Syndax Pharmaceuticals Inc

Previous wording

We are a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Our two lead product candidates are revumenib, and axatilimab. We are developing revumenib, a potent, selective, small molecule inhibitor of the menin-MLL binding interaction for the treatment of KMT2A rearranged, or KMT2Ar, also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including acute lymphoblastic leukemia, or ALL, and acute myeloid leukemia, or AML, and nucleophosmin1, also known as NPM1, mutant AML. We are also exploring the use of revumenib as a treatment in solid tumors, specifically its activity in metastatic colorectal cancer. We are developing axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 receptor, or CSF-1R, in chronic graft-versus-host disease, or cGVHD, as well as idiopathic pulmonary fibrosis, or IPF. We plan to continue to leverage the technical and business expertise of our management team and scientific collaborators to license, acquire and develop additional therapeutics to expand our pipeline.

Current wording

We are a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Our two lead product candidates are revumenib and axatilimab. We are developing revumenib, a potent, selective, small molecule inhibitor of the menin-MLL binding interaction for the treatment of KMT2A rearranged, or KMT2Ar, also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including acute lymphoblastic leukemia, or ALL, and acute myeloid leukemia, or AML, and nucleophosmin1, also known as NPM1, mutant AML. We are also exploring the use of revumenib as a treatment in solid tumors, specifically its activity in metastatic microsatellite stable, or MSS, colorectal cancer, or CRC. We are developing axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 receptor, or CSF-1R, in chronic graft-versus-host disease, or cGVHD, as well as idiopathic pulmonary fibrosis, or IPF. We plan to continue to leverage the technical and business expertise of our management team and scientific collaborators to license, acquire and develop additional therapeutics to expand our pipeline.

Previous wording

We have no products approved for commercial sale and have not generated any product revenues from product sales to date. We continue to incur significant research and development and other expenses related to our ongoing operations. Except for 2021, we have not been profitable and have incurred losses in each period since our inception in 2005. For the three months ended March 31, 2024 and 2023, we reported a net loss of $72.4 million and $41.1 million, respectively. As of March 31, 2024, we had an accumulated deficit of $974.8 million. As of March 31, 2024, we had cash, cash equivalents and short and long-term investments of $522.0 million.

Current wording

We have no products approved for commercial sale and have not generated any product revenues from product sales to date. We continue to incur significant research and development and other expenses related to our ongoing operations. Except for 2021, we have not been profitable and have incurred losses in each period since our inception in 2005. For the six months ended June 30, 2024 and 2023, we reported a net loss of $140.5 million and $85.7 million, respectively. As of June 30, 2024, we had an accumulated deficit of $1.0 billion. As of June 30, 2024, we had cash, cash equivalents and short- and long-term investments of $454.6 million.

Previous wording

In March 2024, we announced that the FDA had granted Priority Review for the New Drug Application (NDA) filing for revumenib, a potent, selective small molecule menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia. The NDA filing is being reviewed under the FDA’s Real-Time Oncology Review Program (RTOR) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2024. RTOR allows for a more efficient review and close engagement between the sponsor and the FDA throughout the submission process, which historically has led to earlier approvals.

Current wording

Our New Drug Application, or NDA, for revumenib, a highly selective menin inhibitor, for the treatment of adult and pediatric relapsed or refractory, or R/R, KMT2A-rearranged, or KMT2Ar, acute leukemia was granted Priority Review and is being reviewed by the United States Food and Drug Administration, or FDA, and is being reviewed under the FDA’s Real-Time Oncology Review, or RTOR, Program. On July 29, 2024, we announced that the FDA extended the Prescription Drug User Fee Act, or PDUFA, target action date for the revumenib NDA from September 26, 2024 to December 26, 2024 to provide FDA additional time to conduct a full review of supplemental information provided by us in response to the FDA’s requests.

Previous wording

In March 2024, we also announced the completion of enrollment in the AUGMENT-101 pivotal trial cohort of patients with R/R mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML). Topline data is expected in the fourth quarter of 2024 and could support a supplemental NDA (sNDA) filing for revumenib in R/R mNPM1 AML in the first half of 2025.

