What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-07 compared with 2025-11-06 · 57 added, 73 removed, 139 unchanged (48% of the section changed)

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The TRACTr platform produces T cell engagers (TCEs) with a tumor antigen-binding domain and a CD3 T cell binding domain, while the TRACIr platform produces bispecifics with a tumor antigen-binding domain and a costimulatory CD28 binding domain.

The goal of both platforms is to provide cancer patients with safe and effective therapeutics that direct and guide their immune system to eradicate tumors while minimizing safety concerns.

Our initial focus is on developing a novel class of TRACTr therapeutics designed to target clinically validated TCE drug targets, but overcome liabilities associated with prior generations of TCEs.

While TCE therapeutics have displayed potent anti-tumor activity in hematological cancers, developing TCEs to treat solid tumors has faced challenges due to the limitations of prior TCE technologies, namely (i) on-target healthy tissue immune activation that contributes to cytokine release syndrome (CRS) and healthy tissue toxicity and (ii) poor pharmacokinetics (PK) leading to short half-life.

Our first clinical candidate, JANX007, is a prostate-specific membrane antigen or PSMA-TRACTr and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).

In December 2024, we announced updated interim clinical data for JANX007 which displayed meaningful and prolonged PSA drops, encouraging anti-tumor activity, a favorable safety profile including CRS and treatment-related adverse events (TRAEs) primarily limited to Cycle 1 and lower grades, and PK consistent with the TRACTr mechanism-of-action.

In May 2025, we provided updated results from the patients reported in December 2024 which displayed a consistent durability and safety profile that supported the initiation of Phase 1b expansion studies.

Our second clinical candidate, JANX008, is an epidermal growth factor receptor or EGFR-TRACTr and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer.

The first patient for this trial was dosed in April 2023 and in February 2024 we announced positive early data for JANX008 that displayed anti-tumor activity in multiple tumor types with low-grade CRS and predominantly low-grade TRAEs.

The Adaptive Immune Response Modulator (ARM) platform builds upon our expertise to redesign bispecific TCEs to overcome the limitations of conventional TCEs in autoimmune diseases and oncology.

This platform aims to create differentiated product candidates that have a large safety window, off-the-shelf format positioning for higher dosing, rapid development and potential for improved performance.

The lead program, a CD19-ARM, has displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates, supporting a potentially differentiated profile.

The goal of our TRACTr and TRACIr platforms is to provide cancer patients with safe and effective therapeutics that direct and guide their immune system to eradicate tumors while minimizing safety concerns.

Our initial focus is on developing a novel class of TRACTr therapeutics designed to target clinically validated TCE drug targets while overcoming the liabilities associated with prior generations of TCEs.

While TCE therapeutics have demonstrated potent anti-tumor activity in hematological cancers, development in solid tumors has been limited by challenges associated with prior TCE technologies, including (i) on-target healthy tissue immune activation that contributes to cytokine release syndrome (CRS) and healthy tissue toxicity and (ii) poor pharmacokinetics (PK) leading to short half-life.

Our lead clinical candidate, JANX007, is a prostate-specific membrane antigen (PSMA)-targeted TRACTr being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).

We are also advancing JANX014, a double-masked PSMA-targeted TRACTr, which entered clinical evaluation in April 2026.

In addition, we are developing JANX013, a PSMA-targeted TRACIr incorporating CD28 costimulation, which is planned to enter clinical development in the second half of 2026.

Our ARM platform builds upon our expertise to redesign bispecific T cell engagers to address the limitations of conventional approaches in autoimmune diseases and oncology.

The platform is designed to enable controlled T cell activation and expansion followed by contraction, with the goal of achieving deep and durable target cell depletion while improving safety and convenience.

In February 2026, we initiated a Phase 1 clinical study of our CD19-ARM program (JANX011), which is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JANX011 in healthy volunteers.

JANX011 is being developed for autoimmune diseases, and the initiation of this study represents an important step in the advancement of our ARM platform from preclinical development into the clinic.

We are also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

In April 2026, we announced the decision to voluntarily discontinue further clinical development of JANX008, an epidermal growth factor receptor (EFGR)-targeted TRACTr program, following internal review of the data from the Phase 1a portion of the study because the overall magnitude and consistency of activity were not sufficient to support continued development relative to other pipeline programs and we have determined to prioritize development resources toward other pipeline opportunities.

We were incorporated in June 2017.

To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, business development, raising capital, developing and optimizing our technology platform, identifying potential product candidates, undertaking research and development for our lead programs, establishing and enhancing our intellectual property portfolio and providing general and administrative support for these operations.

All of our product candidates and research programs other than JANX007 and JANX008 are in preclinical development, and none have been approved for commercial sale.

