X4 Pharmaceuticals Inc

Previous wording

We are a biopharmaceutical company discovering, developing, and commercializing novel therapeutics for the treatment of rare diseases and those with limited treatment options, with a focus on conditions resulting from dysfunction of the immune system. On April 29, 2024, we announced that the U.S. FDA approved our NDA for mavorixafor, which is being marketed in the U.S. under the trade name XOLREMDI, for use as an oral, once-daily therapy in patients aged 12 years of age and older with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, to increase the number of circulating mature neutrophils and lymphocytes. WHIM syndrome is a rare combined primary immunodeficiency and chronic neutropenic disorder. Concurrent with the U.S. approval of XOLREMDI and pursuant to its Rare Pediatric Disease designation, the FDA granted us a Priority Review Voucher that we sold to another drug sponsor shortly thereafter.

Current wording

We are a biopharmaceutical company discovering, developing, and commercializing novel therapeutics for the treatment of rare diseases and those with limited treatment options, with a focus on conditions resulting from dysfunction of the immune system. On April 29, 2024, we announced that the U.S. FDA approved our NDA for mavorixafor, which is being marketed in the U.S. under the trade name XOLREMDI, for use as an oral, once-daily therapy in patients aged 12 years of age and older with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, to increase the number of circulating mature neutrophils and lymphocytes. WHIM syndrome is a rare combined primary immunodeficiency and chronic neutropenic disorder. Concurrent with the U.S. approval of XOLREMDI and pursuant to its Rare Pediatric Disease designation, the FDA granted us a PRV that we sold to another drug sponsor shortly thereafter.

Previous wording

We are currently engaged in our U.S. launch of XOLREMDI in WHIM syndrome and have built out our go-to-market organization, with all key hires across commercial and medical functions now complete. We have increased our interactions with targeted physicians and rare disease patient advocacy organizations and continued our disease-awareness campaign to further the understanding of WHIM syndrome and to educate patients and physicians on the importance and benefits of early diagnosis. We have entered into agreements with a third-party logistics organization and a specialty pharmacy to support the distribution of XOLREMDI in the U.S., to mitigate barriers to product access, to provide a suite of patient support services to help patients through their treatment journey. We are planning to seek regulatory approvals to commercialize mavorixafor outside of the U.S. by submitting an application for regulatory approval of mavorixafor for the treatment of WHIM syndrome to the European Medicines Agency (“EMA”) by early 2025. We are also exploring additional potential opportunities in geographies where we may be able to efficiently leverage our FDA approval.

Current wording

We are currently engaged in our U.S. launch of XOLREMDI in WHIM syndrome, continuing our engagements with physicians and rare disease patient advocacy organizations and our disease-awareness campaign to further the understanding of WHIM syndrome and educate patients and physicians on the importance and benefits of early diagnosis. We have entered into agreements with a third-party logistics organization and a specialty pharmacy to support the distribution of XOLREMDI in the U.S., to mitigate barriers to product access, and to provide a suite of patient support services to help patients through their treatment journey. We are planning to seek regulatory approval to commercialize mavorixafor for WHIM syndrome outside of the U.S. by submitting a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) by early 2025. We are also exploring additional potential commercial and distribution opportunities in geographies where we may be able to efficiently leverage our FDA approval.

Previous wording

Phase 2 Clinical Trial in Chronic Neutropenia

Current wording

Phase 2 Clinical Study in Chronic Neutropenia

Previous wording

We continue to advance mavorixafor for the treatment of people with certain chronic neutropenic disorders following positive results from a Phase 1b clinical trial of a single dose of mavorixafor in people with idiopathic, cyclic, and congenital chronic neutropenia (“CN”). We are now completing a Phase 2 clinical trial evaluating the durability of effect, safety, and tolerability of chronic dosing of once-daily oral mavorixafor with or without concurrent treatment with injectable granulocyte colony-stimulating factor (“G-CSF”) in the same patient population. In June 2024, we announced positive interim clinical data from this Phase 2 clinical trial assessing the efficacy and safety of mavorixafor in the treatment of people with CN. The interim analysis of data from the ongoing six-month study showed that once-daily oral mavorixafor was generally well tolerated and durably increased participants’ absolute neutrophil counts (“ANC”) both as a monotherapy and in combination with stable doses of G-CSF, the only therapy approved in the U.S. for severe chronic neutropenia. Full data from the Phase 2 CN trial, including data from a treatment group of participants receiving mavorixafor and dose-adjusted G-CSF, are expected to be presented in November 2024.

