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| Statement |
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| Importantly, we are encouraged by the extended durability seen from REZPEG |
| And so, we’re very, very happy the case is moving forward |
| So, it’s actually a very favorable environment to enroll patients |
| Through its unique mechanism, REZPEG also has the potential to provide patients with superior efficacy as well as more favorable infrequent dosing |
| So the promise of an age of durability and restore immune privilege is definitely really encouraging and exciting to this, that they’re speaking to |
| So we’re doing very well |
| Based on the data we generated to date on REZPEG in the skin-related autoimmune condition of atopic dermatitis, psoriasis, and in patients with cutaneous manifestations of lupus, we believe REZPEG has strong scientific rationale in this setting of alopecia and could have the potential to be a highly differentiated treatment option with a similar remittive effect for this unserved patient population |
| Looking forward to 2024 and beyond, our financial position remains strong, in part reflecting the cost savings initiatives we undertook last year |
| As Howard stated earlier, today’s announcement of a $30 million financing further strengthens our cash position |
| The LEAD antibody is called NKTR-0165 and it has highly desirable properties including exquisite TNFR2 cell activity, TNFR2 agonism in primary human cells, activity in multiple preclinical efficacy models, and a very well-tolerated profile in early non-GLP toxicology studies |
| Moving to alopecia areata, we believe REZPEG has strong scientific rationale this indication |
| This puts us in a strong financial position and extends our cash runway from our previous guidance, which was the middle of 2026, to now well into the third quarter of 2027 |
| These promising data have us and KOL’s very enthusiastic about the potentials for long-lasting responses and infrequent maintenance dosing with REZPEG in the setting of atopic dermatitis |
| It has demonstrated a well-tolerated safety profile and clear clinical efficacy in atopic dermatitis and also psoriasis and in patients with cutaneous manifestations of lupus |
| This is a very exciting result and suggests that REZPEG has the potential to be the first remitted therapy for atopic dermatitis |
| This is all very, very attractive for recruiting patients to the study |
| These will be highly meaningful data catalysts for Nektar |
| The doctors really do see that, one, REZPEG has a very rapid onset of action; number two, the depth of response that we’ve seen with being percent changed and EASI after only 12 weeks of treatment, when most studies look at an induction period of 16 weeks, the doctors have been very impressed with that |
| We ended the year in a very strong financial position with $329.4 million in cash and investments and with no debt on our balance sheet |
| And consequently, a bona fide TNFR2 agonist would be an incredibly exciting addition to our pipeline |
| Additionally, REZPEG was well-tolerated and treatment with REZPEG did not induce anti-drug antibodies in patients, which has been reported with some examples of the IL-2 mutein class |
| In line with our objectives to advance our immunology pipeline, today we announced a $30 million financing that further bolsters Nektar’s financial position as we head into transformative data catalysts |
| And then certainly for the benefit of their patients, they really love the durability that we saw when patients were off treatment for 9 consecutive months and they were able to maintain that very deep response in EASI |
| Importantly, we are pleased to bring on a new high-quality long-term investor, TCG Crossover, who clearly shares our belief in the potential of REZPEG, at a price of $1.20 per share, the transaction represents a premium of over 80% to Nektar’s 30-day VWAP |
| TNFR2 has been shown to potentiate the suppressive effects and overall functional properties of T regs, and the program is built on what we have learned through our deep experience with REZPEG and T reg field and represents a promising mechanism for treatment of autoimmune disease, including multiple sclerosis and ulcerative colitis |
| Biologically speaking REZPEG through its central pathway of T reg rescue, which is uniquely poised to address the diversity of immunopathology, providing broad potential for targeting multiple dermal diseases, including alopecia |
| We believe there are major opportunities in this disease state that the differentiated profile of REZPEG could potentially address |
| NKTR-255 is IL-15-based mechanism of action holds a great promise as a combination agent of cell therapies and other mechanisms such as checkpoint inhibitors, and we are exploring the best partnering paths for continued development of this drug candidate |
| Our deep experience with REZPEG to date across the totality of this clinical program gives us convictions in our ongoing Phase 2b studies in atopic dermatitis and alopecia areata |
| And in terms of the feedback, we’re really pleased with the type of screening we are seeing, and we believe this is driven by the data that was presented by Jonathan Silverberg at EADV 2023 |
| Statement |
|---|
| This specifically in atopic dermatitis, there are three important issues that patients with this disease continue to face: first, there is a need for great efficacy, specifically a deeper magnitude of response and rapid onset of treatment; second, patients lack durable responses and therapy-free remission |
| alopecia areata is also a disease of the skin, where your immune system starts to attack the hair follicles, thereby, weakening the ability of stem cells to grow hair |
| Our net loss for the fourth quarter of 2023 was $42.1 million or $0.22 per share |
| For the full year of 2023, our net loss was $276.1 million or $1.45 per share |
| Once current therapies are discontinued, the patients rebound rapidly; and third, treatments with favorable safety profiles are lacking |
| And once the patient stops taking a JAK inhibitor, which may happen for a variety of reasons, including toxicity, their hair falls out again rapidly |
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