Nektar Therapeutics (NASDAQ: NKTR) shows 52-week Phase 2b alopecia efficacy and safety for rezpegaldesleukin
Rhea-AI Filing Summary
Nektar Therapeutics reported 52-week topline results from its Phase 2b REZOLVE-AA study of rezpegaldesleukin in severe-to-very-severe alopecia areata. In a 16-week blinded extension to week 52, 29% of patients on the 18 µg/kg dose and 31% on the 24 µg/kg dose achieved new SALT Score ≤20 responses, meaning at least 80% scalp hair coverage, versus none on placebo. For the overall study population at week 52, 25.8% on low dose and 27.6% on high dose reached SALT ≤20 compared with 6.7% on placebo, and 30.2% and 35.0% reached SALT ≤30 versus 8.4% on placebo. Clinically meaningful improvements (SALT50 and SALT30) were also higher with rezpegaldesleukin, and 94% of patients in the extension completed 52 weeks. Safety remained favorable, with nearly all adverse events mild to moderate, low discontinuation due to adverse events, and mainly transient injection site reactions. The company states that these data support advancing rezpegaldesleukin into late-stage development in alopecia areata.
Positive
- Phase 2b 52-week efficacy signal: At week 52, 25.8% (18 µg/kg) and 27.6% (24 µg/kg) of rezpegaldesleukin-treated patients achieved SALT Score ≤20 versus 6.7% on placebo, with additional responders emerging between weeks 36 and 52.
- Favorable chronic safety profile: Nearly all treatment-emergent adverse events were mild to moderate, 94% of extension patients completed 52 weeks, and discontinuation due to adverse events across all rezpegaldesleukin-exposed patients was reported at 1.4%.
- Progression toward late-stage development: The company states that the REZOLVE-AA results support advancement of rezpegaldesleukin into late-stage (registrational) development in alopecia areata, potentially opening a new biologic class in this indication.
Negative
- None.
Insights
Phase 2b data show meaningful hair regrowth and clean safety, backing late-stage plans.
The 52-week REZOLVE-AA results indicate rezpegaldesleukin delivers clinically relevant responses in severe-to-very-severe alopecia areata. At week 52, around a quarter to a third of treated patients reached SALT Score ≤20 or ≤30, versus single-digit rates on placebo, suggesting a real efficacy signal in a hard-to-treat population.
Durability and deepening of response are important: additional patients converted to SALT ≤20 between weeks 36 and 52, and SALT50/SALT30 rates roughly tripled versus placebo. The safety profile looks favorable for chronic use, with nearly all treatment-emergent adverse events mild to moderate, 94% completion in the extension, and a low overall discontinuation rate due to adverse events.
The company explicitly frames these data as supporting advancement into registrational trials and positions rezpegaldesleukin as a potential first-in-class T-regulatory cell biologic alternative to JAK inhibitors, which carry boxed warnings and relapse concerns. Future value will hinge on Phase 3 design, replication of efficacy at scale, and how regulators view the endpoints and safety over longer follow-up.
8-K Event Classification
Key Figures
Key Terms
Severity of Alopecia Tool (SALT) Score medical
treatment-emergent adverse events (TEAEs) medical
Fast Track designation regulatory
regulatory T cells medical
alopecia areata medical
Phase 2b regulatory
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| Item 7.01 | Regulation FD. |
On April 20, 2026, Nektar Therapeutics (the “Company”) issued a press release reporting 52-week topline results from the blinded 16-week treatment extension period of its REZOLVE-AA study of rezpegaldesleukin, a novel regulatory T-cell biologic, in patients with severe-to-very-severe alopecia areata (“AA”). A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
On April 20, 2026, the Company made available a presentation that includes certain additional information regarding its REZOLVE-AA study of rezpegaldesleukin. A copy of this presentation is furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K. This presentation is also available on the investor relations section of the Company’s website at https://ir.nektar.com/. Information contained on the Company’s website is not incorporated by reference into this Current Report on Form 8-K, and you should not consider any information on, or that can be accessed from, the Company’s website as part of this Current Report on Form 8-K.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibits 99.1 and 99.2.
| Item 8.01 | Other Events. |
Phase 2b REZOLVE-AA Results – Blinded 16-Week Treatment Extension Period
On April 20, 2026, the Company announced 52-week topline results from the blinded 16-week treatment extension period of its REZOLVE-AA study of rezpegaldesleukin.
REZOLVE-AA is a global study being conducted in 92 patients with severe-to-very-severe alopecia areata. During the initial 36-week induction phase, patients were randomized (3:3:2) to receive one of two rezpegaldesleukin doses or placebo, administered as twice-monthly subcutaneous injections. Mean baseline Severity of Alopecia Tool (SALT) Scores for patients enrolled in the study were 78.5 in the rezpegaldesleukin treatment arms as compared to 76.6 in placebo. Median time from onset of disease was 6.9 years in the treatment arms and 6.1 years in placebo. Following completion of the induction phase, patients with a SALT Score greater than 20 at week 36 who also demonstrated hair growth were eligible to continue on rezpegaldesleukin at their induction dose level in a blinded 16-week exploratory treatment extension through week 52.
A total of 31 patients continued into the blinded 16-week treatment extension period with 27 patients in the twice-monthly rezpegaldesleukin dose arms (low dose of 18 µg/kg, n=14) and (high dose of 24 µg/kg, n=13) and 4 patients continuing in the placebo arm.
From week 36 to week 52, 29% of patients at low dose and 31% of patients at high dose achieved new SALT Score ≤20 responses as compared to none in the placebo arm. A SALT Score ≤20 is achieved when a patient has 80% or more of their scalp covered by hair.
At week 52 for overall study population1, patients who achieved SALT Score ≤20 were 25.8% in low dose rezpegaldesleukin arm (versus 14.8% at week 36) and 27.6% in high dose rezpegaldesleukin arm (versus 15.6% at week 36) as compared to 6.7% with placebo (versus 6.7% at week 36) with a p-value of 0.049.2
At week 52 for overall study population1, patients who achieved SALT Score ≤30 were 30.2% in low dose rezpegaldesleukin arm (versus 21.9% at week 36) and 35.0% in high dose rezpegaldesleukin arm (versus 29.0% at week 36) as compared to 8.4% with placebo (versus 8.4% at week 36), with a p-value of 0.023.2 A SALT Score ≤30 is achieved when a patient has 70% or more of their scalp covered by hair.
