Rezolute to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

On February 4, 2026 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), reported that management will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026, taking place February 11-12, 2026 in New York.

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Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their Guggenheim representative.

(Press release, Rezolute, FEB 4, 2026, View Source [SID1234662482])

Lilly reports fourth-quarter 2025 financial results and provides 2026 guidance

On February 4, 2026 Eli Lilly and Company (NYSE: LLY) reported its financial results for the fourth-quarter of 2025 and provided 2026 financial guidance.

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"2025 was an important year for Lilly," said David A. Ricks, Lilly’s chair and CEO. "We reached millions more patients—launching Inluriyo, expanding Mounjaro and Kisunla globally, and submitting orforglipron for approval. We expanded our manufacturing capacity, and through our U.S. government agreement, opened new access to obesity medicines. Entering our 150th year with a deep pipeline and platforms like LillyDirect, we’re positioned to reach more patients than ever and expand our global health impact."

Financial Results

$ in millions, except

per share data

Fourth-Quarter

2025

2024

% Change

Revenue

$ 19,292

$ 13,533

43 %

Net income – Reported

6,636

4,410

50 %

Earnings per share – Reported

7.39

4.88

51 %

Net income – Non-GAAP

6,771

4,806

41 %

Earnings per share – Non-GAAP

7.54

5.32

42 %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Fourth-Quarter Reported Results
In Q4 2025, worldwide revenue was $19.3 billion, an increase of 43% compared with Q4 2024, driven by a 46% increase in volume, partially offset by a 5% decrease due to lower realized prices. Key Products[1] revenue grew to $13.8 billion in Q4 2025, led by Mounjaro and Zepbound.

Revenue in the U.S. increased 43% to $12.9 billion, driven by a 50% increase in volume, partially offset by a 7% decrease due to lower realized prices. The increase in U.S. volume and decline in realized prices were driven by Zepbound and Mounjaro.

Revenue outside the U.S. increased 43% to $6.4 billion, driven by a 38% increase in volume and to a lesser extent a 4% favorable impact on foreign exchange rates. The volume increase outside the U.S. was driven primarily by Mounjaro, partially offset by Jardiance. Volume growth was negatively impacted by a one-time benefit of $300 million related to Jardiance, associated with an amendment to the company’s collaboration with Boehringer Ingelheim, in Q4 2024.

1 The Company defines Key Products as Ebglyss, Inluriyo (effective Q4 2025), Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio and Zepbound.

Gross margin increased 43% to $15.9 billion in Q4 2025. Gross margin as a percent of revenue was 82.5%, an increase of 0.3 percentage points. The increase in gross margin percent was primarily driven by favorable product mix and improved cost of production, partially offset by lower realized prices.

In Q4 2025, research and development expenses increased 26% to $3.8 billion, or 20% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling and administrative expenses increased 29% to $3.1 billion in Q4 2025, primarily driven by promotional efforts supporting ongoing and planned launches.

The effective tax rate was 19.7% in Q4 2025 compared with 12.5% in Q4 2024 primarily driven by a less favorable jurisdictional mix of earnings in Q4 2025 relative to Q4 2024. Additionally, the effective tax rate for Q4 2025 was unfavorably impacted by U.S. tax law changes enacted earlier in 2025.

In Q4 2025, net income and earnings per share (EPS) were $6.6 billion and $7.39, respectively, compared with net income of $4.4 billion and EPS of $4.88 in Q4 2024. EPS in Q4 2025 and Q4 2024 included acquired IPR&D charges of $0.52 and $0.19, respectively.

Fourth-Quarter Non-GAAP Measures
On a non-GAAP basis, Q4 2025 gross margin increased 42% to $16.0 billion. Gross margin as a percent of revenue was 83.2%, consistent with Q4 2024. Favorable product mix and improved cost of production were offset by lower realized prices.

The non-GAAP effective tax rate was 19.7% in Q4 2025 compared with 13.2% in Q4 2024 primarily driven by a less favorable jurisdictional mix of earnings in Q4 2025 relative to Q4 2024. Additionally, the effective tax rate for Q4 2025 was unfavorably impacted by U.S. tax law changes enacted earlier in 2025.

