Vor Biopharma Inc.
For the period ended Mar 31, 2025. Filed May 14, 2025.
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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.
Mar 31, 2025 · Filed May 14, 2025
VOR$19.88+6.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0000950170-24-123245
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0000950170-25-071349
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 118 previous paragraphs and 74 current paragraphs.
43 unchanged; 22 reworded; 9 added; 46 removed; 7 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 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 (9)
Current report
On May 8, 2025, we announced that we are winding down our clinical and manufacturing operations, including our ongoing clinical trials, and conducting a process to explore strategic alternatives to maximize shareholder value, including, among other alternatives, a potential sale or licensing of our assets, an in-license arrangement, sale of the company, business combination, merger or other strategic action. In conjunction with this strategic process, we also announced a reduction of our workforce by 147 full-time employees, or approximately 95% of our then-current employee base. The reduction of workforce is expected to result in approximately $10.9 million in severance costs and such costs are primarily expected to be incurred in the second quarter of 2025. We estimate we will incur additional costs related to our wind down activities, including but not limited to impairment charges, losses on disposals of assets, contract termination costs and other incremental expenses as a result of the strategic process. The amount of such charges and costs could be material to our results of operations and financial condition. The exact amounts and timing of recognition of such charges and costs is not yet known.
Current report
Research and development activities have been central to our business model, prior to our decision to wind down clinical and manufacturing operations in May 2025. We generally expect that our research and development expenses will decrease significantly as we wind down these operations. We may also incur other charges or cash expenditures due to events that may occur as a result of, or associated with, our wind down of clinical and manufacturing operations and review of strategic alternatives. The exact amounts of the charges and costs that we expect to incur, and the timing thereof, are currently unknown and such costs and charges could be material to our results of operation and financial condition.
Current report
We generally expect that our general and administrative expenses will decrease significantly as we wind down our clinical and manufacturing operations, including through the implementation of our workforce reduction in May 2025. However, we may also incur other charges or cash expenditures due to events that may occur as a result of, or associated with, our wind down of clinical and manufacturing operations and review of strategic alternatives. The exact amounts of the charges and costs that we expect to incur, and the timing thereof, are currently unknown and such costs and charges could be material to our results of operation and financial condition.
Current report
General and administrative expenses were $6.6 million for the three months ended March 31, 2025, compared to $8.0 million for the three months ended March 31, 2024. The decrease of $1.4 million was primarily due to a decrease in stock-based compensation expense and personnel costs.
Current report
However, as of the date of filing our Shelf Registration Statement, our public float was less than $75 million. As a result, we are subject to the limitations of General Instruction I.B.6 to Form S-3 until such time as our public float exceeds $75 million, which means we only have the capacity to sell shares up to one-third of our public float under shelf registration statements in any twelve-month period. We will remain constrained by the limitations of General Instruction I.B.6 to Form S-3 until such time as our public float exceeds $75 million, at which time the number of securities we may sell under a Form S-3 registration statement will no longer be constrained by the limitations of General Instruction I.B.6 to Form S-3.
Current report
Based on our current business plan and current capital resources, management has concluded that there is substantial doubt regarding our ability to continue as a going concern for a period of 12 months from the date of issuance of the accompanying condensed consolidated financial statements. The accompanying financial statements have been prepared on a going concern basis and do not include any adjustments to the carrying amounts and classification of assets and liabilities that may be necessary if we were unable to continue as a going concern.
Current report
We expect our expenses to decrease substantially in connection with the wind down of our clinical and manufacturing operations. However, we may incur substantial additional expenses and other charges as we conduct our strategic alternatives review and evaluate and seek to consummate strategic transactions to maximize shareholder value.
Current report
If, for any reason, we utilize our capital resources more quickly than anticipated or are unable to obtain additional funding on a timely basis and/or complete a strategic transaction, we may be required to further revise our business plan and strategy or cease operations. This may limit the strategic options available to us. As a result, our business, financial condition, and results of operations could be materially affected.
Current report
As discussed within Note 13, Subsequent Events, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, on May 5, 2025, the Company’s board of directors approved the wind down of our clinical and manufacturing operations. As a result, our existing contractual obligations and commitments may be renegotiated, amended or altered as we wind down operations and explore strategic alternatives to maximize shareholder value. The estimated impact of such activities was described within our Current Report on Form 8-K filed on May 8, 2025.
