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TRAX 10-K & 10-Q changes, risk factors and insider trading

First Tracks Biotherapeutics, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 2091349 · All filings on SEC.gov

Everything below is quoted or computed from First Tracks Biotherapeutics, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

0Form 4 filings reporting open-market purchases (last 180 days)
2Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

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What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-12 (period ending 2026-06-30) with 10-Q filed 2026-05-14 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

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Removed heading “We may be unable to achieve some or all of the benefits that we expect to achieve from the Spin-Off.”

Removed heading “Our share price may fluctuate significantly, and there can be no assurance that the combined trading prices of a share of our common stock and a share of AnaptysBio, Inc.’s common stock would exceed the trading price of a share of AnaptysBio, Inc. common stock absent the Spin-Off.”

Removed heading “The market price of First Tracks Biotherapeutics shares may be affected by factors different from those affecting AnaptysBio, Inc. shares prior to completion of the transaction.”

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“The results of operations of First Tracks Biotherapeutics and the market price of the First Tracks Biotherapeutics shares, after completion of the transaction, may be affected by factors – both those related to the Spin-Off and other general factors, some of which are beyond our control – different from those that previously affected the independent results of operations and the market prices of AnaptysBio, Inc. shares. Accordingly, the market price and performance of First Tracks Biotherapeutics shares is likely to be different from the performance of AnaptysBio, Inc. …”
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“Furthermore, our business profile and market capitalization may not fit the investment objectives of some AnaptysBio, Inc. stockholders and, as a result, these AnaptysBio, Inc. stockholders potentially have been, and may continue to, sell their shares of our common stock after the Spin-Off. See “—Substantial sales of shares of our common stock may occur in the future, which could cause our share price to decline or be volatile.” Should the market price of our shares drop significantly, stockholders may institute securities class action lawsuits against us. …”
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“Our share price may fluctuate significantly, and there can be no assurance that the combined trading prices of a share of our common stock and a share of AnaptysBio, Inc.’s common stock would exceed the trading price of a share of AnaptysBio, Inc. common stock absent the Spin-Off.”
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“The market price of First Tracks Biotherapeutics shares may be affected by factors different from those affecting AnaptysBio, Inc. shares prior to completion of the transaction.”
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“We may be unable to achieve some or all of the benefits that we expect to achieve from the Spin-Off.”
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“We may be unable to achieve the full strategic and financial benefits expected to result from the Spin-Off, or such benefits may be delayed or not occur at all. We believe that, as an independent, publicly traded company, we are able to, among other things, focus on First Tracks Biotherapeutics’ distinctive set of assets, business objectives and unique opportunities for long-term growth and profitability. …”
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Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this Quarterly Report, including our combined financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations, and growth prospects. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment.

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We share some of our directors and executive officers with AnaptysBio, Inc.AnaptysBio. This overlap may give rise to certain conflicts of interest.

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Further, as a clinical stageclinical-stage business, we may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown factors. We will need to transition from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

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For our anti-CD122 antagonist antibody program, our clinical competitors include an anti-CD122 antagonist antibody, FB-102 (Forte BioscienceBioscience, acquisition by Argenyx BV expected to close in Q3 2026) in Phase 2a development for the treatment of CeD, Phase 1b development for the treatment of vitiligo, and Phase 1b development for the treatment of alopecia areata, and twothree anti-IL-15 monoclonal antibodies, GIA632 (Novartis) in Phase 2 development for atopic dermatitis, Phase 2 development for vitiligo, and with proof-of-concept, Phase 1b data for the treatment of CeD and EoE, and TEV-53408 (Teva), in Phase 2 development for the treatment of CeD and vitiligo. To date, there are no FDA-approved therapies for the treatment of celiac disease and only one FDA-approved biologic, Dupixent, for the treatment of EoE.

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We are a clinical-stage biotechnology company with a limited operating history. We have no approved products. Our ability to generate revenue and become profitable depends upon our ability, alone or with any future collaborators, to successfully complete the development of our product candidates for our target indications and to obtain necessary regulatory approvals. Further, following the Spin-Off, we will no longer generate revenue from the potential royalty revenue streams held by AnaptysBio, Inc.AnaptysBio (i.e.i.e., the financial collaboration for Jemperli with GSK and for imsidolimab with Vanda).

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We have incurred, and expect to continue to incur, operating losses. We had a net loss of $50.5$33.4 million and $47.2$83.9 million for the three and six months ended MarchJune 31,30, 20262026, respectively, and a net loss of $42.4 million and $89.6 million for the three and six months ended June 30, 2025, respectively.

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We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with federal and state health care fraud and abuse laws and regulations, to report financial information or data accurately or to disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We willhave adoptadopted a code of conduct prior to the closing of the Spin-Off, but it is not always possible to identify and deter employee misconduct. The precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

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We may be unable to achieve some or all of the benefits that we expect to achieve from the Spin-Off.

