INDEX TO QUARTERLY REPORT ON FORM 10-Q
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| PART I. FINANCIAL INFORMATION | | | |
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| Item 1. Financial Statements | | 5 | |
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| Condensed Consolidated Balance Sheets at March 31, 2024 and December 31, 2023 | | 5 | |
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| Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended March 31, 2024 and 2023 | | 6 | |
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| Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended March 31, 2024 and 2023 | | 7 | |
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| Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2024 and 2023 | | 8 | |
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| Notes to Unaudited Condensed Consolidated Financial Statements | | 9 | |
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| Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 27 | |
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| Item 3. Quantitative and Qualitative Disclosures about Market Risk | | 42 | |
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| Item 4. Controls and Procedures | | 42 | |
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| PART II. OTHER INFORMATION | | | |
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| Item 1. Legal Proceedings | | 43 | |
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| Item 1A. Risk Factors | | 43 | |
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| Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | | 43 | |
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| Item 3. Defaults Upon Senior Securities | | 43 | |
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| Item 4. Mine Safety Disclosures | | 43 | |
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| Item 5. Other Information | | 43 | |
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| Item 6. Exhibits | | 44 | |
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| Signatures | | 45 | |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
| ● | how long we expect to maintain liquidity to fund our planned level of operations and our ability to obtain additional funds for our operations; |
| ● | the development of our drug and vaccine candidates, including when we expect to undertake, initiate and complete clinical trials of our drug and vaccine candidates; |
| ● | the expectation, plans, projections, initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials, compassionate uses, Investigational New Drug (“IND”) filings, Clinical Trial Application (“CTA”) filings, New Drug Application (“NDA”) filings, Biologics License Application (“BLA”), and other regulatory submissions; |
| ● | regulatory developments involving products and our facilities, including the ability to obtain regulatory approvals or otherwise bring products to market; |
| ● | the regulatory status of our drug and vaccine candidates, including our ability to obtain and maintain orphan drug, rare pediatric and Regenerative Medicine Advanced Therapy (“RMAT”) designations for our lead product candidate, CAP-1002; |
| ● | our use of clinical research centers, third party manufacturers and other contractors; |
| ● | our ability to find collaborative partners for research, development and commercialization of potential products and retain commercial rights for our product candidates in the collaborations; |
| ● | our ability to manufacture products for clinical and commercial use; |
| ● | our ability to procure materials necessary for the manufacture of our product candidates; |
| ● | our ability to protect our patents and other intellectual property; |
| ● | our ability to raise additional financing and the terms of any additional financing; |
| ● | our ability to market any of our products; |
| ● | the implementation of our business model and strategic plans for our business, technologies and product candidates; |
| ● | our estimates of our expenses, ongoing losses, future revenue, future reimbursement prices for any commercial products, and capital requirements; |
| ● | the impact of taxes on our business; |
| ● | our ability to compete against other companies and research institutions; |
| ● | our ability to expand our operations internationally; |
| ● | the effect of potential strategic transactions on our business; |
| ● | acceptance of our products by doctors, patients or payors and the availability of reimbursement for our product candidates; |
| ● | our ability to attract and retain key personnel; and |
| ● | the volatility of our stock price. |
We caution you that the forward-looking statements highlighted above do not encompass all of the forward-looking statements made in this Quarterly Report on Form 10 - Q.
You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this Quarterly Report on Form 10-Q primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations and prospects. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors. Moreover, we operate in a very competitive and challenging environment. New risks and uncertainties
emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. Additionally, final data may differ significantly from preliminary data reported in this document.
The forward-looking statements made in this Quarterly Report on Form 10-Q relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report on Form 10-Q to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make, if any.
This Quarterly Report on Form 10-Q also contains data, estimates and forecasts that are based on independent industry publications or other publicly available information, as well as other information based on our internal sources. Although we believe that the third-party sources referred to in this Quarterly Report on Form 10-Q are reliable, we have not independently verified the information provided by these third parties. While we are not aware of any misstatements regarding any third-party information presented in this report, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors.
