CAMP

MKT CAP $212.7MP/E —DIV YIELD —FCF YIELD -13.50%REV TTM $4.2M +40.2%NET INCOME −$107.2MNET CASH —52W 2.90 – 7.13SEC XBRL · TTM TO Invalid Date

How CAMP rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

76%

of sentences unchanged

Added

156

new sentences

Dropped

178

sentences removed

Length

−990

words, now 46,799

New in FY2025

Since our inception, we have focused primarily on developing our proprietary RAP Platform, identifying, developing and progressing our product candidates through preclinical and clinical development, organizing and staffing our company, research and development activities, establishing and protecting our intellectual property portfolio, and raising capital.
We are still in the early stages of development of our product candidates and our lead product candidate, CMP-002, has not yet entered clinical trials.
For the years ended December 31, 2025 and 2024, we reported net losses of $80.4 million and $51.8 million, respectively.
As of December 31, 2025, we had an accumulated deficit of $292.2 million.
We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue the research and development of, and seek regulatory approvals for, our lead product candidate CMP-002 for the treatment of SYNGAP1-related disorder (“SYNGAP1”), along with any other current or future product candidates we may develop.
We anticipate that our expenses will increase substantially if and as we: • finalize preclinical development for CMP-002 and advance into clinical trials; • advance current and future product candidates through preclinical studies and clinical trials; • expand the capabilities of our RAP Platform and seek to identify and develop additional product candidates; • seek marketing approvals for any product candidates that successfully complete clinical trials; • obtain, expand, maintain, defend and enforce our intellectual property portfolio; • hire additional clinical, regulatory and scientific personnel; • contract with third-party manufacturers for preclinical and clinical supply to support any future product candidates we may develop and for commercial supply with respect to any such product candidates that receive regulatory approval; • ultimately establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; and • add operational, legal, compliance, financial and management information systems and personnel to support our research, product development and future commercialization efforts.
Our product candidates are in varying stages of development.
We expect that it will be several years, if ever, before we have a product candidate ready for commercialization.
As of December 31, 2025, we had cash and cash equivalents of $109.5 million.
Based on our current operating plan, we estimate that our cash and cash equivalents as of December 31, 2025 will be sufficient to fund our operating expenses and capital expenditure requirements into 2028.
Our future capital requirements will depend on many factors, including, but not limited to: • the initiation, type, number, scope, progress, expansions, results, costs and timing of preclinical studies and clinical trials of CMP-002 and any future product candidates we may choose to pursue, including the costs of modification to clinical development plans based on feedback that we may receive from regulatory authorities and any third-party products used as combination agents in our clinical trials; • the costs and timing of manufacturing for our product candidates, including commercial manufacturing at sufficient scale, if any product candidate is approved; • the costs, timing and outcome of regulatory meetings and reviews of our product candidates or any future product candidates, including requirements of regulatory authorities in any additional jurisdictions in which we may seek approval and any future product candidates; • the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights; • the costs associated with hiring additional personnel and consultants as our clinical and preclinical activities increase; • the timing and payment of milestone, royalty or other payments we must make or may receive pursuant to our existing and potential future license or collaboration agreements with third parties; • the costs and timing of establishing or securing sales and marketing capabilities if our product candidates or any product candidate is approved; • our ability to achieve sufficient market acceptance, coverage, and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; • patients’ ability and willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; • the terms and timing of establishing and maintaining collaborations, licenses, and other similar arrangements; and • costs associated with any products or technologies that we may in-license or acquire.
We are early in our development efforts and our lead product candidate has not yet entered clinical trials.
Pending successful completion of Good Laboratory Practices (“GLP”) toxicology studies and regulatory clearance, we intend to initiate a global Phase 1/2 clinical trial of CMP-002 in individuals with SYNGAP1 as early as the second half of 2026.
In each jurisdiction, clinical trials are subject to applicable regulatory requirements and must be reviewed and authorized by the applicable regulatory authorities and reviewed and approved by the applicable ethics committees or institutional review boards prior to initiation and as amended during the course of the trial.
