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

We recently began our clinical trial for CTIM-76 and CT-95 and no clinical studies have begun on CT-95 or CT-202. It will be several years, if ever, before we obtain regulatory approval for a therapeutic product candidate, at which time any revenues for such product candidate will depend upon many factors, including market conditions, costs and effectiveness of manufacturing, sales, marketing and distribution operations related to such product candidate, the scope of intellectual property protection for such product candidate, and the terms of any collaboration or other strategic arrangement we may have with respect to such product candidate and levels of reimbursement from third-party payors.

If we are unable to develop and commercialize one or more product candidates either alone or with collaborators, including through the potential out-licensing of our product candidates, or if revenues from any product candidate that receives marketing approval or is commercialized are insufficient, we may not achieve profitability or sustain profitability, which would have an adverse effect on the value of our common stock, which would be materially adversely affected.stock.

Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to obtain sufficient funding on a timely basis or on favorable terms, we may be required to significantly delay, reduce or eliminate one or more of our research or product development programs and/or commercialization efforts or we might have to obtain funds through arrangements, such as selling or out-licensing our product candidates, with collaborative partners or others that may require us to relinquish rights to our technologies or product candidates that we otherwise would not relinquish. We may also be unable to expand our operations or otherwise capitalize on business opportunities as desired. Any of these events could materially adversely affect our financial condition and business prospects.

Our recent obtainment of the rights to CT-202 and the acquisition of CT-95, and any other future acquisition that we may undertake, involve risks related to the integration of the acquired assets into the Company after the acquisition is completed. These risks include delays in development timelines, increased expenses, and assumption of undisclosed liabilities.

Investment in biopharmaceutical product development is a highly speculative endeavor and entails substantial upfront capital expenditures. There is significant risk that any product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, obtain any required regulatory approvals or become commercially viable. Our product candidates and the therapeutic approach we are using are new and unproven. We had commenced Phase 2 human clinical trials for ONA-XR, but we ceased development of this product candidate and have only recently initiated clinical trials for one of our other product candidates, and we have not demonstrated an ability to successfully complete any clinical trials, obtain any required marketing approvals, manufacture products, conduct sales, marketing and distribution activities, or arrange for a third party to do any of the foregoing on our behalf.

InflationInflation, geopolitical developments, global supply chain disruptions and public health concerns could adversely affect our business and results of operations.

While inflation in the United States has been relatively low in recent years, the economy in the United States has encountered a materialhigher level of inflation since 2021. Although inflation eased somewhat in 2024, itInflation has raised our costs for commodities, labor, materials, and services and other costs required to grow and operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition. Additionally, increases in inflation, along with public health concerns, geopolitical developments, and global supply chain disruptions,disruptions and public health concerns, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment,instability, which may make it more difficult, costly,difficult or dilutivecostly for us to secure additional financing.financing or acquire the supplies necessary to run our clinical trials. A failure to adequately respond to these risks could have a material adverse impact on our financial condition, results of operations, or cash flows.

•our ability, and the ability of any third parties with whom we contract, to remain in good standing with regulatory agencies and to develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices (“cGMPs”);

•the prevalence, duration and severity of potentialany side effects or other safety issues experienced with our product candidates or future approved products, ifincluding anywhen tested or used in combination with other approved products or product candidates;

Any product candidatecandidate, whether used alone or in combination with other approved products or product candidates, may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require it to be taken off the market, require it to include safety warnings or otherwise limit its sales.

Serious adverse events or undesirable side effects caused by a product candidatecandidate, whether used alone or in combination with other approved products or product candidates, could cause us or regulatory authorities to interrupt, delay or halt 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 authorities. Results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. For example, certain patients treated with ONA-XR,CTIM-76 ouror former product candidate,CT-95 experienced adverse events that included, but were not limited to, cytokine release syndrome, fatigue, liver enzyme elevations and nausea.

If unacceptable side effects arise in the development of any product candidate, we, the FDA or comparable foreign regulatory authorities, the institutional review boards (“IRBs”) at the institutions in which our studies are conducted, or the data safety monitoring board, if constituted for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of a product 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 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 expect to have to train medical personnel using a product candidatecandidate, whether used alone or in combination with other approved products or product candidates, to understand the side effect profiles for our clinical trials and upon any commercialization of any product candidate. Inadequate training in recognizing or managing the potential side effects of any product candidatecandidate, whether used alone or in combination with other approved products or product candidates, could result in patient injury or death. Any of these occurrences may harm our business, financial condition and prospects significantly.

Additionally, if any product candidate receives marketing approval, and we or others later identify undesirable side effects caused by such product, whether used alone or in combination with other approved products or product candidates, a number of potentially significant negative consequences could result, including:

We cannot assure you that our assumptions used in determining expected clinical trial timelines are correct or that we will not experience delays or difficulties in enrollment, or be required by the FDA or othersimilar regulatory authorities outside the United States to increase our enrollment, which would result in the delay of completion of such trials beyond our expected timelines.

