCRS”) Annual Meeting 2025. The Rhea Trial enrolled a similar patient population as the Ersa Trial, and evaluated the same outcomes, with the same dosing regimens, except the Rhea Trial participants received XDEMVY vehicle. Both the Ersa and Rhea Trials also assessed patient reported outcomes for some of the most commonly reported patient symptoms in Demodex blepharitis and MGD, namely fluctuating vision, itching, redness, and burning.

Current wording

In December 2023, we announced positive topline results of the Ersa Trial evaluating XDEMVY administered twice daily (“BID”) or three times a day (“TID”) for 6 weeks and 12 weeks for the treatment of MGD in patients with Demodex mites. XDEMVY demonstrated statistically significant and clinically meaningful improvements compared to baseline in two objective measures of the disease: the presence and quality of liquid secretion as measured by the Meibomian Gland Secretion Score; and the number of glands secreting normal or clear liquid. In November 2024, additional positive data was presented from the Ersa Trial as well as data from the Rhea Trial, a pilot study evaluating XDEMVY vehicle for the treatment of MGD in patients with Demodex mites, at the American Academy of Optometry Annual Meeting 2024, and in April 2025 at the American Society of Cataract and Refractive Surgery Annual Meeting 2025. The Rhea Trial enrolled a similar patient population as the Ersa Trial, and evaluated the same outcomes, with the same dosing regimens, except the Rhea Trial participants received XDEMVY vehicle. Both the Ersa and Rhea Trials also assessed patient reported outcomes for some of the most commonly reported patient symptoms in Demodex blepharitis and MGD, namely fluctuating vision, itching, redness, and burning.

Previous wording

The presentations, which combined the Ersa and Rhea Trials data in a pooled analysis, demonstrated that XDEMVY provided statistically significant and clinically meaningful improvements of the meibomian glands from baseline and when compared to vehicle, including at least three times more glands secreting normal or clear liquid in patients treated with XDEMVY compared to vehicle at day 43. These improvements were shown across three objective measures of MGD: i) the presence and quality of liquid secretion as measured by the Meibomian Gland Secretion Score; ii) the number of glands secreting normal or clear liquid; and iii) the number of glands yielding any liquid. Improvements were also demonstrated across certain patient reported outcomes, including fluctuating vision, itching and redness. Further, XDEMVY demonstrated statistically significant rates of collarette cure and lid margin erythema cure that are consistent with previous XDEMVY studies. No statistically significant differences were observed between the BID and TID treatment arms in both the Ersa and Rhea Trials, respectively, and XDEMVY and the XDEMVY vehicle were well tolerated. Given the positive results of these trials, plus the FDA’s feedback that these patients are already covered under XDEMVY’s label for the treatment of Demodex blepharitis, our medical affairs team is continuing to move forward with sharing this data with ECPs.

Current wording

The presentations, which combined the Ersa and Rhea Trials data in a pooled analysis, demonstrated that XDEMVY provided statistically significant and clinically meaningful improvements of the meibomian glands from baseline and when compared to vehicle, including at least three times more glands secreting normal or clear liquid in patients treated with XDEMVY compared to vehicle at day 43. These improvements were shown across three objective measures of MGD: (i) the presence and quality of liquid secretion as measured by the Meibomian Gland Secretion Score; (ii) the number of glands secreting normal or clear liquid; and (iii) the number of glands yielding any liquid. Improvements were also demonstrated across certain patient reported outcomes, including fluctuating vision, itching and redness. Further, XDEMVY demonstrated statistically significant rates of collarette cure and lid margin erythema cure that are consistent with previous XDEMVY studies. No statistically significant differences were observed between the BID and TID treatment arms in both the Ersa and Rhea Trials, respectively, and XDEMVY and the XDEMVY vehicle were well tolerated. Given the positive results of these trials, plus the FDA’s feedback that these patients are already covered under XDEMVY’s label for the treatment of Demodex blepharitis, our medical affairs team continues to share this data with ECPs.

Previous wording

In March 2026, we initiated and have since completed enrollment in the Calliope Trial evaluating TP-05, a novel investigational lotilaner-based oral prophylactic designed to kill ticks before potential disease transmission. Topline results are expected in the first half of 2027, which we believe could support a Phase 3-ready package by the end of 2027.

