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Ovid Therapeutics Inc

For the period ended Jun 30, 2024. Filed Aug 13, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 13, 2024

OVID$2.85+10.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-14.

0001628280-24-023067

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-13.

0001628280-24-036860

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 91 previous paragraphs and 99 current paragraphs.

61 unchanged; 22 reworded; 15 added; 8 removed; 0 previous and 1 current paragraphs rearranged.

Tables are not compared: 4 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (15)

Current report

In 2021, we sold our rights to soticlestat to Takeda, who studied it in two pivotal Phase 3 trials in Lennox-Gastaut syndrome and Dravet syndrome. On June 17, 2024, Takeda announced topline results of those trials. Given that the two Phase 3 Takeda trials evaluating soticlestat for the treatment of Dravet and Lennox-Gastaut syndromes did not meet their primary endpoints, it is uncertain whether Takeda will continue to progress, or elect to terminate the development of soticlestat as contemplated by the RLT Agreement, in which case we may not receive some or all of the royalty and milestone payments under the RLT Agreement. Takeda has publicly announced plans to engage with regulatory authorities to discuss the totality of the data generated by the study in Dravet syndrome to determine next steps.

Current report

On June 28, 2024, we announced a reduction of our workforce to prioritize our programs and extend our cash runway. We reduced our workforce by 17 people, or approximately 43% of our previous headcount. The organizational restructuring was effective as of July 11, 2024. All employees affected by the organizational restructuring were eligible to receive, among other things, severance payments and the continuation of group health insurance coverage for a specified time period post-termination, contingent upon such employee’s execution of a general release of claims against the Company.

Current report

We estimate that we will incur approximately $3.7 million in charges related to the organizational restructuring, which represents cash expenditures for severance and notice period payments, benefits and other related costs. We expect that the execution of the organizational restructuring will be substantially completed by the end of the third quarter of 2024 and that the majority of the cash payments related to the organizational restructuring will be substantially completed by the end of the second quarter of 2025.

Current report

General and administrative expenses were $8.1 million and $8.2 million for the three months ended June 30, 2024 and 2023, respectively. Costs of the organizational restructuring of approximately $1.8 million were recognized during the three months ended June 30, 2024, but will be paid over an extended period. Similar severance costs of $1.0 million were also recognized in the same period in 2023.

Current report

Revenue of $317,000 was generated in the six months ended June 30, 2024, compared to revenue of $141,000 recognized in the same period in 2023. Revenue in both periods consisted of royalties on net sales pursuant to an out-licensing agreement.

Current report

During the six months ended June 30, 2024, research and development expenses were $23.0 million compared to $12.6 million for the same period in 2023. The increase of $10.4 million primarily relates to $8.8 million in expenses associated with the acceleration of preclinical and clinical research and development in OV329 and OV888/GV101 as well as costs associated with the organizational restructuring announced in June 2024. Payroll and payroll related costs of the organizational restructuring of $1.6 million were recognized during the three months ended June 30, 2024, but will be paid over an extended period.

Current report

General and administrative expenses were $15.3 million for the six months ended June 30, 2024 compared to $16.6 million for the same period in 2023. The decrease of $1.3 million was primarily due to various cost reduction strategies during the period. Additionally, costs of the organizational restructuring of approximately $1.8 million were recognized during the three months ended June 30, 2024, but will be paid over an extended period.

Current report

Other income (expense), net for the six months ended June 30, 2024 results from unrealized gain (loss) on long-term equity investments and interest earned and accretion of discount on marketable securities. Additionally, other income of $29.0 million was recognized during the period relating to an adjustment to the royalty monetization liability under the Ligand Agreement, resulting from our reassessment of certain assumptions underlying the valuation of the royalty monetization liability, resulting from Takeda’s reported soticlestat Phase 3 study results. Other income, net for the six months ended June 30, 2024 was $34.8 million compared to $3.3 million for the same period in 2023. Aside from the adjustment to the royalty monetization liability, the increase between the periods is primarily due to net unrealized gains recorded on the long-term equity investments.

Current report

In June 2024 we announced an organizational restructuring which included a reduction of our workforce to prioritize our programs and extend our cash runway.

