Jasper Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
View on SEC.govAbout 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.
Sep 30, 2024 · Filed Nov 7, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001213900-24-067897
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001213900-24-095173
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 101 previous paragraphs and 99 current paragraphs.
64 unchanged; 33 reworded; 1 added; 3 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 69 previous and 76 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 (1)
Current report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Removed paragraphs (3)
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2023
Previous report
Stanford Sponsored Research Agreement*
Previous report
Effective September 2020, we entered into a sponsored research agreement with Stanford for a research program related to the treatment of Fanconi Anemia patients in Bone Marrow Failure requiring allogeneic transplant with non-sibling donors at Stanford Lucile Packard Children’s Hospital using briquilimab. As consideration for the services performed by Stanford under this sponsored research agreement, we agreed to pay Stanford a total of $0.9 million over approximately three years upon the achievement of development and clinical milestones, including FDA filings and patient enrollment. In February 2021, we paid $0.3 million related to the achievement of the first milestone under this agreement. In February 2022, the second milestone was achieved, and we paid $0.3 million in March 2022. The third and final milestone in the amount of $0.3 million was achieved in July 2023 and was recognized as a research and development expense in the condensed consolidated statements of operations and comprehensive loss for the year ended December 31, 2023.
Reworded paragraphs (33)
Previous wording
We are a clinical-stage biotechnology company focused on developing therapeutics targeting mast cell driven diseases such as Chronic Spontaneous Urticaria (“CSU”), Chronic Inducible Urticaria (“CIndU”) and Asthma. We also have ongoing programs in diseases where targeting diseased hemopoietic stem cells can provide benefits, such as Lower to Intermediate Risk Myelodysplastic Syndrome (“LR-MDS”), and stem cell transplant conditioning regimens.
Current wording
We are a clinical-stage biotechnology company focused on developing therapeutics targeting mast cell driven diseases such as Chronic Spontaneous Urticaria (“CSU”), Chronic Inducible Urticaria (“CIndU”) and Asthma. We also have ongoing programs in diseases where targeting diseased hemopoietic stem cells can provide benefits, such as stem cell transplant conditioning regimens.
Previous wording
Our lead product candidate, briquilimab, is a monoclonal antibody designed to block stem cell factor (“SCF”) from binding to and signaling through the CD117 (“c-Kit”) receptor on mast and stem cells. The SCF/c-Kit pathway is a survival signal for mast cells and we believe that blocking this pathway may lead to depletion of these cells from skin, which could lead to significant clinical benefit for patients with mast-cell driven diseases such as chronic urticarias. To that end, we have commenced a Phase 1b/2a clinical study in CSU, a Phase 1b/2a clinical study in CIndU, are planning to commence a Phase 1b/2a study in Asthma and are actively evaluating the potential for briquilimab in additional mast cell driven diseases.
Current wording
Our lead product candidate, briquilimab, is a monoclonal antibody designed to block stem cell factor (“SCF”) from binding to and signaling through the CD117 (“c-Kit”) receptor on mast and stem cells. The SCF/c-Kit pathway is a survival signal for mast cells and we believe that blocking this pathway may lead to depletion of these cells from skin, which could lead to significant clinical benefit for patients with mast-cell driven diseases such as chronic urticarias. To that end, we are focusing on advancing a portfolio of clinical programs in mast cell driven diseases. Development highlights include:
Previous wording
We also believe that utilizing briquilimab to block SCF binding and signaling can result in the depletion of diseased hematopoietic stem cells (“HSCs”) from the bone marrow in certain hematologic malignancies such as myelodysplastic syndrome (“MDS”), and as a result, we are currently enrolling a Phase 1 trial evaluating briquilimab as a second-line therapy in patients with LR-MDS. We are also developing briquilimab as a one-time conditioning therapy in severe combined immunodeficiency (“SCID”) patients undergoing a second stem cell transplant for which we are currently conducting a Phase 1/2 clinical trial. Briquilimab is also being studied by our academic and institutional partners, Stanford University and the National Institutes of Health, in other transplant settings, including Fanconi Anemia (“FA”), sickle cell disease (“SCD”), chronic granulomatous disease and GATA-2 Type MDS.
