Tango Therapeutics, Inc.
For the period ended Mar 31, 2025. Filed May 12, 2025.
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.
Mar 31, 2025 · Filed May 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-06.
0000950170-24-121818
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0000950170-25-068549
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 124 previous paragraphs and 113 current paragraphs.
70 unchanged; 25 reworded; 17 added; 26 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 4 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 (17)
Current report
We are currently developing two MTA-cooperative PRMT5 inhibitors: TNG462 for non-CNS cancers, including pancreatic and lung cancer, and TNG456, our next-generation, brain-penetrant PRMT5 inhibitor, for CNS cancers, including GBM.
Current report
In November 2024, we reported positive early data from the ongoing Phase 1/2 clinical trial of TNG462, demonstrating durable clinical activity across multiple cancer types with a good safety and tolerability profile. We are currently enrolling patients in the ongoing TNG462 Phase 1/2 monotherapy clinical trial and plan to provide a clinical data update on TNG462 in the second half of 2025.
Current report
Based on promising preclinical data, we plan to initiate a combination trial with TNG462, including RAS(ON) multi-selective inhibitor, daraxonrasib, and RAS(ON) G12D-selective inhibitor, zoldonrasib (Revolution Medicines). This trial is expected to begin enrolling in the second quarter of 2025.
Current report
Based on preclinical data showing favorable potency and MTAP selectivity and sufficient brain penetrance, TNG456 will move into clinical development and focus on GBM. The FDA cleared the TNG456 IND in January 2025 and we plan to begin enrolling patients in a Phase 1/2 clinical trial in the second quarter of 2025.
Current report
TNG260 is a first-in-class CoREST inhibitor, which in preclinical studies reversed the immune evasion effect of STK11 loss-of-function mutations. TNG260 has a favorable safety, tolerability and pharmacokinetic profile in dose escalation, and clinical proof-of-mechanism has now been established based on pharmacodynamic data from on-treatment patient biopsies. We are enrolling patients in the dose expansion portion of the Phase 1/2 trial and we plan to provide clinical data for TNG260 in the second half of 2025.
Current report
TNG961 is a development candidate targeting HBS1L in FOCAD-deleted solid tumors. FOCAD deletion occurs in 20-40% of all MTAP-deleted cancers. FOCAD deletion is common in NSCLC, occurring in ~7% of these patients. 20-40% of cancers with MTAP deletion have a coincident FOCAD deletion on chromosome 9, and cancers with FOCAD deletion are dependent on HBS1L for mRNA processing, thus protein synthesis. By degrading HBS1L and disrupting the HBS1L/PELO complex, TNG961 causes tumor regression in FOCAD-deleted preclinical models of multiple histologies.
Current report
Research and Development Expenses
Current report
*In November 2024, we announced we stopped enrollment in the TNG908 Phase 1/2 trial due to insufficient brain exposure for GBM clinical activity and portfolio prioritization. Expenses beyond November 2024 related to previously enrolled patients and close-out clinical trial costs.
Current report
General and Administrative Expenses
Current report
Interest Income
Current report
Provision for Income Taxes
Current report
Research and Development Expenses
Current report
Research and development expense was $36.4 million for the three months ended March 31, 2025 compared to $38.1 million for the three months ended March 31, 2024. The decrease of $1.6 million was primarily driven by a $5.8 million decrease due to the discontinuation of the TNG908 and TNG348 clinical programs. This decrease was partially offset by a $3.5 million increase related to TNG961 and TNG456 and a $1.1 million increase in personnel-related costs, including share-based compensation expense and additional headcount to support our research and development activities.
Current report
General and Administrative Expenses
Current report
General and administrative expense was $11.5 million for the three months ended March 31, 2025 compared to $10.7 million for the three months ended March 31, 2024. The increase of $0.8 million was primarily due to $0.7 million in personnel-related costs, including share-based compensation expense and additional headcount.
Current report
Interest Income
Current report
Provision for Income Taxes
Removed paragraphs (26)
Previous report
We are developing multiple MTA-cooperative PRMT5 inhibitors that are designed to work selectively in cancer cells with an MTAP deletion. MTAP-deletion occurs in approximately 10% to 15% of all human tumors, including NSCLC and pancreatic cancer.