All of our product candidates and research programs other than JANX007, JANX011 and JANX014 are in preclinical development, and none have been approved for commercial sale.

We have never generated any revenue from product sales and have incurred net losses each year since we commenced operations.

We have funded our operations primarily with the net proceeds from the issuance of convertible promissory notes, the issuance of convertible preferred stock, the exercise of common stock options, proceeds from our initial public offering (IPO), the issuance of common stock and pre-funded common stock warrants in public and/or underwritten offerings and amounts received under a collaboration agreement with Merck Sharp & Dohme Corp.

We have funded our operations primarily with the net proceeds from the issuance of convertible promissory notes, the issuance of convertible preferred stock, the exercise of common stock options, proceeds from our initial public offering (IPO), the issuance of common stock and pre-funded common stock warrants in public and/or underwritten offerings and amounts received under collaboration agreements with Merck Sharp & Dohme Corp.

(Merck) and Bristol-Myers Squibb Company (BMS).

We have incurred operating losses since our inception and have not yet generated any product revenue.

Our net losses were $81.7 million and $48.8 million for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, we had an accumulated deficit of $319.4 million.

Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on a variety of factors including the timing and scope of our clinical and preclinical studies and our expenditures on other research and development activities and the timing of any revenue recognition under our collaboration agreement with Merck.

Our net losses were $24.4 million and $23.5 million for the three months ended March 31, 2026 and 2025, respectively.

As of March 31, 2026, we had an accumulated deficit of $375.7 million.

We expect our expenses and operating losses will increase substantially and that we will continue to incur significant losses for the foreseeable future as we conduct our ongoing and planned research and development activities and conduct preclinical studies and clinical trials, hire additional personnel, protect our intellectual property and incur additional costs associated with being a public company.

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Merck provided research funding under the collaboration through August 2024, after which our research services for both collaboration targets were completed.

Our Research Collaboration with BMS

In January 2026, we entered into an exclusive license and collaboration agreement (the BMS Agreement) with Bristol-Myers Squibb Company (BMS) to develop an undisclosed, novel tumor-activated therapeutic targeting a validated solid tumor antigen expressed across several human cancer types.

Under the BMS Agreement, BMS received an exclusive worldwide license, under the relevant patents and know-how owned or in-licensed by us, to develop, manufacture, commercialize and otherwise exploit a tumor-activated therapeutic targeting the collaboration target.

In addition, we are responsible for conducting, at our own expense and pursuant to an agreed joint development plan, pre-clinical development until Investigational New Drug application (IND) submission for the collaboration target.

In return, we have received an upfront payment of $15.0 million, will receive $35.0 million related to a developmental milestone achieved in March 2026, we are entitled to reimbursement of expenses associated with certain research and development activities we are required to perform under the BMS Agreement and will be eligible to receive $750.0 million in additional payments contingent upon successful completion of certain milestones.

We are also entitled to tiered royalties on global product sales, with the applicable royalty rates ranging from high-single digit to low-double digit percentages, subject to certain customary reductions.

Risks and Uncertainties

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To date, we have not generated any revenues from the commercial sale of any products, and we do not expect to generate revenues from the commercial sale of any products for the foreseeable future, if ever.

We recognized $10.0 million and $10.6 million of revenue under the Merck Agreement for the nine months ended September 30, 2025 and 2024, respectively.

Under the Merck Agreement, we recognized no

revenue for each of the three months ended March 31, 2026 and 2025, respectively.

Under the BMS Agreement, we recognized $3.7 million for the three months ended March 31, 2026.

Research and Development

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Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024 (in thousands)

Three Months Ended September 30,

Collaboration revenue

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Collaboration Revenue

Collaboration revenues were $10.0 million and $0.4 million for the three months ended September 30, 2025 and 2024, respectively.

The increase of $9.6 million was primarily due to the achievement of a developmental milestone related to the First Collaboration Target under the Merck Agreement in August 2025.

Research and Development Expense

The following table summarizes our direct and indirect research and development expenses for the three months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Direct costs:

Preclinical stage programs and other direct unallocated costs

Total direct costs

Indirect costs

Total research and development expenses

Research and development expenses were $34.6 million and $18.6 million for the three months ended September 30, 2025 and 2024, respectively.

The increase of $16.0 million was primarily due to increases in preclinical stage programs and other direct unallocated costs of $10.0 million, which was primarily attributable to manufacturing costs.

Additional increases included indirect costs as a result of increased compensation costs of $4.0 million, direct costs related to the development of JANX007 of $1.6 million and direct costs related to the development of JANX008 of $0.4 million.

General and Administrative Expense

General and administrative expenses were $10.6 million and $17.7 million for the three months ended September 30, 2025 and 2024, respectively.