Removed paragraphs (46)
Previous report
Leveraging our expertise in HSC biology and genome engineering, we genetically modify HSCs to remove surface targets and then provide these cells as hematopoietic cell transplants (“HCTs”) to patients. Once these cells engraft into bone marrow, the patient’s healthy cells are shielded because they no longer express the surface target, leaving only the cancerous cells exposed. We believe this will unlock the potential of targeted therapies to selectively destroy cancerous cells while shielding healthy cells. As a result, our shielded transplants are designed to limit the on-target toxicities associated with these targeted therapies, thereby enhancing their utility, and broadening their applicability. We intend to pair our shielded transplants with targeted therapeutics such as antibody drug conjugates (“ADCs”) or VCAR33 ALLO, a chimeric antigen receptor (“CAR”)-T therapy designed to target CD33, to bring potentially transformative outcomes to patients and establish a new standard of care Treatment System in AML.
Previous report
We are developing trem-cel, a shielded transplant, which we believe has the potential to transform the treatment for AML and other blood cancers. Trem-cel is created by genetically modifying healthy donor HSCs in order to remove the CD33 surface target. We intend to develop trem-cel as a HCT product candidate to replace the standard of care in transplant settings. We are actively enrolling and treating patients in VBP101, our first-in-human Phase 1/2a trial of trem-cel in combination with Mylotarg. We released clinical data on 18 patients treated in this trial in September 2024. The data demonstrated:
Previous report
Reliable engraftment, robust platelet recovery, and high CD33 editing efficiency with full myeloid chimerism at Day 28;
Previous report
Shielding of the blood system, with maintained neutrophil and platelet counts across multiple Mylotarg doses of 0.5, 1, and 2 mg/m 2;
Previous report
Broadened therapeutic index for Mylotarg with drug exposure represented by AUC which is related to efficacy, consistent with labeled Mylotarg doses, and with maximal concentrations, measured by Cmax and related to veno-occlusive disease, well below known toxic range; and
Previous report
Early evidence suggesting patient benefit as measured by relapse-free survival when compared to published high-risk AML comparators, with only four patients relapsing, two of which occurred before Mylotarg treatment, and two occurring following Mylotarg, both with TP53 mutation.
Previous report
We expect to provide our next clinical data update at the American Society of Hematology (ASH) 2024 annual meeting in December 2024.
Previous report
VCAR33 ALLO is manufactured from lymphocytes collected from the patient’s original transplant donor, generating a CAR-T cell product that is exactly matched to the recipient’s engrafted blood system. By using healthy transplant donor cells as the starting material to produce VCAR33 ALLO, the CAR-T cells have a more stem-like phenotype, leading to greater potential for expansion, persistence, and anti-leukemia activity compared to a product derived from a patient’s own lymphocytes. In January 2024 we dosed the first patient with VCAR33 ALLO in VBP301 and are continuing to dose patients in this study. In September 2024, we announced encouragingin vivo CAR-T expansion data from the first three patients treated, all at the lowest dose of 1 x 106 CAR+ cells/kg.
Previous report
We believe that the combination of trem-cel followed by treatment with VCAR33 ALLO in the post-transplant setting, which we refer to as the trem-cel + VCAR33 Treatment System, may transform patient outcomes and offer the potential for cures for patients that have limited treatment options. The trem-cel + VCAR33 Treatment System would utilize the same healthy donor allogenic cell source for both trem-cel and VCAR33 ALLO. We plan to collect initial data on trem-cel from the VBP101 clinical trial and initial clinical data from the VCAR33 ALLO program prior to IND submission for the trem-cel + VCAR33 Treatment System. However, the VBP301 protocol allows for patients who have received a trem-cel transplant on the VBP101 study to enroll in VBP301 and receive VCAR33 ALLO. This may provide valuable early insights into the potential of the trem-cel + VCAR33 Treatment System to enable a more potent therapy and durable responses post-transplant.
Previous report
In September 2024, we announced a new preclinical asset, VADC45, which has a number of potential opportunities in oncology, gene therapy, and autoimmune disorders. VADC45 is an ADC designed to target the CD45 protein. CD45 is a well-validated target for a wide variety of blood cancers with clinical proof of concept. The linker-payload used in VADC45 is also clinically validated. VADC45 has the potential to treat a number of diseases, including treatment of hematologic malignancies, as a targeted conditioning agent for gene therapies such as for sickle cell disease, holistic immune reset for autoimmune disorders, and for our approach of combining this asset with epitope modification of CD45 to shield healthy stem cells. We already have robust preclinical data for VADC45 and are progressing IND-enabling studies to enable future Phase 1 studies.