We recentlyhave initiated Phase 1 clinical trials for CTIM-76,CTIM-76 anticipateand dosingCT-95 in 2025 and are planning for the firstinitiation patientof ina the CT-95 Phase 1first-in-human trial infor the second quarter of 2025, and CT-202 is still in the IND validation process.CT-202. We may be unsuccessful in advancing any product candidate during clinical development or otherwise into clinical development or in identifying and developing additional product candidates.

Even if we do commence additional clinical trials of product candidates and continue to identify new product candidates, such product candidates may never be approved. Failure to successfully identify and develop new product candidates and obtain regulatory approvals for our productsproduct candidates would have a material adverse effect on our business and financial condition and could cause us to cease operations.

We sometimes estimate, orand may in the future estimate, the timing of the accomplishment of various scientific, clinical, manufacturing, regulatory and other product development objectives. These milestones may include our expectations regarding the commencement or completion of scientific studies or clinical trials, the submission of regulatory filings, the receipt of marketing approval or the realization of other commercialization objectives.

The achievement of many of these milestones may be outside of our control. All of these milestones are based on a variety of assumptions, including assumptions regarding capital resources, constraints and priorities, progress of and results from development activities and the receipt of key regulatory approvals or actions, any of which may cause the timing of achievement of the milestones to vary considerably from our estimates. For example, in 20242025 we adjusted our guidance regarding the anticipated dosing of the first patient in the CTIM-76CT-95 Phase 1 trial.

As of March 1, 2025,2026, we had twelvefifteen full-time employees. We also have various consultants who we rely on for research and development, business development and other services. While we believe this structure enables us to reduce certain infrastructure costs, the small size of our centralized team may limit our ability to devote adequate personnel, time and resources to support the operations of our business, including our research and development activities, and the management of financial, accounting and reporting matters. If our centralized team fails to provide adequate administrative, research and development, or other services across our entire organization, our business, financial condition and results of operations could be harmed.

We are highly dependent on the research and development experience, technical skills, leadership and continued service of certain members of our management and scientific teams, including Martin Lehr, our Chief Executive Officer, Dr. ClaudioKaren Dansky Ullmann,Chagin, our Chief Medical Officer, Jennifer Minai-Azary, our Chief Financial Officer, and Alex Levit, our Chief Legal Officer.

InActual addition,events ainvolving supplierlimited liquidity, defaults, non-performance or collaborationother partneradverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems, which could be adversely affectedaffect byus anyand ofour thesuppliers liquidityand riskscollaboration that are described above.partners. Any supplier or collaboration partner bankruptcy or insolvency, or the failure of any collaboration partner to make payments when due, or any breach or default by a supplier or collaboration partner, or the loss of any significant supplier or collaboration partner relationships, could result in material losses to us and may have a material adverse impact on our business.

We have relied on and we expect to continue to rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as contract research organizations (“CROs”), to conduct preclinical studies and clinical trials for product candidates. Nevertheless, we are responsible for ensuring that each of our studies and trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on such third parties will not relieve us of our regulatory responsibilities. For example, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with regulations, commonly referred to as good clinical practices (“GCPs”),GCPs, for conducting, monitoring, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.

We face significant competition in establishing relationships with appropriate collaborators. In addition, there havecontinues beento abe significant number of recent business combinationsconsolidation among large pharmaceutical companiescompanies, thatwhich havehas resulted in a reduced number of potential future collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include, among other things and as applicable for the type of potential product, an assessment of the opportunities and risks of our product candidates, the design or results of studies or trials, the likelihood of approval, if necessary, by the U.S. Department of Agriculture, the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products and industry and market conditions generally.

The research, testing, manufacturing, labeling, approval, selling, import, export, marketing, and distribution of drug products, including biologics and pharmaceuticals, are subject to extensive regulation by the FDA and other regulatory authorities in the United States. We expect the novel nature of our product candidates to create further challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercial development of CLDN6, MSLN and Nectin-4 therapies for cancer. The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure. The novel mechanism of action and immunotherapy characteristics of our TCE bsAb product candidates may present unique clinical safety risks, which could delay or prevent regulatory approval. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain licensure of product candidates based on the completed clinical trials, as the FDA often makes decisions consistent with the Advisory Committee’s recommendations. Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.

We could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of a product candidate in lieu of prescribing existing treatments that have established safety and efficacy profiles. Further, a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such trials are being conducted or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions, lack of adequate funding to continue the clinical trial, or based on a recommendation by the Data Safety Monitoring Committee. The FDA’s review of our data of our clinical trials may, depending on the data, also result in the delay, suspension or termination of one or more clinical trials, which would also delay or prevent the initiation of our other planned clinical trials. If we experience termination of, or delays in the completion of, any clinical trial of a product candidate, the commercial prospects for such product candidate will be harmed, and our ability to generate product revenue will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue. In addition, because the product candidates utilize a TCE bsAb mechanism of action, clinical development may be particularly susceptible to immune-mediated adverse events, which may required protocol modifications, dose interruptions or reductions, enhanced patient monitoring, or hospitalization requirements, and could delay, suspend or prevent the completion of clinical trials.