Current report

While we expect that the organizational restructuring and the majority of the related cash payments will be substantially completed by the second quarter of 2025, we may incur other charges or cash expenditures not currently contemplated due to unanticipated events that may occur, including in connection with the implementation of the organizational restructuring. Additionally, we may not achieve the expected benefits of these cost reduction measures and other cost reduction plans on the anticipated timeline, or at all, which could otherwise accelerate our liquidity needs and could force us to further curtail or suspend our operations.
Removed paragraphs (8)

Previous report

In connection with Takeda's second quarter earnings announcement in October 2023, Takeda reiterated the anticipated timeline for regulatory filing of the two pivotal Phase 3 trials evaluating soticlestat for Lennox-Gastaut and Dravet syndromes are expected in Takeda’s 2024 fiscal year. Under the royalty, license and termination agreement (“RLT Agreement”) with Takeda, if soticlestat is successfully approved and commercialized, we are eligible to receive up to $660 million in regulatory and commercial milestones and tiered royalties up to 20% on all indications and regions. In October 2023, we entered into the purchase and sale agreement (“Ligand Agreement”) for the sale to Ligand Pharmaceuticals Incorporated (“Ligand”) of a 13% interest in the potential milestone and royalty payments that we are eligible to receive under the RLT Agreement. Under the Ligand Agreement, Ligand paid us $30.0 million, less $100,000 of reimbursable expenses. We retain ownership of 87% of such potential milestone and royalty payments.

Previous report

General and administrative expenses were $7.2 million and $8.3 million for the three months ended March 31, 2024 and 2023, respectively. The decrease of $1.2 million between periods was due to reduction in force of general and administrative roles during the second quarter of 2023 as well as strategic cost-reduction initiatives.
Reworded paragraphs (22)

Previous wording

We are a biopharmaceutical company committed to developing medicines that transform the lives of people with certain epilepsies and brain conditions with seizure symptoms in a manner that is scientifically driven and patient focused. We have set out to be a leader in the field of certain epilepsies and intractable neurological diseases with seizure symptoms. Our differentiated pipeline of potential small molecule medicines has produced four unique anti-seizure programs to date, three of which we are actively developing, and the fourth, which we co-developed, was subsequently repurchased by Takeda Company Limited (“Takeda”). This pipeline was curated using an integrated and disciplined approach to business development, research, and clinical development. All of the programs in our pipeline act upon either extrinsic or intrinsic factors modulating neuronal hyperexcitability, which we believe underlies seizures and other neurological conditions. Our management team has substantial understanding of rare disease and neurological conditions gained from the management team's collective experience and contributions to the development and launch of more than 25 approved medicines in their respective careers prior to joining Ovid. Such experience includes many approved anti-seizure medicines. Our knowledge of the underlying biologic targets driving hyperexcitability and the pathology of refractory epilepsies has produced clinical-stage development programs, the most advanced of which was soticlestat, our rights to which were repurchased by Takeda in 2021 and is being actively studied by Takeda in two pivotal Phase 3 trials in Lennox-Gastaut syndrome and Dravet syndrome. Two of our three programs are in clinical trials. We expect to submit an investigational new drug (“IND”) application to begin clinical trials for the third program in the second half of 2024.

Current wording

We are a biopharmaceutical company committed to developing medicines that transform the lives of people with certain epilepsies and brain conditions with seizure symptoms in a manner that is scientifically driven and patient focused. We have set out to be a leader in the field of certain epilepsies and intractable neurological diseases with seizure symptoms. Our differentiated pipeline of potential small molecule medicines has produced four unique anti-seizure programs to date, three of which we are actively developing, and the fourth, which we co-developed, was subsequently repurchased by Takeda Company Limited (“Takeda”) in 2021. This pipeline was curated using an integrated and disciplined approach to business development, research, and clinical development. All of the programs in our pipeline act upon either extrinsic or intrinsic factors modulating neuronal hyperexcitability, which we believe underlies seizures and other neurological conditions. Our management team has substantial understanding of rare disease and neurological conditions gained from the management team’s collective experience and contributions to the development and launch of more than 25 approved medicines in their respective careers prior to joining Ovid. Such experience includes many approved anti-seizure medicines. Our knowledge of the underlying biologic targets driving hyperexcitability and the pathology of refractory epilepsies has produced clinical-stage development program. Two of our three programs are in clinical trials. We expect to submit an investigational new drug (“IND”) application, or the equivalent in jurisdictions outside of the U.S., to begin clinical trials for the third program in the second half of 2024.