On a non-GAAP basis, Q4 2025 net income and EPS were $6.8 billion and $7.54, respectively, compared with net income of $4.8 billion and EPS of $5.32 in Q4 2024. Non-GAAP EPS in Q4 2025 and Q4 2024 included acquired IPR&D charges of $0.52 and $0.19, respectively.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Fourth-Quarter

2025

2024

% Change

Earnings per share (reported)

$ 7.39

$ 4.88

51 %

Amortization of intangible assets

.11

.12

Asset impairment, restructuring and other special charges

.07

.30

Net losses (gains) on investments in equity securities

(.03)

.02

Earnings per share (non-GAAP)

$ 7.54

$ 5.32

42 %

Acquired IPR&D

.52

.19

174 %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

Fourth-Quarter

Full Year

Selected Products

2025

2024

% Change

2025

2024

% Change

Mounjaro

$ 7,409

$ 3,530

110 %

$ 22,965

$ 11,540

99 %

Zepbound(1)

4,261

1,907

123 %

13,542

4,926

175 %

Verzenio

1,604

1,555

3 %

5,723

5,307

8 %

Total Revenue

19,292

13,533

43 %

65,179

45,043

45 %

(1) Tirzepatide is marketed for obesity under the brand name Zepbound in Canada, Japan, and the United States.

Mounjaro
For Q4 2025, worldwide Mounjaro revenue increased 110% to $7.4 billion. U.S. revenue was $4.1 billion, an increase of 57%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $3.3 billion compared with $899 million in Q4 2024, primarily driven by volume growth.

Zepbound
For Q4 2025, U.S. Zepbound revenue increased 122% to $4.2 billion, compared with $1.9 billion in Q4 2024, primarily driven by increased demand, partially offset by lower realized prices.

Verzenio
For Q4 2025, worldwide Verzenio revenue increased 3% to $1.6 billion. U.S. revenue was $997 million, a decrease of 4%. Revenue outside the U.S. was $608 million, an increase of 18%, primarily driven by volume growth.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

Regulatory

Lilly’s sofetabart mipitecan receives U.S. FDA’s Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer (announcement)

U.S. FDA approves expanded indication for Lilly’s Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor (announcement)

Clinical

Lilly’s Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with active psoriatic arthritis and obesity or overweight (announcement)

Lilly’s orforglipron helped people maintain weight loss after switching from injectable incretins to oral GLP-1 therapy in first-of-its-kind Phase 3 trial (announcement)

Updated data for Lilly’s Inluriyo (imlunestrant) reinforce efficacy results as monotherapy and in combination with Verzenio (abemaciclib) in ER+, HER2- advanced breast cancer (announcement)

Lilly’s triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful Phase 3 trial (announcement)

Lilly’s Jaypirca (pirtobrutinib) significantly improved progression-free survival, reducing the risk of progression or death by 80%, versus chemoimmunotherapy in patients with treatment-naïve CLL/SLL (announcement)

Lilly’s Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib) (announcement)

Lilly’s selective amylin agonist, eloralintide, demonstrated meaningful weight loss and favorable tolerability in a Phase 2 study of adults with obesity or overweight (announcement)

Other

Lilly selects Pennsylvania as home for its newest injectable medicine and device manufacturing facility (announcement)

NVIDIA and Lilly Announce Co-Innovation AI Lab to Reinvent Drug Discovery In the Age of AI (announcement)

Lilly to acquire Ventyx Biosciences to advance oral therapies targeting inflammatory-mediated diseases (announcement)

Lilly to build $6 billion facility to manufacture active pharmaceutical ingredients in Alabama (announcement)

Lilly and Adverum announce expiration and completion of Adverum tender offer and acquisition (announcement)

Carolyn Bertozzi returns to Lilly board of directors (announcement)

Lilly announces plans to open Lilly Gateway Labs site in Philadelphia (announcement)

Lilly announces two new Executive Committee members and expansion of leadership roles to prepare for next wave of growth (announcement)

Lilly and U.S. government agree to expand access to obesity medicines to millions of Americans (announcement)

Lilly plans to build a new $3 billion facility to boost oral medicine manufacturing capacity in Europe for patients worldwide (announcement)

For information on important public announcements, visit the news section of Lilly’s website.

2026 Financial Guidance
In addition to providing guidance for GAAP revenue, Lilly provides guidance for certain non-GAAP measures. Lilly does not provide reconciliations of forward-looking non-GAAP measures to the most directly comparable GAAP measures because comparable GAAP measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for a reconciliation. In particular, Lilly cannot reasonably predict certain items including net gains and losses on equity securities, asset impairment, acquisition or divestiture-related items, restructuring and other adjustments, without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on Lilly’s reported results in accordance with GAAP.

The following table summarizes the company’s full-year 2026 financial guidance:

2026 Guidance

Revenue

$80 to $83 billion

Performance Margin(1)(2)

46.0% to 47.5%

Tax Rate(2)(3)

18% to 19%

Earnings per Share(2)(3)(4)

$33.50 to $35.00

(1) The Company defines performance margin as gross margin less research and development
and marketing, selling, and administrative expenses divided by revenue.

(2) Excludes the impact of intangible asset amortization.

(3) Guidance does not include acquired in-process research and development (IPR&D) either
incurred or expected to be incurred, after December 31, 2025.

(4) 2026 assumes shares outstanding of approximately 894 million

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q4 2025 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.

(Press release, Eli Lilly, FEB 4, 2026, View Source [SID1234662468])

Beyond Cancer Abstract Featuring Phase 1 Data on Intratumoral Ultra-High Concentration Nitric Oxide (UNO) in Solid Tumor Metastases to be Presented at the AACR Annual Meeting 2026

On February 4, 2026 Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors and subsidiary of Beyond Air, Inc. (NASDAQ: XAIR), reported being selected to present an abstract featuring data from the Phase 1 trial of intratumoral UNO in solid tumor metastases at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, which is scheduled to be held from Friday, April 17th, through Wednesday, April 22nd, at the San Diego Convention Center in San Diego, California. The original submitted abstract titles and text are scheduled to be published in an Online Itinerary Planner on March 17, 2026 at 4:30 PM ET / 1:30 PM PT.

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AACR Annual Meeting 2026 Abstract Details:
Presenter: Amichay Meirovitz, MD, Soroka University Medical Center, Beersheba, Israel
Session Category: Experimental and Molecular Therapeutics
Session Title: Innovative Therapeutic Modalities and Translational Platforms
Session Start: April 19, 2026 at 5:00 PM ET / 2:00 PM PT
Session End: April 19, 2026 at 8:00 PM ET / 5:00 PM PT
Location: Poster Section 13, San Diego Convention Center
Poster Board Number: 22
Poster Number: 304

(Press release, Beyond Air, FEB 4, 2026, View Source [SID1234662483])

Evogene and Shanghai Lishan Biopharmaceuticals Co. Announce
Exclusive Licensing Agreement for BMC128, a Microbiome-Based
Therapeutic for Renal and Lung Cancer

On February 4, 2026 Evogene Ltd. (Nasdaq/TASE: EVGN) ("Evogene"), a pioneering computational chemistry company specializing in generative design of small molecules for the pharmaceutical and agricultural industries, and Shanghai Lishan Biopharmaceuticals Co., Ltd. ("Lishan Biotech"), a China-based clinical-stage biotechnology company focused on innovative therapies in the fields of immunity and inflammation, reported that Biomica Ltd. ("Biomica"), Evogene’s subsidiary and Lishan Biotech entered into an exclusive worldwide licensing agreement for BMC128 (designated as LS-LBP-002 by Lishan Biotech), a first-in-class microbiome-based therapeutic designed to enhance anti-tumor immune activity. BMC128 was developed by Biomica and is currently completing a Phase 1 clinical study, showing promising early clinical results.

BMC128 is a live biopharmaceutical consortium composed of four human gut bacterial strains with defined functional capabilities that enhance responses to immunotherapy and stimulate anti-tumor immune activity. BMC128 is currently completing a Phase 1 clinical study in renal cell carcinoma and non-small cell lung cancer and has demonstrated encouraging early clinical promise. Results to date show an excellent safety and tolerability profile, together with early signs of efficacy, including a high proportion of patients with previously progressive disease achieving stable disease during treatment.

Under the agreement, Lishan Biotech will assume responsibility for global clinical development, manufacturing, and commercialization of BMC128. Biomica will be eligible to receive development milestone payments and royalties on future commercial sales, in accordance with an agreed-upon schedule.

Lishan Biotech plans to advance BMC128 into a Phase 2 clinical study and to pursue regulatory filings in both China and the United States for future commercialization.

Dr. Weijie Chen, Chairman of Lishan Biotech, stated: "This collaboration ensures that BMC128 continues to advance toward its next clinical milestones. We are impressed by the effects observed with BMC128 in lung and renal cancer patients who had experienced disease progression prior to treatment, and we look forward to advancing the program through further development and ultimately toward commercialization, for the benefit of cancer patients worldwide."

Ofer Haviv, CEO of Evogene and Biomica, commented: "We are pleased to partner with Lishan Biotech as BMC128 enters its next phase of development. Lishan Biotech’s strong development capabilities and commitment to innovative microbiome-based therapeutics position this program for meaningful value creation in difficult-to-treat cancers. As a major shareholder of Biomica, Evogene expects to benefit from BMC128’s future success."

Dr. Jing Bao, MD, a Director (Board Member) of Biomica Ltd with a PhD from the Weizmann Institute of Science, stated: "We are very pleased to see the execution of this meaningful and impactful collaboration agreement. This partnership brings together China’s clinical development capabilities with Israel’s innovation in microbiome science. We believe the success of this project will benefit patients worldwide and contribute to important breakthroughs in microbiome-based therapeutics."

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(Press release, Evogene, FEB 4, 2026, View Source [SID1234662469])

Providence Therapeutics Announces World-First Personalized Pediatric mRNA Cancer Vaccine Trial

On February 4, 2026 Providence Therapeutics, a Canadian clinical-stage mRNA biotechnology company, reported a world-first clinical trial evaluating personalized mRNA cancer vaccines for children with advanced and treatment-resistant brain tumors.

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The PaedNEO-VAX trial, funded by Providence Therapeutics, in combination with the Australian Government and a host of philanthropic donors, is the first multi-site pediatric study to test individualized mRNA vaccines designed specifically for each child’s cancer.

The trial is co-led by The University of Queensland and the South Australian Health and Medical Research Institute (SAHMRI) and will begin in March 2026 across seven pediatric hospitals in Queensland, South Australia, New South Wales, Victoria, and Western Australia. It is sponsored by the Australia & New Zealand Children’s Haematology and Oncology Group (ANZCHOG).

Providence Therapeutics is contributing its proprietary mRNA vaccine platform and manufacturing expertise to support the creation of personalized vaccines tailored to each patient’s tumor biology.

A New Frontier for Pediatric Brain Cancer

PaedNEO-VAX is open to children and adolescents with relapsed or refractory high-grade brain tumors, including high-grade glioma, diffuse midline glioma, medulloblastoma, and ependymoma.

Phase I will establish safety and optimal dosing, while Phase II will evaluate clinical outcomes such as disease progression, survival, and quality of life for patients and families.

Using genome sequencing and advanced data analysis, tumor-specific targets will be identified for each child. Customized mRNA vaccines will then be manufactured in Australia by Southern RNA, with an expected turnaround of approximately 10 weeks from enrollment to dosing.

"Where Hope and Science Intersect"

Providence’s interest in pediatric brain cancer is deeply rooted and personal.

"In 2013, my 13-year-old son Adam was diagnosed with glioblastoma multiforme (GBM) and given about 12 months to live. We were fortunate that we were able to get him into remission, and in 2015 I founded Providence Therapeutics with the mission to be ready if his cancer came back." said Brad Sorenson, Founder and CEO of Providence Therapeutics. "In early 2024 that horrible day came when his GBM recurred in his brainstem and throughout his spine, and we rushed to make a personalized vaccine for him. Adam was the first person to receive a Providence cancer vaccine, and he responded remarkably well. It is a rare good-news story, and he is still doing well today. Providence’s mission today is to see Adam’s success shared as widely as possible."

"This trial embodies our mantra of ‘Where Hope and Science Intersect.’ After more than a decade of scientific work, Providence is honoured to help bring hope to families facing devastating diagnoses. We are proud to support this world-first pediatric trial in Australia and hopeful that it will pave the way for similar initiatives in Canada and throughout the world."

An Open Invitation to Canada and the USA

Providence Therapeutics views this landmark trial as both a scientific breakthrough and a model for collaboration.

Following the Australian example, Providence welcomes dialogue with Canadian and USA leaders, cancer foundations, and cancer research organizations interested in exploring how similar cancer vaccine programs could be advanced in Canada and the USA.

This trial demonstrates what is possible when public investment, clinical leadership, and patient-driven innovation align — offering children and families facing the most aggressive cancers something profoundly needed: Hope.

(Press release, Providence Therapeutics, FEB 4, 2026, View Source [SID1234662484])