Q3 2023 Nektar Therapeutics Earnings Call
[music].
Speaker 1: any input. Please try again. We have been ordered to connect to the some of the samples in the IL-2 Muting class.
Speaker 1: Compared with placebo, there were sustained increases in absolute numbers of circulating total and CD25 bright T-reg. We didn't detect any increase in arms. Reconnecting you to the conference. Increase in CD25 bright T-reg number was 10 fold above the main part. We didn't detect any increase in the highest respite. Please try again or wait to be reconnected to the temperature. It is either shorter than typical induction period of 12 weeks as compared with a 16 to 24 week induction period for most other biologics.
Speaker 1: There were clear improvements for all of the security. We didn't detect any input, reconnecting you to the Corp. The BIGA.
Speaker 1: BSA, itch, NRS, DLQI, and poem. These improvements begin as early as weeks 2 to 4 and continue through week 12 of treatment.
Speaker 1: To give you some perspective,
Speaker 1: With historical studies in atopic dermatitis, the lower dose level of redheads and improvements we saw were similar to those observed for biologic therapies.
Speaker 1: We didn't detect any input. Please try again or we could be reconnected to the conference.
Speaker 2: The 83% improvement in EZ-score for baseline observed that only 12 weeks of induction with RASBAG was superior to what was seen in the PILAMAB study at the EECE.
Speaker 1: These promising data have us in KOLs. Very good to see you. Very good to see you. Any input? Please try again. Or wait to be reconnected to the conference. We'll be making something with ResPag in the setting of a topic during the times.
Speaker 3: The results we have obtained so far with ResPEG are significant for a number of reasons.
Speaker 2: Firstly, before this work was conducted, relatively little was known about the ability to restore Treg function to reverse immunological pathogenesis and improve the severity of dermal and cutaneous diseases.
Speaker 3: Now, with ResTag and its T-reg mechanism,
Speaker 3: We have demonstrated clinical efficacy.
Speaker 2: against the cutaneous manifestations of lupus, psoriasis, and atopic dermatitis.
Speaker 3: These results begin to validate the T-Rag mechanism for the treatment of multiple pathologists. Please try again or wait to be reconnected to the conference. The attractive mechanism employs the body's own immune system to restore tolerance by inducing the T-Rag pathway.
Speaker 3: and presents a novel approach differing from the available broad or targeted strategies to block inflammatory pathways in terminal diseases such as atopic dermatitis. Secondly, our hypothesis is that the administration of the agonist drug ResPEC induces Treg expansion and engages multiple immunoregulatory mechanisms.
Speaker 2: to facilitate immune tolerance and regulation by attenuating do not detect any input ambulance's immune holders.
Speaker 3: suppressing antigen presenting cell activity, fostering the tolerogenic integrity. We believe the science translates to the durability of response we observed in the atopic dermatitis trial.
Speaker 2: and is a differentiating element that allows us to pursue an every three-month dosing regimen in our ongoing phase 2 being. Reconnecting you to the conference.
Speaker 2: Biologically speaking, ResTag, through its essential pathway of Treg rescue, is uniquely poised to address the diversity of immune pathology.
Speaker 4: giving a broad potential for targeting multiple dermal diseases.
Speaker 2: including atopic dermatitis, alopecia areata, and others. We didn't detect any input. In October , we initiated the phase 2B study of ResPEG, and Biologic Naive Atopic Dermatitis patient. We didn't detect any input. Our goal is to enroll roughly 400 patients with three different regiments of ResPEG. systems of Doyle.
Speaker 4: versus placebo evaluated over a 16-week induction period.
Speaker 2: After the induction period, patients that meet at the threshold to advance from induction to meet will be re-grandified.
Speaker 4: into one of two maintenance regimens.
Speaker 2: at different dosages at either once a month or once every three month dosing schedule that will continue for another twenty eight weeks.
Speaker 2: We expect the study will take approximately 54 weeks to conduct, and we expect data in the first half of 2025.
Speaker 2: We didn't, we also plan to initiate a phase 2B study of RAS tag in Alopecia areata later in early next year. We didn't detect, Alopecia areata, please try again, or wait to be reconnected to the conference. As the only approved agents are JAK inhibitors.
Speaker 4: which come with a black box warning and lack durability after cessation of dosing.
Speaker 4: For these reasons, we did not expect any opportunity for that to be a conference. We are connecting you to the conference. We are not able to buy a logic therapy in Palatisha, Ariata.
Speaker 4: And as I just mentioned, we believe that respagation is a life to be reconnected to the conference. And addressing this indication, which is essentially a dermal disease of the scalp.
Speaker 5: across all of our studies with nearly 600 people treated.
Speaker 5: We didn't expect any input. We're connecting you to the conference. He rag, sell Pharmacodynamic Profile.
Speaker 5: Different autoimmune. We didn't detect any input. Please try again or wait to be reconnected. Together. We believe there's strong rationale for ResPECT for the treatment of alopecia.
Speaker 6: The Phase II B study plans to recruit roughly 80 patients with moderate to severe health care. We don't detect any input. It will be randomizing you to the corresponding. The red tag or placebo.
Speaker 5: As Howard mentioned, while it was previously our plan to run a FAT2A trial, please try again or wait to be reconnected to the conference. After reviewing historical trials in this indication, we decided to increase the size of our setting to achieve a phase to be designed at minimal incremental costs.
Speaker 6: We didn't detect any of the reconnecting you to the conference. And then serve up to 48 weeks in total.
Speaker 5: Our primary endpoint for this study, please try again, or wait to be reconnected to the Comfort Facial Tool at week 36, which is very standard in the field.
Speaker 5: We will also be looking at a number of other secondary endpoints, including proportionate patients with reduced early-inputs, reconnecting you to the company. Now turning to our lead immunology research program, TNFR2 Agony and Agony. We did the pregnancy. We did the pregnancy. Please try to, and highly reconnected to your friends, neuronal cells and others.
Speaker 5: And TNFR2 agonism has been shown to potentially the suppressive effect and overall functional properties of T-rays.
Speaker 5: Building upon what we know.
Speaker 6: the potential of regulatory detailed mechanisms. This makes this program incredibly exciting to us.
Speaker 6: Next term has identified two lead animal that we have now validated for slightly M-R2. Please try again or want to be reconnected to the constant. Delta X specificity in TNFR2 agonism and primary human cell-based assays.
Speaker 6: We believe that a selected TNF R2 agonist holds great promise for the treatment of multiple autoabutunities and are aggressively pursuing this program and on track to submit our IND in 2024.
Speaker 5: We didn't know I'd like to turn the call. Please try again to provide a brief. We connected to five program in ecology and our recent collaboration with. Mary.
Thank you, Jay-Z. Moving to Nectar 255, we are continuing our work with Nectar 255 while we evaluate strategic partnering pathways.
We believe there is a potential broad application for NECTAR-255 for enhanced efficacy of cellular therapy. And to that end, as Howard mentioned earlier, we are pleased to have recently announced our new clinical study collaboration with a leading cell therapy company, Cellular Biomedicine Group, to evaluate NECTAR-255 in combination with their TIL therapy known as CTIL-051. The study, which is being conducted by and fully funded by CBMG, is an advanced non-small cell lung cancer patients who do not respond to anti-PD-1 therapy.
With few treatment options for the individual, we are excited about the potential for this regimen to help patients.
Preclinical and early clinical data. We didn't have the right to improve the look. Please try again. And we reconnected to the other therapies, such as TIL to increase specific anti-tumor activities.
The first investigator site is at Duke University.
with a leader in the lung cancer research field, Dr. Scott and Tony. Positive data from this study could lead to exploration of a pathway for accelerated approval by our partner, CBMG. Our other studies are continuing in cell therapy, and we expect that we could see data reported next year from these trials, including the Phase II Javelin Bladder Medley Study, which is being conducted and funded by our partner, Merck KVA. Because of its unique potential as a combination agent with cell therapies and other mechanisms, we are exploring the best partnering and development path for continued development of Nectar 255.
And with that, I will turn the call over to Jennifer for a review of our financial guidance. Jennifer? Thank you, Mary. We didn't detect any input. Good afternoon, everyone. We're reconnecting you to the conference. We ended the third quarter with $373 million in cash and investments with no debt on our balance sheet. Please try again.
Slightly higher than our prior projection of $315 million.
As we had previously announced earlier this year, we reduced our sample-to-cell base workforce by approximately 60%. And this personnel reduction represents approximately a $30 million year in operating expense reduction. The costs related to the restructuring were substantially paid in June .
We will fully realize annual savings in 2024.
a result of this restructure. We didn't detect and our financial reconnecting use of the conference with a cash runway that extends into the middle of 2026.
We didn't detect any input. Please try again. We'll wait to be reconnected to the conference.
In Q3, we recorded a $10 million non-cash impairment charge for real estate-least assets in San Francisco.
which contributed $0.05 to our net loss per share in support. As a result, for the full year, we now expect to recognize restructuring impairment and cost-determinated programs of approximately $50 million to $55 million.
which includes $37 million of non-cash impairment charges recognized through the first nine months of 2023.
There is more to you than you can take. Any warm thank you would be to connect you to the conference.
We now expect G&A operating expense for the full year of 2023 to be between $80 million and $85 million, which includes approximately $15 to $20 million of non-cash depreciation and stock comp expense.
Our GAAP revenue for full year 2023 is still expected to be between $80 million and $90 million. This revenue includes $65 million to $70 million in non-cash royalties and $15 million to $20 million in product savings. We anticipate full year GAAP R&D operating expenses will range between $105 million and $115 million.
which includes approximately $15 million to $20 million of non-cash appreciation and stock market expense.
Our full-year non-cash interest expense
We didn't detect any input. Please try again or wait to be reconnected to the conference. As I stated earlier, we expect to end this year with at least $320 million in cash and investments.
And, with that, we will now open the call for questions.
We didn't detect any input. Thank you. Reconnecting you to the reminder to ask a question, please press star one on your telephone, and wait for your name to be announced. We didn't detect any input. So withdraw your question. Please try again. We didn't detect any input. Please try again. Please press star one on your phone. We connected to the conference. Please stand by.
And our first question will come from we date the tenant from Oppenheimer we can take you to the conference.
Oh, hey, congrats on the progress. We didn't detect any input. Please try again. Or wait to be reconnected to the question. Talk about the Phase 2B trial in a topic dermatitis and congrats on the initiation of that study. Can you just talk about the feedback you're hearing from investigators? We didn't detect any input. We're connecting you to the conference. Enrollment rates and when you expect to complete the test. We didn't detect any input. Please try again. Or wait to be reconnected to the conference. I'm going to ask Mary as she's been meeting with a lot of these investigators over the past.
A couple of months to comment on that.
Thank you Jennifer and thank you Jay for asking the question. We didn't detect the number. We recently attended the conference in Berlin and we were able to meet with 30 different investigators. Please try again and we're going to recruit this trial at a hundred different clinical sites in the United States, Canada, Europe and Australia. And I could tell you that the investigators are very excited about. We connected the conference and the action and its application and atopic dermatitis. We didn't detect any of the presentations. Please try again. And Dr. John , we reconnected to the conference was very well attended and very well received and John .
Gilbert Berg, you know.
mentioned that for many years we've known the importance of T regulatory cells but we had never seen any data from a drug that actually expands T regulatory cells to improve any indication of Please try again or wait to be reconnected to the conference. reduction in The mean easy score from baseline. This was what he calls best in industry.
So there is a widespread enthusiasm from the investigators. I will tell you that a couple of the things that are...
very compelling about our clinical trial. We didn't detect any input. Please try again. We have a very good baseline profile. Our drug is highly tolerable and we've now shown that in roughly 600 patients. Number two, they really like the idea in the maintenance setting that we're going to evaluate monthly and reconnecting you to the conference maintenance regimen. And number three, the fact that their patients are going to be able to We didn't detect any input. Please try again. Or wait to be reconnected to the conference. Week is very attractive to their patients and to the investigators as well. So we feel that we will absolutely be able to deliver this trial on track and on time with data.
you to the conference. That's the data available in the first half of 2025. Hope that answers your question. We didn't detect any input. Please try again or wait to be reconnected to the conference. On the Phase IIB study of ResPEG and alopecia areata, can you just talk about how you're thinking about dosing and then what's the bar there to initiate a Phase III study? We didn't detect any input. Reconnecting you to the conference. With recently approved oral drugs and alopecia.
We didn't detect any input. Please try again. We'll wait to be reconnected to the conference. Sure, I'm happy to address that.
So, you know, the JAK inhibitors, as you know, are efficacious. We see an effect after roughly 36 weeks of treatment. There are, as you know, many problems with JAK inhibitors. One, when you stop taking JAK inhibitors, patients very rapidly lose their hair. And of course, you're well aware that there are black box warnings with the JAK inhibitors. You know, we very closely looked at the barositinib data, and we believe if we have efficacy similar to barositinib, but don't accompany two things. One, a rapid loss of hair after cessation of treatment with the ability to have, again, just the color we're looking at in...
in atopic dermatitis, a maintenance regimen that is far more convenient and favorable for the patient, we believe that a biologic would have no great appeal in the area of tesha areata. We are going to look at two different doses versus placebo, and we will evaluate this on a 36-point-and-again, I think, analogous or better efficacy than has been seen with the JAK inhibitors with an improved safety profile, tolerability profile, and without accompanying black box warnings that would make a highly competitive in this space.
Great, thank you for that. We didn't declare any input. Please try again, or wait to be reconnected to the conference. Thank you very much, Jay.
Thank you. And as a reminder to ask a question, please press star 11.
We didn't detect and our next question we can let Chris of the Cudley-Tani from Goldman Sachs. Your line is open.
Hi everyone, this is Charlie on the call. Chris, thanks so much for taking that question. Congrats on the conference. Just a couple quick ones from us. First, on the 255 plans for strategic partnership, wondering if there's any update on the expected timeline for that partnership. I know year end 23 was the previous target. Wondering if that was still the case or if we had a new timeline in mind at this point. And then on the subsequent pipeline with the TNFR2, I&D coming next year, wondering if there's any update on the PEG CSF1 program and whether we should expect an I&D from that program more on the 2025 sort of scale. Thank you.
So I'm going to have Howard take the first part of that question on 255. We didn't detect any input. I'm reconnecting you to the conference.
So yeah, sure, good question. Look, Nectar 255 is a potentially very exciting program. We see that we just completed a.
collaboration with CBMG and in combination with TIL therapy, we have a collaboration with Merck KGA. We didn't detect any input. We're reconnecting you to the conference. There's a lot going on with 255. We also have our own study running at the Fred Hutchinson Cancer Center. We didn't detect any input. Please try again or wait to be reconnected. There are companies that are interested. I think as a strategic, we would like to complete a strategic collaboration for Nectar 255. Our focus as a company is in immunology now, although I think this is a very exciting asset. We didn't detect any input. I can't give you specifics as to when and how a collaboration will get done, but we're making great progress there. We didn't detect any input. Please try again or wait to be reconnected.
potential application for NECTA 255. So we'll keep you posted. I don't know that it's going to be end of this year, next year, can't say for sure, but clearly we're focused on that and I do think... We didn't detect any input. Lizzie, would you handle the PEG CFS 1 question?
Certainly. Yeah, thanks for the question. So, at this time, we really prioritized our efforts on the TNF R2 program. And that's really for a couple of reasons. The first is that TNF R2 builds on a complementary pathway around targeting the IL-2 pathway that Respeg engages.
So, for example, you know, that any in the NFR to please try again, wait to be reconnected to the strongest signals.
that induces NF-kappaB in cells like key rags.
And it's also one of the strongest signals for controlling FOXP3 expression.
which is critical enzyme for both compressive...
and differentiated and strong T-reg response. We didn't detect any input. Please try again. We'll wait to be reconnected to the conference. So it's really a target that's very, very important.
hot, you know at this time.
It's really built off of what we know and have learned through our deep experience. We didn't detect any input. Reconnecting you to the conference. And it also lets us leverage all that knowledge in advance of our prioritized network. We didn't detect any input. Please try again or wait to be reconnected to the conference. The PEG-CSF program we will work on in the future, but it's really TNFR2 where we're focused on right now. PEG-CSF fueling experience in Focus believe it or not… finite poverty
I'll also say that
As we've had the opportunity to discuss that program with some other outside entities, we have received a lot of interest around the program. We're finding many companies, like Barbas and large biotech and others, that have really allocated time for TNFR2 into their strategy.
So much is known around TNF inhibition.
you know, with drugs like Humira.
you know, glue maps, flicks, map-end-rolls, and so on, and it had such a profound effect on rheumatology.
And through that, that we didn't detect please try again or wait to be reconnected to the conference. What's missing? Would you just block all TNF alpha signaling, which includes also blocking the TNF R2 pathway?
So, this is something that we're very excited about, like all of the input, where we're really prioritizing our energy. We're very excited that we're on track. We didn't detect any input to please try again. We'll wait to be reconnected to the conference saving into the manufacturing setting and we're on track to be submitting our next year in 2024 for that program.
Great, that's helpful. Thank you all so much. We didn't detect any input. Reconnecting you to the conference. Thank you.
And I am showing no further questions from our phone lines. And I'd like to turn the conference back over to Howard Robin for any closing remarks. We'll wait to be reconnected to the conference. Well, thank you everyone for joining us today. And we remain focused on executing on the development of Respeg in our immunology focused research programs. And I think we have a clearly defined path forward. I'd like to thank all of our employees for their efforts and their hard work. And I want to thank our shareholders for their continued support. So we look forward to providing you with updates on our progress in truth and thanks for joining us.
This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.
We didn't detect any input reconnecting you to the conference.