On April 30, 2024 Incyte (Nasdaq:INCY) reported 2024 first quarter financial results, and provides a status update on the Company’s clinical development portfolio (Press release, Incyte, APR 30, 2024, View Source [SID1234642464]).

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"In the first quarter of 2024, total revenues grew 9% year-over-year driven by patient demand growth in the U.S. for Opzelura (ruxolitinib) cream and Jakafi (ruxolitinib). As anticipated, the revenue growth during the quarter was offset by an inventory drawdown for Jakafi and the typical first quarter net pricing dynamics," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We made important progress with our clinical pipeline including the initiation of two Phase 1 studies evaluating our JAK2V617F inhibitor and KRASG12D inhibitor. We also recently announced an agreement to acquire Escient Pharmaceuticals, pending the appropriate regulatory review process. Escient’s lead compound EP262, is a first-in-class, potent, highly selective, once-daily small molecule designed to block mast cell activation, independent from IgE. We believe this novel mechanism has broad clinical utility in a number of conditions including chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and other diseases."

Key First Quarter 2024 Company Updates

•In February 2024, Incyte announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.
•In February 2024, Incyte entered into an asset purchase agreement with MorphoSys AG which gave Incyte exclusive global rights for tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy marketed in the U.S. as Monjuvi (tafasitamab-cxix) and outside of the U.S. as Minjuvi (tafasitamab).
•In March 2024, multiple abstracts featuring data from Incyte’s dermatology portfolio were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, including two late-breaking oral presentations for ruxolitinib cream (Opzelura) in hidradenitis suppurativa (HS) and povorcitinib in prurigo nodularis (PN).
•In April 2024, Incyte and China Medical System Holdings Limited announced the Companies entered into a Collaboration and License Agreement, through a wholly-owned dermatology medical aesthetic subsidiary CMS Skinhealth, for the development and commercialization of povorcitinib, a selective oral JAK1 inhibitor, in Mainland China, Hong Kong, Macau, Taiwan Region and eleven Southeast Asian countries.
•In April 2024, Incyte and Escient Pharmaceuticals, a clinical-stage drug development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders, entered into a definitive agreement under which Incyte has agreed to acquire Escient and its clinical development portfolio, including EP262, a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor (MRGPRX2) and EP547, a first-in-class oral MRGPRX4 antagonist. Under the terms of the agreement, Incyte will acquire Escient and its assets for $750 million plus Escient’s net cash remaining at the close of the transaction, subject to customary adjustments. The acquisition is subject to clearance under the Hart-Scott-Rodino Act, among other customary conditions, and will become effective promptly following the satisfaction or waiver of these conditions.
Jakafi:
Net product revenues for the first quarter 2024 of $572 million (-1% Y/Y):
▪Total paid patients increased 5% in the first quarter of 2024 versus the same quarter in the prior year, with growth across all indications and leading to the highest quarterly paid patient demand for Jakafi since launch.
▪Patients on free drug in the fourth quarter of 2023 gradually returned to paid demand during the first quarter of 2024; as a result, the percent of patients on free drug returned to more normalized levels during the first quarter of 2024.
▪Channel inventory at the end of the first quarter of 2024 decreased by approximately $55 million versus the fourth quarter of 2023.
Opzelura:
Net product revenues for the first quarter 2024 of $86 million (+52% Y/Y):
▪Net product revenues growth in the first quarter of 2024 were driven by patient demand, refills and expansion in payer coverage as the launch in atopic dermatitis (AD) and vitiligo continues.
▪Net product revenues of $6 million in the first quarter of 2024 in Europe where the launch is ongoing in Germany, Austria and initial uptake has begun in France.
Additional Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
▪Combination trials of ruxolitinib twice daily (BID) with zilurgisertib (INCB000928) and BETi (INCB057643) are ongoing and continue to enroll. A Phase 3 study for BETi is anticipated to initiate in the second half of 2024 and clinical proof-of-concept for zilurgisertib is anticipated by mid-2024.
▪The Phase 1 studies evaluating INCA033989 (mCALR) and INCB100658 (JAK2V617F) are ongoing and enrolling patients.