Current wording

We expect to report topline data from the AUGMENT-101 pivotal trial cohort of patients with R/R mutant nucleophosmin, or mNPM1, acute myeloid leukemia, or AML, in the fourth quarter of 2024. Positive data could support a supplemental NDA, or sNDA, filing for revumenib in R/R mNPM1 AML in the first half of 2025.

Previous wording

Multiple Phase 1 combination trials of revumenib in mNPM1 and KMT2Ar acute leukemias are ongoing across the treatment landscape. The trials are expanding to validate recommended Phase 2 doses, with additional data expected in the second half of 2024. These trials include:

Current wording

Multiple Phase 1 combination trials of revumenib in mNPM1 and KMT2Ar acute leukemias are ongoing across the treatment landscape. These trials include:

Previous wording

BEAT-AML: Evaluating the combination of revumenib with venetoclax and Azacytidine in front-line AML patients. This trial is being conducted as part of the Leukemia & Lymphoma Society’s Beat AML® Master Clinical Trial.

Current wording

BEAT AML: Evaluating the combination of revumenib with venetoclax and azacitidine in front-line AML patients. This trial is being conducted as part of the Leukemia & Lymphoma Society’s Beat AML® Master Clinical Trial. We presented updated positive data from the trial at the European Hematology Association, or EHA, 2024 Congress, showing a 96% (23 of 24 pts) composite complete remission, or CRc, rate in patients with newly diagnosed mNPM1 or KMT2Ar AML. The BEAT AML trial is expanding to validate the recommended Phase 2 dose of the combination of revumenib with venetoclax and azacitidine.

Previous wording

SAVE: Evaluating the all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in R/R AML or mixed phenotype acute leukemias. The trial is being conducted by investigators from the MD Anderson Cancer Center.

Current wording

SAVE: Evaluating the all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in R/R AML or mixed phenotype acute leukemias. The trial is being conducted by investigators from MD Anderson Cancer Center. The trial is expanding to validate the recommended Phase 2 doses, with additional data expected in the second half of 2024.

Previous wording

A Phase 1 trial of revumenib in combination with 7+3 chemotherapy followed by maintenance treatment in newly diagnosed patients with mNPM1 or KMT2Ar acute leukemias was initiated during the quarter.

Current wording

Intensive chemotherapy: Evaluating the combination of revumenib with intensive chemotherapy (7+3) followed by revumenib maintenance treatment in newly diagnosed patients with mNPM1 or KMT2Ar acute leukemias. The Phase 1 trial is designed to identify the recommended Phase 2 dose for this combination to support further development.

Previous wording

AUGMENT-102: Evaluating the combination of revumenib with fludarabine and cytarabine in patients with R/R acute leukemias.

Current wording

We presented updated data from the AUGMENT-102 trial evaluating the combination of revumenib with fludarabine and cytarabine in patients with R/R acute leukemias at the EHA 2024 Congress. Treatment with the combination in R/R mNPM1, NUP98-rearranged, or NUP98r, or KMT2Ar acute leukemia patients resulted in a 52% (14 of 27 pts) CRc rate.

Previous wording

In February, we announced that the FDA had accepted the Biologics License Application (BLA) filing for axatilimab, an anti-CSF-1R antibody, in patients with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. The application was granted Priority Review and assigned a PDUFA action date of August 28, 2024.

Current wording

The Biologics License Application, or BLA, for axatilimab, an anti-CSF-1R antibody, for patients with cGVHD after failure of at least two prior lines of systemic therapy, is under FDA Priority Review with a PDUFA action date of August 28, 2024.

Previous wording

Enrollment is ongoing in a 26-week randomized, double-blinded, placebo-controlled Phase 2 trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis (IPF).

Current wording

Enrollment is ongoing in a 26-week randomized, double-blinded, placebo-controlled Phase 2 trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis, or IPF.

Previous wording

Our partner Incyte plans to initiate two combination trials with axatilimab in chronic GVHD in 2024, including a Phase 2 combination trial with ruxolitinib and a Phase 3 combination trial with steroids.

Current wording

Our partner, Incyte, plans to initiate two combination trials with axatilimab in earlier lines of treatment for chronic GVHD in the second half of 2024, including a Phase 2 combination trial with ruxolitinib and a Phase 3 combination trial with steroids.