Current wording

In March 2026, we initiated and have since completed enrollment in the Calliope Trial evaluating TP-05, a novel investigational lotilaner-based oral prophylactic designed to kill ticks before potential disease transmission. Enrollment was completed in June 2026 and topline results are expected in the first half of 2027, which we believe could support a Phase 3-ready package by the end of 2027.

Previous wording

In July 2026, we acquired iRenix, pursuant to an Agreement and Plan of Merger with iRenix, Dolores Merger Sub, Inc. and Fortis Advisors LLC, as the securityholders’ representative. In connection with the iRenix Acquisition, we acquired IRX-101. We are exploring the potential of IRX-101 as an investigational ocular antiseptic to reduce post-procedural pain and corneal toxicity in patients receiving intravitreal therapy. More than 11 million intravitreal injections are performed in the U.S. each year, the vast majority of which rely on povidone-iodine as a pre-procedural antiseptic. For many patients, povidone-iodine is associated with significant ocular surface toxicity, resulting in corneal damage and pain that can persist for days following treatment. Despite this, and despite being contraindicated in patients with iodine sensitivity, there have been no new FDA-approved ocular antiseptics in more than four decades. We believe IRX-101 has the potential to meaningfully improve that experience while maintaining the antiseptic activity physicians depend on.

Current wording

In July 2026, we acquired IRX-101 in connection with our iRenix Acquisition. We are exploring the potential of IRX-101 as an investigational ocular antiseptic to reduce post-procedural pain and corneal toxicity in patients receiving repeated intravitreal therapy. More than 11 million intravitreal injections are performed in the U.S. each year, the vast majority of which rely on povidone-iodine as a pre-procedural antiseptic. For many patients, povidone-iodine is associated with significant ocular surface toxicity, resulting in corneal damage and pain that can persist for days following treatment. Despite this, and despite being contraindicated in patients with iodine sensitivity, there have been no new FDA-approved ocular antiseptics in more than four decades. We believe IRX-101 has the potential to meaningfully improve that experience while maintaining the antiseptic activity physicians depend on.

Previous wording

Based on this data and in alignment with feedback from the FDA, we plan to initiate the COMFORT Trial. The study is expected to begin enrolling in the first half of 2027 with topline results expected in 2028.

Current wording

Based on this data and in alignment with feedback from the FDA, we plan to initiate the Phase 3 Comfort Trial. The study is expected to begin enrolling in the first half of 2027 with topline results expected in 2028.

Previous wording

On August 5, 2026, we entered into the Purchase Agreement for the PIPE Transaction. Pursuant to the terms of the Purchase Agreement, we agreed to issue and sell an aggregate of 2,098,519 shares of our common stock at a purchase price of $56.00 per share, and pre-funded warrants to purchase an aggregate of 133,625 shares of our common stock at a purchase price of $55.9999 per pre-funded warrant (the purchase price per share less $0.0001, the exercise price of the pre-funded warrants), which is expected to result in gross proceeds of $125.0 million, before deducting placement agent fees and other offering expenses. The PIPE Transaction is expected to close on August 7, 2026, subject to satisfaction of customary closing conditions.

Current wording

On August 7, 2026, we completed a private placement of an aggregate of 2,098,519 shares of our common stock at a purchase price of $56.00 per share and pre-funded warrants to purchase an aggregate of 133,625 shares of our common stock at a purchase price of $55.9999 per pre-funded warrant (the purchase price per share less $0.0001, the exercise price of the pre-funded warrants), which resulted in net proceeds of approximately $120.1 million, after deducting placement agent fees and other offering expenses (the “PIPE Transaction”).

Previous wording

To date, we have financed our operations through private placements of preferred stock, convertible promissory notes, net proceeds from issuance of common stock in our IPO, our subsequent Follow-On Public Offerings and our 2023 ATM Prospectus, as well as proceeds from net product sales, our China Out-License, and drawdowns from the 2024 Credit Facility and the previous loan and security agreement with Hercules Capital, Inc. and Silicon Valley Bank, a division of First Citizens Bank & Trust Company (the “2022 Credit Facility”, and collectively the “Credit Facilities”). On August 5, 2026, we entered into the Purchase Agreement for the PIPE Transaction, which is expected to close on August 7, 2026, subject to satisfaction of customary closing conditions.