Previous report
We operate an in-house clinical manufacturing facility in Cambridge, Massachusetts to support development of our shielded transplants and CAR-T therapeutic candidates for patients with blood cancers. While this facility is now operational, we continue to rely on third-party contract manufacturers for our required raw materials, manufacturing devices, active pharmaceutical ingredients and finished product for our research and clinical manufacturing. Since our inception in December 2015, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific planning, conducting discovery and research activities, acquiring or discovering product candidates, establishing and protecting our intellectual property portfolio, developing and progressing our product candidates and preparing for clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and component materials, building out our internal clinical manufacturing facility, and providing general and administrative support for these operations. We do not have any product candidates approved for sale and have not generated any revenue from product sales. Through September 30, 2024, we funded our operations primarily through the sale of equity securities and debt financings and have received aggregate net proceeds from these transactions of approximately $464.4 million.
Previous report
Research and development activities are central to our business model. We expect that our research and development expenses will increase significantly for the foreseeable future as we continue to identify and develop product candidates, particularly as more of our product candidates move into clinical development and later stages of clinical development.
Previous report
the timing and progress of preclinical and clinical development activities;
Previous report
the number and scope of preclinical and clinical programs we decide to pursue;
Previous report
our ability to maintain our current research and development programs and to establish new ones;
Previous report
establishing an appropriate safety profile with IND-enabling studies;
Previous report
the number of sites and patients included in the clinical trials;
Previous report
the countries in which the clinical trials are conducted;
Previous report
per patient trial costs;
Previous report
successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates or complications with donors;
Previous report
the number of trials required for regulatory approval;
Previous report
our ability to establish new licensing or collaboration arrangements;
Previous report
the performance of our current and future collaborators, if any;
Previous report
the impact of any business interruptions to our operations or to those of the third parties with whom we work;
Previous report
launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; and
Previous report
maintaining a continued acceptable safety profile of the product candidates following approval.
Previous report
We expect that our general and administrative expenses will increase as our business expands and we hire additional personnel to support our continued research and development activities, including our clinical programs.
Previous report
Research and development expenses were $68.0 million for the nine months ended September 30, 2024, compared to $73.4 million for the nine months ended September 30, 2023. The decrease of $5.5 million was primarily due to a decrease in license payments, preclinical expenses, and stock-based compensation expense, partially offset by an increase in personnel-related costs driven by additional headcount to support our clinical and manufacturing activities and an increase in clinical trial costs to support our trem-cel and VCAR33 ALLO programs.
Previous report
General and administrative expenses were $6.7 million for the three months ended September 30, 2024, compared to $7.7 million for the three months ended September 30, 2023. The decrease of $1.0 million was primarily due to a decrease in professional fees and stock-based compensation expense.
Previous report
General and administrative expenses were $21.9 million for the nine months ended September 30, 2024, compared to $24.5 million for the nine months ended September 30, 2023. The decrease of $2.6 million was primarily due to a decrease in professional fees and stock-based compensation expense, partially offset by an increase in personnel costs.
Previous report
As of September 30, 2024, there were no material changes in our short-term and long-term cash requirements from those disclosed in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2023 Annual Report.
Previous report
Based on our current business plan and current capital resources, management has concluded that there is substantial doubt regarding our ability to continue as a going concern. We expect that our existing cash, cash equivalents and marketable securities at September 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2025. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.
Previous report
We expect our expenses to increase substantially if, and as, we:
Previous report
continue research and preclinical and clinical development of our product candidates, including in particular the expenses associated with our clinical trials;
Previous report
incur both internal and third party manufacturing costs to support our preclinical studies and clinical trials of our product candidates and, if approved, their commercialization;
Previous report
seek to identify and develop additional product candidates;
Previous report
make investments in our platform, including the continuing costs of developing and maintaining our internal manufacturing capabilities;
Previous report
seek regulatory and marketing approvals for our product candidates;
Previous report
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates;
Previous report
adapt our regulatory compliance efforts to incorporate requirements to applicable marketed products;
Showing the first 40 of 46 passages. Open the source sections for the rest.
Reworded paragraphs (22)
Previous wording
We have incurred significant operating losses since inception, including net losses of $27.6 million and $86.2 million, respectively, for the three and nine months ended September 30, 2024, and $117.9 million for the year ended December 31, 2023. As of September 30, 2024, we had an accumulated deficit of $426.3 million.