Previous report
In November 2024, we announced that, based on data from our ongoing Phase 1/2 clinical trial, we plan to move TNG462, a MTA-cooperative PRMT5 inhibitor, into the next stage of development. The investigational new drug (IND) application for TNG462 was cleared by the U.S. Food and Drug Administration (FDA) in the first quarter of 2023 and we announced the first patient in the Phase 1/2 clinical trial was dosed in July 2023. In the ongoing Phase 1/2 clinical trial, TNG462 has demonstrated durable clinical activity across multiple tumor types, including NSCLC and pancreatic cancer, and has a good tolerability and safety profile. We continue to evaluate TNG462 efficacy and tolerability at 200 mg, 250 mg and 300 mg daily, predominantly in NSCLC and pancreatic cancer. We plan to provide further clinical updates on TNG462 in 2025. Additionally, we plan to enroll patients in multiple combination clinical trials with TNG462 in the first half of 2025, including targeted combinations with (i) two RAS(ON) inhibitors, (RAS(ON) multi-selective inhibitor, RMC-6236, and RAS(ON) G12D-selective inhibitor RMC-9805, both from Revolution Medicines, Inc.), (ii) osimertinib (AstraZeneca), and (iii) pembrolizumab (Merck & Co., Inc.). Combinations of TNG462 and standard of care chemotherapy for NSCLC and pancreatic cancer also are being planned as potential paths to approval in the first line setting. We are initiating conversations with the FDA in preparation for multiple registrational studies.
Previous report
In November 2024, we announced that we are stopping enrollment of TNG908, a brain-penetrant MTA-cooperative inhibitor of PRMT5, to resource to our other programs, TNG462 and TNG456. Data from our Phase 1/2 clinical trial demonstrated that TNG908 is clinically active and well-tolerated in non-central nervous system solid tumors (including NSCLC and pancreatic cancer). No partial responses by RANO criteria were observed in the 23 evaluable GBM patients who were treated at active doses.
Previous report
We plan to enroll patients in a Phase 1/2 clinical trial for TNG456, a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor, in the first half of 2025. We plan to evaluate TNG456 as a monotherapy and in combination with the brain-penetrant CDK4/6 inhibitor, abemaciclib (Lilly), in GBM, NSCLC and selected other solid tumors. Preclinical studies suggest that TNG456 has increased selectivity and potency compared to TNG908.
Previous report
Discovered as part of our immune evasion target discovery platform, TNG260 is a first-in-class CoREST inhibitor, which reverses the immune evasion effect of STK11 loss-of-function mutations. STK11 loss-of-function mutations are present in approximately 15% of NSCLC, 15% of cervical cancers, 10% of carcinoma of unknown primary, 5% of breast cancers and 3% of pancreatic cancers. In syngeneic models with an STK11 mutation and an intact immune system, the combination of TNG260 with an anti-PD-1 antibody resulted in sustained complete tumor regressions and the induction of immune memory against re-implantation of tumors. These preclinical data demonstrate that TNG260 in combination with an anti-PD-1 antibody is active in cancers with STK11 mutation, a setting where an anti-PD-1 antibody alone is inactive. In the first quarter of 2023, the FDA cleared the TNG260 IND and we announced the first patient in the Phase 1/2 clinical trial was dosed in July 2023. The TNG260 Phase 1/2 clinical trial is ongoing, evaluating the safety, pharmacokinetics, PD and efficacy of TNG260 in combination with pembrolizumab, with a one cycle single agent run-in phase to evaluate the safety and PK of TNG260, in patients with locally advanced or metastatic solid tumors with an STK11 loss-of-function mutation. To date, the safety, tolerability and pharmacokinetics profiles are favorable. Clinical data from the ongoing trial are expected in 2025. We believe that TNG260 could be among the first oncology molecules to leverage the benefits of genetically-based patient selection (STK11-mutation) with checkpoint inhibitor therapy.
Previous report
Collaboration revenue of $11.6 million and $10.7 million for the three months ended September 30, 2024 and 2023, respectively, was derived from the Gilead collaboration. Collaboration revenue increased due to changes to estimated costs expected to be incurred under the collaboration.
Previous report
Research and development expense was $33.3 million for the three months ended September 30, 2024 compared to $27.1 million for the three months ended September 30, 2023. The increase of $6.1 million was primarily due to a $3.0 million increase relating to the advancement of TNG462 and our preclinical programs. Additionally, the increase was also due to $2.8 million in personnel-related costs, including share-based compensation expense and additional headcount to support our research and development activities.