Current wording

To date, we have financed our operations through private placements of preferred stock, convertible promissory notes, net proceeds from the issuance of common stock in our IPO, our subsequent Follow-On Public Offerings, our 2023 ATM Prospectus and the PIPE Transaction, as well as proceeds from net product sales, our China Out-License, and drawdowns from the 2024 Credit Facility and the previous loan and security agreement (collectively the “Credit Facilities”).

Previous wording

We have incurred significant net operating losses (“NOLs”) in every year since our inception and expect to continue to incur significant operating expenses as we continue to commercialize XDEMVY for Demodex blepharitis and as we advance our other product candidates through clinical trials, regulatory submissions, and potential commercialization. Our net losses were $18.6 million and $20.3 million for the three months ended June 30, 2026 and 2025, respectively, and $25.5 million and $45.5 million for the six months ended June 30, 2026 and 2025, respectively. Our net losses may fluctuate significantly from quarter to quarter and year to year and could be substantial. We anticipate that our operating expenses will increase significantly as we:

Current wording

We have incurred significant net operating losses (“NOLs”) in every year since our inception and expect to continue to incur significant operating expenses as we continue to commercialize XDEMVY for Demodex blepharitis and as we advance our other product candidates through clinical trials, regulatory submissions, and potential commercialization. Our net losses were $668.3 million and $12.6 million for the three months ended September 30, 2026 and 2025, respectively, and

Previous wording

•advance the clinical development of various pipeline programs, including TP-04 for the potential treatment of ocular rosacea and TP-05 for the potential Lyme disease prophylaxis;

Current wording

•advance the clinical development of various pipeline programs, including TP-04 for the potential treatment of ocular rosacea, TP-05 for the potential Lyme disease prophylaxis, IRX-101 for the potential use as an ocular antiseptic, and ALK-001 for the potential treatment of Stargardt disease;

Previous wording

As of June 30, 2026, our aggregate cash, cash equivalents and marketable securities was $449.7 million – see the section below titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources.”

Current wording

As of September 30, 2026, our aggregate cash, cash equivalents and marketable securities was $309.6 million – see the section below titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources.”

Previous wording

Recent global economic conditions have been marked by significant volatility and heightened trade tensions. In addition, persistent inflationary pressures, a prolonged higher interest rate environment, energy supply disruptions in certain regions, evolving trade policies, including increased tariffs, regulatory uncertainty, and ongoing and emerging geopolitical conflicts, including war, have contributed to regional and global macroeconomic challenges. These conditions have created uncertainty in global markets and may continue to impact economic conditions for an extended period.

Current wording

Recent global economic conditions have been marked by significant volatility and heightened trade tensions. In addition, persistent inflationary pressures, a prolonged higher interest rate environment, energy supply disruptions in certain regions, evolving trade policies, including increased tariffs, regulatory uncertainty, and ongoing and emerging geopolitical conflicts, including war, have contributed to regional and global macroeconomic challenges. These conditions have created uncertainty in global markets and may continue to impact economic conditions for an extended period. While we have attempted to mitigate the effects of tariffs by entering into an agreement with the U.S. Department of Commerce, if we materially breach such agreement, including by making insufficient onshoring progress, the U.S. Department of Commerce may terminate the agreement and any tariff rate reductions we have been granted.

Previous wording

During the three months ended June 30, 2026 and 2025, we recognized revenue of $173.9 million and $102.7 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments, an increase of 69% compared to the prior year period. This increase in revenue was driven by higher volume and improvement in the gross-to-net discounts.

Current wording

During the three months ended September 30, 2026 and 2025, we recognized revenue of $194.6 million and $118.7 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments, an increase of approximately 64% compared to the prior year period. This increase in revenue was driven by higher volume and improvement in the gross-to-net discounts.

