Q4 2021 Cyteir Therapeutics Inc Earnings Call
and Chief Executive Officer, and Dave Gallaro, our Vice President of Finance. Andrew Jenjofs, our Chief Business Officer, and Paul Seacrest, our Chief Client HIPAA Officer, will join for Q&A.
And Dave <unk>, our vice President of Finance, Andrew <unk>, Our Chief business Officer, and Paul <unk>, Our Chief Scientific officer will join for Q&A.
I would like to remind everyone that some of the statements we make on this call will include forward-looking statements.
I would like to remind everyone that some of the statements. We make on this call will include forward looking statements actual events or results could differ materially from those expressed or implied by any forward looking statements. As a result of various risks uncertainties and other factors, including those set forth in our most recent filings with the SEC and.
Actual events and results could differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties, and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC. With that, I will turn the call over to Margaret.
Any other future filings that we may make with the SEC.
That I will turn the call over to markets.
Thanks Lisa.
Margaret: 2021 was an exciting year for PsychTier with solid execution and advancement of our LEAD program CYT 0851 as we met key clinical objectives discussed during our IPO in June . Importantly, we entered the next stages of clinical development, Phase II monotherapy and Phase I in combination with chemotherapy.
2021 was an exciting year perfect here with solid execution and advancement of our lead program <unk> hundred one as we met key clinical objectives discussed during our IPO in June importantly, we entered the next stages of clinical development phase II monotherapy in phase one in combination with chemotherapy.
Margaret: We have strengthened our management, clinical, and research teams, which positions us well to achieve multiple key milestones in 2022, including reporting data from the monotherapy and combination of studies with CYP 0851.
Thankfully, our management clinical and research teams, which positions us well to achieve multiple key milestones in 2022, including reporting data from the monotherapy and combination studies with CYP or <unk>.
Margaret: But before I preview 2022 in more detail, let me summarize the accomplishments we've made over the past year.
But before I previewed 2022 in more detail, let me summarize the accomplishments we've made over the past year.
Margaret: As a reminder, our lead product candidate is CYTO851, which is designed to inhibit DNA repair. This novel and patented drug is in a phase one study in combination and a phase two study as monotherapy in patients with relapsed or refractory hematologic malignancies and solid tumors.
As a reminder, our lead product candidate <unk> hundred one which is designed to inhibit DNA repair. This novel and patented drug is in a phase one study in combination and a phase II study as monotherapy in patients with relapsed or refractory hematologic malignancies and solid tumors as this tip.
Margaret: As is typical of such studies, we are evaluating the safety of CYTO-851 in patients who have failed multiple cancer therapies and who have exhausted all available therapeutic options while exploring early signs of efficacy.
Nicole offset studies, we are evaluating the safety of <unk> hundred one in patients who have failed multiple cancer therapies, and who have exhausted all available therapeutic options, while exploring early signs of efficacy. These patients have progressive tumors and need an effective treatment. If <unk> hundred one has shown to be safe and efficacious.
Margaret: These patients have progressive tumors and need an effective treatment. If CYTO-851 is shown to be safe and efficacious in these heavily pretreated patients with poor prognosis, we'll look for opportunities to bring CYTO-851 into earlier lines of therapy.
Mrs. In these heavily pretreated patients with poor prognosis, we will look for opportunities to bring <unk> into earlier lines of therapy.
Margaret: Over the past year for CYTOA-A51, we completed the Phase 1 portion of our trial and determined the recommended Phase 2 dose.
Over the past year of four <unk> hundred one we completed the phase one portion of our trial and determined the recommended phase II dose.
Margaret: In this dose escalation portion of the first in human trial of CYTO851, we escalated the dose 40-fold in 12 cohorts and determined the maximum tolerated dose of 600 milligrams per day and a recommended phase 2 dose of 400 milligrams per day taken orally once a day.
In this dose escalation portion of the first in human trial of <unk>, one we escalated the dose 40 fold and 12 cohorts and determined the maximum tolerated dose of 600 milligrams per day and a recommended phase II dose of 400 milligrams per day taken orally. Once a day, we are pleased with this dose regimen.
Margaret: We're pleased with this dose recommendation. This dose level, if proven effective, should be straightforward for patients to manage as a once-daily medication schedule is convenient and easy to follow.
Station this dose level, if proven effective should be straightforward for patients to manage as a once daily medication schedule is convenient and easy to follow.
Margaret: An interim analysis of our ongoing Phase 1-2 study of CYTO-851, as presented previously, showed that CYTO-851 provided disease control in 20 of 46 response-evaluable patients, including three responses in non-Hodgkin lymphoma and soft tissue sarcoma. On a standalone basis, this data is encouraging. It is further encouraging considering the high unmet need in patients so heavily pretreated prior to their participation in our study.
An interim analysis of our ongoing phase one two study of <unk> hundred one as presented previously showed that <unk> 501 provided disease control in 'twenty of 46 response, evaluable patients, including three responses in non Hodgkin lymphoma in soft tissue sarcoma on a standalone basis. This data is encouraging.
It is further encouraging considering the high unmet need in patients so heavily pre treated prior to their participation in our study.
Margaret: Furthermore, the safety profile shown in these patients is quite encouraging. CYTO851 has been well tolerated today, which differentiates it from other phase one drugs given the level of activity we are observing.
Furthermore, the safety profile shown in these patients is quite encouraging CYP 380, 501 has been well tolerated today, which differentiates it from other phase one drugs given the level of activity we are observing.
Margaret: Of the 73 patients enrolled in the study, 58% reported at least one treatment-related adverse event, and only 16% of patients reported at least one grade 3-4 treatment-related adverse event. Importantly, across all dose levels, 42% of patients had no treatment-related adverse event.
Of the 73 patients enrolled in this study 58% reported at least one treatment related adverse events and only 16% of patients reported at least one grade three four treatment related adverse events importantly across all dose levels, 42% of patients had no treatment related adverse events. Most importantly.
Margaret: Most importantly, we've not observed any clinically significant myelosuppression, neuropathy, vomiting, or diarrhea, which are some of the most common adverse events that pose challenges in drug development.
We have not observed any clinically significant milo suppression neuropathy, vomiting, or diarrhea, which is some of the most common adverse events that post challenges in drug development. The adverse events reported at the recommended phase II dose are primarily low grade. The three most common treatment related adverse events were fatigue reported by 'twenty one.
Margaret: The adverse events reported at the recommended phase 2 dose are primarily low-grade. The three most common treatment-related adverse events were fatigue, reported by 21% of patients, hyperuricemia, reported by 11% of patients, and nausea, reported by 11% of patients.
