Nektar Therapeutics (NKTR) 2026年第二季度业绩电话会议：REZPEG三期临床推进

核心要点

• Nektar Therapeutics在2026年第二季度末拥有10.2亿美元的现金和投资，且无债务。管理层表示，现金储备可支持运营至2028年第三季度，超过了预计于2028年中期公布的特应性皮炎初始III期临床试验结果的时间。
• 第二季度非现金特许权使用费收入为1010万美元。净亏损共计4060万美元，即每股基本和稀释亏损1.23美元。
• rezpegaldesleukin（简称REZPEG）的全球ZENITH-AD III期项目已于7月开始对患者进行随机分组。前两项研究针对未接受过生物制剂和JAK抑制剂治疗的初治患者，而一项针对既往接受过治疗的患者的研究计划于2026年9月底前启动。
• 在与美国食品药品监督管理局（FDA）讨论后，Nektar确定了一项涉及850名斑秃患者的单项REZPEG注册III期临床研究。公司计划于2027年初启动ZENITH-AA研究，并预计在2029年下半年获取数据。
• Nektar将2026年底的现金和投资指引上调至8.15亿美元至8.40亿美元。全年收入指引维持在4000万美元至4500万美元。
• 即将出现的临床催化剂包括：2026年第四季度的REZOLVE-AA停药后数据、2027年第一季度的特应性皮炎停药后数据，以及2027年由TrialNet赞助的1型糖尿病研究的初始数据。

核心财务数据

业务与运营表现

REZPEG特应性皮炎III期项目

Nektar已启动针对中重度特应性皮炎的全球ZENITH-AD项目。前两项关键研究各将招募510名12岁及以上的患者，并按2:1的比例随机分配接受每两周每公斤24微克的REZPEG治疗或安慰剂。

这些研究包括一个24周的诱导期，随后是持续至第52周的28周维持治疗期。评估将涵盖每月一次和每季度一次的维持给药剂量方案。第三项III期研究将在既往接受过治疗的患者中采用相同的试验设计，旨在支持二线及后续治疗的应用。

管理层预计将于2028年中期获取初始III期数据。如果结果积极，Nektar计划于2029年提交生物制品许可申请。

该项目包括涵盖IGA、EASI-75、瘙痒、皮肤疼痛和睡眠的美国及全球注册终点。次要终点还将评估哮喘和鼻窦症状。管理层相信，这些指标有助于彰显REZPEG通过调节性T细胞机制以及跨多种炎症通路的潜在疗效所带来的差异化优势。

注册性斑秃研究

Nektar与FDA就单项注册性III期研究ZENITH-AA达成一致。该试验将招募850名12岁及以上的患者，评估在52周内每两周每公斤24微克剂量的REZPEG与安慰剂对比的疗效。

主要终点是第52周时的SALT评分达到20分或以下，对应至少80%的头皮头发覆盖率。在经历延长的洗脱期前提下，该研究将纳入初治和既往接受过治疗的患者，并允许当前发病病程长达8年。

公司计划于2027年初启动该研究，并预计在2029年下半年获取数据。患者可进入长期延长线研究，以评估疗效持久性和长期安全性。

REZOLVE-AA研究中为期24周的停药观察部分预计将于2026年第四季度公布数据。Nektar将利用研究结果评估52周后的维持给药频次应维持在每月两次还是可调整为每月一次。

其他管线进展

由TrialNet赞助并提供资金的REZPEG治疗新发1型糖尿病的II期研究仍在进行中。预计首个患者队列的数据将于2027年公布。

Nektar还计划在2026年底前启动REZPEG另一项适应症的临床研究。管理层提及皮肤红斑狼疮和其他自身免疫性疾病为正在考量的领域，但尚未公布最终选择。

早期阶段的工作仍在继续推进，包括双价TNFR2激动剂抗体NKTR-0165，以及结合了TNFR2激动作用与先前在风湿病学中已验证的拮抗表位的双特异性分子NKTR-0166。

管理层业绩指引

管理层预计，随着III期临床试验以及配套的化学、制造与控制（CMC）工作的推进，2026年季度的研发支出将有所增加。

风险与关注事项

• 特应性皮炎生物制品许可申请（BLA）的时间点以及拟定的斑秃批准路径取决于积极的III期临床结果及随后的监管审评。
• REZPEG拟定的更低给药频次维持方案仍处于评估中。即将公布的停药后数据将为给药间隔能否超越现有方案提供依据。
• 管理层的商业化定位得到了医生市场调研和II期数据的部分支持；在一线治疗中的接纳度以及在经治患者中的表现尚未在III期试验中得到证实。
• Nektar指出，对于接受过生物制剂治疗的特应性皮炎患者，目前尚无公认的随机安慰剂基准，这限制了不同研究之间的直接比较。
• 与正在进行的诉讼相关的联邦陪审团审判计划于2026年9月8日在旧金山开庭。管理层拒绝提供更多细节，但表示相信公司处于有利地位。