MPN and GVHD Programs Indication and status
Ruxolitinib XR (QD)
(JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD
Ruxolitinib + zilurgisertib
(JAK1/JAK2 + ALK2) Myelofibrosis: Phase 2
Ruxolitinib + INCB57643
(JAK1/JAK2 + BET) Myelofibrosis: Phase 2
Ruxolitinib + CK08041
(JAK1/JAK2 + CB-Tregs)
Myelofibrosis: Phase 1
Axatilimab (anti-CSF-1R)2
Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201); BLA under review in the U.S.
Ruxolitinib + axatilimab2
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 2 in preparation
Steroids + axatilimab2
(Steroids + anti-CSF-1R)
Chronic GVHD: Phase 3 in preparation
INCA033989
(mCALR) Myelofibrosis, essential thrombocythemia: Phase 1
INCB160058
(JAK2V617Fi) Phase 1

1 Development collaboration with Cellenkos, Inc.
2 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
•In January 2024, Incyte highlighted promising early clinical efficacy data for its selective small molecule inhibitor of CDK2 (INCB123667), which demonstrated its potential use as monotherapy or combination therapy for late-stage cancers. In a Phase 1 study of INCB123667, early clinical activity was observed with several partial responses (PR) achieved in patients with amplification/over expression of CCNE1, a cell cycle regulator and potential predictive biomarker. Tumor shrinkage was observed across multiple tumor types, including CCNE1+ patients with ovarian cancer. The safety profile of INCB123667 aligns with the mechanism of action. Additional data is expected to be presented in 2024.
•In April 2024, Incyte presented new preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 highlighting its KRASG12D inhibitor (INCB161734). INCB161734 is a potent, selective, and orally bioavailable KRAS G12D inhibitor which is efficacious against KRAS G12D mutant tumors in preclinical models. The potential benefit of INCB161734 for patients with KRAS G12D mutant disease is under investigation in an ongoing Phase 1 study. The KRASG12D mutation is found in 40% of pancreatic ductal adenocarcinoma patients, 15% of colorectal cancer patients, and 5% of non-small cell lung cancer patients and with no approved G12D-targeting agents, represents a significant medical need.
3

Oncology Programs Indication and status
Pemigatinib (Pemazyre)
(FGFR1/2/3)
Myeloid/lymphoid neoplasms (MLN): approved in the U.S. and Japan
Cholangiocarcinoma (CCA): Phase 3 (FIGHT-302)
Tafasitamab (Monjuvi/Minjuvi)
(CD19)
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 (inMIND)
Retifanlimab (Zynyz)1
(PD-1)
Merkel cell carcinoma (MCC): approved in the U.S.
Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303)
Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304)
MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)
INCB99280
(Oral PD-L1) Solid tumors (combination): Phase 1
Solid tumors (monotherapy): Phase 2
Cutaneous squamous cell carcinoma (cSCC): Phase 2
INCB99318
(Oral PD-L1) Solid tumors: Phase 1
INCB123667
(CDK2i) Solid tumors with Amplification/ Overexpression of CCNE1: Phase 1
INCB161734
(KRASG12D) Advanced metastatic solid tumors with a KRAS G12D mutation: Phase 1

1 Retifanlimab licensed from MacroGenics.
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Opzelura
▪In March 2024, Incyte presented data at the 2024 AAD Annual Meeting from its randomized, placebo-controlled, Phase 2 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura) in adults with mild/moderate HS. At Week 16, patients receiving ruxolitinib cream 1.5% twice daily (BID) had significantly greater decreases from baseline versus placebo in total abscess and inflammatory nodule (AN) count, the primary endpoint of the study. The overall safety profile of ruxolitinib cream was consistent with previous data, and no new safety signals were observed. A Phase 3 study is currently being evaluated.
▪Ruxolitinib cream in other indications: Phase 2 studies in lichen planus and lichen sclerosus have completed enrollment. Two Phase 3 trials evaluating ruxolitinib cream in PN are ongoing.
Povorcitinib (INCB54707)
▪The Phase 2, randomized, double-blind, placebo-controlled, dose ranging study evaluating the efficacy and safety of povorcitinib in participants with PN were presented at the 2024 AAD Annual Meeting with the study meeting its primary and secondary endpoints following 16 weeks of treatment across all dosing groups, reinforcing povorcitinib’s potential role in treating PN. A Phase 3 study in PN is being planned.
▪Asthma and chronic spontaneous urticaria: Two Phase 2 trials in asthma and chronic spontaneous urticaria are enrolling.
4

