Tarsus Pharmaceuticals, Inc.

Previous wording

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, advancements, discoveries, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to actual results or to changes in our expectations.

Current wording

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, advancements, discoveries, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to actual results or to changes in our expectations, except as required by law.

Previous wording

◦Recognized $102.7 million in net product sales, an increase of 152% year over year.

Current wording

◦Recognized $118.7 million in net product sales, an increase of approximately 147% year over year.

Previous wording

◦Dispensed approximately 91,000 bottles of XDEMVY to patients.

Current wording

◦Delivered more than 103,000 bottles of XDEMVY to patients.

Previous wording

◦Recognized a gross-to-net discount of approximately 45%.

Current wording

◦Obtained broad, high quality coverage, with more than 90% of commercial, Medicare and Medicaid lives covered leading to a gross-to-net discount of 44.7%.

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: 1) the presence and quality of liquid secretion as measured by the Meibomian Gland Secretion Score; 2) the number of glands secreting normal or clear liquid; and 3) 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 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.

Previous wording

In February 2024, we announced positive topline results from the Galatea trial, a Phase 2a trial evaluating TP-04, an investigational sterile aqueous gel formulation of lotilaner, for the treatment of rosacea (the "Galatea Trial"). The positive topline results demonstrated statistically significant improvements (p<0.05) in inflammatory lesions and Investigator's Global Assessment score (change in baseline and success rate) were observed compared to vehicle at week 12. TP-04 was generally well tolerated. After review of this data with the FDA and key opinion leaders, we decided to pursue development of TP-04 for the potential treatment for ocular rosacea, a highly prevalent and underserved eye disease with no FDA-approved therapy. In January 2025, we announced plans to initiate a Phase 2 study in the second half of 2025 for the potential treatment of ocular rosacea, which remains on track.

Current wording

In February 2024, we announced positive topline results from the Galatea trial, a Phase 2a trial evaluating TP-04, an investigational sterile aqueous gel formulation of lotilaner, for the treatment of rosacea (the “Galatea Trial”). The positive topline results demonstrated statistically significant improvements (p<0.05) in inflammatory lesions and Investigator's Global Assessment score (change in baseline and success rate) were observed compared to vehicle at week 12. TP-04 was generally well tolerated. After review of this data with the FDA and key opinion leaders, we decided to pursue development of TP-04 for the potential treatment for ocular rosacea, a highly prevalent and underserved eye disease with no FDA-approved therapy. In January 2025, we announced plans to initiate a Phase 2 study for the potential treatment of ocular rosacea in the second half of 2025, which we expect to initiate in December 2025, with topline results expected by year-end 2026.

Previous wording

We believe TP-05 is currently the only non-vaccine, drug-based prophylaxis in development that targets ticks, and potentially prevents Lyme disease transmission. It is designed to rapidly and durably provide systemic blood levels of lotilaner potentially sufficient to kill infected ticks attached to the human body before they can transmit the Borrelia bacteria that causes Lyme disease.

Current wording

We believe TP-05 is currently the only on-demand, oral tablet in development that targets ticks, and potentially prevents Lyme disease transmission. It is designed to rapidly and durably provide systemic blood levels of lotilaner potentially sufficient to kill infected ticks attached to the human body before they can transmit the Borrelia bacteria that causes Lyme disease.

Previous wording

In February 2024, we announced positive topline results from the Carpo trial, which demonstrated statistical significance in the mortality of ticks compared to vehicle (p<0.001), regardless of treatment arm, and was well tolerated (the "Carpo Trial"). The Carpo Trial is designed to evaluate TP-05, an investigational oral systemic, non-vaccine pharmacological prophylactic for the potential prevention of Lyme disease in humans. The Carpo Trial evaluated the efficacy of TP-05 in killing lab grown, non-disease carrying ticks after they have attached to the skin of healthy volunteers, as well as confirm the safety, tolerability, and blood concentration of TP-05.

Current wording

In February 2024, we announced positive topline results from the Carpo trial, which demonstrated statistical significance in the mortality of ticks compared to vehicle (p<0.001), regardless of treatment arm, and was well tolerated (the “Carpo Trial”). The Carpo Trial was designed to evaluate TP-05, an investigational oral systemic, non-vaccine pharmacological prophylactic for the potential prevention of Lyme disease in humans. The Carpo Trial evaluated the efficacy of TP-05 in killing lab grown, non-disease carrying ticks after they have attached to the skin of healthy volunteers, as well as confirm the safety, tolerability, and blood concentration of TP-05.