Previous wording

For the three months ended June 30, 2026 and 2025, we recognized $12.1 million and $6.2 million, respectively, in cost of sales for XDEMVY, and gross margins remained consistent at 93% and 94% for the respective periods. Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of XDEMVY, including raw materials, third-party manufacturing costs, packaging services, freight-in, third-party royalties payable on our product sales, net, and amortization of capitalized intangible assets associated with XDEMVY.

Current wording

For the three months ended September 30, 2026 and 2025, we recognized $13.9 million and $8.3 million, respectively, in cost of sales for XDEMVY, and gross margins remained consistent at 93% for both periods. Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of XDEMVY, including raw materials, third-party manufacturing costs, packaging services, freight-in, third-party royalties payable on our product sales, net, and amortization of capitalized intangible assets associated with XDEMVY.

Previous wording

Research and development expenses increased by $15.4 million for the three months ended June 30, 2026, as compared to the prior year period. The increase was primarily attributable to (i) an $8.0 million increase in TP-05 program expenses related to our Calliope Trial, which we initiated in March 2026 and has since completed enrollment, (ii) a $3.2 million increase in payroll and personnel-related costs (including increased stock-based compensation expense of $1.1 million) primarily due to employee additions to support our product development initiatives, (iii) a $3.1 million increase in TP-03 program expenses, and (iv) a $0.5 million increase in other early-stage development expenses.

Current wording

The remaining increase of $14.2 million was primarily attributable to (i) a $6.8 million increase in TP-05 program expenses related to our Calliope Trial, which we initiated in March 2026 and has since completed enrollment, (ii) a $3.8 million increase in payroll and personnel-related costs (including $1.4 million of recurring stock-based compensation expense), primarily due to employee additions to support our product development initiatives, (iii) a $1.8 million increase in TP-04 program expenses, (iv) $0.8 million of IRX-101 program expenses due to the iRenix Acquisition, and (v) a $2.0 million increase in other early-stage program expenses. The increases were partially offset by a $1.1 million decrease in TP-03 program expenses.

Previous wording

Selling, general and administrative expenses increased by $47.7 million for the three months ended June 30, 2026, as compared to the prior year period. The increase was primarily attributable to (i) a $21.2 million increase in commercial and marketing costs, including DTC advertising costs, as we continued to expand our promotional activities for XDEMVY, (ii) a $19.5 million increase in expenses associated with patient support functions, information technology, legal, and professional services, and (iii) a $6.7 million increase in payroll and personnel-related costs (including increased stock-based compensation expense of $3.9 million) primarily due to commercial and corporate employee additions to support our continued growth and expansion of our commercial leadership team. We expect vendor-related expenses to increase during 2026 as we continue to expand our commercial activities for XDEMVY and invest in other corporate initiatives.

Current wording

The remaining increase of $29.6 million was primarily attributable to (i) an $11.7 million increase in commercial and marketing costs, including DTC advertising costs, as we continued to expand our promotional activities for XDEMVY, (ii) a $9.6 million increase in expenses associated with patient support functions, information technology, legal, and professional services, and (iii) an $8.3 million increase in payroll and personnel-related costs (including $2.0 million of recurring stock-based compensation expense) primarily due to commercial and corporate employee additions to support our continued growth and expansion of our commercial leadership team. We expect vendor-related expenses to continue to increase during the remainder of 2026 as a result of our recent acquisitions, the continued expansion of our commercial activities for XDEMVY, and investments in other corporate initiatives.

Previous wording

Other income (expense), net increased by $2.6 million for the six months ended June 30, 2026, as compared to the prior year period and primarily related to a $2.8 million gain on exchange of long-term investments (see Note 12), partially offset by a $0.3 million decrease in interest income earned on our cash, cash equivalents and marketable securities.

Current wording

Other income (expense), net decreased by $3.5 million for the three months ended September 30, 2026, as compared to the prior year period and primarily related to a $3.3 million loss on the initial consolidation of a VIE and a $0.3 million decrease in interest income earned on our cash, cash equivalents and marketable securities.