IAI and Dermatology Programs Indication and status
Ruxolitinib cream (Opzelura)1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3)
Vitiligo: Approved in the U.S. and Europe
Lichen planus: Phase 2
Lichen sclerosus: Phase 2
Hidradenitis suppurativa: Phase 2; Phase 3 being evaluated
Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2)
Ruxolitinib cream + UVB
(JAK1/JAK2 + phototherapy) Vitiligo: Phase 2
Povorcitinib
(JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 3 (STOP-V1, STOP-V2)
Prurigo nodularis: Phase 3 to start in 2024
Asthma: Phase 2
Chronic spontaneous urticaria: Phase 2
INCA034460
(anti-IL-15Rβ) Vitiligo: Phase 1 initiated

1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.
Other
Other Program Indication and Phase
Zilurgisertib
(ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2

Discovery and other early development
Modality Candidates
Monoclonal antibodies
INCAGN2385 (LAG-3)1, INCAGN2390 (TIM-3)1
Bi-specific antibodies
INCA32459 (LAG-3xPD-1)2, INCA33890 (TGFβR2xPD-1)2

1 Discovery collaboration with Agenus.
2 Development in collaboration with Merus.
Partnered
Partnered Programs Indication and Phase
Ruxolitinib (Jakavi)1
(JAK1/JAK2)
Acute and chronic GVHD: Approved in Europe and Japan
Baricitinib (Olumiant)2
(JAK1/JAK2)
AD: Approved in Europe and Japan
Severe alopecia areata (AA): Approved in the U.S., Europe and Japan
Capmatinib (Tabrecta)3
(MET)
NSCLC (with MET exon 14 skipping mutations): Approved in the U.S., Europe and Japan

1 Ruxolitinib (Jakavi) licensed to Novartis ex-U.S. for use in hematology and oncology excluding topical administration.
2 Baricitinib (Olumiant) licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis.
3 Capmatinib (Tabrecta) licensed to Novartis.
5

2024 First Quarter Financial Results
The financial measures presented in this press release for the three months ended March 31, 2024 and 2023 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.
As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.
Financial Highlights
Financial Highlights
(unaudited, in thousands, except per share amounts)
Three Months Ended
March 31,
2024 2023
Total GAAP revenues $ 880,889 $ 808,673
Total GAAP operating income 91,898 24,770
Total Non-GAAP operating income 161,183 89,729
GAAP net income 169,548 21,703
Non-GAAP net income 145,269 84,577
GAAP basic EPS $ 0.76 $ 0.10
Non-GAAP basic EPS $ 0.65 $ 0.38
GAAP diluted EPS $ 0.75 $ 0.10
Non-GAAP diluted EPS $ 0.64 $ 0.37

6

Revenue Details
Revenue Details
(unaudited, in thousands)
Three Months Ended
March 31, %
Change
(as reported)
%
Change
(constant currency)1
2024 2023
Net product revenues:
Jakafi $ 571,839 $ 579,969 (1 %) (1 %)
Opzelura 85,724 56,552 52 % 51 %
Iclusig 30,343 27,685 10 % 8 %
Pemazyre 17,676 22,475 (21 %) (22 %)
Minjuvi/Monjuvi 23,874 6,556 264 % 262 %
Zynyz 467 — NM NM
Total net product revenues 729,923 693,237 5 % 5 %
Royalty revenues:
Jakavi 89,595 76,692 17 % 19 %
Olumiant 30,589 34,155 (10 %) (8 %)
Tabrecta 5,234 4,177 25 % NA
Pemazyre 548 412 33 % NM
Total royalty revenues 125,966 115,436 9 %
Total net product and royalty revenues 855,889 808,673 6 %
Milestone and contract revenues 25,000 — NM NM
Total GAAP revenues $ 880,889 $ 808,673 9 %

NM = not meaningful
NA = not available
1.Percentage change in constant currency is calculated using 2023 foreign exchange rates to recalculate 2024 results.
Product and Royalty Revenues Product revenues and product and royalty revenues for the quarter ended March 31, 2024 increased 5% and 6%, respectively, over the prior year comparative period, primarily driven by a 52% year-over-year increase in Opzelura net product revenue due to the growth in new patient starts and refills, an increase in Minjuvi/Monjuvi net product revenues, following the acquisition of the exclusive global rights to tafasitamab in February 2024, and an increase in Jakavi royalty revenues.
7