At week 52 for overall study population1, patients who achieved SALT50 (showing at least a 50% improvement in SALT Score from baseline) were 37.7% in low dose rezpegaldesleukin arm and 38.8% in high dose rezpegaldesleukin arm as compared to 13.6% with placebo.1
At week 52 for overall study population1, patients who achieved SALT30 (showing at least a 30% improvement in SALT Score from baseline) were 45.6% in low dose rezpegaldesleukin arm and 47.6% in high dose rezpegaldesleukin arm as compared to 24.2% with placebo.1
The Company plans to submit the REZOLVE-AA results for presentation at a medical conference in 2026.
Consistent with prior studies, a favorable safety and tolerability profile was observed with longer twice-monthly dosing for 52 weeks. Nearly all treatment-emergent adverse events (TEAEs) were mild-to-moderate in severity which resolved without intervention. 94% of patients in the blinded 16-week treatment extension completed 52 weeks of treatment and there were no patients who discontinued during the extension because of a TEAE. The most common TEAEs were injection site reactions (ISR) with the majority being mild to moderate in nature (erythema) which self-resolved within 5 days. There were no patients in the study who discontinued treatment due to an injection site reaction (ISR).
| 1. | For 52-week analysis, data for week 0-36 in modified intent-to-treat (mITT) adapted population are imputed following primary estimand. The mITT adapted population excludes 4 patients with major study eligibility violations before week 36. These patients did not continue into the blinded 16-week treatment extension. Data for patients in non-treatment extension set in week 40, 44, 48 and 52 are carried forward from week 36 data. Missing data for patients in treatment extension set for week 40, 44, 48 and 52 are imputed using the multiple imputation method. Descriptive summary statistics (p-values) are exploratory analyses. |
| 2. | Primary estimand analysis was used at time of week 36 database lock in mITT adapted population. Patients who used prohibited medications for the treatment of AA or who discontinued treatment due to lack of efficacy were considered nonresponders (using baseline observation carry forward (BLOCF) for continuous endpoints, and nonresponder imputation for binary endpoints), regardless of observed clinical response. Data after patients who discontinued due to other reasons are set to missing and all missing data are imputed using the multiple imputation method. |
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, and timing relating to the Company’s rezpegaldesleukin program in alopecia areata, including statements regarding the safety and efficacy profile and therapeutic potential of rezpegaldesleukin, and plans and timing of future data releases. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this Current Report on Form 8-K are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: (i) the Company’s statements regarding the therapeutic potential of rezpegaldesleukin are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin is an investigational agent and continued research and development for this drug candidate is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin is in clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in the United States; and (vi) certain other risk factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recent Annual Report on Form 10-K, subsequent Quarterly Reports
on Form 10-Q and any other filings that the Company has made or may make with the U.S. Securities and Exchange Commission in the future. Such forward-looking statements are based on current expectations and projections about future events and are therefore subject to risks and uncertainties, which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations. Therefore, you should not rely on any of these forward-looking statements. The Company does not assume any obligation to update the forward-looking information contained in this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Press release issued by Nektar Therapeutics on April 20, 2026, furnished herewith | |
| 99.2 | Nektar Therapeutics Corporate Presentation, furnished herewith | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NEKTAR THERAPEUTICS | ||||||
| Date: April 20, 2026 | By: | /s/ Elizabeth Zhang | ||||
| Elizabeth Zhang | ||||||
| Vice President, Legal | ||||||
Exhibit 99.1
52-Week Topline Results from 16-Week Blinded Treatment Extension of REZOLVE-AA
Demonstrate Deepening of Responses in Severe-to-Very-Severe Alopecia Areata with
Rezpegaldesleukin
29% and 31% of patients in the 18 µg/kg and 24 µg/kg extension arms, respectively, achieved
new SALT Score ≤20 from week 36 to week 52 with continued twice-monthly treatment
Increasing proportions of patients achieved clinically meaningful hair growth thresholds across
numerous SALT measurements with 94% of patients completing treatment extension
Favorable safety profile with twice-monthly dosing maintained throughout 52 weeks, consistent
with previously reported results
Results support advancement of rezpegaldesleukin into late-stage development in alopecia areata
SAN FRANCISCO, Apr. 20, 2026—Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today announced new results from a blinded 16-week treatment extension period in its Phase 2b REZOLVE-AA study. The study is evaluating investigational rezpegaldesleukin, a first-in-class IL-2 pathway agonist and regulatory T-cell (Treg) biologic, in patients with severe-to-very-severe alopecia areata.
REZOLVE-AA is a global study being conducted in 92 patients with severe-to-very-severe alopecia areata. During the initial 36-week induction phase, patients were randomized (3:3:2) to receive one of two rezpegaldesleukin doses or placebo, administered as twice-monthly subcutaneous injections. Mean baseline Severity of Alopecia Tool (SALT) Scores for patients enrolled in the study were 78.5 in the rezpegaldesleukin treatment arms as compared to 76.6 in placebo. Median time from onset of disease was 6.9 years in the treatment arms and 6.1 years in placebo. Following completion of the induction phase, patients with a SALT Score greater than 20 at week 36 who also demonstrated hair growth were eligible to continue on rezpegaldesleukin at their induction dose level in a blinded 16-week exploratory treatment extension through week 52.
Extended Twice-Monthly Treatment with Rezpegaldesleukin Improved SALT Scores at 52 Weeks
A total of 31 patients continued into the blinded 16-week treatment extension period with 27 patients in the twice-monthly rezpegaldesleukin dose arms (low dose of 18 µg/kg, n=14) and (high dose of 24 µg/kg, n=13) and 4 patients continuing in the placebo arm.
From week 36 to week 52, 29% of patients at low dose and 31% of patients at high dose achieved new SALT Score ≤20 responses as compared to none in the placebo arm. A SALT Score ≤20 is achieved when a patient has 80% or more of their scalp covered by hair.
At week 52 for overall study population1, patients who achieved SALT Score ≤20 were 25.8% in low dose rezpegaldesleukin arm (versus 14.8% at week 362) and 27.6% in high dose rezpegaldesleukin arm (versus 15.6% at week 362) as compared to 6.7% with placebo (versus 6.7% at week 362) with a p-value of 0.049.3
“The new SALT≤20 responders in this set of patients treated out to 52 weeks reflect how the T regulatory cell mechanism of REZPEG can have more clinical benefit over time, a phenomenon the investigators observed in the Phase 2 study in atopic dermatitis as well,” said Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences. “Given the prescribing and safety limitations of JAK inhibitors, these new data point to the potential for rezpegaldesleukin to be the first safe and effective biologic in alopecia areata, which may completely transform the management of the disease.”