Previous wording

We believe we are on track for potential European regulatory approval expected in 2027, for a preservative-free formulation of XDEMVY for the potential treatment of Demodex blepharitis.

Current wording

We believe we are on track for potential European regulatory submission expected in 2026, and approval expected in 2027, for a preservative-free formulation of XDEMVY for the potential treatment of Demodex blepharitis.

Previous wording

In Japan, we plan to meet with regulatory authorities in the second half of 2025 to help determine a regulatory path forward for Demodex blepharitis. The Elara prevalence study showed high prevalence and significant impact of Demodex blepharitis in Japan, consistent with U.S. findings.

Current wording

Communications with regulatory authorities in Japan are ongoing to help determine a regulatory path forward for Demodex blepharitis. The Elara prevalence study showed high prevalence and significant impact of Demodex blepharitis in Japan, consistent with U.S. findings.

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").

Current wording

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”).

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 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 $20.3 million and $33.3 million for the three months ended June 30, 2025 and 2024, respectively, and $45.6 million and $69.0 million for the six months ended June 30, 2025 and 2024, 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 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 $12.6 million and $23.4 million for the three months ended September 30, 2025 and 2024, respectively, and $58.0 million and $92.4 million for the nine months ended September 30, 2025 and 2024, 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:

Previous wording

Until such time as we can generate significant revenue from product sales and achieve profitability, if ever, we expect to finance our operations through public equity or debt financings, or collaborations, strategic alliances, or licensing arrangements with third parties. Adequate funding may not be available to us when needed on acceptable terms, or at all. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional capital or enter into such agreements as and when needed, we could be forced to significantly delay, scale back, or discontinue our product development and/or commercialization plans, which would negatively and adversely affect our financial condition.

Current wording

We expect to finance our operations through existing capital balances, revenue from product sales, public equity or debt financings, or collaborations, strategic alliances, or licensing arrangements with third parties. Adequate funding may not be available to us when needed on acceptable terms, or at all. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional capital or enter into such agreements as and when needed, we could be forced to significantly delay, scale back, or discontinue our product development and/or commercialization plans, which would negatively and adversely affect our financial condition.

Previous wording

As of June 30, 2025, our aggregate cash, cash equivalents and marketable securities was $381.1 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, 2025, our aggregate cash, cash equivalents and marketable securities was $401.8 million – see the section below titled “Management's Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources.”

Previous wording

Comparison of the Six Months Ended

Current wording

Comparison of the Three Months Ended

Previous wording

During the three months ended June 30, 2025 and 2024, we recognized revenue of $102.7 million and $40.8 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments driven by approximately 91,000 bottles of XDEMVY delivered to patients compared to 37,000 bottles delivered in the prior year period.

Current wording

During the three months ended September 30, 2025 and 2024, we recognized revenue of $118.7 million and $48.1 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments primarily driven by approximately 103,000 bottles of XDEMVY delivered to patients compared to approximately 41,400 bottles delivered to patients in the prior year period.

Previous wording

For the three months ended June 30, 2025 and 2024, we recognized $6.2 million and $3.0 million, respectively, in cost of sales for XDEMVY. Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of

Current wording

For the three months ended September 30, 2025 and 2024, we recognized $8.3 million and $3.2 million, respectively, in cost of sales for XDEMVY. 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 $3.3 million for the three months ended June 30, 2025, as compared to the prior year period. The increase was primarily due to (i) $0.8 million of increased TP-04 program expenses, (ii) $1.3 million of increased payroll and personnel-related costs (including a slight increase in stock-based compensation expense) related to employee additions to drive our product development initiatives, (iii) $1.0 million of increased early-stage programs, and (iv) $0.3 million of increased other indirect expenses. These increases were partially offset by $0.2 million of decreased TP-03 program expenses.

Current wording

Research and development expenses increased by $4.2 million for the three months ended September 30, 2025, as compared to the prior year period. The increase was primarily due to (i) $0.8 million of increased TP-04 program expenses, (ii) $2.9 million of increased payroll and personnel-related costs (including increased stock-based compensation expense of $1.2 million) related to employee additions to drive our product development initiatives, (iii) $0.7 million of increased early-stage programs, and (iv) $0.4 million of increased other indirect expenses. These increases were partially offset by $0.8 million of decreased TP-05 program expenses.