Current wording
We also believe that utilizing briquilimab to block SCF binding and signaling can selectively result in the depletion of diseased hematopoietic stem cells (“HSCs”) from the bone marrow in certain hematologic malignancies such as myelodysplastic syndrome (“MDS”). We evaluated briquilimab in a Phase 1 trial as a second-line therapy in patients with Lower to Intermediate Risk Myelodysplastic Syndrome (“LR-MDS”) and briquilimab demonstrated an ability to deplete diseased HSCs and was well-tolerated by patients without exacerbating pre-existing anemia, neutropenia or thrombocytopenia. However, the reduction in diseased HSCs did not ultimately translate into an improvement in hematopoiesis for patients, and as a result we have discontinued development of briquilimab in LR-MDS. We are also developing briquilimab as a one-time conditioning therapy in severe combined immunodeficiency (“SCID”) patients undergoing a second stem cell transplant for which we are currently conducting a Phase 1/2 clinical trial. Briquilimab is also being studied by our academic and institutional partners, Stanford University and the National Institutes of Health, in other transplant settings, including Fanconi Anemia (“FA”), sickle cell disease (“SCD”), chronic granulomatous disease and GATA-2 Type MDS.
Previous wording
We have incurred significant losses and negative cash flows from operations since our inception. During the three and six months ended June 30, 2024, we incurred net losses of $14.6 million and $28.3 million, respectively. During the three and six months ended June 30, 2023, we incurred net losses of $16.1 million and $30.3 million, respectively. During the six months ended June 30, 2024 and 2023, we had negative cash flows from operations of $27.4 million and $23.6 million, respectively. As of June 30, 2024, we had an accumulated deficit of $197.9 million.
Current wording
We have incurred significant losses and negative cash flows from operations since our inception. During the three and nine months ended September 30, 2024, we incurred net losses of $18.6 million and $46.9 million, respectively. During the three and nine months ended September 30, 2023, we incurred net losses of $17.5 million and $47.9 million, respectively. During the nine months ended September 30, 2024 and 2023, we had negative cash flows from operations of $41.5 million and $35.6 million, respectively. As of September 30, 2024, we had an accumulated deficit of $216.5 million.
Previous wording
We had cash and cash equivalents of $106.8 million as of June 30, 2024. We expect that our existing cash and cash equivalents will be sufficient to fund our operating plan for at least twelve months from the date of filing of this Quarterly Report. We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon successful development, approval and commercialization of our product candidates and upon achievement of sufficient revenues to support our cost structure. We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. We may never achieve profitability, and unless we do and until then, we will need to continue to raise additional capital.
Current wording
We had cash and cash equivalents of $92.5 million as of September 30, 2024. We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon successful development, approval and commercialization of our product candidates and upon achievement of sufficient revenues to support our cost structure. We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. We may never achieve profitability, and unless we do and until then, we will need to continue to raise additional capital.
Previous wording
Other income (expense), net includes foreign currency transactions gains and losses, interest income, changes in the fair value of common stock warrant liability and earnout liability. These financial instruments were classified as liabilities in our condensed consolidated balance sheets and re-measured at each reporting period end until they are exercised, settled or have expired. In January 2023, all outstanding common stock warrants met equity classification and are no longer remeasured. The estimated fair value of the earnout liability was less than $0.1 million as of June 30, 2024 and was minimal as of December 31, 2023, due to the price of our common stock relative to the price that would trigger a release of the earnout shares.