Current wording

Following positive results from a Phase 1b clinical study of a single dose of mavorixafor in people with idiopathic, cyclic, and congenital chronic neutropenia (“CN”), we recently completed and announced positive results from a Phase 2 clinical study evaluating the durability of effect, safety, and tolerability of chronic dosing of once-daily oral mavorixafor with or without concurrent treatment with injectable granulocyte colony-stimulating factor (“G-CSF”) in the same patient population.

Previous wording

We recently initiated our pivotal global, Phase 3 clinical trial, (the “4WARD” study) to evaluate the efficacy, safety, and tolerability of oral, once-daily mavorixafor (with or without stable doses of G-CSF) in people with congenital, acquired primary autoimmune, or idiopathic CN who are experiencing recurrent and/or serious infections. The 52-week trial is a randomized, double-blind, placebo-controlled, multicenter study aiming to enroll 150 participants.

Current wording

We continue to progress our global, pivotal Phase 3 clinical trial, (the “4WARD” study) to evaluate the efficacy, safety, and tolerability of oral, once-daily mavorixafor (with or without stable doses of G-CSF) in people with congenital, acquired primary autoimmune, or idiopathic CN who are experiencing recurrent and/or serious infections. The 52-week trial is a randomized, double-blind, placebo-controlled, multicenter study aiming to enroll 150 participants. We believe we are on track to complete enrollment in the 4WARD study in mid-2025.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of the Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

The following table summarizes the results of our operations for the three and six months ended June 30, 2024 and 2023:

Current wording

The following table summarizes the results of our operations for the three and nine months ended September 30, 2024 and 2023:

Previous wording

Revenue from the sale of our drug product was $0.6 million for the three and six months ended June 30, 2024. There was no product revenue in the prior periods. We sell our approved drug product in the U.S. to a specialty pharmacy that dispenses the product to patients who have been prescribed our drug product by their health-care providers. Our outsourced patient “Hub”, which we refer to as X4Connect TM, processes in-bound prescriptions, performs an insurance investigation, and enrolls patients on our patient-assistance program. Gross product revenue is recorded based on the amount of drug product delivered to the specialty pharmacy at our wholesale acquisition cost. For the three and six months ended June 30, 2024, such invoiced revenue was $0.7 million. For these periods, revenue was reduced by $0.1 million for distributor discounts, estimated rebates that we may owe to U.S. government payors, future co-pay assistance payments that we may owe for patients who enroll in our patient assistance program, and for potential product returns, resulting in “net” revenue of $0.6 million for these periods. Under our return goods policy, drug product that is within six months of expiration may be returned for a refund less processing fees. As we have just recently launched our first drug product in the U.S, we have no history of returns or downstream rebates or co-pay assistance payments. Therefore, we expect to adjust these estimates quarterly as new information becomes available.

Current wording

Net revenue from the sale of our drug product was $0.6 million and $1.1 million for the three and nine months ended September 30, 2024, respectively. There was no product revenue in the prior periods. We sell our approved drug product in the U.S. to a specialty pharmacy that dispenses the product to patients who have been prescribed our drug product by their health-care providers. Net revenue includes reserves for distributor discounts, estimated rebates that we may owe to U.S. government payors, future co-pay assistance payments that we may owe for patients who enroll in our patient assistance program, and for potential product returns. As we have just recently launched our first drug product in the U.S., we have limited history of returns or downstream rebates or co-pay assistance payments. Therefore, we expect to adjust these estimates quarterly as new information becomes available.

Previous wording

For the three and six months ended June 30, 2024, cost of revenue of $0.3 million, primarily consists of an insignificant amount of drug product direct costs, $0.125 million for the amortization of an intangible asset related to accrued and paid milestone payments associated with our Genzyme license agreement, approximately $0.1 million of accrued sales-based royalty payments due under our Genzyme license agreement, and approximately $0.1 million of costs related to expediting the supply of drug product into the channel shortly following FDA approval. We expect that as we begin to capitalize inventory costs related to the production of our active pharmaceutical ingredient, which is the primary cost of our inventory, cost of revenue will increase per unit. Had we capitalized these research and development costs into inventory, cost of revenue would have been higher by an insignificant amount.