Previous report
General and administrative expense was $11.2 million for the three months ended September 30, 2024 compared to $9.2 million for the three months ended September 30, 2023. The increase of $2.0 million was primarily due to $1.5 million in personnel-related costs, including share-based compensation expense and additional headcount.
Previous report
Comparison of the nine months ended September 30, 2024 and 2023
Previous report
Collaboration Revenue
Previous report
License Revenue
Previous report
License revenue was $12.1 million for the nine months ended September 30, 2024, compared to $5.0 million for the nine months ended September 30, 2023. The increase is primarily due to licensing a program to Gilead for $12.0 million during the second quarter of 2024 as compared to Gilead licensing a program for $5.0 million during the second quarter of 2023.
Previous report
Research and development expense was $110.0 million for the nine months ended September 30, 2024 compared to $83.9 million for the nine months ended September 30, 2023. The increase of $26.1 million was primarily due to a $14.0 million increase relating to the advancement of our clinical and preclinical programs. Additionally, the increase was also due to $10.0 million in personnel-related costs, including share-based compensation expense and additional headcount to support our research and development activities.
Previous report
General and administrative expense was $32.7 million for the nine months ended September 30, 2024 compared to $26.4 million for the nine months ended September 30, 2023. The increase of $6.3 million was primarily due to $5.5 million in personnel-related costs, including share-based compensation expense and additional headcount.
Previous report
Interest income was $6.1 million for the nine months ended September 30, 2024 compared to $4.4 million for the nine months ended September 30, 2023, with the increase attributed to an increase in interest rates in 2024 as compared to 2023.
Previous report
Other income, net was $6.1 million for the nine months ended September 30, 2024 compared to other income, net of $3.9 million for the nine months ended September 30, 2023, with the increase attributed to accretion on investments purchased at a discount.
Previous report
Comparison of the nine months ended September 30, 2024 and 2023
Previous report
Emerging Growth Company and Smaller Reporting Company Status
Previous report
We are an “emerging growth company,” under the JOBS Act. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of delayed adoption of new or revised accounting standards and, therefore, we will be subject to the same requirements to adopt new or revised accounting standards as private entities. As an emerging growth company, we may take advantage of certain exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company:
Previous report
we may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations in our periodic reports and registration statements, including this Quarterly Report on Form 10-Q;
Previous report
we may avail ourselves of the exemption from providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;
Previous report
we may provide reduced disclosure about our executive compensation arrangements; and
Previous report
we may not require nonbinding advisory votes on executive compensation or stockholder approval of any golden parachute payments.
Previous report
We will remain an emerging growth company until the earliest of (i) December 31, 2025, (ii) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, provided we have been subject to the Exchange Act for at least 12 calendar months and have filed at least one annual report pursuant to the Exchange Act or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. We may choose to take advantage of some but not all of these exemptions.
Previous report
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Previous report
On the last business day of our second quarter in 2024, the aggregate market value of our shares of common stock held by non-affiliates exceeded $700 million. As a result, as of December 31, 2024, we will be considered a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, and we will cease to be an “emerging growth company” as defined in the JOBS Act. We will no longer be exempt from the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, and our independent registered public accounting firm will evaluate and report on the effectiveness of internal control over financial reporting. The Company will also no longer be permitted to take advantage of reduced reporting requirements for smaller reporting companies.
Reworded paragraphs (25)
Previous wording
Tango Therapeutics was founded with a clear mission: discover the next generation of precision medicines to help patients with cancer through addressing the specific genetic alterations that fuel the cancer. We leverage our state-of-the-art target discovery platform to identify novel targets and develop new drugs directed at tumor suppressor gene loss in defined patient populations with high unmet medical need. Tumor suppressor gene loss remains a largely unaddressed target space specifically because these genetic events cannot be directly targeted. Our novel small molecules are designed to be selectively active in cancer cells with specific tumor suppressor gene loss, killing those cancer cells while sparing normal cells. We also are extending this target space beyond the classic, cell-autonomous effects of tumor suppressor gene loss to include the discovery of novel targets that reverse the effects of tumor suppressor gene loss that prevent the immune system from recognizing and killing cancer cells (immune evasion). We believe our approach will provide the ability to deliver the deep, sustained target inhibition necessary to optimize tumor response and clinical benefit as a result of the unique ability of synthetic lethal targeting to spare normal cells.
