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| Statement |
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| So, I am really, really confident that everything that we've learned about this marketplace pretends that we're going to have a really successful launch for 3107 |
| Administration with CELLECTRA, our proprietary electroporation device was well-tolerated by patients was easy-to-use for healthcare providers in the Phase 1/2 trial consistent with its use in other trials |
| We were very excited by what we saw in that study and it really goes back to one of the strengths of the platform, our ability to generate these antigen specific cytotoxic CD8 T cells that we know are capable of getting to the tumor |
| And perhaps most importantly, we believe that INO-3107 offers potential compelling clinical and commercial advantages that will serve as an important foundation to our commercial efforts |
| We also shared encouraging results for INO-4201 as an Ebola booster vaccine, continue to advance other clinical-stage candidates and made progress with promising preclinical research opportunities for next generation candidates adding to the positive momentum |
| This combined data set provides compelling evidence to support our belief in the potential of INO-3112 and LOQTORZI |
| So, I think we're pretty well-positioned from a manufacturing standpoint to be able to build up the launch inventory and be able to support the market need over the first couple of years pretty easily |
| Thanks to a strong strategic vision that prioritizes promising candidates with strong commercial potential |
| Based on previous trial data and the growing body of research indicating that DNA medicines are adept at combating HPV-related diseases, there is a strong rationale in combining 3112 with a proven PD-1 inhibitor |
| Looking ahead, several key catalysts will help continue that momentum across our pipeline |
| And we have advanced DNA medicine for patients around the world that could potentially benefit from its promise |
| In the first quarter of 2023, we shared positive results from our Phase 1/2 trial, which were later published in a leading peer-reviewed journal read by our future physician customer base |
| And so, so far, everything every interaction we've had with Coherus has been very positive |
| Earlier I mentioned the encouraging results we announced in early 2023 from our Phase 1b clinical trial of 4201 as Ebola vaccine booster candidate |
| And so, we're just really very encouraged to continue with that partnership and perform the clinical trial |
| In combination, this therapeutic approach is designed to leverage the antigen specific T-cells elicited by 3112 and the anti-tumor immunity generated by LOQTORZI to potentially provide improved patient outcomes |
| To achieve this transformation, we have prioritized our product pipeline to focus on 3107 and other promising late-stage assets, all with high unmet medical need and strong commercial potential |
| For 3112 we saw really encouraging data both as a monotherapy and in combination with durvalumab |
| We have built a foundation for long-term success that we will continue to build on |
| They're really great candidates |
| While there's still much work to be done, I'm confident in our commercial launch strategy for several important reasons |
| In the trial, INO-3107 was immunogenic and generally well-tolerated and over 80% of patients across the disease severity continuum had a reduction in the number of surgeries compared to the previous year |
| We're excited about what the future holds for these innovative technologies and look forward to sharing more in the year ahead |
| So, we're very excited to move this program forward |
| As Jacque, Mike and Mark have noted, we have made significant progress across our pipeline over the past year, advancing key candidates while working successfully to reduce our operational spend after our pipeline reprioritization |
| In addition to the significant progress made with 3107, our strategic refocus helped drive progress across the pipeline including a new clinical collaboration and supply agreement with Coherus BioSciences to develop INO-3107 in combination with LOQTORZI for throat cancer |
| And so, we are confident that sort of based on our market projections and our estimates around adoption etcetera that we'll be able to sort of fully meet the demand for 3107 |
| And so, from a surgical perspective, as Mark said, they really would, they're just as excited as the patients, I think, for looking for a non-surgical treatment for these patients |
| From a commercial standpoint, INO-3107 offers several key differentiators |
| So again, the combination of patients who originate for treatment for RRP, the fact that surgery is inadequate and burden and causes a lot of morbidity and that physicians are looking for alternative really puts us in a good position with 3107 |
| Statement |
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| However, those 25% of patients who have their cancer progress face very poor clinical outcomes |
| And whilst we were disappointed that AstraZeneca decided not to move durvalumab forward in the head and neck space |
| This puts an extreme physical and emotional burden on patients, including the threat of permanent vocal cord damage, impacting the patient's ability to speak normally ever again |
| As you can see from this slide, we have again reduced our total operating spend dropping from $56.1 million in the fourth quarter of 2022 to $27.5 million in the fourth quarter of 2023, a 51% decrease |
| So, that is certainly not a concern for us |
| And similarly from a patient perspective, as Mike mentioned, it's a devastating disease and even with the reduction of sort of one surgery a year could be life changing for them |
| So again, that isn't of any concern to us |
| For those who are not familiar with RRP, it is a devastating rare disease of the respiratory tract caused by HPV-6 and HPV-11 |
| These factors combined to bring our net loss for the fourth quarter of 2023 to $25 million or $1.10 per share basic and dilutive and our net loss for the full-year 2023 to $135.1 million or $6.09 per share basic and dilutive |
| I guess the first thing I would say from a commercial perspective, I've never been more excited about launching a new product |
| They recognize that while surgery is hugely beneficial for the patients, they understand that sooner or later, there is going to be damage caused |
| A recent study found that even patients who have had less than five surgery, face a 50% chance of permanent vocal cord damage |
| RRP most commonly causes difficulty speaking or complete voice loss, difficulty swallowing, shortness of breath, and choking episodes |
| There's no disincentive for them to use this I know 3107 because the current standard-of-care is wholly inadequate |
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