Current wording
We have incurred significant operating losses since inception, including net losses of $32.5 million for the three months ended March 31, 2025 and $116.9 million for the year ended December 31, 2024. As of March 31, 2025, we had an accumulated deficit of $489.5 million.
Previous wording
As of September 30, 2024, we had cash, cash equivalents and marketable securities of $62.8 million. We expect that our cash, cash equivalents and marketable securities at September 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2025.
Current wording
As of March 31, 2025, we had cash, cash equivalents and marketable securities of $60.0 million. We do not expect that our cash, cash equivalents and marketable securities at March 31, 2025 will enable us to fund our operations beyond one year from the date that these condensed consolidated financial statements are issued.
Previous wording
We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for our product candidates are successful and result in marketing approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such agreements.
Current wording
We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for any product candidates that we may in-license as part of our strategic review process are successful and result in marketing approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such agreements.
Previous wording
research and development expenses incurred under agreements with CROs and other scientific development services;
Current wording
research and development expenses incurred under agreements with clinical research organizations (“CROs”) and other scientific development services;
Previous wording
costs of laboratory supplies and acquiring and developing preclinical and clinical trial materials, including expenses associated with our CMOs; and
Current wording
costs of laboratory supplies and acquiring and developing preclinical and clinical trial materials, including expenses associated with our clinical manufacturing organizations (“CMOs”); and
Previous wording
A significant portion of our research and development costs have been external costs, which we track by stage of development, preclinical or clinical. However we do not track our internal research and development expenses on a program specific basis because these costs are deployed across multiple projects and, as such, are not separately classified.
Current wording
A significant portion of our research and development costs have been external costs, which we track by program.
Previous wording
The successful development of our product candidates in the future is highly uncertain. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of our product candidates, if approved. This is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of:
Current wording
The successful development of our product candidates or any product candidates that we may in-license as part of our strategic review in the future is highly uncertain. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of our product candidates, if approved. This is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of successfully completing clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities; establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; government regulation and regulatory guidance; obtaining, maintaining, defending and enforcing intellectual property rights; launching commercial sales of product candidates, if approved; and the availability of funding sufficient for foreseeable and unforeseeable operating expenses and capital expenditure requirements. Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates.
Previous wording
Interest income consists of interest income earned on our cash, cash equivalents, restricted cash and marketable securities held in financial institutions.
Current wording
Interest income consists of interest income earned on our cash, cash equivalents, restricted cash equivalents and marketable securities held in financial institutions.
Previous wording
Comparison of Three and Nine Months Ended September 30, 2024 and 2023
Current wording
Comparison of Three Months Ended March 31, 2025 and 2024
Previous wording
Research and development expenses were $21.8 million for the three months ended September 30, 2024, compared to $27.6 million for the three months ended September 30, 2023. The decrease of $5.8 million was due to a decrease in license payments, preclinical expenses, and manufacturing starting materials, offset in part by an increase in clinical trial costs to support our trem-cel and VCAR33 ALLO programs.
Current wording
Research and development expenses were $26.7 million for the three months ended March 31, 2025, compared to $24.3 million for the three months ended March 31, 2024. The increase of $2.4 million was primarily due to an increase in clinical trial costs to support our trem-cel and VCAR33 programs as well as an increase in lab supplies and consumables.
Previous wording
Other income decreased by $1.2 million during the three months ended September 30, 2024, compared to the three months ended September 30, 2023. Other income decreased by $2.6 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. The decrease in other income in both periods was due to decreases in interest earned from our cash, cash equivalents, restricted cash and marketable securities as the Company held lower balances of cash, cash equivalents and marketable securities.
Current wording
Other income decreased by $0.7 million during the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease in other income was due to decreases in interest earned from our cash, cash equivalents, restricted cash equivalents and marketable securities as we held lower balances of cash, cash equivalents and marketable securities during the 2025 period.
Previous wording
Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. We have funded our operations primarily through the sale of equity securities and have received aggregate net proceeds from financing transactions of approximately $464.4 million as of September 30, 2024.
Current wording
Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. We have funded our operations primarily through the sale of equity securities and have received aggregate net proceeds from financing transactions of approximately $517.1 million as of March 31, 2025.