Previous wording

Over time, we have built a replicable and scalable approach to develop small molecule candidates, which begins with conducting animal disease models and toxicology studies in the pre-clinic to build evidence and confidence before moving into the clinic. Initially, we are pursuing therapeutic assets for rare epilepsies and seizure disorders as they can leverage cost-efficient and accelerated development programs and they can be evaluated with concrete and measurable endpoints such as seizures and electroencephalogram (“EEG”) readings. In addition to seizures, if successfully developed and marketed, we intend to explore our pipeline assets for broader neurologic indications caused by neuronal hyperexcitabilty, as applicable. Our cohesive focus in rare epilepsies and seizures reinforces our belief that we can develop and produce multiple novel medicines, scale our infrastructure, and thereby succeed in our mission.

Current wording

Over time, we have built a replicable and scalable approach to develop small molecule candidates, which begins with conducting animal disease models and toxicology studies in the pre-clinic to build evidence and confidence before moving into the clinic. Initially, we are pursuing therapeutic assets for rare epilepsies and seizure disorders as they can leverage cost-efficient and accelerated development programs and they can be evaluated with concrete and measurable endpoints such as seizures and electroencephalogram (“EEG”) readings. In addition to seizures, if successfully developed and marketed, we intend to explore our pipeline assets for broader neurologic indications caused by neuronal hyperexcitability, as applicable. Our cohesive focus in rare epilepsies and seizures reinforces our belief that we can develop and produce multiple novel medicines, scale our infrastructure, and thereby succeed in our mission.

Previous wording

Since our inception in April 2014, we have devoted substantially all of our efforts to organizing and planning our business, building our management and technical team, acquiring operating assets and raising capital. We have historically funded our business primarily through the sale of our capital stock. Through March 31, 2024, we have raised net proceeds of $275.4 million from the sale of our capital stock. We have also, in previous periods, generated revenue through license and collaboration agreements, including $196.0 million from the RLT Agreement and $30.0 million from the Ligand Agreement. As of March 31, 2024, we had $90.3 million in cash, cash equivalents and marketable securities and an accumulated deficit of $289.6 million.

Current wording

Since our inception in April 2014, we have devoted substantially all of our efforts to organizing and planning our business, building our management and technical team, acquiring operating assets and raising capital. We have historically funded our business primarily through the sale of our capital stock. Through June 30, 2024, we have raised net proceeds of $275.4 million from the sale of our capital stock. We have also, in previous periods, generated revenue through license and collaboration agreements, including $196.0 million from our royalty, license and termination agreement (“RLT Agreement”) with Takeda Pharmaceutical Company Limited (“Takeda”) and $30.0 million from our purchase and sale agreement (“Ligand Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”). As of June 30, 2024, we had $77.0 million in cash, cash equivalents and marketable securities and an accumulated deficit of $281.0 million.

Previous wording

We expect to continue to incur significant expenses and operating losses for at least the next several years. Our net losses may fluctuate significantly from period to period, depending on the timing of our planned clinical trials and expenditures on our other research and development and commercial development activities. We expect our expenses will increase substantially over time as we:

Current wording

We expect to incur significant expenses and operating losses for at least the next several years. Our net losses may fluctuate significantly from period to period, depending on the timing of our planned clinical trials and expenditures on our other research and development and commercial development activities. We expect our expenses will increase substantially over time as we:

Previous wording

In May 2023, we in-licensed OV888 (formerly GV101) and a library of highly-selective Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitors from Graviton Biosciences and entered into a research and collaboration agreement with Graviton Biosciences. Under the collaboration, Graviton is responsible for developing the lead program through Phase 2 development and we will then assume responsibility for Phase 3 development and commercialization. The lead program from this collaboration, OV888, is in a Phase 1 multiple-ascending dose study. OV888 is formulated as a hard gel cap, which we expect to be the future clinical formulation. That Phase 1 study is anticipated to be completed in the first half of 2024. Ovid and Graviton intend to initiate a signal-finding trial in people living with cerebral cavernous malformations in the second half of 2024. No serious adverse events have been observed in the Phase 1 study thus far.