Operating Expenses
Operating Expense Summary
(unaudited, in thousands)
Three Months Ended
March 31, %
Change
2024 2023
GAAP cost of product revenues $ 60,956 $ 56,822 7 %
Non-GAAP cost of product revenues1
54,959 50,669 8 %
GAAP research and development 429,260 406,641 6 %
Non-GAAP research and development2
388,437 375,620 3 %
GAAP selling, general and administrative 300,256 315,606 (5 %)
Non-GAAP selling, general and administrative3
277,335 294,017 (6 %)
GAAP (gain) loss on change in fair value of acquisition-related contingent consideration (456) 6,196 (107 %)
Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration4
— — — %
GAAP (profit) and loss sharing under collaboration agreements (1,025) (1,362) (25 %)

1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.
2 Non-GAAP research and development expenses exclude the cost of stock-based compensation and MorphoSys transition costs.
3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation and MorphoSys transition costs.
4 Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration is null.
Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended March 31, 2024 increased 7% and 8%, respectively, compared to the same period in 2023 primarily due to growth in net product revenues.
Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended March 31, 2024 increased 6% and 3%, respectively, compared to the same period in 2023 primarily due to continued investment in our late stage development assets.
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended March 31, 2024 decreased 5% and 6%, respectively, compared to the same period in 2023 primarily due to the timing of consumer marketing activities and of certain other expenses.
Other Financial Information
Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended March 31, 2024, compared to the same periods in 2023, was due primarily to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig.
Operating income GAAP and Non-GAAP operating income for the three months ended March 31, 2024 increased 271% and 80%, respectively, compared to the same period in 2023, driven by growth in total revenues and stable operating expenses.
Cash, cash equivalents and marketable securities position As of March 31, 2024 and December 31, 2023, cash, cash equivalents and marketable securities totaled $3.9 billion and $3.7 billion, respectively.
8

2024 Financial Guidance
Incyte is maintaining its full year 2024 revenue and expense guidance. Incyte’s guidance is summarized below. Guidance does not include revenue from any potential new product launches or the impact of the acquisition of Escient Pharmaceuticals or any other potential future strategic transactions.
Guidance
Jakafi net product revenues $2,690 – $2,750 million
Other Hematology/Oncology net product revenues(1)
$325 – $360 million
GAAP Cost of product revenues 7 – 8% of net product revenues
Non-GAAP Cost of product revenues(2)
6 – 7% of net product revenues
GAAP Research and development expenses $1,720 – $1,760 million
Non-GAAP Research and development expenses(3)
$1,580 – $1,615 million
GAAP Selling, general and administrative expenses $1,210 – $1,240 million
Non-GAAP Selling, general and administrative expenses(3)
$1,115 – $1,140 million

1Pemazyre in the U.S., EU and Japan; Monjuvi and Zynyz in the U.S.; and Iclusig and Minjuvi in the EU.
2Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.
3 Adjusted to exclude the estimated cost of stock-based compensation.
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13745743.
If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13745743.
The conference call will also be webcast live and can be accessed at investor.incyte.com.

On April 30, 2024 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company advancing innovative gamma-delta T cell therapies, reported that the first patient in its Phase 2 clinical trial evaluating INB-400 in patients with newly diagnosed glioblastoma multiforme (GBM) has been successfully dosed at the Cleveland Clinic in Ohio (Press release, In8bio, APR 30, 2024, View Source [SID1234642463]).

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INB-400 is the Company’s first autologous gamma-delta T cell therapy product candidate genetically engineered to survive chemotherapy and maintain the natural ability to recognize, engage and kill cancer cells when dosed along with current, standard-of-care treatments such as temozolomide (Temodar, or TMZ). Arm A of the INB-400 trial is expected to enroll up to 40 patients. INB-400 was granted Orphan Drug Designation by the FDA in 2023.

"The initiation of patient dosing in our Phase 2 trial of INB-400 represents an important milestone for both IN8bio and patients with newly diagnosed GBM who have limited therapeutic options," said William Ho, CEO and co-founder of IN8bio. "Our novel approach combines engineered, chemotherapy-resistant gamma-delta T cells with standard-of-care treatments to potentially drive deeper responses and improved patient outcomes in difficult-to-treat cancers. We look forward to advancing INB-400 at multiple leading medical centers across the United States for patients with GBM and sharing updates, including long-term follow up data from the Phase 1 INB-200 program, at medical meetings this year."

Gamma-delta T cells are naturally occurring immune cells with unique properties enabling them to naturally differentiate between healthy and cancerous tissues. They serve to bridge between the innate and adaptive immune system, contributing to direct tumor cell killing as well as immune memory, cell recruitment and activation to drive deeper immune responses.