Previous wording

Selling, general and administrative expenses increased by $44.2 million for the three months ended June 30, 2025, as compared to the prior year period. The increase was primarily due to (i) $7.1 million of increased payroll and personnel-related costs (including increased stock-based compensation expense of $0.7 million) for commercial and corporate employee additions to support our business growth and commercial leadership hires for XDEMVY, (ii) $30.2 million of increased commercial and marketing costs, including DTC advertising costs, as we continued our commercial expansion of XDEMVY and (iii) $6.9 million of increased information technology applications, legal, professional and other corporate expenses. We expect increased vendor expenses in 2025 given further growth and expansion of our commercial activities for XDEMVY and other corporate initiatives.

Current wording

Selling, general and administrative expenses increased by $50.7 million for the three months ended September 30, 2025, as compared to the prior year period. The increase was primarily due to (i) $7.4 million of increased payroll and personnel-related costs (including increased stock-based compensation expense of $3.5 million) for commercial and corporate employee additions to support our business growth and commercial leadership hires for XDEMVY, (ii) $26.1 million of increased commercial and marketing costs, including direct-to-consumer (“DTC”) advertising costs, as we continued our commercial expansion of XDEMVY and (iii) $17.2 million of increased variable costs including certain patient assistance programs, fees related to increased bottles dispensed, information technology applications, legal, professional and other corporate expenses. Our field sales headcount and associated vendor expenses increased in 2025 due to further growth and expansion of our commercial activities for XDEMVY and other corporate initiatives.

Previous wording

On July 4, 2025, the One Big Beautiful Bill Act (the “OBBB Act”) was enacted in the U.S, which contains a broad range of tax reform provisions affecting businesses. We are currently evaluating the potential impact of the OBBB Act on our financial position, but do not expect it to materially impact our effective tax rate or cash flows during the current fiscal year. As the legislation was signed into law after the quarter ended June 30, 2025, any potential impact is not included in our operating results for the three months ended June 30, 2025.

Current wording

In July 2025, the One Big Beautiful Bill Act (the “OBBB Act”) was enacted in the U.S, which contains a broad range of tax reform provisions affecting businesses. We evaluated the impact of the OBBB Act on our financial position and it did not have a material impact on our effective tax rate or cash flows during the three months ended September 30, 2025.

Previous wording

During the six months ended June 30, 2025 and 2024, we recognized revenue of $181.0 million and $65.5 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments driven by approximately 163,000 bottles of XDEMVY delivered to patients, compared to 63,000 bottles delivered in the prior year period.

Current wording

During the nine months ended September 30, 2025 and 2024, we recognized revenue of $299.7 million and $113.7 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments primarily driven by approximately 266,000 bottles of XDEMVY delivered to patients, compared to approximately 104,400 bottles delivered to patients in the prior year period.

Previous wording

During the six months ended June 30, 2025, we did not recognize any license fees and collaboration revenue. During the six months ended June 30, 2024, we recognized $2.9 million of license fees and collaboration revenue including (i) $2.5 million for a termination payment related to the Novation Agreement, and (ii) $0.4 million for a warrant termination payment (see Note 9).

Current wording

During the nine months ended September 30, 2025, we did not recognize any license fees and collaboration revenue. During the nine months ended September 30, 2024, we recognized $2.9 million of license fees and collaboration revenue including (i) $2.5 million for a termination payment related to the Novation Agreement, and (ii) $0.4 million for a warrant termination payment (see Note 9).

Previous wording

For the six months ended June 30, 2025 and 2024, we recognized $11.4 million and $4.7 million, respectively, in cost of sales of XDEMVY. 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, and freight-in, as well as 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, 2025 and 2024, we recognized $19.8 million and $7.9 million, respectively, in cost of sales of XDEMVY. 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, and freight-in, as well as 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 $5.6 million for the six months ended June 30, 2025, as compared to the prior year period. The increase was primarily due to (i) $2.2 million of increased indirect expenses related to payroll and personnel-related costs (including increased stock-based compensation expense of $0.1 million) for employee additions to drive our product development initiatives, (ii) $0.6 million of increased other indirect expenses, (iii) $1.9 million of increased early-stage programs, (iv) $1.3 million of increased TP-04 program expenses and (v) $0.2 million of increased TP-05 program expenses. These increases were partially offset by $0.7 million of decreased TP-03 program expenses.

