Tarsus Pharmaceuticals Inc

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"), and March 2024 (the "March 2024 Public Offering", collectively the “Follow-On Public Offerings”), as well as proceeds from our sales agreement prospectus (the "2023 ATM Prospectus"), and drawdowns from our loan and security agreement (the "2024 Credit Facility") with funds associated with Pharmakon Advisors, LP ("Pharmakon").

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"), and drawdowns from our loan and security agreement (the "2024 Credit Facility") with funds associated with Pharmakon Advisors, LP ("Pharmakon").

Previous wording

To date, we have completed seven clinical trials that include a Phase 3 Saturn-2 trial, a Phase 2b/3 Saturn-1 trial, four Phase 2 trials, and a Phase 1 trial for XDEMVY in Demodex blepharitis, all of which met their primary, secondary and/or certain exploratory endpoints, with the drug well tolerated throughout each trial. We have also completed, and/or have ongoing clinical trials for the potential treatment of Demodex blepharitis in patients with MGD including the Ersa clinical trial involving XDEMVY, and the Rhea clinical trial involving XDEMVY vehicle; TP-04 for the potential treatment of rosacea, and TP-05 for potential Lyme disease prophylaxis, among others.

Current wording

To date, we have completed seven clinical trials that include a Phase 3 Saturn-2 trial, a Phase 2b/3 Saturn-1 trial, four Phase 2 trials, and a Phase 1 trial for XDEMVY in Demodex blepharitis, all of which met their primary, secondary and/or certain exploratory endpoints, with the drug well tolerated throughout each trial. We have also completed, and/or have ongoing clinical trials for the potential treatment of Demodex blepharitis in patients with Meibomian Gland Disease ("MGD") including the Ersa clinical trial involving XDEMVY, and the Rhea clinical trial involving an XDEMVY vehicle; TP-04 for the potential treatment of Ocular Rosacea, and TP-05 for potential Lyme disease prophylaxis, among others.

Previous wording

We intend to further advance our pipeline with the lotilaner API to address several diseases in human medicine, including eye care, dermatology, and infectious disease prevention. We are investigating the development of our product candidates to address targeted diseases with high unmet medical needs, which currently include TP-04, a novel gel formulation of lotilaner for the potential treatment of rosacea and TP-05, a novel investigative oral formulation of lotilaner, for potential Lyme disease prophylaxis and community malaria reduction.

Current wording

We intend to further advance our pipeline with the lotilaner API to address several diseases in human medicine, including eye care, and infectious disease prevention. We are investigating the development of our product candidates to address targeted diseases with high unmet medical needs, which currently include TP-04, a novel gel formulation of lotilaner for the potential treatment of Ocular Rosacea and TP-05, a novel investigational oral formulation of lotilaner, for potential Lyme disease prophylaxis and community malaria reduction.

Previous wording

TP-03 Demodex blepharitis in patients with Meibomian Gland Disease (MGD), Ersa and Rhea Trials: In December 2023, we announced positive topline results of the Ersa pilot clinical trial evaluating XDEMVY (lotilaner ophthalmic solution, 0.25%) 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 Ersa as well as data from Rhea, 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. The Rhea study enrolled a similar patient population as Ersa, and evaluated the same outcomes, with the same dosing regimens, except Rhea participants received XDEMVY vehicle. Both the Ersa and Rhea studies 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 ("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 Ersa, 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 AAOpt presentation, which combined the Ersa and Rhea data in a pooled analysis, demonstrated that XDEMVY provided statistically significant and clinically meaningful improvements from baseline and when compared to vehicle. These improvements were shown across three objective measures of MGD: the presence and quality of liquid secretion as measured by the Meibomian Gland Secretion Score; the number of glands secreting normal or clear liquid; and 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 studies, respectively, and XDEMVY and the XDEMVY vehicle were well tolerated. Given the positive results of these studies, 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 moving 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: 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 moving forward with sharing this data with ECPs.

Previous wording

TP-04 Rosacea, Galatea Trial: In February 2024, we announced positive topline results from the Galatea trial evaluating TP-04, a novel gel formulation of lotilaner, for the treatment of rosacea which 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. We plan to discuss and determine the potential regulatory path with the FDA by the end of 2024 and provide an update that is anticipated by the earnings call for the fiscal year ended 2024.