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We may be unable to achieve the full strategic and financial benefits expected to result from the Spin-Off, or such benefits may be delayed or not occur at all. We believe that, as an independent, publicly traded company, we are able to, among other things, focus on First Tracks Biotherapeutics’ distinctive set of assets, business objectives and unique opportunities for long-term growth and profitability. First Tracks Biotherapeutics will be able to tailor capital and corporate resources to its own operating and financial objectives and will have increased flexibility to pursue independent strategic and financial plans and strategic partnerships without considering competing priorities of AnaptysBio, Inc. Being independent enables First Tracks Biotherapeutics to create independent capital structures that will afford it direct access to the debt and equity capital markets, allow investors to evaluate the investment characteristics of First Tracks Biotherapeutics and enable First Tracks Biotherapeutics to maintain an employee base more aligned with its specific operating and financial objectives.

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We may be unable to achieve some or all of the benefits that we expect to achieve as an independent company in the time we expect, if at all, for a variety of reasons, including: (i) we may be more susceptible to market fluctuations, actions by activist stockholders, and other adverse events than if we were still a part of AnaptysBio, Inc.; (ii) our businesses are less diversified than AnaptysBio, Inc.’s businesses prior to the Spin-Off; (iii) the actions required to separate AnaptysBio, Inc.’s and our respective businesses could disrupt our operations; and (iv) economic and business conditions that affect First Tracks Biotherapeutics and the biotechnology industry generally and any material changes in global, political, economic, business, competitive, market or regulatory forces. If we fail to achieve some or all of the benefits that we expect to achieve as an independent company, or do not achieve them in the time we expect, our business, financial condition, cash flows, and results of operations could be adversely affected.

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As an independent, publicly traded company, we may not enjoy the same benefits that we did as part of AnaptysBio, Inc.AnaptysBio.

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As an independent, publicly traded company, we may become more susceptible to market fluctuations and other adverse events than we would have been if we were still a part of AnaptysBio, Inc.AnaptysBio. As part of AnaptysBio, Inc., we were able to enjoy certain benefits from AnaptysBio, Inc.’sAnaptysBio’s operating diversity, cost of capital and borrowing capacity, and opportunities to pursue integrated strategies with AnaptysBio, Inc.’sAnaptysBio’s other businesses. As an independent, publicly traded company, we may not have the same benefits. As an independent, publicly traded company, we will need to continue to develop new strategies, and it may be more difficult for us to recruit or retain key personnel.

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Prior to the Spin-Off, we operated as part of AnaptysBio, Inc.AnaptysBio. The financial information included in this Quarterly Report through the date of the Spin-Off has been prepared from AnaptysBio, Inc.’sAnaptysBio’s historical accounting records and is derived from the combinedconsolidated financial statements of AnaptysBio, Inc.AnaptysBio to present First Tracks Biotherapeutics, Inc.Biotherapeutics as if it had been operating on a standalone basis. Accordingly, this information may not necessarily reflect what our financial condition, results of operations or cash flows would have been had we been a standalone company during the periods presented or what our financial condition, results of operations and cash flows may be in the future, primarily because of the following factors:

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We entered into a Transition Services Agreement pursuant to which we provide AnaptysBio, Inc.AnaptysBio with certain specified services for a limited time, to ensure an orderly transition following the Spin-Off. The services we provide consist of digital technology, business development, human resources, supply chain, and finance, among others.

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We entered into agreements and transactions with AnaptysBio, Inc.AnaptysBio that did not exist prior to the Spin-Off, such as our provision of transition and other services to AnaptysBio, Inc.,AnaptysBio and have undertaken indemnification obligations, which may cause us to incur new costs.

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Our working capital requirements and capital expenditures were historically satisfied as part of AnaptysBio, Inc.’sAnaptysBio’s corporate-wide cash management and centralized funding programs, and our cost of capital may differ significantly from the historical amounts reflected in our historical financial statements.

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When ourOur business was under common ownership with the other businesses of AnaptysBio, Inc., and we benefited from AnaptysBio, Inc.’sAnaptysBio’s existing collaborations and related royalty revenue streams, from which we no longer benefit.

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Certain of our directors and employees may have actual or potential conflicts of interest because of their financial interests in, or because of their previous or continuing positions with, AnaptysBio, Inc.AnaptysBio or other entities with which we have commercial arrangements.