At week 52 for overall study population1, patients who achieved SALT Score ≤30 were 30.2% in low dose rezpegaldesleukin arm (versus 21.9% at week 362) and 35.0% in high dose rezpegaldesleukin arm (versus 29.0% at week 362) as compared to 8.4% with placebo (versus 8.4% at week 362), with a p-value of 0.023.3 A SALT Score ≤30 is achieved when a patient has 70% or more of their scalp covered by hair.
“These extension treatment data to 52 weeks demonstrate the potential of rezpegaldesleukin to deliver truly meaningful clinical outcomes for patients with severe-to-very-severe alopecia areata,” said David Rosmarin, MD, Chair of the Department of Dermatology and Associate Professor of Dermatology at the Indiana University School of Medicine. “We are in need of a new mechanism for a first-line systemic treatment option as an alternative to the class of agents currently approved for patients. The safety profile combined with a significantly higher number of patients achieving SALT Score ≤20 with continued treatment reinforce that this first-in-class Treg mechanism could emerge as the treatment of choice for patients with alopecia areata, including also those with moderate disease.”
At week 52 for overall study population1, patients who achieved SALT50 (showing at least a 50% improvement in SALT Score from baseline) were 37.7% in low dose rezpegaldesleukin arm and 38.8% in high dose rezpegaldesleukin arm as compared to 13.6% with placebo.1
At week 52 for overall study population1, patients who achieved SALT30 (showing at least a 30% improvement in SALT Score from baseline) were 45.6% in low dose rezpegaldesleukin arm and 47.6% in high dose rezpegaldesleukin arm as compared to 24.2% with placebo.1
“We are excited that rezpegaldesleukin has now demonstrated great promise in two large immune-mediated disease settings as we advance into registrational trials,” said Howard W. Robin, President and CEO of Nektar Therapeutics. “As a completely novel mechanism of action in immunology which leverages T regulatory cell biology, we’ve shown that rezpegaldesleukin could offer compelling efficacy and safety advantages for patients battling various auto-immune conditions.”
Nektar plans to submit the REZOLVE-AA results for presentation at a medical conference in 2026.
Rezpegaldesleukin Well Tolerated with Safety Profile Consistent with Previously Reported Results
Consistent with prior studies, a favorable safety and tolerability profile was observed with longer twice-monthly dosing for 52 weeks. Nearly all treatment-emergent adverse events (TEAEs) were mild-to-moderate in severity which resolved without intervention. 94% of patients in the blinded 16-week treatment extension completed 52 weeks of treatment and there were no patients who discontinued during the extension because of a TEAE. The most common TEAEs were injection site reactions (ISR) with the majority being mild to moderate in nature (erythema) which self-resolved within 5 days. There were no patients in the study who discontinued treatment due to an injection site reaction (ISR).
About REZOLVE-AA
The REZOLVE-AA (NCT06340360) study enrolled patients with severe-to-very-severe alopecia areata who have not previously been treated with a JAK inhibitor or other biologic. Patients were randomized across two different dose regimens of rezpegaldesleukin or placebo. The trial completed enrollment in February 2025, with patients enrolled across approximately 30 sites globally, with 64% of patients in Poland; 23% in Canada; and 13% in the United States.
About Rezpegaldesleukin
Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person’s body. A failure of the body’s self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. Rezpegaldesleukin is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It targets the interleukin-2 receptor complex in the body to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, rezpegaldesleukin may act to bring the immune system back into balance.
In February 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. In July 2025, the FDA granted Fast Track designation for rezpegaldesleukin for the treatment of severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kg.
Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases, including atopic dermatitis, alopecia areata and Type 1 diabetes. It is wholly owned by Nektar Therapeutics.
About Alopecia Areata
Alopecia areata is a disease where a patient’s own immune system attacks hair follicles resulting in hair loss.4 The lifetime incidence of alopecia areata is 2% in both men and women.4 Nearly 6.7 million people in the U.S. and 160 million worldwide develop alopecia areata in their lifetime. About 700,000 people in the U.S. currently have some form of alopecia areata.5 It is often associated with other auto-immune conditions as well as depression and anxiety.6 The disease has a tremendous impact on quality of life for patients.6 Available therapies for alopecia are not durable and have high relapse rates and there is an urgent unmet medical need for novel, more effective therapies for patients.
About Nektar Therapeutics
Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar’s lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in one Phase 2b clinical trial in atopic dermatitis, one Phase 2b clinical trial in alopecia areata, and one Phase 2 clinical trial in Type 1 diabetes mellitus. Nektar’s pipeline also includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422.
Nektar is headquartered in San Francisco, California. For further information, visit www.nektar.com and follow us on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: “can,” “develop,” “potential,” “expand,” “address,” “may,” “plan” and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the safety and efficacy profile and therapeutic potential of, and future development plans for, rezpegaldesleukin, NKTR-0165, NKTR-0166, and NKTR-422, and potential patient preferences and market adoption related thereto, and plans and timing of future data releases. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are in clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) data reported from ongoing clinical trials are necessarily interim data only and the final results will change based on continuing observations; (v) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (vi) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in the United States; (vii) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (viii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2026. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
For Investors:
Vivian Wu
628-895-0661
VWu@nektar.com
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com
For Media:
Susan Roberts
LifeSci Communications
202-779-0929
sroberts@lifescicomms.com
| 1. | For 52-week analysis, data for week 0-36 in modified intent-to-treat (mITT) adapted population are imputed following primary estimand. The mITT adapted population excludes 4 patients with major study eligibility violations before week 36. These patients did not continue into the blinded 16-week treatment extension. Data for patients in non-treatment extension set in week 40, 44, 48 and 52 are carried forward from week 36 data. Missing data for patients in treatment extension set for week 40, 44, 48 and 52 are imputed using the multiple imputation method. Descriptive summary statistics (p-values) are exploratory analyses. |
| 2. | Rosmarin et al. (2026, March 27-31). Novel Regulatory T-cell enhancing Biologic Rezpegaldesleukin: Phase 2b Efficacy, Safety, and Baseline Severity-Dependent Treatment Response in Moderate-to-Severe Atopic Dermatitis. 2026 American Academy of Dermatology (AAD), Denver, Colorado |
| 3. | Primary estimand analysis was used at time of week 36 database lock in mITT adapted population. Patients who used prohibited medications for the treatment of AA or who discontinued treatment due to lack of efficacy were considered nonresponders (using baseline observation carry forward (BLOCF) for continuous endpoints, and nonresponder imputation for binary endpoints), regardless of observed clinical response. Data after patients who discontinued due to other reasons are set to missing and all missing data are imputed using the multiple imputation method. |
| 4. | Lintzeri, D.A., Constantinou, A., Hillmann, K., Ghoreschi, K., Vogt, A. and Blume- Peytavi, U. (2022), Alopecia areata – Current understanding and management. JDDG: Journal der Deutschen Dermatologischen Gesellschaft, 20: 59-90. https://doi.org/10.1111/ddg.14689 |
| 5. | National Alopecia Areata Foundation |
| 6. | Alhanshali L, Buontempo MG, Lo Sicco KI, Shapiro J. Alopecia Areata: Burden of Disease, Approach to Treatment, and Current Unmet Needs. Clin Cosmet Investig Dermatol. 2023;16:803-820 https://doi.org/10.2147/CCID.S376096 |
Exhibit 99.2 Phase 2b REZOLVE-AA 52-Week Topline Results: 16-Week Extension Treatment Period Rezpegaldesleukin in Patients with Severe-to-Very-Severe Alopecia Areata April 20, 2026
Forward-Looking Statements Safe Harbor Statement This presentation and any accompanying oral discussion contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Nektar Therapeutics (the “Company” or “Nektar”)’s plans, progress, and timing relating to the Company’s rezpegaldesleukin programs in alopecia areata, atopic dermatitis and T1 diabetes, timing for the 52-week off drug durability data from the Phase 2b REZOLVE-AD (atopic dermatitis) trial and the presentation of data, timing for the 24-week off drug durability data from the Phase 2b REZOLVE-AA (alopecia areata) and the presentation of data, rezpegaldesleukin’s potential to be a first-in-class T regulatory cell therapy, the potential market opportunity in alopecia areata, atopic dermatitis and T1 diabetes and high unmet need for a new mechanism of action, the Company’s current and future research and development plans or expectations, the structure, timing and success of the Company’s planned clinical trials, the potential benefits of any of the Company’s current or future product candidates in treating patients, and the Company’s goals and strategy. Nektar intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this presentation are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: risks related to the success, cost, and timing of the Company’s development activities and clinical trials, risks related to the Company’s dependence on the success of rezpegaldesleukin, the outcomes of competitive immunotherapy clinical trials, significant competition for the Company’s product candidates, the risk that preliminary and interim data from the Company’s clinical studies are subject to audit and verification procedures that could result in material changes in the final data and may change as more patient data become available, risks related to delays in clinical trials, risks related to dependence on third parties to conduct clinical trials, risks regarding future capital requirements, risks related to dependence on the Company’s collaboration agreements, risks related to the Company’s reliance on contract manufacturers and suppliers, risks related to obtaining regulatory approval for the Company’s drug candidates, risks related to the Company’s ability to protect and maintain its intellectual property position, risks related to legal proceedings and related litigation costs and liabilities and other risk factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Nektar’s most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and any other filings that Nektar has made or may make with the U.S. Securities and Exchange Commission in the future. Any forward-looking statements contained in this presentation represent Nektar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Nektar explicitly disclaims any obligation to update any forward-looking statements. Certain information contained in this presentation may be derived from information provided by industry sources. The Company believes such information is accurate and that the sources from which it has been obtained are reliable. However, the Company cannot guarantee the accuracy of, and has not independently verified, such information. 2
Rezpegaldesleukin (REZPEG) Phase 2 Program Spans Immune-Mediated Diseases to Evaluate the Causal Biology of Tregs Atopic Dermatitis (REZOLVE-AD) Alopecia Areata (REZOLVE-AA) Type 1 Diabetes (T1D) Metabolic Disease Inflammatory Skin Disease Inflammatory Skin Disease • Achieved TPP with data indicating • Achieved TPP with data indicating • Ongoing phase 2 placebo-controlled strong clinical efficacy and safety clinical efficacy similar to low-dose clinical trial in patients with new onset profile with differentiation to IL-13, IL- Olumiant® (JAK inhibitor) and a Stage 3 T1D 1,2 31, JAKi and OX-40 MoAs superior differentiated safety profile • Sponsored and funded by TrialNet • Only biologic in development to • First biologic to demonstrate clear (NIH/NIDDK) Type 1 Diabetes demonstrate positive efficacy data in proof-of concept in severe-to-very- Consortium 3 comorbid asthma severe AA • Initial data expected in 2027 4 5 4 G7 Market Size ($B) G7 Market Size ($B) G7 Market Size ($B) $34.1 $5.9 $5.2 1 in 4 patients $3.6 $17.9 with AtD have comorbid asthma $0.2 2025 2032 (E) 2025 2033 (E) 2025 2032 (E) Sources: 1. Silverberg J, et al. Nature Communications (2025); 2. Silverberg J, et al. EADV (2025); 3. Corren J, et al. ACAAI (2025); 4. Evaluate Pharma WW Market Size Estimates; 5. Decision Resources Group TPP: Target Product Profile; (E): Estimate; Olumiant® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. 3
Opportunity for REZPEG in Alopecia Areata (AA) 2 Actual and Projected Sales of JAK inhibitors in AA • ~160 million people worldwide are affected by alopecia areata (WW Sales in USD, 2023 – 2033) (AA), including those who currently have it, have had it, or are 1 expected to develop it $5.2 B Patients with AA and their • In the US, ~6.7 million people will have AA at some point in their Physicians are Seeking lifetime, with ~700,000 individuals currently living with the Alternative First-Line 1 condition Treatment Options 1 • Notably, 80% of patients show signs of AA before 40 • Many patients are refractory to available therapies, and long- term use is associated with troublesome side effects and safety 2 risks $171 M • Currently, the only approved systemic treatments for AA are JAK 2023 2033 (E) inhibitors, which carry multiple boxed warnings and are also Rinvoq Olumiant Litfulo Leqselvi associated with high relapse rates upon discontinuation Sources: 1. National Alopecia Areata Foundation; 2. DRG – Unmet Needs of Alopecia Areata (accessed: 4.9.2026) WW: worldwide; (E): Estimate; RINVOQ® (upadacitinib) is a registered trademark of AbbVie Biotechnology Ltd; Olumiant® (baricitinib) is a registered trademark (Registration #5745831) owned by Eli Lilly and Company; LITFULO® (ritlecitinib) is a registered trademark owned by Pfizer Inc.; Leqselvi (deuruxolitinib) is a registered trademark of Pharmaceutical Industries, Inc. 4
Collapse of Immune Privilege in Alopecia Areata Alopecia Areata is a Disease that Occurs When the Immune System Attacks Hair Follicles Causing Hair Loss Healthy Alopecia Areata Intact immune privilege Collapse of immune privilege Source: Adapted from Paus et al., Journal of Investigative Dermatology 2003 5
Majority of Physicians Report They Would Try Patients on Alternate Therapies for AA Before Prescribing JAK inhibitors 54% of physicians report they would try patients on alternate Challenges with JAKi Class therapies for AA before 1 § Boxed warnings for serious infections, mortality, malignancy, prescribing JAKi major adverse cardiovascular events (MACE), and thrombosis § Class-related risks such as cytopenias, hepatic enzyme elevations, and lipid changes require routine safety monitoring § Extensive testing required prior to initiating therapy and while on 46% therapy to monitor TB, CBC, LFTs, and lipids 54% § 80% of patients who go off low-dose Olumiant eventually 2 rebound (90% SALT Score ≤20 responders rebound) Source: 1. Adapted from Nohria et al., Journal of the American Academy of Dermatology 2024; 2. King et al., JAMA Dermatol. 2024 6
Unmet Need for Patients with Alopecia Areata AAD 2026: Baricitinib Real World Claims Data “Poor persistence observed among patients treated with baricitinib suggest there is an unmet need for effective 1 treatment for patients with AA” Source: 1. Mostaghimi et al., AAD 2025 7
An Efficacious and Safe Biologic with Novel MoA Could Redefine First- line Systemic Therapy in Alopecia Areata We believe there is a strong need for a non-JAKi based Sub-Q biologic to treat patients with AA, which could provide: § Better suitability for chronic use: Circumvents JAKi class safety issues, including boxed warnings, that limit JAKi use in AA § Easier adherence: Infrequent twice-monthly dosing of a biologic may be advantageous over oral daily dosing for long-term treatment § Extended biologic pharmacodynamic effect: Opportunity for more durable and stable efficacy even in the setting of non-compliance § No need for lab monitoring: Simplifies prescribing in dermatology clinics, which are not optimized for chronic lab management § Payer-friendly profile: Fewer restrictions and risk-based exclusions; more straightforward access and broader eligibility 8
Phase 2b REZOLVE-AA Study Evaluating REZPEG for Alopecia Areata Severe-to-Very-Severe Alopecia Areata (NCT06340360) - Granted Fast Track Designation in July 2025 Exploratory Treatment Extension Key Eligibility Criteria Induction Q2W (Weeks 0-36) Week 36 Analyses and Follow-up Primary: • Adult patients (18+) Blinded 16-week • Mean % SALT reduction at • Severe-to-very-severe AA treatment extension: Week 36 • SALT ≥50 REZPEG 24 µg/kg Patients with a SALT • >6 months since Score greater than 20 n=35 Key Secondaries: diagnosis to exclude at Week 36 who also • SALT ≥ 30% reduction from unstable AA demonstrated hair 3:3:2 REZPEG 18 µg/kg baseline (SALT ) 30 • No spontaneous growth N=92 n=37 • Absolute SALT Score ≤30 improvement over the past 6 months • Absolute SALT Score ≤20 • 8-week washout of prior • Absolute SALT Score ≤10 Placebo medication for AA • Clinician-Reported Outcome n=20 24-week follow-up (ClinRO) Eyebrow and period after 36 or 52 Eyelash (exploratory) Stratification by baseline weeks of treatment SALT Score ≥50 to <95 vs ≥95 • Safety to 100 Severity of Alopecia Tool (SALT) is a validated endpoint to assess the extent of scalp‐ hair loss in patients with alopecia areata 9
Goals of 16-week Treatment Extension in REZOLVE-AA § Assess if additional dosing beyond 36 weeks enables more patients to achieve SALT Score ≤20 § SALT Score ≤20 is the registrational endpoint for Phase 3 in alopecia areata § REZOLVE-AA allowed 31 patients with a SALT Score >20 at week 36 to continue treatment for an additional 16 weeks (if they demonstrated hair growth)* § Allow for evaluation of safety for twice-monthly dosing over 52 weeks § Establish whether a 36-week or 52-week treatment induction should be used for Phase 3 *Patients who achieved SALT Score ≤20 at week 36 were not eligible to enter treatment extension; one placebo patient with a SALT Score ≤20 at week 36 entered into extension based on investigator’s request, which was granted as an exception 10
Blinded 16-Week Exploratory Treatment Extension for REZOLVE-AA A Total of 31 Patients Entered into Treatment Extension Extension Q2W (Weeks 36-52) 52-Week Exploratory Endpoints Patient with a SALT Score greater than 20 • New SALT Score ≤20 Responders Weeks at Week 36 who also demonstrated hair growth 36-52 Patients continued at same dose from induction (80% or more hair coverage on scalp) Blinded 16-week treatment extension: REZPEG 24 µg/kg • Overall SALT Score ≤20 at Week 52* Patients with a n=13 SALT Score greater • Overall SALT Score ≤30 at Week 52* than 20 at Week 36 (70% or more hair coverage on scalp) 3:3:2 who also demonstrated REZPEG 18 µg/kg N=92 • SALT Score SALT at Week 52* hair growth n=14 30 (30% improvement from baseline SALT) n=31 • Overall SALT at Week 52* Placebo 50 (50% improvement from baseline SALT) n=4 A *Modified intent-to-treat adapted (mITT ): excludes 4 patients with major study eligibility violations (post-hoc); No patient with study eligibility violations entered into the 16-week treatment extension 11
REZPEG-Treated Patients in Extension Achieved Deepening of Response Best Percent Improvement in SALT Score from Baseline While on Study Treatment 94% of patients in extension completed treatment to week 52 Extension Patients Extension Patients 36-week Induction (N=31) 52-week Treatment (N=31) * * REZPEG (N=27) Placebo (N=4) REZPEG (N=27) Placebo (N=4) 4% (1/27) achieved ≥75% reduction from baseline SALT 26% (7/27) achieved ≥75% reduction from baseline SALT *Discontinued prior to week 52 due to patient decision; one placebo patient with a SALT Score ≤20 at week 36 entered into extension based on investigator’s request, which was granted as an exception 12
Conversions to SALT Score ≤20 with Additional 16 Weeks of Treatment A Total of 31 Patients Entered into Treatment Extension New SALT Score ≤20 Responders at Week 52 in Patients Who Enter Treatment Extension § There were 8 new SALT Score 40 ≤20 responses in 27 patients 31% 29% treated with REZPEG 30 § There were no new SALT Score 20 ≤20 responses in placebo 10 § Data strongly support a 52-week dosing induction in Phase 3 0% 0 REZPEG REZPEG Placebo 18 µg/kg arm 24 µg/kg arm n=4 n=14 n=13 Analysis by multiple imputation (slide 31); two patients discontinued prior to week 52 due to patient decision 13 Responders (%)
More Patients Treated with REZPEG Achieved SALT Score ≤20 at Week 52 Overall SALT Score ≤20 (80% or more hair coverage on scalp) A Data for mITT analysis set are imputed from week 0 to week 36 following primary estimand. Data for patients in non-treatment extension set in week 40, 44, 48 and 52 are carried forward from week 36 data. Missing data for patients in treatment extension set for week 40, 44, 48 and 52 are imputed using the multiple imputation method. 14
REZPEG Met Our Target Product Profile Olumiant® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.**Placebo data based on Figure S9 from King et al., NEJM 2022 15 This is a cross-trial comparison and includes data from different clinical studies and is not a head-to-head comparison.
More Patients Treated with REZPEG Achieved SALT Score ≤30 at Week 52 SALT Score ≤30 (70% or more hair coverage on scalp) REZPEG 24 µg/kg, Q2W (N=33) REZPEG 18 µg/kg, Q2W (N=36) Placebo (N=19) A Data for mITT analysis set are imputed from week 0 to week 36 following primary estimand. Data for patients in non-treatment extension set in week 40, 44, 48 and 52 are carried forward from week 36 data. Missing data for patients in treatment extension set for week 40, 44, 48 and 52 are imputed using the multiple imputation method. 16
Promising Data for a Biologic in AA SALT (At Least 30 Percent Improvement from Baseline in SALT) 30 Single site Phase 2 IST study Adapted from Guttman et al., Allergy 2022 17 This is a cross-trial comparison and includes data from different clinical studies and is not a head-to-head comparison.
Promising Data for a Biologic in AA SALT (At Least 50 Percent Improvement from Baseline in SALT) 50 Single site Phase 2 IST study Adapted from Guttman et al., Allergy 2022 18 This is a cross-trial comparison and includes data from different clinical studies and is not a head-to-head comparison.
REZOLVE-AA: Safety Profile in Alopecia Areata at 52 Weeks Consistent With Previously Reported Studies q No new safety findings observed with longer Q2W dosing out to 52 weeks q Nearly all AEs were mild to moderate in severity and self-resolved q No patients discontinued during 16-week extension due to an adverse event § Discontinuation rate due to AEs over 52 weeks of treatment was low (1.4%) for all REZPEG-exposed patients q No patients discontinued treatment due to an ISR over 52 weeks of treatment § Lower frequency of ISRs observed over longer dosing duration in extension § Majority of ISRs were mild to moderate (erythema) and self-resolved within 5 days q No observed increased risk or safety signal for: oral herpes, conjunctivitis, facial swelling or erythema, oral (aphthous) ulcers, myocardial infarction, pulmonary embolus, deep venous thrombosis and malignancy q No AEs observed that could require JAKi-like laboratory testing and monitoring 19
Case Study #1: Patient Achieved SALT Score ≤20 by Week 44 Baseline § 40-year-old white male § Diagnosis 8 months prior to treatment § 52 weeks of 24 µg/kg REZPEG treatment Week 36 SALT Score through study treatment Week 52 20
Case Study #2: Patient Achieved SALT Score ≤20 by Week 48 § 20-year-old white female § Diagnosed 6 years prior to treatment § 52 weeks of 24 µg/kg REZPEG treatment SALT Score through study treatment 21
Case Study #3: Patient Achieved SALT Score ≤20 by Week 52 § 64-year-old white female § Diagnosed 13 years prior to treatment § 52 weeks of 24 µg/kg REZPEG treatment SALT Score through study treatment 22
Case Study #4: Patient Achieved SALT Score ≤20 by Week 48 § 50-year-old white female § Diagnosed 2.1 years prior to treatment § 52 weeks of 18 µg/kg REZPEG treatment SALT Score through study treatment 23
Case Study #5: Patient Achieved SALT Score ≤20 by Week 44 § 64-year-old white female § Diagnosed 10 months prior to treatment § 52 weeks of 18 µg/kg REZPEG treatment SALT Score through study treatment 24
Key Questions Answered With Clinical Study Design Elements of the Phase 2b REZOLVE-AA Program Key Questions Findings • Sub-Q Q2W dosing of REZPEG demonstrates clear and consistent separation from placebo Phase 2 Can a Treg biologic drug with infrequent dosing on all measures of efficacy offer meaningful clinical benefit and a robust • Safety profile consistent with prior studies and REZOLVE-AA safety profile compared to available therapies? highly differentiated from previously reported data on JAKi Study • Most profound increase in hair regrowth begins after week 16 and continues beyond What are the kinetics of hair regrowth with a the 36-week induction Treg mechanism at 36 weeks? At 52 weeks? • Phase 3 induction endpoint planned to be at 52 weeks Represents first study to evaluate whether REZPEG What is the optimal dose for Phase 3? • Phase 3 dose established at 24 µg/kg Q2W has favorable clinical activity and safety profile in Should a 52-week induction be used in Phase 3 patients with severe-to-very- • Data support 52-week induction for Phase 3 in order to achieve the SALT Score ≤20 severe AA SALT Score ≤20 registrational endpoint registrational endpoint? 25
Anticipated Next Steps in Alopecia Areata and for REZPEG • Conduct End of Phase 2 meeting with FDA in Q2 2026 to align on Phase 3 registrational strategy Alopecia Areata • Additional data readout from REZOLVE-AA Study: 24-week off treatment data in Q4 2026 • Initiation of ZENITH-AD Phase 3 program in patients with moderate-to-severe atopic dermatitis in June/July 2026 Atopic Dermatitis • Additional data readout from REZOLVE-AD Study: 52-week off treatment data in Q1 2027 Type 1 Diabetes • Initial data in Type 1 diabetes in 2027 • Initiation of proof-of-concept study for a potential new indication for REZPEG in 2H Other Indications 2026 26
Expanding Potential Opportunities for REZPEG (Treg MOA Activity) • Food Allergy • Vitiligo Th2-Driven • Asthma (Allergic and Non- • Dermatomyositis Skin and Other Diseases allergic) • Ischemic Heart Disease • Allergic Rhinitis • Transplant Rejection • Chronic Rhinosinusitis • Inflammatory Bowel Disease (Maintenance of Remission) • Systemic Lupus • Type 1 Diabetes Erythematosus/Cutaneous • Autoimmune Hepatitis Rheumatology Lupus Erythematosus • Vasculitis Auto-Immune Diseases • Sjogren’s Syndrome • Chronic and Acute Graft vs. • Rheumatoid Arthritis Host Disease (Maintenance of • Scleroderma Remission) • Idiopathic Thrombocytopenia • Multiple Sclerosis • Amyotrophic Lateral Sclerosis 27