Previous wording
In order to fund our future operations, including our planned clinical trials, on March 14, 2022, we filed a universal shelf registration statement (the “Shelf Registration Statement”), to provide for aggregate offerings of up to $350.0 million of common stock, preferred stock, debt securities, warrants or any combination thereof. As of September 30, 2024, $274.4 million remains available under this Shelf Registration Statement, including $119.7 million reserved for at-the market offerings discussed below.
Current wording
On March 20, 2025, we filed a universal shelf registration statement (the “Shelf Registration Statement”), to provide for aggregate offerings of up to $350.0 million of common stock, preferred stock, debt securities, warrants or any combination thereof. As of March 31, 2025, $350.0 million remains available under this Shelf Registration Statement, including $119.7 million reserved for at-the market offerings discussed below.
Previous wording
In December 2022, we entered into a Sales Agreement with Stifel, Nicolaus & Company, Incorporated (“Stifel”) as the agent (the "Stifel ATM Facility"). Pursuant to the Stifel ATM Facility, we may offer and sell shares of common stock with an aggregate value of up to $125.0 million. We will pay Stifel a commission of up to 3.0% of the gross proceeds of any common stock sold through Stifel. We sold 249,096 shares of our common stock under the Stifel ATM Facility during the nine months ended September 30, 2024 at a weighted-average price per share of $1.64 for aggregate net proceeds of $0.4 million, after deducting commissions. As of September 30, 2024, $119.7 million remained available to be sold under the Stifel ATM Facility.
Current wording
In December 2022, we entered into a Sales Agreement with Stifel, Nicolaus & Company, Incorporated (“Stifel”) as the agent (the "Stifel ATM Facility"). Pursuant to the Stifel ATM Facility, we may offer and sell shares of common stock with an aggregate value of up to $125.0 million, subject to our filing a prospectus supplement to the base prospectus included in our Shelf Registration Statement covering the offer and sale of shares of our common stock pursuant to the Stifel ATM Facility and subject to the limitations of General Instruction I.B.6 of Form S-3. We will pay Stifel a commission of up to 3.0% of the gross proceeds of any common stock sold through Stifel. We did not sell any shares of our common stock under the Stifel ATM Facility during the three months ended March 31, 2025. As of March 31, 2025, $119.7 million remained available to be sold under the Stifel ATM Facility.
Previous wording
As of September 30, 2024, we had cash, cash equivalents and marketable securities of $62.8 million. We will need to raise additional capital to fund our planned future operations. However, we cannot guarantee that we will be able to obtain sufficient additional funding or that if we do obtain additional funding, that such funding will be obtainable on terms satisfactory to us.
Current wording
As of March 31, 2025, we had cash, cash equivalents and marketable securities of $60.0 million. Depending on the outcome of our strategic review process, we may need to raise substantial additional capital to fund our future operations. However, we cannot guarantee that we will be able to obtain sufficient additional funding or that if we do obtain additional funding, that such funding will be obtainable on terms satisfactory to us.
Previous wording
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the public or private sale of our equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. To the extent that we raise additional capital through the sale of our equity or convertible debt securities, including through the use of the Stifel ATM Facility, the ownership interest of our shareholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity financing, 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. If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. If we raise funds through strategic collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our platform technology, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our ability to raise additional funds may be adversely impacted by worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical tensions and adverse macroeconomic conditions or otherwise. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.
Current wording
If we are successful in consummating a strategic transaction that enables us to continue to develop our current or new product candidates, we will require substantial additional funding to expand our operations, hire additional personnel, initiate and successfully complete preclinical studies and clinical trials, obtain marketing approval and generate revenue from sales of our product candidates, if approved, and protect our intellectual property. We would expect to finance our operations through the public or private sale of our equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. Because of the uncertain outcome of our strategic review process and the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of our future expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.
Previous wording
Net cash used in operating activities was $76.3 million for the nine months ended September 30, 2023, reflecting a net loss of $91.6 million, offset by non-cash adjustments to operating assets and liabilities of $1.4 million and non-cash charges of $13.9 million. The non-cash charges primarily consisted of stock-based compensation expense of $11.5 million, non-cash lease expense of $3.5 million and depreciation expense of $2.6 million, offset by $3.7 million of non-cash interest earned on marketable securities.
Current wording
Net cash used in operating activities was $31.1 million for the three months ended March 31, 2025, reflecting a net loss of $32.5 million and net cash used of $2.6 million for operating assets and liabilities, which were partially offset by non-cash charges of $4.1 million. The non-cash charges primarily consisted of stock-based compensation expense of $1.9 million, non-cash lease expense of $1.3 million and depreciation expense of $0.8 million.