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Certain of our executive officers and our directors have continued to serve as executive officers and directors of AnaptysBio, Inc.AnaptysBio following completion of the Spin-Off. In light of the substantial operational, scientific and development demands associated with First Tracks Biotherapeutics as a clinical-stage biotechnology business focused on the development and potential commercialization of innovative therapeutics for autoimmune and inflammatory diseases, including ANB033, rosnilimab and ANB101, we expect that our executive officers will devote a majority of their working time to First Tracks Biotherapeutics. Given their ongoing responsibilities to AnaptysBio, Inc, certain of our executive officers are not be able to devote their full time, effort and attention exclusively to our company’s affairs. In addition, because of their current positions with AnaptysBio, Inc., certain of our executive officers and directors own equity interests in both us and AnaptysBio, Inc.AnaptysBio. Continuing ownership of AnaptysBio, Inc.AnaptysBio shares and equity awards could create, or appear to create, potential conflicts of interest if we and AnaptysBio, Inc.AnaptysBio face decisions that could have implications for both us and AnaptysBio, Inc.AnaptysBio. Potential conflicts of interest could arise in connection with the resolution of any dispute between us and AnaptysBio, Inc.AnaptysBio regarding the terms of the agreements governing the Spin-Off and our relationship with AnaptysBio, Inc.AnaptysBio following the Spin-Off. Potential conflicts of interest may also arise out of any commercial arrangements that we or AnaptysBio, Inc.AnaptysBio may enter into in the future. A dispute regarding a potential or actual conflict of interest involving us and AnaptysBio, Inc.AnaptysBio or any of such other companies could negatively impact our businesses, results of operations, cash flows, and financial condition. In addition, public perception of such an actual or apparent conflict of interest could pose reputational risks and expose us to increased scrutiny from investors and regulators. Although we have policies governing conflicts of interest, including a written Related Party Transaction Policy applicable to our executive officers, directors and nominees for director, they may not sufficiently protect against these risks.

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In addition, the stock market in general, and the Nasdaq Stock Market LLC (the “Exchange”) and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of shares of our common stock, regardless of our actual operating performance. In the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigation has often been instituted against these companies. AnaptysBio, Inc.AnaptysBio has been subject to securities litigation in the past, and any future securities litigation could result in substantial costs and a diversion of our management’s attention and resources. The realization of any of the above risks or any of a broad range of other risks, including those described in this “Risk Factors” section, could have a dramatic and adverse impact on the market price of shares of our common stock.

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Our share price may fluctuate significantly, and there can be no assurance that the combined trading prices of a share of our common stock and a share of AnaptysBio, Inc.’s common stock would exceed the trading price of a share of AnaptysBio, Inc. common stock absent the Spin-Off.

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The market price of a share of First Tracks Biotherapeutics common stock may fluctuate widely depending on many factors, some of which may be beyond our control.

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Furthermore, our business profile and market capitalization may not fit the investment objectives of some AnaptysBio, Inc. stockholders and, as a result, these AnaptysBio, Inc. stockholders potentially have been, and may continue to, sell their shares of our common stock after the Spin-Off. See “—Substantial sales of shares of our common stock may occur in the future, which could cause our share price to decline or be volatile.” Should the market price of our shares drop significantly, stockholders may institute securities class action lawsuits against us. A lawsuit against us could cause us to incur substantial costs and could divert the time and attention of our management and other resources.

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The market price of First Tracks Biotherapeutics shares may be affected by factors different from those affecting AnaptysBio, Inc. shares prior to completion of the transaction.

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The results of operations of First Tracks Biotherapeutics and the market price of the First Tracks Biotherapeutics shares, after completion of the transaction, may be affected by factors – both those related to the Spin-Off and other general factors, some of which are beyond our control – different from those that previously affected the independent results of operations and the market prices of AnaptysBio, Inc. shares. Accordingly, the market price and performance of First Tracks Biotherapeutics shares is likely to be different from the performance of AnaptysBio, Inc. shares in the absence of the transaction. The nature of our business and industry subject us, and our share price, to volatility. In addition, general fluctuations in stock markets or adverse factors in the biotechnology industry could have a material adverse effect on the market for, or liquidity of, First Tracks Biotherapeutics shares, regardless of First Tracks Biotherapeutics’ actual operating performance following the completion of the Spin-Off. Should the market price of our shares drop significantly, stockholders may institute securities class action lawsuits against us. A lawsuit against us could cause us to incur substantial costs and could divert the time and attention of our management and other resources.

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We are an “emerging growth company” and will be able to take advantage of reduced disclosure requirements applicable to “emerging growth companies,” which could make shares of our common stock less attractive to investors.

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As a public company, we will continue to incur significant legal, accounting and other expenses, and these expenses may increase even more after we are no longer an “emerging growth company” or a “smaller reporting company.” We will continue to be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 as well as rules adopted, and to be adopted, by the SEC and the Exchange. Our management and other personnel devote a substantial amount of time to these compliance initiatives. In addition, changing laws, regulations, and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs, and making some activities more time consuming. We intend to invest resources to comply with evolving laws, regulations, and standards, and this investment may result in general and administrative expenses and a diversion of management’s time and attention. If our efforts to comply with new laws, regulations, and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us and our business may be adversely affected. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to incur substantial costs to maintain sufficient coverage. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these and future requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our Board,board of directors (“Board”), our Board committees or as executive officers. After we are no longer an “emerging growth company,” and can no longer take advantage of the reporting exemptions available to “emerging growth companies” as discussed above, we expect to incur additional management time and cost to comply with the more stringent reporting requirements applicable to companies that are deemed accelerated filers or large accelerated filers, including complying with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. We cannot predict or estimate the amount of additional costs we may incur as a result of becoming a public company or the timing and materiality of such costs.