Previous wording

In July 2025, the OBBB Act was enacted in the U.S., which contains a broad range of tax reform provisions affecting businesses, including permitting the immediate expensing of domestic research and development expenditures. Provision for income taxes was $2.7 million for the three months ended June 30, 2026, primarily due to $2.4 million of state income tax expense resulting from states that do not conform to the OBBB Act and therefore continue to require the capitalization and amortization of domestic research and development expenditures. There was no provision for income taxes recorded during the three months ended June 30, 2025.

Current wording

In July 2025, the OBBB Act was enacted in the U.S., which contains a broad range of tax reform provisions affecting businesses, including permitting the immediate expensing of domestic research and development expenditures. Provision for income taxes was $4.6 million for the three months ended September 30, 2026, primarily due to $4.3 million of state income tax expense resulting from states that do not conform to the OBBB Act and therefore continue to require the capitalization and amortization of domestic research and development expenditures. There was no provision for income taxes recorded during the three months ended September 30, 2025.

Previous wording

During the six months ended June 30, 2026 and 2025, we recognized revenue of $319.3 million and $181.0 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments, a year-over-year increase of more than 76%. This increase in revenue was driven by higher volume and improvement in the gross-to-net discounts.

Current wording

During the nine months ended September 30, 2026 and 2025, we recognized revenue of $513.9 million and $299.7 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments, a year-over-year increase of approximately 71%. This increase in revenue was driven by higher volume and improvement in the gross-to-net discounts.

Previous wording

For the six months ended June 30, 2026, we recognized $16.7 million in license fees and collaboration revenue related to (i) a $15.0 million regulatory milestone achievement under the China Out-License (see Note 9) and (ii) $1.7 million of required China withholding tax payable by GrandPharma on the associated milestone (see Note 11). The milestone payment was recorded on a gross basis, which increased license fees and collaboration revenue by $1.7 million, with an equal offsetting amount recorded as foreign tax expense within provision for income taxes. During the six months ended June 30, 2025, we did not recognize any license fees and collaboration revenue.

Current wording

For the nine months ended September 30, 2026, we recognized $16.7 million in license fees and collaboration revenue related to (i) a $15.0 million regulatory milestone achievement under the China Out-License (see Note 10) and (ii) $1.7 million of required China withholding tax payable by GrandPharma on the associated milestone (see Note 12). The milestone payment was recorded on a gross basis, which increased license fees and collaboration revenue by $1.7 million, with an equal offsetting amount recorded as foreign tax expense within provision for income taxes. During the nine months ended September 30, 2025, we did not recognize any license fees and collaboration revenue.

Previous wording

For the six months ended June 30, 2026 and 2025, we recognized $21.5 million and $11.4 million, respectively, in cost of sales for XDEMVY, and gross margins remained consistent at 93% and 94% for the respective periods. Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of XDEMVY, including raw materials, third-party manufacturing costs, packaging services, freight-in, third-party royalties payable on our product sales, net, and amortization of capitalized intangible assets associated with XDEMVY.

Current wording

For the nine months ended September 30, 2026 and 2025, we recognized $35.4 million and $19.8 million, respectively, in cost of sales for XDEMVY, and gross margins remained consistent at 93% for both periods. Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of XDEMVY, including raw materials, third-party manufacturing costs, packaging services, freight-in, third-party royalties payable on our product sales, net, and amortization of capitalized intangible assets associated with XDEMVY.

Previous wording

Research and development expenses increased by $23.4 million for the six months ended June 30, 2026, as compared to the prior year period. The increase was primarily attributable to (i) a $9.4 million increase in TP-05 program expenses related to our Calliope Trial, which we initiated in March 2026 and has since completed enrollment, (ii) a $6.9 million increase in payroll and personnel-related costs (including increased stock-based compensation expense of $2.6 million) primarily due to employee additions to support our product development initiatives, (iii) a $4.0 million increase in TP-03 program expenses, (iv) a $2.0 million upfront payment made upon execution of the February 2026 In-License Agreements (see Note 8), and (v) a $0.5 million increase in other indirect expenses.