Ongoing Phase 2 Study Sponsored and Funded by TrialNet (NIH/NIDDK) Type 1 Diabetes Consortium About the Study: Commercial Opportunity for Type 1 • Ongoing phase 2 placebo-controlled clinical trial in approximately 66 Diabetes adults and children with new onset stage 3 T1D • Evaluating REZPEG’s Treg MoA for preservation of beta cell function in 1 G7 Market Size ($B) Stage 3 New Onset T1D $5.9 B • Initial data expected in 2027 $3.6 B Scientific Rationale • In T1D, the destruction of insulin-producing pancreatic beta cells is caused by T cells of the immune system • Regulatory T cells (Tregs) act upstream of these T cell and pro- inflammatory cytokines to reduce their activity; by increasing the number and functionality of regulatory T cells, this investigational 2025 2032 (E) therapy aims to slow the progression of new onset T1D. Sources: 1. Evaluate Pharma WW Market Size Estimates (E): Estimate 28
Opportunity in Cutaneous Lupus Erythematosus REZPEG Demonstrated a Dose-Dependent Reduction in CLASI-A Score in Patients with Lupus Patients with Systemic Lupus Erythematosus and Cutaneous Involvement Mean Change in CLASI-A Score from Phase 1 Study Patients with a CLASI-A score of ≥4 at baseline (N=22) 1.0 0.25 -0.25 Placebo 0.0 (n=4) -1.40 -1.0 REZPEG 3 μg/kg -1.80 (n=5) -1.60 -2.0 -2.00 REZPEG 6 μg/kg (n=5) -3.0 -2.75 REZPEG 12 μg/kg -3.50 -4.0 (n=4) -4.00 REZPEG 24 μg/kg -5.0 -5.00 (n=4) -6.0 0 28 43 Days Dose Administration Source: 1. Fanton et al., Journal of Translational Autoimmunity 2022 CLASI-A, cutaneous lupus erythematosus disease area and severity index–activity; SLE: systemic lupus erythematosus 29 Change from baseline in CLASI-A score (mean)
Jonathan Silverberg, MD, PhD, MPH Professor of Dermatology at The George Washington University School of Medicine and Health Sciences Director of Clinical Research and Contact Dermatitis Dr. Silverberg is the Director of Clinical Research and Contact Dermatitis. Dr. Silverberg's area of clinical subspecialty is inflammatory skin disease. Dr. Silverberg has also been a local, national and/or international principal investigator for numerous clinical trials for novel treatments in inflammatory skin disorders. Dr. Silverberg's research interests include drug development, clinical trial design, biomarkers, dermato-epidemiology, health services research, patient-reported outcomes, comorbidities and burden of inflammatory skin disease and evidence-based dermatology. His publications include more than 1,000 peer-reviewed articles, abstracts and book chapters. He is an associate editor for the Journal of the American Academy of Dermatology, British Journal of Dermatology and Current Dermatology Reports. David Rosmarin, MD Chair of the Department of Dermatology at Indiana University School of Medicine Kampen-Norins Scholar in Dermatology Dr. Rosmarin is nationally recognized and serves as a referral for physicians with difficult to manage inflammatory diseases such as alopecia areata. Previously, Dr. Rosmarin served as the Director of the Clinical Trials Unit in the Department of Dermatology at Tufts Medical Center. His research interests focus on development of novel therapeutics and investigating novel uses of established therapies, with a particular focus on chronic skin diseases such as alopecia areata, atopic dermatitis, vitiligo, discoid lupus, and hidradenitis suppurativa. Dr. Rosmarin went to medical school at NYU, dermatology residency at Boston University-Tufts combined training program, and fellowship at Brigham and Women’s Hospital. Benjamin N. Ungar MD Assistant Professor, Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai Director of the Alopecia Center of Excellence and as Director of the Rosacea & Seborrheic Dermatitis Clinic Dr. Ungar's clinical and research focus specialization is in inflammatory skin diseases, as well as how the immunology of the skin relates to the systemic components of the diseases he studies. His research is centered on atopic dermatitis and alopecia areata, as well as diseases such as seborrheic dermatitis. Dr. Ungar has authored or coauthored more than 75 original articles and more than 45 abstracts. He has led various talks on alopecia areata both in the United States and abroad. Dr. Ungar received his medical degree from the Icahn School of Medicine at Mount Sinai. He completed his internship at NYU Winthrop Hospital in Mineola, New York, followed by a residency in dermatology at the Icahn School of Medicine at Mount Sinai, from which he graduated as the chief resident. KOL Panel
Appendix (Data tables, additional materials) 31
REZOLVE-AA: Week 52 Data Readout - Statistical Methods Exploratory Analyses Including Data During Treatment Extension Period • Week 0 up to Week 36 for mITT patients: Follow Primary Estimand Analysis used at time of Week 36 DBL • mITT patients who used prohibited medications for the treatment of AA or who discontinued treatment due to lack of efficacy were considered NONRESPONDERS (using baseline observation carry forward (BLOCF) for continuous endpoints, and nonresponder imputation for binary endpoints), regardless of observed clinical response • Data after patients who discontinued due to other reasons are set to missing and all missing data are imputed using the multiple imputation method. • Week 40 to Week 52 for non-treatment extension patients: Carry forward imputed data from Week 36 to Week 40, 44, 48, and 52 • Week 40 to Week 52 for treatment extension patients: Data after patients who discontinued due to other reasons are set to missing and all missing data are imputed using the multiple imputation method. • Only two patients discontinued before week 52 in treatment extension. (one on 18 µg/kg Q2W and one on 24 µg/kg Q2W) Statistical Analysis Methods • Descriptive summary statistics including p-values are all exploratory in nature 32
Patient Disposition in REZOLVE-AA REZPEG REZPEG REZPEG Placebo 18 µg/kg Q2W 24 µg/kg Q2W Total N = 37 N = 35 N = 72 N=20 Completed Study Treatment at W36 24 (64.9%) 21 (60.0%) 45 (62.5%) 11 (55.0%) Entered the treatment extension period 14 (37.8%) 13 (37.1%) 27 (37.5%) 4 (20.0%) Completed Treatment at W52 13 (92.9%) 12 (92.3%) 25 (92.6%) 4 (100.0%) Discontinue treatment before W52 1 (7.1%) 1 (7.7%) 2 (7.4%) 0 1 Withdrawal by Subject/Patient Decision 1 (7.1%) 1 (7.7%) 2 (7.4%) 0 Discontinued Treatment before W36 Discontinued during weeks 0 – 16 7 (18.9%) 8 (22.9%) 15 (20.8%) 5 (25.0%) Discontinued during weeks 16 - 36 6 (16.2%) 6 (17.1%) 12 (16.7%) 4 (20.0%) Reasons for Discontinuations before W36 Withdrawal by Subject/Patient Decision 10 (27.0%) 10 (28.6%) 20 (27.8%) 7 (35.0%) 2 New pregnancy during treatment 0 1 (2.9%) 1 (1.4%) 0 Eosinophilia 0 1 (2.9%) 1 (1.4%) 0 Worsening of AA 0 0 0 1 (5.0%) Lost to Follow-up 2 (5.4%) 1 (2.9%) 3 (4.2%) 0 Lack of Efficacy to Study Treatment 0 1 (2.9%) 1 (1.4%) 1 (5.0%) Other 1 (2.7%) 0 1 (1.4%) 0 1. Two patients discontinued prior to week 52 without a SALT Score ≤20 response (one from each dose arm) 2. Patient discontinued treatment and had a delivery of a healthy infant. 33
Safety Analysis Set - Overall Period: ≥ 10% REZPEG Total or Placebo Arm Summary of Treatment Emergent Adverse Events (TEAEs) System Organ Class REZPEG 18 µg/kg Q2W REZPEG 24 µg/kg Q2W REZPEG Total Placebo Preferred Term N = 37 N = 35 N = 72 N=20 1 Patients With at Least One TEAE 35 (94.6%) 35 (100.0%) 70 (97.2%) 15 (75.0%) General disorders and administration site conditions 35 (94.6%) 32 (91.4%) 67 (93.1%) 7 (35.0%) Injection site reaction 34 (91.9%) 32 (91.4%) 66 (91.7%) 6 (30.0%) Infections and infestations 18 (48.6%) 17 (48.6%) 35 (48.6%) 9 (45.0%) Upper respiratory tract infection 6 (16.2%) 5 (14.3%) 11 (15.3%) 1 (5.0%) Nasopharyngitis 5 (13.5%) 6 (17.1%) 11 (15.3%) 2 (10.0%) Oral herpes 2 (5.4%) 3 (8.6%) 5 (6.9%) 2 (10.0%) Urinary tract infection 2 (5.4%) 3 (8.6%) 5 (6.9%) 2 (10.0%) Musculoskeletal and connective tissue disorders 10 (27.0%) 10 (28.6%) 20 (27.8%) 5 (25.0%) Arthralgia 4 (10.8%) 6 (17.1%) 10 (13.9%) 2 (10.0%) Nervous system disorders 7 (18.9%) 9 (25.7%) 16 (22.2%) 3 (15.0%) Headache 4 (10.8%) 6 (17.1%) 10 (13.9%) 3 (15.0%) Blood and lymphatic system disorders 6 (16.2%) 10 (28.6%) 16 (22.2%) 1 (5.0%) Eosinophilia 0 5 (14.3%) 5 (6.9%) 0 Gastrointestinal disorders 6 (16.2%) 10 (28.6%) 16 (22.2%) 3 (15.0%) Gastroesophageal reflux disease 0 0 0 2 (10.0%) Skin and subcutaneous tissue disorders 6 (16.2%) 9 (25.7%) 15 (20.8%) 6 (30.0%) Alopecia 0 1 (2.9%) 1 (1.4%) 2 (10.0%) Respiratory, thoracic and mediastinal disorders 4 (10.8%) 8 (22.9%) 12 (16.7%) 2 (10.0%) Investigations 3 (8.1%) 7 (20.0%) 10 (13.9%) 2 (10.0%) 1 Injury (all deemed unrelated) 3 (8.1%) 5 (14.3%) 8 (11.1%) 0 Eye disorders 3 (8.1%) 2 (5.7%) 5 (6.9%) 2 (10.0%) 1. One patient in the 18 µg/kg had a serious AE of a gun shot wound and continued in the study. One patient in the 24 µg/kg had a severe ISR and continued treatment. One patient in the 24 µg/kg in the treatment extension had a serious AE of craniofacial fracture, and continued in the study. 34
Lower Frequency of ISRs Observed Over Longer Dosing Duration in Extension 96.9% 100 80 55.8% 60 48.8% Induction Period 43.3% 39.1% 40 20 7.9% 4.9% 2.7% 0.3% 0.2% 0.0% 0.0% 0 Placebo Rezpeg 24 ug/kg Q2W Rezpeg 18 ug/kg Q2W (N=293) (N=489) (N=541) No ISR Mild Moderate Severe 100% 100 81.1% 80 60.6% 60 36.5% Extension Period 40 16.7% 20 2.9% 2.2% 0% 0% 0% 0% 0% 0 Placebo Rezpeg 24 ug/kg Q2W Rezpeg 18 ug/kg Q2W (N=31) (N=90) (N=104) N= number of REZPEG administrations in REZPEG arms and number of placebo administrations in placebo arms Mild: Faint erythema, asymptomatic, no or mild itch, no or mild tenderness Moderate: Notable/great erythema, widespread itch, readily apparent induration, moderate pain Severe: Widespread and constant itch limiting daily life, gross deviation of normal anatomic contour for induration, severe pain 35 % of ISRs in each arm across % of ISRs in each arm across all dose administrations all dose administrations
REZPEG mITT Population Achieved High SALT Score ≤20 at Week 52 Data for mITT Analysis Set are imputed from Week 0 to Week 36 following Primary Estimand. Data for patients in non-Treatment Extension Set in Week 40, 44, 48 and 52 are carried forward from Week 36 data. Missing data for patients in Treatment Extension Set for Week 40, 44, 48 and 52 are imputed using Multiple Imputation. 36