Current wording

In February 2024, we announced positive topline results from the Galatea trial, a Phase 2a trial evaluating TP-04, a novel gel formulation of lotilaner, for the treatment of rosacea. 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.

Previous wording

TP-05 Lyme Disease, Carpo Trial: 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 is designed to evaluate TP-05, a novel investigative oral, 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. We plan to discuss and determine the potential regulatory path with the FDA by the end of 2024 and provide an update that is anticipated by the earnings call for the fiscal year ended 2024.

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 is designed to evaluate TP-05, a novel investigational oral, 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 are initiating stability testing of a preservative-free formulation of XDEMVY for Europe with potential approval anticipated in the second half of 2027.

Current wording

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

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 in May 2022, August 2023, and March 2024, and our 2023 ATM Prospectus, as well as proceeds from net product sales, our China Out-License, and drawdowns from our Credit Facilities.

Current 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").

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 loss was $23.4 million and $39.1 million for the three months ended September 30, 2024 and 2023, respectively, and $92.4 million and $94.0 million for the nine months ended September 30, 2024 and 2023, 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 $25.1 million and $35.7 million for the three months ended March 31, 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

•commercialize XDEMVY and our other products for which we obtain regulatory approvals;

Current wording

•continue to commercialize XDEMVY and our other product candidates for which we obtain regulatory approvals;

Previous wording

•advance the clinical development of TP-04 for the potential treatment of rosacea and TP-05 for the potential Lyme disease prophylaxis;

Current wording

•advance the clinical development of TP-04 for the potential treatment of Ocular Rosacea and TP-05 for the potential Lyme disease prophylaxis;

Previous wording

•add information systems and personnel to support our product development and commercialization efforts, and to enable us to operate as a public company.

Current wording

•add information systems and personnel to support our product development and continued commercialization efforts, and to enable us to operate as a public company.

Previous wording

We began generating product sales during the three months ended September 30, 2023 following the FDA approval of XDEMVY in July 2023 and our subsequent commercial launch in August 2023. Our reported revenue within license fees and collaboration revenue is from our China Out-License and clinical supply agreement; we expect to report additional revenue under this caption in future periods from GrandPharma related to the Novation Agreement.

Current wording

We began generating XDEMVY product sales in August 2023, following FDA approval in July 2023. Our reported revenue within license fees and collaboration revenue is from our China Out-License and clinical supply agreement; we expect to report additional revenue under this caption in future periods.

Previous wording

As of September 30, 2024, our aggregate cash, cash equivalents and marketable securities was $317.0 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 March 31, 2025, our aggregate cash, cash equivalents and marketable securities was $407.9 million – see the section below titled "Management's Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources."

Previous wording

Recently, the economy has experienced downward pressure, and together with high rates of inflation and energy supply issues experienced in certain regions, war and geopolitical conflicts, have led to regional and/or global macroeconomic challenges, the effects of which may be of an extended duration.

Current wording

Recently, the economy has experienced significant volatility and escalating trade tensions. Together with high rates of inflation and energy supply issues experienced in certain regions, the potential enactment of tariffs, war and geopolitical conflicts, these conditions have led to regional and/or global macroeconomic challenges, the effects of which may be of an extended duration.

Previous wording

During the three months ended September 30, 2024 and 2023 we recognized revenue of $48.1 million and $1.7 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments driven by approximately 41,400 bottles of XDEMVY delivered to patients compared to 1,700 bottles delivered in the prior year period.

Current wording

During the three months ended March 31, 2025 and 2024 we recognized revenue of $78.3 million and $24.7 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments driven by approximately 72,000 bottles of XDEMVY delivered to patients compared to 26,000 bottles delivered in the prior year period.

Previous wording

For the three months ended September 30, 2024 and 2023, we recognized $3.2 million and $0.4 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, 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 three months ended March 31, 2025 and 2024, we recognized $5.2 million and $1.7 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 for the three months ended September 30, 2024 remained consistent when compared to the prior year period. The slight increase was primarily due to (i) $0.2 million of increased TP-03 program expenses, (ii) $0.2 million of increased payroll and personnel-related costs (including increased stock-based compensation expense of $0.1 million) related to employee additions to drive our product development initiatives, and (iii) $0.2 million of other indirect expenses. These increases were partially offset by (i) $0.3 million of decreased TP-04 program expenses and (ii) $0.2 million of decreased early-stage programs.

Current wording

Research and development expenses increased by $2.3 million for the three months ended March 31, 2025, as compared to the prior year period. The increase was primarily due to (i) $0.5 million of increased TP-04 program expenses, (ii) $0.9 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) $0.9 million of increased early-stage programs, and (iv) $0.3 million of increased other indirect expenses. These increases were partially offset by $0.4 million of decreased TP-03 program expenses.

Previous wording

Selling, general and administrative expenses increased by $27.6 million for the three months ended September 30, 2024, as compared to the prior year period. The increase was primarily due to (i) $9.5 million of increased payroll and employee-related costs (including increased stock-based compensation expense of $2.0 million) for commercial and corporate employee additions to support our business growth and commercial leadership hires for XDEMVY, (ii) $10.5 million of increased commercial and marketing costs as we continued our commercial expansion for the commercial launch of XDEMVY, and (iii) $7.5 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 2024 due to further growth and expansion of our commercial activities for XDEMVY.

Current wording

Selling, general and administrative expenses increased by $33.4 million for the three months ended March 31, 2025, as compared to the prior year period. The increase was primarily due to (i) $9.6 million of increased payroll and personnel-related costs (including increased stock-based compensation expense of $1.4 million) for commercial and corporate employee additions to support our business growth and commercial leadership hires for XDEMVY, and (ii) $25.6 million of increased commercial and marketing costs, including direct-to-consumer advertising costs, as we continued our commercial expansion of XDEMVY. The increases were partially offset by $1.9 million of decreased 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.

Previous wording

Other income (expense), net remained consistent period over period primarily due to $1.6 million of increased interest expense related to the Credit Facilities (as defined below), partially offset by (i) $1.3 million of increased interest income earned on our cash, cash equivalents and marketable securities, (ii) $0.1 million related to our LianBio common stock that was sold in June 2024, and (iii) $0.1 million of other miscellaneous income items.

Current wording

Other income (expense), net decreased by $0.8 million compared to the prior year period primarily due to $1.2 million of increased interest expense related to the Credit Facilities, partially offset by $0.3 million of increased interest income earned on our cash, cash equivalents and marketable securities and $0.1 million of other miscellaneous income.

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 net product sales, the China Out-License, and drawdowns from our Credit Facilities. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $317.0 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 March 31, 2025, we had cash, cash equivalents and marketable securities of $407.9 million.

Previous wording

In February 2024, we filed an automatic shelf registration statement on Form S-3 ASR (the "2024 Shelf Registration Statement"). In March 2024 we completed the March 2024 Public Offering, an underwritten follow-on public offering under the 2024 Shelf Registration Statement on Form S-3 of 2,812,500 shares of our common stock, par value $0.0001 per share, and, in lieu of common stock to a certain investor, pre-funded warrants to purchase 312,500 shares of our common stock. The price to the public was $32.00 per share and $31.9999 per pre-funded warrant, which was the price to the public of each share of common stock sold in the March 2024 Public Offering, minus the $0.0001 exercise price per pre-funded warrant. We also granted the underwriters a 30-day option to purchase up to 468,750 additional shares of its common stock at the public offering price of $32.00 per share, which the underwriters exercised in full in March 2024. We received $107.7 million in aggregate net proceeds, after deducting underwriting discounts, commissions, and other estimated offering-related expenses.

Current wording

In February 2024, we filed an automatic shelf registration statement on Form S-3 ASR (the "2024 Shelf Registration Statement"). In March 2024, we completed the March 2024 Public Offering. The 2024 Public Offering was an underwritten follow-on public offering under the 2024 Shelf Registration Statement, pursuant to which we sold 2,812,500 shares of our common stock, and, in lieu of common stock to a certain investor, pre-funded warrants to purchase 312,500 shares of our common stock. The price to the public was $32.00 per share and $31.9999 per pre-funded warrant, which was the price to the public of each share of common stock sold in the March 2024 Public Offering, minus the $0.0001 exercise price per pre-funded warrant. We also granted the underwriters a 30-day option to purchase up to 468,750 additional shares of our common stock at the public offering price of $32.00 per share, which the underwriters exercised in full in March 2024. We received $107.7 million of aggregate net proceeds, after deducting underwriting discounts, commissions, and other estimated offering-related expenses.

Previous wording

In August 2023, we completed the August 2023 Public Offering in which 5,714,285 shares of our common stock were sold at a public offering price of $17.50 per share. In September 2023, the underwriters partially exercised an option to purchase an additional 355,164 shares of our common stock at the public offering price of $17.50 per share. After giving effect to the exercise of the underwriters' option, we sold a total of 6,069,449 shares and received aggregate net proceeds of $99.3 million, after deducting underwriting discounts, commissions, and other offering-related expenses.

Current wording

In March 2025, we completed an underwritten follow-on public offering under the 2024 Shelf Registration Statement pursuant to which we sold 2,808,988 shares of our common stock. The price to the public was $44.50 per share. We also granted the underwriters a 30-day option to purchase up to 421,348 additional shares of our common stock at the public offering price of $44.50 per share, which the underwriters exercised in full in March 2025. We received approximately $134.8 million of aggregate net proceeds, after deducting underwriting discounts, commissions, and other estimated offering-related expenses.

Previous wording

As of the date of this filing, we have received $86.1 million of total proceeds in connection with our China Out-License comprised of (i) $15.0 million of initial consideration, (ii) $67.5 million for the achievement of specified milestones, (iii) $0.7 million related to a special cash dividend, (iv) $2.5 million related to the Novation Agreement, and (v) $0.4 million related to the Warrant Termination Agreement.

Current wording

As of the date of this filing, we have received $86.1 million of total proceeds in connection with our China Out-License comprised of (i) $15.0 million of initial consideration, (ii) $67.5 million for the achievement of specified milestones, (iii) $0.7 million related to a special cash dividend, (iv) $2.5 million related to the Novation Agreement, and (v) $0.4 million related to a warrant termination agreement.

Previous wording

As of September 30, 2024 the Company is eligible to receive further consideration from GrandPharma upon the achievement of additional TP-03 events, including: (i) $20.0 million of potential future regulatory and/or patent milestones; (ii) $100.0 million of potential future China-based TP-03 sales threshold milestones; and (iii) tiered low-to-high-teen royalties for China Territory TP-03 product sales.

Current wording

As of March 31, 2025 we are eligible to receive further consideration from GrandPharma upon the achievement of additional TP-03 events, including: (i) additional regulatory approval and/or patent issuance milestones and one-time payments of up to an aggregate of $20.0 million; (ii) China-based TP-03 sales threshold milestones of up to an aggregate of $100.0 million; and (iii) tiered low-to-high-teen royalties for China Territory TP-03 product sales.

Previous wording

In February 2022, we executed the Credit Facility with Hercules Capital, Inc. and SVB (the "2022 Credit Facility"). Concurrent with the execution of the 2022 Credit Facility we drew $20.0 million. The 2022 Credit Facility was amended in January 2023 and August 2023. The Credit Facility, as amended, set a maximum interest rate, updated the terms of prepayment and included an extended period to drawdown the tranche associated with the New Drug Application("NDA") submission. In March 2023 and September 2023, respectively, we made draws of $5.0 million (including SVB's commitment of $1.25 million) from the $25.0 million tranche associated with the NDA submission of TP-03. We did not incur any lender fees as part of the 2022 Credit Facility.

Current wording

In February 2022, we executed the 2022 Credit Facility. Concurrent with the execution of the 2022 Credit Facility we drew $20.0 million. The 2022 Credit Facility was amended in 2023. During 2023, we made two separate draws totaling $10.0 million from the $25.0 million tranche associated with the New Drug Application ("NDA") submission of TP-03. We did not incur lender fees as part of the 2022 Credit Facility.

Previous wording

In April 2024, the Company executed the 2024 Credit Facility with Pharmakon with maturity in April 2029. Upon execution, we made a $75.0 million draw from the initial tranche, a portion of which was utilized to repay all outstanding indebtedness associated with the 2022 Credit Facility, for total net proceeds of $39.6 million. The 2024 Credit Facility provides for three potential additional term loan tranches in principal amounts up to $25.0 million, $50.0 million, and $50.0 million, respectively, subject to customary conditions to funding and, in the case of the last two tranches, achieving minimum net sales milestones. The three additional tranches may be requested on or prior to December 31, 2024, June 30, 2025 and December 31, 2025, respectively.

Current wording

In April 2024, we executed the 2024 Credit Facility with Pharmakon with maturity in April 2029. The 2024 Credit Facility is collateralized by substantially all of our presently existing and subsequently acquired assets. Upon execution, we made a $75.0 million draw from the initial tranche, a portion of which was utilized to repay all outstanding indebtedness associated with the 2022 Credit Facility, for total net proceeds of $39.6 million. The 2024 Credit Facility provided for three potential additional term loan tranches in principal amounts up to $25.0 million, $50.0 million, and $50.0 million, respectively, subject to customary conditions to funding and, in the case of the last two tranches, achieving minimum net sales milestones. We did not draw on the first additional tranche of $25.0 million, which expired on December 31, 2024. The two additional tranches may be requested at our option on or prior to June 30, 2025 and December 31, 2025, respectively.

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 $337.1 million and $244.7 million as of September 30, 2024 and December 31, 2023.

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 $385.3 million and $360.2 million as of March 31, 2025 and December 31, 2024, respectively.

Previous wording

We believe that our cash, cash equivalents and marketable securities of $317.0 million as of September 30, 2024 is sufficient to fund our current and planned operations for at least the next twelve months from this Quarterly Report on Form 10-Q. We also anticipate having additional availability from our 2024 Credit Facility of at least $25.0 million on or prior to December 31, 2024 and another $100 million contingent on reaching certain sales milestones (including the $5.0 million sales-based milestone triggered in September 2024 and expected to be paid in the fourth quarter of 2024). 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 $407.9 million as of March 31, 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 $100.0 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

As part of the 2023 Shelf Registration Statement, we concurrently filed the 2023 ATM Prospectus with Jefferies covering the sale of up to $100.0 million of our common stock pursuant to an Open Market Sale 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. We have not sold any shares of our common stock under the 2023 ATM Prospectus during the three and nine months ended September 30, 2024. 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.

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 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 three months ended March 31, 2025 or the year ended December 31, 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 given the commercial launch of XDEMVY. We may also encounter unforeseen expenses, difficulties, complications, delays and other currently unknown factors that could adversely affect our business.

Current 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.

Previous wording

•the achievement of milestones or occurrence of other developments that trigger payments under any collaboration agreements we might have at such time and availability of our 2024 Credit Facility;

Current wording

•the achievement of milestones or occurrence of other developments that trigger payments under any collaboration agreements we might have at such time;

Previous wording

The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented below:

Current wording

The following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for each of the periods presented below:

Previous wording

Net cash used in operating activities was $78.2 million for the nine months ended September 30, 2023, which primarily consisted of our net loss of $94.0 million, partially offset by net increases in non-cash and other charges of $12.7 million and net operating assets and liabilities of $3.1 million. The net increase in non-cash and other charges were primarily related to stock-based compensation expense of $14.3 million, depreciation expense of $0.5 million and non-cash lease expense of $0.4 million, partially offset by net amortization/accretion on marketable securities of $3.0 million. The net increase in net operating assets and liabilities was primarily due to accounts payable and other accrued liabilities of $5.2 million, accrued payroll and benefits of $2.4 million, and other receivables of $2.6 million, partially offset by cash decreases including $5.4 million of accounts receivable and $1.0 million of prepaid expenses.

Current wording

Net cash used in operating activities was $20.7 million for the three months ended March 31, 2025, which primarily consisted of a net loss of $25.1 million and a net decrease in net operating assets and liabilities of $1.9 million, partially offset by net increases in non-cash and other charges of $6.4 million. The decrease in net operating assets and liabilities were primarily due to cash decreases in accounts receivable of $15.7 million and accrued payroll and benefits of $5.9 million, partially offset by cash increases including $11.3 million of accounts payable and other accrued liabilities and $8.7 million of prepaid expenses. The increase in net non-cash and other charges were primarily related to stock-based compensation expense of $6.9 million and amortization of intangible assets and depreciation of property, plant and equipment totaling $0.5 million, partially offset by net amortization/accretion of marketable securities of $1.3 million.

Previous wording

Net cash used in operating activities was $60.8 million for the nine months ended September 30, 2024, which primarily consisted of our 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 were 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.

Current wording

Net cash used in operating activities was $37.8 million for the three months ended March 31, 2024, which primarily consisted of a net loss of $35.7 million and a net decrease in net operating assets and liabilities of $8.6 million, partially offset by net increases in non-cash and other charges of $6.5 million. The net decrease in net operating assets and liabilities were primarily due to an increase in accounts receivable of $13.3 million and a decrease in accrued payroll and benefits of $7.3 million, partially offset by an increase in accounts payable and other accrued liabilities of $12.3 million. The net non-cash and other charges were primarily related to stock-based compensation expense of $5.5 million and unrealized loss on equity investments of $0.6 million.

Previous wording

Net cash used in investing activities was $139.6 million for the nine months ended September 30, 2024, and primarily relates to (i) $172.7 million of purchased marketable securities (ii) $3.0 million of purchased long-term investments, and (iii) $1.5 million of purchased manufacturing equipment, office equipment, and furniture and fixtures. These cash decreases were partially offset by $37.5 million of proceeds from maturities of marketable securities.

Current wording

Net cash used in investing activities was $34.9 million for the three months ended March 31, 2025, and primarily related to $125.6 million of purchased marketable securities and $0.6 million of purchased property, plant and equipment. These cash decreases were partially offset by $91.2 million of proceeds from sales and maturities of marketable securities.

Previous wording

Net cash provided by investing activities was $122.8 million for the nine months ended September 30, 2023, and primarily related to $156.9 million of proceeds from maturities of marketable securities, partially offset by (i) $28.7 million of purchased marketable securities, (ii) $4.0 million of additions to intangible assets related to the first commercial sale of XDEMVY and (iii) $1.5 million of purchased furniture, fixtures and leasehold improvements for our laboratory and administrative offices.

Current wording

Net cash used in investing activities was $102.2 million for the three months ended March 31, 2024, and primarily related to $104.6 million of purchased marketable securities and $0.2 million of purchased property, plant and equipment, partially offset by $2.5 million of proceeds from maturities of marketable securities.

Previous wording

Net cash provided by financing activities was $151.7 million for the nine months ended September 30, 2024, and primarily relates to (i) $98.3 million of net proceeds from the issuance of common stock related to the March 2024 Public Offering, (ii) $9.4 million of net proceeds from the issuance of pre-funded warrants related to 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 our ESPP, partially offset by (i) $31.9 million of debt extinguishment payments on the 2022 Credit Facility, and (ii) $3.5 million of cash paid for loan issuance costs on the 2024 Credit Facility.

Current wording

Net cash provided by financing activities was $136.6 million for the three months ended March 31, 2025, and related to $135.1 million of net proceeds from the issuance of common stock related to the March 2025 Public Offering and $1.4 million of proceeds from employee stock option exercises.

Previous wording

Net cash provided by financing activities was $110.4 million for the nine months ended September 30, 2023, which primarily relates to (i) $99.4 million of net proceeds from the issuance of common stock related to the August 2023 Public Offering, (ii) $10.0 million of proceeds from our 2022 Credit Facility, (iii) $0.5 million of proceeds from our ESPP, and $0.6 million of proceeds from employee stock option exercises.

Current wording

Net cash provided by financing activities was $108.8 million for the three months ended March 31, 2024, which primarily related to $98.6 million of net proceeds from the issuance of common stock and $9.4 million of net proceeds from the issuance of pre-funded warrants related to the March 2024 Public Offering, and $0.8 million of proceeds from employee stock option exercises.