Current wording

The remaining increase of $37.6 million was primarily attributable to (i) a $16.3 million increase in TP-05 program expenses related to our Calliope Trial, which we initiated in March 2026 and has since completed enrollment, (ii) a $10.7 million increase in payroll and personnel-related costs (including $4.0 million of recurring stock-based compensation expense), primarily due to employee additions to support our product development initiatives, (iii) a $2.9 million increase in TP-03 program expenses, (iv) a $1.8 million increase in TP-04 program expenses, (v) a $2.4 million increase in other early-stage program expenses, (vi) $0.8 million of IRX-101 program expenses due to the iRenix Acquisition, (vii) $0.7 million of other indirect expenses, and (viii) a $2.0 million upfront payment made upon execution of the February 2026 In-License Agreements (see Note 9).

Previous wording

Selling, general and administrative expenses increased by $99.1 million for the six months ended June 30, 2026, as compared to the prior year period. The increase was primarily attributable to (i) a $47.0 million increase in commercial and marketing costs, including DTC advertising costs, as we continued to expand our promotional activities for XDEMVY, (ii) a $40.7 million increase in costs associated with patient support functions, information technology, legal, and professional services, and (iii) an $11.1 million increase in payroll and personnel-related costs (including increased stock-based compensation expense of $7.4 million) primarily due to commercial and corporate employee additions to support our continued growth and the expansion of our commercial leadership team. We expect vendor-related expenses to continue to increase during 2026 as we continue to expand our commercial activities for XDEMVY and invest in other corporate initiatives.

Current wording

The remaining increase of $128.7 million was primarily attributable to (i) a $58.6 million increase in commercial and marketing costs, including DTC advertising costs, as we continued to expand our promotional activities for XDEMVY, (ii) a $50.4 million increase in costs associated with patient support functions, information technology, legal, and professional services, and (iii) a $19.7 million increase in payroll and personnel-related costs (including $9.4 million of recurring stock-based compensation expense) primarily due to commercial and corporate employee additions to support our continued growth and the expansion of our commercial leadership team. We expect vendor-related expenses to continue to increase during the remainder of 2026 as a result of our recent acquisitions, the continued expansion of our commercial activities for XDEMVY, and investments in other corporate initiatives.

Previous wording

Other income (expense), net increased by $2.2 million for the three months ended June 30, 2026, as compared to the prior year period and primarily related to a $2.8 million gain on exchange of long-term investments (see Note 12), partially offset by a $0.5 million decrease in interest income earned on our cash, cash equivalents and marketable securities.

Current wording

Other income (expense), net decreased by $1.0 million for the nine months ended September 30, 2026, as compared to the prior year period and primarily related to a $3.3 million loss on initial consolidation of a VIE and a $0.6 million decrease in interest income earned on our cash, cash equivalents and marketable securities, partially offset by a $2.8 million gain on exchange of long-term investments.

Previous wording

In July 2025, the OBBB Act was enacted in the U.S., which contains a broad range of tax reform provisions affecting businesses, including permitting the immediate expensing of domestic research and development expenditures. Provision for income taxes was $5.1 million for the six months ended June 30, 2026, primarily due to (i) $3.1 million of state income tax expense resulting from states that do not conform to the OBBB Act and therefore continue to require the capitalization and amortization of domestic research and development expenditures and (ii) $1.7 million of foreign withholding tax expense in connection with our China Out-License and a milestone that was achieved during the six months ended June 30, 2026. There was no provision for income taxes recorded during the six months ended June 30, 2025.

Current wording

In July 2025, the OBBB Act was enacted in the U.S., which contains a broad range of tax reform provisions affecting businesses, including permitting the immediate expensing of domestic research and development expenditures. Provision for income taxes was $9.7 million for the nine months ended September 30, 2026, primarily due to (i) $7.4 million of state income tax expense resulting from states that do not conform to the OBBB Act and therefore continue to require the capitalization and amortization of domestic research and development expenditures and (ii) $1.7 million of foreign withholding tax expense in connection with our China Out-License and a milestone that was achieved during the nine months ended September 30, 2026. There was no provision for income taxes recorded during the nine months ended September 30, 2025.

