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

We currently have no products that are approved for commercial sale and may never be able to develop a marketable product. To date, we have invested a significant portion of our efforts and financial resources on the development of PIPE-791 and PIPE-307. We wholly-own, and are pursuing the clinical development of, PIPE-791 for the treatment of IPF, PrMSIPF and chronic pain associated with two separate indications, OACOAP and LBP.CLBP. In February 2023, we entered into the J&J License Agreement, pursuant to which we granted J&J an exclusive, worldwide license to develop, manufacture and commercialize PIPE-307 in all indications in exchange for an upfront payment and the right to receive future milestone payments and royalties. We arehave conductingcompleted atwo Phase 21 clinical trialtrials of PIPE-307 forin thehealthy potentialvolunteers. treatment of RRMS, and inIn December 2024, J&J began recruiting an estimated 124 adult participants for a Phase 2 Moonlight-1 trial of PIPE-307/JNJ-89495120PIPE-307, forrenamed theby potentialJ&J treatmentto of MDD.JNJ-89495120. This trial is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study to evaluate the efficacy, safetysafety, and tolerability of PIPE-307/JNJ-89495120 as a monotherapy in adult participants with MDD. AfterIn November 2025, we completereported thetopline data from our Phase 2 clinicalVISTA fortrial of PIPE-307 for the potential treatment of RRMS,patients with RRMS. The trial demonstrated acceptable safety and tolerability at both doses that were investigated in the trial. The trial did not meet its prespecified primary and secondary efficacy endpoints. J&J has sole discretion towhether determineor whethernot to pursue further development ofdevelop PIPE-307 for thisRRMS, indicationMDD or any other indication. Our future success is, therefore, dependent on our ability to successfully complete clinical development for, obtain regulatory approval for, and successfully commercialize PIPE-791 and on J&J’s efforts to successfully complete clinical development for, obtain regulatory approval for, and successfully commercialize PIPE-307. We cannot be certain that we or J&J, respectively, will be able to successfully complete any of these activities or that, even if PIPE-791 and/or PIPE-307 receive regulatory approval, such products will be able to successfully compete against therapies and technologies offered by other companies.

PIPE-791 and PIPE-307 are currently in the early stages of clinical development. We have completed a Phase 1 clinicaltrial trialto evaluate the safety, tolerability, and PK of single and multiple doses of PIPE-791 in healthy volunteers inas supportwell as a Phase 1b open-label trial that measured the relationship of clinicalPK developmentto brain RO by PET imaging, and we recently initiated a Phase 2 trial of PIPE-791 in IPF,IPF. PrMSIn andthe infourth Novemberquarter 2024of 2025, we receivedcompleted authorizationenrollment of our IND from the FDA to initiatein an exploratory PIPE-791 Phase 1b, randomized, double-blind, placebo-controlled, crossovercrossover, studychronic pain trial for the treatment of PIPE-791 in chronic pain associated with OAtwo separate indications, COAP and LBP.CLBP. We have completed two Phase 1 trials of PIPE-307 in healthy volunteers and are conducting a Phase 2 trial of PIPE-307 for the potential treatment of RRMS.volunteers. In December 2024, J&J began recruiting an estimated 124 adult participants for a Phase 2 Moonlight-1 trial of PIPE-307/JNJ-89495120PIPE-307, forrenamed theby potentialJ&J treatmentto of MDD.JNJ-89495120. This trial is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study to evaluate the efficacy, safetysafety, and tolerability of PIPE-307/JNJ-89495120 as a monotherapy in adult participants with MDD. In November 2025, we reported topline data from our Phase 2 VISTA trial of PIPE-307 for the treatment of patients with RRMS. The trial demonstrated acceptable safety and tolerability at both doses that were investigated in the trial. The trial did not meet its prespecified primary and secondary efficacy endpoints. The results from our preclinical studies and the early clinical trials for these drug candidates may not be predictive of the results of the current clinical trials being conducted and any later-stage clinical trials conducted for these drug candidates. In addition, results of third-party studies, as well as our evaluations of third-party compounds, may not be predictive of results for our drug candidates. Drug candidates in clinical trials, including PIPE-791 and PIPE-307, may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and early-stage clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in advancing through the clinical trial process due to lack of efficacy or adverse safety profiles, notwithstanding earlier promising results. In addition, conclusions based on promising data from analyses of clinical results may be shown to be incorrect in subsequent clinical trials that have pre-specified end points or may not be considered adequate by regulatory authorities. Even if the current and anticipated clinical trials for PIPE-791 and PIPE-307 are completed as planned, we cannot be certain that their results will support the safety and efficacy requirements sufficient to pursue later clinical trials and eventually obtain regulatory approval, and, as a result, we may never generate commercial revenues from these drug candidates. Moreover, if we or J&J are not able to differentiate PIPE-791 and PIPE-307, respectively, against other approved products for the indications being targeted for PIPE-791 and PIPE-307, or if any of the other circumstances described above occur, our business would be materially harmed and our ability to generate revenue from these drug candidates would be severely impaired.

