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| PART I - FINANCIAL INFORMATION | 1 | |
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| Item 1. | Financial Statements (unaudited) | 1 |
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| | Condensed Consolidated Balance Sheets | 1 |
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| | Condensed Consolidated Statements of Operations and Comprehensive Loss | 2 |
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| | Condensed Consolidated Statements of Shareholders’ Equity | 3 |
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| | Condensed Consolidated Statements of Cash Flows | 4 |
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| | Notes to Condensed Consolidated Financial Statements | 5 |
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| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 23 |
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| Item 3. | Quantitative and Qualitative Disclosure About Market Risk | 36 |
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| Item 4. | Controls and Procedures | 37 |
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| PART II - OTHER INFORMATION | 37 | |
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| Item 1. | Legal Proceedings | 37 |
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| Item 1A. | Risk Factors | 38 |
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| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 97 |
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| Item 3. | Defaults Upon Senior Securities | 97 |
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| Item 4. | Mine Safety Disclosures | 97 |
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| Item 5. | Other Information | 97 |
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| Item 6. | Exhibits | 98 |
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| SIGNATURES |
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SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or this Quarterly Report, contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements may be identified by such forward-looking terminology as “will,” “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:
| ● | the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; |
| ● | our ability to advance our product candidates into, and successfully complete, clinical trials; |
| ● | our reliance on the success of our product candidates in our pipeline programs for our Bicycle® Drug Conjugates, or BDC® molecules, and Bicycle Radioconjugates, or BRC® molecules, as well as our other pipeline programs; |
| ● | our ability to utilize our screening platform to identify and advance additional product candidates into clinical development; |
| ● | the timing or likelihood of regulatory filings and approvals, including communications with and feedback from the FDA and other regulatory agencies; |
| ● | the commercialization of our product candidates, if approved; |
| ● | our ability to develop sales and marketing capabilities; |
| ● | the pricing, coverage and reimbursement of our product candidates, if approved; |
| ● | the implementation of our business model, strategic plans for our business, product candidates and technology; |
| ● | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
| ● | our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; |
| ● | costs associated with defending intellectual property infringement, product liability and other claims; |
| ● | regulatory developments in the United States, the United Kingdom and other jurisdictions and changes to the laws and regulations of the United States, England and Wales, and other jurisdictions; |
| ● | estimates of our expenses, future revenues, capital requirements, share performance and our needs for additional financing; |
| ● | the potential benefits of strategic collaboration agreements and our ability to enter into additional strategic arrangements or partnerships; |
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| ● | our ability to maintain and establish collaborations or obtain additional grant funding; |
| ● | the rate and degree of market acceptance of any approved products; |
| ● | developments relating to our competitors and our industry, including competing therapies; |
| ● | our hiring plans and our ability to attract and retain qualified employees and key personnel; |
| ● | our ability to effectively manage our potential growth; |
| ● | our estimates regarding expected future cost savings and charges associated with our strategic reprioritization and workforce reduction announced in March 2026; |
| ● | our expected qualification as R&D intensive for the year ended December 31, 2026, under the Finance Act 2024; |
| ● | the impact of adverse global economic conditions, including those arising from changes in global trade policies, on our operations and the potential disruption in the operations and business of third-party manufacturers, contract research organizations, or CROs, other service providers, and collaborators with whom we conduct business; |
| ● | potential adverse developments affecting the financial services industry; |
| ● | potential business interruptions resulting from geo-political actions, such as war and terrorism, or the perception that such hostilities may be imminent; |
| ● | our failure or perceived failure to comply with existing or future laws, regulations, contracts, self-regulatory schemes, standards, and other obligations related to data privacy and security (including our ability to identify and respond to potential future security incidents); and |
| ● | other risks and uncertainties, including those listed under the caption “Risk Factors.” |
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part II, Item 1A and elsewhere in this Quarterly Report. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement.
In addition, any forward-looking statement in this Quarterly Report represents our views only as of the date of this Quarterly Report and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
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