Current wording
Other income (expense), net includes foreign currency transactions gains and losses, interest income, changes in the fair value of common stock warrant liability and earnout liability. These financial instruments were classified as liabilities in our condensed consolidated balance sheets and re-measured at each reporting period end until they are exercised, settled or have expired. In January 2023, all outstanding common stock warrants met equity classification and are no longer remeasured. The estimated fair value of the earnout liability was minimal as of December 31, 2023, due to the price of our common stock relative to the price that would trigger a release of the earnout shares. The earnout liability expired in September 2024 as the common stock price targets were not achieved prior to the expiration of the earnout period.
Previous wording
Research and development expenses decreased by $2.0 million, from $13.3 million for the three months ended June 30, 2023 to $11.3 million for the three months ended June 30, 2024, mainly due to a decrease in product development activities.
Current wording
Research and development expenses decreased by $0.4 million, from $14.8 million for the three months ended September 30, 2023 to $14.5 million for the three months ended September 30, 2024, mainly due to a decrease in product development activities.
Previous wording
External clinical research organizations (“CRO”), contract manufacturing organization (“CMO”) and other third-party preclinical studies and clinical trials expenses decreased by $3.8 million, from $7.7 million for the three months ended June 30, 2023 to $3.9 million for the three months ended June 30, 2024. The decrease is primarily due to a $4.4 million decrease in manufacturing expenses, partially offset by an increase of $0.4 million in CRO expenses and an increase of $0.1 million in other clinical studies and trial related expenses. Other external research and development costs increased by $0.6 million, from $0.5 million for the three months ended June 30, 2023 to $1.1 million for the three months ended June 30, 2024 due to increases in purchases of laboratory materials and supplies and other miscellaneous costs.
Current wording
External clinical research organizations (“CRO”), contract manufacturing organizations (“CMO”) and other third-party preclinical studies and clinical trials expenses decreased by $3.5 million, from $9.4 million for the three months ended September 30, 2023 to $5.9 million for the three months ended September 30, 2024. The decrease is primarily due to a $5.3 million decrease in manufacturing expenses, partially offset by an increase of $1.8 million in CRO expenses and an increase of $0.1 million in other clinical studies and trial related expenses. Expenses related to professional consulting services increased by $0.2 million, from $1.2 million for the three months ended September 30, 2023 to $1.4 million for the three months ended September 30, 2024, due to additional work performed by consultants related to our pre-clinical studies. Other external research and development costs increased by $0.6 million, from $0.6 million for the three months ended September 30, 2023 to $1.2 million for the three months ended September 30, 2024 due to increases in purchases of laboratory materials and supplies and other miscellaneous costs.
Previous wording
Personnel-related costs, including employee payroll and related expenses increased by $1.1 million, from $2.6 million for the three months ended June 30, 2023 to $3.8 million for the three months ended June 30, 2024, as a result of hiring additional employees in our research and development organization. Facilities and overheads include common facilities, human resources and information technology related expenses allocated to research and development, which increased by $0.2 million, from $1.2 million for the three months ended June 30, 2023 to $1.4 million for the three months ended June 30, 2024.
Current wording
Personnel-related costs, including employee payroll and related expenses, increased by $1.5 million, from $2.5 million for the three months ended September 30, 2023 to $4.0 million for the three months ended September 30, 2024, as a result of hiring additional employees in our research and development organization. Facilities and overheads include common facilities, human resources and information technology related expenses allocated to research and development, which increased by $0.7 million, from $1.3 million for the three months ended September 30, 2023 to $2.0 million for the three months ended September 30, 2024.
Previous wording
General and administrative expenses increased by $0.2 million, from $4.5 million for the three months ended June 30, 2023 to $4.7 million for the three months ended June 30, 2024. Employee payroll and related expenses increased by $0.8 million, from $1.9 million for the three months ended June 30, 2023 to $2.7 million for the three months ended June 30, 2024, as a result of continued hiring of executives and administrative employees. Stock-based compensation expenses were $1.0 million and $0.9 million for the three months ended June 30, 2024 and 2023, respectively. Expenses related to professional consulting services decreased by $0.3 million, from $1.9 million for the three months ended June 30, 2023 to $1.6 million for the three months ended June 30, 2024. Other expenses, decreased by $0.3 million for the three months ended June 30, 2024 as compared to the three months ended June 30, 2023, primarily related to decreased insurance expenses.
Current wording
General and administrative expenses increased by $0.9 million, from $4.5 million for the three months ended September 30, 2023 to $5.4 million for the three months ended September 30, 2024. Employee payroll and related expenses increased by $0.8 million, from $2.2 million for the three months ended September 30, 2023 to $3.0 million for the three months ended September 30, 2024, as a result of continued hiring of executives and administrative employees. Stock-based compensation expenses were $1.4 million and $1.0 million for the three months ended September 30, 2024 and 2023, respectively. Expenses related to professional consulting services increased by $0.1 million, from $1.9 million for the three months ended September 30, 2023 to $2.0 million for the three months ended September 30, 2024. Rent expenses increased by $0.1 million, from $0.2 million for the three months ended September 30, 2023 to $0.3 million for the three months ended September 30, 2024, primarily related to a new short-term lease.
Previous wording
Total other income, net decreased by $0.3 million, from $1.7 million for the three months ended June 30, 2023 to $1.4 million for the three months ended June 30, 2024.
Current wording
Total other income, net decreased by $0.5 million, from $1.8 million for the three months ended September 30, 2023 to $1.3 million for the three months ended September 30, 2024.
Previous wording
Interest income increased by $0.1 million, from $1.4 million for the three months ended June 30, 2023 to $1.5 million for the three months ended June 30, 2024, primarily due to higher cash balances invested in money market funds.
Current wording
Interest income decreased by $0.1 million, from $1.4 million for the three months ended September 30, 2023 to $1.3 million for the three months ended September 30, 2024, primarily due to lower cash balances invested in money market funds.
Previous wording
Our earnout liability relates to the sponsor earnout shares placed in escrow upon the closing of the business combination in September 2021. These shares will be released from escrow upon achieving agreed-upon common stock price targets within the specified period. Refer to Note 7 in our condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report for additional details. This liability is recorded at fair value using a Monte Carlo simulation model and is re-measured at each period end until shares are released or forfeited. The significant inputs used in the Monte Carlo model include the expected volatility of our common stock, the expected risk-free interest rate, the expected common stock closing price and the expected term when shares will be released. We recognized less than $0.1 million and $0.3 million of other expense related to the increase in the fair value of the earnout liability for the six months ended June 30, 2024 and 2023, respectively, mainly due to the increase in our common stock price during the respective periods.
Current wording
Our earnout liability related to the sponsor earnout shares placed in escrow upon the closing of the business combination in September 2021. These shares would have been released from escrow upon achieving agreed-upon common stock price targets within the specified period. The common stock price targets were not achieved prior to the expiration of the earnout period in September 2024. Refer to Note 7 in our condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report for additional details. The earnout liability was recorded at fair value using a Monte Carlo simulation model and re-measured at each period end until it expired. The significant inputs used in the Monte Carlo model included the expected volatility of our common stock, the expected risk-free interest rate, the expected common stock closing price and the expected term when shares would be released. We recognized $0.3 million of other income related to changes in the fair value of the earnout liability for the three months ended September 30, 2023. The earnout liability was valued at zero at the expiration date and less than $0.1 million was recognized as other income for the three months ended September 30, 2024.
Previous wording
Other expense, net is comprised of foreign currency transactions gains and losses and was less than $0.1 million and $0.1 million for the six months ended June 30, 2024 and 2023, respectively.
Current wording
Other income (expense), net is comprised of foreign currency transactions gains and losses and was $0.1 million gain and $0.1 million loss for the three months ended September 30, 2024 and 2023, respectively.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands, except percentages):
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands, except percentages):
Previous wording
Research and development expenses decreased by $1.5 million, from $23.1 million for the six months ended June 30, 2023 to $21.6 million for the six months ended June 30, 2024, mainly due to a decrease in product development activities.
Current wording
Research and development expenses decreased by $2.0 million, from $38.0 million for the nine months ended September 30, 2023 to $36.0 million for the nine months ended September 30, 2024, mainly due to a decrease in product development activities.
Previous wording
External CRO, CMO and other third-party preclinical studies and clinical trials expenses decreased by $4.5 million, from $12.4 million for the six months ended June 30, 2023 to $7.9 million for the six months ended June 30, 2024. The decrease is primarily due to a $6.7 million decrease in manufacturing expenses and a $0.4 million decrease in expenses related to pre-clinical studies, partially offset by an increase of $2.5 million in CRO expenses and an increase of $0.1 million in other clinical studies and trial related expenses. Expenses related to professional consulting services increased by $0.2 million, from $2.2 million for the six months ended June 30, 2023 to $2.5 million for the six months ended June 30, 2024, due to additional work performed by consultants related to our pre-clinical studies. Other external research and development costs increased by $0.5 million, from $1.2 million for the six months ended June 30, 2023 to $1.7 million for the six months ended June 30, 2024 due to increases in purchases of laboratory materials and supplies and other miscellaneous costs.
Current wording
External CRO, CMO and other third-party preclinical studies and clinical trials expenses decreased by $8.0 million, from $21.8 million for the nine months ended September 30, 2023 to $13.8 million for the nine months ended September 30, 2024. The decrease is primarily due to a $12.0 million decrease in manufacturing expenses and a $0.4 million decrease in expenses related to pre-clinical studies, partially offset by an increase of $4.3 million in CRO expenses and an increase of $0.1 million in other clinical studies and trial related expenses. Expenses related to professional consulting services increased by $0.4 million, from $3.4 million for the nine months ended September 30, 2023 to $3.9 million for the nine months ended September 30, 2024, due to additional work performed by consultants related to our pre-clinical studies. Other external research and development costs increased by $1.1 million, from $1.8 million for the nine months ended September 30, 2023 to $2.9 million for the nine months ended September 30, 2024 due to increases in purchases of laboratory materials and supplies and other miscellaneous costs.
Previous wording
Our external costs by program for the six months ended June 30, 2024 and 2023 were as follows (in thousands):
Current wording
Our external costs by program for the nine months ended September 30, 2024 and 2023 were as follows (in thousands):
Previous wording
Personnel-related costs, including employee payroll and related expenses increased by $1.9 million, from $5.0 million for the six months ended June 30, 2023 to $6.8 million for the six months ended June 30, 2024, as a result of hiring additional employees in our research and development organization. Stock-based compensation expenses decreased by $0.2 million, from $1.0 million for the six months ended June 30, 2023 to $0.8 million for the six months ended June 30, 2024. Facilities and overheads include common facilities, human resources and information technology related expenses allocated to research and development, which increased by $0.3 million, from $2.3 million for the six months ended June 30, 2023 to $2.6 million for the six months ended June 30, 2024.
Current wording
Personnel-related costs, including employee payroll and related expenses increased by $3.4 million, from $7.4 million for the nine months ended September 30, 2023 to $10.8 million for the nine months ended September 30, 2024, as a result of hiring additional employees in our research and development organization. Facilities and overheads include common facilities, human resources and information technology related expenses allocated to research and development, which increased by $1.1 million, from $3.5 million for the nine months ended September 30, 2023 to $4.6 million for the nine months ended September 30, 2024.
Previous wording
General and administrative expenses increased by $0.8 million, from $8.7 million for the six months ended June 30, 2023 to $9.5 million for the six months ended June 30, 2024. Employee payroll and related expenses increased by $1.6 million, from $3.6 million for the six months ended June 30, 2023 to $5.2 million for the six months ended June 30, 2024, as a result of continued hiring of executives and administrative employees. Stock-based compensation expenses were $1.8 million and $1.7 million for the six months ended June 30, 2024 and 2023, respectively. Expenses related to professional consulting services decreased by $0.1 million, from $3.4 million for the six months ended June 30, 2023 to $3.3 million for the six months ended June 30, 2024. Other expenses, including insurance, office supplies, subscriptions and other miscellaneous expenses, decreased by $0.8 million for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023, primarily related to decreased insurance expenses, investor and public relations related expenses and expensed software.
Current wording
General and administrative expenses increased by $1.7 million, from $13.2 million for the nine months ended September 30, 2023 to $14.9 million for the nine months ended September 30, 2024. Employee payroll and related expenses increased by $2.4 million, from $5.8 million for the nine months ended September 30, 2023 to $8.2 million for the nine months ended September 30, 2024, as a result of continued hiring of executives and administrative employees. Stock-based compensation expenses were $3.2 million and $2.7 million for the nine months ended September 30, 2024 and 2023, respectively. Expenses related to professional consulting services were $5.3 million for each of the nine months ended September 30, 2024 and 2023. Rent expenses were $0.6 million for each of the nine months ended September 30, 2024 and 2023. Other expenses, including insurance, office supplies, subscriptions and other miscellaneous expenses, decreased by $0.8 million for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, primarily related to decreased insurance expenses, investor and public relations related expenses and expensed software.
Previous wording
Total other income, net increased by $1.4 million, from $1.4 million for the six months ended June 30, 2023 to $2.8 million for the six months ended June 30, 2024.
Current wording
Total other income, net increased by $0.7 million, from $3.3 million for the nine months ended September 30, 2023 to $4.0 million for the nine months ended September 30, 2024.
Previous wording
Interest income increased by $0.3 million, from $2.5 million for the six months ended June 30, 2023 to $2.8 million for the six months ended June 30, 2024, primarily due to higher cash balances invested in money market funds.
Current wording
Interest income increased by $0.1 million, from $4.0 million for the nine months ended September 30, 2023 to $4.1 million for the nine months ended September 30, 2024, primarily due to higher cash balances invested in money market funds.
Previous wording
We recognized zero and $0.6 million of other expenses related to the change in the fair value of the common stock warrants for the six months ended June 30, 2024 and 2023, respectively. These warrants are publicly traded, were classified as liabilities and were remeasured at fair value, which was the closing market price of a warrant, at the end of each reporting period until January 2023. In January 2023, an investor converted all its outstanding shares of non-voting common stock into shares of voting common stock, and we no longer have any outstanding shares of non-voting common stock. As such, the outstanding warrants met equity classification criteria, were reclassified to equity and are no longer remeasured at fair value at the end of each reporting period.
Current wording
We recognized $0.6 million of other expenses related to the change in the fair value of the common stock warrants for the nine months ended September 30, 2023. These warrants are publicly traded, were classified as liabilities and were remeasured at fair value, which was the closing market price of a warrant, at the end of each reporting period until January 2023. In January 2023, an investor converted all its outstanding shares of non-voting common stock into shares of voting common stock, and we no longer have any outstanding shares of non-voting common stock. As such, the outstanding warrants met equity classification criteria, were reclassified to equity and are no longer remeasured at fair value at the end of each reporting period.
Previous wording
Other expense, net is comprised of foreign currency transactions gains and losses and was less than $0.1 million and $0.2 million for the six months ended June 30, 2024 and 2023, respectively.
Current wording
Other expense, net is comprised of foreign currency transactions gains and losses and was $0.1 million loss for each of the nine months ended September 30, 2024 and 2023.
Previous wording
As of June 30, 2024, we had $106.8 million of cash and cash equivalents.
Current wording
As of September 30, 2024, we had $92.5 million of cash and cash equivalents.
Previous wording
We have incurred significant losses and negative cash flows from operations since our inception. As of June 30, 2024, we had an accumulated deficit of $197.9 million. Based on our current operating plan, we have concluded that our existing cash and cash equivalents will be sufficient to fund our current operating plan for at least the next twelve months from the date of filing of this Quarterly Report. We have based these estimates on our current assumptions, which may require future adjustments based on our ongoing business decisions.
Current wording
We have incurred significant losses and negative cash flows from operations since our inception. As of September 30, 2024, we had an accumulated deficit of $216.5 million. Given our recurring losses from operations and negative cash flows, and based on our current operating plan, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year from the date of filing of this Quarterly Report. We expect to finance our future cash needs through equity or debt financings, collaborations or a combination of these approaches. The sale of equity or convertible debt securities may result in dilution to our stockholders, and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. Debt financings may subject us to covenant limitations or restrictions on our ability to take specific actions, such as incurring additional debt or making capital expenditures. Our ability to raise additional funds may be adversely impacted by negative global economic conditions and any disruptions to and volatility in the credit and financial markets in the United States and worldwide or other factors. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable or acceptable to us. If we are unable to obtain adequate financing when needed or on terms favorable or acceptable to us, we may be forced to delay, reduce the scope of or eliminate one or more of our research and development programs.
Previous wording
In August 2020 and January 2022, we leased approximately 13,400 square feet of space for our headquarters in Redwood City, California. The lease expires in August 2026. We have an option to extend the term for an additional five years to August 2031. In addition to base rent, we pay our share of operating expenses and taxes. As of June 30, 2024, our rent commitments under the lease agreement were $1.2 million within the next 12 months from June 30, 2024, and $1.3 million for the remainder of the lease term.
Current wording
In August 2020 and January 2022, we leased approximately 13,400 square feet of space for our headquarters in Redwood City, California. The lease expires in August 2026. We have an option to extend the term for an additional five years to August 2031. In addition to base rent, we pay our share of operating expenses and taxes. As of September 30, 2024, our rent commitments under the lease agreement were $1.2 million within the next 12 months from September 30, 2024, and $1.0 million for the remainder of the lease term.
Previous wording
Net cash used in operating activities was $27.4 million and $23.6 million for the six months ended June 30, 2024 and 2023, respectively.
Current wording
Net cash used in operating activities was $41.5 million and $35.6 million for the nine months ended September 30, 2024 and 2023, respectively.
Previous wording
Cash used in operating activities in the six months ended June 30, 2024 was primarily due to our net loss for the period of $28.3 million, adjusted by non-cash net loss of $3.5 million and a net change of $2.6 million in our net operating assets and liabilities. The non-cash amounts consisted of $2.7 million related to stock-based compensation expense, $0.6 million related to depreciation and amortization expense, and $0.2 million non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to a decrease of $1.3 million in accounts payable, a decrease of $1.2 million in accrued expenses and other current liabilities, a decrease of $0.5 million in operating lease liability, offset by a decrease of $0.2 million in prepaid expenses and other current assets and a decrease of $0.2 million in other non-current assets.
Current wording
Cash used in operating activities in the nine months ended September 30, 2024 was primarily due to our net loss for the period of $46.9 million, adjusted by non-cash net loss of $6.1 million and a net change of $0.7 million in our net operating assets and liabilities. The non-cash amounts consisted of $4.6 million related to stock-based compensation expense, $1.1 million related to depreciation and amortization expense and $0.4 million of non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to a decrease of $1.1 million in accounts payable, a decrease of $0.7 million in operating lease liability and an increase of $0.3 million in prepaid expenses and other current assets, offset by an increase of $1.1 million in accrued expenses and other current liabilities and a decrease of $0.3 million in other non-current assets.
Previous wording
Cash used in operating activities in the six months ended June 30, 2023 was primarily due to our net loss for the period of $30.3 million, adjusted by non-cash net loss of $4.3 million and a net change of $2.4 million in our net operating assets and liabilities. The non-cash amounts consisted of $2.7 million related to stock-based compensation expense, $0.9 million net loss related to the changes in fair value of common stock warrant liability and the earnout liability, $0.5 million related to depreciation and amortization expense and $0.2 million non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to an increase of $2.0 million in accrued expenses and other current liabilities, a decrease of $0.7 million in other receivables and a decrease of $0.3 million in other non-current assets, partially offset by a decrease of $0.4 million in operating lease liability and a decrease of $0.2 million in accounts payable.
Current wording
Cash used in operating activities in the nine months ended September 30, 2023 was primarily due to our net loss for the period of $47.9 million, adjusted by non-cash net loss of $5.8 million and a net change of $6.5 million in our net operating assets and liabilities. The non-cash amounts consisted of $4.1 million related to stock-based compensation expense, $0.6 million net loss related to the changes in fair value of common stock warrant liability and the earnout liability, $0.8 million related to depreciation and amortization expense and $0.3 million non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to an increase of $3.2 million in accrued expenses and other current liabilities, an increase of $1.5 million in accounts payable, a decrease of $0.7 million in other receivables, a decrease of $1.5 million in prepaid expenses and other current assets and a decrease of $0.3 million in other non-current assets, partially offset by a decrease of $0.6 million in operating lease liability and a decrease of less than $0.1 million in other non-current liabilities.
Previous wording
Cash used in investing activities was $0.2 million and less than $0.1 million for the six months ended June 30, 2024 and 2023, respectively, which primarily consisted of leasehold improvements, purchases of the computer and lab equipment.
Current wording
Cash used in investing activities was $0.5 million and less than $0.1 million for the nine months ended September 30, 2024 and 2023, respectively, which primarily consisted of leasehold improvements, purchases of the computer and lab equipment.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2024 was $47.5 million, which consisted primarily of net proceeds from the issuance and sale of shares of common stock in an underwritten public offering of $47.2 million and cash received from the exercise of stock options of $0.3 million.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2024 was $47.5 million, which consisted primarily of net proceeds from the issuance and sale of shares of common stock in an underwritten public offering of $47.2 million, cash received from the exercise of stock options of $0.3 million and cash received from the issuance of common stock in connection with purchases under our employee stock purchase plan of less than $0.1 million.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2023 was $101.2 million, which consisted primarily of net proceeds from the issuance and sale of shares of common stock in an underwritten public offering and the ATM Offering of $101.5 million, cash received from the exercise of stock options of $0.4 million and cash received from the issuance of common stock upon Employee Stock Purchase Plan purchase of less than $0.1 million, partially offset by taxes withheld and paid related to net settlement of equity awards of $0.7 million.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2023 was $101.2 million, which consisted primarily of net proceeds from the issuance and sale of shares of common stock in an underwritten public offering and the ATM Offering of $101.5 million, cash received from the exercise of stock options of $0.4 million and cash received from the issuance of common stock in connection with purchases under our employee stock purchase plan of less than $0.1 million, partially offset by taxes withheld and paid related to net settlement of equity awards of $0.7 million.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Our earnout liability related to the sponsor earnout shares placed in escrow upon the closing of the business combination in September 2021. These shares would have been released from escrow upon achieving agreed-upon common stock price targets within the specified period. The common stock price targets were not achieved and the earnout liability expired in September 2024. We recognized zero and less than $0.1 million of other expense related to the changes in the fair value of the earnout liability for the nine months ended September 30, 2024 and 2023, respectively.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Our earnout liability relates to the sponsor earnout shares placed in escrow upon the closing of the business combination in September 2021. These shares will be released from escrow upon achieving agreed-upon common stock price targets within the specified period. Refer to Note 7 in our condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report for additional details. This liability is recorded at fair value using a Monte Carlo simulation model and is re-measured at each period end until shares are released or forfeited. The significant inputs used in the Monte Carlo model include the expected volatility of our common stock, the expected risk-free interest rate, the expected common stock closing price and the expected term when shares will be released. We recognized zero and $0.4 million of other income related to changes in the fair value of the earnout liability for the six months ended June 30, 2024 and 2023, respectively, mainly due to changes in our common stock price during the respective periods.