分析师问答集锦

• 停药后疗效持久性：REZOLVE-AA研究招募了92名患者，其中31名患者进入了16周的延长线研究。Nektar计划对所有随机分组的患者进行评估，其中延长线队列的数据预计对维持给药决策尤具参考价值。
• 特应性皮炎定位：管理层表示，针对医生的调研支持其在一线、二线及后续线治疗中的潜在应用。医生强调了其新颖机制、每季度一次维持给药的潜力以及IIb期安全性特征，包括在REZPEG治疗组中未观察到感染风险增加或结膜炎。
• 既往接受过治疗的患者：基于REZPEG的上游作用机制和外部先例，管理层预计在接受过生物制剂和JAK抑制剂治疗的患者中的疗效将与初治患者相似。这仍是管理层的一种预估，将在第三项ZENITH-AD研究中予以检验。
• EADV大会汇报：REZOLVE-AD维持期数据和REZOLVE-AA第52周数据计划于2026年10月在维也纳举行的EADV大会上作口头报告。如果数据可用，可能会加入停药斑秃数据，但公司未作承诺，因为研究仍处于双盲状态且数据库尚未锁定。
• 竞争格局：管理层表示，近期报道的一项包含33名患者的开放标签斑秃研究很难与REZPEG进行比较，因为该研究缺乏安慰剂对照，且使用了更具选择性的受试人群。Nektar强调，其IIb期研究是随机、安慰剂对照的，且招募了更广泛的受试人群。

业绩电话会议完整文字记录

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完整财报电话会议逐字稿

管理层陈述

Operator

Hello, and thank you for standing by. Welcome to the Nektar Therapeutics Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to Vivian Wu from Nektar Investor Relations to kick things off. Please go ahead.

Vivian Wu

Thank you, Crystal, and good afternoon, everyone. Thank you for joining us today.

On today's call, you will hear from Howard Robin, our President and Chief Executive Officer; Dr. Jonathan Zalevsky, our Chief Research and Development Officer; and Linda Rubinstein, our Chief Financial Officer. Dr. Mary Tagliaferri, our Chief Medical Officer, will also be available during the Q&A.

Before we begin, I would like to remind you that we will be making forward-looking statements regarding our business, including statements related to the therapeutic and commercial potential and development plans for rezpegaldesleukin, the timing and expectations for clinical trials, clinical data presentations and regulatory submissions, regulatory interactions, our expected cash runway and other statements regarding the future of our business. Because forward-looking statements relate to the future, they are subject to uncertainties and risks that are difficult to predict and many of which are outside of our control.

For a discussion of these risks and uncertainties, please refer to our filings with the SEC, including our most recent Form 10-K and subsequent filings. We undertake no obligation to update these forward-looking statements, except as required by law. Live webcast and replay of this call will be available on the Investor Relations section of our website at nektar.com.

With that, I will hand the call over to Howard.

Howard W. Robin

Thank you, Vivian. Thank you to everyone for joining us this afternoon.

In July, we achieved yet another important milestone in Nektar with the initiation of the global ZENITH AD program, Phase III AD program for rezpegaldesleukin, also known as REZPEG, in moderate to severe atopic dermatitis. We're excited to be advancing this very important novel medicine towards registration in the first of several potential indications.

Following our end of Phase II meeting with the FDA, we also finalized the design of a single registrational Phase III study for REZPEG in alopecia areata, which we plan to initiate in early 2027.

The registrational study designs for REZPEG build on the positive clinical data we've generated in the first half of this year in patients with atopic dermatitis and alopecia areata and also reflects input from our completed regulatory meetings.

JZ will talk more about these designs later on during the call. And importantly, with the first Phase III studies in atopic dermatitis now underway, we expect top line data from these studies in mid-2028 and if positive, expect to submit a BLA in 2029.

As a novel T-reg agonist mechanism, REZPEG works fundamentally different by acting upstream of multiple inflammatory pathways to restore immune balance. And to that end, we continue to evaluate new indications for expansion of REZPEG's development in the future.

Through TrialNet, we are evaluating its potential in type 1 diabetes in an ongoing Phase II study. We also believe there are other autoimmune conditions where a T-reg mechanism could benefit patients, and we, therefore, view REZPEG as a potential pipeline in a product.

Importantly, the market opportunity and patient need in each of our 2 lead indications are substantial. More than 15 million people in the United States have moderate to severe atopic dermatitis and currently fewer than 10% are treated with a systemic therapy.

We believe that this market will grow with the introduction of novel mechanisms of action as was the case in the psoriasis market and that REZPEG is highly differentiated from the other novel MOAs approved or in development.

We know that roughly half of the patients on currently available IL-13-based agents, including Dupixent, either don't respond to therapy or lose their response over time. This leaves a large unmet need for a new therapeutic option. We believe REZPEG has the potential to alter the treatment paradigm in this indication by offering a differentiated efficacy and safety profile, with a long-term, highly attractive monthly or quarterly maintenance dosing regimen.

We recently completed extensive market research, which included our 52-week maintenance data for REZPEG. The research reinforces our commercial thesis in atopic dermatitis. We interviewed and surveyed 151 high-volume prescribers and key opinion leaders in the United States and Europe.

A recurrent theme that came up in the research was physician enthusiasm for a novel mechanism of action as compared to overlapping mechanisms of action in the IL-13 class. The REZOLVE-AD data was viewed highly positively, including EASI-75 and Itch NRS responses. The quarterly dosing schedule for maintenance and the EASI-100 rates were called out as notable and differentiating.

The data in comorbid asthma was also cited as a key differentiator as physicians see patients with a range of other autoimmune and allergic comorbidities, which could benefit from a T-reg therapeutic approach.