The Phase 2 study will evaluate the safety and tolerability of INB-400 in patients with newly diagnosed GBM in combination with TMZ. In Arm A of the trial, investigators will administer T cells to patients on the first day of each of six 28-day maintenance cycles concurrent with TMZ for up to six doses. The primary endpoint of the study is overall survival rate at 12 months. Secondary endpoints include safety and tolerability, overall response rate, time to progression, and progression-free survival.

Since 2005, the standard-of-care treatment for GBM has been surgical resection followed by radiation and chemotherapy and six cycles of maintenance temozolomide therapy, referred to as the Stupp regimen. Most patients relapse in six to seven months, with very few patients surviving beyond five years. INB-400 is engineered to be resistant to alkylating chemotherapy, enabling it to be used in combination with the current standard-of-care TMZ to amplify immune signals, maximize tumor killing, and eliminate cancer cells.

More information about the Phase 2 study (NCT05664243) can be found at www.clinicaltrials.gov.

About INB-400

INB-400 is IN8bio’s DeltEx chemotherapy resistant autologous drug-resistant immunotherapy (DRI). INB-400 was granted Orphan Drug Designation for the treatment of glioblastoma multiforme (GBM) by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation. GBM remains a significant unmet need, treatment options and associated outcomes for GBM, highly aggressive and difficult-to-treat brain cancer, have remained largely unchanged for more than 18 years, with a median progression free survival of 6-7 months and overall survival of 14-16 months. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or "off-the-shelf" DeltEx DRI.

On April 30, 2024 The Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. (NASDAQ: IBRX), a next-generation immunotherapy company, reported that it will discuss the implications of the recent FDA approval of ANKTIVA (nogapendekin alfa inbakicept-pmln) for use in combination with bacillus Calmette-Guerin (BCG) for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors at the American Urological Association Annual Meeting (AUA 2024) this week in San Antonio, Texas (Press release, ImmunityBio, APR 30, 2024, View Source [SID1234642462]).

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Patrick Soon-Shiong, M.D., will discuss the company’s novel FDA-designated Breakthrough Therapy ANKTIVA, and its potential as an alternative therapy to radical surgery for patients with advanced cases of bladder cancer that have failed to respond to the current standard of care of BCG adminstered alone. Dr. Soon-Shiong will describe how the tumor evades BCG therapy and how ANKTIVA rescues BCG when combined with ANKTIVA, revealing details of ImmunityBio’s Cancer Moonshot strategy of transforming "MHC Negative" (cold) bladder cancer cells as a mechanism of tumor evasion from BCG, to "MHC Positive" (hot) tumors via ANKTIVA’s activation of NK and T cells, resulting in complete durable response.

"The realization that this transformation of MHC- to MHC+ could rescue exhausted or immune-evaded T cells was the basis of our Cancer Moonshot announced in 2016. Our QUILT program provided insight that this strategy of transforming MHC- to MHC+ applies to all tumor types that have entered the escape phase, and the approval of ANKTIVA marks our first step to the next evolution of immunotherapy by orchestrating both the innate and adaptive immune system. I very much look forward to elaborating on the details with Dr. Sam Chang at the AUA conference," said Dr. Patrick Soon-Shiong.

Hosting Dr. Soon-Shiong will be Dr. Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center. Dr. Chang was a principal investigator for ImmunityBio’s QUILT 3.032 study, which produced the data on which the FDA approval was based. The fireside chat, titled "A Deep Dive with Patrick Soon-Shiong: Next Generation Immunotherapy for NMIBC," will take place Friday, May 3, 2024 at 3:15 CDT in the Learning Lab, located in the AUA Square, in front of the Science & Technology Hall of the Henry B. González Convention Center in San Antonio, Texas.

In addition, at the AUA Annual Meeting, ImmunityBio’s Chief Medical Officer Sandeep "Bobby" Reddy, M.D., will present the latest findings from the Company’s QUILT 3.032 and QUILT 2.005 studies.

MP16-03: N-803 plus BCG Complete Response rate in NMIBC CIS subjects: BCG refractory, relapsed, checkpoint failure, and chemotherapy failure; updated results (QUILT 3.032). Friday, May 3, 2024 from 1:00 to 3:00 in Room 221B
QUILT 2.005: A comparison of intravesical Bacillus Calmette-Guerin (BCG) in combination with the IL-15 superagonist N-803 to BCG alone in patients with BCG-naïve NMIBC. Sunday, May 5, 2024 from 10:32 to 10:40 am in the Learning Lab.