Current wording

Research and development expenses increased by $9.8 million for the nine months ended September 30, 2025, as compared to the prior year period. The increase was primarily due to (i) $5.1 million of increased payroll and personnel-related costs (including increased stock-based compensation expense of $1.3 million) for employee additions to drive our product development initiatives, (ii) $1.0 million of increased other indirect expenses, (iii) $2.6 million of increased early-stage programs, and (iv) $2.1 million of increased TP-04 program expenses. These increases were partially offset by $0.6 million of decreased TP-05 program expenses and $0.5 million of decreased TP-03 program expenses.

Previous wording

Selling, general and administrative expenses increased by $77.6 million for the six months ended June 30, 2025, as compared to the prior year period. The increase was primarily due to (i) $16.6 million of increased payroll and employee-related costs (including increased stock-based compensation expense of $2.1 million) for commercial and corporate employee additions to support our business growth and commercial leadership hires for XDEMVY, (ii) $55.9 million of increased commercial and marketing costs, including DTC advertising costs, as we continued our commercial expansion for the commercial launch of XDEMVY, and (iii) $5.0 million of increased information technology applications, legal, professional and other corporate expenses. Our field sales headcount and associated vendor expenses have continued to increase during 2025 due to further growth and expansion of our commercial activities for XDEMVY.

Current wording

Selling, general and administrative expenses increased by $128.4 million for the nine months ended September 30, 2025, as compared to the prior year period. The increase was primarily due to (i) $24.0 million of increased payroll and personnel-related costs (including increased stock-based compensation expense of $5.6 million) for commercial and corporate employee additions to support our business growth and commercial leadership hires for XDEMVY, (ii) $81.5 million of increased commercial and marketing costs, including DTC advertising costs, as we continued our commercial expansion for the commercial launch of XDEMVY, and (iii) $22.9 million of increased variable costs including certain patient assistance programs, fees related to increased bottles dispensed, information technology applications, legal, professional and other corporate expenses. Our field sales headcount and associated vendor expenses increased during 2025 due to further growth and expansion of our commercial activities for XDEMVY and other corporate initiatives.

Previous wording

Other income (expense), net increased by $1.0 million primarily due to a $1.9 million loss on debt extinguishment related to the 2022 Credit Facility (see Note 10), which was recognized in the prior year period and $0.4 million of increased interest income earned on our cash, cash equivalents and marketable securities, partially offset by $1.4 million of increased interest expense related to the Credit Facilities.

Current wording

Other income (expense), net increased by $1.2 million primarily due to a $1.9 million loss on debt extinguishment related to the 2022 Credit Facility (see Note 10), which was recognized in the prior year period and $0.4 million of increased interest income earned on our cash, cash equivalents and marketable securities, partially offset by $1.2 million of increased interest expense related to the Credit Facilities.

Previous wording

On July 4, 2025, the OBBB Act was enacted in the U.S, which contains a broad range of tax reform provisions affecting businesses. We are currently evaluating the potential impact of the OBBB Act on our financial position, but do not expect it to materially impact our effective tax rate or cash flows during the current fiscal year. As the legislation was signed into law after the quarter ended June 30, 2025, any potential impact is not included in our operating results for 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. We evaluated the potential impact of the OBBB Act on our financial position and it did not have a material impact on our effective tax rate or cash flows 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, 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 product sales, net, the China Out-License, and drawdowns from our Credit Facilities. As of June 30, 2025, we had cash, cash equivalents and marketable securities of $381.1 million.

Current wording

Since our inception, we have financed our operations substantially through private placements of preferred stock, 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 product sales, net, the China Out-License, and drawdowns from our Credit Facilities. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $401.8 million.

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. We have incurred significant losses and negative cash flows from operations since our inception and had an accumulated deficit of $405.7 million and $360.2 million as of June 30, 2025 and December 31, 2024, 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. We have incurred significant losses and negative cash flows from operations since our inception and had an accumulated deficit of $418.3 million and $360.2 million as of September 30, 2025 and December 31, 2024, respectively.