Notably, safety was viewed as a key differentiator with no increased risk for infection and no conjunctivitis observed in the REZPEG treatment arms in our Phase IIb REZOLVE-AD study. Importantly, 150 out of the 151 physicians interviewed said that injection site reactions were not a hindrance to prescribing or a barrier for patients and actually preferred a self-resolving short-lived ISR over managing longer duration conjunctivitis.

It was clear that physicians would welcome a novel immune modulating mechanism like REZPEG in the treatment paradigm and that REZPEG would likely be prescribed across first, second and third-line populations. The research supports our decision to pursue a label with our registrational program in atopic dermatitis that captures both treatment-naive and experienced patients.

Turning to the opportunity in alopecia areata. Nearly 6.7 million people in the United States are affected by the disease and the large majority currently go untreated. There are well-known safety challenges associated with JAK inhibitors, which is the only approved class to treat severe patients, and that has limited their use.

In spite of that, the market for agents currently approved for alopecia areata is still projected to grow to $5 billion in 2033. But more than half of dermatologists are not comfortable prescribing these agents given their box warnings and an ongoing monitoring burden.

Our REZPEG market research with physicians in alopecia areata reaffirms this hesitation to prescribe JAK inhibitors. And in addition to REZPEG's safety profile observed to date and its novel MOA, physicians and patients in our research cited REZPEG's twice monthly dosing for alopecia areata patients as more attractive than once-daily oral dosing. Physicians also noted the ability to ensure patient compliance with treatment is much higher with an injectable twice monthly regimen. The research reaffirms our belief that REZPEG has the potential to become a preferred first-line treatment option for patients with severe to very severe alopecia areata.

Before I hand the call to JZ, I will note that we ended the quarter in a strong financial position with over $1 billion in cash and investments, and our cash runway extends into the third quarter of 2028 past the initial Phase III atopic dermatitis data readouts in mid-2028.

Our team is laser-focused on successful execution of our Phase III programs and advancing REZPEG to BLA submission as quickly as possible.

With that, I'll turn the call over to JZ.

Jonathan Zalevsky

Thank you, Howard, and good afternoon, everyone. Everything we have learned about REZPEG from the data from the clinical programs to date points to a consistent and we believe differentiated clinical profile, meaningful efficacy, a favorable safety profile with dosing as infrequent as once a quarter and responses that continue to deepen over time.

As Howard stated, REZPEG works upstream of the currently approved agents in the diseases we are targeting. It stimulates regulatory T cells and gets closest to natural causal biology to restore the immune balance that is disrupted in autoimmune and inflammatory disease rather than blocking a single target or even multiple targets downstream.

REZPEG is able to correct Th1, Th2, Th17 and other upstream inflammatory dysfunctions that can drive disease pathology across atopic dermatitis, alopecia areata and other autoimmune diseases. Because regulatory T cells target the underlying immune imbalance of inflammatory and autoimmune diseases, we have seen REZPEG produce very high durability over time.

This was our key hypothesis when we developed REZPEG, and it is supported by the data we reported from our monthly and quarterly dosing regimens in our Phase IIb program. In our first Phase I study, following a 12-week treatment cycle, we observed durability of clinical responses for approximately 9 months off treatment, which we have previously published.

As Howard mentioned, ZENITH-AD, our global Phase III program in atopic dermatitis is now up and running. The first 2 studies, both in biologic and JAK inhibitor naive patients were initiated, and we started randomizing patients back in July. The planned study in treatment-experienced patients is set to start by the end of September.

As a reminder, each of the 2 pivotal biologic naive studies will enroll 510 adolescent and adult patients aged 12 and older randomized 2:1 to REZPEG at 24 micrograms per kilogram every 2 weeks or placebo. There is a 24-week induction period followed by a 28-week maintenance period through week 52, during which we will evaluate both monthly and quarterly dosing.

The third Phase III study in treatment-experienced patients has the same design and is expected to support a second line and later usage in the label. Taken together, the studies are designed to support a potential label in this patient population that captures both naive and experienced patients spanning first line, second line and later line usage.

The studies are designed to support U.S. and global registration with an IGA-related primary endpoint for the U.S. and co-primary endpoints of EASI-75 and IGA for significant territories outside the U.S., along with multiplicity protected secondary endpoints for key patient-reported outcomes such as Itch numerical rating scale or NRS, skin pain NRS and Atopic Dermatitis Sleep Scale or ADSS.

As you know, many patients with atopic dermatitis also have other comorbidities, including asthma and allergic rhinitis. As a T-reg-based mechanism, REZPEG is designed to work upstream of targeted -- REZPEG is uniquely positioned to simultaneously address multiple autoimmune and inflammatory manifestations at once.

And to that end, we also include a number of multiplicity protected secondary endpoints that will help us explore this benefit. The first being ACQ-5, which measures improvement in patient-reported asthma symptoms. Approximately 25% of patients with moderate to severe atopic dermatitis also have asthma. And in our Phase IIb setting, REZPEG produced statistically significant improvements in ACQ-5 versus placebo, including in patients with uncontrolled asthma at baseline.

A second endpoint we've included is the Sino-Nasal Outcome Test 22. This is referred to with the acronym SNOT-22, a validated patient-reported measure of Sino-Nasal symptoms. Rhinitis is a type 2 inflammatory comorbidity found in patients with atopic dermatitis. And up to 30% of patients with atopic dermatitis also have a comorbidity of allergic rhinitis.

On this endpoint in our Phase IIb study, we measured SNOT-22 for patients with self-reported symptoms and which extended also into patients who had self-reported asthma with rhinitis. We are including SNOT-22 as a secondary endpoint in our Phase III studies, and we are excited to share with you that we plan to present the SNOT-22 data from the REZOLVE-AD study at a future medical meeting.

Our strong REZOLVE-AD Phase IIb data underlies the design of our Phase III program. In REZOLVE-AD, we saw a rapid onset of skin clearance and itch relief early in treatment, and we saw those responses deepen over time rather than plateau. With less frequent monthly and quarterly maintenance dosing, we achieved high rates of complete skin clearance, including up to a fivefold increase in EASI-100 rates during the 36-week maintenance treatment period, a level of response rarely achieved. As Howard said, we expect the first data from the Phase III program in mid-2028 and if positive, expect to submit a BLA in 2029.

Turning to alopecia areata. We recently held our end of Phase II meeting with the FDA, and we received alignment to conduct a single registrational Phase III study, which we are calling ZENITH-AA.

In the pivotal study, we have finalized, 850 adolescent and adult patients aged 12 and older will be randomized to receive REZPEG at 24 micrograms per kilogram every 2 weeks or placebo with treatment continuing through 52 weeks. The study will include patients that have a current episode of alopecia areata of up to 8 years. This was the inclusion criteria for all of the JAK inhibitor Phase III trials as well as our Phase IIb randomized placebo-controlled study.

We will include both patients who are naive to systemic treatment, including biologics and JAK inhibitors as well as those who have been treated with a prior systemic agent provided they have undergone an extended washout period.

The primary endpoint will be a SALT score of 20 or less at week 52, which corresponds to 80% or more scalp hair coverage. This is the established registrational endpoint for patients with severe to very severe alopecia areata at baseline.

Key secondary endpoints include SALT scores of 10 or less and 30 or less, along with 50%, 75% and 90% SALT reductions from baseline, which capture increasing degrees of hair regrowth. You'll recall that we observed improvement with REZPEG treatment across all these endpoints in our Phase IIb trial.

Patients from the study will also have the ability to roll over into a long-term extension, which will allow us to characterize durability of response on treatment and long-term safety. We plan to initiate the Phase III alopecia areata study in early 2027, and we expect data in the second half of 2029, and if positive, would expect to seek approval in alopecia areata as the second indication shortly following our planned submission in atopic dermatitis.

We expect to have data from the 24-week off-treatment period of the Phase IIb REZOLVE-AA study in alopecia areata in the fourth quarter of this year. Our objective for measuring patients in the off-treatment period is to determine a maintenance dosing regimen beyond 52 weeks, whether we continue to dose it twice-monthly or offer additional once-a-month regimen.

As you know, we already have an advantageous dosing schedule of twice monthly as compared to a daily JAK inhibitor. As Howard pointed out earlier, our market research has reinforced for us that both physicians and patients would prefer a less frequent injectable regimen as opposed to daily oral administration.

When you couple this dosing regimen advantage with the safety profile observed to date, we believe REZPEG has the potential to become an important first-line treatment for this indication. In addition, data sets from both our lead programs in atopic dermatitis and alopecia areata have been accepted for oral presentations at the European Academy of Dermatology and Venereology, or EADV congress to take place in Vienna in October. These presentations will feature the REZOLVE-AD maintenance data covering both the patients who maintain their response and those who develop new and deepening responses over time, including complete clearance as well as the REZOLVE-AA week 52 data. We're grateful for the opportunity to present these data at this important meeting.

Beyond our 2 lead indications, the Phase II study of REZPEG in new onset type 1 diabetes sponsored and funded by TrialNet is ongoing. As a reminder, this is the same consortium that ran the foundational studies for teplizumab, the only approved therapy in this setting, and they bring expertise and a deep commitment to finding better options for patients with this disease. We're looking forward to the data from the first cohort of patients in this type 1 diabetes study in 2027.

As this program matures, we continue to evaluate additional opportunities for REZPEG in other potential indications. And as I mentioned earlier, REZPEG is fundamentally different from therapies that block a single downstream inflammatory mediator. REZPEG acts upstream by expanding regulatory T cells and enhancing their suppressive function, thereby restoring immune tolerance and reestablishing regulatory control over pathogenic immune responses. Our objective is to start a clinical study prior to year-end, which would allow us to evaluate REZPEG's activity in a new indication.

Turning to our earlier pipeline programs. We are continuing our development of our TNFR2 programs. NKTR-0165 is our bivalent TNFR2 agonist antibody, a molecule with very high specificity for signaling for TNFR2 on T-regs to enhance their ability to regulate the immune system.

We believe this mechanism has potential across a range of indications, including MS, ulcerative colitis and vitiligo. Because NKTR-0165 demonstrated strong monomeric activity, we realized the TNFR2 molecule could be incorporated in the design of bispecific and trispecific constructs in combination with validated targets. Therefore, we are designing a pipeline of TNFR2 containing bispecific molecules that pair TNFR2 agonism with other antibody targets.

The first of these programs, NKTR-0166 is a bispecific molecule that combines a TNFR2 agonist epitope with an antagonist epitope previously validated in rheumatology. This dual mechanism gives NKTR-0166 the potential to modify disease pathogenesis across multiple autoimmune settings. We are continuing our research in both TNFR2 programs, and we'll share more as they progress.

With that, I will turn the call over to Linda to review our financial results. Linda?

Linda Rubinstein

Thank you, JZ, and good afternoon, everyone. On today's call, I'll review our quarterly financials for the second quarter of 2026 and our 2026 financial guidance. We ended the second quarter of 2026 with $1.02 billion in cash and investments with no debt on our balance sheet.

In April, we completed an underwritten public offering, resulting in approximately $350 million in net proceeds. We are increasing our cash guidance for year-end 2026, and we now expect to end 2026 with approximately $815 million to $840 million in cash and investments.

Turning to the income statement. Our second quarter 2026 noncash royalty revenue totaled $10.1 million. Full year revenue for 2026 is still expected to total $40 million to $45 million. Our R&D expenses were $39.1 million for the second quarter of 2026, and we now anticipate full year R&D expense to range between $210 million and $230 million, including approximately $5 million to $10 million of noncash depreciation and stock-based compensation expense. As a reminder, we expect R&D expense to increase on a quarterly basis in 2026 as our Phase III clinical studies and supporting CMC activities progress.

Our G&A expenses were $12.8 million for the second quarter. We continue to expect G&A expenses for the full year 2026 to be between $60 million and $65 million, including approximately $5 million of noncash depreciation and stock-based compensation expense.

Noncash interest expense for the second quarter was $7.2 million, and we expect noncash interest expense to total approximately $30 million to $35 million for 2026. Our net loss for the second quarter was $40.6 million or $1.23 basic and diluted net loss per share.

And as I stated earlier, we now expect to end 2026 with between $815 million and $840 million in cash and investments. Our financial position is strong, enabling us to continue investing in our REZPEG atopic dermatitis and alopecia areata programs as well as advancing our TNFR2 agonist antibody program, which includes NKTR-0165 and NKTR-0166.

I'll now turn it over to the operator for Q&A.

Operator

[Operator Instructions] And our first question will come from Yasmeen Rahimi from Piper Sandler.

分析师问答

Yasmeen Rahimi

Congrats on getting the alignment of the ZENITH-AA study and kicking that off. So congrats and great updates. You guys do always a wonderful job helping us think about the next catalyst in terms of thinking about timing, the type of data we will get and the expectation. And I would love to do that ahead of the next important data readout, which will be the withdrawal data that is going to come in the fourth quarter. Could you maybe talk about what your expectations are in terms of what is the size of the cohort? What do you expect to see that would be and whether any of that off-treatment AA data inform in any way sort of the data collection that will be ongoing in your Phase III study?

Howard W. Robin

Yes. Thank you. That's a great question. I'll let Mary take that question.

Mary Tagliaferri

Great. Yasmeen, thank you so much for congratulating us on having our Phase III program in atopic dermatitis kick off. We're very excited about that as well.

So as you know, we have a 24-week follow-up off-treatment period in the REZOLVE-AA study. This is an ongoing part of our trial. And in the fourth quarter, we will have the data. We enrolled 92 patients total into the trial. And then of those 92, 31 went on into our 16-week extension. We do follow every patient who was enrolled into the study for that 24-week off treatment. And with respect to the Phase III, the most important for us is after 52 weeks of treatment on the Phase III alopecia areata registrational study, we will continue to follow those patients in a long-term extension study.

And these data will really help to instruct should treatment continue to be on an every 2-week basis or can we extend that frequency in a maintenance period to a longer time point such as dosing once a month. So we're really excited to look at those data, so we can have more clarity on treatment after 52 weeks in our Phase III program.

Likewise, in the first quarter of next year, we will have 52-week off-treatment data for our atopic dermatitis Phase IIb study. And in that, again, we're really looking to instruct what should the dosing be after 52 weeks of treatment. And should -- or are there patients that experience durability of responses beyond, say, a dosing interval that we evaluated in the Phase IIb such as 2 monthly and every 3 monthly.

We did see, of course, in our Phase IIb that patients experienced great durability and many experienced a deepening of response. Now we want to look at in this 52-week off treatment, how those responses are maintained and the durability of those responses to see if it's feasible to extend that dosing interval beyond quarterly.

Operator

Our next question comes from Samantha Semenkow from Citi.

Samantha Semenkow

And thank you for all of the details in the recent market research that you shared in atopic derm. I'm just wondering if you could elaborate a bit more on how physicians are thinking about prescribing REZPEG in the first-line setting. Are there certain patient population or patient characteristics that physicians are identifying that are best suited for REZPEG? And did your market research give any indication on the breakdown of the portion that would be candidates, say, for first line versus second line or later?

Howard W. Robin

Yes, very good question. Look, the market research that we did was extensive, and we want to understand how to position our drug because at some point, it is a completely novel mechanism and everybody thinks that there's going to be -- have to be a step-through through IL-13 to ultimately get to something like a T-reg mechanism.

And we don't find that to be the case. I think overall, as I said earlier, there's only about 10% of the population with atopic dermatitis that's being treated with systemic therapies. So it's an enormous upside market potential. And even the patients that are getting IL-13s, which is sort of the gold standard right now, I think those patients -- about half of those patients either don't respond or fail after a year or so.

So there's lots of opportunity for REZPEG as a first-line indication. Clearly, as a second-line indication, it fits that definition perfectly since we know how many patients fail IL-13. And with a quarterly maintenance dosing regimen, it makes it a very easy drug to take for those patients. But I do think we'll get a significant share of the first-line market as well once patients get experience.Remember, it doesn't cause any infection. It doesn't cause conjunctivitis and those problems, those side effects are potentially much more serious than mild to moderate self-resolving ISRs.

So overall, we're pretty happy about getting our first-line market share.

Operator

Our next question comes from Jay Olson from Oppenheimer.

Jay Olson

Thinking about eventually moving into the first-line setting.

Howard W. Robin

I'm sorry, I barely heard that question. Could you say it again louder?

Operator

Our next question comes from Cha Cha Yang from Jefferies.

Cha Cha Yang

This is Cha Cha on for Roger. Thank you so much for the updates as always very informative and very colorful. I was wondering if you could give us some comments on the pretrial that happened last week. Any color that you can give on the outcomes of that? And then what impact you expect those outcomes to have on your upcoming September trial?

Howard W. Robin

Yes. Look, always a good question. But of course, it's -- you can't really -- we can't really comment on an ongoing litigation. I can tell you that the trial is scheduled -- a jury trial is scheduled in federal court in San Francisco for September 8. And we believe we have a very strong position. And that's unfortunately all I can tell you about it at this point. So I'd love to give you more, but it's difficult to comment on ongoing litigation.

Operator

Our next question comes from Arthur He from H.C. Wainwright.

Yu He

Congrats on the progress. And Mary, congrats to get the single trial for the AA study sign off. So for that part, I just wonder for the off-drug data in the fourth quarter, for the patients who finished the -- only finished the 36 week, are we also looking to the data from that part of patients there?

Mary Tagliaferri

Arthur, yes, we will be looking at both patients as well as those patients that completed the 52 weeks of treatment. Obviously, I think what will be most instructive and valuable to our decision-making will be those patients. There were 31 of them that went into the long-term extension -- went into the 16-week extension. But we will be looking at all the 92 patients that we randomized into the study and providing an update on the totality of the findings.

Yu He

Okay. So just one quick squeezing. So when you were talking to the FDA, did they put some requirement for a medium or minimal duration for the current episode for the alopecia patient?

Mary Tagliaferri

Yes. Thank you for asking. We will be following the same convention as JAK inhibitors. And our study design did provide for patients that have up to 8 years of their current episode. We do know that there are some other people who've looked at a more enriched patient population that only have a current episode of up to 4 years duration of their current episode. And however, we don't think that reflects the actual population of patients with alopecia areata, and we want to have a very broad label.

So we did design a study that will include both patients who are JAK inhibitor naive and JAK inhibitor experienced. We'll have adolescent patients as well as adult patients, and we will be looking at patients who have a duration of their current episode less than 4 years and 4 to 8 years. We think having the broadest label has the greatest commercial potential as well as serving the broadest proportion of patients and certainly a study that's in line with the prior JAK inhibitor studies.

Operator

Our next question comes from Mayank Mamtani from B. Riley Securities.

Mayank Mamtani

I appreciate the level of detail. Two-parter question. On the EADV, what's the incremental data set that we should expect? And if there's a chance off-treatment REZOLVE-AA data could also be presented because it's October 1, technically fourth quarter? And I also could help with the enthusiasm for enrollment in your global alopecia Phase III.

And on the maintenance atopic derm data, should -- just based on your Phase Ib where we got EASI-75 up to 9 months, can you just highlight what are the differences in this off-treatment versus what we saw in your Phase Ib? And should we also expect to see some of the EASI-100 responders keep that off-treatment remission?

Mary Tagliaferri

Great. Thanks, Mayank, for your questions. Certainly, as JZ mentioned, we're really pleased to have the 2 oral presentations accepted at EADV. I think this really highlights the promise of our novel mechanism of action and of course, the strength of our clinical data. We -- when we submitted the abstracts, of course, we did not have the 24-week follow-up data. And therefore, of course, our abstract doesn't include this portion of our study. The study is still ongoing and blinded.

Now -- that being said, we -- it is possible that we could include the 24-week data, as you mentioned, this could be very valuable and of significant interest. We cannot make that decision today. If we do have the data readout in time and we are ready, we would love to include those data as well in our oral presentation by Dr. David Rosmarin at EADV. But again, at this time, we can't make that commitment because the trial is still ongoing, and we haven't even locked that part of the database. But thank you for asking. It is a possibility, but again, it's not in our abstract.

With respect to your second question about the maintenance data and the data of 52 weeks off treatment for the Phase IIb in atopic dermatitis, you're correct, -- we did show off-treatment data from our Phase Ib for 9 months. The difference here is now we'll have 3 additional months of follow-up post withdrawal from drug.

And we think that this is extremely important to us to look at, again, that durability of those responses. And again, we'll be able to look at the EASI-75 and as you mentioned, the EASI-100 and the EASI-90, we did see consistently that patients continue to improve with ongoing REZPEG treatment, and we did see this deepening of response.

Now we want to look at these patients being off treatment, and we will be able to look at the 9-month time mark like we did in the Phase Ib as well as 52 weeks off treatment. And this will be extremely valuable to look at the optimal dosing. And after 52 weeks of treatment, can patients have less frequent maintenance dosing and some patients -- for some patients that could be longer than every 3 months. So we're really excited to look at those data and really closely examine the durability of those responses. So thank you for asking those 2 questions.

Operator

Our next question comes from Julian Harrison from BTIG.

Julian Harrison

Congrats on all the recent progress. First, I'm wondering if you have any updated views on REZPEG's competitive positioning in alopecia areata in light of a recent data set last month from another non-JAK treatment option in development in the broader space. And then taking a step back, keeping in mind REZPEG's pipeline and the product potential, I'm wondering if you thought at all about supporting any signal-seeking efforts on an IIT basis. I'm sure you've done some investigator requests. Is that something you're open to? Or are future trials best to keep full control of at Nektar?

Howard W. Robin

Yes, 2 very good questions. So first of all, regarding competition in alopecia areata, look, the study that was just released data that was just released, and I'll let Mary comment a little more on this, very little difficult to interpret. And it was also a single-arm study. So it wasn't a blinded study. It's a little difficult to interpret. And quite frankly, it had a patient population that was much less severe or much earlier on in their disease than what we're planning. I think Mary did talk about the difference between 4 years and 8 years. And I'll let her comment on that in a moment.

And to your second question about looking at other indications, yes, we are in the process of considering which indications we would like to do some pilot studies to get some proof-of-concept studies. I think -- look, we were very successful in the lupus study when we looked at the data on a weight-based dosing rather than a fixed-based dosing. And I think there's a potential for working in cutaneous lupus as well. And there's a number of other indications, just as we're doing in type 1 diabetes that could warrant a -- whether it's an investigator-sponsored trial, you lose a little bit of control there perhaps or it's our own pilot studies. I do think that to support the value of a T-reg mechanism, I do think there's other indications that we will be looking at.

I'll let Mary come back to your first question for some more insight.

Mary Tagliaferri

Yes, sure. Julians, Howard mentioned this in our prepared remarks. We view the alopecia areata market as very large. And certainly, these patients are underserved by JAK inhibitors. So I think as seasoned biotech executives, clinicians and scientists, we love innovation, and we love to see innovation in a space where there's huge potential for growth.

Now that being said, as Howard mentioned, the Q32 results are really difficult to interpret. It was a small, only 33 patients, open-label study with no placebo. And as we've mentioned now twice, enrolling a selective patient population and restricting eligibility really skews results in the favor of any drug that's being tested.

By contrast, our Phase IIb study was randomized, it was placebo-controlled. We looked at more than one dose. We allowed a broad patient population that was consistent with JAK inhibitor studies. So the generalizability has greater potential. And we had a very standard Phase IIb trial that then was recognized by the FDA as being sufficient to move forward into a Phase III study.

So ultimately, we remain very encouraged by our efficacy and safety profile. And I know the dermatology community at large is really looking forward to beginning enrollment in our study in the first quarter of next year for these reasons. So thanks for asking.

Operator

Our next question will come from Marc Frahm from TD Cowen.

Marc Frahm

Congrats on all the progress in getting the Phase III up and running. Maybe just, Howard, you touched a little bit about kind of the different unmet needs in the AD market, particularly as you think about treatment naive versus experienced patients. Just how do you guys view that as likely to kind of impact the relative enrollment pace for these Phase IIIs in the 2 different kind of flavors of Phase III, different patient sizes, but also different levels of unmet need?

Howard W. Robin

Yes. Good question. I certainly think -- look, with the absence of OX40s, it certainly limits the opportunities for new mechanisms of action. And I think REZPEG is obviously unique in that sense. So I don't think patient enrollment will be an issue there. I think it will actually go fairly quickly. I can't tell you exactly what it will look like. We just started the studies, but I'm hopeful that it goes fairly quickly, recognizing that as a new mechanism goes, there's really nothing else at the moment.

We'll see what the STAT6 data looks like, upcoming data. But I don't think that's as complete a mechanism as REZPEG. I can let JZ comment on that a little bit, if you'd like. But overall, I think the market -- I don't think people understand how large this market is. Let's assume the market by 2033 is probably $35 billion, and that's 10% of the patients getting treated.

So I think, look, there's other good drugs out there. I'm not -- I mean, Apogee's drug is certainly a good drug. I think STAT6 could be a very important mechanism. But the fact of the matter is the market is enormous. And if you have a novel mechanism, you should be able to get a reasonable market share of a market that at 10% of the patients being treated is already planned to be $35 billion.

I'll let JZ comment a little bit on why we think REZPEG is probably one of the best opportunities in treating a disease like AD.

Jonathan Zalevsky

Yes. Marc, thanks, Howard. Yes, I mean I think that this point was touched on briefly, okay, first. I mean one of the things that our market research showed us is that we would have good first-line penetration. And that's really because the -- pretty much the entirety of the available approaches that physicians have and even the pipelines, including agents like STAT6, they're really all targeting the same pathway, right?

They're in a very Th2 dominant inhibitory state. They may be acting on more than one node, but they're acting really on the singular pathway. And our market research really shows that a new MOA was extremely important for physicians. And many indicated they would use a new MOA first. And so we think this will really help position REZPEG nicely.

As you heard about our Phase III study design, they're really taking advantage of not just what we've learned, but really even strengthening on where we saw the greatest differentiation in our Phase II data, and they're pushing that even more to give REZPEG a really big opportunity for a very highly differentiated label at the end of this registrational program.

Operator

Our next question comes from Jessica Fye from JPMorgan.

Jessica Fye

Can you expand a little bit on your expectations for REZPEG's effect size in biologic experienced patients compared to biologic-naive patients in AD? And how should we think about benchmarking the biologic experienced AD Phase III trial that you're running, is Ebglyss a good comp there? Or if not, what should we think about?

Howard W. Robin

Okay. That's -- thank you for the question. It's a very good question. I'll let either JZ or Mary answer it in a little more detail, but I can tell you that we looked very closely at whether there's any biological reason, any mechanistic reason why a patient who fails IL-13 would not respond to a completely different mechanism, and we couldn't find one. So I don't -- I think we should be successful in treating experienced patients. I'm going to let JZ and Mary comment a little more on that.

Mary Tagliaferri

Yes, I can just start and JZ can finish. Yes, Jessica, I think you're bringing up a very important point. Lebrikizumab was studied in the ADAPT study. And these were patients treated with lebrikizumab after Dupixent, and there was no diminution of efficacy. 57% of the Dupi exposed patients who were treated with lebrikizumab had an EASI-75 at week 16.

And in the lebri Phase III studies, the ADvocate-1 and the ADvocate-2, the EASI-75 at week 16 was 52% and 59% in that naive population. So we -- and the ADAPT study did include patients who also had an inadequate response to dupi. So given this precedent, this trial data and the REZPEG mechanism of action that augments the regulatory networks rather than just blocking a single downstream inflammatory mediator, we do expect the efficacy in the biologic and JAK inhibitor experienced patients to be very similar to the naive patients.

And I'll let JZ expand further if you want on the mechanism of action, JZ.

Jonathan Zalevsky

No, thank you. And I think you touched on a lot of the key points that our mechanism with the T-reg induction, if anything, is meant to really help patients for whom inhibition of IL-13 or IL-4 and 13 is no longer adequate, right, to control their disease. This is one of the greatest features, right, of the T-reg approach is it acts upstream of all of those factors.

And we look forward to continuing to elaborate on this. You raised a very important point, which is that while the ADAPT study is useful, as Mary explained, it's an open-label single-arm study. And so there hasn't really been a true benchmark published, for example, for placebo in this patient population. So all of these are all things that are going to be components of some potential data to be reported if Sanofi reports the results of their amlitelimab study in this patient population. That was designed as a randomized controlled trial. That will create one important piece of information for the placebo.

But overall, we're extremely excited to have this third study as part of our registrational program. We expect REZPEG has a very, very good opportunity to be efficacious in this patient population for all the reasons we've explained. And with the study like that under REZPEG's belt as part of our BLA, it really allows us to have a much more differentiated label for REZPEG.

Operator

And our next question will come from Andy Hsieh from William Blair.

Tsan-Yu Hsieh

So Howard, you mentioned about the physician survey that you did. It's super helpful for you to share with us. I'm curious if you have probed the group about durability as a means for differentiation. Is there a time that these physicians are looking at either the 3-month or 6-month time frame?

And my second question has to do with the type 1 diabetes trial that you're running with TrialNet. It seems like REZPEG is being treated for 6 months, but the primary endpoint is measured at 12 months. So can we infer from that, that there is a little bit of off treatment effect that we can extrapolate from the trial?

Howard W. Robin

Sure. Very good questions. I'll let Mary answer the question regarding the TrialNet type 1 diabetes study. I can tell you from our market research, time, duration or onset of action was important, but the most important thing is long-term durability. And you could see that if you look at our maintenance data, the drug -- the results keep getting stronger and stronger, and I expect that they'll continue that way.

I think one of the other things that was very important to physicians was a manageable side effect profile. And as I said, ISRs didn't concern them at all. They were much more -- they were actually much more concerned about infections and conjunctivitis than they were ISRs. But overall, a durability of response that continues to improve was very important to the physicians.

Mary, do you want to take the question on the type 1 diabetes trial.

Jonathan Zalevsky

Thanks, Howard. I'll actually -- I'll do that. So yes, I want to describe a little bit about how that study is designed. So if you recall the teplizumab studies, the CD3 antibody. So the way that works is it's a very short treatment course, right? It's just a few cycles at the very beginning. But that actually is enough to alter the whole trajectory of the disease.

So TrialNet was very excited that they could dose longer with REZPEG that they did with teplizumab. So that was exciting for them. And so they selected a 6-month course. The mixed meal tolerance test C-peptide levels, they're measured throughout through a year. So they're measured both during the treatment as well as the 6 months after the treatment. But again, the whole theory and understanding of the disease, its progression and the worsening that people have is it's well understood that a course of intervention will change the whole slope of the disease and provide the therapeutic benefit that we're looking for.

So that's why the study was designed this way. It's very much in the -- right in the sweet spot of how these kinds of type 1 diabetes studies are done.

Operator

And I'm showing no further questions from our phone lines. I'd now like to pass it back to Howard Robin for any closing remarks.

Howard W. Robin

Well, thank you, everyone, for joining us today. And it's not often that a company develops a new MOA that has the potential to greatly help patients in need. And I want to thank our employees for their diligence and commitment and also our shareholders for their continued support. So stay tuned, and thank you very much again. Good afternoon.

Operator

This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.