1% of patients <unk> reported by 11% of patients and nausea reported by 11% of patients no patient at or below the recommended phase II dose discontinued treatment for treatment related adverse events and short in 2021, we demonstrated <unk> clinical proof.
Margaret: No patient at or below the recommended phase 2 dose discontinued treatment for treatment-related adverse events. In short,
Margaret: In 2021, we demonstrated CYTOA51 clinical proof of concept with disease control and radiologic responses with a safety profile consisting primarily of mild grade 1 and 2 treatment-related adverse events. Now, while we're encouraged by these data, we recognize that the study of CYTOA51 remains early. We're eager to see further clinical results from our CYTOA51 study.
A concept with disease control and radiological responses with a safety profile, consisting primarily of mild grade one and two treatment related adverse events now while we are encouraged by these data we recognize that the study of <unk> 501 remains early we're eager to see further clinical results from our <unk> hundred one.
Studies the phase one two study of <unk> hundred one as a monotherapy continues before the end of 'twenty. Two we anticipate reporting additional data from this study at the start of 2022, we were ready to initiate six phase III monotherapy expansion cohorts in solid tumors and hematologic.
Margaret: The Phase 1-2 study of CYT0851 as a monotherapy continues. Before the end of 22, we anticipate reporting additional data from this study.
Margaret: At the start of 2022, we were ready to initiate six Phase II monotherapy expansion cohorts in solid tumors and hematologic malignancies as part of our ongoing Phase I-II trial. The first patient was enrolled in January 2022. Before the end of this year, we anticipate data from these expansion cohorts.
<unk> is part of our ongoing phase one two trial. The first patient was enrolled in January 2022 before the end of this year, we anticipate data from these expansion cohorts.
Margaret: Preclinical, in vitro, and in vivo data demonstrate synergy or additivity when certain chemotherapy drugs were combined with CYTO-851. Once we established that CYTO-851 did not cause significant myelosuppression in humans, it allowed us to begin the evaluation of CYTO-851 in combination with standard of care anticancer therapies with the first patient enrolled in December .
Preclinical in vitro and in vivo data demonstrates synergy or additivity and certain chemotherapy drugs were combined with sea <unk> at 501. Once we establish that <unk> did not cause significant minus suppression in humans. It allowed us to begin the evaluation of <unk> hundred one in combination.
The standard of care anti cancer therapies with the first patient enrolled in December .
Margaret: Similar to our monotherapy expansion cohorts discussed earlier, we anticipate reporting data before the end of 2022. I will further describe this combination of studies in a moment.
Similar to our monotherapy expansion cohort as discussed earlier, we anticipate reporting data before the end of 2022 I will further describe this combination studies in a moment.
Margaret: It is not only CYTO-851 which has us encouraged. From our discovery platform, in 2021, we advanced two additional targets in distinct DNA damage response pathways denomination, and I've moved those into high-throughput screening to identify lead compounds.
It is not only <unk> hundred one which has us encouraged from our discovery platform in 2021, we advanced two additional targets and distinct DNA damage response pathways denomination and move those into high throughput screening to identify lead compounds. The first of these undisclosed targets with target too.
Margaret: The first of these undisclosed new targets, Target 2, plays a key role in non-homologous end-joining, or NHEJ, and the second, Target 3, in microhomology-mediated end-joining. Both of them are DNA repair pathways.
Plays a key role in non homologous enjoining or NH, a J and the second target III and micro homology mediated and joining both of them are DNA repair pathways for both targeted drug discovery projects, we have identified subsets of cancer patients that we believe uniquely depend on the target.
Margaret: For both targeted drug discovery projects, we have identified subsets of cancer patients' deaths we believe uniquely depend on the target of interest for their survival, and we're working to identify patient selection biomarkers to identify these cancer subsets for use in drug candidate development.
Of interest for their survival and we are working to identify patient selection biomarkers to identify these cancer subset for use in drug candidate development.
Margaret: Both undisclosed target projects are currently in lead generation and will enter the lead optimization stage in 2022.
Both undisclosed target projects are currently in lead generation and will enter the lead optimization stage in 2022.
Margaret: For these targets, rather than use a phenotypic screen, as we did for CYT 0851 and 1853, we are using a more traditional drug discovery approach by first identifying the molecular target of interest, then developing assays to measure the inhibition of its function, and screening for molecules that inhibit the protein from carrying out DNA repair functions.
For these targets rather than use a phenotypic screens as we did for <unk> 501, and $18 53, we are using a more traditional drug discovery approach by first identifying the molecular target of interest then developing assays to measure the inhibition of its function and screening for molecules inhibitor protein from carrying out DNA repair.
Both undisclosed target projects are in preclinical stage, and we anticipate reaching the drug candidate nomination stage in 2023.
Margaret: Both undisclosed target projects are in preclinical stage, and we anticipate reaching the drug candidate nomination stage in 2023.
Margaret: CYT1853 was developed as a next generation drug to be more potent than CYT0851. Thus potentially could be used to treat cancers not treated well with CYT0851 or that have become resistant to it.
CYP $18 53 was developed as a next generation drug to be more potent than <unk> 501 that potentially could be used to treat cancers not treated with <unk> 501 will that have become resistant to it in 2021, we advanced <unk> $18 53 towards <unk>.
Margaret: In 2021, we advance CYT 1853 towards an IND. And by the end of 22, we should be able to define the development path for this product candidate.
And by the end of 'twenty, two we should be able to define the development path for this product candidate.
Margaret: We are completing IND-enabling toxicology studies with 1853 in the first half of 22. And if the data supports an overall risk-benefit improvement and differentiation from CYTO851, we plan to file an IND by year-end 22.
We are completing IND, enabling toxicology studies with $18 53 in the first half of 'twenty, two and if the data supports and overall risk benefit improvement and differentiation from <unk> hundred one we plan to file an IND by year end 'twenty two.
Margaret: In addition to our progress in advancing our multiple product candidates, other notable highlights for 2021 include.
In addition to our progress in advancing our multiple product candidates. Other notable highlights for 2021 include we further strengthened our team we expanded our chemistry discovery biology, and translational teams and laboratory footprint to support our goal to become a leading biotech company developing and commercializing <unk>.
Margaret: We further strengthened our team. We expanded our chemistry, discovery biology, and translational teams, and laboratory footprint to support our goal to become a leading biotech company developing and commercializing next-generation precision oncology medicines that inhibit DNA damage response and cause cancer cell death through synthetic lethality.