Previous wording

We believe our cash, cash equivalents and marketable securities of $381.1 million as of June 30, 2025, is sufficient to fund our current and planned operations for at least the next twelve months from the date of filing this Quarterly Report on Form 10-Q. We have additional availability from our 2024 Credit Facility of $50.0 million contingent on reaching certain sales milestones. Our cash runway estimate is predicated on current assumptions for future revenue, operating expenses, and debt availability 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

We believe our cash, cash equivalents and marketable securities of $401.8 million as of September 30, 2025, is sufficient to fund our current and planned operations for at least the next twelve months from the date of filing this Quarterly Report on Form 10-Q. We have additional availability from our 2024 Credit Facility of $50.0 million contingent on reaching certain sales milestones. Our cash runway estimate is predicated on current assumptions for future revenue, operating expenses, and debt availability 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.

Previous wording

In November 2023, we filed a shelf registration statement on Form S-3 that was declared effective by the SEC on November 21, 2023, (the "2023 Shelf Registration Statement"), and as part of the 2023 Shelf Registration Statement, we concurrently filed the 2023 ATM Prospectus with Jefferies. The 2023 ATM Prospectus covers the sale of up to $100.0 million of our common stock pursuant to an Open Market Sales Agreement TM we entered into with Jefferies in 2021 (the "ATM Sales Agreement"). Under the terms of the 2023 ATM Prospectus and ATM Sales Agreement, Jefferies will act as the Company's sales agent and is entitled to compensation for its services equal to 3% of the gross proceeds of any shares of common stock sold. In December 2023, we sold 1,000,000 shares of our common stock under the 2023 ATM Prospectus for $20.00 per share and received net proceeds of $19.2 million, after deducting broker commission and offering-related expenses. We have not sold any shares of our common stock under the 2023 ATM Prospectus during the six months ended June 30, 2025 and 2024.

Current wording

In November 2023, we filed a shelf registration statement on Form S-3 that was declared effective by the SEC on November 21, 2023, (the “2023 Shelf Registration Statement”), and as part of the 2023 Shelf Registration Statement, we concurrently filed the 2023 ATM Prospectus with Jefferies. The 2023 ATM Prospectus covers the sale of up to $100.0 million of our common stock pursuant to an Open Market Sales AgreementTM we entered into with Jefferies in 2021 (the “ATM Sales Agreement”). Under the terms of the 2023 ATM Prospectus and ATM Sales Agreement, Jefferies will act as the Company's sales agent and is entitled to compensation for its services equal to 3% of the gross proceeds of any shares of common stock sold. In December 2023, we sold 1,000,000 shares of our common stock under the 2023 ATM Prospectus for $20.00 per share and received net proceeds of $19.2 million, after deducting broker commission and offering-related expenses. We have not sold any shares of our common stock under the 2023 ATM Prospectus during the nine months ended September 30, 2025 and 2024.

Previous wording

We expect to incur significant operating losses for the foreseeable future, and for these losses to further increase, as we expand our clinical development programs for our other product candidates and continue to commercialize XDEMVY. We may also encounter unforeseen expenses, difficulties, complications, delays and other currently unknown factors that could adversely affect our business.

Current wording

While we have generated revenue from the launch of XDEMVY, we expect to incur significant operating losses for the foreseeable future, and for these losses to further increase, as we expand our clinical development programs for our other product candidates and continue to commercialize XDEMVY. We may also encounter unforeseen expenses, difficulties, complications, delays and other currently unknown factors that could adversely affect our business.

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 net increases in non-cash and other charges of $13.7 million. The decrease in net operating assets and liabilities were primarily due to cash decreases in prepaid expenses of $14.4 million, accounts receivable of $11.6 million, accrued payroll and benefits of $4.2 million and inventories of $1.3 million, partially offset by a cash increase of $13.6 million of accounts payable and other accrued liabilities. The increase in net non-cash and other charges were primarily related to stock-based compensation expense of $15.2 million and amortization of intangible assets and depreciation of property, plant and equipment totaling $0.9 million, partially offset by net amortization/accretion of marketable securities of $3.0 million.

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 net increases in operating assets and liabilities of $1.1 million and non-cash and other charges of $25.2 million. The increase in net operating assets and liabilities was primarily due to cash increases in accounts payable and other accrued liabilities of $37.4 million, partially offset by cash decreases including accounts receivable of $25.9 million, prepaid expenses of $6.5 million, accrued payroll and benefits of $2.3 million and inventories of $1.2 million. The increase in net non-cash and other charges was primarily related to stock-based compensation expense of $27.4 million and amortization of intangible assets and depreciation of property, plant and equipment totaling $1.4 million, partially offset by net amortization/accretion of marketable securities of $4.6 million.

Previous wording

Net cash used in operating activities was $52.2 million for the six months ended June 30, 2024, which primarily consisted of a net loss of $69.0 million, partially offset by a net increase in net operating assets and liabilities of $1.7 million and a net increase in non-cash and other charges of $15.2 million. The increase in net operating assets and liabilities was primarily due to an increase in accounts payable and other accrued liabilities of $19.4 million and a decrease in prepaid expenses of $1.8 million, partially offset by cash decreases including $12.9 million of accounts receivable, $5.2 million of accrued payroll and benefits, and $1.6 million of inventory. The net non-cash and other charges were primarily related to stock-based compensation expense of $13.0 million and a loss on debt extinguishment of $1.9 million.

Current wording

Net cash used in operating activities was $60.8 million for the nine months ended September 30, 2024, which primarily consisted of a net loss of $92.4 million, partially offset by net increases in non-cash and other charges of $22.0 million and net operating assets and liabilities of $9.6 million. The increase in net non-cash and other charges was primarily related to stock-based compensation expense of $20.4 million and a loss on debt extinguishment of $1.9 million. The increase in net operating assets and liabilities was primarily due to cash increases in accounts payable and other accrued liabilities of $25.3 million and prepaid expenses of $0.7 million, partially offset by cash decreases including $12.5 million of accounts receivable, $1.9 million of accrued payroll and benefits, and $2.3 million of inventory.

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, plant and equipment. These cash decreases were partially offset by $170.2 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, plant and equipment. These cash decreases were partially offset by $269.7 million of proceeds from maturities of marketable securities.

Previous wording

Net cash used in investing activities was $142.7 million for the six months ended June 30, 2024, and related to $151.6 million of purchased marketable securities, $3.0 million of purchased long-term investments, and $1.2 million of purchased property, plant and equipment, partially offset by $13.0 million of proceeds from maturities of marketable securities.

Current wording

Net cash used in investing activities was $139.6 million for the nine months ended September 30, 2024, and related to $172.7 million of purchased marketable securities, $3.0 million of purchased long-term investments, and $1.5 million of purchased property, plant and equipment. These cash decreases were partially offset by $37.5 million of proceeds from maturities of marketable securities.

Previous wording

Net cash provided by financing activities was $138.5 million for the six months ended June 30, 2025, and related to $134.8 million of net proceeds from the issuance of common stock in the March 2025 Public Offering, $2.6 million of proceeds from employee stock option exercises and $1.1 million of proceeds from the issuance of common stock for our employee stock purchase plan ("ESPP").

Current wording

Net cash provided by financing activities was $141.1 million for the nine months ended September 30, 2025, and related to $134.8 million of net proceeds from the issuance of common stock in the March 2025 Public Offering, $5.2 million of proceeds from employee stock option exercises and $1.1 million of proceeds from the issuance of common stock for our employee stock purchase plan (“ESPP”).

Previous wording

Net cash provided by financing activities was $151.1 million for the six months ended June 30, 2024, and primarily related to (i) $98.3 million of net proceeds from the issuance of common stock in the March 2024 Public Offering, (ii) $9.4 million of net proceeds from the issuance of pre-funded warrants in the March 2024 Public Offering, (iii) $75 million of proceeds from an initial draw against our 2024 Credit Facility, (iv) $2.6 million of proceeds from employee stock option exercises, and (v) $1.1 million of proceeds from the issuance of common stock for our ESPP. These increases to cash were partially offset by $31.9 million of payments on the 2022 Credit Facility, and $3.5 million of cash paid for loan issuance costs on the 2024 Credit Facility.

Current wording

Net cash provided by financing activities was $151.7 million for the nine months ended September 30, 2024, and primarily related to (i) $98.3 million of net proceeds from the issuance of common stock in the March 2024 Public Offering, (ii) $9.4 million of net proceeds from the issuance of pre-funded warrants in the March 2024 Public Offering, (iii) $75.0 million of proceeds from an initial draw against our 2024 Credit Facility, (iv) $3.3 million of proceeds from employee stock option exercises, and (v) $1.1 million of proceeds from the issuance of common stock for our ESPP. These increases to cash were partially offset by $31.9 million of debt extinguishment payments on the 2022 Credit Facility, and $3.5 million of cash paid for loan issuance costs on the 2024 Credit Facility.