Commencing clinical trials outside the United States similarly requires the submission and authorization of comparable clinical trial applications or notifications, and compliance with local requirements relating to, among other things, trial conduct, informed consent, safety reporting, importation and handling of investigational product, and data integrity.
In the event that the FDA or any comparable foreign regulatory authority or ethics committee requires us to complete additional preclinical studies or we are required to satisfy other requests prior to commencing clinical trials, the start of our planned Phase 1/2 CMP-002 clinical trial and any future clinical trials may be delayed.
Even after we receive and incorporate guidance from applicable regulatory authorities, such authorities could disagree that we have satisfied their requirements to commence any clinical trial or continue or change their position on the acceptability of our trial design or the clinical endpoints selected, which may require us to complete additional preclinical studies or clinical trials or impose stricter approval conditions than we currently expect, which could delay the start or completion of such clinical trials or require more capital resources than we currently anticipate to start or complete such clinical trials.
Commercialization of any of our current or future product candidates will require preclinical and clinical development; regulatory and marketing approval issued by regulators in any jurisdiction where we seek to commercialize such product candidates, such as the FDA and the European Commission (the “EC”) following a favorable assessment performed by the European Medicines Agency (the “EMA”); manufacturing supply, capacity and expertise; a commercial organization; and significant marketing efforts.
The success of any of our current or future product candidates will depend on many factors, including the following: • timely and successful completion of preclinical studies; • acceptance of INDs or comparable foreign applications that allow commencement of clinical trials or future clinical trials for any product candidates we may develop; • successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices (“GCPs”), current GLPs, and any additional regulatory requirements from foreign regulatory authorities; • positive results from our clinical trials that support a finding of safety and effectiveness and an acceptable risk-benefit profile in the intended populations; • receipt of marketing approvals from applicable regulatory authorities; • establishment of arrangements through our own facilities or with third-party manufacturers for clinical supply and, where applicable, commercial manufacturing capabilities; • establishment, maintenance, defense and enforcement of patent, trademark, trade secret and other intellectual property protection or regulatory exclusivity for any product candidates we may develop; • commercial launch of any product candidates we may develop, if approved, whether alone or in collaboration with others; • obtaining and maintaining third-party coverage and adequate reimbursement; • effectively competing against other therapies; • acceptance of the benefits and use of our product candidates we may develop, including method of administration, if and when approved, by patients the medical community and third-party payors; and • maintaining a continued acceptable safety profile of our products following regulatory approval.
Our business is highly dependent on our lead product candidate, CMP-002, and we must complete clinical testing before we can seek regulatory approval and begin commercialization of any of our product candidates.
If we are unable to obtain regulatory approval for, and successfully commercialize, our current product candidates, our business may be materially harmed, and such failure may affect the viability of any future product candidates.
There is no guarantee that we will be able to advance CMP-002, our lead development candidate, into clinical trials, or that the results obtained in any future clinical trials we may conduct will be sufficient to obtain regulatory approval for any current or future product candidates.
In addition, because our product candidates will be based on our RAP Platform and antisense oligonucleotide (“ASO”) technology, if any of our product candidates encounter safety or efficacy problems, developmental delays, regulatory issues, or other problems, our development plans and business related to our other future product candidates could be significantly harmed.
A failure of one of our product candidates may affect the ability to obtain regulatory approval to continue or conduct clinical programs for our other or future product candidates.
All of our product candidates are still in varying stages of development.
In addition, we have not successfully developed any product candidates, and our ability to identify and develop additional product candidates may never materialize.
Before we can commence clinical trials for a product candidate, we must complete extensive preclinical testing and studies that support clearance of our regulatory filings, including IND applications to the FDA in the United States and other similar regulatory filings in other jurisdictions.
We cannot be certain if the outcome of our preclinical studies and clinical trials will ultimately support further development of our product candidates or future programs or whether the FDA or comparable foreign regulatory authorities will accept our proposed clinical programs or whether the outcome of our preclinical testing and studies will ultimately support the further development of our product candidates.
As a result, we cannot be sure that we will be able to submit INDs and other similar regulatory filings for our preclinical programs on the timelines we expect, if at all, and we cannot be sure that submission of such regulatory filings will result in the FDA or comparable foreign regulatory authorities allowing clinical trials to begin.
Other events that may prevent successful or timely completion of clinical development include: • delays in reaching a consensus with regulatory authorities on trial design; • delays in reaching agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical trial sites; • delays in opening clinical trial sites or obtaining required approval from institutional review boards (“IRBs”) or independent ethics committees, or the equivalent review groups for sites outside the United States, at each clinical trial site; • imposition of a clinical hold by regulatory authorities as a result of a serious adverse event or manufacturing concerns or after an inspection of our clinical trial operations or trial sites; • negative or inconclusive results observed in clinical trials, including failure to demonstrate statistical significance, which could lead us, or cause regulators to require us, to conduct additional clinical trials or abandon product development programs; • failure by us, any CROs we engage or any other third parties to adhere to clinical trial requirements; • failure to perform in accordance with the FDA’s GCPs, Good Manufacturing Practices (“GMP”) regulations or those of other regulatory authorities; • failure by physicians to adhere to delivery protocols, leading to protocol deviations and variable results; • inappropriate storage or failure of storage facilities or storage equipment of preclinical or clinical trial samples; • delays in the testing, validation, manufacturing and delivery of our product candidates to the clinical sites, including delays by third parties with whom we have contracted to perform certain of those functions; • failure of our third-party contractors to comply with regulatory requirements or to meet their contractual obligations to us in a timely manner, or at all; • inability to recruit patients to participate in a clinical trial, including as a result of competition with other pharmaceutical and biotechnology companies and the patient population size for our product candidates; • delays in having patients complete participation in a clinical trial or return for post-treatment follow-up; • clinical trial sites or patients dropping out of a trial; • selection of clinical endpoints that require prolonged periods of clinical observation or analysis of the resulting data, or clinical endpoints that have broad variability or inconsistency, resulting in negative or indeterminable results; • occurrence of serious adverse events associated with a product candidate in development by another company, which are viewed to outweigh its potential benefits, and which may negatively impact the perception of our current or future product candidates due to a similarity in technology or approach; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; • changes in the legal or regulatory regimes domestically or internationally related to patient rights and privacy; • lack of adequate funding to continue the clinical trial; or • lack of diminished revenue potential of the programs due to competition.
Clinical trials must be conducted in accordance with the legal requirements, regulations or guidelines of the FDA and other applicable regulatory authorities, and are subject to oversight by these governmental agencies and IRBs or ethics committees at the medical institutions where the clinical trials are conducted.
We could encounter delays if a clinical trial is suspended or terminated by us, by the data safety monitoring board for such trial or by the FDA or any other regulatory authority, or if the IRBs of the institutions in which such trials are being conducted suspend or terminate the participation of their clinical investigators and sites subject to their review.
Such authorities may suspend or terminate a clinical trial 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 or lack of adequate funding to continue the clinical trial.
Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities.
The FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the trial.
The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized.
This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of our product candidates.
Further, conducting clinical trials in foreign countries, such as our planned Phase 1/2 clinical trial of CMP-002 for the treatment of SYNGAP1, presents additional risks that may delay completion of our clinical trials.
We are in the early stages of development of our programs and plan to initiate a global Phase 1/2 clinical trial of our lead product candidate, CMP-002, in individuals with SYNGAP1, but we have not yet received regulatory clearance to commence clinical activities for CMP-002.
As a result, our belief in the potential success of CMP-002 is based on early research and preclinical studies.

and 116 more.

Gone since FY2024

Since our inception, we have focused primarily on developing our proprietary RNA Actuating Platform, or RAP Platform, identifying, developing and progressing our product candidates through preclinical and clinical development, organizing and staffing our company, research and development activities, establishing and protecting our intellectual property portfolio, and raising capital.
We are still in the early stages of development of our product candidates and our lead product candidate is only in a Phase 1 clinical trial.
For the years ended December 31, 2024 and 2023, we reported net losses of $51.8 million and $49.3 million, respectively.
As of December 31, 2024, we had an accumulated deficit of $211.8 million.
We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue the research and development of, and seek regulatory approvals for, our lead product candidate CMP-CPS-001 for the treatment of urea cycle disorders (“UCDs”), along with any other current or future product candidates we may develop.
We anticipate that our expenses will increase substantially if and as we: • advance our lead product candidate, CMP-CPS-001, through clinical trials; • finalize preclinical development for our program for SYNGAP1-related disorders; • conduct preclinical studies and clinical trials of any future product candidates; • expand the capabilities of our RAP Platform and seek to identify and develop additional product candidates; • seek to identify additional product candidates; • seek marketing approvals for any product candidates that successfully complete clinical trials; • obtain, expand, maintain, defend and enforce our intellectual property portfolio; • hire additional clinical, regulatory and scientific personnel; • contract with manufacturing sources for preclinical and clinical development of any future product candidates we may develop and commercial supply with respect to any such product candidates that receive regulatory approval; • ultimately establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; and • add operational, legal, compliance, financial and management information systems and personnel to support our research, product development and future commercialization efforts, as well as to support our operations as a public company.
Our product candidates are in varying stages of preclinical and clinical development.
We have not completed a clinical trial of any product candidate, and we expect that it will be several years, if ever, before we have a product candidate ready for commercialization.
As of December 31, 2024, we had cash and cash equivalents of $64.0 million.
Based on our current operating plan, we estimate that our cash and cash equivalents as of December 31, 2024 will be sufficient to fund our operating expenses and capital expenditure requirements into the second quarter of 2026.
Our future capital requirements will depend on many factors, including, but not limited to: • the scope, timing and progress of our ongoing CMP-CPS-001 clinical trial; • the initiation, type, number, scope, progress, expansions, results, costs and timing of preclinical studies and clinical trials of our product candidates and any future product candidates we may choose to pursue, including the costs of modification to clinical development plans based on feedback that we may receive from regulatory authorities and any third-party products used as combination agents in our clinical trials; • the costs and timing of manufacturing for our product candidates, including commercial manufacturing at sufficient scale, if any product candidate is approved; • the costs, timing and outcome of regulatory meetings and reviews of our product candidates or any future product candidates, including requirements of regulatory authorities in any additional jurisdictions in which we may seek approval and any future product candidates; • the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights; • our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting; • the costs associated with hiring additional personnel and consultants as our clinical and preclinical activities increase; • the timing and payment of milestone, royalty or other payments we must make or may receive pursuant to our existing and potential future license or collaboration agreements with third parties; • the costs and timing of establishing or securing sales and marketing capabilities if our product candidates or any product candidate is approved; • our ability to achieve sufficient market acceptance, coverage, and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; • patients’ ability and willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; • the terms and timing of establishing and maintaining collaborations, licenses, and other similar arrangements; and • costs associated with any products or technologies that we may in-license or acquire.
We do not have any committed external source of funds.
Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.
In its report accompanying our audited financial statements for the years ended December 31, 2024 and 2023, our independent registered public accounting firm included an explanatory paragraph stating that our recurring losses from operation raise substantial doubt about our ability to continue as a going concern for a period of one year after the date the financial statements are issued.
See Note 1 to our consolidated financial statements appearing elsewhere in our Annual Report for additional information on our assessment.
Our future viability is dependent on our ability to generate cash from our operating activities or to raise additional capital to finance our operations.
There is no assurance that we will succeed in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all.
The perception that we might be unable to continue as a going concern may also make it more difficult to obtain financing for the continuation of our operations on terms that are favorable to us, or at all, and could result in the loss of confidence by investors, suppliers and employees.
If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements and it is likely that our investors will lose all or a part of their investment.
Our product candidates are in varying stages of preclinical and clinical development and we have not completed a clinical trial of any product candidate.
We are early in our development efforts and our lead product candidate is only in a Phase 1 clinical trial.
We are currently conducting a Phase 1 clinical trial of CMP-CPS-001 in Australia.
Clinical trials conducted in Australia using “unapproved therapeutic goods,” or those that have not yet been evaluated by the Therapeutic Goods Association (the “TGA”) for quality, safety and efficacy, must occur pursuant to either the Clinical Trial Notification Scheme or the Clinical Trial Approval Scheme.
In each case, the trial is supervised by a Human Research Ethics Committee (“HREC”), an independent review committee set up under the guidelines of the Australian National Health and Medical Research Council that reviews, approves and provides continuing oversight of trial protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
In the event that the FDA or TGA requires us to complete additional preclinical studies or we are required to satisfy other requests prior to commencing clinical trials, the start of any future clinical trials may be delayed.
Even after we receive and incorporate guidance from the FDA, an applicable HREC or the TGA, such authorities could disagree that we have satisfied their requirements to commence any clinical trial or continue or change their position on the acceptability of our trial design or the clinical endpoints selected, which may require us to complete additional preclinical studies or clinical trials or impose stricter approval conditions than we currently expect, which could delay the start or completion of such clinical trials or require more capital resources than we currently anticipate to start or complete such clinical trials.
We anticipate that for one or more of our product candidates, clinical trials will need to be conducted utilizing sites and patients in the European Union and the United Kingdom.
Similar processes and risks are applicable to clinical trial applications (“CTAs”) in the European Union as well as the United Kingdom as exist in other regions.
Regulators for the European Union and/or for local countries may request additional preclinical studies or may reject the request to initiate clinical trials in humans.
Requests for additional preclinical studies prior to commencing clinical trials may result in the delay of future clinical trials.
Even after we receive and incorporate guidance from EU and/or local country regulators, the regulatory authorities may disagree with our position that we have satisfied their requirements, require additional preclinical studies or clinical trials, or refuse to approve the product candidate.
Commercialization of any of our current or future product candidates will require preclinical and clinical development; regulatory and marketing approval issued by regulators in any jurisdiction where we seek to commercialize such product candidates, such as the FDA, TGA and the European Commission (the “EC”) following a favorable assessment performed by the European Medicines Agency (the “EMA”); manufacturing supply, capacity and expertise; a commercial organization; and significant marketing efforts.
The success of any of our current or future product candidates will depend on many factors, including the following: • timely and successful completion of preclinical studies; • acceptance of INDs or comparable foreign applications that allow commencement of clinical trials or future clinical trials for any product candidates we may develop; • successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices (“GCPs”), current Good Laboratory Practices (“GLPs”) and any additional regulatory requirements from foreign regulatory authorities; • positive results from our clinical trials that support a finding of safety and effectiveness and an acceptable risk-benefit profile in the intended populations; • receipt of marketing approvals from applicable regulatory authorities; • establishment of arrangements through our own facilities or with third-party manufacturers for clinical supply and, where applicable, commercial manufacturing capabilities; • establishment, maintenance, defense and enforcement of patent, trademark, trade secret and other intellectual property protection or regulatory exclusivity for any product candidates we may develop; • commercial launch of any product candidates we may develop, if approved, whether alone or in collaboration with others; • obtaining and maintaining third-party coverage and adequate reimbursement; • effectively competing against other therapies; • acceptance of the benefits and use of our product candidates we may develop, including method of administration, if and when approved, by patients the medical community and third-party payors; and • maintaining a continued acceptable safety profile of our products following regulatory approval.
Our business is highly dependent on our lead product candidate, CMP-CPS-001, as our sole clinical-stage program, and we must complete clinical testing before we can seek regulatory approval and begin commercialization of any of our other product candidates.
If we are unable to obtain regulatory approval for, and successfully commercialize, CMP-CPS-001, our business may be materially harmed and such failure may affect the viability of our other product candidates.
There is no guarantee that the results obtained in our ongoing Phase 1 clinical trial of CMP-CPS-001 or our planned future clinical trials will be sufficient to obtain regulatory approval.
In addition, because CMP-CPS-001 is our most advanced product candidate, and because our future product candidates will be based on our RAP Platform and antisense oligonucleotide (“ASO”) technology, if our lead product candidate encounters safety or efficacy problems, developmental delays, regulatory issues, or other problems, our development plans and business related to our other future product candidates could be significantly harmed.
A failure of our lead product candidate may affect the ability to obtain regulatory approval to continue or conduct clinical programs for our other or future product candidates.
All of our product candidates are still in varying stages of preclinical and clinical development.
In addition, we have not completed a clinical trial of any product candidate or successfully developed any product candidates, and our ability to identify and develop additional product candidates may never materialize.

and 138 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch CAMP. Know when insiders buy.

One email the day a filing lands. Free.