Previous wording

The current inflationary environment may materially affect our business and operating results by increasing the cost of our clinical trial materials and supplies, driving the U.S. Federal Reserve system to increase interest rates, which in turn increased our overhead costs. Rising interest rates could make it more difficult for us to obtain traditional financing on acceptable terms, if at all. Additionally, the ongoing recession risk together with the foregoing, could result in further economic uncertainty and volatility in the capital markets in the near term and, as a result could negatively affect our operations. Furthermore, such economic conditions have produced downward pressure on share prices. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, additional high inflation could increase our operating costs, including our labor costs and research and development costs. These costs may also be negatively impacted due to supply chain constraints, global geopolitical tensions as a result of the ongoing war between Russia and Ukraine and the war in Israel, worsening macroeconomic conditions and employee availability and wage increases, which may result in additional stress on our working capital.

Current wording

The current inflationary environment may materially affect our business and operating results by increasing our overhead costs, including the costs of our clinical trial materials and supplies. High interest rates could make it more difficult for us to obtain traditional financing on acceptable terms, if at all. Additionally, the ongoing recession risk together with the foregoing, could result in further economic uncertainty and volatility in the capital markets in the near term and, as a result could negatively affect our operations. Furthermore, such economic conditions have produced downward pressure on share prices. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, additional high inflation could increase our operating costs, including our labor costs and research and development costs. These costs may also be negatively impacted due to supply chain constraints, global geopolitical tensions as a result of the ongoing wars between Russia and Ukraine and the war in Gaza, worsening macroeconomic conditions and employee availability and wage increases, which may result in additional stress on our working capital.

Previous wording

To date, we have not generated any product revenues. Our ability to generate revenue and become profitable depends upon our ability to obtain marketing approval of and successfully commercialize our product candidates. We generated no revenue during the three months ended March 31, 2024 and 2023.

Current wording

To date, we have not generated any product revenues. Our ability to generate revenue depends upon our ability to obtain marketing approval of, and successfully commercialize our product candidates. Our revenue for the three and six months ended June 30, 2024 was solely derived from the achievement of milestones in connection with our license agreement with Eddingpharm Investment Company Limited, or Eddingpharm. We generated no revenue during the three and six months ended June 30, 2023.

Previous wording

In September 2021, we granted Incyte an exclusive license to develop and commercialize axatilimab in the United States and the rest of the world. For the three months ended March 31, 2024, no revenue has been recognized under the Incyte Agreements.

Current wording

In September 2021, we granted Incyte an exclusive worldwide license to develop and commercialize axatilimab. For the three and six months ended June 30, 2024, no revenue has been recognized under the Incyte Agreements.

Previous wording

Selling, general and administrative expenses consist primarily of employee-related expenses, including salaries, benefits, non-cash stock-based compensation and travel expenses, for our employees in executive, finance, human resources, business development and support functions. Other selling, general and administrative expenses include facility-related costs not otherwise allocated to research and development expenses and accounting, tax, legal, information technology and consulting services. We anticipate that our selling, general and administrative expenses will further increase in the future as we continue to increase our headcount to support our continued research and development and anticipated commercialization of our product candidates. Additionally, in anticipation of expected regulatory approvals of revumenib and axatilimab, we have begun preparation for commercial launches of both drug candidates and, as as result, expect an increase in employee-related and sales and marketing expenses and other commercial expenses in 2024.

Current wording

Selling, general and administrative expenses consist primarily of pre-commercialization costs as well as employee-related expenses, including salaries, benefits, non-cash stock-based compensation and travel expenses, for our employees in executive, finance, human resources, business development and support functions. Other selling, general and administrative expenses include facility-related costs not otherwise allocated to research and development expenses and accounting, tax, legal, information technology and consulting services. We anticipate that our selling, general and administrative expenses will further increase in the future as we continue to increase our headcount to support our continued research and development. Additionally, in anticipation of expected regulatory approvals of revumenib and axatilimab, we have begun preparation for commercial launches of both drug candidates and, as result, expect an increase in employee-related as well as sales and marketing expenses and other commercial expenses.

Previous wording

Comparison of the three months ended March 31, 2024 and 2023:

Current wording

Comparison of the three and six months ended June 30, 2024 and 2023:

Previous wording

For the three months ended March 31, 2024, our total research and development expenses increased $22.4 million, or 66%, from the comparable quarter in the prior period. The increase is primarily due to:

Current wording

For the three and six months ended June 30, 2024, our total research and development expenses increased $13.9 million, or 40% and $36.3 million, or 53%, respectively, from the comparable quarter in the prior period. The increase is primarily due to:

Previous wording

An increase of $6.2 million in personnel costs, including non-cash stock-based compensation, and other expenses related to increases in headcount to support on-going clinical trials and regulatory expenses, NDA activities and related expenses and overhead expenses (e.g., information technology and facilities).

Current wording

An increase of $4.2 million and $10.4 million, for the three and six months ended June 30, 2024, respectively, in personnel costs, including non-cash stock-based compensation, and other expenses related to increases in headcount to support on-going clinical trials, NDA and sNDA, activities, and includes salaries and related expenses and overhead expenses (e.g. information technology and facilities).

Previous wording

The following table summarizes the internal and external research and development expenses for the three months ended March 31, 2024 and 2023:

Current wording

The following table summarizes the internal and external research and development expenses for the three and six months ended June 30, 2024 and 2023:

Previous wording

The following tables summarizes the selling, general and administrative expenses for the three months ended March 31, 2024 and 2023:

Current wording

The following tables summarizes the selling, general and administrative expenses for the three and six months ended June 30, 2024 and 2023:

Previous wording

For the three months ended March 31, 2024, our total selling, general and administrative expenses increased $11.1 million, or 92%, from the comparable quarter in the prior period. The increase primarily is due to:

Current wording

For the three and six months ended June 30, 2024, our total selling, general and administrative expenses increased $14.1 million, or 95% and $25.2 million, or 94%, respectively, from the comparable quarter in the prior period. The increase primarily is due to:

Previous wording

An increase of $1.5 million related to increases in information technology and legal-related expenses.

Current wording

An increase of $0.5 million and $2.0 million, for the three and six months ended June 30, 2024, respectively, related to increases in information technology, human resource and legal expenses.

Previous wording

An increase of $5.2 million in personnel costs, including non-cash stock-based compensation, and related costs related to increases in headcount to support a growing research and development organization and preparation of both commercial launches.

Current wording

An increase of $7.8 million and $13.1 million, for the three and six months ended June 30, 2024, respectively, in personnel costs, including non-cash stock-based compensation, and related costs related to increases in headcount to support a growing research and development organization and preparation of commercial launches.

Previous wording

For the three months ended March 31, 2024, interest income increased by $2.2 million, or 43%, from the comparable period in the prior year. The increase is primarily due to higher interest rates and increased average balance on cash equivalents and short and long-term investments.

Current wording

For the three and six months ended June 30, 2024, interest income increased by $1.1 million, or 21%, and $3.3 million, or 32%, respectively, from the comparable period in the prior year. The increase is primarily due to higher interest rates and increased average balance on cash equivalents and short and long-term investments.

Previous wording

For the three months ended March 31, 2024, interest expense increased by $15,000, or 38%, from the comparable period in the prior year. The increase is primarily due to our operational and capital leases.

Current wording

For the three and six months ended June 30, 2024, interest expense increased by $10 thousand, or 29%, and $25 thousand, or 33%, respectively, from the comparable period in the prior year. The increase is primarily due to our operational and capital leases.

Previous wording

For the three months ended March 31, 2024, total other income (expense), net decreased from the comparable prior period primarily due to a decrease in foreign currency losses on short and long-term investments.

Current wording

For the three and six months ended June 30, 2024, total other income (expense) , net decreased from the comparable prior period primarily due to a decrease in foreign currency losses on short and long-term investments.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2024, was $83.5 million and consisted of our net loss of $72.4 million adjusted for non-cash items, including stock-based compensation of $8.9 million, an investment accretion of $3.8 million, a net decrease in operating assets and liabilities of $16.5 million and an increase in operating lease and depreciation expenses of $0.2 million. The increase in net loss was primarily due to increased clinical trial activities and manufacturing expenses. The net decrease in operating assets and liabilities primarily consisted of decreased accrued expenses and other liabilities of $6.7 million, other receivables of $6.1 million, prepayments and deposits of $2.9 million, accounts payable of $1.2 million, partially offset by collaboration receivables of $0.3 million.