Previous wording
Net cash used in operating activities was $75.6 million for the nine months ended September 30, 2024, reflecting a net loss of $86.2 million and net cash used of $2.8 million for operating assets and liabilities, which were offset by non-cash charges of $13.4 million. The non-cash charges primarily consisted of stock-based compensation expense of $8.1 million, non-cash lease expense of $3.8 million and depreciation expense of $2.7 million, offset by $1.1 million of non-cash interest earned on marketable securities.
Current wording
Net cash used in operating activities was $30.5 million for the three months ended March 31, 2024, reflecting a net loss of $30.8 million and net cash used of $4.1 million for operating assets and liabilities, which were partially offset by non-cash charges of $4.5 million. The non-cash charges primarily consisted of stock-based compensation expense of $3.1 million, non-cash lease expense of $1.2 million and depreciation expense of $0.9 million, partially offset by $0.8 million of non-cash interest earned on marketable securities.
Previous wording
The $0.7 million decrease in net cash used in operating activities for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily due to a decrease in research and development expenses offset by differences in the timing of payments for costs incurred during each respective period.
Current wording
The $0.6 million increase in net cash used in operating activities for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was primarily due to an increase in research and development expenses and decrease in stock-based compensation, partially offset by differences in the timing of payments for costs incurred during each respective period.
Previous wording
Net cash provided by investing activities was $96.9 million for the nine months ended September 30, 2024, which consisted of proceeds of $107.0 million from the maturity of marketable securities, offset by purchases of $9.9 million of marketable securities and $0.2 million of property and equipment. Net cash provided by investing activities was $60.7 million for the nine months ended September 30, 2023, which consisted of proceeds of $120.0 million from the maturity of marketable securities, offset by purchases of $58.4 million of marketable securities and $1.0 million of property and equipment.
Current wording
Net cash used in investing activities was $0.2 million for the three months ended March 31, 2025, which consisted primarily of purchases of $0.2 million of property and equipment. Net cash provided by investing activities was $44.0 million for the three months ended March 31, 2024, which consisted of proceeds of $54.0 million from the maturity of marketable securities, partially offset by purchases of $9.9 million of marketable securities and $0.1 million of property and equipment.
Previous wording
Net cash provided by financing activities was $0.1 million for the nine months ended September 30, 2024, which consisted of proceeds from the issuance of common stock under the Stifel ATM Facility of $0.3 million and proceeds from exercise of stock options and issuance of shares under the ESPP of $0.1 million, offset by $0.3 million of taxes paid related to net share settlement of equity awards. Net cash provided by financing activities was $2.9 million for the nine months ended September 30, 2023, which consisted of proceeds from the issuance of common stock under the Stifel ATM Facility of $4.6 million, and proceeds from stock option exercises and purchases of common stock under the ESPP of $0.2 million, offset by the payment of $0.7 million of issuance costs related to the underwritten public offering under our Shelf Registration Statement and concurrent private placement that closed in December 2022, and $1.2 million of taxes paid related to net share settlement of equity awards.
Current wording
Net cash used in financing activities was $0.6 million for the three months ended March 31, 2025, which consisted of $0.5 million of issuance costs related to the December 2024 private placement and $0.1 million of taxes paid related to net share settlement of equity awards. Net cash provided by financing activities was $0.1 million for the three months ended March 31, 2024, which consisted of proceeds from the issuance of common stock under the Stifel ATM Facility of $0.3 million, partially offset by $0.2 million of taxes paid related to net share settlement of equity awards.
Previous wording
Contractual obligations relate to future minimum lease payments for existing non-cancellable leases primarily relating to corporate office and laboratory real estate, with terms expiring through February 2030. During the nine months ended September 30, 2024, there were no significant changes in contractual obligations and commitments from that described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Other Commitments” in our 2023 Annual Report.
Current wording
Contractual obligations relate to future minimum lease payments for existing non-cancellable leases primarily relating to corporate office and laboratory real estate, with terms expiring through February 2030. During the three months ended March 31, 2025, there were no significant changes in contractual obligations and commitments from that described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Other Commitments” in our 2024 Annual Report.
Rearranged previous paragraphs (7)
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the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;
Previous report — wording carried elsewhere
the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities;
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establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
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significant and changing government regulation and regulatory guidance;
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obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
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Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates.
Previous report — wording carried elsewhere
maintain, expand, enforce, defend and protect our intellectual property;