On April 30, 2024 HiFiBiO Therapeutics, an innovative clinical stage biotechnology company committed to improving patient lives with single cell precision, reported its participation in the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), set for May 31-June 4, 2024, in Chicago, IL (Press release, HiFiBiO Therapeutics, APR 30, 2024, View Source [SID1234642461]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The company will present Phase 1 trial data on two novel agonists: the first-in-class TNFR2 agonist HFB200301 (NCT05238883) and the next-generation OX40 agonist HFB301001 (NCT05229601). These agonists were developed using HiFiBiO’s innovative Drug Intelligence Science (DIS) platform, which incorporates microfluidic single-cell technology and advanced AI/ML data analysis to assess patient tumor samples. The aim is to select optimal tumor types and predictive biomarkers to enhance the probability of clinical success. Insights gained from these Phase 1 trials will guide the recommended dosages and patient stratification strategy for Phase 2.

In addition to advancing Dose Expansion studies for each of the agonists, the company is also advancing a third clinical program, the best-in-class BTLA antagonist HFB200603 (NCT05789069).

HiFiBiO’s novel immunotherapies and robust translational strategy demonstrate the company’s deep commitment to innovative research and its development of impactful therapies to address unmet medical needs.

Details on the poster presentations are as follows:

Title: Phase I dose escalation trial of the first-in-class TNFR2 agonist monoclonal antibody, HFB200301, in monotherapy and in combination with tislelizumab, an anti-PD-1 monoclonal antibody, in adult patients with advanced solid tumors

Abstract Number: 2526

Session Date and Time: 6/1/2024. 9 – 12 pm CDT

Presenter: Desamparados Roda, MD, PhD, Hospital Clínico Universitario de Valencia

Title: A phase I monotherapy dose escalation study of HFB301001, a novel next generation OX40 agonist monoclonal antibody, in adult patients with advanced solid tumors

Abstract Number: 2531

Session Date and Time: 6/1/2024. 9 – 12 pm CDT

Presenter: Anthony El-Khoueiry, MD, University of Southern California Norris Comprehensive Cancer Center

Abstracts highlighting initial data will be available at meetings.asco.org/abstracts-presentations on May 23 at 5:00 PM ET. The posters will be available on the HiFiBiO Therapeutics website shortly after the live presentation.

On April 30, 2024 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the first quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones (Press release, Exelixis, APR 30, 2024, View Source [SID1234642460]).

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"In the first quarter of 2024, Exelixis made important progress to advance a diverse, multi-product portfolio of small molecules and biotherapeutics with the potential to improve standards of care for patients with cancer," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "The team continued to execute across our three ongoing pivotal trials for zanzalintinib, as well as the phase 1 studies of our tissue-factor targeting ADC, XB002, and our small molecule USP1 inhibitor, XL309. We expect to provide updates from these programs as clinical data mature. In addition, we are on track for up to three Investigational New Drug filings this year, pending continued supportive preclinical data."

Dr. Morrissey continued: "We also continued to pursue our label expansion plans for cabozantinib to drive future potential revenue growth of our flagship franchise and will provide additional updates on our regulatory strategies for both neuroendocrine tumors and metastatic castration-resistant prostate cancer, when appropriate. We believe the recent restructuring of our business, announced in January, further enhances our integrated research, development and commercial capabilities to deliver an innovative pipeline of cancer therapies for patients, while continuing to return capital back to our shareholders through our 2024 share repurchase program. As we drive the commercial and pipeline components of our business forward, we remain steadfast in our defense of cabozantinib’s intellectual property and anticipate a ruling on the second bench trial for our ongoing litigation with MSN Pharmaceuticals in the spring timeframe of this year."

First Quarter 2024 Financial Results

Total revenues for the quarter ended March 31, 2024 were $425.2 million, as compared to $408.8 million for the comparable period in 2023.

Total revenues for the quarter ended March 31, 2024 included net product revenues of $378.5 million, as compared to $363.4 million for the comparable period in 2023. The increase in net product revenues was primarily due to an increase in sales volume, partially offset by a decrease in average net selling price.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $46.7 million for the quarter ended March 31, 2024, as compared to $45.4 million for the comparable period in 2023. The increase in collaboration revenues was primarily due to higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, Ipsen Pharma SAS and Takeda Pharmaceutical Company Limited, partially offset by a decrease in development cost reimbursements earned.

Research and development expenses for the quarter ended March 31, 2024 were $227.7 million, as compared to $234.2 million for the comparable period in 2023. The decrease in research and development expenses was primarily related to a decrease in license and other collaboration costs, partially offset by an increase in clinical trial costs.