We may experience delays in initiating and successfully completing the clinical trials that we intend to conduct, including our current and planned clinical trials for PIPE-791 and PIPE-307.PIPE-791. Any delays in initiating and successfully completing our clinical trials could increase our costs, slow the development and approval process and harm the commercial prospects of our drug candidates. Similarly, J&J may experience delays in initiating and completing the clinical development of PIPE-307, which would delay our receipt of potential milestone payments or royalties under the J&J License Agreement. Any of these occurrences could materially harm our business, financial condition and results of operations.

We may experience delays in initiating and completing any clinical trials that we intend to conduct, including our current and planned clinical trials for PIPE-791 and PIPE-307,PIPE-791, and we do not know whether our clinical trials will begin on time, need to be redesigned, enroll sufficient numbers of patients on time, or be completed on schedule, or at all. J&J will face similar concerns for its current and any future clinical trials it conducts for PIPE-307. A clinical trial can be delayed for a variety of reasons, including delays related to:

If the commencement or completion of any clinical trials for PIPE-791 or PIPE-307any of our future drug candidates is delayed, or if a clinical trial is terminated prior to completion, the commercial prospects of the applicable drug candidate could be harmed, and our ability to generate revenues or royalties from such drug candidate may be delayed. In addition, any delays in our clinical trials could increase our costs, slow the development and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences could materially harm our business, financial condition and results of operations. In addition, many of the factors that may cause, or lead to, a delay in the commencement or completion of a clinical trial may also ultimately lead to the denial of regulatory approval of the applicable drug candidate.

We intend to explore the development of PIPE-791 in indications in addition to IPF, PrMSIPF and chronic pain associated, initially, with OACOAP and LBP. In addition, we have designated CTX-343, a peripherally-restricted LPA1R antagonist, as a drug candidate.CLBP. We also intend to continue to explore additional drug candidates based on our clinical translational approach and drug development efforts. In each case, we may fail to successfully identify additional indications for PIPE-791,PIPE-791or identify and develop CTX-343, or identify viable new drug candidates for clinical development. If we fail to identify additional indications for PIPE-791 or additional potential drug candidates, our business and growth plans could be materially harmed. Further, under the terms of our License Agreement with J&J, J&J has sole discretion to determine whether to pursue further development of PIPE-307 for RRMSRRMS, MDD or any other indication.

We have previously conducted clinical trials outside of the United States, including our Phase 1 clinical trial of PIPE-307, which was conducted under authorization of the Australian Therapeutic Goods Administration (“TGA”) and the National Health and Medical Research Council (“NHMRC”) and both a Phase 1b PET study of PIPE-307,PIPE-307 as well as a Phase 1b PET clinical trial for PIPE-791 in IPF and PrMS, which waswere conducted under the authorization of the Research Ethics Committee (“REC”) and the MHRA in the United Kingdom. We completedAdditionally, our recently initiated Phase 1b PET clinical2 trial for PIPE-307 in RRMS in the United Kingdom, and we are conducting our Phase 1b PET clinical trial forof PIPE-791 in IPF andwill PrMSbe inconducted the United Kingdom.globally. We also plan to conduct additional clinical trials outside the United States in the future. Although the FDA and other foreign regulatory authorities may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to certain conditions imposed by these regulators. For example, non-clinical toxicology studies for our Phase 1b PET study of PIPE-307 were performed in China that were not GLP compliant and – as China is not a signatory on the Organization for Economic Co-operation and Development (“OECD”), Mutual Acceptance of Data system, a multilateral agreement that allows participating countries to share the results of various non-clinical tests performed using OECD methods and principles – the non-clinical data were not considered acceptable to support the trial. While the Phase 1b was approved on the basis of clinical safety data, the MHRA stated that prior to Marketing Authorization Approval of PIPE-307 in the United Kingdom, an inspection or further evaluation could be triggered. Further, in cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; and (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations. In general, the patient population for any clinical trials conducted outside the United States must be representative of the population for whom we intend to label the drug candidate in the United States. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory authorities have similar approval requirements for clinical trials. In addition, such trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. Further, the FDA must be able to validate the data from the clinical trial through an onsite inspection if it deems such inspection necessary. In addition, when clinical trials are conducted only at sites outside of the United States, such trials may not be subject to IND review, meaning the FDA may not provide advance comment on the clinical protocols for the trials, and therefore there is an additional potential risk that the FDA could determine that the trial design or protocol for a non-U.S. clinical trial was inadequate, which would likely require an additional clinical trial in order to obtain FDA approval. If the FDA does not accept data from any clinical trials we conduct outside the United States, it would likely result in the need for additional clinical trials, which would be costly and time consuming and delay our drug development plans, which could materially harm our business, financial condition, results of operations and prospects.

Serious adverse events or undesirable side effects caused by PIPE-791 or PIPE-307 could cause us or J&J, as applicable, or regulatory authorities to interrupt, delay, or halt the clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities for these drug candidates. Results of any clinical trial for PIPE-791 or PIPE-307 could reveal a high and unacceptable severity and prevalence of side effects. If unacceptable side effects arise in the development of any drug candidate, we or J&J, as applicable, the FDA, or the IRBs or IECs at the institutions in which a studyclinical trial is being conducted, or the DSMB, if constituted for a clinical trial, could recommend a suspension or termination of the clinical trial, or the FDA or comparable foreign regulatory authorities could prohibit the further development of or deny approval of a drug candidate for any or all targeted indications. In addition, drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a clinical trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We or J&J, as applicable, may need to train medical personnel regarding the proper administration protocols for PIPE-791 and PIPE-307 and to understand the potential side effect profiles for these drug candidates. Inadequate training in recognizing or managing the potential side effects of PIPE-791 or PIPE-307 could result in patient injury or death. Any of these occurrences may harm our business, financial condition, results of operations and prospects significantly.

We have focused our effortsfocus on developing selective compounds targeting challenging molecular pathways and have built a portfolio of small molecule drug candidates. We believe our two clinical stage,clinical-stage, internally-discovered drug candidates, PIPE-791 and PIPE-307, will have broad applicability across multiple NI&I indications. We are developing PIPE-307 in collaboration with J&J.

Our wholly-owned lead asset, PIPE-791, is a novel, brain penetrant, small molecule inhibitor of the LPA1R in development for IPF, PrMS,IPF and chronic pain. LPA1R antagonism is a clinically validated mechanism in IPF, and we believe that our preclinical studies andstudies, Phase 1 healthy volunteer data, and Phase 1 PET data support the development of PIPE-791 for IPF, as well as PrMSIPF and chronic pain. Specifically, based on its high bioavailability, high selectivity, low plasma protein binding, and long receptor residence time in our preclinical studies compared to the preclinical data of other LPA1R antagonists,time, we believe PIPE-791 has the potential to be a differentiated LPA1R therapy. We have completed a Phase 1 clinical trial of PIPE-791 in healthy volunteers in support of clinical development in IPF, PrMS and chronic pain. In DecemberSeptember 2024,2025, we commencedreported apositive top-line data from our completed Phase 1b open-labelPET trial towhich measuremeasured the relationship of PK to lung and brain receptor occupancyRO by PET imaging. We expect the top-lineThe data from this trial will be available in the second quarter of 2025. This Phase 1b PET trial willfurther informaffirmed the planned dose selection for our planned Phase 2 trialstrial of PIPE-791 in IPFIPF, andwhich PrMS.was initiated in December 2025. In November 2024, the FDAfourth authorized our IND for the treatmentquarter of chronic pain associated with two separate indications, OA and LBP. On March 4, 2025, we announcedcompleted theenrollment initiationfor ofa patient dosing in an exploratory PIPE-791 Phasephase 1b, randomized, double-blind, placebo-controlled, crossover,crossover chronicstudy painwhich trial.was We expectdesigned to enrollexplore approximatelythe 40safety patientsand atefficacy upof tooral five sitesPIPE-791 in thesubjects U.S.,with andCOAP aor treatment duration of 28 days.CLBP. We anticipate top-line data from this trial in earlythe second quarter of 2026.

Our second novel drug candidate, PIPE-307, is a novel,selective, small molecule selectivesmall-molecule inhibitor of the M1R, in development for depression and RRMS. We have completed two Phase 1 trials of PIPE-307 in healthy volunteers. In 2023, we initiated a Phase 2 VISTA trial of PIPE-307 for the potential treatment of RRMS. In January 2025, we announced that we have fully enrolled our Phase 2 VISTA trial. We expect the top-line data from this trial will be available in the second half of 2025. In December 2024, J&J began recruiting an estimated 124 adult participants for athe Phase 2 Moonlight-1 trial of PIPE-307/JNJ-89495120PIPE-307, forrenamed theby potentialJ&J treatmentto of MDD.JNJ-89495120. This trial is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study to evaluate the efficacy, safetysafety, and tolerability of PIPE-307/JNJ-89495120 as a monotherapy in adult participants with MDD. In November 2025, we reported top-line data from our Phase 2 VISTA trial of PIPE-307 for the treatment of patients with RRMS. The trial demonstrated acceptable safety and tolerability at both doses that were investigated in the trial. The trial did not meet its prespecified primary and secondary efficacy endpoints. J&J has sole discretion whether or not to further develop PIPE-307 for RRMS, MDD or any other indication. We believe PIPE-307 is the most advanced selective M1R antagonist in clinical development.

Other Income (Expense)

We are subject to corporate U.S. federal and state income taxation. As of December 31, 20242025 and 2023,2024, we had federal net operating loss carryforwards of $46.7$135.5 million and $37.3$46.7 million, respectively, and state net operating loss carryforwards of $81.4 million and $81.4 million, respectively. As a result of the TCJA, for U.S. federal income tax purposes, net operating losses generated prior to JanuaryDecember 1,31, 20182017 can be carried forward for up to 20 years, while net operating losses generated on or after JanuaryDecember 1,31, 20182017 can be carried forward indefinitely, but are limited to 80% utilization against future taxable income each year. Out of the total federal net operating losses, approximately $135.5 million were generated after December 31, 2017, and therefore do not expire. Utilization of our net operating loss carryforwards may be subject to a substantial annual limitation due to the ownership change limitations provided by the IRC and similar state provisions. This annual limitation may result in the expiration of our net operating losses and credits before utilization.

General and administrative expenses. General and administrative expenses were $12.5$16.5 million and $6.3$12.5 million for the years ended December 31, 20242025 and 2023,2024, respectively. The increase of $6.2$4.0 million was primarily due to a $2.8 million increase in non-cash stock-based compensation, a $1.6 million increase in consulting and legal expenses, a $1.3$2.0 million increase in personnel-related expenses related to an overall increase in personnel from period to period, $1.6 million increase in non-cash stock-based compensation, $0.3 million increase in facilities costs, and a $0.5$0.1 million increase in director and officer insurance associated with our recently completed IPO.insurance.

Interest income. Interest income was $8.9$8.2 million and $4.6$8.9 million for the years ended December 31, 20242025 and 2023,2024, respectively. The increasedecrease of $4.3$0.7 million was due to ana increase in funds invested in marketable securities and an increasedecrease in the yields earned on our cash equivalents and marketable securities.securities from period to period.

We have incurred net losses and negative cash flows from operations in nearly every reporting period since our inception and anticipate that we will continue to incur net losses for the foreseeable future. We expect to incur substantial expenditures as we advance our drug candidates through clinical development, undergo the regulatory approval process, engage in other research and development activities to expand our pipeline of drug candidates, expand our operations and headcount, maintain and expand our intellectual property portfolio and, if we obtain approval for one or more of our drug candidates, launch commercial activities. We alsohave incurred and expect to continue to incur additional costs associated with our operating as a public company, including significant legal, accounting, investor relations, director and officer insurance, and other expenses that we did not incur as a private company.

Through December 31, 2024,2025, we have funded our operations primarily throughfrom the issuancesale of convertibleequity promissorysecurities notes, the private placements of ourand convertible preferredequity stock,securities, and the J&J License Agreement, our Loan Agreement with First Citizens, and net proceeds from our initial public offering (“IPO”).Agreement. Through December 31, 2024,2025, we have raised gross proceeds of approximately $312.8$431.6 million fromthrough theequity issuance of our convertible preferred stock, promissory notes, our Class A common stock in the IPO,issuances and have received an upfront payment from the J&J License Agreement of $50.0 million. Upon the closing of ourthe IPO, our outstanding convertible preferred stock automatically converted into Class A common stock or Class B common stock, as applicable. In April 2024, we raised approximately $107.9 million in net proceeds from the IPO of our shares of Class A common stock. As of December 31, 2024, we had an accumulated deficit of $117.4 million.

As of December 31, 2024,2025, we had an accumulated deficit of $177.4 million. As of December 31, 2025, we had cash, cash equivalents and marketable securities of $204.8$262.9 million. Based on our current operating plan, we believe that our existing cash and cash equivalents and short-termmarketable investments,securities, will be sufficient to meet our anticipated operating expenses and capital expenditure requirements through at least the next 12 months, following the date of this Annual Report.

Net cash used in operating activities for the year ended December 31, 2025 was primarily related to our net loss of $60.0 million and a $6.0 million change in operating assets and liabilities, partially offset by $10.7 million of non-cash charges such as stock-based compensation, depreciation and amortization, operating lease expense, and accretion of premiums/discounts on marketable securities. Net cash used in operating activities for the year ended December 31, 2024 was primarily duerelated to our net loss of $42.3 million, partially offset by $4.1 million of non-cash charges such as stock-based compensation, depreciation and amortization, operating lease expense, accretion of premiums/discounts on marketable securities, and change in fair value of an outstanding warrant to purchase shares of our common stock. Also impacting our net cash used in operating activities for the year ended December 31, 2024 was a $5.3 million increase in our in operating assets and liabilities. Net cash provided by operating activities for the year ended December 31, 2023 was primarily due to our net income of $22.7 million, offset by $2.3 million of non-cash charges such as stock-based compensation, depreciation and amortization, non-cash operating lease expense, accretion of premiums/discounts on marketable securities, the change in fair value of our investor rights and obligations liability, and accretion of debt discount, and a $1.0 million change in operating assets and liabilities.

Investing in our common stock involves a high degree of risk. In addition to the information set forth in this Quarterly Report on Form 10-Q, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our condensed financial statements and related notes, you should consider carefully the factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 5, 2026. The occurrence of any of the risks and uncertainties described in such Annual Report could materially and adversely affect our business, financial condition, results of operations and prospects. In that event, the price of our common stock could decline and you could lose part or all of your investment. Furthermore, such risks are not the only ones we face; additional risks and uncertainties not currently known or that we currently deem to be immaterial may also materially adversely affect our business, financial condition or results of operations. The below risk factor updates and replaces the risk factor with the same title in Part I, Item 1A, “Risk Factors” of the Company’s Annual Report on Form 10-K. Except as set forth below, there have been no material changes from the risk factors set forth in Part I, Item 1A of the Company’s Annual Report on Form 10-K.

We are a clinical-stage biopharmaceutical company pioneering structurally differentiated small molecule therapies for theinflammatory treatmentand offibrotic NI&I indicationsdiseases with significant unmet need. We target biological pathways associated with specific clinical impairments that we believe, once modulated, will demonstrably alter the course of disease.

We focus on developing selective compounds targeting challenging molecular pathways and have built a portfolio of small molecule drug candidates. We believe our two clinical stage, internally-discovered drug candidates, PIPE-791 and PIPE-307, will have broad applicability across multiple NI&I indications. We are developing PIPE-307 in collaboration with J&J.

Our wholly-owned lead asset, PIPE-791, is a novel, brain penetrant, small molecule inhibitor of the lysophosphatidic acid receptor 1 receptor (“LPA1RLPAR1”) in development for idiopathic pulmonary fibrosis (“IPF”) and chronic pain. LPA1RLPAR1 antagonism is a clinically validated mechanism in IPF, and we believe that our preclinical studies, Phase 1 healthy volunteer data, and Phase 1 positron emission tomography (“PET”) data support the development of PIPE-791 for IPFIPF, chronic pain and chronicother pain.fibrotic diseases. Specifically, based on its high bioavailability, high selectivity, low plasma protein binding, and long receptor residence time, we believe PIPE-791 has the potential to be a differentiated LPA1RLPAR1 therapy.therapy with broad therapeutic potential (portfolio in a pill). In September 2025, we reported positive top-line data from our completed Phase 1b PET trialtrial, which measured the relationship of pharmacokinetics to receptor occupancy (“RO”) by PET imaging. The data from the Phase 1b PET trial further affirmed the planned dose selection for our Phase 2 trial of PIPE-791 in IPF,IPF. whichThe wasCompany initiated patient dosing in DecemberPROPEL-IPF, 2025.a global Phase 2 clinical trial evaluating PIPE-791 for the treatment of patients with IPF, in the first quarter of 2026. PROPEL-IPF is a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy, safety, tolerability and pharmacokinetics of once-daily, oral PIPE-791 in approximately 324 IPF patients. The primary efficacy endpoint is the change from baseline through week 26 in absolute forced vital capacity (FVC mL). To date, the Company has activated more than 50 clinical trial sites. In the fourth quarter of 2025, we completed enrollment for a Phase 1b, randomized, double-blind, placebo-controlled, crossover study which was designed to explore the safety and efficacy of oral PIPE-791 in subjects with chronic osteoarthritic pain or chronic low back pain. We announced positive topline data from this trial in April 2026. The Phase 1b trial achieved its primary endpoint demonstrating favorable safety and tolerability.tolerability with no clinically-relevant orthostatic events. We also observed encouraging trends across multiple exploratory efficacy endpoints including improvements in measures of pain, and other functional patient-reported outcomes. We believe these results support further evaluation of PIPE-791 in chronic pain.

Our secondpartnered novel drug candidate, PIPE-307, is a selective, small-molecule inhibitor of the muscarinic type 1 receptor (“M1R”), in development for depression and relapse-remitting multiple sclerosis (“RRMS”).depression. We have completed two Phase 1 trials of PIPE-307 in healthy volunteers. In December 2024, J&J begancompleted recruitingenrollment anof estimated 124107 adult participants for theits Phase 2 Moonlight-1 trial of PIPE-307, renamed by J&J to JNJ-89495120.JNJ-89495120, in June 2026. This trial is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, and tolerability of PIPE-307/JNJ-89495120 as a monotherapy in adult participants with major depressive disorder (“MDD”). We estimate this trial to be completed in June 2026. In November 2025, we reported top-line data from our Phase 2 VISTA trial of PIPE-307 for the treatment of patients with RRMS. The trial demonstrated acceptable safety and tolerability at both doses that were investigated in the trial. The trial did not meet its prespecified primary and secondary efficacy endpoints. J&J has sole discretion whether or not to further develop PIPE-307 for RRMS, MDD, or any other indication. We believe PIPE-307 is the most advanced selective M1R antagonist in clinical development.

We have a portfolio of novel and proprietary small molecule programs that we believe can modulate innate pathways to restore function in NI&Iinflammatory indications.and fibrotic diseases. We retain worldwide rights to our LPA1RLPAR1 programs and discovery portfolio, and we have partnered with J&J for the development and potential commercialization efforts of PIPE-307.

(1)We made a strategic decision to defer further clinical development of our PIPE-791 progressive multiple sclerosis (“PrMS”) program and to defer the initiation of clinical development for our CTX-343 program until funding is obtained to specifically move thesethis programsprogram forward.

(2)J&J has sole discretion whether or not to further develop PIPE-307 for RRMSMDD andor MDD.any other indication.

We are also actively conducting preclinical and discovery-phase experiments targeting other NI&Ivarious indications where our internally-discovered molecules may have therapeutic potential.

In December 2024, J&J begancompleted recruitingenrollment anof estimated 124107 adult participants for theits Phase 2 Moonlight-1 trial of PIPE-307, renamed by J&J to JNJ-89495120.JNJ-89495120, in June 2026. This trial is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, and tolerability of PIPE-307/JNJ-89495120 as a monotherapy in adult participants with MDD. We estimate this trial to be completed in June 2026.

We recognize license revenues as identified performance obligations are satisfied or other events occur, specifically related to our J&J License Agreement. Pursuant to the terms of the J&J License Agreement, we received an upfront payment of $50.0 million in May 2023. We are also eligible to receive approximately $1.0 billion in non-refundable, non-creditable milestone payments, pursuant to the terms of the J&J License Agreement. Additionally, we are eligible to receive tiered royalties in the low-double digit to high-teen percent range on net sales of products containing PIPE-307. We determined that the initial transaction price under the J&J License Agreement equals $50.0 million, consisting solely of the upfront, non-refundable payment of $50.0 million received during the year ended December 31, 2023. There was no revenue recognized for the three and six months ended MarchJune 31,30, 2026 and 2025. We do not have any products approved for sale and we have not yet generated any revenue from product sales.

Certain employee activities that cannot be allocated to any one specific project or management related activities are considered indirect costs. The following tables summarize our research and development expenses for the three and six months ended MarchJune 31,30, 2026 and 2025. The direct external development program expenses reflect external costs attributable to our clinical development and preclinical programs and personnel costs that can be directly attributed to a development program. The unallocated internal research and development costs include unallocated personnel costs, facility costs, stock-based compensation, laboratory consumables and discovery and research related activities.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Research and development expenses. Research and development expenses were $11.6$12.7 million and $13.7$14.1 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The decrease of $2.1$1.4 million from period to period was due to the following:

•$2.5$2.0 million decrease in contract research organization costs due to a $2.3$2.1 million decrease in costs related to the completed VISTA Phase 2 clinical trial for PIPE-307 for the treatment of RRMS,relapse-remitting multiple sclerosis (“RRMS”), a $1.4 million decrease in costs related to the completed Phase 1b PET trial for PIPE-791, and a $0.5$0.9 million decrease in costs related to the Phase 1b trial for PIPE-791 for the treatment of chronic painpain, and a $0.4 million decrease in costs related to the completed Phase 1b PET trial for PIPE-791 partially offset by a $1.7$1.4 million increase in costs related to the Phase 2 trial for PIPE-791 for the treatment of IPF, and

Partially offsetting these decreases was a $0.8$0.7 million increase in noncash stock-based compensation, $0.4 million increase in personnel-related expense related to an overall increase in personnel from period to period, $0.6 million increase in noncash stock-based compensation, and a $0.1$0.2 million increase in facilities costs, and $0.2 million increase in equipment costs.

General and administrative expenses. General and administrative expenses were $5.3$4.7 million and $4.4$3.8 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The increase of $0.9 million was due to a $0.6$0.7 million increase in noncash stock-based compensation and a $0.2 million increase in personnel-related expenses related to an overall increase in personnel from period to period.

Interest income. Interest income was $2.5$2.3 million and $2.3$2.0 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The increase of $0.2$0.3 million was due to an increase in funds invested in marketable securities during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025.

Through MarchJune 31,30, 2026, we have funded our operations primarily from the sale of equity securities, convertible equity securities, and the J&J License Agreement. Through MarchJune 31,30, 2026, we have raised gross proceeds of approximately $431.6 million through equity issuances and an upfront payment from the J&J License Agreement of $50.0 million. As of MarchJune 31,30, 2026, we had an accumulated deficit of $191.8$207.0 million.

As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $246.3$236.6 million. Based on our current operating plan, we believe that our existing cash and cash equivalents and marketable securities, will be sufficient to meet our anticipated operating expenses and capital expenditure requirements through at least the next 12 months following the date of this Quarterly Report on Form 10-Q.

In May 2025, we entered into the ATM Sales Agreement relating to the offer and sale of up to $75.0 million in shares of our Class A common stock, par value $0.001 per share in the ATM Program. During the year ended December 31, 2025, we sold 3,241,110 shares of our Class A common stock pursuant to the ATM Sales Agreement generating net proceeds of $19.0 million. In March 2026, we entered into the ATM Amendment with Leerink Partners to increase the aggregate offering price of the shares of our Class A common stock that we may sell pursuant to the ATM Sales Agreement. In connection with the ATM Amendment, we filed the ATM Prospectus Supplement,Supplement pursuantfor to which we maythe offer and sellsale of up to $100.0 million in shares of our Class A common stock under the Amended ATM Sales Agreement, exclusive of amounts previously sold under the ATM Sales Agreement. We did not sell any shares of our Class A common stock under the Amended ATM Amended Sales Agreement during the three and six months ended MarchJune 31,30, 2026.

Net cash used in operating activities was $16.3$27.8 million for the threesix months ended MarchJune 31,30, 2026, which primarily related to our net loss of $14.5$29.6 million and a $5.9 million change in operating assets and liabilities, partially offset by $4.1$7.8 million of noncash charges for stock-based compensation, depreciation and amortization, accretion of premiums/discounts on investments, and noncash operating lease expense. Net cash used in operating activities was $14.4$30.1 million for the threesix months ended MarchJune 31,30, 2025, which primarily related to our net loss of $16.0$32.0 million and a $1.1$3.0 million change in operating assets and liabilities, partially offset by $2.7$4.9 million of non-cash charges for stock-based compensation, depreciation and amortization, accretion of premiums/discounts on investments, and non-cash operating lease expense.

Net cash used in investing activities was $39.3$34.5 million for the threesix months ended MarchJune 31,30, 2026, which related to $97.1$142.9 million of purchases of marketable securities and $0.3 million forof purchases of property and equipment, partially offset by $58.1$108.8 million of sales and maturities of marketable securities. Net cash provided by investing activities was $14.9$28.8 million for the threesix months ended MarchJune 31,30, 2025, which primarily related to $48.7$88.0 million of sales and maturities of marketable securities, partially offset by $33.7$59.1 million of purchases of marketable securities.securities and $0.1 million of purchases of property and equipment.

Net cash provided by financing activities was approximately $0.1$1.3 million for the threesix months ended MarchJune 31,30, 2026, which was primarily related to $0.2$0.8 million of proceeds from the employee stock purchase plan and $0.7 million of proceeds from the exercise of stock options, partially offset by $0.1 million in payments of deferred offering costs. Net cash provided by financing activities was $24,000$0.1 million for the threesix months ended MarchJune 31,30, 2025, which primarily related to $0.3 million of proceeds from the exerciseemployee stock purchase plan, partially offset by $0.2 million in payments of stockdeferred options.offering costs.

Our contractual obligations and commitments relate to our operating leases that relate primarily to our leases of office and laboratory space in San Diego, California and leased equipment used in connection with our on-going Phase 2 clinical trial of PIPE-791 for the treatment of IPF. Our total contractual commitments for our lease agreements amount to approximately $8.0$7.4 million as of MarchJune 31,30, 2026.