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| Statement |
|---|
| I am very excited to join the Corvus team to advance the development of a very promising pipeline |
| The progression-free survival in our hands is 6.2 months, which is substantially better than the 1.6 and 3.0 months I mentioned earlier |
| We believe Corvus is positioned to build value in the near-term with significant upcoming clinical milestones for soquelitinib in oncology and immune diseases, further strengthening our ongoing business development, which is concentrated on partnering opportunities for ITK inhibition |
| Given all this, we believe soquelitinib and our next-generation ITK inhibitors can be an attractive opportunity for partners, given the unique mechanism of action, human safety data with soquelitinib from our Phase 1 lymphoma trial, the large and diverse market opportunities in oncology and immunology, and our strong intellectual property position with issued composition of matter patents for soquelitinib extending out to November 2037, not including likely extensions |
| The median PFS, progression-free survival, for our patients and the primary endpoint for our Phase 3 trial remains at 6.2 months, which is substantially better than reported for the standard agents |
| The opportunity to join Corvus at this time was very appealing with a number of potential milestones and key inflection points for the company over the next six to 12 months, including the start of our Phase 3 trial, soquelitinib for relapsed PTCL, which is addressing an indication with significant unmet need and provides the opportunity to bring an important new treatment option to patients and to create value for Corvus |
| We have seen increasing momentum in partnering interest since the announcement of our Phase 3 registration trial in the third quarter of 2023 and recent publications on the activity of soquelitinib and preclinical models of cancer and immune diseases |
| Together, these factors make the PTCL opportunity substantial for a novel effective treatment as is seen with other disease-modifying therapies in the hematology space |
| Encouragingly, as we enroll more patients, we continue to see that the deep response rate exceeds our 32% benchmark based on 14 evaluable patients that have received at least one follow-up assessment, up from eight evaluable patients at our Q3 call |
| We -- the power, we have about 89%, 90% power to see an improvement from about three and a half months to five and a half months, which is our target, okay? Rosemary Li Thank you so much |
| More broadly, we view PTCL as an entry point with numerous potential ways to expand the opportunity and to help more patients with solid tumors and immune diseases |
| 100 gives you pretty good occupancy, but not -- it's not complete, but probably good enough to cause some biologic effect |
| Soquelitinib represents a near-term commercial opportunity with our planned Phase 3 trial protocol intended to enroll 150 patients |
| Although not studied head-to-head, the ORR, complete response rate, disease control rate, progression-free survival, and overall survival for this group compares favorably to the results seen with belinostat or pralatrexate, which are the standard chemotherapies for PTCL and that we will be comparing against in a Phase 3 trial |
| Our Phase 1 data continues to improve as we have longer follow-up |
| The market for drugs to treat hematologic malignancies is large at approximately $55 billion and is projected to grow to $90 billion by 2028 |
| Corvus has become a pioneer in the research and development of ITK inhibition as a new therapeutic modality to benefit patients with a diverse range of diseases |
| And I think we'll get an idea very early, not only about the efficacy, but also about the biologic activity because remember, the reason that we're picking atopic dermatitis first is that it is very much what's called a Th2, T helper cell 2 disease, a disease mediated by IL-4 and 5 and 13, and we know that our drug blocks the Th2 function very well |
| In cancer, Corvus is focusing in areas of high unmet need with a novel target and with significant commercial potential |
| PTCL has a very high unmet need with a very low survival rate of under 20% in five years, so there is a desperate need for new and effective therapies |
| Recently, published data demonstrated the potential role of ITK in a broad range of indications, and we have expanded our capabilities and approach to business development with the appointment of Jeff Arcara as Chief Business Officer |
| So, this is a very important study in that we get data quickly and it's very informative, not only for the purpose of atopic dermatitis, but it opens up the whole field |
| In 2024, we are focused on two key value drivers to further confirm and advance this opportunity; first, begin patient enrollment in a registrational Phase 3 trial of soquelitinib for patients with relapsed PTCL, or peripheral T cell lymphomas, an indication with no fully FDA-approved therapies and significant unmet need |
| Rosemary Li Thank you so much |
| Richard Miller Thank you, Leiv and good afternoon everyone |
| Then we go to the next dose regimen, which is 200 milligrams once-a-day, because we think that once-a-day dosing will be effective, and we think it's more convenient, of course |
| Thank you very much |
| Thanks |
| Thanks |
| Jeff? Jeff Arcara Thank you, Richard and good afternoon everyone |
| Statement |
|---|
| Pralatrexate suffers from an additional toxicity, mucositis |
| The net loss for the fourth quarter of 2023 was $6.7 million, including a $1.4 million non-cash loss related to Angel Pharmaceuticals, our partner in China |
| I think two questions from us |
| In relapsed disease, especially in this disease, people live such a short time that in half your case, it's difficult to even get people beyond a few months |
| This compares to a net loss of $9.8 million for the same period in 2022, which included a $4.6 million non-cash loss related to Angel Pharmaceuticals |
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