Previous wording

Since our inception, we have financed our operations substantially through private placements of preferred stock, convertible promissory notes, net proceeds from the issuance of common stock through our IPO, Follow-on Public Offerings, and the 2023 ATM Prospectus, as well as proceeds from net product sales, the China Out-License, and drawdowns from our Credit Facilities. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $449.7 million. On August 5, 2026, we entered into the Purchase Agreement for the PIPE Transaction, which is expected to result in gross proceeds of $125.0 million, before deducting placement agent fees and other offering expenses. The PIPE Transaction is expected to close on August 7, 2026, subject to satisfaction of customary closing conditions.

Current wording

Since our inception, we have financed our operations substantially through private placements of preferred stock, convertible promissory notes, net proceeds from the issuance of common stock through our IPO, Follow-on Public Offerings, the 2023 ATM Prospectus and the PIPE Transaction, as well as proceeds from net product sales, the China Out-License, drawdowns from our Credit Facilities. As of September 30, 2026, we had cash, cash equivalents and marketable securities of $309.6 million.

Previous wording

PIPE Transaction: On August 5, 2026, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a syndicate of existing and new healthcare investors for the sale of shares of our common stock and pre-funded warrants to purchase shares of our common stock in a private placement. Pursuant to the terms of the Purchase Agreement, we agreed to issue and sell an aggregate of 2,098,519 shares of our common stock at a purchase price of $56.00 per share and pre-funded warrants to purchase an aggregate of 133,625 shares of our common stock at a purchase price of $55.9999 per pre-funded warrant (the purchase price per share less $0.0001, the exercise price of the pre-funded warrants), which is expected to result in gross proceeds of $125.0 million, before deducting placement agent fees and other offering expenses. The PIPE Transaction is expected to close on August 7, 2026, subject to satisfaction of customary closing conditions.

Current wording

On August 7, 2026, we completed a private placement of an aggregate of 2,098,519 shares of our common stock at a purchase price of $56.00 per share, and pre-funded warrants to purchase an aggregate of 133,625 shares of our common stock at a purchase price of $55.9999 per pre-funded warrant (the purchase price per share less $0.0001, the exercise price of the pre-funded warrants), which resulted in net proceeds of approximately $120.1 million, after deducting placement agent fees and other offering expenses.

Previous wording

Our operating expenditures currently consist of cost of sales, research and development costs (including activities within our preclinical, clinical, regulatory, and drug manufacturing initiatives) and selling, general and administrative costs. Our use of cash is impacted by the timing and extent of payments for each of these activities and other business requirements. Although we have recently generated positive cash flows from operations, we have historically incurred significant losses and generated negative cash flows from operations since our inception. As of June 30, 2026 and December 31, 2025, we had accumulated deficits of $452.1 million and $426.6 million, respectively.

Current wording

Our operating expenditures currently consist of cost of sales, research and development costs (including activities within our preclinical, clinical, regulatory, and drug manufacturing initiatives) and selling, general and administrative costs. Our use of cash is impacted by the timing and extent of payments for each of these activities and other business requirements. Although we have recently generated positive cash flows from operations, we have historically incurred significant losses and generated negative cash flows from operations since our inception. As of September 30, 2026 and December 31, 2025, we had accumulated deficits of $1,120.5 million and $426.6 million, respectively.

Previous wording

As of the date of this filing, we have paid $37.5 million of cash consideration (the “iRenix Upfront Payment”) in connection with the iRenix Acquisition and have agreed to pay, subject to the consummation of the Alkeus Acquisition, $270.0 million of cash consideration in connection with the Alkeus Acquisition (see Note 13) (the “Alkeus Upfront Payment”). Further, we expect to receive an additional $125.0 million in gross proceeds upon the closing of the PIPE Transaction, which is expected to occur on August 7, 2026, subject to satisfaction of customary closing conditions. After giving effect to the iRenix Upfront Payment and assuming that we will pay the Alkeus Upfront Payment upon the consummation of the Alkeus Acquisition and will receive the gross proceeds upon the closing of the PIPE Transaction, we believe that our remaining cash, cash equivalents and marketable securities will be sufficient to fund our current and planned operations for at least the next twelve months following the filing date of this Quarterly Report on Form 10-Q. Our cash runway estimate is predicated on current assumptions regarding future revenue, operating expenses, and the availability of debt and equity financing, and may require future adjustments. Accordingly, we may be required to raise additional capital earlier than we currently expect based on our cash requirements and market dynamics.