Current wording
Tango Therapeutics was founded with a clear mission: to discover the next wave of targeted therapies in oncology by addressing the specific genetic alterations that drive cancer. We develop new drugs directed at tumor suppressor gene loss in defined patient populations with high unmet medical need. Tumor suppressor gene loss remains a largely unaddressed target space specifically because these genetic events cannot be directly targeted. Our novel small molecules are designed to be selectively active in cancer cells with specific genetic alterations, killing those cancer cells while sparing normal cells. We also are extending this target space beyond the classic, cell-autonomous effects of tumor suppressor gene loss to include the discovery of novel targets that reverse tumor suppressor gene mediated immune evasion which prevents the immune system from recognizing and killing cancer cells. We believe our approach will provide the ability to deliver deep, durable target inhibition with favorable tolerability and safety profiles, thus potentially maximizing clinical benefit.
Previous wording
Since the Company's inception, we have focused primarily on organizing and staffing our company, business planning, raising capital, discovering product candidates, securing related intellectual property, and conducting research and development activities for our programs. To date, we have funded our operations primarily through equity financings and from the proceeds received from our collaboration agreement with Gilead. Since inception, we have raised an aggregate of $166.9 million of gross proceeds from the sale of our preferred shares, $342.1 million in gross proceeds through the closing of the Business Combination and simultaneous financing transactions, $237.1 million through our collaboration with Gilead and $123.0 million of gross proceeds through (i) $80.0 million from the private placement of common shares and pre-funded warrants to purchase common shares in August 2023 and (ii) $43.0 million from our "at-the-market" stock offering program.
Current wording
Since the Company's inception, we have focused primarily on organizing and staffing our company, business planning, raising capital, discovering product candidates, securing related intellectual property, and conducting research and development activities for our programs. To date, we have funded our operations primarily through equity financings and from the proceeds received from our collaboration agreement with Gilead. Since inception, we have raised an aggregate of $166.9 million of gross proceeds from the sale of our preferred shares, $342.1 million in gross proceeds through the closing of the Business Combination and simultaneous financing transactions, $237.1 million through our collaboration with Gilead and $123.0 million of gross proceeds through (i) $80.0 million from the private placement of common shares and pre-funded warrants to purchase common shares in August 2023 and (ii) $43.0 million from our "at-the-market" stock offering program in January 2024.
Previous wording
We expect that our existing cash, cash equivalents and marketable securities on hand as of September 30, 2024 of $293.3 million will enable us to fund our operating expenses and capital expenditure requirements at least into the third quarter of 2026. Since inception, we have incurred significant operating losses. For the nine months ended September 30, 2024 and 2023, our net losses were $92.6 million and $71.0 million, respectively. We had an accumulated deficit of $463.9 million as of September 30, 2024. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, and maintain and expand our intellectual property portfolio. We also expect to hire additional personnel, pay for accounting, audit, legal, regulatory and consulting services, and pay costs associated with maintaining compliance with Nasdaq listing rules and the requirements of the U.S. Securities and Exchange Commission, director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies, our clinical trials, and our expenditures on other research and development activities.
Current wording
We expect that our existing cash, cash equivalents and marketable securities on hand as of March 31, 2025 of $216.7 million will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027. Since inception, we have incurred significant operating losses. For the three months ended March 31, 2025 and 2024, our net losses were $39.9 million and $37.9 million, respectively. We had an accumulated deficit of $541.4 million as of March 31, 2025. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, and maintain and expand our intellectual property portfolio. We also expect to hire additional personnel, pay for accounting, audit, legal, regulatory and consulting services, and pay costs associated with maintaining compliance with Nasdaq listing rules and the requirements of the U.S. Securities and Exchange Commission, director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies, our clinical trials, and our expenditures on other research and development activities.
Previous wording
In September 2022, we entered into a sales agreement (the Sales Agreement) with Jefferies LLC (Jefferies), which permits us to sell from time to time, at our option, up to an aggregate of $100.0 million of shares of common stock through Jefferies, as sales agent. Sales of the common stock, if any, will be made by methods deemed to be "at-the-market" stock offerings. The Sales Agreement will terminate upon the earliest of: (a) the sale of $100.0 million of shares of our common stock or (b) the termination of the Sales Agreement by us or Jefferies.