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As a public company, we continue to be subject to significant requirements for enhanced financial reporting and internal controls. Effective internal control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, is designed to prevent fraud. The process of designing and implementing effective internal controls is a continuous effort that requires us to anticipate and react to changes in our business and the economic and regulatory environment, and to expend significant resources to maintain a system of internal controls that is adequate to satisfy our reporting obligations as a public company. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations on a timely basis, result in material misstatements in our combined financial statements and harm our results of operations. In addition, we will be required, pursuant to Section 404(a) of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting in the second annual report following the completion of the Spin-Off. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. The rules governing the standards that must be met for our management to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation. Testing and maintaining internal controls may divert our management’s attention from other matters that are important to our business.

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If we fail to maintain an effective internal control environment, we could suffer material misstatements in our combined financial statements and fail to meet our reporting obligations, which would likely cause investors to lose confidence in our reported financial information. Additionally, ineffective internal control over financial reporting could expose us to increased risk of fraud or misuse of corporate assets and subject us to potential delisting from the Exchange, regulatory investigations, civil or criminal sanctions and litigation, any of which would have a material adverse effect on our business, results of operations and financial condition.

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Our amended and restated certificate of incorporation and bylaws,bylaws contain provisions that could depress the market price of shares of our common stock by acting to discourage, delay or prevent a change in control of our company or changes in our management that the stockholders of our company may deem advantageous. These provisions, among other things, willthings:

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Our bylaws, to the fullest extent permitted by law, will provide that the Court of Chancery of the State of Delaware is the exclusive forum for: any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the DGCL, our amended and restated certificate of incorporation, or our bylaws; or any action asserting a claim that is governed by the internal affairs doctrine. This exclusive forum provision willdoes not apply to suits brought to enforce a duty or liability created by the Securities Exchange Act of 1934, as amended, or Exchange Act. It could apply, however, to a suit that falls within one or more of the categories enumerated in the exclusive forum provision.

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Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all claims brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. Our bylaws will provide that the federal district courts of the United States of America will,are, to the fullest extent permitted by law, be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, or the Federal Forum Provision, including for all causes of action asserted against any defendant named in such complaint. For the avoidance of doubt, this provision is intended to benefit and may be enforced by us, our officers and directors, the underwriters to any offering giving rise to such complaint, and any other professional entity whose profession gives authority to a statement made by that person or entity and who has prepared or certified any part of the documents underlying an offering of our securities. Our decision to adopt a Federal Forum Provision followed a decision by the Supreme Court of the State of Delaware holding that such provisions are facially valid under Delaware law. While federal or other state courts may not follow the holding of the Delaware Supreme Court or may determine that the Federal Forum Provision should be enforced in a particular case, application of the Federal Forum Provision means that suits brought by our stockholders to enforce any duty or liability created by the Securities Act must be brought in federal court and cannot be brought in state court, and our stockholders cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Section 27 of the Exchange Act creates exclusive federal jurisdiction over all claims brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. In addition, neither the exclusive forum provision nor the Federal Forum Provision applies to suits brought to enforce any duty or liability created by the Exchange Act. Accordingly, actions by our stockholders to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder must be brought in federal court, and our stockholders cannot waive compliance with the federal securities laws and the rules and regulations thereunder.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

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“On March 26, 2026, First Tracks Biotherapeutics and EcoR1 Capital Fund Qualified, L.P. …”
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“General and administrative expenses were $28.1 million during the six months ended June 30, 2026 compared to $16.4 million during the six months ended June 30, 2025, an increase of approximately $11.7 million. The increase is primarily due to a $2.6 million increase in personnel costs, an increase of $5.1 million in stock compensation expense, and a $5.0 million increase in legal expenses, offset by a $1.0 million decrease in other general and administrative expenses.”
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Research and development expenses were $34.0$25.6 million during the three months ended MarchJune 31,30, 2026 compared to $41.5$39.3 million during the three months ended MarchJune 31,30, 2025, a decrease of $7.5$13.7 million. The decrease is primarily attributable to ana $8.4$11.1 million decrease in clinical expensesand related expenses, and a decrease of $0.9$2.6 million in other research and development expenses, offset by a $1.5 million increasedecrease in salaries and related costs, including an increase of $0.1 million in stock compensation expense, $0.2 million increase in manufacturing expenses and a $0.1 million increase in recruiting expenses.expense.
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“Net cash used in operating activities during the six months ended June 30, 2025 of $83.6 million was primarily due to our net loss of $89.6 million, adjusted for addbacks for non-cash expenses of $13.3 million, which includes depreciation, stock-based compensation, amortization of operating ROU assets, and income from marketable securities, and net decreases in working capital of $7.3 million.”
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“Research and development expenses were $59.6 million during the six months ended June 30, 2026 compared to $80.7 million during the six months ended June 30, 2025, a decrease of $21.1 million. The decrease is primarily attributable to a $20.1 million decrease in clinical and related expenses, and a $1.0 million decrease in salaraies and related costs, including stock compensation.”
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You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited combined financial statements and related notes for the three months ended MarchJune 31,30, 2026, included in Part I, Item 1 of this Quarterly Report and with our audited combined financial statements and related notes thereto for the year ended December 31, 2025 included in our Form 10 filed with the Securities and Exchange Commission on March 27, 2026. This discussion and other sections of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as our plans, objectives, expectations, intentions, and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section entitled “Risk Factors” included in Part II, Item 1A of this Quarterly Report. You should also carefully read “Special Note Regarding Forward-Looking Statements”.