Current wording

For the three and nine months ended September 30, 2024, cost of revenue of $0.2 million and $0.5 million, respectively, primarily consists of amortization of an intangible asset related to accrued and paid milestone payments associated with our Genzyme license agreement, sales-based royalty payments due under our Genzyme license agreement, and an insignificant amount of drug product direct costs. We expect that as we begin to capitalize inventory costs related to the production of our active pharmaceutical ingredient, which is the primary cost of our inventory, cost of revenue will increase per unit. Had we capitalized these research and development costs into inventory, cost of revenue would have been higher by an insignificant amount.

Previous wording

Research and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates. For the three and six months ended June 30, 2024 and 2023, research and development costs were primarily focused on the advancement and commercialization of mavorixafor. Research and development costs include employee salaries and related expenses, preclinical and clinical development expenses, internal and third-party costs of manufacturing our drug products for use in our preclinical studies and clinical trials. Research and development expenses also include facility, depreciation and other expenses; costs related to compliance with regulatory requirements; and prior to the FDA’s approval of our drug product in the U.S., payments made under third-party licensing agreements were charged to research and development expense.

Current wording

Research and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates. For the three and nine months ended September 30, 2024 and 2023, research and development costs were primarily focused on the advancement and commercialization of mavorixafor. Research and development costs include employee salaries and related expenses, preclinical and clinical development expenses, internal and third-party costs of manufacturing our drug products for use in our preclinical studies and clinical trials. Research and development expenses also include facility, depreciation and other expenses; costs related to compliance with regulatory requirements; and prior to the FDA’s approval of our drug product in the U.S., payments made under third-party licensing agreements were charged to research and development expense.

Previous wording

Research and development expenses increased by $5.3 million and $3.1 million in the three and six months ended June 30, 2024, respectively, as compared to the same periods in the prior year. Research and development cost increased in the current quarter primarily due to an increase in clinical operations costs, including CRO fees and pass-through costs, associated with our Phase 2 CN trial and the launch of our Phase 3 CN clinical trial, as well as increased regulatory, medical affairs and quality costs associated with our second quarter product launch and clinical trials. Research and development expenses were also higher in the current three and six-month periods due to an increase in personnel within our research and development functions. Such increase in the six month period ended June 30, 2024 was partially offset by a $5.0 million in-license fee related to a development milestone under our Genzyme agreement that was changed to research and development expense in 2023 where no such similar charges to research and development expense were recorded in the six months ended June 30, 2024.

Current wording

Research and development expenses were generally flat and increased by $3.2 million in the three and nine months ended September 30, 2024, respectively, as compared to the same periods in the prior year. Research and development cost increased in the current nine-month period primarily due to an increase in clinical operations costs, including CRO fees and pass-through costs, associated with the completion of our Phase 2 CN trial and the launch of our Phase 3 CN clinical trial, as well as increased regulatory, medical affairs and quality costs associated with our product launch. Research and development expenses were also higher in the current nine-month periods due to an increase in personnel within our research and development functions. Such increase in the nine months ended September 30, 2024 was partially offset by a $5.0 million in-license fee related to a development milestone under our Genzyme agreement that was changed to research and development expense in 2023 where no such similar charges to research and development expense were recorded in the nine months ended September 30, 2024.

Previous wording

Selling, general and administrative expenses increased by approximately $3.1 million and $13.3 million in the three and six months ended June 30, 2024, respectively, as compared to the same three month and six month periods in the prior year, respectively, primarily due to an increase in our sales and marketing expenses, which increased by $4.1 million and $9.0 million in the three and six month periods ended June 30, 2024, respectively, as compared to the prior period, as we built out our sales and marketing infrastructure to support the pre-launch and post-launch activities of our approved product, XOLREMDI in the U.S. Costs related to commercial launch activities contributed to the increase in selling, general and administrative expenses during the current three and six-month period. Selling, general and administrative costs also increased in the current six months ended June 30, 2024 as compared to the same period in the prior year due to increases in legal costs, outside consulting fees, recruiting and information technology costs. Selling, general and administrative expenses include compensation expenses for stock appreciation rights (“SARs”) granted to our executive officers. We measure these SARs at fair value primarily based on our closing stock price, which may continue to be volatile.

Current wording

Selling, general and administrative expenses increased by approximately $7.6 million and $20.8 million in the three and nine months ended September 30, 2024, respectively, as compared to the same periods in the prior year. For the three months ended September 30, 2024, selling, general and administrative expense increased primarily due to an increase in general and administrative expenses, primarily due to an increase in compensation expense related to outstanding stock appreciation rights (“SARs”) that are measured at fair value, and due to increases in legal costs, outside consulting and professional services fees, and recruiting costs. Sales and marketing expenses increased by $3.4 million in the three months ended September 30, 2024 as compared to the prior period, as we continue to build out our sales and marketing infrastructure to support the launch activities of our approved product, XOLREMDI in the U.S.