Current wording
In September 2022, we entered into a sales agreement (the Sales Agreement) with Jefferies LLC (Jefferies), which permits us to sell from time to time, at our option, up to an aggregate of $100.0 million of shares of our common stock through Jefferies, as sales agent. Sales of the common stock, if any, will be made by methods deemed to be "at-the-market" stock offerings. The Sales Agreement will terminate upon the earliest of: (a) the sale of $100.0 million of shares of our common stock or (b) the termination of the Sales Agreement by us or Jefferies. To date, the Company has sold 4,001,200 shares of common stock under this program for gross proceeds of $43.0 million.
Previous wording
As of September 30, 2024, $132.5 million has been recognized as collaboration revenue related to the upfront and research option-extension payments from the Gilead Agreement and the 2018 Gilead Agreement (the Gilead Agreements).
Current wording
As of March 31, 2025, $142.0 million has been recognized as collaboration revenue related to the upfront and research option-extension payments from the Gilead Agreements.
Previous wording
During the three months ended September 30, 2024 and 2023, we recognized $11.6 million and $10.7 million, respectively, and during the nine months ended September 30, 2024 and 2023, we recognized $25.9 million and $26.1 million, respectively, of collaboration revenue associated with the Gilead Agreements based on performance completed during each period.
Current wording
During the three months ended March 31, 2025 and 2024, we recognized $5.4 million and $6.5 million, respectively, of collaboration revenue associated with the Gilead agreements based on performance completed during each period.
Previous wording
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent, utilities and insurance.
Current wording
facilities, information technology systems, depreciation and other allocated expenses, which include direct and allocated expenses for rent, utilities and insurance.
Previous wording
We do not allocate employee costs, costs associated with our target discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We characterize research and development costs incurred prior to the identification of a product candidate as discovery costs. We use internal resources primarily to conduct our research and discovery activities as well as for managing our preclinical, development and manufacturing activities.
Current wording
We do not allocate employee costs or costs associated with our target discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We characterize research and development costs incurred prior to the identification of a product candidate as discovery costs. We use internal resources primarily to conduct our research and discovery activities as well as for managing our preclinical, development and manufacturing activities.
Previous wording
In May 2024, we announced the discontinuation of TNG348, a USP1 inhibitor, due to toxicity observed in the dose escalation portion of our phase 1/2 clinical trial. The phase 1/2 clinical trial was evaluating TNG348 in BRCA1/2-mutant and other HRD+ cancers for safety, pharmacokinetics, pharmacodynamics and efficacy.
Current wording
**In May 2024, we announced the discontinuation of TNG348, a USP1 inhibitor, due to toxicity observed in the dose escalation portion of our Phase 1/2 clinical trial. Expenses beyond May 2024 related to close-out clinical trial costs.
Previous wording
The successful development of our product candidates is highly uncertain. We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of our product candidates and manufacturing processes and conduct discovery and research activities for our preclinical programs. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates or the timing of regulatory filings in connection with clinical trials or regulatory approval, due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. Our clinical development costs have, and are expected to increase significantly with the commencement and continuation of our clinical trials. We anticipate that our expenses will increase substantially, particularly due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of:
Current wording
The successful development of our product candidates is highly uncertain. We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of our product candidates and manufacturing processes and conduct discovery and research activities for our preclinical programs. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates or the timing of regulatory filings in connection with clinical trials or regulatory approval, due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. Our clinical development costs have, and are expected to continue to increase significantly with the commencement and continuation of our current and planned clinical trials, including our planned combination clinical trials. We anticipate that our expenses will increase substantially, particularly due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of:
Previous wording
successful enrollment in and completion of clinical trials;
Current wording
successful enrollment in and completion of our clinical trials, including our combination clinical trials;
Previous wording
receipt of marketing approvals from applicable regulatory authorities;
Current wording
the receipt of marketing approvals from applicable regulatory authorities;
Previous wording
Our provision for income tax consists of an estimate for U.S. federal and state income taxes based on enacted rates, as adjusted for allowable credits, deductions, uncertain tax positions, changes in deferred tax assets and liabilities and changes in tax law. We recorded an insignificant provision for income taxes for each of the three and nine months ended September 30, 2024 and 2023.
Current wording
Our provision for income tax consists of an estimate for U.S. federal and state income taxes based on enacted rates, as adjusted for allowable credits, deductions, uncertain tax positions, changes in deferred tax assets and liabilities and changes in tax law. We recorded an insignificant provision for income taxes for each of the three months ended March 31, 2025 and 2024.