Selling, general and administrative expenses for the quarter ended March 31, 2024 were $114.0 million, as compared to $131.4 million for the comparable period in 2023. The decrease in selling, general and administrative expenses were primarily related to decreases in corporate giving and legal and advisory fees.

Restructuring expenses for the quarter ended March 31, 2024 were $32.8 million. The restructuring expenses primarily consist of severance and employee-related costs, asset impairment and contract termination costs.

Provision for income taxes for the quarter ended March 31, 2024 was $12.0 million, as compared to $8.3 million for the comparable period in 2023.

GAAP net income for the quarter ended March 31, 2024 was $37.3 million, or $0.12 per share, basic and diluted, as compared to GAAP net income of $40.0 million, or $0.12 per share, basic and diluted, for the comparable period in 2023. GAAP net income per share for the quarter ended March 31, 2024 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended March 31, 2024, as compared to the comparable period in 2023, as a result of the stock repurchase programs.

Non-GAAP net income for the quarter ended March 31, 2024 was $52.0 million, or $0.17 per share, basic and diluted, as compared to non-GAAP net income of $52.8 million, or $0.16 per share, basic and diluted, for the comparable period in 2023.

Non-GAAP Financial Measures

To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation expense, adjusted for the related income tax effect for all periods presented.

Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation expense, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.

These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

2024 Financial Guidance

Exelixis is maintaining the previously provided financial guidance for fiscal year 2024 (1):

Total revenues

$1.825 billion – $1.925 billion

Net product revenues (2)

$1.650 billion – $1.750 billion

Cost of goods sold

4% – 5% of net product revenues

Research and development expenses (3)

$925 million – $975 million

Selling, general and administrative expenses (4)

$425 million – $475 million

Effective tax rate

20% – 22%

____________________

(1)

2024 financial guidance excludes expenses related to the restructuring plan announced in January 2024.

(2)

Exelixis’ 2024 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.2% for both CABOMETYX and COMETRIQ effective on January 1, 2024.

(3)

Includes $40 million of non-cash stock-based compensation expense.

(4)

Includes $60 million of non-cash stock-based compensation expense.

Cabozantinib and Pipeline Highlights

Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $378.5 million during the first quarter of 2024, with net product revenues of $376.4 million from CABOMETYX (cabozantinib) and $2.1 million from COMETRIQ (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended March 31, 2024, Exelixis earned $39.6 million in royalty revenues.

Detailed Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Genitourinary Cancers Symposium (ASCO GU). In January, positive results from the primary progression-free survival (PFS) analysis in the global phase 3 CONTACT-02 pivotal trial were presented during an oral abstract session at ASCO (Free ASCO Whitepaper) GU. The results demonstrated a statistically significant improvement in PFS, as assessed by a blinded independent radiology committee (BIRC), for cabozantinib in combination with atezolizumab in the first 400 randomized patients in the intent-to-treat (PFS ITT) population and per protocol. A PFS benefit was observed across all subgroups of high-risk populations who have a poor prognosis and a high unmet need for additional treatment options, notably in patients with liver metastases or those who had received prior docetaxel chemotherapy. A statistically significant improvement in PFS was also observed by BIRC both in the ITT population (n=507) and according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria. An interim analysis for overall survival (OS), conducted at the time of the primary PFS analysis, demonstrated a trend favoring the combination of cabozantinib and atezolizumab. The study continues toward the next analysis of OS, which is anticipated in 2024. CONTACT-02 is evaluating cabozantinib in combination with atezolizumab compared with a second novel hormonal therapy (NHT) in patients with mCRPC and measurable soft-tissue disease who have progressed on one prior NHT. The safety profile of the combination regimen was consistent with the known profiles of each single agent, and no new safety findings were identified.

Four-Year Follow-up Results from Phase 3 CheckMate -9ER Trial Evaluating CABOMETYX in Combination with Nivolumab (OPDIVO) in Previously Untreated Renal Cell Carcinoma (RCC) Presented at ASCO (Free ASCO Whitepaper) GU. In January, four-year follow-up results from the CheckMate -9ER trial were featured in an oral presentation at ASCO (Free ASCO Whitepaper) GU. Results continued to show superior PFS and objective response rates in patients treated with the combination of CABOMETYX and nivolumab over sunitinib, the comparator studied in the trial, regardless of risk classification. Superior OS was also observed in patients treated with the combination. The presentation included data showing health-related quality-of-life benefits with the combination as compared to sunitinib. No new safety concerns were identified in the follow-up analysis.