Current wording

In May 2023, we in-licensed OV888/GV101 and a library of highly selective Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitors from Graviton Bioscience Corporation(“Graviton”)and entered into a research and collaboration agreement with Graviton. Under the collaboration, Graviton is responsible for developing the lead program through Phase 2 development and we will then assume responsibility for Phase 3 development and commercialization. The lead program from this collaboration, OV888/GV101, is formulated as a hard gel capsule, which we expect to be the future clinical formulation. Together with Graviton, we announced positive topline data from a Phase 1 multiple-ascending dose study of OV888/GV101 on July 1, 2024. Ovid and Graviton intend to initiate a signal-finding trial in people living with cerebral cavernous malformations in the second half of 2024.

Previous wording

In December 2022, we initiated a Phase 1 study for OV329, a next-generation GABA-aminotransferase inhibitor, in healthy volunteers. That study is continuing to dose-escalate in the single-ascending dose cohorts and we anticipate initiating amultiple-ascending dose study. No serious adverse events have been observed in the Phase 1 study thus far. At our R&D Day on October 2, 2023, we shared preclinical data demonstrating OV329 elicits an EEG response which is a pharmacodynamic marker of anti-convulsant activity. We subsequently guided that we will be adding a transcranial magnetic stimulation to the Phase 1 study to serve as a second biomarker for efficacy in addition to measuring target engagement via magnetic resonance spectroscopy. The current Phase 1 is expected to be completed in the second half of 2024. Additionally, we announced plans to develop an intravenous (“IV”) formulation of OV329 for potential use in acute seizures based upon emerging evidence that GABA-AT inhibition may be effective in the treatment of status epilepticus. An IND application or the equivalent for the IV formulation is expected in the second half of 2024.

Current wording

In December 2022, we initiated a Phase 1 study for OV329, a next-generation GABA-aminotransferase inhibitor, in healthy volunteers. That study is continuing to dose-escalate in the single-ascending dose cohorts and we anticipate initiating amultiple-ascending dose study. No serious adverse events have been observed in the Phase 1 study thus far. At our R&D Day in October 2023, we shared preclinical data demonstrating OV329 elicits an EEG response which is a pharmacodynamic marker of anti-convulsant activity. We subsequently guided that we will be adding a transcranial magnetic stimulation to the Phase 1 study to serve as a second biomarker for efficacy in addition to measuring target engagement via magnetic resonance spectroscopy. The current Phase 1 is expected to be completed in the second half of 2024. Additionally, we announced plans to develop an intravenous (“IV”) formulation of OV329 for potential use in acute seizures based upon emerging evidence that GABA-AT inhibition may be effective in the treatment of status epilepticus. In June 2024, we decided to pause the development of the IV formulation of OV329 to focus on other preclinical and clinical programs.

Previous wording

We are also developing a portfolio of direct activators of the potassium chloride co-transporter 2 (KCC2) for the potential treatment of seizures and other neurological indications, including OV350. We are conducting multiple non-clinical studies to characterize the therapeutic potential of direct activation of the KCC2 from our library of compounds, which is a biological target implicated in many neurological conditions including seizures. An IV formulation of OV350 is progressing toward an anticipated IND in the second half of 2024. In October 2023, we also presented at our R&D Day animal studies that validate OV350’s potential anti-psychotic properties. We believe non-epilepsy indications may represent future development collaboration opportunities.

Current wording

We are also developing a portfolio of direct activators of the potassium chloride co-transporter 2 (KCC2) for the potential treatment of seizures and other neurological indications, including OV350. We are conducting multiple non-clinical studies to characterize the therapeutic potential of direct activation of the KCC2 from our library of compounds, which is a biological target implicated in many neurological conditions including seizures. An IV formulation of OV350 is progressing toward anticipated regulatory filings or first-in-human studies in the second half of 2024. In October 2023, we also presented at our R&D Day animal studies that validate OV350’s potential anti-psychotic properties. We believe non-epilepsy indications may represent future development collaboration opportunities.

Previous wording

The global economic slowdown, the overall disruption of global healthcare systems and other risks and uncertainties associated with bank failures, public health crises and global geopolitical tensions, like the ongoing war between Russia and Ukraine and the war in Israel, may have a material adverse effect on our business, financial condition, results of operations and growth prospects. The resulting high inflation rates may materially affect our business and corresponding financial position and cash flows. Inflationary factors, such as increases in the cost of our clinical trial materials and supplies, interest rates and overhead costs may adversely affect our operating results. Rising interest rates also present a recent challenge impacting the U.S. economy and could make it more difficult for us to obtain traditional financing on acceptable terms, if at all, in the future. Furthermore, 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, we may experience increases in the near future (especially if inflation rates remain high or begin to rise again) on our operating costs, including our labor costs and research and development costs, 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 global macroeconomic conditions and employee availability and wage increases, which may result in additional stress on our working capital resources.

