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| Statement |
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| The consistently positive outcomes from seminal studies such as BRACELET-1, AWARE-1 and GOBLET have captured the attention and deepening engagement of the clinical oncology community and potential strategic partners |
| The transition to becoming a late-stage biopharma company reflects significant progress in positive clinical and translational data reported from our clinical programs in 2023 |
| The data supporting pela as a novel immunotherapeutic agent with the ability to improve patient outcome continues to grow, and we're setting the stage to add to that this year |
| Positive clinical and translational data helped close 2023 on a high note |
| This collective effort fuels our optimism and drives us towards a future where pela's transformative potential can positively impact countless lives |
| Our positive clinical data is enriching our discussion with a number of current and potential clinical and strategic partners |
| We have assembled a management team that is well-positioned to bring pela to patients, and attracting a Board member like Pat Andrews reflects the strength of our team and pela's potential |
| We believe a user-friendly product interface is important and are confident that pela fits that specification well |
| Our successful track record in scale up and consistent production gives us confidence that our investment in the next level of pela drug substance batches will go well as we continue this work in 2024 and 2025 |
| The MilliporeSigma site has a well-established quality management system and our protocols and procedures are well aligned |
| Key takeaways from my section are we have a well-established product supply chain for pela, we have made numerous batches of material at increasing scale and pela has a long shelf life |
| Furthermore, the promising preliminary results from this cohort support pela's ability to synergize with checkpoint inhibitors and enhance their efficacy in cancers where they've historically provided little benefit |
| This brings us closer to achieving our mission of improving the lives of patients with cancer, so we'll begin the year with significant enthusiasm |
| This data represents an important milestone anticipated to serve as a significant catalyst in bolstering our registration endeavors for pela and a focal point of interest for our prospective biopharma collaborators |
| But we are optimistic that the overall survival will ultimately be in line with the -- and be -- why I say be in line, I don't mean necessarily month-for-month, but that the overall survival will ultimately validate the PFS benefit that we saw and reported nine months ago or so |
| As a result of these relationships, we've been able to collaborate with key opinion leaders in the pancreatic cancer community, and their enthusiasm for pela's potential in this indication reinforces our commitment to bringing new treatment options to patients |
| As we conclude today's call and embark on this New Year, we have a bright outlook for the development of pela and a hopeful outlook for patients with an unwavering dedication to our mission |
| The positive data that we reported throughout 2023 include the BRACELET-1 breast cancer data reported in June have also attracted interest and enhanced ongoing interactions with our clinical collaborators and potential strategic partners |
| And that would provide, I think, a great deal of confidence that the treatment we're evaluating is active at a level higher than what is seen with the standard of care checkpoint inhibitor alone |
| We believe this will enable us to achieve the most critical near-term milestones set out in today's call |
| Positive results from this study could expand the population of pancreatic cancer patients who may benefit from pela-based therapy and may ultimately provide physicians with much needed treatment options for this devastating disease |
| Importantly, the data demonstrated a positive correlation between response rates and pela's ability to induce the expansion of T cell populations, measured by increases in the CelTIL score and the level of tumor infiltrating lymphocytes or pills in the peripheral blood |
| Her experience in navigating registrational trials in oncology and completing transformational business development agreements complements and expands the strategic expertise of our Board |
| We are enthusiastic about this new cohort because it will enable us to study pela in combination with one of the most widely used pancreatic cancer treatment backbones and to directly assess the value of adding a checkpoint inhibitor |
| We are very grateful and encouraged by the support we received from PanCAN to conduct this study |
| Starting with our clinical results, we reported positive clinical data from three cohorts in the Phase 1/2 GOBLET study in pancreatic cancer, colorectal cancer, and anal cancer |
| I'm excited to share the progress we've made over these past few months |
| While anal cancer is very rare, there is no standard of care for these patients who have progressed to advanced disease, so positive results may provide an opportunity for a rapid regulatory pathway |
| Together, all of us, we're pioneering the path filled with hope, determination and the resolute belief that every step forward brings us closer to uplifting patients' lives and the reshaping of the landscape of cancer treatment |
| Positive clinical results were supported by valuable translational data from further analysis of the AWARE-1 breast cancer study and from cohorts in the GOBLET study |
| Statement |
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| Tom Heineman Sorry, for whatever reason, we have a terrible connection |
| The net loss in the fourth quarter of 2023 was $3.9 million, compared to $8.6 million in the fourth quarter of 2022, equating to a net loss of $0.05 per share in the fourth quarter of 2023 compared to $0.14 per share for the same period of 2022 |
| The net loss for the full year of 2023 was $27.8 million, compared to $24.8 million in the full year 2022, equating to a net loss of $0.41 per share for the 2023 period and a net loss of $0.43 per share for the 2022 period on a consolidated basis |
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