Previous wording

We expect selling, general and administrative expenses will remain relatively consistent for the remainder of the current fiscal year.

Current wording

We expect that quarterly selling, general and administrative expenses will remain relatively consistent in the fourth quarter of 2024.

Previous wording

During the quarter ended June 30, 2024, we sold a Priority Review Voucher (“PRV”) awarded to us as a result of the FDA’s approval of XOLREMDI to a third party for $105.0 million in cash. There were no fees associated with the sale. We do not expect to receive or sell a similar PRV in the foreseeable future.

Current wording

During the nine months ended September 30, 2024, we sold a Priority Review Voucher (“PRV”) awarded to us as a result of the FDA’s approval of XOLREMDI to a third party for $105.0 million in cash. There were no fees associated with the sale. We do not expect to receive or sell a similar PRV in the foreseeable future.

Previous wording

Other income (expense), net, for three and six months ended June 30, 2024 increased $49.6 million and $29.9 million, respectively, as compared to the same period in the prior year primarily due to a significant decrease in the fair value of our Class C warrants, which are accounted for as a liability at fair value, relative to the prior period. We value these Class C warrants using the Black-Scholes option pricing model, which includes the market value of our common stock as an input. The market price of shares of our common stock decreased during the second quarter of 2024, which was the primary contributor to the decrease in the Class C warrant liability and associated expense. These Class C warrants will continue to be measured at fair value and may continue to generate gains or losses each quarter, until they are exercised.

Current wording

Other (expense) income, net, for three and nine months ended September 30, 2024 decreased $27.1 million and increased $2.8 million, respectively, as compared to the same periods in the prior year. The increase in other expense (decrease in other income) in the three months ended September 30, 2024 as compared to the prior period was primarily due to a significant gain recognized in the prior period due to a change in the fair value of our Class C warrants, which are accounted for as a liability at fair value, relative to a loss in the current period. These Class C warrants will continue to be measured at fair value and may continue to generate gains or losses each quarter, until they are exercised. Other (expense) income also decreased in the three and nine months ended September 30, 2024 as compared to the prior year periods due to an increase in interest expense as a result of an increase in our borrowings during the current year.

Previous wording

The income tax provision recorded for the three and six months ended June 30, 2024 and 2023 is primarily related to our Austrian subsidiary and our Security Corporation subsidiary that throughout the year holds a portion of our investment portfolio. We did not record a U.S. federal or state provision or benefit for income taxes for the three and six month period ended June 30, 2024 as, although we generated net income and ordinary income for these periods, we are projecting an ordinary loss before income taxes for the full year and we continue to have a full valuation allowance on our net operating loss carryforwards (“NOLs”). We anticipate that we may generate U.S. and state taxable income for the year ended December 31, 2024 that will be either fully or partially offset by our operating loss carryforwards, subject to an annual limitation pursuant to Section 382 of the Internal Revenue Code. For the three and six month period ended June 30, 2023, we did not record an income tax benefit for our losses as we have a full valuation allowance on our NOL carryforwards.

Current wording

The income tax provision recorded for the three and nine months ended September 30, 2024 and 2023 is primarily related to our Austrian subsidiary and its Security Corporation subsidiary that holds a portion of our investment portfolio. We did not record a U.S. federal or state provision or benefit for income taxes in our consolidated statement of operations and comprehensive (loss) income for the three and nine month periods ended September 30, 2024 and 2023. For the nine months ended September 30, 2024, we generated net income and ordinary income. However, as we are projecting an ordinary loss before income taxes for the full year and have a full valuation allowance on our net operating loss carryforwards, we have not recorded a U.S. federal or state income tax expense or benefit for the three month and nine months ended September 30, 2024.

Previous wording

ATM Sales Agreement — We have entered into a Controlled Equity Offering SMSales Agreement (“ATM Sales Agreement”), with certain investment banks (collectively the “Sales Agents”), pursuant to which we may offer and sell, at our sole discretion through one or more of the Sales Agents, shares of our common stock. To date, we have sold approximately $14.3 million of our common stock, net of offering costs, under the ATM Sales Agreement. Pursuant to our Registration Statement on Form S-3 that became effective on August 24, 2023 and the related ATM prospectus contained therein, we may offer and sell shares of our common stock having an aggregate offering price of up to an additional $75 million.