Current wording

The global economic slowdown, the overall disruption of global healthcare systems and other risks and uncertainties associated with bank failures, public health crises and global geopolitical tensions, like the ongoing war between Russia and Ukraine and the war in Israel, may have a material adverse effect on our business, financial condition, results of operations and growth prospects. The resulting high inflation rates may materially affect our business and corresponding financial position and cash flows. Inflationary factors, such as increases in the cost of our clinical trial materials and supplies, interest rates and overhead costs may adversely affect our operating results. Elevated interest rates also present a recent challenge impacting the U.S. economy and could make it more difficult for us to obtain traditional financing on acceptable terms, if at all, in the future. Furthermore, 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, we may experience increases in the near future (especially if inflation rates remain high or begin to rise again) on our operating costs, including our labor costs and research and development costs, 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 global macroeconomic conditions and employee availability and wage increases, which may result in additional stress on our working capital resources.

Previous wording

In addition, we are subject to other challenges and risks specific to our business and our ability to execute on our strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: identifying, acquiring or in-licensing products or product candidates; obtaining regulatory approval of product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements.

Current wording

In addition, we are subject to other challenges and risks specific to our business and our ability to execute on our strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: identifying, acquiring or in-licensing products or product candidates; obtaining regulatory approval of product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; and complying with applicable regulatory requirements.

Previous wording

Other income (expense), net primarily consists of unrealized gains (losses) on long-term equity investments and interest income and accretion of discount on investments in marketable securities.

Current wording

Other income (expense), net primarily consists of unrealized gains (losses) on long-term equity investments, interest income and accretion of discount on investments in marketable securities, and change in fair value of royalty monetization liability.

Previous wording

Royalty revenue of $148,000 and $66,000 was recorded in the three months ended March 31, 2024 and 2023, respectively.

Current wording

Revenue of $169,000 and $75,000 was recorded in the three months ended June 30, 2024 and 2023, respectively, which consisted of royalties on net sales pursuant to an out-licensing agreement.

Previous wording

During the three months ended March 31, 2024, total research and development expenses were $10.4 million, compared to $6.6 million for the same period in 2023. The increase of $3.8 million primarily relates to expenses associated with the acceleration of clinical development in OV329 and OV888 (GV101).

Current wording

During the three months ended June 30, 2024, research and development expenses were $12.6 million, compared to $6.0 million for the same period in 2023. The increase of $6.6 million primarily relates to $4.0 million in expenses associated with the acceleration of preclinical and clinical research and development in OV329 and OV888/GV101 as well as costs associated with the organizational restructuring in June 2024. Payroll and payroll-related expenses of the organizational restructuring of $1.6 million were recognized during the three months ended June 30, 2024, but will be paid over an extended period.

Previous wording

Other income (expense), net for the three months ended March 31, 2024 and 2023 includes unrealized gain (loss) on long-term equity investments and interest earned and accretion of discount on marketable securities. Other income (expense), net for the three months ended March 31, 2024 and 2023 was $5.7 million and $1.5 million, respectively. The increase of $4.2 million is primarily due to unrealized gain recorded on long-term equity investments.

Current wording

Other income (expense), net for the three months ended June 30, 2024 and 2023 includes unrealized gain (loss) on long-term equity investments and interest earned and accretion of discount on marketable securities. Additionally, other income of $29.0 million was recognized during the period relating to an adjustment in fair value of the royalty monetization liability under the Ligand Agreement, resulting from our reassessment of certain assumptions underlying the valuation of the royalty monetization liability due to Takeda’s reported soticlestat Phase 3 study results. Other income (expense), net for the three months ended June 30, 2024 and 2023 was $29.0 million and $1.8 million, respectively.

Previous wording

As of March 31, 2024, we had total cash, cash equivalents and marketable securities of $90.3 million. We believe that our cash, cash equivalents and marketable securities as of March 31, 2024 will fund our projected operating expenses and capital expenditure requirements for at least 12 months from the issuance of this Quarterly Report on Form 10-Q.

