Q2 2024 Oncternal Therapeutics Inc Earnings Call

Greetings and welcome to the eternal therapeutic second quarter, 2024 financial results call.

Operator: At this time, all participants are in a listen-only mode; a question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is my pleasure to introduce your host, Richard Vincent, Chief Financial Officer. Thank you. You may begin.

Speaker Change: At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Richard Vincent, Chief Financial Officer. Thank you.

Richard Vincent: Good afternoon, everyone, and thank you for joining us today. Joining me on the call this afternoon are our President and CEO, Dr. James Breitmeyer, and our CMO, Dr. Salim Yazji. Today's call includes a business update and discussion of our second quarter ended June 30, 2024 financial results that were filed earlier today. A press release and a replay of today's call will be available on the Investor Relations section of Oncternal's website for at least the next 30 days.

Richard Vincent: Thank you, Diego. Good afternoon, everyone, and thank you for joining us today.

Speaker Change: Joining me on the call this afternoon are our President and CEO , Dr. James Breitmeyer and our CMO, Dr. Salim Yazji.

Speaker Change: Today's call includes a business update and discussion of our second quarter ended June 30, 2024 financial results that were filed earlier today.

Speaker Change: Today's press release and a replay of today's call will be available on the Investor Relations section of Oncturnal's website for at least the next 30 days.

Richard Vincent: Please note that certain information discussed on today's call is covered under the State Department provisions of the private securities litigation reform. We will be making forward-looking statements during this call about future events such as our business and product development strategies, the timing of our clinical studies, planned interim data updates, regulatory filings, and our cash runway. Our actual results could differ materially from those stated or implied by these forward-looking statements due to the risks and uncertainties associated with Argus.

Speaker Change: Please note that certain information discussed on today's call is covered under the say part of the provisions of the private securities litigation reform act.

Speaker Change: We will be making forward-looking statements during this call about future events such as our business and product development strategies, the timing of our clinical studies, planned interim data updates, regulatory filings, and our cash runway.

Speaker Change: Our actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with our business.

Richard Vincent: These forward-looking statements should be considered in conjunction with, and are qualified by, the cautionary statements contained in today's press release and our SEC filings, including our form 10Q filed today and our previously filed form 10K for the full year, and it December 31, 2023. This call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 8, 2024. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances occurring after the date of this call. With that said, it is my pleasure to hand the call over to our CEO, Dr. Jim Breitmeyer. Thank you, Rich.

Speaker Change: These forward-looking statements should be considered in conjunction with, and are qualified by,

Speaker Change: The cautionary statements contained in today's press release and our SEC filings, including our form 10Q file today and our previously filed form 10K for the full year and it December 31, 2023.

Speaker Change: This call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 8, 2024. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances occurring after the date of this call.

Speaker Change: With that, it is my pleasure to hand the call over to our CEO , Dr. Jim Breitmeyer.

James Breitmeyer: Thank you, Rich, and good afternoon, everyone. At Oncternal, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical needs. Onct 534, our novel dual action-androgen receptor inhibitor, or Darry, continues to advance through the dose escalation portion of the phase 1 study, and we continue to see strong demand from investigators. As a reminder, preclinical studies showed that ONCT534 inhibited prostate cancer cells through both the ligand-binding domain and the N-terminal domain of the androgen receptor, and it also induced degradation of the androgen receptor.

Speaker Change: Thank you, Rich, and good afternoon, everyone.

Speaker Change: At Octernal, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical needs.

Speaker Change: Onct 534, our novel dual-action androgen receptor inhibitor, or DARI, continues to advance through the dose escalation portion of the Phase 1-2 study, and we continue to see strong demand from investigators.

Speaker Change: As a reminder, preclinical studies showed that ONCT534 inhibited prostate cancer cells through both the ligand binding domain and the N-terminal domain of the androgen receptor, and it also induced degradation of the androgen receptor.

James Breitmeyer: Thanks to this novel mechanism, we believe Onct 534 may address key prostate cancer escape mechanisms from currently approved AR pathway inhibitors, such as enzalutamide and abiraterone, which include multiple LBD mutations, as well as splice variants, such as ARV7.

James Breitmeyer: Thanks to this novel mechanism, we believe ONCT 534 may address key prostate cancer escape mechanisms from currently approved AR pathway inhibitors.

James Breitmeyer: such as enzalutamide and abiraterone, which include multiple LBD mutations as well as splice variants such as ARV7.

James Breitmeyer: The clinical trial is proceeding well. We have not observed any dose-limiting toxicities or other concerning side effects, and we recently announced that the sixth dosing cohort of the study is now fully enrolled. Patience in this cohort are receiving 1,200 milligrams of Ox 34 administered orally once per day. The decision to move to this dose level was made by the study Safety Review Committee after reviewing data from the patients treated to date, including the third dose level of 600 milligrams, 534 data. We plan to share an initial clinical data update for Onct. 534 later in the third quarter.

James Breitmeyer: The clinical trial is preceding well. We have not observed any dose limiting toxicities or other concerning side effects and we recently announced that the sixth dosing cohort of the study is now fully enrolled.

James Breitmeyer: Patients in this cohort are receiving 1,200 milligrams of Onc 34 administered orally once per day.

James Breitmeyer: The decision to move to this dose level was made by the study's safety review committee after reviewing data from the patients treated to date, including the third dose level of 600 mg 534 daily.

James Breitmeyer: We plan to share an initial clinical data update for 0.534 later in the third quarter.

James Breitmeyer: Now switching gears to Onct 808, our autologous ROAR1 targeting CAR-T product. Our Phase 1-2 study in patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR-T treatment, is enrolling and treating patients. There have been no dose-limiting toxicities observed in the current dosing cohort. We expect to report updated clinical results, including data from patients treated with the new dosing schedule, in the fourth quarter of 2024. With that, I now turn the call back to our CFO, Rich Vincent.

James Breitmeyer: Now switching gears to act eight away, our autologous roar one targeting CART product.

James Breitmeyer: Our Phase I-II study in patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR-T treatment, is enrolling and treating patients.

James Breitmeyer: There have been no dose limiting toxicity observed in the current dosing cohort. We expect to report updated clinical results, including data from patients treated with a new dosing schedule in the fourth quarter of 2024.

James Breitmeyer: With this, I now turn the call back to our CFO, Rich Vincent. Rich?

Richard Vincent: Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was $0.8 million for the second quarter ending June 30, 2024. Our total operating expenses for the second quarter ending June 30, 2024 were $9.7 million, including $1.4 million in non-cash, stock-based compensation expense. Research and Development expenses totaled $6.6 million, and General and Administrative expenses totaled $3.1 million. The net loss for the second quarter was $8.6 million, for a net loss of $2.99 per share, basic and diluted.

Richard Vincent: Thank you, Jim. Our revenue is currently derived from research and development grants received from the NIH.

Richard Vincent: Our grant revenue was $0.8 million for the second quarter end of June 30, 2024. Our total operating expenses for the second quarter end of June 30, 2024 were $9.7 million, including $1.4 million in non-cash, stock-based compensation expense.

Richard Vincent: Research and Development expenses totaled $6.6 million, and General and Administrative expenses totaled $3.1 million.

Richard Vincent: Net loss for the second quarter with 8.6 million for a net loss of $2.89 per share, basic and diluted.

Richard Vincent: As of June 32, 2024, we had approximately 3 million shares of common stock outstanding, $21.4 million in cash, cash equivalence, and short-term investments, and no debt. We believe these assets will be sufficient to support our operations into the first quarter of 2025. With respect to upcoming milestones, we are looking forward to following up. For Farong to 534, our lead dairy product candidate, we expect to present initial clinical data in the third quarter of 2024 with additional data readouts in the fourth quarter of 2024.

Richard Vincent: As of June 30, 2024, we had approximately 3 million shares of common stock outstanding, 21.4 million in cash, cash equivalents, and short-term investments, and no debt.

Richard Vincent: We believe these funds will be sufficient to support our operations into the first quarter of 2025.

Richard Vincent: With respect to upcoming milestones, we are looking forward to the following updates. For ONCT 534, our lead DARI product candidate, we expect to present initial clinical data in the third quarter of 2024, with additional data readouts in the fourth quarter of 2024.

Richard Vincent: Farong Day to 8, our law one, I'll tell you where we are. We expect to report a clinical data update in the fourth quarter of 2024. With that, I will turn things back over to the operator for the Q&A portion of this afternoon's call. Diego? Thanks, and at this time, we will conduct our questions.

Richard Vincent: For Long Day to 8, our Lord One, I'll talk to you all about Part T. We expect to report a clinical data update in the fourth quarter of 2024.

Richard Vincent: With that, I will turn things back over to the operator for the Q&A portion of this afternoon's call. Diego?

Operator: And at this time, we will conduct our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset.

Operator: Thank you.

Operator: And at this time, we will conduct our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad.

Operator: A confirmation tone will indicate that your line is in the question queue.

Operator: You may press star 2 if you would like to remove your question from the queue.

Operator: Once again, to ask a question, press star 1. We'll pause for a moment while we poll for questions. And our first question comes from Carl Burns with Northland Capital Markets. Please state your question. Thanks for the question and congratulations on the progress.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset. Once again, to ask a question, press star 1. We'll pause for a moment while we poll for questions.

Operator: and Salim Yazji. Thank you. Thank you.

Operator: And our first question comes from Carl Burns with Northland Capital Markets. Please state your question.

Carl Burns: Thanks for the question and congratulations on the progress. With respect to the clinical data update for 534 in the third quarter, or late third quarter, to be specific, what do you expect? What should we be expecting there? Safety data, which would be inclusive of the 1,200 milligram dose, would we also potentially be expecting PSA reduction numbers, and if so, what would that be through the first high cohorts are all the cool? The name of the platform is...

Carl Burns: Thanks for the question and congratulations on the progress. With respect to the clinical data update for 534 and the third quarter or late third quarter to be presenting, what do you expect?

Speaker Change: What should we be expecting there? Safety data, which would be inclusive of the 1,200 milligram dose. Would we be also potentially expecting PSA reduction numbers? And if so, would that be through the first five cohorts or all the cohorts? And then I have a follow-up as well, thanks.

Salim: Go ahead, Salim.

James Breitmeyer: I mean, it regards what we would expect to expect to... Present safety data for sure and plus some of the PSA parameters probably will be an early one because, based on the follow-up period, it will not be too long.

James Breitmeyer: Yeah, Carl. So, I mean, with regards to what we would expect, we would expect to

James Breitmeyer: present a safety data for sure, and plus some of the PSA parameters probably will be an early one because, you know, based on the follow-up period will be not too long.

Carl Burns: Great, and then the additional clinical data in the fourth quarter, what might that consist of?

Speaker Change: Great. And then the additional clinical data in the fourth quarter, what might that consist of? Thanks.

James Breitmeyer: So, in the first quarter of the additional clinical data, it will probably be more of a longer follow-up, more cohorts, I mean, you know, if we have them, so I think it will be more advanced than what we're going to be showing in the third quarter.

James Breitmeyer: So in the first quarter of the additional clinical data will be probably more of a longer follow-up more

James Breitmeyer: cohorts, I mean, you know, if we have so so I think, I think will be more advanced than what we're going to be showing in the third quarter.

James Breitmeyer: And finally, with respect to 808, how many patients, if you could disclose, have been enrolled with the update that you anticipate in the fourth quarter, and how many subjects might that cover? Yes, Carl, we haven't disclosed the enrollment in the CAR-T program yet, but I think, as you know, and as we show in our corporate deck, we have, we revised the dosing regimen with the CAR-T, which we found were very active, very active T-cells, and we have enrolled patients under the revised and the new dosing regimen. Thanks for watching, and don't forget to like, share, and subscribe to our channel. We're not seeing any ghost-limiting practices. Great, thanks again, and congratulations on the program.

Carl Burns: And finally, with respect to 808, how many patients, if you could disclose, have been enrolled and with the update that you anticipate in the fourth quarter, how many subjects might that be?

Speaker Change: Cover. Thanks.

James Breitmeyer: Yes, Carl, we haven't disclosed the enrollment.

James Breitmeyer: on the CAR T program yet. But I think as as you know, and as we show in our corporate deck, we have

James Breitmeyer: We revised the dosing regimen with the CAR-T, which we found were very active T-cells, and we have enrolled patients under the revised and amended dosing scheme.

Speaker Change: and we're not seeing any dose-limiting toxicity.

James Breitmeyer: i

Carl Burns: Great, thanks again. Congratulations on the progress.

Kemp Dolliver: Our next question comes from Kemp Dolliver with Brookline Capital Markets. Please state your question.

Kemp Dolliver: Okay, thank you.

Speaker Change: Our next question comes from Camp Dahliver with Brookline Capital Market, please stay your question.

Kemp Dolliver: Great, thank you. It was a part of 534, and this question is admittedly speculative, but is there any possibility you would move to higher dose cohorts after you get the data, particularly from the 6th cohort?

Kemp Dolliver: Great, thank you. With regard to 534, and this question is admittedly speculative, but is there any possibility you would...

Speaker Change: Moved to higher dosing cohorts.

Speaker Change: After you get the data, particularly from the sixth cohort.

James Breitmeyer: So, it's a great question, and so we are... We're collecting a lot of data on these patients, and so we have pharmacokinetic data, we've got some interesting and novel biomarker work that we're doing, and then, of course, efficacy and safety. And so decisions about dose levels for any additional cohorts will be made by the Scientific Review Committee based on the totality of available data.

James Breitmeyer: So, Kemp, it's a great question and so we are

James Breitmeyer: We're collecting a lot of data on these patients, and so we have pharmacokinetic data. We've got some interesting ennoveled biomarker work that we're doing, and then of course, the efficacy and the safety, and so decisions about.

James Breitmeyer: Doce levels for any additional cohorts will be made with the scientific review committee based on the totality of available data.

Kemp Dolliver: Okay, that's helpful. And then, again, on the same theme, are there any practical limits with regard to administration? and if you go to higher doses?

Speaker Change: Okay, that's helpful, and then you get on the same thing, are there any practical limits with regard to administration?

James Breitmeyer: So we have a, we're using a 200 milligram tablet, and so it is perfectly feasible to give more than six tablets a day if the data suggests that we should go higher. Great.

James Breitmeyer: if you go to higher doses.

James Breitmeyer: So we have a, we're using a 200 milligram tablet, and so it is perfectly feasible to give more than six tablets a day for, if the data suggests that we should go higher.

Kemp Dolliver: Great. That's all I have for the moment.

Kemp Dolliver: Great. That's all I have for the moment.

Operator: And there are no further questions at this time. I'll hand the floor back to Dr. James Breitmeyer for further remarks.

Speaker Change: Thank you. Thank you, Ken.

Operator: And there are no further questions at this time. I'll hand the floor back to Dr. James Breitmeyer for closing remarks.

James Breitmeyer: As you can see, we remain encouraged by the phase one results from our clinical programs and are looking forward to sharing the clinical data updates with you in the coming months. So, I'd like to thank you for joining us today, and we look forward to updating you throughout this year. Thank you.

Diego: Thank you, Diego.

James Breitmeyer: So, as you can tell, we remain encouraged with the Phase I results from our clinical programs and are looking forward to clinical data updates with you in the coming months. So, I'd like to thank you for joining us today, and we look forward to updating you throughout this year. Thank you, and good afternoon.

Speaker Change: This concludes today's conference. All parties may disconnect. Have a great evening.

James Breitmeyer: [inaudible]

Operator: This concludes today's conference. All parties may disconnect. Have a great evening.