Next generation precision oncology medicines that inhibits DNA damage response and cause cancer cell death through synthetic neutrality, we've been able to recruit highly accomplished and talented people dedicated to bringing new cancer therapies to patients who need them. So desperately I am proud that the team works effectively together and despite the challenges of <unk>.
Margaret: We've been able to recruit highly accomplished and talented people dedicated to bringing new cancer therapies to patients who need them so desperately. I'm proud that the team works effectively together. And despite the challenges of the pandemic and a robust job market that we have experienced minimal employee turnover. We've built a high energy, high performance team that is incredibly collaborative and productive and is motivated to work on promising opportunities as is the core of TechYear's operation.
The pandemic and a robust job market that we have experienced minimal employee turnover. We've built a high energy high performance team that is incredibly collaborative and productive and as motivated to work on promising opportunities. As this is the core of <unk> operations.
Margaret: As Dave will discuss in a moment, we have a strong cash position, and based on our current plans, we believe that our current capital resources are sufficient to fund operations into 2024.
As Dave will discuss in a moment, we have a strong cash position and based on our current plans. We believe that our current capital resources sufficient to fund operations into 2004.
Dave Gallaro: I want to thank our current investors for your support and to express thanks to all investors who participated in our IPO in 2021.
Want to thank our current investors for your support and to express thanks to all investors who participated in our IPO in 2021, our strategy has not changed and we continue to execute on the objectives, we set forth in the IPO to bring <unk> to patients with a high unmet need and to expand our portfolio. We think that there is.
Dave Gallaro: Our strategy has not changed, and we continue to execute on the objectives we set forth in the IPO to bring CYTO-851 to patients with a high unmet need and to expand our portfolio. We think that there's considerable value in our pipeline and platform, and are hopeful that investors will take notice of our progress and upcoming milestones.
Considerable value in our pipeline and platform and are hopeful that investors will take notice of our progress and upcoming milestones.
Dave Gallaro: Before Dave provides details on our financial results, I would add some further comments about our lead product candidate, CYTO851. Through these comments, I hope you gain additional insight into our progress and outlook.
Before Dave provides details on our financial results I would add some further comments about our lead product candidates <unk> 501 through these comments I hope you gain additional insight into our progress and outlook.
Dave Gallaro: The CYTO851 data I commented on earlier was based on data from a November 15, 2021 cutoff of our phase one dose escalation study. As previously reported, CYTO851 was used to treat a total of 73 patients of whom 46 patients or 63% were considered responsive valuable per protocol.
The <unk> 501 data commented on earlier was based on data from our November 15th 2021 cutoff of our phase one dose escalation study as previously reported <unk> 501, what's used to treat a total of 73 patients of whom 46 patients or 63% were considered response evaluable.
Protocol 20 patients of 43% at the best response of stable disease or better one patient experienced a complete response that is still ongoing to patients experienced a partial response and 17 patients experienced stable disease 26 patients experience progressive disease as a reminder, all of.
Dave Gallaro: 20 patients or 43% had a best response of stable disease or better. One patient experienced a complete response that is still ongoing. Two patients experienced a partial response and 17 patients experienced stable disease. 26 patients experienced progressive disease. As a reminder, all of these patients entered the trial having failed multiple lines of prior therapy and had exhausted standard therapy.
These patients entered the trial, having failed multiple lines of prior therapy and had exhausted standard therapies. The disease was progressing prior to the study treatment such that getting a clinical response is expected to be unlikely witnessing favorable disease stabilization from 43% of these high risk patients is quite encouraging.
Dave Gallaro: The disease was progressing prior to the study treatment such that getting a clinical response is expected to be unlikely. Witnessing favorable disease stabilization from 43% of these high-risk patients is quite encouraging.
Dave Gallaro: In solid tumors, there was a partial response in one sarcoma patient that was not confirmed primarily for technical reasons. Notably and encouragingly, the patient stayed on treatment for about a year. And from an initial 25 centimeter total target tumor burden, experienced reduction by over 30% while on study.
In solid tumors that was a partial response and one sarcoma patients that was not confirmed primarily for technical reasons, notably and encouragingly. The patients stayed on treatment for about a year and from an initial 25 centimeter total target tumor burden experienced reduction by over 30% while on study.
Dave Gallaro: we had 16 patients with stable disease across several solid tumors. About half of those have tumor shrinkage, including pancreatic cancer, head and neck cancer, ovarian cancer, and other sarcomas. In hematologic malignancies, we saw one confirmed complete response in a follicular lymphoma patient who entered the trial with bulky, greater than 10 centimeter disease after five prior lines of therapy. The patient continues to be in complete remission and is continuing therapy to date.
We had 16 patients with stable disease across several solid tumors about half of those have tumor shrinkage, including pancreatic cancer head and neck cancer ovarian cancer and other sarcoma in hematologic malignancies. We saw one confirmed complete response in the Follicular lymphoma patients who entered the trial with bulky.
Later than 10 centimeter disease after five prior lines of therapy.
Patients continues to be in complete remission and discontinuing therapy to date. We also observed a confirmed partial response in a diffused large b cell lymphoma patients with more than 100 metastases that within two months became negative.
Dave Gallaro: We also observed a confirmed partial response in a diffuse large B-cell lymphoma patient who had more than 100 metastases that, within two months, became PET-negative.
Dave Gallaro: As of the November data cut, we also had one patient with stable disease. This is remarkable given how advanced this patient's disease was.
As of the November data cut we also had one patient with stable disease. This is remarkable given how advanced these patients disease was.
Dave Gallaro: Duration of treatment is an important indicator of disease control and oncology and of drug safety.
Duration of treatment as an important indicator of disease control in oncology and of drug safety. There were 16 patients thats been treated for four months or longer suggesting that there is clinical benefit with <unk> hundred one treatment when we looked at the treatment duration of their last prior therapy as a control we found that 13 out of those <unk>.
Dave Gallaro: there were 16 patients that have been treated for four months or longer, suggesting that there's clinical benefit with CYT 0851 treatment. When we looked at the treatment duration of their last prior therapy as a control, we found that 13 out of those 16 patients received CYT 0851 longer than their last prior therapy.
16 patients receive <unk> 501 longer than their last prior therapy, which was often an active chemotherapy drug of the 73 patients 19, or 26% were still on treatment as of the November 15th 21 data cutoff.
Dave Gallaro: which was often an active chemotherapy drug. Of the 73 patients, 19 or 26% were still on treatment as of the November 15th, 21 data cutoff.
We plan to present, the full data set from the phase one dose escalation study at a medical Congress in June is accepted for presentation.