Current wording

As of June 30, 2024, we had total cash, cash equivalents and marketable securities of $77.0 million. We believe that our cash, cash equivalents and marketable securities as of June 30, 2024 will fund our projected operating expenses and capital expenditure requirements for at least 12 months from the issuance of this Quarterly Report on Form 10-Q.

Previous wording

Similar to other development-stage biotechnology companies, we have generated limited revenue, which has been through various license and collaboration agreements. With the exception of the three months ended March 31, 2021, when we received a one-time upfront payment of $196.0 million as part of the RLT Agreement, we have incurred losses and experienced negative operating cash flows since our inception and anticipate that we will continue to incur losses and experience negative operating cash flows for at least the next several years. We recorded net losses of approximately $11.7 million and $13.4 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $289.6 million and working capital of $84.3 million.

Current wording

Similar to other development-stage biotechnology companies, we have generated limited revenue, which has been through various license and collaboration agreements, and have financed our operations primarily through the sale of equity securities. We have historically incurred losses and experienced negative operating cash flows for most periods since our inception and anticipate that we will incur losses and experience negative operating cash flows in the future. We recorded net income of $8.5 million (due to an adjustment to the royalty monetization liability under the Ligand Agreement) and net loss of $12.4 million for the three months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $281.0 million and working capital of $66.8 million.

Previous wording

In September 2021, we entered into a 10-year lease agreement for our corporate headquarters with a term commencing March 10, 2022, for approximately 19,000 square feet of office space at Hudson Commons in New York, New York. The lease provides for monthly rental payments over the lease term. The base rent under the lease is currently $2.3 million per year. Rent payments commenced January 10, 2023, and will continue for 10 years following the rent commencement date. We issued a letter of credit in the amount of $1.9 million in association with the execution of the lease agreement, which is reflected as restricted cash on our condensed consolidated balance sheets. Payment obligations under the lease agreement include approximately $1.9 million in the 12 months subsequent to March 31, 2024 and approximately $22.5 million over the remaining term of the agreement. For additional information see Note 5 to our condensed consolidated financial statements under the heading “Leases.”

Current wording

In September 2021, we entered into a 10-year lease agreement for our corporate headquarters with a term commencing March 10, 2022, for approximately 19,000 square feet of office space at Hudson Commons in New York, New York. The lease provides for monthly rental payments over the lease term. The base rent under the lease is currently $2.3 million per year. Rent payments commenced January 10, 2023 and will continue for 10 years following the rent commencement date. We issued a letter of credit in the amount of $1.9 million in association with the execution of the lease agreement, which is reflected as restricted cash on our condensed consolidated balance sheets. Payment obligations under the lease agreement include approximately $2.3 million in the 12 months subsequent to June 30, 2024 and approximately $20.5 million over the remaining term of the agreement. For additional information see Note 5 to our condensed consolidated financial statements under the heading “Leases.”

Previous wording

We have no products approved for commercial sale and have not generated any revenue 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. To the extent that we raise additional capital through future equity offerings or debt financings, ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt and equity financings, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. There can be no assurance that such financings will be obtained on terms acceptable to us, if at all. Additionally, inflation rates have increased recently to levels not seen in decades, contributing to the ongoing economic slowdown. Increased inflation may result in increased operating costs (including labor costs) and may affect our operating budgets. In response to concerns about inflation, the U.S. Federal Reserve has raised, and is expected to further raise, interest rates. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks. If the disruptions and slowdown deepen or persist, we may not be able to access additional capital on favorable terms, or at all, which could in the future negatively affect our ability to pursue our business strategy. If we raise additional funds through collaborations, strategic alliances or licensing agreements with third parties for one or more of our current or future drug candidates, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or to grant licenses on terms that may not be favorable to us. Our failure to raise capital as and when needed would have a material adverse effect on our financial condition and our ability to pursue our business strategy. See “Risk Factors” for additional risks associated with our capital requirements.

Current wording

We have no products approved for commercial sale and have not generated any revenue 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. To the extent that we raise additional capital through future equity offerings or debt financings, ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt and equity financings, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. There can be no assurance that such financings will be obtained on terms acceptable to us, if at all. Additionally, inflation rates have increased recently to levels not seen in decades, contributing to the ongoing economic slowdown. Increased inflation may result in increased operating costs (including labor costs) and may affect our operating budgets. In response to concerns about inflation, the U.S. Federal Reserve has raised, and may further raise, interest rates. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks. If the disruptions and slowdown deepen or persist, we may not be able to access additional capital on favorable terms, or at all, which could in the future negatively affect our ability to pursue our business strategy. If we raise additional funds through collaborations, strategic alliances or licensing agreements with third parties for one or more of our current or future drug candidates, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or to grant licenses on terms that may not be favorable to us. Our failure to raise capital as and when needed would have a material adverse effect on our financial condition and our ability to pursue our business strategy. See “Risk Factors” for additional risks associated with our capital requirements.