The Biologics Price Competition and Innovation Act was enacted as part of PPACA to establish an abbreviated pathway for the approval of biosimilar and interchangeable biological products. The regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an approved biologic. Under the Biologics Price Competition and Innovation Act, an application for a biosimilar product cannot be approved by the FDA until 12 years after the reference product was approved under a BLA. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. Regulatory decisions implementing the Biologics Price Competition and Innovation Act may have a material adverse effect on the future commercial prospects for our biological products.

If and when our clinical trials for our current and any future product candidates are completed and, assuming positive data, we expect to advance to potential registrational trials. The current general approach for FDA approval of a new biologic or drug is for the sponsor to provide dispositive data from twoat least one well-controlled, Phase 3 clinical studiesstudy of the relevant biologic or drug in the relevant patient population.population, although the FDA has historically required, and many foreign regulatory authorities still require, dispositive data from two such studies. Phase 3 clinical studies typically involve hundreds of patients, have significant costs and take years to complete. If the results from our clinical trials are sufficiently compelling, we intend to discuss with the FDA submission of a BLA for the relevant product candidate. However, we do not have any agreement or guidance from the FDA that our regulatory development plans will be sufficient for submission of a BLA for the relevant product candidate. For example, the FDA may require that we conduct a comparative trial against an approved therapy, which would significantly delay our development timelines and require substantially more resources. As well, in 2022 the Oncology Center of Excellence (OCE) of the FDA implemented Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development, which has impacted and could continue to impact our current and future clinical trials and significantly delay our development timelines and require substantially more resources. In addition, because our product candidates utilize a TCE bsAb mechanism of action, clinical development may be subject to risks associated with immune-mediated toxicities, which may require protocol modifications, dose interruptions or reductions, enhanced patient monitoring, or hospitalization and could delay or prevent regulatory approval.

For example, on August 16, 2022, the IRA, was passed, which among other things, allows for CMS to negotiate prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D, beginning with 10 high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond. The legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law or for taking price increases that exceed inflation. The legislation also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000. The effect of the IRA on our business and the healthcare industry in general is not yet known.

Consequently, the issuance and scope of patents cannot be predicted with certainty. Patents, if issued, may be challenged, invalidated or designed around. U.S. patents and patent applications may also be subject to interference or derivation proceedings, and U.S. patents may be subject to reexamination, post-grant review and/or inter partiespartes review proceedings in the USPTO.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. We rely on our, and our licensors rely on their, outside counsel and employ an outside firm to pay these fees due to USPTO and non-U.S. patent agencies. The USPTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. Although an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.

Our commercial success depends in part upon our ability to develop, manufacture, market and sell product candidates without alleged or actual infringement, misappropriation or other violation of the patents and proprietary rights of third parties. Litigation relating to infringement or misappropriation of patent and other intellectual property rights in the pharmaceutical and biotechnology field is common, including patent infringement lawsuits, and such interference, derivation, reexamination, post-grant review, inter partiespartes review and opposition proceedings before the USPTO and corresponding international patent offices.

Numerous United States, EU and other internationally issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we and our collaborators are developing product candidates. For example, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 and March 2042 that potentially cover certain parts of the intellectual property included in CTIM-76. As well, we are aware of a pending patent application in the United States and certain foreign jurisdictions that, if issued, would expire in 2042, and that potentially covers certain parts of the intellectual property included in CTIM-76. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our current and any future product candidates may be subject to claims of infringement of the intellectual property rights of third parties.

Even if we have or obtain patents covering CTIM-76, CT-95, CT-202 and any future product candidates or compositions, others may have filed, and in the future may file, patent applications covering compositions, products or methods that are similar or identical to ours, which could materially affect our ability to successfully develop a product candidate or to successfully commercialize any approved products alone or with collaborators. In addition, because patent applications can take many years to issue, there may be currently pending applications unknown to us that may later result in issued patents that may cover CTIM-76, CT-95, CT-202 or any future product candidates or compositions. These patent applications may have priority over patent applications filed by us. For example, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 and March 2042 that potentially cover certain parts of the intellectual property included in CTIM-76. As well, we are aware of a pending patent application in the United States and certain foreign jurisdictions that, if issued, would expire in 2042, and that potentially covers certain parts of the intellectual property included in CTIM-76. While we believe we will have reasonable defenses against any potential claim of infringement, including challenging the validity of any such patents, we may not be successful in such efforts, and we also may not be able to obtain a license to such patents on commercially reasonable terms, or at all. If such patent is valid and not yet expired when, and if, we receive marketing approval for CTIM-76 we may need to seek a license to such patent, which may not be available on commercially reasonable terms or at all. Failure to receive a license to such patent, or other potentially relevant patents currently unknown to us, could delay the manufacture or commercialization of CTIM-76 or require us to incur additional payments and expenses, including legal fees, court issued damages or settlement costs.

We are a party to intellectual property license agreements that are important to our business and expect to enter into additional license agreements in the future. Our existing license agreements impose, and we expect that future license agreements will impose, various diligence, milestone payment, royalty and other obligations on us. Additionally, we may need to outsource and rely on third parties for many aspects of the development, sales and marketing of any products covered under our current and future license agreements. Delay or failure by these third parties could adversely affect the continuation of our license agreements with our licensors. If we fail to comply with any of our obligations under these agreements, or we are subject to a bankruptcy, our licensors may have the right to terminate the license, in which event we would not be able to market any products covered by the license.

The market price for our common stock is likely to be volatile, in part because our shares have been traded publicly for only a few years. In addition, the market price of our common stock has been, and may continue to be, volatile and fluctuate significantly in response to several factors, most of which we cannot control, including:

We may not be able to regain and maintain compliance with the continued listing requirements of The Nasdaq Stock Market.

Our common stock is listed on The Nasdaq Stock Market. In order to maintain that listing, we must satisfy minimum financial and other requirements including, without limitation, a requirement that our closing bid price be at least $1.00 per share. On February 27, 2025, we received a letter from Nasdaq stating that the we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”) because our common stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. ThisWhile letterwe provideshave ansince initial 180 calendar day period, or until August 26, 2025, in which to regain compliance. We may request stockholder approval to undergo a reverse stock split in order to regainregained compliance with the $1.00Minimum closingBid bidPrice priceRule, requirement. If we do not regain compliance by August 26, 2025, we may be eligible for an additional 180-day grace period. Ifif we fail to regain and maintain compliance with the Minimum Bid Price Rule or we fail to continue to meet allany other applicable continued listing requirementsrequirement for The Nasdaq Stock Market, our common stock may be delisted, which would adversely affect the market liquidity of our common stock and our ability to obtain financing to fund our operations.

We are a clinical-stage biopharmaceutical company advancing TCE bispecific antibodies for solid tumors. WeOur aregoal buildingis to build an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a CLDN6 x CD3 TCE, CT-95, an MSLN x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE.

CTIM-76 is a CLDN6 x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors and absent from or expressed at low levels in healthy adult tissues. IND-enablingWe studieshave onan active IND for CTIM-76 have been completed. On May 2, 2024, we announcedwith the FDA cleared our IND application to support the initiation of a Phase 1 dose escalation and expansion trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers.FDA. We dosed the first patient in our CTIM-76 Phase 1 clinical trial in January 2025. We expect to share initialPhase 1a interim data for the CTIM-76 Phase 1 trial in the first half ofJune 2026.

CT-95 is an MSLN x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately 30% of cancers. We anticipate dosingdosed the first patient in theour CT-95 Phase 1 trial in the second quarter ofApril 2025. We expect to share initialPhase 1a interim data for the CT-95 Phase 1 trial in the middle ofSeptember 2026.

In April 2021, we entered into a collaboration and licensing agreement with Integral Molecular, Inc. (“Integral”) (the “Integral License Agreement”) for the development of a CLDN6 bsAb for cancer therapy. On February 29, 2024, we further amended (the "Second Amendment") the Research Collaboration and License Agreement (the “Integral License Agreement”, as amended) with Integral to reflect updated financial terms. In the course of our further due diligence review of CTIM-76, we determined that certain of the licensed rights under the Integral License Agreement may incorporate intellectual property rights currently held by a third party. Specifically, at the time of the Second Amendment, we arewere aware of issued patents in the United States and certain foreign jurisdictions expiring in January 20342034, and then in 2025 became aware of a patent that issued in the United States expiring in March 2042, in each instance that potentially covercovers certain parts of the intellectual property included in CTIM-76. While we believe we will have reasonable defenses against any potential claim of infringement, we may not be successful in such efforts, and we also may not be able to obtain a license to such patent on commercially reasonable terms, or at all.

As of December 31, 2024,2025, we had cash and cash equivalents of $94.4$66.0 million, which we expect will be sufficient to fund the estimated duration of the Phase 1a dose escalation portions of our CTIM-76 and CT-95 trials, the estimated expenses to initiate patient enrollment in a first-in-human trial for CT-202, as well as our operations into 2027.mid-2027. If the Company is unable to obtain additional financing, the lack of liquidity could have a material adverse effect on the Company’s future prospects.

•costs of funding research performed by third parties, including pursuant to agreements with contract research organizations (“CROs”) that conduct our clinical trials, as well as investigative sites, consultants and CROs that conduct our preclinical and clinical studies;

We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, potential commercialization efforts and increased costs of operating as a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, legal support and accountants, among other expenses. Additionally, we will continue to incur significant costs associated with being a public company, including expenses related to services associated with maintaining compliance with the requirements of Nasdaq and the Securities and Exchange Commission (the “SEC”),SEC, insurance and investor relations costs. If any of our current or future product candidates obtain U.S. regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.

Other Income (Expense)

Other income (expense) is primarily due to the recognition of foreign currency gains or losses as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.

The decrease in ONA-XR expenses of $1.9 million was due to the decision in March 2023 to discontinue development of ONA-XR and focus on the development of CTIM-76. CTIM-76 expenditures decreasedincreased by $9.0$1.3 million, primarily due to decreasesan increase of $6.1$3.1 million in contract manufacturingclinical costs mainlyas duea to the completionresult of manufacturingcontinued activitiesprogression inof earlyour 2024ongoing andPhase $5.01 clinical trial. This increase was partially offset by a decrease of $1.0 million in preclinical costs as a result of the completion of IND-enabling studies in early 2024.2024 Theseand decreasesa were partially offset by an increasedecrease of $2.0$0.8 million in clinicalcontract costsmanufacturing as a result of initiating our Phase 1 clinical trial.costs. CT-95 expense of $4.9 million for 2025 primarily represents $3.7 million in clinical costs and $1.2 million in preclinical, contract manufacturing, and diagnostic development expenses incurred. CT-95 expense of $4.9 million for 2024 primarily represents consideration paid of $3.75 million to acquire the asset from Link in July 2024 and approximately $1.1 million in other expenses, the majority of which werewas $0.6 million of clinical start up costs. CT-202 expense of $15.6 million for 2025 primarily represents $8.7 million in contract manufacturing costs, $4.7 million in preclinical expenses, and a $2.0 million expense related to achieving a development milestone under the BioAtla License Agreement. CT-202 expense of $11.2 million for 2024 primarily represents the $11.0 million consideration paid under the BioAtla License Agreement entered into in September 2024. Personnel-related costs, which include salaries, benefits and stock-based compensation expense, decreasedincreased by approximately $0.2$3.3 million, primarily due to lower averagehigher headcount over the prior year period.as well as termination benefits incurred related to certain employee departures. Other research and development expense increased by approximately $0.1 million, due to allocated expenses as a result of higher headcount over the prior year.

General and administrative expenses decreasedincreased by $0.1$0.6 million from $7.3 million for the year ended December 31, 2023 to $7.2 million for the year ended December 31, 2024.2024 to $7.8 million for the year ended December 31, 2025. The decreaseincrease was primarily driven by a decrease$0.7 million increase in insurance expense of $0.2 millionsalaries and salaries,personnel-related benefitscosts, including share-based compensation, mainly due to higher headcount and stock-based compensation expenseadjustments. ofThe $0.1increase million. These decreases werewas partially offset by ana increasedecrease in otherprofessional administrative costsfees of $0.2$0.1 million.

Interest income increased by approximately $2.0$0.2 million for the year ended December 31, 20242025 as compared to 2023,2024, primarily due to higheradditional interest income earned onfrom higher cash and cash equivalent balances due tofollowing the Private Placement and other sales of common stock.

Other Income (Expense)

Other expenseincome decreasedwas by approximately $0.1$0.2 million for the year ended December 31, 20242025 as compared to 2023other expense of $1,400 in 2024, primarily due to lower foreign currency lossesgains in 2025 as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.

Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception through December 31, 2024,2025, we have funded our operations through the sale of common stock, warrants, convertible debt,debt and convertible preferred stock, common stock and warrants.stock. As of December 31, 2024,2025, we had $94.4$66.0 million in cash and cash equivalents and an accumulated deficit of $94.8$130.9 million.

We expect our cash and cash equivalents at December 31, 20242025 to fund the estimated duration of the Phase 1a dose escalation portions of our CTIM-76 and CT-95 Phase 1 trials, the estimated expenses throughto INDinitiate filingpatient enrollment in a first-in-human trial for CT-202, as well as our operations into 2027.mid-2027. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic transactions and/or marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic transactions or marketing, or distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

During the year ended December 31, 2024,2025, we used $14.6$26.4 million of cash in operating activities. Cash used in operating activities reflected our net loss of $26.7$36.1 millionmillion, andpartially offset by a net change in our operating assets and liabilities of $3.5$6.3 million, partially offset by in-process research and development charges of $14.8$2.0 millionmillion, and non-cash share-based compensation of $0.8$1.3 million. The primary uses of cash were to fund our operations related to the development of our product candidates.

During the year ended December 31, 2023,2024, we used $21.0$14.6 million of cash in operating activities. Cash used in operating activities reflected our net loss of $24.0 million, partially offset by non-cash share-based compensation of $1.1$26.7 million and a net change in our operating assets and liabilities of $1.8$3.5 million, partially offset by in-process research and development charges of $14.8 million and non-cash share-based compensation of $0.8 million. The primary uses of cash were to fund our operations related to the development of our current and former product candidates.

During the year ended December 31, 2024,2025, we used approximately $15,000, of cash in financing activities providedrelated $109.3to million,the consistingpayment of netremaining proceedsoffering of $94.8 millioncosts from the sale of commonATM stock and Pre-Funded Warrants in the Private Placement, as well as net proceeds of $14.5 million from the sale of common stockShares under our ATM Sales Agreement.

Research and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct clinical studies and other research and development activities, acquired IPR&D,in-process research and development, salaries, share-based compensation, and other operational costs related to our research and development activities.

Investing in our common stock involves a high degree of risk. In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors described under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 23, 2026. ThereOther than as described below, there have been no material changes to the risk factors described in that report. The occurrence of any of the events or developments described in our Risk Factors could adversely affect 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. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

We are a clinical-stage biopharmaceutical company advancing TCE bispecific antibodies for solid tumors. Our goal is to build an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a CLDN6 x CD3 TCE, CT-95, an MSLN x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE.

CTIM-76 is a CLDN6 x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors and absent from or expressed at low levels in healthy adult tissues. IND-enabling studies on CTIM-76 have been completed. On May 2, 2024, we announced the FDA cleared our IND application to support the initiation of a Phase 1 dose escalation and expansion trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. We dosed the first patient in our CTIM-76 Phase 1 clinical trial in January 2025. On April 2, 2026, the FDA granted Fast Track designation to CTIM-76 for the treatment of platinum-resistant ovarian cancer in patients that have received all standard of care therapies. We expectpresented to shareinterim Phase 1a interimclinical data for theour CTIM-76 trial in June 2026.

CT-202 is a Nectin-4 x CD3 TCE that targets Nectin-4, a cell surface protein that is highly and frequently overexpressed in a variety of solid tumors, including bladder, colorectal, lung and breast. Nectin-4 is a clinically validated target for cancer therapy using a traditional antibody-drug conjugate, but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a pH-dependent TCE that is designed to be preferentially active within the tumor microenvironment. In April 2026, we received Human Research Ethics Committee approval and Clinical Trial Notification acknowledgement by the Australian Therapeutic Goods Administration to initiate a first-in-human Phase 1 clinical trial of CT-202. We expect to dose theThe first patient in our CT-202 Phase 1 clinical trial evaluating CT-202 in patients with Nectin-4-positive urothelial, colorectal, and triple-negative breast cancers is expected to be dosed in the third quarter of 2026. We also expect to share initial Phase 1a data from the CT-202 trial in the second half of 2027.

We were incorporated in April 2015 under the laws of the State of Delaware. Since inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development, organizing and staffing our company, business planning and raising capital. We operate as one business segment and have incurred recurring losses, the majority of which are attributable to research and development activities, and negative cash flows from operations. We have funded our operations primarily through the sale of common stock, warrants, convertible debt, and convertible preferred stock. Our net loss was $8.7$23.2 million for the threesix months ended MarchJune 31,30, 2026. As of MarchJune 31,30, 2026, we had an accumulated deficit of $139.6$154.1 million.

In April 2021, we entered into a collaboration and licensing agreement with Integral Molecular, Inc. (“Integral”) (the “Integral License Agreement”) for the development of a CLDN6 bsAbbispecific antibodies for cancer therapy. On February 29, 2024, we further amended (the "Integral Second Amendment") the Research Collaborationcollaboration and Licenselicensing Agreementagreement with Integral (as amended, the “Integral License Agreement”, as amended) with Integral to reflect updated financial terms. In the course of our further due diligence review of CTIM-76, we determined that certain of the licensed rights under the Integral License Agreement may incorporate intellectual property rights currently held by a third party. Specifically, at the time of the Integral Second Amendment, we were aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034, and then in 2025 became aware of a patent that issued in the United States expiring in March 2042, in each instance that potentially covers certain parts of the intellectual property included in CTIM-76.While we believe we will have reasonable defenses against any potential claim of infringement, we may not be successful in such efforts, and we also may not be able to obtain a license to such patentpatents on commercially reasonable terms, or at all.

As part of the Integral Second Amendment, Integral’s right to receive certain future payments was reduced as follows: aggregate development and regulatory milestone payments were reduced from $55 million to $15 million, aggregate sales milestone payments were reduced from $130 million to $12.5 million, and a tiered royalty of 8-12% that commenced at first commercial sale was reduced to a flat royalty rate of 6% on net sales beginning no sooner than February 1, 2034. The Integral Second Amendment also narrowed the license grant from Integral to us to only cover CTIM-76, removed any further obligation of us to reimburse Integral for any independently obtained research funding Integral applied against CTIM-76 research, and included mutual releases by the parties.

The reduced development and regulatory milestones now reflect a payment due at each of: (i) first patient’s first screening visit in a Phase 1b/2 or Phase 2 clinical trial for CTIM-76,CTIM-76; (ii) first patient’s first screening visit in a Phase 3 clinical trial for CTIM-76,CTIM-76; (iii) United States marketing approval for CTIM-76,CTIM-76; (iv) European Union marketing approval for CTIM-76,CTIM-76; (v) United Kingdom marketing approval for CTIM-76,CTIM-76; (vi) and Japan marketing approval for CTIM-76. The amended commercial milestones now also reflect a payment due upon the achievement of annual net sales of $500 million and annual net sales of $1 billion.

On September 23, 2024, we entered into a license agreement (the “BioAtla License Agreement”) with BioAtla, Inc. ("BioatlaBioAtla"), pursuant to which we obtained an exclusive, worldwide license to develop, manufacture and commercialize two licensed antibodies (the “BioAtla Assets”), including BA3362 (renamed by the Companyus as CT-202), BioAtla’s Nectin-4 x CD3 TCE.

As partial consideration for the exclusive license under the BioAtla License Agreement, we made an upfront payment of $11.0 million, and BioAtla iswas eligible to receive up to $122.5 million in additional milestone payments based upon the achievement of specified pre-clinical,preclinical, clinical, development and commercial milestones, as well as tiered mid-single-digit to low double-digit royalties on future net sales for products containing the BioAtla Assets, subject to standard reductions. As discussed below, BioAtla’s eligibility to receive these milestone payments and royalties was terminated in connection with the BioAtla License Agreement Amendment (as defined below). In October 2025, we achieved a $2.0 million development milestone under the BioAtla License Agreement.Agreement, which we paid to BioAtla during the year ended December 31, 2025.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $54.5$43.0 million,million. whichBased on our current operating plan and anticipated milestones, we expectbelieve that our cash and cash equivalents as of June 30, 2026 will be sufficient to fund the estimated duration of the Phase 1a dose escalation portions of our CTIM-76 and CT-95 trials, the estimated expenses to initiate patient enrollment in a first-in-human trial for CT-202, as well as our operations into mid-2027.the fourth quarter of 2027. If the Company is unable to obtain additional financing, the lack of liquidity could have a material adverse effect on the Company’s future prospects.

On December 2, 2024, we entered into a Sales Agreement (the “ATM Sales Agreement”) with Leerink Partners LLC (the “Agent”). Pursuant to the terms of the ATM Sales Agreement, we may offer and sell shares of common stock having an aggregate offering amount of up to $75.0 million from time to time through the Agent (the “ATM Shares”). Sales of the ATM Shares may be made in sales deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"). On October 24, 2025, we entered into Amendment No. 1 to Sales Agreement (the “ATM Sales Agreement Amendment”, and together with the ATM Sales Agreement, the “Amended ATM Sales Agreement”) to provide for an increase in the aggregate offering amount under the Amended ATM Sales Agreement, such that following the filing of a new prospectus supplement with respect to the ATM Shares on October 24, 2025, we may offer and sell ATM Shares having an aggregate offering price of up to $75.0 million, exclusive of ATM Shares previously sold in December 2024. The Agent will be entitled to a commission from the Companyus of up to 3.0% of the gross proceeds from the sale of ATM Shares sold under the Amended ATM Sales Agreement.

On May 1, 2024, we entered into a securities purchase agreement (the “Purchase Agreement”) for the private placement (the “Private Placement”) of (i) 59,032,259 shares (the “PIPE Shares”) of our common stock at a purchase price of $1.55 per PIPE Share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase 5,482,741 shares of common stock (the “Warrant Shares”) at a purchase price of $1.549 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable and remain exercisable until exercised in full. During the year ended December 31, 2025, 2,178,200 Pre-Funded Warrants were exercised on a cashless basis, resulting in the issuance of 2,174,983 shares of common stock. As of MarchJune 31,30, 2026, 3,304,541 Pre-Funded Warrants remained outstanding.

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

The following table sets forth our results of operations for the three months ended MarchJune 31,30, 2026 and 2025:

Research and development expenses increased by approximately $3.6$8.3 million for the threesix months ended MarchJune 31,30, 2026 as compared to the same period in 2025. The following table summarizes our research and development expenses for the threesix months ended MarchJune 31,30, 2026 as compared to the same period in 2025:

CTIM-76 expenditures increased by $1.2$2.0 million primarily due to an increase of $1.1$1.9 million in clinical costs related to the CTIM-76 Phase 1 trial. CT-95 expenses increased by $0.6$0.7 million primarily due to an increase of $0.9$1.4 million in clinical costs related to the CT-95 Phase 1 trial, which were partially offset by a $0.2$0.7 million decrease in preclinicalpreclinical, contract manufacturing, and diagnostic development expenses. CT-202 expenses increased by $0.9$5.3 million primarily due to an$6.5 million in consideration paid under the BioAtla License Agreement Amendment entered into in May 2026 and a $0.9 million increase in clinical costs mainly related to the CT-202 Phase 1 trial start up. These increases were partially offset by a decrease of $0.5$1.5 million in contract manufacturing costs and ana increasedecrease of $0.3$0.6 million in clinical start uppreclinical costs. Personnel-related costs, which include salaries, benefits and share-based compensation expense, increased by approximately $0.8$0.3 million, primarily due to higher headcount overoffset by lower termination benefits incurred compared to the priorsame yearperiod period.2025.