Dave Gallaro: We plan to present the full data set from the phase one dose escalation study at a medical congress in June , if accepted for presentation.
Dave Gallaro: As discussed, we've expanded our clinical study of CYTO-851, building upon the differentiated safety profile and encouraging preliminary single agent activity of the drug. We're currently dosing patients in six cohorts in the phase two monotherapy expansion study in pancreatic cancer, ovarian cancer, soft tissue sarcoma, diffuse large B cell lymphoma, follicular lymphoma, and multiple myeloma.
As discussed we've expanded our clinical study of <unk> 501 building upon the differentiated safety profile and encouraging preliminary single agent activity of the drug. We are currently dosing patients in six cohorts in the phase II monotherapy expansion study in pancreatic cancer ovarian cancer soft tissue sarcoma.
The fuse large b cell lymphoma, follicular lymphoma, and multiple myeloma.
Dave Gallaro: We are also enrolling in three Phase I combination cohorts with three approved standard of care anti-cancer therapies, capecitabine, the oral form of 5-fluorouracil, and gemcitabine for solid tumors, and rituximab plus spendamastine for NHL. We expect to have preliminary safety data for the Phase I combination cohorts and to have completed the first stage of the Phase II monotherapy cohorts before the end of 2022.
Also enrolling in three based upon the combination cohorts with three approved standard of care anti cancer therapies take decitabine, the all form a five floor year or so and some <unk> for solid tumors and Rituximab plus bendamustine for NHL, we expect preliminary safety data for the phase <unk> combination cohort.
And to have completed the first phase the phase II monotherapy cohorts before the end of 2022.
Dave Gallaro: We're also working on identifying a patient selection biomarker and elucidating the mechanism of action of CYPO851.
We're also working on identifying the patient selection biomarker and elucidating the mechanism of action of <unk> hundred one recall that $8. One was identified through a phenotypic screening strategy that exploited a novel synthetic lethality between sighted in deaminase over expression and homologous recombination inhibition discrete.
Dave Gallaro: Recall that 8.1 was identified through a phenotypic screening strategy that exploited a novel synthetic lethality between cytidine deaminase overexpression and homologous recombination inhibition.
Dave Gallaro: The screen was designed to select for compounds that induce synthetic lethality in cytogene D aminase overexpressing cancer cells while sparing normal cells.
<unk> was designed to select for compounds that induced synthetic lethality incited in deaminase over expressing cancer cells, while sparing normal cells.
Dave Gallaro: By its nature, this type of screening strategy does not depend on, nor directly lead to, a precise understanding of where the active drug candidates find, nor the precise mechanism of action.
It's nature. This type of screening strategy does not depend on not directly lead to a precise understanding of where the active drug candidate spine, nor the precise mechanism of action.
Dave Gallaro: a better understanding of the binding side of CYT-0851 will allow us to hone in on the patients most likely to respond. While CYT-0851 advances in clinical testing, we continue to make progress on elucidating its molecular target and mechanism of action and plan on updating you during the year on our progress.
Understanding of the binding side of <unk> hundred one will allow us to hone in on the patients most likely to respond while <unk> hundred one advances in clinical testing, we continue to make progress in elucidating its molecular target and mechanism of action and plan on updating you during the year on our progress.
Dave Gallaro: The diseases we're exploring in our Phase I-II trial, pancreatic cancer, sarcoma, ovarian cancer, multiple myeloma, diffuse large B lymphoma, and follicular lymphoma, have large populations who have no additional therapy available to them, either because they've exhausted them or because they're too frail to receive them.
The diseases, we are exploring in our phase one two trial pancreatic cancer sarcoma ovarian cancer multiple myeloma diffuse large b cell lymphoma, and Follicular lymphoma have large populations, who have no additional therapy available to them either because they are exhausted them or because that too frail to receive them.
Dave Gallaro: An oral agent that's well-tolerated and either has sufficient monotherapy activity or can be combined with active stenotherapies may be able to provide meaningful clinical benefit for these patients.
And all agents, that's well tolerated and either has sufficient monotherapy activity or can be combined with active standard therapies may be able to provide meaningful clinical benefit for these patients coming out of 2022, we anticipate having the design for phase II trial with Registrational intent to pursue one or more.
Dave Gallaro: Coming out of 2022, we anticipate having the design for a Phase II trial with registrational intent to pursue one or more indications for CYPOA 851.
Indications FTSE <unk> 501.
Dave Gallaro: As we begin 2022, the CyTEAR team continues to execute on enrolling our clinical trial, advancing our preclinical target programs, further elucidating the CYTO851 mechanism of action, and identifying a potential biomarker to improve patient selectivity.
As we begin 2022, the <unk> team continues to execute on enrolling our clinical trial advancing our preclinical target programs further elucidating the <unk> mechanism of action and identifying a potential biomarker to improve patient selection.
Dave Gallaro: We expect to have safety data on the Phase I CYPO851 combination cohorts and data from the completion of the first phase of the Phase II monotherapy cohorts. We have already made considerable progress in 22 and look forward to updating you on our progress throughout the year.
<unk> safety data on the phase <unk> 501 in combination cohorts and data from the completion of the first stage of the phase II monotherapy cohorts. We've already made considerable progress in 'twenty, two and look forward to updating you on our progress throughout the year.
Dave Gallaro: With that, I'd like to turn the call over to Dave Galliero to review the fourth quarter financials.
With that I'd like to turn the call over to David <unk> to review the fourth quarter financials.
Thanks Marcus.
Dave Galliero: Our full year and fourth quarter 2021 financial results can be found in the press release we issued this afternoon.
Our full year and fourth quarter 2021 financial results can be found in the press release, we issued this afternoon.
Dave Galliero: Additional detail can also be found in our annual report on Form 10-K , the filing of which is now available in the investor relations section of the CyTEA website.
Additional details can also be found in our annual report on Form 10-K filing of which is now available in the Investor Relations section of the <unk> website.
Research and development expenses were $8 3 million for the fourth quarter of 2021 compared to $3 9 million for the same period in 2020 and $31 million for the full year 2021, compared to $16 $8 million for the full year 2020.
Dave Galliero: Research and development expenses were $8.3 million for the fourth quarter of 2021, compared to $3.9 million for the same period in 2020, and $31 million for the full year 2021, compared to $16.8 million for the full year 2020.
Dave Galliero: The year-over-year increase in R&D spending in the comparative period was primarily due to increased research activity, clinical trial expenses, and headcount.
The year over year increase in R&D spending in the comparative periods was primarily due to increased research activity clinical trial expenses and head count.