Previous wording

In November 2023, we filed a shelf registration statement on Form S-3 (Registration No. 333-275307) to replace our prior registration statement that was set to expire. The replacement registration statement allows us to sell up to an aggregate of $250.0 million of our common stock, preferred stock, debt securities and/or warrants (the “S-3 Registration Statement”), which includes a prospectus covering the issuance and sale of up to $75.0 million of common stock pursuant to an at-the-market (“ATM”) offering program. As of March 31, 2024, we had $250.0 million available under our S-3 Registration Statement, including $75.0 million available pursuant to our ATM program.

Current wording

In November 2023, we filed a shelf registration statement on Form S-3 (Registration No. 333-275307) (the “S-3 Registration Statement”) to replace our prior registration statement that was set to expire. The S-3 Registration Statement allows us to sell up to an aggregate of $250.0 million of our common stock, preferred stock, debt securities and/or warrants, which includes a prospectus covering the issuance and sale of up to $75.0 million of common stock pursuant to an at-the-market (“ATM”) offering program. As of June 30, 2024, we had $250.0 million available under our S-3 Registration Statement, including $75.0 million available pursuant to our ATM program.

Previous wording

Net cash used in operating activities was $16.7 million for the three months ended March 31, 2024, which consisted of a net loss of $11.7 million offset by non-cash charges and changes in operating assets and liabilities, primarily related to $2.0 million of stock-based compensation expense. Net cash used in operating activities was $12.1 million for the three months ended March 31, 2023, which consisted of net loss of $13.4 million offset by a net of $1.2 million of non-cash charges and changes in operating assets and liabilities, primarily related to $1.9 million of stock-based compensation expense.

Current wording

Net cash used in operating activities was $30.9 million for the six months ended June 30, 2024, which consisted of net loss of $3.2 million, primarily due to a non-cash fair value adjustment recorded to the royalty monetization liability under the Ligand Agreement. This was offset by non-cash charges and changes in operating assets and liabilities, primarily related to $3.7 million of stock-based compensation expense. Net cash used in operating activities was $23.8 million for the six months ended June 30, 2023, which consisted of net loss of $25.8 million offset non-cash charges and changes in operating assets and liabilities, primarily related to $3.9 million of stock-based compensation expense.

Previous wording

Net cash provided by investing activities was $20.2 million and $30.2 million for the three months ended March 31, 2024 and 2023, respectively, which was due to maturity of marketable securities during the periods.

Current wording

Net cash provided by investing activities was $33.0 million and $50.3 million for the six months ended June 30, 2024 and 2023, respectively, which was due to maturity of marketable securities during the periods.

Previous wording

Net cash provided by financing activities during the three months ended March 31, 2024 and 2023 resulted from proceeds from the exercise of stock options and employee stock purchase plan.

Current wording

Net cash provided by financing activities during the six months ended June 30, 2024 and 2023 resulted from proceeds from the exercise of stock options and purchases under the employee stock purchase plan.

Previous wording

During the three months ended March 31, 2024, there were no material changes to our critical accounting policies as reported for the year ended December 31, 2023 as part of our Annual Report on Form 10-K, which was filed with the SEC on March 8, 2024. In addition, see Note 2 of our Condensed Consolidated Financial Statements under the heading “Recent Accounting Pronouncements” for new accounting pronouncements or changes to the accounting pronouncements during the three months ended March 31, 2024.

Current wording

During the three and six months ended June 30, 2024, there were no material changes to our critical accounting policies as reported for the year ended December 31, 2023 as part of our Annual Report on Form 10-K, which was filed with the SEC on March 8, 2024. In addition, see Note 2 of our condensed consolidated financial statements under the heading “Recent Accounting Pronouncements” for new accounting pronouncements or changes to the accounting pronouncements during the three and six months ended June 30, 2024.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

The following table summarizes the results of our operations for the periods indicated: