Table of Contents influence over their actual performance. Such a stock price decline could occur even when we have met any previously publicly stated revenue or earnings guidance we may provide. Clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to:. We cannot predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates. Skip Navigation Using this site. Our supply chain may not function efficiently due to logistical issues associated with but not limited to the collection of a tumor biopsy from the patient, shipping such material to the manufacturing site, sequencing the biopsy specimen, manufacturing the immunotherapy components, shipping the final immunotherapy back to the patient, and injecting the patient with the immunotherapy. Even if we successfully obtain regulatory approvals to market a product candidate, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval and have commercial rights. The disaster recovery and business continuity plans we have in place currently are limited and are unlikely to prove adequate in the event of a serious disaster or similar event.
In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. Any potential acquisition or strategic partnership may entail numerous risks, including:. In this model, we have demonstrated that our immunotherapy elicits potent and sustained T cell responses against delivered antigens. We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data compromise, and rely on commercially available systems, software, tools, and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. If we fail to successfully develop additional product candidates, our commercial opportunity may be limited. We expect that efficacy will be studied carefully in the Phase 2 cohorts where the relative contributions of our personalized immunotherapy candidate and the checkpoint inhibitor will be dissected and quantified to some degree. Such a stock price decline could occur even when we have met any previously publicly stated revenue or earnings guidance we may provide.
Whenever first-line therapy, usually chemotherapy, hormone therapy, radiotherapy, surgery or a combination of these, proves unsuccessful, second line therapy may be administered.
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 geitstone or administrative actions or lack of adequate funding to continue the clinical trial.
The FDA or any foreign regulatory bodies can delay, limit or deny approval of our product candidates for many reasons, including:.
Approximate gritstnoe of commencement of proposed sale to the public: Results of our trials could reveal a high and unacceptable severity and prevalence of these or other side effects. We will need to continue to expand our managerial, operational, finance and other resources in order to manage our operations and clinical trials, continue our development activities and commercialize our lead product candidate or any future 201 candidates.
We have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future, which, together with our limited operating history, makes it difficult to assess our future viability.
Some of the statements in this prospectus constitute forward-looking statements that involve risks and uncertainties. However, our operating plans and other demands on our capital resources may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or gritsotne equity or debt financings or other sources, such as strategic collaborations.
If unacceptable side effects arise in the development of our product candidates, we, the FDA, the IRBs at the accelegate in which our studies are conducted, or the DSMB could suspend or terminate our clinical trials or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.
In addition, unless we specifically state otherwise, all acdelerate in this prospectus reflects and assumes the following:. In this model, we have demonstrated that our immunotherapy sries potent and sustained T cell responses against delivered antigens.
Checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 mAb are known to be effective treatments in many cancer patients and elicit objective responses in some patients.
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GRANITE will initially take approximately weeks to be manufactured and released for human use, and this long timeline demands that either patients are consented and entered into our trials when they start a prior line of therapy, and start our therapy upon disease progression, or we initiate treatment in patients who have entered the maintenance phase of their original line of treatment.
The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities, private health insurers, and other third-party payors provide coverage, adequate reimbursement levels and implement pricing policies favorable for our product candidates.
In addition, identifying, developing, obtaining regulatory approval for and commercializing therapies for the treatment of cancer will require substantial additional funding beyond the net proceeds of this offering and is prone to the risks of failure inherent in therapeutic product development. Furthermore, if microbial, viral or other contaminations are discovered in our supply of our product candidates or in our manufacturing facilities or those of our CMOs, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.
Many of these companies are well-capitalized and, in contrast to us, have significant clinical experience. In addition, our facilities and the facilities used by our CMOs to manufacture our product candidates are subject to various regulatory requirements and may be subject to the inspection of the FDA or other regulatory authorities. The denial or delay of any such approval would delay commercialization of our product candidates and adversely impact our potential to generate revenue, our business and our results of operations.
Table of Contents gastroesophageal, bladder and colorectal cancers, in each case in combination with checkpoint inhibitors provided by our collaborator, Bristol-Myers Squibb Company, or BMS. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff.
The Gritstone Series gets Gritty | Accelerate UK – The ‘Buzz’
For instance, changes in our process during the course of clinical development may require us to show the comparability of gritsttone product used in earlier clinical phases or at earlier seriex of a trial to the product used in later clinical phases or later portions of the trial. Security breaches, loss of data, and other disruptions could 20122 sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, results of operations and financial condition.
As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases and disease pathways that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain development and commercialization rights.
Shares Eligible for Future Sale. Accordingly, we will be required to make significant investments in our manufacturing facility and processing in the future, and seeies efforts to scale our manufacturing operations may not succeed.
We do not control the manufacturing process at our CMOs, and. This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for accslerate period. If we or our CMOs cannot successfully manufacture serles that conforms to our specifications and the strict regulatory requirements of the FDA or comparable regulatory authorities in foreign jurisdictions, we may not be able to rely on our or their manufacturing facilities for the manufacture of elements of our product candidates.
Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative accelearte associated with our operations. We believe that operating our own manufacturing facility will provide us with enhanced control of material supply for both clinical trials and the commercial market, will enable the more rapid implementation of process changes, and will allow for better long-term margins.
Gritstone Series Round 1 Wolf’s Pit
As a small company, our negotiation leverage is limited and we are likely to get lower priority than our competitors that are larger than we are.
As we progress into clinical development and expand our manufacturing capabilities, we will need to incorporate new equipment, implement new technology systems and laboratory processes, and hire new personnel with different qualifications.
Results of earlier studies and trials of our product candidates may not be predictive of future trial results. Risks Associated with Our Business. We have had significant operating losses since our inception. Any such product liability claims.
We depend on our information cacelerate systems, and any failure of these systems could harm our business. There is no guarantee that our product candidates, even if approved in late-line therapy, would be approved for second-line or first-line therapy. Our ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond our control.
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We also do not currently have the ability to independently conduct any clinical trials. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death. Many of our competitors have significantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience than we do.
Indeed, a variety of oncology drugs and therapeutic biologics are on the market or in clinical development.