Cabozantinib and Zanzalintinib Data Presentations at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Cabozantinib and zanzalintinib will be the subject of 10 presentations at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, which is being held from May 31 through June 4 in Chicago. Notably, presentations will include a biomarker analysis from the clear cell RCC cohort of the phase 1b/2 STELLAR-001 study of zanzalintinib in advanced solid tumors.

Corporate Highlights

Announcement of Key Priorities and Anticipated Milestones for 2024. In January, Exelixis announced its key priorities and anticipated milestones for 2024, including: implementation of a corporate restructuring to prioritize the advancement of the company’s deep pipeline of clinical and near-clinical programs; potential U.S. regulatory filings for cabozantinib in advanced NET and mCRPC indications; the anticipated outcome of the cabozantinib Abbreviated New Drug Application litigation with MSN Pharmaceuticals in the Spring timeframe of 2024; expansion of zanzalintinib’s pivotal development program with priorities defined by emerging phase 1b/2 data and potential clinical co-funding opportunities; advancing JEWEL-101, the phase 1 study of XB002, a next-generation tissue factor-targeting antibody-drug conjugate (ADC), alone and in combination with immunotherapy in a variety of solid tumor settings with the goal of prioritizing sensitive tumor types for full development; accelerating the phase 1 development of XL309, a potentially best-in-class small molecule inhibitor of USP1, as a potential therapy for tumors that have become refractory to PARP inhibitor (PARPi) therapy, including forms of ovarian, breast and prostate cancers, and pursuing potential PARPi combinations; potentially filing three Investigational New Drug applications for XB010 (5T4-MMAE ADC), XB628 (PD-L1 + NKG2A bispecific antibody), and XL495 (small molecule PKMYT1 inhibitor) if preclinical data continue to be supportive; and advancing two new programs to development candidate status, including a small molecule PLK4 inhibitor and an additional ADC. Exelixis presented the details of its key priorities and anticipated milestones at the 42nd Annual J.P. Morgan Healthcare Conference.

Share Repurchase Program. As of March 31, 2024, Exelixis has repurchased $190.7 million of the company’s common stock, at an average price of $22.08 per share. In January, Exelixis announced that the company’s Board of Directors authorized the repurchase of up to an additional $450 million of the company’s common stock before the end of 2024. Upon fulfillment of the 2024 share repurchase program, the company expects to have returned $1 billion to shareholders over two years along with the 2023 program successfully completed in December 2023. Share repurchases under the 2024 program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any share repurchases under the share repurchase program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of Exelixis’ common stock and general market conditions.

Appointments of Two New Board Members with Extensive Drug Development and Corporate Governance Expertise. In January, Exelixis announced the appointments of Mary C. Beckerle, Ph.D., and S. Gail Eckhardt, M.D., to the Exelixis Board of Directors, effective January 5, 2024. Dr. Beckerle is Chief Executive Officer of the Huntsman Cancer Institute and Associate Vice President for Cancer Affairs and Distinguished Professor of Biology and Oncological Sciences at the University of Utah. Since 2006, she has had responsibility for the vision, strategic direction and management of the University’s oncology programs, including research, care, education and community outreach. Dr. Eckhardt is Associate Dean of Experimental Therapeutics at Baylor College of Medicine and Associate Director of Translational Research at the College’s Dan L. Duncan Comprehensive Cancer Center. A recognized leader in translational medicine relative to oncology, she has focused her career on the preclinical and early clinical development of molecularly targeted therapies and combination regimens to treat colorectal and other gastrointestinal cancers.

European Patent Office (EPO) Rules in Favor of Exelixis on Formulation Patent Covering Cabozantinib Tablets. In January, Exelixis successfully defended European Patent number EP2593090 (c-MET Modulator Pharmaceutical Compositions) against three opponents, STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd. and Generics (U.K.) Ltd., in a hearing before the Opposition Division of the EPO. The patent at issue, which expires on July 18, 2031, covers tablet formulations of cabozantinib, including the tablet formulation approved as CABOMETYX (cabozantinib) tablets by the European Medicines Agency. The decision is specific to the European patent at issue and is subject to appeal to the EPO Technical Boards of Appeal.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal period ended March 29, 2024 is indicated as being as of and for the period ended March 31, 2024.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the first quarter of 2024 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, April 30, 2024.

To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.