General and administrative expenses increased by approximately $0.3$0.8 million for the threesix months ended MarchJune 31,30, 2026 as compared to the same period in 2025. The increase was primarily driven by a $0.2$0.5 million increase in salariesprofessional fees. Salaries and personnel related costs, mainly as a result of higherincluding share-based compensation expense. Professional feescompensation, also increased by approximately $0.1$0.3 million asmainly compareddue to thehigher sameheadcount periodand incompensation 2025.adjustments.

Interest income decreased by approximately $0.4$0.9 million for the threesix months ended MarchJune 31,30, 2026 as compared to the same period in 2025, primarily dueas toa result of lower average cash and cash equivalent balances during the threesix months ended MarchJune 31,30, 2026 due to cash used to fund ongoing operations.

Other income was approximately $143,000$0.1 million for the threesix months ended MarchJune 31,30, 2026, as compared to other expense of approximately $7,000$20,000 for the same period in 2025. This change is primarily due to higher foreign currency gains during the threesix months ended MarchJune 31,30, 2026, as compared to foreign currency lossesgains during the prior year period, in each case as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.

Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception through MarchJune 31,30, 2026, we have funded our operations through the sale of common stock, warrants, convertible debt, and convertible preferred stock. As of MarchJune 31,30, 2026, we had $54.5$43.0 million in cash and cash equivalents and an accumulated deficit of $139.6$154.1 million.

WeBased on our current operating plan and anticipated milestones, we expect our cash and cash equivalents at MarchJune 31,30, 2026 will be sufficient to fund the estimated duration of the Phase 1a dose escalation portions of our CTIM-76 and CT-95 trials, the estimated expenses to initiate patient enrollment in a first-in-human trial for CT-202, as well as our operations into mid-2027.the fourth quarter of 2027. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.

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

During the threesix months ended MarchJune 31,30, 2026, we used $11.4$18.4 million of cash in operating activities. Cash used in operating activities reflected our net loss of $8.7$23.2 million and a net change in our operating assets and liabilities of $3.2$2.7 million, partially offset by an in-process research and development charge of $6.5 million and non-cash share-based compensation expense of $0.4$0.9 million. The primary uses of cash were to fund our operations related to the development of our product candidates.

During the threesix months ended MarchJune 31,30, 2025, we used $5.0$10.9 million of cash in operating activities. Cash used in operating activities reflected our net loss of $4.6$13.4 millionmillion, andpartially offset by a net change in our operating assets and liabilities of $0.8$1.8 million,million partially offset byand non-cash share-based compensation expense of $0.3$0.7 million. The primary uses of cash were to fund our operations related to the development of our product candidates.

During the threesix months ended MarchJune 31,30, 2026, wecash used approximately $37,000 of cash in investing activities was attributable to purchasea payment of $4.5 million under the BioAtla License Agreement Amendment, and purchases of property and equipment.equipment totaling $56,000.

During the threesix months ended MarchJune 31,30, 2025, we used approximately $34,000 of cash in operating activities to purchase property and equipment.

We did not have cash flows from financing activities during the threesix months ended MarchJune 31,30, 2026.

During the threesix months ended MarchJune 31,30, 2025, we used approximately $15,000 of cash in financing activities related to the payment of remaining offering costs from the sale of ATM Shares under our ATM Sales Agreement.

During the threesix months ended MarchJune 31,30, 2026, there were no material changes to our critical accounting policies and estimates from those described in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 23, 2026.

Other exemptions and reduced reporting requirements under the JOBS Act include, without limitation, the requirements for providing an auditor’s attestation report on our system of internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements. We will remain an emerging growth company until theDecember 31, 2026, unless we earlier cease to occurqualify as an emerging growth company as a result of (a) the last day of the fiscal year (i) following October 19, 2026, (ii) in which we haveour total annual gross revenuesrevenues, issuance of at least $1.235 billion or (iii) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means that we have been required to file annual and quarterly reports under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), for a period of at least 12 months and have filed at least one annual report pursuant to the Exchange Act and (b) either (i) the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, or (ii) the date on which we have issued more than $1.0 billion in non-convertible debt duringsecurities theor priorstatus three-yearas period.a large accelerated filer.

We are also a “smaller reporting company,” meaning that the market value of our stockcommon equity held by non-affiliates was less than $700.0 million and our annual revenue was less than $100.0 million during the most recently completed fiscal year. We will continue to be a smaller reporting company while either (i) the market value of our stockcommon equity held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stockcommon equity held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.