Previous wording
Collaboration revenue of $25.9 million and $26.1 million for the nine months ended September 30, 2024 and 2023, respectively, was derived from the Gilead collaboration. Research costs incurred under the collaboration were lower during the nine months ended September 30, 2024 which resulted in lower collaboration revenue amounts recognized.
Current wording
Collaboration revenue of $5.4 million and $6.5 million for the three months ended March 31, 2025 and 2024, respectively, was derived from the Gilead collaboration. Research costs incurred under the collaboration were lower during the three months ended March 31, 2025, which resulted in lower collaboration revenue amounts recognized.
Previous wording
Interest income was $1.8 million for the three months ended September 30, 2024 compared to $1.9 million for the three months ended September 30, 2023, with the decrease attributed to a decrease in marketable securities balance in 2024 as compared to 2023.
Current wording
Interest income was $1.6 million for the three months ended March 31, 2025 compared to $2.2 million for the three months ended March 31, 2024, with the decrease attributed to a decrease in our marketable securities balance in 2025 as compared to 2024.
Previous wording
Other income, net was $2.0 million for the three months ended September 30, 2024 compared to other income, net of $1.5 million for the three months ended September 30, 2023, with the increase attributed to accretion on investments purchased at a discount.
Current wording
Other income, net was $1.1 million for the three months ended March 31, 2025 compared to other income, net of $2.2 million for the three months ended March 31, 2024, with the decrease attributed to lower accretion from investments purchased at a discount.
Previous wording
Provision for income taxes was $0.1 million for the three months ended September 30, 2024 and $0.1 million for the three months ended September 30, 2023. The income tax provision amount for the period ended September 30, 2024 is primarily attributable to state taxes on interest income earned on marketable securities.
Current wording
Provision for income taxes was less than $0.1 million for the three months ended March 31, 2025 and less than $0.1 million for the three months ended March 31, 2024. The income tax provision amount for both periods is primarily attributable to state taxes on interest income earned on marketable securities.
Previous wording
Since our inception, we have generated recurring net losses. 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. To date, we have funded our operations primarily through equity financings and from the proceeds received from our collaboration agreement with Gilead. Since inception, we have raised an aggregate of $166.9 million of gross proceeds from the sale of our preferred shares, $342.1 million in gross proceeds from the Business Combination and simultaneous financing transactions, $123.0 million of gross proceeds through (i) the $80.0 million private placement of common shares and pre-funded warrants to purchase common shares in August 2023 and (ii) the $43.0 million from our "at-the-market" stock offering program, and another $237.1 million through our collaboration with Gilead. As of September 30, 2024, we had cash and cash equivalents and marketable securities of $293.3 million.
Current wording
Since our inception, we have generated recurring net losses. We have not yet commercialized any products and we do not expect to generate revenue from sales of any products for several years, if at all. To date, we have funded our operations primarily through equity financings and from the proceeds received from our collaboration agreement with Gilead. Since inception, we have raised an aggregate of $166.9 million of gross proceeds from the sale of our preferred shares, $342.1 million in gross proceeds from the Business Combination and simultaneous financing transactions, $123.0 million of gross proceeds through (i) the $80.0 million private placement of common shares and pre-funded warrants to purchase common shares in August 2023, and (ii) the $43.0 million from our "at-the-market" stock offering program in January 2024, and another $237.1 million through our collaboration with Gilead. As of March 31, 2025, we had cash and cash equivalents and marketable securities of $216.7 million.
Previous wording
We expect that our existing cash, cash equivalents and marketable securities on hand as of September 30, 2024 of $293.3 million will enable us to fund our operating expenses and capital expenditure requirements at least into the third quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.
Current wording
We expect that our existing cash, cash equivalents and marketable securities on hand as of March 31, 2025 of $216.7 million will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027. Extension of cash runway was primarily due to reduction of preclinical pipeline, target discovery efforts and the associated research headcount. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.
Previous wording
The following table summarizes our cash flows for each of the nine month periods presented:
Current wording
The following table summarizes our cash flows for each of the three month periods presented:
Previous wording
Net cash used in operating activities was $94.9 million for the nine months ended September 30, 2024 compared to net cash used in operating activities of $90.5 million for the nine months ended September 30, 2023. The increase in net cash used in operating activities for the nine months ended September 30, 2024 was primarily due to an increase to the net loss as a result of higher operating expenses related to the advancement of our programs and personnel-related costs. The increase was partially offset by changes in operating assets and liabilities and higher non-cash expenses, including stock compensation.
Current wording
Net cash used in operating activities was $41.7 million for the three months ended March 31, 2025 compared to net cash used in operating activities of $37.9 million for the three months ended March 31, 2024. The increase in net cash used in operating activities for the three months ended March 31, 2025 was primarily due to an increase in net loss and an increase to accrued expenses related to the advancement of our programs and personnel-related costs.
Previous wording
Net cash provided by investing activities was $34.1 million for the nine months ended September 30, 2024 compared to net cash provided by investing activities of $7.6 million for the nine months ended September 30, 2023. The change was primarily due to a decrease in purchases of marketable securities as compared to the nine months ended September 30, 2023, which was partially offset by a decrease in sales and maturities of marketable securities as compared to the nine months ended September 30, 2023.
Current wording
Net cash provided by investing activities was $30.6 million for the three months ended March 31, 2025 compared to net cash used in investing activities of $11.2 million for the three months ended March 31, 2024. The change was primarily due to a decrease in purchases of marketable securities as compared to the three months ended March 31, 2024, which was partially offset by a decrease in sales and maturities of marketable securities as compared to the three months ended March 31, 2024.
Previous wording
Net cash provided by financing activities was $46.7 million for the nine months ended September 30, 2024 compared to net cash provided by financing activities of $80.9 million for the nine months ended September 30, 2023. The cash provided by financing activities for the nine months ended September 30, 2024 consisted of the $41.7 million in net proceeds received from our "at-the-market" stock offering program in January 2024, as well as the cash provided from the exercises of stock options and ESPP purchases. The cash provided by financing activities for the nine months ended September 30, 2023 consisted of the net proceeds received from our private placement financing transaction in August 2023 of $79.8 million, as well as the cash provided from the exercises of stock options and ESPP purchases.
Current wording
Net cash provided by financing activities was less than $0.1 million for the three months ended March 31, 2025 compared to net cash provided by financing activities of $43.0 million for the three months ended March 31, 2024. The cash provided by financing activities for the three months ended March 31, 2025 consisted of less than $0.1 million in net proceeds received from the exercises of stock options. The cash provided by financing activities for the three months ended March 31, 2024 consisted of the $41.7 million in net proceeds received from our "at-the-market" stock offering program in January 2024, as well as the cash provided from the exercises of stock options and ESPP purchases.
Previous wording
In the normal course of business, we enter into contracts with third parties for preclinical studies, clinical operations, manufacturing and research and development supplies. These contracts generally do not contain minimum purchase commitments and generally provide for termination on notice, and therefore are cancellable contracts. These payments are not included in the table above as the amount and timing of such payments are not known as of September 30, 2024.
Current wording
In the normal course of business, we enter into contracts with third parties for preclinical studies, clinical operations, manufacturing and research and development supplies. These contracts generally do not contain minimum purchase commitments and generally provide for termination with limited notice, and therefore are cancellable contracts. These payments are not included in the table above as the amount and timing of such payments are not known as of March 31, 2025.
Previous wording
We have also entered into a license agreement under which we may be obligated to make milestone and royalty payments. We have not included future milestone or royalty payments under the agreement in the table above since the payment obligations are contingent upon future events, such as achieving certain development, regulatory, and commercial milestones or generating product sales. As of September 30, 2024 and December 31, 2023, we were unable to estimate the timing or likelihood of achieving these milestones or generating future product sales. Refer to Note 8 to our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023 for a description of our license agreement.
Current wording
We have also entered into a license agreement under which we may be obligated to make milestone and royalty payments. We have not included future milestone or royalty payments under the agreement in the table above since the payment obligations are contingent upon future events, such as achieving certain development, regulatory, and commercial milestones or generating product sales. As of March 31, 2025 and December 31, 2024, we were unable to estimate the timing or likelihood of achieving these milestones or generating future product sales. Refer to Note 8 of our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2024 for a description of our license agreement.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Comparison of the three months ended March 31, 2025 and 2024
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
In January 2024, the Company sold 4,001,200 shares of common stock under this program for gross proceeds of $43.0 million.
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:
Previous report — wording carried elsewhere
Provision for income taxes was $0.2 million for the nine months ended September 30, 2024 and $0.1 million for the nine months ended September 30, 2023. The income tax provision amount for the period ended September 30, 2024 is primarily attributable to state taxes on interest income earned on marketable securities.