Current wording

Net cash used in operating activities for the six months ended June 30, 2024, was $155.2 million and consisted of our net loss of $140.5 million adjusted for non-cash items, which include stock-based compensation of $18.8 million, an investment accretion of $7.5 million, a net decrease in operating assets and liabilities of $26.5 million and an increase in operating lease and depreciation expenses of $0.5 million. The increase in net loss was primarily due to increased clinical trial activities and manufacturing expenses. The net decrease in operating assets and liabilities primarily consisted of decreased accrued expenses and other liabilities of $13.6 million, other receivables of $9.6 million, collaboration payable of $4.1 million, prepayments and deposits of $0.9 million, partially offset by accounts payable of $1.6 million.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2023, was $39.2 million and consisted of our net loss of $41.1 million adjusted for non-cash items, including stock-based compensation of $6.2 million, an investment accretion of $4.0 million, a net decrease in operating assets and liabilities of $0.5 million, and operating lease and depreciation expenses of $0.1 million. The increase in net loss was primarily due to increased clinical trial activities and manufacturing expenses. The net decrease in operating assets and liabilities primarily consisted of accounts payable of $3.7 million, increased prepayments and deposits of

Current wording

Net cash used in operating activities for the six months ended June 30, 2023, was $74.6 million and consisted of our net loss of $85.7 million adjusted for non-cash items, which include stock-based compensation of $14.3 million, an investment accretion of $7.7 million, a net increase in operating assets and liabilities of $4.3 million, and an increase in operating lease and depreciation expenses of $0.2 million. The increase in net loss was primarily due to increased clinical trial activities and manufacturing expenses. The net increase in operating assets and liabilities primarily consisted of accounts payable of $6.6 million, increased other payables of $4.0 million and increased prepaids and deposits of $0.5 million, partially offset by decreased accrued expenses and other liabilities of $6.8 million.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2024, was $99.4 million and was due to $68.0 million in proceeds from the maturities of available-for-sale securities, partially offset by the purchase of $167.4 million of available for sale securities.

Current wording

Net cash used in investing activities for the six months ended June 30, 2024 was $37.6 million and was due to the purchase of $167.4 million of available for sale securities, partially offset by $129.7 million in proceeds from the maturities of available-for-sale securities.

Previous wording

Net provided by in investing activities for the three months ended March 31, 2023, was $19.9 million and was due to $81.5 million in proceeds from the maturities of available-for-sale securities, partially offset by the purchase of $61.6 million of available-for-sale securities.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2023 was $93.8 million and was due to $236.4 million from the maturities of available-for-sale securities, partially offset by the purchase of $142.6 million of available-for-sale securities.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2023, was $2.5 million and was primarily due to proceeds from the exercise of stock options of $2.3 million and employee participation in our ESPP of $0.2 million.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2024, was $2.8 million and was primarily due to proceeds from the exercise of stock options of $2.3 million and employee participation in our 2015 Employee Stock Purchase Plan, or ESPP, of $0.5 million.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2024, was $2.2 million and was primarily due to proceeds from the exercise of stock options of $1.9 million and employee participation in our ESPP of $0.3 million.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2023, was $3.8 million and was primarily due to proceeds from the exercise of stock options of $3.4 million and employee participation in our ESPP of $0.4 million.

Previous wording

As of March 31, 2024, we had cash, cash equivalents and short- and long-term investments totaling $522.0 million. Since our inception, our operations have been primarily financed by net proceeds from our public stock offerings, and revenue from our license agreements. We believe that our present cash, cash equivalents and short and long-term investments as of March 31, 2024, will fund our projected operating expenses and capital expenditure requirements for at least the next 12 months. In addition to our existing cash, cash equivalents, short and long-term investments, we are eligible to receive research and development funding and to earn milestone and other contingent payments for the achievement of defined collaboration objectives and certain development, regulatory and commercial milestones, and royalty payments under our collaboration agreements. Our ability to earn these milestone and contingent payments and the timing of achieving these milestones is primarily dependent upon the outcome of our collaborators’ research and development activities and is uncertain at this time.

Current wording

Since our inception, our operations have been primarily financed by net proceeds from our public stock offerings, and revenue from our license agreements. We believe that our cash, cash equivalents and short- and long-term investments, totaling $454.6 million. as of June 30, 2024, will fund our projected operating expenses and capital expenditure requirements for at least the next 12 months. In addition to our existing cash, cash equivalents, short and long-term investments, we are eligible to receive research and development funding and to earn milestone and other contingent payments for the achievement of defined collaboration objectives and certain development, regulatory and commercial milestones, and royalty payments under our collaboration agreements. Our ability to earn these milestone and contingent payments and the timing of achieving these milestones is primarily dependent upon the outcome of our collaborators’ research and development activities and is uncertain at this time.

Previous wording

the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more trials than we currently expect;

Current wording

the outcome, timing and cost of seeking and obtaining regulatory approvals from the U.S. Food and Drug Administration, or FDA, and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more trials than we currently expect;

Previous wording

We have no products approved for commercial sale and have not generated any product revenues from product sales to date. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings and additional funding from license and collaboration arrangements. Except for any obligations of our collaborators to reimburse us for research and development expenses or to make milestone or royalty payments under our agreements with them, we will not have any committed external source of liquidity.

Current wording

We have no products approved for commercial sale and have not generated any product revenues from product sales to date. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings and additional funding from license and collaboration arrangements. Except for any obligations of our collaborators to reimburse us for research and development expenses or to make milestone or royalty payments under our agreements with them, we will not have any committed external source of liquidity. Our material contractual obligations and commitments as of June 30, 2024, primarily relate to our maturities of operating leases for office space and equipment and capital leases for office equipment. As of June 30, 2024, we have $1.1 million payable within 12 months.

Previous wording

We have incurred losses and cumulative negative cash flows from operations since our inception, excluding the year ended December 31, 2021. As of March 31, 2024, we had an accumulated deficit of $974.8 million. We anticipate that we will likely continue to incur significant losses for at least the next couple of years. We expect that our research and development and selling, general and administrative expenses will continue to increase. As a result, we will need additional capital to fund our operations, which we may raise through a combination of the sale of equity, debt financings, or other sources, including potential collaborations. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or drug candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

Current wording

We have incurred losses and cumulative negative cash flows from operations since our inception, excluding the year ended December 31, 2021. As of June 30, 2024, we had an accumulated deficit of $1.0 billion. We anticipate that we will likely continue to incur significant losses for at least the next couple of years. We expect that our research and development and selling, general and administrative expenses will continue to increase. As a result, we will need additional capital to fund our operations, which we may raise through a combination of the sale of equity, debt financings, or other sources, including potential collaborations. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or drug candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

Previous wording

In May 2023, we entered into a sales agreement with Cowen and Company, LLC, or TD Cowen, under which we could, from time to time, issue and sell shares of our common stock having aggregate sales proceeds of up to $200.0 million, in a series of one or more ATM equity offerings, or the 2023 ATM Program. TD Cowen is not required to sell any specific share amounts but acts as the Company’s sales agent, using commercially reasonable efforts consistent with its normal trading and sales practices. Pursuant to the sales agreement, shares will be sold under the shelf registration statement on Form S-3ASR (Registration No. 333-277424), which became automatically effective upon filing on February 27,2024. Our common stock will be sold at prevailing market prices at the time of the sale, and as a result, prices may vary. For the three months ended March 31, 2024, we did not sell any shares of common stock under the 2023 ATM Program. As of May 1, 2024, the Company had $157.9 million available under the 2023 ATM Program.

Current wording

In May 2023, we entered into a sales agreement with Cowen and Company, LLC, or TD Cowen, under which we could, from time to time, issue and sell shares of our common stock having aggregate sales proceeds of up to $200.0 million, in a series of one or more at-the-market equity offerings, or the 2023 ATM Program. TD Cowen is not required to sell any specific share amounts but acts as the Company’s sales agent, using commercially reasonable efforts consistent with its normal trading and sales practices. Pursuant to the sales agreement, shares will be sold under the shelf registration statement on Form S-3ASR (Registration No. 333-277424), which became automatically effective upon filing on February 27, 2024. Our common stock will be sold at prevailing market prices at the time of the sale, and as a result, prices may vary. For the three and six months ended June 30, 2024, we did not sell any shares of common stock under the 2023 ATM Program. As of July 25, 2024, we had $157.9 million available under the 2023 ATM Program.