Current wording

ATM Sales Agreement — We have entered into a Controlled Equity Offering SMSales Agreement (“ATM Sales Agreement”), with certain investment banks (collectively the “Sales Agents”), pursuant to which we may offer and sell, at our sole discretion through one or more of the Sales Agents, shares of our common stock. To date, we have sold approximately $14.3 million of our common stock, net of offering costs, under the ATM Sales Agreement. Pursuant to our Registration Statement on Form S-3 that became effective on August 24, 2023 and the related ATM prospectus contained therein, we may offer and sell shares of our common stock having an aggregate offering price of up to an additional $75.0 million.

Previous wording

Hercules Loan Agreement—We have a Loan and Security Agreement, amended from time to time, with Hercules Capital, Inc., the (“Hercules Loan Agreement”). The Hercules Loan Agreement provides for a term loan facility of up to $115.0 million, under which we have borrowed an aggregate of $75.0 million of term loans to date, including $20.0 million in new borrowings during the three months ended June 30, 2024, representing the maximum borrowings as of June 30, 2024. The term loan facility allows for $40.0 million in additional borrowings, which includes:

Current wording

Hercules Loan Agreement—We have a Loan and Security Agreement, amended from time to time, with Hercules Capital, Inc. (the “Hercules Loan Agreement”). The Hercules Loan Agreement provides for a term loan facility of up to $115.0 million, under which we have borrowed an aggregate of $75.0 million of term loans to date, including $20.0 million in new borrowings during the nine months ended September 30, 2024, representing the maximum borrowings as of September 30, 2024. The term loan facility allows for $40.0 million in additional borrowings, which includes:

Previous wording

•an additional tranche of $7.5 million, which will be available following achievement of a certain clinical development-related milestone through the earlier of (a) 45 days following achievement of such milestone and (b) December 15, 2024; and

Current wording

•an additional tranche of $7.5 million, is now available following the achievement of a certain clinical development-related milestone through 45 days following achievement of such milestone; and

Previous wording

•an additional tranche of up to $32.5 million, which will be available subject to approval by Hercules in its sole discretion.

Current wording

•an additional tranche of up to $32.5 million, which will be available subject to approval by Hercules Capital, Inc. (“Hercules”) in its sole discretion.

Previous wording

Going Concern—We have evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the our ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. Although we have an approved drug product, sales of the our drug product over the next 12 months will not be sufficient to fund our operating expenses. Since inception, we have incurred significant operating losses and negative cash flows from operations. During the quarter ended June 30, 2024, we sold a PRV for $105.0 million in cash. As of June 30, 2024, we had $168.8 million of cash, cash equivalents and short-term marketable securities, and an accumulated deficit of $438.8 million. Net cash used in operating activities was $63.9 million for the six months ended June 30, 2024.

Current wording

Going Concern—We have evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. Although we have an approved drug product, sales of our drug product over the next 12 months will not be sufficient to fund our operating expenses. Since inception, we have incurred significant operating losses and negative cash flows from operations and we expect to continue to generate operating losses and negative cash flows from operations for the foreseeable future. As of September 30, 2024, we had $135.0 million of cash, cash equivalents and short-term marketable securities, and an accumulated deficit of $475.5 million. Net cash used in operating activities was $97.9 million for the nine months ended September 30, 2024.

Previous wording

To finance its future operations beyond the one-year period following the issuance of these condensed consolidated financial statements, we will need to raise additional capital, which cannot be assured. Unless and until we reach profitability in the future, we will require additional capital to fund our operations, which could be raised through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements, or other collaborations and strategic alliances. If we are unable to obtain funding, we could be forced to delay, reduce, or eliminate some or all of our research and development programs, product portfolio expansion or commercialization efforts, which would adversely affect our business prospects, or we may be unable to continue operations.

Current wording

To alleviate the risk that we violate the Minimum Cash Covenant and to finance our future operations, we will need to raise additional capital, which cannot be assured. Unless and until we reach profitability in the future, we will require additional capital to fund our operations, which could be raised through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements, or other collaborations and strategic alliances. If we are unable to obtain funding, we could be forced to delay, reduce, or eliminate some or all of our research and development programs, product portfolio expansion or commercialization efforts, which would adversely affect our business prospects, or we may be unable to continue operations.

Previous wording

During the six months ended June 30, 2024, net cash used in operating activities was $64 million, primarily resulting from operating expenses of $71 million, adjusted for noncash expenses of $5 million and changes in our operating assets and liabilities of $3 million. Non-cash expenses primarily include stock-based compensation expense, non-cash lease expense and non-cash interest expense. Net cash used in operating activities for the six months ended June 30, 2023 was $48 million, primarily resulting from our net losses of $80 million, adjusted for noncash expenses of $30 million. Net cash used in operating activities increased during the six months ended June 30, 2024 as compared to the same period in the prior year primarily due to increases in our sales and marketing and commercialization expenses associated with the U.S. commercial launch of XOLREMDI.

Current wording

During the nine months ended September 30, 2024, net cash used in operating activities was $97.9 million, primarily resulting from costs and operating expenses of $106.8 million, adjusted for noncash expenses of $7.7 million and changes in our operating assets and liabilities of $1.5 million. Non-cash expenses primarily include stock-based compensation expense, non-cash lease expense, amortization of intangible assets and non-cash interest expense. Net cash used in operations also excludes the gain on sale of a priority review voucher. Net cash used in operating activities for the nine months ended September 30, 2023 was $68.8 million, primarily resulting from our net losses of $82.0 million, adjusted for noncash expenses of $7.5 million. Net cash used in operating activities increased during the nine months ended September 30, 2024 as compared to the same period in the prior year primarily due to increases in our sales and marketing and commercialization expenses associated with the U.S. commercial launch of XOLREMDI.

Previous wording

During the six months ended June 30, 2024, cash provided by investing activities included $105.0 million in proceeds from the sale of a priority review voucher obtained as a result of the approval of our drug product by the FDA. Cash outflows from investing activities included $7.0 million in license payments classified as the acquisition of an intangible assets and $6 million of net investments in short-term marketable securities. During the six months ended June 30, 2023, cash used in investing activities included an investment in short-term marketable debt securities.

Current wording

During the nine months ended September 30, 2024, cash provided by investing activities of $75.6 million included $105 million in proceeds from the sale of a priority review voucher obtained as a result of the approval of our drug product by the FDA. Cash outflows from investing activities included $7.0 million in license payments classified as the acquisition of an intangible assets and $22.1 million of net investments in short-term marketable securities. During the nine months ended September 30, 2023, cash used in investing activities included investments in short-term marketable debt securities.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2024 included $20.0 million of new borrowings on our loan facility. During the six months ended June 30, 2023, net cash provided by financing activities was $67.2 million, consisting primarily of net proceeds from a private placement equity offering that provided net proceeds of $60.7 million.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2024 included $20.0 million of new borrowings on our loan facility. During the nine months ended September 30, 2023, net cash provided by financing activities was $88.4

Previous wording

Based on our cash, cash equivalents and marketable securities on hand as of June 30, 2024 and the increases to our borrowing capacity noted above and in Note 10 to the accompanying condensed consolidated financial statements, we believe that our cash, cash equivalents and marketable securities will allow us to fund operations for at least the next 12 months. In order to fund operations and satisfy the minimum cash covenant in the Hercules Loan Agreement thereafter, we will be required to raise additional capital, which may be through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements, or collaborations and strategic alliances.

Current wording

Based on our cash, cash equivalents and marketable securities on hand as of September 30, 2024 and our current operating plan, we believe that our cash, cash equivalents and marketable securities will not allow us to fund operations for at least the next 12 months. In order to fund operations and satisfy the Minimum Cash Covenant in the Hercules Loan Agreement, we will be required to raise additional capital, which may be through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements, or collaborations and strategic alliances.

Previous wording

During 2025 and beyond, assuming no changes to our current operational expectations, we expect our expenses to be relatively consistent with our current operating expenses excluding the sale of non-financial assets. Because of the numerous risks and uncertainties associated with the future sale of our approved drug product and the research, development, and commercialization of future product candidates, we are unable to estimate the exact amount of our funding requirements. Our short-term and long-term funding requirements will depend on and could increase significantly as a result of many factors, including:

Current wording

During 2025, assuming no changes to our current operational expectations, we expect our expenses to be relatively consistent with our current operating expenses, excluding the sale of non-financial assets. Because of the numerous risks and uncertainties associated with the future sale of our approved drug product and the research, development, and commercialization of future product candidates, we are unable to estimate the exact amount of our funding requirements. Our short-term and long-term funding requirements will depend on and could increase significantly as a result of many factors, including:

Previous wording

Please see Note 10 to the notes to our condensed consolidated financial statements for a full description of our Hercules Loan Agreement.

Current wording

See Note 10 to the notes to our condensed consolidated financial statements for a full description of our Hercules Loan Agreement.