Leronlimab- A novel therapeutic in CCR5+ immuno-oncology

On April 30, 2026 Cytodyn presented its corporate presentation.

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(Presentation, CytoDyn, APR 30, 2026, View Source [SID1234664964])

Huahui Health and BeOne Medicines Enter into a Global Exclusive Option, License and Collaboration Agreement for Innovative Oncology Drug HH160

On April 30, 2026 Huahui Health reported that it has entered into a global exclusive option, license and collaboration agreement with BeOne Medicines for HH160, a novel trispecific antibody in oncology immunotherapy. Under the agreement, BeOne Medicines is granted an exclusive option covering the development, manufacturing, and commercialization of HH160 worldwide.

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Pursuant to the agreement, BeOne Medicines will pay Huahui Health an upfront payment of USD 20 million. Upon exercise of the option by BeOne Medicines, Huahui Health will be entitled to receive an additional USD 100 million option exercise payment. Subject to the achievement of development, regulatory and sales milestones, Huahui Health is eligible to receive milestone payments of up to USD 1.9 billion in milestone payments, as well as tiered royalties on net sales. The parties have also agreed to maintain discussions regarding BeOne Medicines’ potential participation in Huahui Health’s future financing activities, with specific transaction terms and details to be negotiated separately.

Dr. Chen Bin, CEO of Huahui Health, stated, "Huahui Health has established an integrated research and development engine covering the full drug development value chain, enabling the independent identification of novel targets and development of proprietary drug candidates. Our pipeline includes one marketed product and several clinical-stage programs in Phase II, reflecting strong industry recognition of our R&D capabilities. BeOne Medicines is distinguished by its outstanding innovation capacity and global development expertise. We are delighted to deepen our collaboration with BeOne Medicines to advance HH160, a novel trispecific antibody for cancer immunotherapy, and to bring innovative immuno-oncology treatments to patients worldwide as early as possible."

In January 2026, China’s NMPA granted conditional approval to Libevitug injection, Huahui Health’s first commercial product, for chronic hepatitis D infection in adults with or without compensated cirrhosis. As a human monoclonal antibody targeting the PreS1 domain of HBV and HDV envelope protein, it blocks viral entry into hepatocytes. A pioneering first-in-class antibody for viral hepatitis and China’s first approved HDV therapy, Libevitug fills a critical unmet clinical gap. It received Breakthrough Therapy Designation from both NMPA and FDA, with its global Phase III trial now underway.

Going forward, Huahui Health will leverage its robust in-house innovation platforms and full-chain R&D strengths to advance first-in-class and best-in-class candidates across liver diseases and oncology. Backed by a rich layered pipeline spanning preclinical to clinical stages, the company demonstrates outstanding independent innovation and sustainable capacity to deliver original novel drugs worldwide.

About HH160

HH160 is a novel trispecific antibody developed by Huahui Health using its proprietary PolyBoost multispecific antibody platform. HH160 simultaneously targets PD-1, CTLA-4, and VEGF-A, three clinically validated targets in cancer immunotherapy and anti-angiogenesis. Through its "three-in-one" synergistic mechanism of action, HH160 is expected to enhance therapeutic efficacy, achieve tumor-specific drug distribution, and reduce treatment-related adverse effects. Positive preclinical results for HH160 were presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) held in Chicago, United States.

(Press release, Huahui Health, APR 30, 2026, View Source [SID1234664982])

Q1 2026 Results

On April 30, 2026 Bristol-Myers Squibb reported first quarter 2026 financial results.

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(Presentation, Bristol-Myers Squibb, APR 30, 2026, View Source [SID1234664998])

Lilly reports first-quarter 2026 financial results, raises full year guidance, and highlights momentum of new medicines

On April 30, 2026 Eli Lilly and Company (NYSE: LLY) reported its financial results for the first quarter of 2026 and provided updated 2026 financial guidance.

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"2026 is off to a strong start, we delivered 56% revenue growth in the first quarter and raised our full-year revenue guidance by $2 billion," said David A. Ricks, Lilly chair and CEO. "A key milestone was the U.S. FDA approval of Foundayo—the only approved GLP-1 pill that can be taken any time of day, without food and water restrictions. Foundayo will meaningfully expand the number of people who can benefit from GLP-1s. We also delivered pipeline progress across all four therapeutic areas and continued investing in Lilly’s future growth through four acquisitions."

Financial Results

$ in millions, except

per share data

First-Quarter

2026

2025

% Change

Revenue

$ 19,799

$ 12,729

56 %

Net income – Reported

7,396

2,759

168 %

Earnings per share – Reported

8.26

3.06

170 %

Net income – Non-GAAP

7,663

3,004

155 %

Earnings per share – Non-GAAP

8.55

3.34

156 %

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

First-Quarter Reported Results
In Q1 2026, worldwide revenue was $19.8 billion, an increase of 56% compared with Q1 2025, driven by a 65% increase in volume, partially offset by a 13% decrease due to lower realized prices. Key Products1 revenue grew to $13.4 billion in Q1 2026, led by Mounjaro and Zepbound. Key Products revenue in the Immunology, Oncology, and Neuroscience therapeutic areas grew 160% in Q1 2026 compared to Q1 2025.

Revenue in the U.S. increased 43% to $12.1 billion, driven by a 49% increase in volume, partially offset by a 7% decrease due to lower realized prices. The increase in U.S. volume was driven by Zepbound and Mounjaro and the decline in realized prices was primarily driven by Zepbound and Taltz.

Revenue outside the U.S. increased 81% to $7.7 billion, driven by a 95% increase in volume, partially offset by a 25% decrease due to lower realized prices. The lower realized prices outside the U.S. were driven primarily by the addition of Mounjaro to the National Reimbursed Drug List (NRDL) in China. The volume increase outside the U.S. was driven by Mounjaro. Jardiance revenue outside the U.S. included one-time benefits of $250 million in Q1 2026 compared to $370 million in Q1 2025, associated with the company’s collaboration with Boehringer Ingelheim.

1 The Company currently defines Key Products as Ebglyss, Inluriyo, Jaypirca, Kisunla, Mounjaro, Omvoh, and Zepbound. Effective Q1 2026, Verzenio is excluded from Key Products.

Gross margin increased 54% to $16.2 billion in Q1 2026. Gross margin as a percent of revenue was 81.9%, a decrease of 0.6 percentage points versus the same quarter last year. The change was primarily driven by lower realized prices.

In Q1 2026, research and development expenses increased 28% to $3.5 billion, or 18% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling, and administrative expenses increased 19% to $2.9 billion in Q1 2026, primarily driven by promotional efforts supporting ongoing and planned launches.

In Q1 2026, the company recognized acquired in-process research and development (IPR&D) charges of $584 million compared with $1.6 billion in Q1 2025. The Q1 2025 charges primarily related to the acquisition of Scorpion Therapeutics, Inc.’s PI3Kα inhibitor program STX-478.

Asset impairment, restructuring and other special charges of $279 million in Q1 2026 were primarily related to litigation matters. In Q1 2025, there was a charge of $35 million related to intangible asset impairments.

The effective tax rate was 16.4% in Q1 2026 compared with 20.2% in Q1 2025, primarily driven by the unfavorable tax impact of a non-deductible acquired IPR&D charge in Q1 2025. The 2026 and 2025 effective tax rates were impacted by net discrete tax benefits in each period.

In Q1 2026, net income and earnings per share (EPS) were $7.4 billion and $8.26, respectively, compared with net income of $2.8 billion and EPS of $3.06 in Q1 2025. EPS in Q1 2026 and Q1 2025 included acquired IPR&D charges of $0.52 and $1.72, respectively.

First-Quarter Non-GAAP Measures
On a non-GAAP basis, Q1 2026 gross margin increased 54% to $16.4 billion. Gross margin as a percent of revenue was 82.6%, a decrease of 0.9 percentage points versus the same quarter last year. The change was primarily driven by lower realized prices.

The non-GAAP effective tax rate was 16.5% in Q1 2026 compared with 20.2% in Q1 2025, primarily driven by the unfavorable tax impact of a non-deductible acquired IPR&D charge in Q1 2025. The 2026 and 2025 effective tax rates were impacted by net discrete tax benefits in each period.

On a non-GAAP basis, Q1 2026 net income and EPS were $7.7 billion and $8.55, respectively, compared with net income of $3.0 billion and EPS of $3.34 in Q1 2025. Non-GAAP EPS in Q1 2026 and Q1 2025 included acquired IPR&D charges of $0.52 and $1.72, 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.

First-Quarter

2026

2025

% Change

Earnings per share (reported)

$ 8.26

$ 3.06

170 %

Amortization of intangible assets

.11

.11

Asset impairment, restructuring and other special charges

.25

.03

Net losses (gains) on investments in equity securities

(.07)

.13

Earnings per share (non-GAAP)

$ 8.55

$ 3.34

156 %

Acquired IPR&D

.52

1.72

(70) %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

First-Quarter

Selected Products

2026

2025

% Change

Mounjaro

$ 8,662

$ 3,842

125 %

Zepbound(1)

4,160

2,312

80 %

Jaypirca

165

92

79 %

Ebglyss

145

60

141 %

Kisunla

124

22

NM

Omvoh

80

37

115 %

Inluriyo

35

NM

Total Revenue

19,799

12,729

56 %

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

NM – not meaningful

Mounjaro
For Q1 2026, worldwide Mounjaro revenue increased 125% to $8.7 billion. U.S. revenue was $4.2 billion, an increase of 59%, reflecting strong demand, partially offset by lower realized prices. Lower realized prices were partially offset by a favorable one-time adjustment to estimates for rebates and discounts in Q1 2026. Revenue outside the U.S. increased to $4.4 billion compared with $1.2 billion in Q1 2025, primarily driven by volume growth, partially offset by lower realized prices driven by the addition of Mounjaro to the NRDL within the China market.

Zepbound
For Q1 2026, U.S. Zepbound revenue increased 79% to $4.1 billion, compared with $2.3 billion in Q1 2025, primarily driven by strong demand, partially offset by lower realized prices, including previously announced reductions in cash pay prices. Lower realized prices were partially offset by a favorable one-time adjustment to estimates for rebates and discounts in Q1 2026.

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

Regulatory

FDA approves Lilly’s Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions (announcement)

Lilly’s Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata (announcement)

Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen (announcement)

Clinical

ACHIEVE-4, the longest Phase 3 study of Lilly’s Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health (announcement)

Lilly’s Jaypirca (pirtobrutinib) significantly extended progression-free survival when added to a venetoclax time-limited regimen in patients with previously treated CLL/SLL (announcement)

Phase 3b data presented at AAD Annual Meeting show Lilly’s Taltz (ixekizumab) plus Zepbound (tirzepatide) delivered superior efficacy for adults with psoriatic arthritis and obesity (announcement)

Lilly’s EBGLYSS (lebrikizumab-lbkz) delivered up to four years of durable disease control for patients with moderate-to-severe atopic dermatitis (announcement)

Lilly’s triple agonist, retatrutide, demonstrated significant reductions in A1C and weight in first Phase 3 trial for treatment of type 2 diabetes (announcement)

Lilly’s EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive Phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis (announcement)

Lilly’s oral GLP-1, orforglipron, delivered superior blood sugar control and weight loss compared to oral semaglutide in head-to-head type 2 diabetes trial published in The Lancet (announcement)

Patients with Crohn’s disease maintained steroid-free remission for three years with Lilly’s Omvoh (mirikizumab-mrkz) (announcement)

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

Lilly’s Retevmo (selpercatinib) delivers substantial event-free survival benefit as an adjuvant therapy in early-stage RET fusion-positive lung cancer (announcement)

Other

Lilly to acquire Ajax Therapeutics to advance outcomes for patients with myelofibrosis and polycythemia vera (announcement)

Lilly to acquire Kelonia Therapeutics to advance in vivo CAR-T cell therapies (announcement)

Foundayo (orforglipron), Lilly’s new oral GLP-1 pill for weight loss, now available in the U.S. (announcement)

Lilly to acquire Centessa Pharmaceuticals to advance treatments for sleep-wake disorders (announcement)

Lilly Employer Connect platform launches with over fifteen independent program administrators offering tailored obesity coverage options to expand access to patients (announcement)

Lilly to acquire Orna Therapeutics to advance cell therapies (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.

The following table summarizes the company’s updated full-year 2026 non-GAAP financial guidance, reflecting the strong revenue performance in Q1:

Prior

Updated

Revenue

$80 to $83 billion

$82 to $85 billion

Performance Margin(1)(2)

46.0% to 47.5%

47.0% to 48.5%

Tax Rate(1)(3)

18% to 19%

Unchanged

Earnings per Share(1)(3)(4)

$33.50 to $35.00

$35.50 to $37.00

(1) 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. See Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) table
below for additional Non-GAAP information.

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

(3) Guidance does not include acquired in-process research and development (IPR&D) incurred after March 31, 2026.

(4) 2026 assumes shares outstanding of approximately 895 million and foreign currency exchange rate assumptions of 1.16 (Euro), 153
(Yen) and 7.1 (Yuan)

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q1 2026 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, APR 30, 2026, View Source [SID1234664965])

Factor Bioscience to Showcase Engineered iMacrophages (FACT-112) Targeting Ovarian Cancer In Vivo at ISCT 2026

On April 30, 2026 Factor Bioscience Inc., a Cambridge-based biotechnology company focused on using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported its participation in the International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting to be held in Dublin, Ireland from May 6-9, 2026. Factor will deliver an oral presentation on FACT-112, Factor’s IL12-expressing iMacrophage program for solid tumors.

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"We are excited to share the latest pre-clinical data from our FACT-112 program at ISCT," said Dr. Matt Angel, Co-Founder, Chairman and CEO of Factor. "The striking anti-tumor activity of our engineered iMacrophages, demonstrated in vivo, represents a major milestone for the company, underscoring our commitment to translating cutting-edge science into clinically meaningful therapies."

Factor’s Associate Director of Cell Engineering, Ian Hay, who will deliver the presentation, added, "these data illustrate the intrinsic capacity of IL12-expressing iMacrophages to repolarize the immunosuppressive ovarian tumor microenvironment and elicit immune-mediated tumor rejection. We are excited about the potential to develop FACT-112 into a safe, effective option to patients with solid tumors."

Details of the oral presentation are below:

"iPSC-Derived Macrophages Engineered to Express IL-12 Modulate the Tumor Microenvironment and Support T Cell Lysis of Ovarian Cancer Models" -to be presented by Ian Hay on Wednesday, May 6 from 1:00-2:00 pm GMT, in the Immunotherapy Oral Presentation Session.

For more information about the International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting, visit www.isctglobal.org/annual-meeting.

(Press release, Factor Bioscience, APR 30, 2026, View Source [SID1234664983])