Current wording

As of the date of this filing, we believe that our remaining cash, cash equivalents and marketable securities will be sufficient to fund our current and planned operations for at least the next twelve months following the filing date of this Quarterly Report on Form 10-Q. Our cash runway estimate is predicated on current assumptions regarding future revenue, operating expenses, and the availability of debt and equity financing, and may require future adjustments. Our cash runway estimate does not assume the payment of any of the contingent milestone or royalty obligations under the iRenix Acquisition or the Alkeus Acquisition, none of which we currently consider probable of becoming payable in the near term. If any of these milestones were to be achieved, the related payments would be significant and would reduce our cash runway. Accordingly, we may be required to raise additional capital earlier than we currently expect based on our cash requirements and market dynamics.

Previous wording

Net cash provided by operating activities was $36.6 million for the six months ended June 30, 2026, which primarily consisted of a net loss of $25.5 million, offset by a net increase in operating assets and liabilities of $39.2 million and non-cash charges of $22.9 million. Our cash inflows primarily related to $530.0 million of cash receipts from XDEMVY net product sales, and $15.0 million from GrandPharma for a regulatory milestone achievement under the China Out-License. These cash inflows were partially offset by (i) $430.7 million of vendor payments, (ii) $58.9 million of personnel-related costs, and (iii) $16.4 million of royalty payments.

Current wording

Net cash provided by operating activities was $30.6 million for the nine months ended September 30, 2026, which primarily consisted of a net loss of $693.9 million, offset by a net increase in operating assets and liabilities of $36.5 million and non-cash charges of $687.9 million. Our cash inflows primarily related to $854.2 million of cash receipts from XDEMVY net product sales. These cash inflows were partially offset by (i) $724.7 million of vendor payments, (ii) $76.4 million of personnel-related costs, and (iii) $25.8 million of royalty payments.

Previous wording

Net cash used in operating activities was $50.0 million for the six months ended June 30, 2025, which primarily consisted of a net loss of $45.5 million and a net decrease in operating assets and liabilities of $18.3 million, partially offset by non-cash charges of $13.7 million. Our cash outflows primarily related to: (i) $292.5 million of vendor payments, (ii) $51.9 million of personnel-related costs, and (iii) $7.2 million of royalty payments. These cash outflows were partially offset by cash receipts of $303.6 million related to XDEMVY net product sales.

Current wording

Net cash used in operating activities was $31.8 million for the nine months ended September 30, 2025, which primarily consisted of a net loss of $58.0 million, partially offset by non-cash charges of $25.2 million and a net increase in operating assets and liabilities of $1.1 million. Our cash outflows primarily related to: (i) $435.8 million of vendor payments, (ii) $72.0 million of personnel-related costs, and (iii) $12.4 million of royalty payments. These cash outflows were partially offset by cash receipts of $490.8 million related to XDEMVY net product sales.

Previous wording

Net cash used in investing activities was $86.6 million for the six months ended June 30, 2025, and related to $255.3 million of purchased marketable securities and $1.6 million of purchased property and equipment, partially offset by $170.2 million of proceeds from maturities of marketable securities.

Current wording

Net cash used in investing activities was $210.2 million for the nine months ended September 30, 2026, and related to $223.1 million of cash paid for the Alkeus Acquisition, $37.3 million of cash paid for the iRenix Acquisition, $129.2 million of purchased marketable securities, and $11.1 million of purchased property and equipment, partially offset by $190.5 million of proceeds from maturities of marketable securities.

Previous wording

Net cash used in investing activities was $20.7 million for the six months ended June 30, 2026, and related to $129.2 million of purchased marketable securities and $9.9 million of purchased property and equipment, partially offset by $118.4 million of proceeds from maturities of marketable securities.

Current wording

Net cash used in investing activities was $91.4 million for the nine months ended September 30, 2025, and related to $357.6 million of purchased marketable securities and $3.5 million of purchased property and equipment, partially offset by $269.7 million of proceeds from maturities of marketable securities.