General and administrative expenses were $3 6 million for the fourth quarter of 2021 compared to $1 5 million for the same period in 2020.
Dave Galliero: General and administrative expenses were $3.6 million for the fourth quarter of 2021 compared to $1.5 million for the same period in 2020 and $11.3 million for the full year 2021 compared to $4.2 million for the full year 2020.
And $11 3 million for the full year 2021, compared to $4 $2 million for the full year 2020.
Dave Galliero: The year-over-year increase in G&A expenses in the comparative period was primarily due to employee-related costs, as well as other administrative expenses associated with company growth and operating as a public company.
The year over year increase in G&A expenses in the comparative periods was primarily due to employee related costs as well as other administrative expenses associated with company growth and operating as a public company.
Dave Galliero: Net loss was $11.8 million or $0.34 per share in the fourth quarter of 2021 compared to $5.4 million or $2.92 per share for the same period in 2020.
Net loss was $11 8 million or <unk> 34 per share in the fourth quarter of 2021 compared to $5 4 million or $2 92 per share for the same period in 2020.
Dave Galliero: For the full year 2021, net loss was $42.1 million, or $2.16 per share, compared to $20.8 million, or $13.60 per share for the full year 2020.
For the full year 2021, net loss was $42 1 million or $2 16 per share.
Third to $28 million or $13 60 per share for the full year 2020.
Dave Galliero: During 2021, our net cash used in operating activities was $36 million.
During 2021, our net cash used in operating activities was $36 million.
Dave Galliero: We expect this level of cash burn to increase as we continue to advance our clinical trials, progress our preclinical activities, and operate as a public company for the full year.
We expect this level of cash burn to increase as we continue to advance our clinical trials progress our preclinical activities and operate as a public company for the full year.
Dave Galliero: Due to the nature and timing of drug development, we anticipate that our cash spending will be variable from quarter to quarter.
Due to the nature and timing of drug development, we anticipate that our cash spending will be variable from quarter to quarter.
Dave Galliero: We ended 2021 with cash and cash equivalents of $189.7 million.
We ended 2021 with cash and cash equivalents of $189 7 million.
Dave Galliero: Based on our current plans, we expect our current capital resources to fund our operations into 2024. I'd now like to hand the call back to Marcus for closing remarks.
Based on our current plans, we expect our current capital resources to fund our operations into 2024.
Now I'd like to hand, the call back to Marcus for closing remarks. Thanks.
Thanks, Dave in summary, we believe that <unk> hundred one has the potential to achieved blockbuster status across hematologic malignancies, and solid tumors as a monotherapy or in combination with standard of care chemotherapy agents. The clinical milestones we expect to achieve in 2022 are expected to support the initiation of one or more of a.
Marcus: We believe that CYTO-851 has the potential to achieve blockbuster status across hematologic malignancies and solid tumors as a monotherapy or in combination with standard of care chemotherapy agents.
Marcus: The clinical milestones we expect to achieve in 2022 are expected to support the initiation of one or more potential registration trials expected to begin in 2023. In addition, we're building a pipeline of novel synthetic lethal DDR drug candidates with two new targets nominated in 2021. Our rapid pace of progress is supported by a team of veteran industry experience, drug discoverers and developers that know what to do.
<unk> Registrational trial expected to begin in 2023. In addition, we are building a pipeline of novel synthetic lethal DDR drug candidates with two new targets nominated in 2021, our rapid pace of progress is supported by a team of veteran industry experienced drug discoverers and developers that know what to do.
Marcus: While much of our current work is ongoing, we anticipate multiple opportunities in 2022, be they medical conferences or R&D conference calls, where we will have the opportunity to report results. I want to thank the patients and investigators for supporting the CYTO 851 clinical study and the employees of Cytere for their tireless dedication. With that, Operator, please open.
While much of our current work is ongoing we anticipate multiple opportunities in 2020 to be the medical conferences R&D conference calls, where we will have the opportunity to report results I want to thank the patients and investigators for supporting the <unk> hundred one clinical study and the employees of sites here for that.
Wireless dedication with that operator, please open the line for questions.
Speaker Change: Thank you. As a reminder, if you would like to ask any questions, please press star followed by one on your telephone keypads now.
Thank you as a reminder, if you would like to ask any questions. Please press star followed by one on your kind of thank you Pat now.
Okay.
We have our first question on the phone lines from.
Speaker Change: Anupam Rama of J.P. Morgan. So, Anupam, please go ahead.
Anytime <unk> of JP Morgan.
Please go ahead.
Anupam Rama: Hey, guys. Thanks so much for taking the question. I just had a clarification on data readout timelines. So the monotherapy dose escalation data you said is potentially in June , and then potentially some monotherapy expansion data in the second half.
Hey, guys. Thanks, so much for taking the question I just had a clarification on sort of data readout timelines. So the monotherapy dose escalation data.
It's potentially in June and then potentially some monotherapy expansion data in the second half.
Anupam Rama: of this year, right, but focused on safety only with the potential for efficacy. And then combination data in the second half of the year, right, focused mostly on safety. Just wanted to clarify if I have all that right.
Of this year right.
On safety only what is the potential for efficacy and then.
Combination data in the second half of the year right focus mostly on safety just wanted to clarify if I have all that right.
Speaker Change: Yeah, thanks Anupam. Exactly as you said, so we've submitted an abstract for pencil presentation in June . We'll know very soon whether that's been accepted and that would.
Yes. Thanks.
<unk> as you said so we have submitted an abstract for presentation in June .
Soon whether thats been accepted that.
Speaker Change: an update on the Phase 1 data. If you recall, the last cut we took, and that's in the 10-K, is from November 15. So that will be updated in the presentation if it gets selected. And then we are actively enrolling in nine cohorts, six monotherapy cohorts. These are Simon 2 stage, and we expect interim analyses to be done this year towards in the second half.
An update on the phase one data.
If you recall the last cut we took and Thats in the 10-K as from November 15, so that will be updated in the presentation.
It gets selected and then we are actively enrolling in line cohorts six monotherapy cohorts.
He is a Simon two stage and we expect interim analysis to be done this year to awards in the second half and then we can either use academic meetings scientific meetings to present, the interim results or.
Speaker Change: And then we can either use academic meetings, scientific meetings to present the interim results or do R&D days or other activities that would allow us to share top-line interim data with the public.
R&D days or other activities that would allow us to share topline interim data with the public.
Speaker Change: And that's true for the monotherapy cohorts, as well as the phase one safety readouts in combination with the three different chemotherapy regimens. So those are actively enrolling. We are starting at a dose of 100 milligrams with 851, so there are only up to four cohorts that we could potentially do, so we're very confident that we can enroll those this year and report the results. For more information visit www.FEMA.gov
And Thats true for the monotherapy.