The decrease of $7.1 million was primarily due to a decrease in stock-based compensation expense, which was driven by the modification of a former executive and director’s equity awards in 2024.

Other income was $10.9 million and $7.8 million for the three months ended September 30, 2025 and 2024, respectively.

The increase of $3.1 million was due to an increase in cash and cash equivalents and short-term investments resulting in increased interest income.

Comparison of the Nine Months Ended September 30, 2025 and 2024 (in thousands)

Nine Months Ended September 30,

Comparison of the Three Months Ended March 31, 2026 and 2025 (in thousands)

Three Months Ended March 31,

Collaboration revenue

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Collaboration Revenue

Collaboration revenues were $10.0 million and $10.6 million for the nine months ended September 30, 2025 and 2024, respectively.

The decrease of $0.6 million was primarily due to an increase in milestone revenue under the Merck Agreement, offset by the completion of our research activities under the Merck Agreement in August 2024.

Collaboration revenues were $3.7 million and $0 for the three months ended March 31, 2026 and 2025, respectively.

The increase of $3.7 million was due to the execution of the BMS Agreement in January 2026 and the related revenue recognized based on the full-time equivalent hours and costs incurred in the performance of research services required.

Research and Development Expense

The following table summarizes our direct and indirect research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):

Nine Months Ended September 30,

The following table summarizes our direct and indirect research and development expenses for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Direct costs:

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Total research and development expenses

Research and development expenses were $94.3 million and $47.6 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $46.7 million was primarily due to increases in preclinical stage programs and other direct unallocated costs of $24.8 million, indirect costs as a result of increased compensation costs of $13.5 million, direct costs related to the development of JANX007 of $7.5 million and direct costs related to the development of JANX008 of $0.9 million.

Research and development expenses were $26.8 million and $25.1 million for the three months ended March 31, 2026 and 2025, respectively.

The increase of $1.7 million was primarily due to increases in preclinical stage programs and other direct unallocated costs of $1.4 million.

Additional increases included indirect costs as a result of increased personnel costs of $0.9 million and direct costs related to the development of JANX007 of $0.9 million.

This was offset by decreases in direct costs related to the development of JANX011 of $1.3 million and direct costs related to the development of JANX008 of $0.2 million.

General and Administrative Expense

General and administrative expenses were $30.9 million and $32.8 million for the nine months ended September 30, 2025 and 2024, respectively.

The decrease of $1.9 million was primarily due to a decrease in stock-based compensation of $3.9 million as a result of incremental stock-based compensation expense taken in 2024 due to the modification of a former director and executive officer’s equity awards.

This was offset by increases in compensation costs of $1.4 million and other general and administrative costs of $0.6 million.

Other income was $33.6 million and $21.0 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $12.6 million was due to an increase in cash and cash equivalents and short-term investments resulting in increased interest income.

General and administrative expenses were $11.1 million and $9.8 million for the three months ended March 31, 2026 and 2025, respectively.

The increase of $1.3 million was primarily due to increases in consulting and professional fees of $0.9 million, personnel costs of $0.9 million and other general and administrative costs of $0.3 million, offset by a decrease in stock-based compensation expense of $0.8 million.

Other income was $9.9 million and $11.4 million for the three months ended March 31, 2026 and 2025, respectively.

The decrease of $1.5 million was due to a decrease in cash and cash equivalents and short-term investments resulting in decreased interest income.

Liquidity and Capital Resources

We have incurred net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses and negative cash flows for the foreseeable future.

As of September 30, 2025, we had cash, cash equivalents, restricted cash and short-term investments of $989.8 million.

As of March 31, 2026, we had cash, cash equivalents, restricted cash and short-term investments of $957.2 million.

Inclusive in this amount is $0.8 million of restricted cash that is not available for current use.

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In May 2024, we filed a shelf registration statement on Form S-3ASR which included a new prospectus which covers the offering, issuance and sale of up to a maximum aggregate offering price of $150.0 million of our common under the Sale Agreement.

As of September 30, 2025, $150.0 million of common stock remained available for sale under the Sale Agreement.

As of March 31, 2026, $150.0 million of common stock remained available for sale under the Sale Agreement.

In July 2023, we closed an underwritten offering of 4,153,717 shares of our common stock and pre-funded warrants to purchase 583,483 shares of common stock at an exercise price of $0.001 per share.

The shares of common stock were sold at a price of $12.46 per share and the pre-funded common stock warrants were sold at a price of $12.459 per pre-funded common stock warrant, resulting in gross proceeds of $59.0 million.

Fees related to the offering included underwriting discounts, commissions, and offering expenses in the aggregate amount of $2.5 million, resulting in net proceeds of $56.5 million.