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Spin-Off from AnaptysBio, Inc.AnaptysBio

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In September 2025, AnaptysBio, Inc.AnaptysBio announced its intention to separate its business into two independent, publicly traded companies (the “Spin-Off”). The spun-out company, First Tracks Biotherapeutics, would be a clinical-stage biotechnology company focused on the development and potential commercialization of innovative therapeutics for autoimmune and inflammatory diseases, including ANB033, rosnilimab and ANB101. AnaptysBio, Inc.AnaptysBio would hold and continue to manage the financial collaboration for Jemperli with GSK and for imsidolimab with Vanda, with a focus on protecting and returning value of the royalties to its stockholders. As part of the Spin-Off, AnaptysBio, Inc.AnaptysBio transferred the assets, liabilities and operations of its biopharma development business to First Tracks Biotherapeutics. The Spin-Off was approved by the AnaptysBio,AnaptysBio Incboard Boardof directors and completed on April 20, 2026.

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First Tracks Biotherapeutics’ historical combined financial statements have been prepared on a standalone basis and are derived from AnaptysBio, Inc.’sAnaptysBio consolidated financial statements and accounting records. Therefore, these financial statements reflect, in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”), First Tracks Biotherapeutics’ combined financial position, results of operations and cash flows as the business was historically operated as part of AnaptysBio, Inc.AnaptysBio prior to the Spin-Off. They may not be indicative of First Tracks Biotherapeutics’ future performance and do not necessarily reflect what First Tracks Biotherapeutics’ combined financial position, results of operations and cash flows would have been had First Tracks Biotherapeutics operated as a separate, publicly traded company during the periods presented, particularly because the Company expects that changes will occur in our operating structure and its capitalization as a result of the separation from AnaptysBio,AnaptysBio. Inc.Following the Spin-Off, the financial statements no longer include allocations from AnaptysBio.

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First Tracks Biotherapeutics’ combined statements of operations through the date of the Spin-Off reflect allocations of certain expenses, including research and development expenses and administrative expenses, and allocations of certain assets and liabilities from the consolidated financial statements of AnaptysBio, Inc., as applicable. Management believes these cost allocation methods are reasonable and reflect the services provided to First Tracks Biotherapeutics during the periods presented. The allocations may not, however, be indicative of the actual expenses that would have been incurred had First Tracks Biotherapeutics operated as a standalone public company. Related party cost allocations are further described in Note 5. Related-Party Transactions to the combined financial statements. First Tracks Biotherapeutics expects to provide some of the services related to these general and administrative functions to AnaptysBio, Inc.AnaptysBio on a transitional basis following the Spin-Off. These services will be provided under the Transition Services Agreement.

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We entered into a Separation and Distribution Agreement and a Transition Services Agreement with AnaptysBio, Inc.AnaptysBio to govern the Spin-Off and our relationship with AnaptysBio, Inc.AnaptysBio following the Spin-Off. These agreements will provide for the allocation between First Tracks Biotherapeutics and AnaptysBio, Inc.AnaptysBio of AnaptysBio, Inc.’sAnaptysBio’s assets, employees, liabilities and obligations (including its property, employee benefits and tax-related assets and liabilities) attributable to periods prior to, at and after the Spin-Off and will govern certain relationships between First Tracks Biotherapeutics and AnaptysBio, Inc.AnaptysBio after the Spin-Off.

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Certain third-party investors (the “Private Placement Investors”) purchased shares of First Tracks Biotherapeutics common stock from First Tracks Biotherapeutics and EcoR1 Capital Fund Qualified, L.P. (the “Selling Stockholder”) in the private placement that closed on April 20, 2026 (the “Private Placement”). Pursuant to the purchase agreement by and between First Tracks Biotherapeutics, the Selling Stockholder and the Private Placement Investors, First Tracks Biotherapeutics issued and sold an aggregate of 5,791,479 shares of First Tracks Biotherapeutics common stock and the Selling Stockholder sold an aggregate of 4,705,575 shares of First Tracks Biotherapeutics common stock (the “Secondary Shares”) that the Selling Stockholder received in the Spin-Off to the Private Placement Investors in the Private Placement, at a purchase price of $13.81 per share. The aggregate gross proceeds to First Tracks Biotherapeutics from the sale of the Primary Shares waswere approximately $80 million, before deducting offering expenses. The Private Placement closed immediately after the closing of the Spin-Off. Leerink Partners LLC and Barclays Capital Inc. served as placement agents for the Private Placement and received a placement fee from the Company in connection therewith.

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We are a clinical stageclinical-stage biotechnology company advancing antibody therapies that modulate immune pathways implicated in autoimmune and inflammatory diseases. Our pipeline includes ANB033, a CD122 antagonist in development for celiac disease and eosinophilic esophagitis; rosnilimab, a pathogenic T cell depleter in development for rheumatoid arthritis; and ANB101, a BDCA2 modulator.

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ANB033 is an antagonist of CD122, the common beta subunit shared by the IL-15 and IL-2 receptors. IL-15 and IL-2 signaling mediate the proliferation and survival of subsets of CD8+ and CD4+ T+ cells, NK cells, as well as ILC2s. ANB033 is an antibody designed with an optimal epitope and affinity to CD122 that inhibits IL-15 and IL-2 signaling through both the intermediate affinity IL-2 receptor (comprised of CD122 and the common gamma subunit, CD132) expressed by cytolytic CD8 T cells as well as NK cells and the high affinity IL-2 receptor (comprised of CD122, CD132 and the alpha receptor subunit for IL-2, CD25) expressed by activated CD4 Th1 and Th2 T cells as well as ILC2. Antagonizing CD122 has the potential to achieve and maintain remission of inflammation through the reduction of disease-causing cytolytic CD8 T cell subsets, including intraepithelial lymphocytes (“IELs”), NK cells and reducing inflammatory cytokine secretion by activated CD4+ Th1 and Th2 cells, as well as ILC2 cells.

Reworded

We announced top-line data from a healthy volunteer Phase 1a trial of ANB033 in October 2025 that demonstrated no safety concerns at any dose and a rapid and sustained PK profile. A total of 80 subjects were enrolled in the randomized, double-blind, placebo-controlled healthy volunteer Phase 1 trial, where SAD cohorts received SC or IV single doses of ANB033 or placebo, while MAD cohorts received four weekly SC doses of ANB033. ANB033 was generally well-tolerated and no SAE discontinuations or dose-limiting toxicities were observed in the study. ANB033 demonstrated an estimated two-to-three week half-life and full receptor occupancy for SC and IV routes of administration. A dose response was observed on relevant PD biomarkers. We observed responsive effects in the peripheral blood with both IV and SC modes of administration. In this trial, treatment with ANB033 resulted in: 1) a 70-75% reduction in CD122-expressing CD8 T cells, which did not result in a meaningful reduction in overall CD8 T cells; 2) effectively elimination of effectively all CD122-expressing NK cells, but the overall NK cell count remained above the levels believed to be needed to maintain immune competency as not all NK cells in humans express CD122 and 3) no observed overall reductions onof regulatory T cell counts.

Reworded

We are conducting a randomized placebo-controlled 60-patient,~70-patient, global Phase 1b trial cohort of ANB033 in celiac disease (“CeD”). This trial will assess both a cohort of patients with baseline villus height to crypt depth (“Vh:Cd”) ratio greater than 2.0 in a gluten-challenge to assess prevention of further mucosal damage, as well as a cohort of patients with a Vh:Cd ratio less than 2.0,or equal to 2.5, who will not be subjected to a gluten-challenge, to assess the ability to heal mucosal damage in symptom-controlledpatients patients.with active symptoms. The two distinct cohorts will enrolleach 30 patients each,be randomized 1:1 between one dose level of subcutaneously administered ANB033 dose and placebo. Key assessments include safety and tolerability, efficacy assessments including the change in Vh:Cd ratio, IEL counts, and PROs, such as the Celiac Disease Symptom Diary (“CDSD”), as well as PK and immunogenicity.

Added

The FDA granted Fast Track designation to ANB033 for the treatment of people with CeD on a gluten-free diet.

Reworded

In February 2025, we announced initial data that was updated in June 2025, from rosnilimab’s randomized, placebo-controlled, global 424-patient, Phase 2b clinical trial for moderate-to-severe rheumatoid arthritis. Patients were randomized to receive either 100mg of subcutaneous rosnilimab every four weeks (“Q4W”), 400mg Q4W, 600mg every two weeks, or placebo.

Reworded

During the three-month placebo-controlled period, the trial achieved its primary endpoint by observing the reduction of disease activity using the disease activity score, 28 joints (DAS-28“DAS28”) C-Reactive Protein (“CRP”) score as well as ACR20 response (an accepted Phase 3 registrational endpoint), at Week 12 in all three doses of rosnilimab compared to placebo. Rosnilimab achieved its secondary endpoint by demonstrating statistical significance in at least one dose and numerical superiority at all doses, including once monthly administration, on ACR20, ACR50 and with respect to the clinical disease activity index (“CDAI”) low disease activity (“LDA”) score at Week 12. Specifically, at Week 12, ACR20 achieved statistical significance at 100 mg (p < 0.05), 400 mg (p < 0.01), and 600 mg (p < 0.001); ACR50 achieved statistical significance at 600 mg (p < 0.05); and CDAI LDA achieved statistical significance at 100 mg (p < 0.05) and 400 mg (p < 0.01).

Reworded

We completed an End-of-Phase 2 (“EOP2”) meeting with the FDA in the first quarter of 2026.

Reworded

Clinical outcomes were further substantiated by objective translational data. An approximately 50% reduction in the mean CRP from baseline, an objective measure of inflammation, was observed through Week 28 in rosnilimab patients who entered the all-active period. Additionally, translational blood and synovial biopsy biomarker data showed differentiated and consistent immunological impact with on-target pharmacological activity in rosnilimab patients that was not observed on placebo. In blood, rosnilimab demonstrated rapid, deep and sustained reductions of approximately 90% in pathogenic T cells (largely Tph, TphTfh and Teff cells), and an increase in total Tregs. Additionally, synovial biopsies of the most impacted joint taken at baseline and after six weeks showed a deep reduction of approximately 90% in pathogenic T cells (largely Tph cells) at the 400mg Q4W and 600mg Q2W doses, showing a dose response relative to the 100mg Q4W dose.

Reworded

We initiated a Phase 1 clinical trial of ANB101 in healthy volunteers in March 2025 and completed the trial isin ongoing.August 2026. ANB101 preclinical data suggests it is a more potent antibody compared to litifilimab with a longer half-life that results in a deeper and more durable PD effect on pDC depletion.

Reworded

We are an emerging growth company (“EGC”). The Jumpstart Our Business Startups Act (the “JOBS Act”) contains provisions that, among other things, reduce certain reporting requirements for an EGC. We have elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our audited combined financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. Refer to Note 2 to our combined financial statements included elsewhere in this Quarterly Report for additional information regarding new or revised accounting pronouncements.

Reworded

Results of Operations—Comparison of the Three and Six Months Ended MarchJune 31,30, 2026 and 2025

Reworded

Research and development expenses were $34.0$25.6 million during the three months ended MarchJune 31,30, 2026 compared to $41.5$39.3 million during the three months ended MarchJune 31,30, 2025, a decrease of $7.5$13.7 million. The decrease is primarily attributable to ana $8.4$11.1 million decrease in clinical expensesand related expenses, and a decrease of $0.9$2.6 million in other research and development expenses, offset by a $1.5 million increasedecrease in salaries and related costs, including an increase of $0.1 million in stock compensation expense, $0.2 million increase in manufacturing expenses and a $0.1 million increase in recruiting expenses.expense.

Added

Research and development expenses were $59.6 million during the six months ended June 30, 2026 compared to $80.7 million during the six months ended June 30, 2025, a decrease of $21.1 million. The decrease is primarily attributable to a $20.1 million decrease in clinical and related expenses, and a $1.0 million decrease in salaraies and related costs, including stock compensation.

Reworded

General and administrative expenses were $18.9$9.3 million during the three months ended MarchJune 31,30, 2026 compared to $9.8$6.6 million during the three months ended MarchJune 31,30, 2025, an increase of approximately $9.1$2.7 million. The increase is primarily due to a $4.7$2.0 million increase in personnel costs, including an increase of $3.6$1.1 million in stock compensation expense, and a $3.8$1.0 million increase in legal expenses, andoffset by a $0.7$1.4 million increasedecrease in other general and administrative expenses, offset by a $0.1 million decrease in market research costs.expenses.

Added

General and administrative expenses were $28.1 million during the six months ended June 30, 2026 compared to $16.4 million during the six months ended June 30, 2025, an increase of approximately $11.7 million. The increase is primarily due to a $2.6 million increase in personnel costs, an increase of $5.1 million in stock compensation expense, and a $5.0 million increase in legal expenses, offset by a $1.0 million decrease in other general and administrative expenses.

Reworded

Interest income was $2.3$1.6 million and $4.1$3.5 million during the three months ended MarchJune 31,30, 2026 and 2025, respectively, which primarily related to our short-term and long-term investments. The decrease in interest income is primarily due to the decrease in investment balances, as well as the timing of sales, maturities and purchases of our investments.

Added

Interest income was $3.9 million and $7.6 million during the six months ended June 30, 2026 and 2025, respectively, which primarily related to our short-term and long-term investments. The decrease in interest income is primarily due to the decrease in investment balances, as well as the timing of sales, maturities and purchases of our investments.

Reworded

Other expense, net was less than $0.1 million during the three and six months ended MarchJune 31,30, 2026 and 2025, respectively.

Removed

As of March 31, 2026, and prior to the Spin-Off, we had $286.5 million in cash and cash equivalents.

Reworded

Our working capital requirements and capital expenditures have historically been satisfied as part of AnaptysBio, Inc.’sAnaptysBio’s corporate-wide cash management and centralized funding programs. This arrangement is not reflective of the manner in which we would have financed our operations had we been a standalone public company during the periods presented. Following the Spin-Off, we expect to incur significant expenses and operating losses for the foreseeable future as we continue the clinical development of our programs and our research activities. We have not yet commercialized any products and we do not expect to generate revenue from sales of products in the near future, if at all.

Added

Private Placement

Added

On March 26, 2026, First Tracks Biotherapeutics and EcoR1 Capital Fund Qualified, L.P. (“EcoR1”) entered into a securities purchase agreement (the “Purchase Agreement”) with certain third party investors (collectively, the “Selling Stockholders” and each, a “Selling Stockholder”), pursuant to which, following the closing of the Spin-Off, First Tracks Biotherapeutics issued and sold an aggregate 5,791,479 shares of First Tracks Biotherapeutics common stock (the “Primary Shares”), and EcoR1 sold an aggregate of 4,705,575 shares of First Tracks Biotherapeutics common stock (the “Secondary Shares”) that EcoR1 received in the to the Selling Stockholders, at a purchase price of $13.81 per share (the “Private Placement”). The aggregate gross proceeds to First Tracks Biotherapeutics from the sale of the Primary Shares was approximately $80 million, before deducting offering expenses. First Tracks Biotherapeutics did not receive any proceeds from the sale of the Secondary Shares.

Reworded

Cash and cash equivalents totaled $286.5$168.0 million as of MarchJune 31,30, 2026, compared to $311.6 million as of December 31, 2025.

Reworded

Based on our current plans, we believe that our existing cash, cash equivalents and investments will fund our current operating plan for at least the next 12 months from the issuance of our combined financial statements. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect and we may fail to complete development of one or more of our products. Additionally, the process of testing product candidates in clinical trials and seeking regulatory approval is costly, and the timing of progress and expenses in these trials is uncertain.

Reworded

The following table summarizes our cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025:

Removed

Net cash used in operating activities during the three months ended March 31, 2026 of $32.6 million was primarily due to our net loss of $50.5 million, adjusted for addbacks for non-cash expenses of $11.6 million, which includes depreciation and stock-based compensation, and net increases in working capital of $6.3 million.

Reworded

Net cash used in operating activities during the threesix months ended MarchJune 31,30, 20252026 of $45.0$64.5 million was primarily due to our net loss of $47.2$83.9 million, adjusted for addbacks for non-cash expenses of $6.7$20.3 million, which includes depreciation, stock-based compensation, amortization of operating ROUright-of-use assets, and income from marketable securities,securities and net decreases in working capital of $4.5$0.9 million.

Added

Net cash used in operating activities during the six months ended June 30, 2025 of $83.6 million was primarily due to our net loss of $89.6 million, adjusted for addbacks for non-cash expenses of $13.3 million, which includes depreciation, stock-based compensation, amortization of operating ROU assets, and income from marketable securities, and net decreases in working capital of $7.3 million.

Reworded

Cash provided by investing activities during the threesix months ended MarchJune 31,30, 2026 of $35.0 million, primarily relates to the timing of sales, maturitiessale and purchasesmaturities of investments.

Reworded

Cash provided by investing activities during the threesix months ended MarchJune 31,30, 2025 was $14.8$51.3 million, primarily due to the sale and maturities of investments of $137.4$228.1 million, offset by the acquisition of investments of $122.6$176.8 million.

Reworded

The net cash providedused byin financing activities during the threesix months ended MarchJune 31,30, 2026 andwas 2025 of $7.9 million and $5.7$40.7 million, respectively, wasprimarily due to the proceeds from our public offering and the separation from AnaptysBio offset by the net investment by AnaptysBio.

Added

The net cash used in financing activities during the six months ended June 30, 2025 of $46.4 million was due to the net investment by AnaptysBio.

TRAX insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 2 filings (2 insiders, 2 trade dates, 4,744,840 shares, about $66.7M). Net open-market shares: -4,744,840 (purchases minus sales); net value about -$66.7M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-09-15Orwin John A
Director
Option exercise 1,300— —17,995 SEC
2026-09-02Ware J. Anthony
Director
Option exercise 39,265$5.74 $225.4K54,925 SEC
2026-09-02Ware J. Anthony
Director
Open-market sale 39,265$44.78 $1.8M15,660 SEC
2026-06-15Jain Rita
Director
Option exercise 7,330— —19,194 SEC
2026-06-15Ware J. Anthony
Director
Option exercise 6,030— —15,660 SEC
2026-06-15Schmid John P.
Director
Option exercise 6,030— —37,652 SEC
2026-06-15Orwin John A
Director
Option exercise 6,030— —16,695 SEC
2026-06-15Marquet Magda
Director
Option exercise 6,030— —15,960 SEC
2026-06-15Fenton Dennis M
Director
Option exercise 6,030— —10,995 SEC
2026-04-20Ecor1 Capital, Llc
10% owner
Open-market sale 4,705,575$13.81 $65.0M3,174,519 SEC
2026-04-20Anaptysbio, Inc
10% owner
Other 100— —0 SEC

Well-known investors holding TRAX (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Point72 Asset Management (Steve Cohen) ORD SHS2026-06-30408,330$8.2M0.01%New position
Citadel Advisors (Ken Griffin) ORD SHS2026-06-30168,790$3.4M0.0%New position
D. E. Shaw & Co. ORD SHS2026-06-30128,130$2.6M0.0%New position
AQR Capital Management (Cliff Asness) ORD SHS2026-06-3028,812$579.7K0.0%New position

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when TRAX files, watchlists and downloadable comparisons.