Cohorts as well as the phase one safety Readouts in combination with three different chemotherapy regiment. So those are actively enrolling we are starting.
Most of the 100 milligrams was 85, one so they are only up to four cohorts that we could potentially do so we're very confident that we can enroll those this year and report. The results. Now. These are typical phase one designs, they're designed to elucidate the safety but of course, if we.
Speaker Change: Now, these are typical phase one designs. They're designed to elucidate the safety, but of course.
Speaker Change: If we're starting to see responses, it might get interesting.
We're starting to see responses it might get interesting you might expect a response or two from the chemo agents themselves, but especially with the <unk> and Gemcitabine with response rates expect that are in the single digits.
Speaker Change: You might expect a response or two from the chemo agents themselves, but especially with the K-Citabine and M-Citabine, response rates expected are in the single digits.
Speaker Change: And so after a couple of responses, it might get very interesting. With bendamustine rituxan, that's more difficult, of course, as the response rate there is substantial and we'll probably not know until we have a randomized trial, or, of course, unless a patient responds with a failed bendamustine rituxan.
And so after a couple of responses that make it very interesting with Bendamustine rituxan, that's more difficult of course as the response rate there is substantial and we will.
Probably not know until we have a randomized trial or of course, unless a patient's responsiveness has been the most EBITDA. So yes. The timeline is exactly as you said.
Speaker Change: So, yes, the timeline is exactly as you said.
Thanks, so much for the clarification.
Speaker Change: Thank you. We now have our next question on the line from Jeff Howe of Morgan Stanley . So please go ahead when you're ready, Jeff.
Thank you we now have our next question on line from Jeff Stein with Morgan Stanley . Please go ahead, Thank you, Mike and Jeff.
Thanks for taking the question you mentioned that the Crs still ongoing can you provide an update on the other two responses like how are the patients doing and do they remain on drug.
Jeff Howe: Thanks for taking the question. You mentioned that the CR is still ongoing. Can you provide an update on the other two responses, like how are the patients doing and do they remain on drugs?
Speaker Change: Yeah, so I think we have responded to the DLBCL partial response that was an elderly patient with more than 100 metastases, was doing well through month six, and then developed the CNS lesion. As you may recall, 851 does not cross the blood brain barrier and in patients with extra nodal disease of diffuse large piece of lymphoma.
Yes. So I think we have responded to the <unk> partial response that was of elderly patients with more than 100 metastases.
It was doing well through month, six and then develop the CNS lesion.
As you May recall $8, one does not cross the blood brain barrier and in patients with extra nodal disease of the fuse large b cell lymphoma.
Speaker Change: about 15% up to 20% will develop CNS disease, so they're at a higher risk of that. That patient still had complete control of the other bony metastases, nodal metastases, liver metastases, but did succumb, I think at about around month eight from the CNS metastasis.
$50 up to 20% of the world developed CNS disease. So they are at a higher risk of that.
Patients still have complete control of the other.
Owning metastases nodal metastases liver metastases, but to come I think that's around month eight.
From the CNS metastasis.
Speaker Change: and the stable disease is still ongoing as well.
The stable disease is still ongoing as well.
Speaker Change: Great, thanks. And then for your DDR platform, I know the two targets are not yet disclosed, but could you just talk generally about the subset of cancers that depend on the targets of interest and what you estimate to be the size of the addressable market? Thanks.
Great. Thanks, and then for your DDR platform I know that your targets are not yet disclosed but could you just talk generally about the subset of cancers that depend on the targets of interest in what you estimate to be the size of the addressable market. Thanks.
Speaker Change: Yeah, so, you know, we're really focusing on DNA damage repair, double strand break repair, and, you know, the major repair pathways there. So the two targets we have are in different major DNA repair pathways. We're still understanding the patient populations. We've got subsets of a few different solid tumor indications.
Yes, so we're really focusing on DNA damage repair double strand break repair and the major repair pathways. There. So the two targets that we have are in different major DNA repair pathways, we're still understanding the patient.
Populations, we've got subsets of a few different solid tumor indications.
Speaker Change: that we think there's a synthetic lethal relationship with a pre-existing condition in those cancer types that we're going to continue to pursue as we move forward with this.
We think there is a synthetically for relationship with a pre existing condition in those cancer types that we're going to continue to pursue as we move forward with this.
Thank you.
Speaker Change: Jeff, as we're validating that biomarker, you know, then I think we'll have a better handle on the size, but potentially for target two, it's substantial. It is a very common biomarker.
So as we as the validating Jeff as we're validating that biomarker.
Then I think we'll have a better handle on the size, but potentially for target to its substantial.
Is a very common biomarker.
We now have our next question from <unk>.
Speaker Change: Taveen Ahmed of Bank of America, so please go ahead.
<unk> Ahmad with Bank of America. Please go ahead.
Taveen Ahmed: Hi, good afternoon. Thanks for taking my questions for 851 for the data that you have asked to present at ASCO.
Hi, good afternoon. Thanks for taking my questions for <unk> hundred one for the data that you have asked to present that at scale.
Taveen Ahmed: In total, how many patients would that be, just to be clear? And then, the data cutoff was November 15th, but would you be able to update that data to the most recent if that presentation does get accepted for the June conference?
And in total how many patients would that be.
Just to be clear and then.
The data cutoff with November 15th, but would you be able to.
Update that data too.
Yes.
Presentation does get acceptance.
<unk> Conference and then separately for 1853.
Taveen Ahmed: And then separately, for 1853, your plan is to file the IND by year-end 22. And you talked about things that need to be completed, but what is the biggest gaining factor right now? Thank you.
The filing IMD by year end 'twenty channel.
And you talked about things I need to be completed but what is the biggest gaining factor right now. Thank you.
Speaker Change: Yeah, thanks for the question. So with respect to the potential upcoming presentation, the note that the abstract was based on the same data cut that was used for the JP Moring presentation. So the numbers will look identical, but there will be a data cut that has not been made yet. That is an April look.
Yes, and thanks for the question so with respect to the potential upcoming presentations.
Note that the abstract was based on the same data cut that was used for the JP Morgan presentation. So the numbers will look.
Identical, but there will be.
Data cut that has not been made yet.
As in April and look at the data, which will have more than 80 patients and they'll have a follow up.
Speaker Change: at the data, which will have more than 80 patients and will have follow-up all the way through them. So it will be quite different from the abstract.
Way through them so.
Got.
It will be quite different from the abstract.