In March 2024, we closed an underwritten offering of 5,397,301 shares of our common stock and pre-funded warrants to purchase 1,935,483 shares of common stock at an exercise price of $0.001 per share.

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The specific terms of any offering under the shelf registration statement are established at the time of such offering.

In December 2024, we closed an underwritten offering of 6,150,793 shares of our common stock and pre-funded warrants to purchase 238,095 shares of common stock at an exercise price of $0.001 per share.

The shares of common stock were sold at a price of $63.00 per share and the pre-funded common stock warrants were sold at a price of $62.999 per pre-funded common stock warrant, resulting in gross proceeds of $402.5 million.

Fees related to the offering included underwriting discounts, commissions, and offering expenses in the aggregate amount of $24.6 million, resulting in net proceeds of $377.9 million.

The following summarizes our cash flows for the periods indicated (in thousands):

Nine Months Ended September 30,

Three Months Ended March 31,

Net cash provided by (used in):

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Financing activities

Net increase (decrease) in cash, cash equivalents and restricted cash

Net decrease in cash, cash equivalents and restricted cash

Operating Activities

Net cash used in operating activities of $53.7 million for the nine months ended September 30, 2025 was primarily due to our net loss of $81.7 million and a change in operating assets and liabilities and other non-cash charges of $2.7 million, adjusted for $30.7 million of stock-based compensation expense.

Net cash used in operating activities of $27.1 million for the nine months ended September 30, 2024 was primarily due to our net loss of $48.8 million and a change in operating assets and liabilities and other non-cash charges of $5.1 million, adjusted for $26.8 million of stock-based compensation expense.

Net cash used in operating activities of $12.3 million for the three months ended March 31, 2026 was primarily due to our net loss of $24.4 million, an increase of $35.0 million of accounts receivable and a change in remaining operating assets and liabilities and other non-cash charges of $8.5 million, offset by $46.3 million of deferred revenue and $9.3 million of stock-based compensation expense.

Net cash used in operating activities of $17.0 million for the three months ended March 31, 2025 was primarily due to our net loss of $23.5 million and a change in operating assets and liabilities and other non-cash charges of $4.2 million, offset by $10.7 million of stock-based compensation expense.

Investing Activities

Net cash used in investing activities of $330.5 million for the nine months ended September 30, 2025 was primarily due to $329.6 million of net purchases of short-term investments and by our purchase of property and equipment of $0.9 million.

Net cash used in investing activities of $291.9 million for the nine months ended September 30, 2024 was primarily due to $291.6 million of net purchases of short-term investments and by our purchase of property and equipment of $0.3 million.

Net cash provided by investing activities of $8.3 million for the three months ended March 31, 2026 was primarily due to $8.6 million of net maturities of short-term investments, offset by our purchase of property and equipment of $0.3 million.

Net cash used in investing activities of $340.4 million for the three months ended March 31, 2025 was primarily due to $340.0 million of net purchases of short-term investments and by our purchase of property and equipment of $0.4 million.

Financing Activities

Net cash provided by financing activities of $2.0 million for the nine months ended September 30, 2025 was primarily due to proceeds from stock option exercises and shares issued under our employee stock purchase plan (ESPP) of $2.3 million, adjusted for issuance costs paid in connection with an underwritten offering in December 2024 of $0.3 million.

Net cash provided by financing activities of $326.6 million for the nine months ended September 30, 2024 was primarily due to proceeds from the issuance of common stock and pre-funded common stock warrants, net of issuance costs, of $320.1 million and proceeds from stock option exercises and shares issued under our ESPP of $6.5 million.

Net cash provided by financing activities of $3.5 million for the three months ended March 31, 2026 was due to proceeds from stock option exercises.

Net cash provided by financing activities of $0.6 million for the three months ended March 31, 2025 was primarily due to proceeds from stock option exercises of $0.9 million, adjusted for issuance costs paid in connection with an underwritten offering in December 2024 of $0.3 million.

Funding Requirements

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Our future capital requirements will depend on many factors, including:

• the initiation, trial design, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of our product candidates, and in particular the clinical trials for JANX007 and JANX008;

• the number and characteristics of clinical programs that we pursue;

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If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay,

limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Contractual Obligations and Commitments

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For a description of our critical accounting policies, see Item 1 of Part I, “Notes to Unaudited Condensed Financial Statements — Note 1 — Organization and Summary of Significant Accounting Policies” of this Quarterly Report and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Estimates” contained in our Annual Report on Form 10-K, filed with the SEC on February 26, 2026.

There have not been any material changes to the critical accounting policies discussed therein during the nine months ended September 30, 2025.

There have not been any material changes to the critical accounting policies discussed therein during the three months ended March 31, 2026.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis