Category Archives: Immunology

Humanized Mouse and Rat Model Market worth $338 million | MarketsandMarkets – Yahoo Finance

CHICAGO, May 8, 2023 /PRNewswire/ -- The humanized mouse and rat model industry is expected to witness significant growth in the near future. These models are essential tools in biomedical research and drug development, allowing scientists to better understand human diseases and evaluate the efficacy and safety of potential treatments. Humanized mouse and rat models are created by introducing human genes, cells, or tissues into the animal models, enabling the simulation of human physiological and pathological processes. With advancements in gene-editing technologies like CRISPR-Cas9, the creation of more precise and sophisticated humanized models is becoming possible. This opens up new avenues for studying complex diseases, such as cancer, autoimmune disorders, and infectious diseases, and facilitates the development of targeted therapies. The use of humanized models in preclinical studies can help accelerate the drug discovery process, reduce costs, and improve the success rates of clinical trials. As a result, the humanized mouse and rat model industry is poised to play a pivotal role in advancing biomedical research and personalized medicine in the near future.

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Humanized Mouse and Rat Model Marketin terms of revenue was estimated to be worth $237 million in 2022 and is poised to reach $338 million by 2027, growing at a CAGR of 7.4% from 2022 to 2027 according to a new report by MarketsandMarkets. Factors such as advances in genomics, proteomics, and metabolomics; completion of the human genome map; the development of targeted diagnostics and therapeutics; and the growing emphasis on health, wellness, and preventive measures are driving the demand for personalized medicine and, subsequently the demand for relevant humanized mouse and rat research models. Also, grants from government and private organizations for cancer research have also supported the development of humanized models in oncology. For instance, in 2020, the US NIH funded a large-scale project to find treatments for rare genetic diseases with a five-year grant of USD 10,625,000 to The Jackson Laboratory Center for Precision Genetics. In the same year, The Jackson Laboratory received a grant from the NIH for its Mouse Mutant Resource and Research Centers (MMRRC) program, established in 2009. The new grant provides a total of USD 6,119,082 over five years to the MMRRC. With such grants and funding from the government and private sectors, the demand for humanized mouse models is expected to increase.

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Humanized Mouse and Rat Model MarketScope:

Report Coverage

Details

Market Revenue in 2022

$237 million

Estimated Value by 2027

$338 million

Growth Rate

Poised to grow at a CAGR of 7.4%

Market Size Available for

2020-2027

Forecast Period

20222027

Forecast Units

Value (USD Million)

Report Coverage

Revenue Forecast, Competitive Landscape, Growth Factors, and Trends

Segments Covered

Type, Application, End User, and Region

Geographies Covered

North America, Europe, Asia Pacific, Latin America (LATAM) and Middle East and Africa (MEA)

Report Highlights

Updated financial information / product portfolio of players

Key Market Opportunities

Rising demand for humanized PDX models

Key Market Drivers

Increasing research activities using humanized models

The genetic humanized mouse model segment accounted for the largest share of the humanized mouse model segment in the humanized mouse and rat model market in 2021.

Based on type, the humanized mouse and rat model market has been segmented into humanized mouse models and humanized rat models. The humanized mouse models' segment is further divided into genetic humanized mouse models and cell-based humanized mouse models. In 2021, genetic humanized mouse segment accounted for the largest share of humanized mouse model market. Advances in genetic engineering technologies, such as gene targeting and gene editing, have led to the development of genetically engineered humanized mouse models that serve as an important tool for a variety of research applications. In addition to the widespread use of these mice in diverse research areas, the emerging CRISPR technology, increasing focus on personalized medicine with the continuous introduction of new models, and various licensing agreements are expected to drive market growth.

The immunology and infectious diseases segment accounted for the second largest share of the application segment in the humanized mouse and rat model market in 2021.

Based on application, the humanized mouse and rat model market is segmented into oncology, immunology and infectious diseases, neuroscience, Hematopoiesis, toxicology, and other applications. Immunology and Infectious diseases segment accounted for the second largest share of the humanized mouse and rat model market in 2021. Mouse models are used in immunology and inflammation studies as they help assess the physiological relevance of an experimental finding. The use of mouse models allows suitable alterations in the mouse genome at random or in specific regions, enabling a detailed study of immunological processes. They also assist in identifying the function of newly identified surface receptors in host defense as well as the developmental consequences of a disturbed signaling pathway or removing a transcription factor. Such mouse models are developed on a large scale in laboratories or institutes and are used for application in Immunology and Infectious diseases segment. Thus, making it the second largest segment in the market.

The Asia Pacific region is the fastest-growing region of the humanized mouse and rat model market in 2021.

Based on the region, the humanized mouse and rat model market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific market is estimated to register the highest growth during the forecast period. Global pharmaceutical firms are increasingly moving to APAC to tap into its thriving market and lower their production costs by shifting manufacturing and laboratory testing to the region. The rapidly increasing demand for the outsourcing of quality control safety testing (including efficacy testing) in countries such as China, India, Japan, and Singapore is expected to drive market growth in the Asia Pacific during the forecast period.

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Humanized Mouse and Rat Model Market Dynamics:

Drivers:

Increasing research activities using humanized models

Rising demand for personalized medicine

Continuous support and initiatives from government and private sectors for cancer research

Growing R&D activities in pharmaceutical and biotechnology sectors

Restraints:

High cost of custom humanized models

Laws and regulations for ethical use of animal models in research

Opportunities:

Rising demand for humanized PDX models

Emergence of CRISPR as a powerful tool in biomedical research

Rising demand for humanized rat models

Challenges:

Alternatives for animal testing

Limitations of humanized mouse models

Key Market Players:

Key players in the humanized mouse and rat model Market include Charles River Laboratories International, Inc. (US), The Jackson Laboratory (JAX) (US), Taconic Biosciences, Inc. (US), Crown Bioscience (US), and Envigo (US).

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Recent Developments:

In January 2022, Taconic Biosciences, Inc. (US) launched the huNOG-EXL EA (early access) humanized immune system (HIS) mouse.

In October 2021, The Jackson Laboratory (US) acquired RMS Business of Charles River Laboratories Japan, Inc. (Japan) which is Charles River Laboratories Japan's Research Models & Services (RMS) business as a wholly-owned subsidiary.

In September 2021, Biocytogen (US) collaborated with Envigo (US) in order to support the research applications of the triple immunodeficient B-NDG mouse. Envigo is the exclusive provider of B-NDG mice in the US, Europe, and certain APAC regions.

In March 2021, Charles River Laboratories International, Inc. (US) acquired Cognate BioServices, Inc. (US) a cell and gene therapy contract development and manufacturing organization (CDMO) offering comprehensive manufacturing solutions for cell therapies. The acquisition expanded Charles River's broad capabilities across the major CDMO platforms for cell and gene therapies.

Humanized Mouse and Rat Model Market Advantages:

Enhanced translatability: Humanized mouse and rat models closely mimic human physiology and disease conditions, allowing for more accurate translation of research findings to human patients. This increases the likelihood of successful translation from preclinical studies to clinical trials.

Study of human-specific diseases: Humanized models enable the study of human-specific diseases that cannot be effectively studied in traditional animal models. These models provide insights into the mechanisms of diseases such as cancer, autoimmune disorders, and infectious diseases, leading to the development of targeted therapies.

Evaluation of drug efficacy and safety: Humanized models allow researchers to evaluate the efficacy and safety of potential drug candidates in a more relevant and predictive manner. This leads to more informed decision-making in drug development, reducing the likelihood of failures in later stages of clinical trials.

Personalized medicine advancements: Humanized models enable the exploration of personalized medicine approaches by allowing researchers to assess the response of specific patient populations to different therapies. This can aid in the development of tailored treatments and improve patient outcomes.

Reduction in animal usage: By using humanized models, researchers can minimize the reliance on traditional animal models, reducing the number of animals used in research studies while obtaining more clinically relevant data.

Humanized Mouse and Rat Model Market - Report Highlights:

Refinements in the chapters of the humanized mouse and rat model market

Updated financial information/service portfolio of players

Updated market developments of profiled players

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Humanized Mouse and Rat Model Market worth $338 million | MarketsandMarkets - Yahoo Finance

Nektar Therapeutics (NASDAQ:NKTR) Q1 2023 Earnings Call Transcript – Yahoo Finance

Nektar Therapeutics (NASDAQ:NKTR) Q1 2023 Earnings Call Transcript May 9, 2023

Operator: Good day and thank you for standing by. Welcome to the Nektar Therapeutics First Quarter 2023 Financial Results Conference Call. Please be advised that todays conference is being recorded. I would now like to hand the conference over to your speaker today, Vivian Wu. Please go ahead.

Vivian Wu: Thank you, Crystal and good afternoon everyone. Thank you for joining us today. With us on the call are Howard Robin, our President and CEO; Dr. Jonathan Zalevsky, our Chief of Research and Development; Dr. Mary Tagliaferri, our Chief Medical Officer; and Sandra Gardiner, our acting Chief Financial Officer. On todays call, we expect to make forward-looking statements regarding our business, including statements regarding the therapeutic potential of and future development plans for drug candidates and research programs, the timing of the initiation of clinical studies and the availability of clinical data for our drug candidates, the timing and plans for future clinical data presentations, the formation future development plans or success of our collaboration arrangements, the expectations following our corporate restructuring and reorganization, financial guidance and certain 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. Our actual results may differ materially from these statements. Important risks and uncertainties are set forth in our Form 10-K that was filed on February 28, 2023, which is available at sec.gov. We undertake no obligation to update any of these forward-looking statements, whether as a result of new information, future developments or otherwise. A webcast of this call will be available on the IR page of Nektars website at nektar.com. With that said, I would like to hand the call over to our President and CEO, Howard Robin. Howard?

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Howard Robin: Thank you, Vivian, and thank you all for joining us today. As you know, a few weeks ago, we announced our plans to implement a new strategic plan and cost restructuring at Nektar. And Im pleased to report today that we enacted the plan quickly and that we will begin to see ongoing expense savings starting in the third quarter of this year. The new plan focuses our company more clearly on immunology and importantly, also extends our cash runway through at least the middle of 2026. A core element of our new pipeline focus and plan is on the advancement of REZPEG, and we intend to move quickly to initiate a well-powered randomized Phase 2b study for REZPEG in patients with atopic dermatitis. We were incredibly pleased to have regained the rights to this first-in-class regulatory T cell program from Lilly.

Importantly, there are no royalties owed to Lilly for this transfer and REZPEG now becomes a wholly owned asset of Nektars. Atopic dermatitis, as a target indication for REZPEG, is attractive to us for several reasons, not the least of which is the strength of the data that has been generated for REZPEG in patients with atopic dermatitis. The non-topical biologic treatment landscape is significantly growing. The approvals of DUPIXENT and other IL-13 based biologics have driven this growth. In the U.S. alone, approximately 16 million people are living with atopic dermatitis with 3 out of 4 of these affected by moderate to severe disease. In 2021, biologic sales for atopic dermatitis were close to $5 billion and sales continue to grow. That being said, atopic dermatitis is a disease area where there is still a very high unmet need for novel biologic treatment options.

Most notably, the mechanisms available to patients today after they fail topical treatments overlap and fall into either the category of IL-13 based mechanisms or JAK inhibitor. Both mechanisms have limitations on efficacy and both have some notable safety challenges, which include black box warnings with the JAK inhibitor class. Even with the growth in the adoption of these mechanisms, at least 50% of patients dont respond to these therapies at all, and many patients see a rebound in their disease after coming off these therapies. This opens a real opportunity for REZPEG to be introduced as the first regulatory T cell mechanism that is differentiated from these overlapping existing mechanisms. The Phase 1b data for REZPEG was compelling and set the stage for us to measure the potential for REZPEG be a remitted therapy with longer-term disease control and less frequent maintenance dosing.

JZ will review the data reported for REZPEG in a few minutes, including the quality and durability of responses we saw in patients. Now as we mentioned in our reprioritization plan with a focus on immunology, well also continue the development of our IL-15 program, NKTR-255 in cancer, while we explore strategic partnership options. NKTR-255 is being developed in combination with cell therapies, and we believe it could be a valuable adjuvant therapy for companies focused in the area of cell therapy. Our Phase 2 study of NKTR-255 in combination with approved cell therapies, BREYANZI and Yescarta, as well as the Phase 2 JAVELIN Bladder Medley study with Mercy KGaA will continue while we seek a development partner. We continue to see great value in NKTR-255 and early data showed its promise as a potentiator of cell therapies that could benefit patients suffering from very difficult-to-treat cancers.

Our goal is to find a strategic co-development partner this year. As Ive stated earlier, our primary focus is on immunology. And to that end, we have 2 preclinical candidates advancing, a TNFR2 antibody program and a PEG CFS 1 program, which JZ will discuss in a moment. Our goal is to have an IND ready in 2024 for at least 1 of these programs. Were deeply grateful to our employees for their commitment and dedication to Nektar and the patients we aim to serve. The decisions over the past month to further reduce our head count have been difficult, but we believe these are the right decisions to maximize the success of REZPEG and our immunology programs. Were confident that our focus on immunology is the best path forward to bring important potential therapies to patients and to create value for our shareholders.

And now Ill pass the call to JZ to review the programs in more detail.

Jonathan Zalevsky: Thanks, Howard. Starting with REZPEG. This is a unique molecule that has shown promising efficacy in multiple clinical trials as a single agent. Our goal with this program is to address the underlying Treg deficiencies and consequent overactivity of effector T cells in these diseases by selectively activating and expanding Tregs. REZPEG is uniquely positioned as the most advanced IL-2-based Treg mechanism in the clinic with opportunity and potential in a number of autoimmune disease indications. . Now Howard touched on 1 of these indications, atopic dermatitis. Management of atopic dermatitis has a few main goals. The first goal is the rapid efficacious treatment of the acute phase of the plant. And second, this is a far more challenging control of the chronic disease in the long term.

And given that most patients with moderate to severe disease need medication for many years, the safety profile is also critically important. The current treatment landscape for patients with moderate to severe disease that requires systemic therapy has 2 major classes of medicines currently approved for standard of care. One class of these target key cytokines that drive the TH2 inflammation pathway, the flagship in this class is DUPIXENT or dupilumab, which blocks the IL-4 and IL-13 pathways. Lebrikizumab which is expecting approval later this year and the recentfly approved Adbry both target and block IL-13 only. While DUPIXENT is a very successful drug, there is now real-world data that describes some of its limitations. One real-world evidence study shows the lack of durable efficacy in that 79% of patients that discontinued DUPIXENT lost disease control after an average of 4 months and needed to restart therapy.

Another real-word study showed that 27% of patients taking DUPIXENT developed moderate to severe conjunctivitis, requiring treatment with anti-inflammatory eye drops or appointments. The other major class of therapies for atopic dermatitis are the JAK inhibitors. These interfere with T cell activation and thus suppress inflammation in the dermis. JAK inhibitors show impressive efficacy in atopic dermatitis, but they carry multiple black-box warnings making them less attractive for chronic use. Because the JAK inhibitors are associated with these multiple safety risks, the FDA had only granted a label for the JAK inhibitors in patients whose disease is not adequately controlled with other systemic drug products, including biologics. In the clinic, because of the black-box warnings, dermatologists acknowledge that JAK inhibitors are not suited for many of their patients, including individuals greater than 65 years old or those with the comorbidities associated with the black-box warning.

Like DUPIXENT, patients that discontinue JAK inhibitors also quickly lose disease control and relapse. Unlike IL-13 blockers and JAK inhibitors, which both block their respective pathways, REZPEG is designed to target the IL-2 receptor complex and stimulate the expansion and function of Treg cells. These in turn suppress the harmful T cells that are driving the underlying pathology of atopic dermatitis. REZPEG aims to restore homeostasis in the immune system through the proliferation of T-reg cells rather than just blocking effector cells. And consequently, REZPEG provides a completely different mechanism of action compared to the other drugs that are currently approved or under development in the atopic dermatitis space. The Phase 1b data from our first initial proof-of-concept study in moderate-to-severe atopic dermatitis reinforces our conviction in REZPEG.

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The 12-week Phase 1b study conducted by Lilly tested two doses of REZPEG compared to placebo and then followed patients for 36 additional weeks after the last dose of therapy. Last September, we presented the interim data from this trial. REZPEG demonstrated a dose-dependent reduction in eczema area and severity index scores in patients, also known as the ES score with approximately a 70% reduction in scores at week 12 at the highest dose tested. We also saw a dose-dependent improvement in the investigator global assessment for atopic dermatitis and itch responder rates through week 12 of treatment. Consistent with the REZPEG mechanism of action, total Tregs and CD25bright Tregs increased versus placebo through week 12. The efficacy observed at 12 weeks of treatment with REZPEG is in line with efficacy observed after 16 weeks of treatment with DUPIXENT.

But clearly, the most fascinating observation from the study was that when we looked at patients 36 weeks after we stopped dosing REZPEG, their skin scores and other measurements of disease activity remain very low. And this is an effect that is not observed with DUPIXENT. This has us and KOLs very enthusiastic about the potential for long-lasting responses and infrequent maintenance dosing with REZPEG in the setting of atopic dermatitis.. We have now received the final data for this study from Eli Lilly, and the study results positively extend the interim results previously reported. In addition, these data include additional efficacy endpoints that were not covered in last years EADV presentation. To briefly touch on some of these, we observed a dose-dependent decrease in the percentage of body surface area involved with atopic dermatitis, also known as BSA in patients treated with REZPEG with patients at the highest dose level reaching a 72% reduction in BSA at week 12 as a reminder, BSA continuous measurement that correlates with EASI.

We also observed dose-dependent reductions in 2 patient-reported outcome measures, the Dermatology Life Quality Index, also known as DLQI, and the patient-oriented eczema measure or POEM. In addition, the final data set has data for more patients completing the 36-week observation period. We are very excited about the data obtained in this study. REZPEG showed efficacy across all measures of physician-reported disease activity and patient-reported outcomes. And these effects were durable and maintained after patients stopped REZPEG administration at week 12. We look forward to ending in the coming months. When we develop REZPEG at Nektar, our hypothesis was that restoring Treg populations in patients with autoimmune disease would restore the normal balance of the immune system and potentially provide a disease-modifying therapy.

We are excited to see the long duration of sustained response observed in the atopic dermatitis study, consistent with this hypothesis. These collective data demonstrate REZPEGs potential as a remit of therapy and support the quick advancement of REZPEG to move into a Phase 2b study in atopic dermatitis later this year. We are now finalizing the Phase 2b study, which will give the industry standard Phase 2 study design similarly to Phase 2 work conducted for approved IL-13 and other agents. This will allow us to evaluate multiple dose regimens of REZPEG in a 16-week induction period followed by a 28-week maintenance period. We believe the study design will enable data to be better compared to prior Phase 2 studies at a 16-week primary endpoint readout at the end of the induction period.

We have assembled a scientific steering committee for this trial and we are pleased to announce that Dr. Jonathan Silverberg from the George Washington University School of Medicine and Health Sciences will be the Chair of this committee. We are truly excited for REZPEGs potential as a first-in-class Treg stimulator, and we look forward to initiating this Phase 2b study in patients with moderate-to-severe atopic dermatitis this year. The Phase 2 top line data reported in lupus earlier this year also demonstrated clinically meaningful improvements as compared to placebo across key secondary end points, including BICLA and LLDAS at the mid-dose level. And since we reported the data, we have had time to meet with many thought leaders in the field of lupus.

Their reaction to our study results has been positive and provided us with many insights. In their feedback, the thought leaders focused on REZPEGs rapid onset of BICLA and LLDAS response as well as the magnitude of the effect on these endpoints was observed. There is agreement that the Phase 2b data provides ample evidence to design a Phase 3 registrational study around these approvable end points. While we remain very interested in lupus, to be clear, we are prioritizing first the Phase 2b study in atopic dermatitis because it will allow us to rapidly reach a definitive result in a randomized study. We may have the opportunity to revisit a development strategy in lupus once we get the results from this atopic dermatitis study. We are extremely excited about REZPEG now being a wholly owned component of our pipeline.

While our near-term focus is on atopic dermatitis, we continue to believe that REZPEG has broad potential in multiple indications. As development of this program progresses, we will continue to evaluate further opportunities and indications for REZPEG. Moving to NKTR-255. We are evaluating strategic partnership options for the asset, while we continue our NKTR-sponsored Phase 2study of NKTR-255 in combination with cell therapies and the Phase 2 JAVELIN Bladder Medley Study with our partner, Merck KGaA. NKTR-255 is an agent that engages the full biology of the IL-15 pathway to provide functional activation and homeostatic control of IL-15 responses of immune cells, mainly natural killer cells, CD8 T cells and immune memory subsets. As the full agonist of the IL-15 pathway, it can signal through both cis and trans presentation of the TRIMERIC-IL-15 receptor complex.

NKTR-255 can be combined with multiple mechanisms ranging from targeted therapies, to cell therapies, including CAR-T and even TCR therapies and checkpoint inhibitors to potentially improve the efficacy of these agents. While we continue to see great value in this program with NKTR-255 showing broad potential applicability across oncology indications, we believe prioritizing our immunology programs provides great opportunity to create value for our shareholders. We believe further development of NKTR-255 with the strategic partner is, therefore, the best path forward for our program, and our goal is to find a partner this year. With this reprioritization, the NKTR-255 study in combination with DARZALEX FASPRO in multiple myeloma and in combination with cetuximab in solid tumors are wrapping up as we prioritize the cell therapy in bladder cancer sites.

Now turning to our preclinical research programs. We are advancing our research pipeline with a focus on autoimmune disease. The first program we are working on is our new PEG colony-stimulating factor, also known as CSF1 program. PEG CSF1 is the polyethylene glycol or PEG modified version of the CSF1 protein. This molecule was engineered to optimize their receptor interaction and the exposure to selectively modulate the resolution processes of inflammation. We believe this program has applications in a number of therapeutic indications, including acute and chronic inflammation as well as fibrosis. And we are excited to be ramping up the program. Our second preclinical program is our TNFR2 agonist antibody being developed in collaboration with biologic design.

TNFR2 is highly expressed on Tregs, neuronal cells and endothelial cells, and TNFR2 agonism has been shown to potentiate the suppressive effect and overall functional properties of Tregs. If absent, it is associated with CNS autoimmunity. While its presence has been associated with protective effects for neuronal cells as well as other cell populations and tissues in the body. The lead antibodies we have identified shows selective Treg binding and signaling, which enables them to be developed specifically for autoimmune disease. We are very excited about this program and its potential to suppress inflammation and promote the human resolution. We plan to file an IND for at least one of these programs in 2024 and look forward to keeping you updated on our progress as these programs mature.

And with that, I will turn the call over to Sandy for a review of our cost restructuring plan and financial guidance.

Sandra Gardiner: Thank you, JZ, and good afternoon, everyone. Id like to first outline the actions we are taking currently in the second quarter as part of our cost restructuring plan to reduce operating expenses. And then I will provide 2023 financial guidance. We ended the first quarter with approximately $457 million in cash and investments with no debt on our balance sheet. As we announced in April, we have reduced our San Francisco-based workforce by approximately 60%. Costs related to the restructuring will be paid by the end of June in the second quarter. We now have approximately 55 employees based in San Francisco going forward. On an annual run rate basis, the reduction to personnel represents approximately $30 million a year in operating expense reductions.

We will have quarterly savings beginning in the third quarter of 2023, and we expect to fully realize these annual savings in 2024. With these reductions in annual operating expenses, as Howard stated, our plan allows for Nektar to have a cash runway through at least the middle of 2026 with our existing cash on hand. Any cash brought in from partnering or other strategic activities would further extend this runway and bolster the balance sheet. Before I move on to 2023 financial guidance, I will note a few non-cash items that were recorded during the first quarter of 2023. First, we recorded a one-time non-cash charge of $76.5 million to impair the goodwill that was previously recorded on our balance sheet, primarily from two acquisitions made over 17 years ago, the 2001 acquisition of Share Water Corporation and the 2005 acquisition of Aerogen.

In Q1, we also recorded a $13.2 million noncash impairment primarily for leased assets. These aggregate non-cash impairment charges of $89.7 million contributed $0.48 to our net loss per share in Q1 2023. Excluding these non-cash impairment charges, net loss on a non-GAAP basis for the first quarter of 2023 and was $47.3 million or $0.25 basic and diluted loss per share. Ill now review our 2023 financial guidance. We expect to end 2023 with at least $315 million in cash and investments. In the second quarter of 2023, we will have non-recurring cash payments of approximately $8 million in connection with our reduction in head count. We expect our net cash usage to decrease in the second half of the year after these payments are made in June.

As I said earlier, this reduction in net cash utilization extends our cash runway through at least the middle of 2026. Our GAAP revenue for full year 2023 is expected to be between $80 million and $90 million. This revenue includes $65 million to $70 million in non-cash royalties and $15 million to $20 million in product sales. We anticipate full year 2023 GAAP R&D operating expenses will range between $105 million and $115 million, which includes approximately $15 million to $20 million of non-cash depreciation and stock compensation expense. We expect G&A operating expense for full year 2023 and to be between $75 million and $80 million, which includes approximately $15 million to $20 million of noncash depreciation and stock compensation expense.

For the full year 2023, we expect to recognize restructuring, impairment and costs of terminated programs of approximately $30 million to $35 million, $13.2 million of which is a non-cash impairment that I mentioned earlier and was recognized in Q1 2023. Our full year 2023 non-cash interest expense is expected to be between $20 million and $25 million. And with that, well now open the call for questions. Operator?

See also 20 Most Used Prescription Drugs In The USand 15 Biggest Immunotherapy Companies in the World.

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Nektar Therapeutics (NASDAQ:NKTR) Q1 2023 Earnings Call Transcript - Yahoo Finance

Mercks $10.8 billion takeover of Prometheus gives it a foothold in immunology – MarketWatch

Merck & Co.s $10.8 billion acquisition of Prometheus Biosciences Inc., which it announced Sunday, is a strategic positive that will help the drug company diversify its portfolio and reduce the risk of an overreliance on its cancer drug Keytruda, analysts said Monday.

San Diego, Calif.-based Prometheus RXDX is a clinical-stage biotechnology company focusing on autoimmune treatments, such as PRA023, a treatment under development for illnesses such as ulcerative colitis and Crohns disease.

This transaction adds further diversity to our overall portfolio and is an important building block in strengthening the sustainable innovation engine that will drive our long-term success, Merck Chief Executive Rob Davis told analysts on a call to discuss the deal, according to a FactSet transcript.

BofA analysts said diversity is a key goal for Merck, given that Keytruda is expected to account for more than 45% of total revenue by 2025.

Whilewe wouldnt expect todays proposed transaction to meaningfully move Mercks shareson Monday given its relative size, we see the deal as a strategic positive and another step in the right direction to diversify Keytruda concentration risk, analysts led by Geoff Meacham wrote in a note to clients.

Also see:Moderna, Merck combo cancer-vaccine treatment shows significant promise

BofA has a buy rating on Merck MRK

Prometheus had a market cap of about $5.42 billion as of Fridays close. Its stock is up 3.7% year to date but has skyrocketed 225% over the past 12 months, with much of the gains coming afterPRA023 advanced to Phase 3 clinical trialsin December. The news of the Merck deal with its 70% premium sent the stock up 69% on Monday.

PRA023 is an antibody that binds TL1A,a target associated with both intestinal inflammation and fibrosis, said the BofA analysts. Phase 2 studies have demonstrated the best-in-class potential for the drug, which is a potential disrupter in the inflammatory and immunology space and has a pipeline that stretches beyond inflammatory bowel disease, or IBD, they wrote.

Read now: Merck and Eisai report disappointing results from trials of combination treatment for melanoma and colorectal cancer

IBD is the umbrella term used to describe diseases including Crohns and ulcerative colitis, both of which cause chronic inflammation of the gastrointestinal tract, leading to diarrhea, rectal bleeding, abdominal pain, fatigue and weight loss.

Prometheus has a roughly $5 billion potential by 2030, the analysts said, although they noted that with Phase 3 studies to be launched this year, there is still a lot of wood to chop before commercialization, which is expected by 2026.

Stifel analysts led by Annabel Samimy said: We see Merck as having captured a plum asset with potentially little competition (due to exposure overlap amongst most other large pharma) adding a strong franchise in immune-mediated/fibrotic conditions to its current focus areas in oncology, infectious disease, and cardio-metabolic disorders.

Stifel is not anticipating any major antitrust issues to arise, given that the deal is Mercks first foray into the immune-mediated space, while other big drug companies, including Bristol Myers Squibb Co. BMY , AbbVie Inc. ABBV , Pfizer Inc. PFE and Johnson & Johnson

See now: Moderna is developing a vaccine against the tick-borne Lyme disease, in a first for the company

Guggenheim analysts led by Yatin Suneja said the deal is the cherry on top of its Best Idea for 2023, which was to buy Prometheus stock.

PRA023 is a potential game changer that could break through the efficacy ceiling that has plagued the [IBD] space for years, they wrote. The deal is not just good for Merck, either Prometheus gets the global infrastructure and resources of a big pharma company to help push through Phase 3 trials.

Given the big opportunity for 2023 in IBD, we see this valuation as reasonable and dont expect any competing offers, they wrote.

Guggenheim has a buy rating on Merck.

Mercks stock was down 0.5% Monday but has gained 3.4% in the year to date, while the S&P 500 SPX has gained 7.8%.

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Mercks $10.8 billion takeover of Prometheus gives it a foothold in immunology - MarketWatch

Genmab and argenx Enter Partnership to Advance Antibody Therapies in Immunology and Oncology – GlobeNewswire

Media Release

COPENHAGEN, Denmark; April 17, 2023

GenmabA/S(Nasdaq:GMAB) andargenx(Euronext & Nasdaq:ARGX) announced today that Genmabandargenxhave entered into a collaboration agreement to jointly discover, develop and commercialize novel therapeutic antibodies with applications in immunology, as well as in oncology therapeutic areas.Themultiyear collaboration will leverage the antibody engineering expertise and knowledge of disease biology of both companies to accelerate the identification and development of novel antibody therapeutic candidates with a goal to address unmet patient needs in immunology and cancer.

Genmabis entering the therapeutic area of immunologyand inflammationas asteppingstoneto achievingitsvision that by 2030, our knock-your-socks-offKYSOantibody medicines will be transforming the lives of people with cancer and other serious diseases, said Jan van de Winkel, Ph.D., Chief ExecutiveOfficer,Genmab. By partnering with argenx, we will be able to combine our deep knowledge of the biology and therapeutic power of antibodies and have an opportunity to address patients needs in oncology as well as in immunology and inflammation.

Our core mission is to innovate on behalf of patients by translating immunology breakthroughs into novel pipeline candidates. We do this through a model of co-creation which has led to eight molecules demonstrating human proof-of-concept in our pipeline, said Tim Van Hauwermeiren, Chief Executive Officer, argenx. Through our collaboration with Genmab, we are bringing together our combined antibody discovery, development and commercialization expertise to unlock insights on the disease pathways that we will address. This allows us to broaden our capabilities and maximize the opportunity to generate novel therapeutic antibodies within autoimmunity or cancer.

Collaboration DetailsAs per the agreement,argenxandGenmabwill each have access to the suites of proprietary antibody technologies of both companies to advance the identification of lead antibody candidates against differentiated disease targets. Under the terms of the agreement, argenx and Genmab will jointly discover, develop and commercialize products emerging from the collaboration while equally sharing costs as well as any potential future profits. The collaboration will initially focus on two differentiated targets, including one within immunology and one within cancer, with the potential to expand to more.

About Genmab Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.

About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and- only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, and the EU. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visitwww.argenx.comand follow us onLinkedIn,Twitter,andInstagram.

Genmab Contacts

Media

Jyoti Sharma, Director, Communications T: +1 609 480 9844; E: jysh@genmab.com

Investor Relations

Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.com

argenx Contacts

Media

Erin Murphyemurphy@argenx.com

Investors

Beth DelGiaccobdelgiacco@argenx.com

Genmab Forward-looking Statements This Media Release contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody and HexElect.

argenx Forward-looking StatementsThe contents of this announcement include statements that are, or may be deemed to be, forward- looking statements. These forward-looking statements can be identified by the use of forward- looking terminology, including the terms believes, hope, estimates, anticipates, expects, intends, may, will, or should and include statements argenx makes regarding the impact of the transitionof the chief operatingofficer; its launchstrategytomake VYVGARTavailable inthe EU, China, Canadaandselect otherregions;the VYVGARTmulti-dimensional expansionstrategy; its expansionthroughpotential regulatoryapprovals andlaunches and the planned launchof SC efgartigimod, ifapproved;the timingofdata readoutsandnew clinical efficacydata; theregulatory reviews andregulatoryapproval timinginthe United States,EU andJapan forSCefgartigimod forthe treatment ofgMG andthe long-term safety andtolerability ofSC efgartigimod; thetherapeutic potentialof itsproduct candidates; the intendedresults of itsstrategy andits collaborationpartners,advancement of, andanticipated clinical developmentandregulatorymilestonesandplans, including the timing of planned clinical trials; and the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involverisksanduncertainties, andreadersarecautionedthatanysuchforward-lookingstatementsarenotguaranteesoffutureperformance.argenxsactualresultsmaydiffermateriallyfrom thosepredictedbytheforward-lookingstatementsasaresultofvariousimportantfactors, includingtheeffectsoftheCOVID-19pandemic,inflationanddeflationandthecorrespondingfluctuationsininterestrates;regionalinstabilityandconflicts,suchastheconflictbetweenRussiaandUkraine,argenxsexpectationsregardingtheinherentuncertainties associatedwithcompetitivedevelopments,preclinicalandclinicaltrialandproductdevelopmentactivitiesandregulatoryapprovalrequirements;argenxsrelianceoncollaborationswiththirdparties;estimatingthecommercialpotentialof argenxsproductcandidates;argenxsabilitytoobtainandmaintainprotectionofintellectualpropertyfor itstechnologiesanddrugs; argenxslimitedoperatinghistory;andargenxsabilitytoobtainadditionalfundingforoperationsandtocompletethedevelopmentandcommercializationofitsproductcandidates.Afurtherlistanddescriptionofthese risks, uncertainties andotherrisks canbe foundin argenxsU.S. Securities andExchange Commission(SEC)filings andreports, includingin argenxsmostrecent annual report onForm20-Ffiled with the SEC as well assubsequent filingsandreports filed byargenxwith theSEC.Giventhese uncertainties,the readeris advised not toplace any undue reliance onsuchforward-lookingstatements.Theseforward-lookingstatements speak onlyas ofthe dateof publicationof this document. argenx undertakesnoobligationto publicly update or revisethe informationinthis pressrelease, including any forward-looking statements, except as may be required by law.

Media Releaseno.04CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab and argenx Enter Partnership to Advance Antibody Therapies in Immunology and Oncology - GlobeNewswire

Merck to buy Prometheus Biosciences for US$10.8b – theSundaily

Merck will pay US$200 per share for the California-based biotechnology company that specialises in treatments for autoimmune diseases. That represents a 75% premium to the US$114.01 closing price for Prometheus shares on Friday.

This is allowing us to move into immunology in a strong way and will allow us sustainable growth, we think, well into the 2030s given the long patent life, Merck chief executive Robert Davis said in an interview.

Davis said the Prometheus drug, PRA023, being developed to treat ulcerative colitis, Crohns disease, and other autoimmune conditions, could be a multibillion-dollar seller for Merck. He said the recent release of encouraging Phase II clinical trial results drove Merck to pounce.

Weve been watching their clinical development programme for a while, Davis said.

If the deal closes in the third quarter of this year as hoped, Merck could launch a late-stage ulcerative colitis study of the drug in the fourth quarter or first quarter of 2024, Davis said.

Merck has been looking for deals to protect itself from eventual revenue loss as patents on its blockbuster cancer immunotherapy Keytruda begin to expire toward the end of the decade. The company reported nearly US$21 billion in Keytruda sales last year.

Davis said revenue from the Prometheus acquisition could start to roll in around the time Keytruda patents could potentially expire.

Davis compared the deal to one he struck in 2021 for Acceleron, which allowed Merck to quickly build out its pipeline of cardiovascular drugs.

I believe now we have a very strong portfolio in the cardiometabolic space. We see this acquisition of Prometheus building out a similar portfolio in the immunology space, Davis said, adding that Merck brings scale, global reach and significant capital to deploy.

Last summer, Merck was reportedly in talks to buy cancer focused biotech Seagen Inc, but rival Pfizer Inc ended up striking a US$43 billion deal for Seagen last month.

Davis said Merck would continue to be opportunistic on acquisitions, but is agnostic about size.

We look where we see the most compelling science, and where that science aligns with value we move, he said, noting that the company is not interested in large transformative or cost-synergy driven deals.

Mercks talks with Prometheus were first reported by The Wall Street Journal.

The company in February forecast 2023 earnings below Wall Street estimates and a steep decline in sales of its Covid-19 antiviral treatment. - Reuters

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Merck to buy Prometheus Biosciences for US$10.8b - theSundaily

Nektar Therapeutics Announces Strategic Reprioritization and Cost Restructuring Plan – Yahoo Finance

-- Pipeline focus will prioritize programs in immunology, including REZPEG and several immunology research programs --

-- Development of NKTR-255 in diffuse large B-cell lymphoma and bladder cancer to continue as strategic partnering options are pursued --

-- Cost restructuring plan reduces San Francisco-based workforce by approximately 60% and extends cash runway into the middle of 2026 --

-- Company to announce financial results for the first quarter of 2023 after close of U.S.-based financial markets on May 9, 2023 --

SAN FRANCISCO, April 17, 2023 /PRNewswire/ --Nektar Therapeutics (Nasdaq: NKTR) today announced a strategic reprioritization and cost restructuring plan that includes a new pipeline focus on immunology, as well as several cost reduction initiatives, which the company expects will significantly reduce future operating expenses and extend its cash runway into the middle of 2026.

(PRNewsfoto/Nektar Therapeutics)

Key elements of the new plan include:

Prioritize REZPEG development: Nektar intends to work with Eli Lilly to ensure the continuation of REZPEG development whether it is under the existing Eli Lilly agreement or Nektar regains the rights to REZPEG. The Phase 1b data for REZPEG in atopic dermatitis previously presented at the EADV meeting in September 2022 showed that a dose-dependent improvement was observed in key efficacy measures of mean change in EASI, EASI-75, vIGA-AD scores, and Itch NRS 4-point improvement ratesover placebo with 12 weeks of treatment. These improvements were observed for an additional 36 weeks following the 12-week treatment period. These proof-of-concept data show REZPEG's ability to stimulate Tregs to target an immune system imbalance resulting in an improvement of disease activity in patients. The Phase 1b data were recently highlighted in a talk by Eric Lawrence Simpson, MD, FAAD at the 2023 American Academy of Dermatology (AAD) Annual Meeting on March 17, 2023 in the scientific session covering atopic dermatitis, as a potential future remittive therapy.

Continue development of lead oncology asset, NKTR-255, while seeking a strategic development partner: As part of the strategic reprioritization, Nektar will continue its Phase 2 study of NKTR-255 in combination with cell therapies and the Phase 2 JAVELIN Bladder Medley Study with partner Merck KGaA while it explores strategic partnership options for NKTR-255. NKTR-255 is an investigational IL-15 receptor agonist designed to boost antitumor immunity by increasing the proliferation and survival of natural killer and memory CD8+ T cells and may have broad potential applicability across oncology indications.

Continue core research programs in immunology: Nektar will continue to advance two preclinical pipeline candidates in auto-immune diseases including a new PEG-Colony Stimulating Factor (CSF1) program and a separate TNFR2 agonist antibody being developed in collaboration with Biolojic Design. The company plans to file an IND for at least one of these programs in 2024.

Implement a cost restructuring plan: As part of the strategic reprioritization, Nektar also plans to reduce its San Francisco-based workforce by approximately 60%. Once the cost restructuring plan has been fully completed, the company is expected to have approximately 55 employees based in San Francisco. The company anticipates that its Huntsville manufacturing facility, which supports several large pharmaceutical partners, will continue to operate with its current staff. The restructuring also includes actions to reduce additional operating costs and is expected to be substantially completed by June 2023.

Story continues

"Following a comprehensive review of our portfolio, we have made the decision to prioritize the advancement of our immunology programs," said Howard W. Robin, President and CEO of Nektar. "We intend to work with Eli Lilly either to continue REZPEG's development in the clinic under our existing agreement or to regain the rights to REZPEG for Nektar. We believe the strong data generated for this asset demonstrates its potential as a remittive therapy in atopic dermatitis and sets the stage to move quickly into a Phase 2b study. REZPEG would be positioned as a novel potential therapeutic in a significant, growing biologic treatment landscape."

"The strategic initiative we announced today is intended to further streamline our operations and to extend considerably our cash runway into the middle of 2026," continued Robin. "Although the actions we are taking today are difficult, we are incredibly grateful for the contributions of the employees departing Nektar."

Nektar had cash, cash equivalents, and marketable securities of approximately $456 million as of March 31, 2023. These significant reductions in the company's operating expenses, including personnel-related costs and external expenses, are expected to extend the company's cash runway into the middle of 2026. Projected annual savings from the headcount reduction will be fully realized in 2024 and represent an annual savings of approximately $30 million. Nektar expects non-recurring cash payments of approximately $8 million, primarily in the second quarter of 2023 associated principally with the workforce reduction.

Executive Management Changes

As part of this initiative, Nektar also announced several changes to its executive team:

Dr.Brian Kotzin, Nektar's Chief Medical Officer, will be stepping down from his full-time role but will continue to serve in an ongoing role as a strategic advisor to the company. Dr. Mary Tagliaferri, current Chief Development Officer, will assume the role of Chief Medical Officer.

Jillian Thomsen will be stepping down from her role as Chief Financial Officer (CFO) and will depart the company in June following a transition period. The company has appointed Sandra Gardiner to the role of acting CFO. Sandra is a skilled business and finance executive with over 30 years of financial and accounting experience. She is a partner at FLG Partners, a leading CFO services firm in Silicon Valley.

Kevin Brodbeck, Nektar's SVP of Technical Operations, will depart the company in June following a transition period. Ken Franke, current VP of Biologics Development & Manufacturing will assume Kevin's responsibilities.

The company thanks its departing executives for their contributions to Nektar.

Conference Call Details to Announce First Quarter 2023 Financial Results:

Nektar will announce its financial results for the first quarter 2023 on Tuesday, May 9, 2023, after the close of U.S.-based financial markets. Howard W. Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time.

The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: http://ir.nektar.com/. The web broadcast of the conference call will be available for replay through June 4, 2023.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

About Nektar Therapeutics

Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional manufacturing operations in Huntsville, Alabama. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

About Rezpegaldesleukin (REZPEG)

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. REZPEG is an investigational, potential first-in-class T regulatory cell stimulator that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It is designed to target the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, REZPEG may act to bring the immune system back into balance. REZPEG is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases.

About NKTR-255

NKTR-255 is a biologic that targets the IL-15 pathway in order to activate the body's innate and adaptive immunity. Through optimal engagement of the IL-15 receptor complex, NKTR-255 is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response.

Preclinical findings suggest NKTR-255 has the potential to synergistically combine with antibody-dependent cellular cytotoxicity molecules as well as to enhance CAR-T therapies. A Phase 2/3 study is underway that combines NKTR-255 with approved CAR-T cell therapies in patients with diffuse large B-cell lymphoma, which is currently recruiting (NCT05664217).

There are two ongoing investigator sponsored trials (ISTs) evaluating NKTR-255 following treatment with a CAR-T cell therapy. Fred Hutchinson Cancer Center is conducting a Phase 1 study evaluating NKTR-255 in combination with CD19 CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphoma (NCT05359211), and Stanford University is conducting a Phase 1 study evaluating NKTR-255 in combination with CD19/22 CAR-T cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (NCT03233854).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements which can be identified by words such as: "will," "may," "advance," "support," "develop," "provide," "expect," "aim," "potential" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for rezpegaldesleukin, NKTR-255 and our other drug candidates in research programs, the prospects and plans for our collaborations with other companies, the timing of the initiation of clinical studies and the data readouts for our drug candidates, our expectations regarding our 2023 cost restructuring plan and reduction in our San Francisco-based workforce, including the anticipated cost savings and non-recurringcash payment related to, and the timing for completion of, the cost restructuring plan, and our expected working capital and cash runway. 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-255 and our other drug candidates are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-255 and our other drug candidates are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin, NKTR-255 and our other drug candidates are in various stages of 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 challenges caused by the COVID-19 pandemic, 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) we may not achieve the expected cost savings we expect from our 2022 corporate restructuring and reorganization plan or our 2023 cost restructuring plan and we may undertake additional restructuring and cost-saving activities in the future, (vi) 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 (vii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2023. 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.

Contact:

For Investors:Vivian Wu of Nektar Therapeutics628-895-0661

For Media:David Rosen of Argot Partners(212) 600-1902david.rosen@argotpartners.com

Cision

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Nektar Therapeutics Announces Strategic Reprioritization and Cost Restructuring Plan - Yahoo Finance

Merck Strengthens Immunology Pipeline with Acquisition of … – Merck

April 16, 2023 6:00 am ET

PRA023 is a novel, late-stage candidate for ulcerative colitis and Crohns disease and other autoimmune conditions

Prometheus Biosciences comprehensive data set enables target discovery and precision medicine approach in inflammation and immunology

RAHWAY, N.J. & SAN DIEGO--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Prometheus Biosciences, Inc. (Prometheus) (Nasdaq: RXDX) today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire Prometheus for $200.00 per share in cash for a total equity value of approximately $10.8 billion.

At Merck, we are committed to delivering on our purpose to save and improve lives and continue to identify and secure opportunities where compelling science and value creation align, said Robert M. Davis, chairman and chief executive officer, Merck. The agreement with Prometheus will accelerate our growing presence in immunology where there remains substantial unmet patient need. This transaction adds diversity to our overall portfolio and is an important building block as we strengthen the sustainable innovation engine that will drive our growth well into the next decade.

Prometheus is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. The companys lead candidate, PRA023, is a humanized monoclonal antibody (mAb) directed to tumor necrosis factor (TNF)-like ligand 1A (TL1A), a target associated with both intestinal inflammation and fibrosis.

Prometheus was established to revolutionize the treatment of immune-mediated diseases through the application of a powerful precision medicine approach, said Mark McKenna, chairman and chief executive officer of Prometheus Biosciences. This agreement with Merck, a leader in biopharmaceutical research and development, allows Prometheus to maximize the potential for PRA023, while continuing to apply our technology and expertise to fuel further discoveries to address the needs of patients with immune disorders.

Prometheus is developing PRA023 for the treatment of immune-mediated diseases including ulcerative colitis (UC), Crohns disease (CD), and other autoimmune conditions. In December 2022, the company announced positive results for PRA023 from ARTEMIS-UC, a Phase 2, placebo controlled, study evaluating safety and efficacy in patients with moderate to severely active UC and APOLLO-CD a Phase 2A, open-label, study evaluating safety and efficacy in patients with moderate to severe CD. The findings were recently presented at the 18th Congress of European Crohns and Colitis Organisation (ECCO).

By applying a portfolio of powerful analytic tools to a comprehensive collection of IBD samples, Prometheus identified important disease insights that have now yielded a promising late-stage candidate, said Dr. Dean Y. Li, president, Merck Research Laboratories. I look forward to working with the talented Prometheus team to establish a new paradigm of precision treatment for immune diseases.

Under the terms of the acquisition agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Prometheus. The acquisition is subject to Prometheus Biosciences shareholder approval. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the third quarter of 2023.

A copy of the merger agreement pursuant to the transaction will be filed with the Securities and Exchange Commission (SEC) and will be publicly available. In addition, Merck and Prometheus will file annual, quarterly and current reports and other information with the SEC, which are available to the public from commercial document-retrieval services and at the SECs website at http://www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge on Mercks internet website at http://www.merck.com or by contacting Merck at 126 East Lincoln Avenue P.O. Box 2000, Rahway, NJ 07065 USA, or (908) 740-4000. Copies of the documents filed with the SEC by Prometheus may be obtained at no charge on Prometheus internet website at https://www.prometheusbiosciences.com or by contacting Prometheus at 3050 Science Park Road, San Diego, CA 92121 or (646) 241-4400.

Advisors

Morgan Stanley & Co. LLC acted as financial advisor to Merck in this transaction and Paul, Weiss, Rifkind, Wharton & Garrison LLP as its legal advisors. Centerview Partners LLC and Goldman Sachs & Co. LLC acted as financial advisors to Prometheus and Latham & Watkins LLP as the companys legal advisor.

About inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a term used to collectively describe Crohns disease and ulcerative colitis. These conditions are characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the tissues lining the GI tract.Both ulcerative colitis and Crohn's disease usually are characterized by diarrhea, rectal bleeding, abdominal pain, fatigue and weight loss.

About PRA023

PRA023 is a humanized monoclonal antibody directed to tumor necrosis factor (TNF)-like ligand 1A (TL1A). PRA023 binds both soluble and membrane associated human TL1A with high affinity and specificity. Prometheus is developing PRA023 for the treatment of immune-mediated diseases including UC, CD, and other autoimmune conditions.

About Prometheus Biosciences

Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. The companys precision medicine platform, Prometheus360, combines proprietary machine learning-based analytical approaches with one of the worlds largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.

Investor Call

Merck will hold an investor call on Monday, April 17, at 8:00 a.m. EDT to discuss this proposed acquisition. Journalists who wish to ask questions are requested to contact a member of Mercks Media Relations team at the conclusion of the call. To listen to the call, please visit https://www.merck.com/investor-relations/events-and-presentations/.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA includes statements that are not statements of historical fact, or forward-looking statements, including with respect to Mercks proposed acquisition of Prometheus. Such forward-looking statements include, but are not limited to, the ability of Merck and Prometheus to complete the transactions contemplated by the merger agreement, including the parties ability to satisfy the conditions to the consummation of the merger contemplated thereby and the other conditions set forth in the merger agreement, statements about the expected timetable for completing the transaction, Mercks and Prometheuss beliefs and expectations and statements about the benefits sought to be achieved in Mercks proposed acquisition of Prometheus, the potential effects of the acquisition on both Merck and Prometheus, the possibility of any termination of the merger agreement, as well as the expected benefits and success of Prometheuss product candidates. These statements are based upon the current beliefs and expectations of Mercks management and are subject to significant risks and uncertainties. There can be no guarantees that the conditions to the closing of the proposed transaction will be satisfied on the expected timetable or at all, with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, uncertainties as to the timing of the merger; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the merger contemplated thereby may not be satisfied or waived (including the failure to obtain the requisite vote by Prometheuss stockholders); the effects of disruption from the transactions contemplated by the merger agreement and the impact of the announcement and pendency of the transactions on Prometheuss business; the risk that stockholder litigation in connection with the merger may result in significant costs of defense, indemnification and liability; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Mercks ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Mercks patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Mercks 2022 Annual Report on Form 10-K and Mercks other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov).

Forward-Looking Statements of Prometheus Biosciences

Prometheus cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Prometheus current beliefs and expectations. Such forward-looking statements include but are not limited to statements regarding the companys plans to advance PRA023 into Phase 3 trials in UC and CD, including the timing thereof. The inclusion of forward-looking statements should not be regarded as a representation by Prometheus that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results Prometheus reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; interim results of a clinical trial do not predict final results and the clinical outcomes may materially change following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient data become available, including from Cohort 2 of the ARTEMIS-UC trial; potential delays in the commencement, enrollment and completion of clinical trials and preclinical studies; the results of clinical trials are not necessarily predictive of future results; Prometheus dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; Prometheus ability to develop diagnostics for its therapeutic product candidates; unexpected adverse side effects or inadequate efficacy of its product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; planned future trials of PRA023 may not support regulatory registration; regulatory developments in the United States and foreign countries; Prometheus ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or otherwise disrupting its preclinical studies, clinical trials, manufacturing and supply chain; and other risks described in the companys prior press releases and filings with the Securities and Exchange Commission (SEC), including under the heading Risk Factors in Prometheus most recent annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Prometheus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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Merck Strengthens Immunology Pipeline with Acquisition of ... - Merck

Day of Immunology 2023 Discovery Tour at the Doherty Institute – The Peter Doherty Institute for Infection and Immunity

17 Apr 2023

Add to my calendar28/04/2023 4:00 pm28/04/2023 5:30 pmAustralia/MelbourneDay of Immunology 2023 Discovery Tour at the Doherty InstituteDoherty Institute, 792 Elizabeth StreetDD/MM/YYYY

WHEN28 Apr 20234.00 - 5.30pm

WHEREDoherty Institute, 792 Elizabeth Street

As part of the Day of Immunology Victoria & Tasmania, organised by the Australia and New Zealand Society for Immunology (ASI), the Doherty Instituteis opening its doors to the public. Discovery tours provide a unique opportunity for the community to find out more about medical research, see our state-of-the-art facilities, learn about our exciting discoveries and talk to passionate scientists about their research.

Thetour runs for approximately 75 minutes.

This is a free event however registration is essential. If you or someone you know are interested in attending the tour, please register using the link below before Wednesday, 26 April 2023.

https://www.immunology.org.au/events/-ASI-Public-Event-DoI-Discovery-Tour-at-the-Doherty-Institute-2023/

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Day of Immunology 2023 Discovery Tour at the Doherty Institute - The Peter Doherty Institute for Infection and Immunity

How I found a broader impact as a PhD student through podcasting – Nature.com

A professional studio is a luxury not every aspiring producer has or needs.Credit: Kjetil Kolbjrnsrud/Alamy

I remember, during my first year as an immunology PhD student, struggling with the broader impacts outreach section of my US National Science Foundation (NSF) graduate fellowship application one morning before heading into the laboratory.

Before graduate school at the University of California, San Diego, I spent several years as a research associate, studying allergic disease. In this role, I mentored many undergraduate and masters students and attended patient-advocacy group meetings to share our laboratorys work. Still, I felt that my outreach was neither broad nor impactful enough for the grant proposal.

Eventually, it was time to go to the lab; I put in my headphones, started an episode of my favourite podcast at the time, The Tim Ferriss Show, and walked to campus. When I arrived, the idea hit me: I would make a science podcast.

To get started, I used my phone to record simple audio versions of journal club presentations that Id given in the past year. I had put so much time into these talks, but only a handful of people had seen them which seemed inefficient. With a podcast, I could share fascinating immunology work and my perspective on it in an accessible, scalable and enduring format.

Collection: Science and social media

I love listening to podcasts because I can tune into them any time, anywhere: sitting in traffic, working out at the gym or doing cell culture work. Although I started the podcast with my colleagues in mind, I made sure that the content was accessible to lay listeners by adding more detail and background information. Aware of the importance of branding, I thought long and hard about a clever name for the show.

After recording the first episode, I edited it with the free audio-editing software Audacity and hosted the cleaned-up tracks on SoundCloud, which I then uploaded to major podcast platforms, including Apple Podcasts and Spotify. The first episode went live in 2019. I shared episode links with my connections on Twitter and LinkedIn and with my lab and graduate-programme colleagues, and plugged the podcast in nearly every conversation I had at conferences. The entire process took a few weeks for each episode, and cost nothing. And just like that, the immunology podcast Inflammatory Content was born.

Kellen Cavagnero records an episode of Inflammatory Content.Credit: Consuelo Sauceda

After about six months, I had recorded ten episodes with a few hours of content. Fans started reaching out to me on Twitter, telling me they enjoyed the show and requesting episodes on certain topics. The positive feedback inspired me to keep going and improve the quality of the podcast. I learnt that a programme at my university had US National Institutes of Health funds available for outreach, so I applied and was awarded US$1,000 to buy professional recording equipment, including two Audio-Technica microphones.

To further increase the production value of the show, I added a musical intro and outro using free public-domain tracks from Googles Audio Library. I also experimented with a new episode format. My favourite podcasts are interview-based, so I asked Alan ONeill, a postdoctoral researcher in my lab who had just published an exciting paper, to be my guinea pig. We spoke about his article, career trajectory and philosophies on science and mentorship. I next had my thesis adviser on, then committee members, and then other professors at my university. I am now three years into podcasting and have released seven long-form interviews and a dozen solo episodes that have received tens of thousands of listens.

Going forward, I would like to interview more scientists outside my university. Now that the podcast is relatively established, my unsolicited interview requests have a higher success rate, making this possible. I would also like to scale up the amount of content I release. The current bottleneck for me is the time-consuming editing process. To address this, I am recruiting an intern and working to improve my interview skills, so my episodes will require less editing.

This podcast has had a broader impact than I could have imagined. I now have the privilege of having deep conversations with scientists I admire and sharing these conversations with the world. Some of my favourites are the episodes with infectious-disease physician Victor Nizet, dermatologist Richard Gallo and immunologist Mitchell Kronenberg: these senior investigators have launched numerous trainees into independent careers and are chock-full of wisdom.

Not only has Inflammatory Content had a positive impact on the listeners, but by forcing me to listen carefully and communicate clearly and concisely, it has made me a better scientist and educator. Moreover, through the podcast, Ive made strong connections with professors with whom I might pursue postdoctoral research in the future. I was even awarded the NSF fellowship, and I feel that including details about the podcast in my application played a big part.

I hope my story inspires others to pursue outreach through podcasting. This is a burgeoning medium, and it is important that scientists at all career stages use podcasts to share their work and their stories, for the benefit of the scientific community and society at large. I encourage anyone interested in getting started to take the leap. Start something, learn along the way and see where it goes.

This is an article from the Nature Careers Community, a place for Nature readers to share their professional experiences and advice. Guest posts are encouraged.

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How I found a broader impact as a PhD student through podcasting - Nature.com