And then with respect to agencies.
Speaker Change: Yeah, 1853. So the IND-enabling GLP tox studies will be wrapped up in the second quarter.
Yes, it's interesting.
So.
The IND, enabling Tox studies will be wrapped up in the second quarter and.
Speaker Change: and what's still ongoing are, number one, manufacturing. Number two are studies really looking at the in vivo efficacy head-to-head with 851. And there, we really need to establish that the risk-benefit profile is substantially differentiated from 851. And also,
What's still ongoing our number one manufacturing number two.
Our studies really looking at the in vivo efficacy head to head with a five one.
We really need to establish that the risk benefit profile is substantially differentiated from <unk> and also.
Speaker Change: waiting for us to see what the results are for 851 because if these expansion cohorts or the combination with chemo is looking very exciting, then 1853 would be a distraction and we'd be better off spending our energy on 851. So those are the gating items. In either case, if it's a go, we will be ready to file the IND by the end of the year.
Waiting for us to see what the results are for ATI one because.
If these expansion cohorts of the combination with chemo is looking very exciting than $8 53 would be a distraction and we'd be better off spending our energy on 801.
So those are the gating items.
In either case, if it's a go.
We will be ready to file the IND by the end of the year.
Okay. Thank you.
Yes.
Yeah.
Speaker Change: Thank you. We now have the next question on the phone lines from Robert Driscoll of Redfish Security so please go ahead Robert whenever you're ready.
Thank you. The next question on the same line from <unk>.
<unk> of Wedbush Securities.
Please go ahead no no maybe already.
Great guys. Thanks for taking the questions first just wanted if you could talk a little more on the preclinical experience you have with nearly 501 and some of the combinations.
Robert Driscoll: Great, guys. Thanks for taking the questions. First, just wanted to talk a little more on the preclinical experience you have with 0851 and some of the combinations, particularly with, particularly with regards to safety. And then second, if you're able to talk a little bit more about the work you're doing to elucidate the precise mechanism of 0851.
Particularly we're particularly with regards to safety and then second if you are able to talk a little bit more about the work you're doing to elucidate the precise mechanism of 051.
Robert Driscoll: And whether you might expect 1853 to act similarly or on a different molecular target, she achieved that DNA repair deficient. Thanks.
And whether you might expect 18 53 tracks similarly on a different molecular targets to achieve that DNA repair deficiency.
Yes, so the.
Speaker Change: Yeah, so the, maybe in reverse order, the mechanism of action of 1853 is very similar to 851. It's really, it was designed to be a more potent compound. And so the screening assay will, was identical, and so we expect the MOA to.
Maybe in reverse order the mechanism of action of <unk> 53 is very similar to $8. One it's really it was designed to be a more potent compound.
No.
The screening assay.
It was identical and so we expect the MLA.
Speaker Change: Then with respect to that MOA question, we have made substantial progress and are going to update investors on that work, which would then speak about the MOA and also biomarker development later this year.
Identical.
With respect to that.
While egg question.
Made substantial progress and.
Going to update that.
<unk> on that work.
Then let's speak about the MAA and also by a market development later this year.
Speaker Change: And then, with respect to the in vivo studies and in vitro studies and chemo combinations, first of all, I can just comment on the safety and then I can talk about the efficacy. But the combination with chemotherapy has been well tolerated in the animals treated, but of course they are rodents and so they're hardy. But based on the overall clinical profile, when you think of it, even at 1,200 milligrams, we had absolutely no myelosuppression to speak of.
And then with respect to the in vivo studies.
In vitro studies chemo combinations first of all I can comment on the safety in the hall can talk about the.
The efficacy.
But the combination with chemotherapy has been well tolerated in the animals treated but of course, they are rodents and so.
Hardy.
But based on the overall clinical profile when you think of it even at 1200 milligrams, we had absolutely no mindless depression to speak of.
Speaker Change: We have no vomiting. We have minimal nausea and minimal fatigue in a very small subset of patients, right? So only about 20% of patients have reported fatigue. So we're very confident that in the clinic we can combine H5-1 with chemotherapy.
We have no vomiting, we.
Minimal nausea and minimal fatigue.
A very small subset of patients right, so only about 20% of patients.
Reported fatigue, so where.
Very confident that in the clinic, we can combine <unk> with chemotherapy and I think Paul can speak.
Speaker Change: And I think Paul can speak to the preclinical efficacy side of the work with them. Yeah, this is Paul. So, the preclinical, the approach we took to a combination was very broad.
The preclinical efficacy side of work with them.
This is Paul so the preclinical the.
Approach, we took to the combination was very broad.
Paul Seacrest: you know, understanding that we are impacting DNA damage repair.
Understanding that we are impacting DNA damage repair.
Paul Seacrest: There were several logical combination agents to look at, and we took, I think we looked at over 20 different agents in more than a dozen different tumor types.
Several logical combination.
Combination agents to look at Edwards.
I think we looked at over 20 different agents and <unk>.
More than a dozen different tumor types and really prioritize based on the activity that we saw so in some cases, we saw fairly decent.
Paul Seacrest: and really prioritized based on the activity that we saw. So in some cases, we saw fairly decent synergistic effects. Other cases, it was more additive. In many of the cases, in what we ended up taking forward with the 5-fluorouracil gemcitabine.
Synergistic effects other cases, it was more additive and many of the cases and what we ended up taking forward with a five dollar or euro sales Gemcitabine, we saw pretty dramatic effects in the deepening of scale. So more tumor cells died at the same concentrations when you added.
Paul Seacrest: we saw pretty dramatic effects in the deepening of kill. So more tumor cells died at the same concentrations when you added the tolerated doses of 0851 in with the chemotherapy. And that was really kind of the driver between that and then what were those tumor types where we may be seeing some activity and that we might want to move into that made the most sense.
The tolerated doses of OE, Taiwan in with the chemotherapy and that was really kind of the driver between that and then what were those tumor types, where we may be seeing some activity and that we might want to move into that made the most sense.
Speaker Change: Yeah, and I think we had discussed previously the combination with PARP inhibitors, but really...
Yes, and I think we have discussed previously the combination with PARP inhibitors, but really when you think of commercially the opportunity is much greater so with <unk>. It.
Speaker Change: It could be applicable in ER-positive breast cancer, metastatic, gibbsite amine is often the first or second line for metastatic patients that have failed hormonal therapy, pancreatic cancer, as well as other GI malignancies, colorectal cancer in particular. Those patient numbers get huge very rapidly. Gemocytabine similarly could be for breast cancer, pancreatic cancer, or ovarian cancer. So there again the numbers get large. And then lymphoma, you know, that landscape is changing. But the...
Could be applicable in ER positive breast cancer metastatic capecitabine as often in the first or second line.
Metastatic patients that have failed hormonal therapy pancreatic cancer as well as other Gi malignancies colorectal cancer in particular.
Those patient numbers get that gets huge very rapidly gemcitabine similarly could be for a breast cancer pancreatic cancer or ovarian cancer and so there again the numbers get large and then lymphoma that landscape is changing.
Speaker Change: And then lymphoma, you know, that landscape is changing, but the treatment of DLVCL continues to be combination therapy. So there we went with bendamustine reduction. We do have preclinical enhancement of the bendamustine effect when we combine it with 851, and that, of course, could also be applicable to folliculum forma and natal cell lymphoma.
Got it.
Treatment of <unk> continues to be.
Combination therapy. So there we went with Bendamustine rituxan that we do have preclinical.
The enhancement of the Panamax into effect, when we combine that with $8 one.
And that of course could also be applicable to follicular lymphoma mantle cell lymphoma. So.
Speaker Change: If we can do this safely, we will be differentiated from all the other DDR compounds, or most of them primarily. And then of course, if we see the enhancement of activity as we saw in the preclinical models, that would be then very encouraging. So primarily, this year you will see the safety and potentially we'll have a glimpse of the efficacy.
If we can do this safely we will be differentiated from all the other DDR comprehend or most of them primarily.
And then of course, if we see the enhancement of activity as we saw in the preclinical models that would be then very encouraging right. So.
Primarily this year, you will see the safety and potentially will have a glimpse of the efficacy.
Okay.
Great. Thanks very much.
Thank you Robert.
Speaker Change: Thank you, Robert. We now have another question on the line from Tim Chang of Northland Securities. So, Tim, your line is open.
Another question on the line from Tim Chiang does Northland Securities.
Ken Your line is open.
Tim Chang: All right, thanks. Marcus, is there any way you could provide an update on just how the expansion of cohorts are enrolling? Obviously, you just initiated the studies, what, in January . But I was just sort of wondering, are the enrollments starting to pick up just because
Alright. Thanks.
Mark is there any way you could provide an update on just how the expansion cohorts are enrolling obviously is just initiated this study in.
In January but I was just sort of wondering.
Are the enrollment starting to pick up.
Just because.
Marcus: Yeah, Omicron, Marion has sort of pulled back. I just wanted to get some comments from you on that.
On the accounting.
Maryann has sort of pulled back.
I just wanted to get some.
Comments from you on that.
Speaker Change: Yeah, thanks for the question. The you know, we managed to do quite well during the pandemic. We enrolled 12 cohorts in 24 months. So that's 2 months a cohort. And the safety assessment alone is 28 days. So, basically, we managed to get that data in the database and enroll the patients freedom for months. Get in the database. Have a safety committee meeting in 2 months. A cohort throughout the pandemic.
Yes, Kevin Thanks for the question.
We managed to do quite well during the pandemic, we enrolled 12 cohorts in 24 months. So thats two months a cohort in the safety assessment alone is 28 days. So basically we managed to get that data in the database and the broader patients treat them for months get in the database have a safety committee meeting and two months of cohort.
Throughout the pandemic.
Speaker Change: Unfortunately, I think the beginning of this year was particularly hard for research centers where they had staffing issues, patient issues. So Omicron, I think, hit all of us harder than the rest of the pandemic. So January , things were very slow. Mid-February, they started to pick up. And I think now in March, we are back on track and hopeful that we can catch up with our enrollment goals for the rest of the year. So yeah, we're actively enrolling and sites are actively screening again.
Unfortunately, I think the beginning of this year.
What's particularly hard for research centers, where they had staffing issues patient issues. The omicron I think hit all of us harder.
The rest of the pandemic so January .
Things were very slow.
Mid February they started to pick up and I think now in March we are back on track and hopeful that we can catch up with our enrollment goals for the rest of the year. So yes, we are actively enrolling and sites are actively screening again.
Speaker Change: And Marcus, for this expansion study, it's 18 study sites. Is that right?
And market.
So this expansion study, it's 18 study sites does it right.
Marcus: That's correct. Yeah, we we have only US sites. We have 18 sites open for enrollment. There are 15 of them are major academic centers throughout the country and then the three community centers.
That's correct yes.
Have only U S sites, we have 18 sites open for enrollment there are.
15 of them are major academic centers throughout the country and then the community centers.
Yes.
Okay, great. Thanks for the details.
Yes.
Thank you Andrew.
Speaker Change: Thank you. As a reminder, to ask any further questions today, please press star followed by one on your telephone keypad now.
As a reminder to ask any further questions. Today. Please press star followed by one on your kind of think keypad Chow.
Speaker Change: As we have most of the questions registered, I would like to hand the call back to Marcus Wenzler for some closing remarks.
And you have no further questions registered I would like to hand, the call back to market.
For some closing remarks.
Marcus Wenzler: Well, I thank all of you for joining us today for this first annual earnings call that we have as a public company. I think 21 has been a great year and 21, 22 will be even better. Importantly, we have data readouts from six monotherapy phase two cohorts. These will be interim analyses by the end of the year, as well as data readout from the phase one combination with three different chemo regiments.
Well I. Thank all of you for joining us today.
First the annual earnings call that we have as a public company I think 'twenty one has been a great year in 'twenty, one 'twenty two will be even better importantly, we have data readouts from six monotherapy phase two cohorts. These will be interim analysis by the end of the year as well as data.
A readout from the phase one combination with three different chemo regimens.
Marcus Wenzler: Any one of these nine cohorts has the potential to lead to a registration trial, and so by the end of the year, we could potentially have that registration strategy. We're building a deep pipeline of novel synthetic ER drugs. We have now the capabilities in-house to do that, and importantly, we have cash into 2024. I think we're well-positioned. We're going to focus on executing our research strategy and have significant milestones in this year. Thank you so much for your attention.
Any one of these nine cohorts has the potential to lead to a registration trial and so by the end of the year, we could potentially have that registration strategy.
We're building a deep pipeline of novel synthetic drugs, we have now the capabilities in house to do that.
And importantly, we have cash into 2024, I think we are well positioned we're going to focus on executing our research strategy and have significant milestones in this year. Thank you so much for your attention bye bye.
Speaker Change: Thank you for joining. That does conclude today's call. You may now disconnect your line.
Thank you for joining that does conclude today's call you may now disconnect your line.
Speaker Change: Thanks for watching.
Yeah.
Okay.