aTyr Pharma Presents Preclinical Data for NRP2-Targeting Antibody ATYR2810 at the American Association for Cancer Research (AACR) Annual Meeting 2025

On April 29, 2025 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported that the Company will present a poster featuring preclinical data for ATYR2810, a monoclonal antibody targeting neuropilin-2 (NRP2), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, which is being held April 25 – 30, 2025, in Chicago, IL (Press release, aTyr Pharma, APR 29, 2025, View Source [SID1234652330]).

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"Aggressive cancers like glioblastoma multiforme (GBM) continue to show drug resistance, and the efficacy of current immunotherapies may be limited due to immunosuppressive myeloid cells in the tumor microenvironment that contribute to drug resistance. We are pleased to see that ATYR2810 appears to combat drug resistance mechanisms, and we are particularly encouraged by its ability to increase survival and improve the effectiveness of checkpoint inhibitors in a GBM model," said Leslie A. Nangle, Ph.D., Vice President, Research, at aTyr. "These findings, which were generated as part of our ongoing research collaboration with Dr. Michael Lim and Stanford Medicine, demonstrate the role of NRP2 in maintaining the immunosuppressive tumor microenvironment and suggest that blocking NRP2 may offer a new approach to treating GBM, both as a monotherapy and in combination with anti-PD-1 therapies."

Details of the poster presentation appear below. The poster will be available on the aTyr website once presented.

Title: Immunosuppressive myeloid cells can be modulated with NRP2-targeting antibody ATYR2810 leading to enhanced anti-tumor immunity
Authors: Christoph Burkart, Clara Polizzi, John Choi, Max Pastenes, Alison Barber, Michael Lim, Leslie Nangle. aTyr Pharma, San Diego. Department of Neurosurgery, Stanford School of Medicine, Stanford.
Session: Antibodies and Antibody-Drug Conjugates
Poster Number: 27
Date and Time: Tuesday, April 29, 2025 from 9:00AM – 12:00PM CT
Location: Poster Board Section 36, McCormick Place Convention Center, Chicago, IL

The poster presents preclinical research evaluating the use of ATYR2810 in syngeneic tumor models including the orthotopic CT-2A mouse model of GBM, which has a high prevalence of myeloid-derived suppressor cells that exhibit enriched expression of NRP2 and promote an immunosuppressive tumor microenvironment. The findings demonstrate that ATYR2810 when used as a single agent enhanced anti-tumor immunity and resulted in a significant increase in overall survival. Additionally, when combined with an anti-PD-1 agent, ATYR2810 further increased survival and reduced tumor size. These findings suggest that modulating NRP2 may offer a new approach to reversing the immunosuppressive function of myeloid cells in the tumor microenvironment.

AstraZeneca’s Q1 2025 Financial Results

On April 29, 2025 AstraZeneca reported Q1 2025 Financial Results (Press release, AstraZeneca, APR 29, 2025, View Source [SID1234652346]).

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Revenue and EPS summary

Q1 2025

% Change

$m

Actual

CER1

– Product Sales

12,875

6

9

– Alliance Revenue

639

40

42

Product Revenue2

13,514

7

10

Collaboration Revenue

74

64

Total Revenue

13,588

7

10

Reported EPS ($)

1.88

34

32

Core3 EPS ($)

2.49

21

21

Key performance elements for Q1 2025

(Growth numbers at constant exchange rates)

Total Revenue up 10% to $13,588m, driven by double-digit growth in Oncology and BioPharmaceuticals
Growth in Total Revenue across all major geographic regions
Core Operating profit increased 12%
Core Tax rate of 16% in the quarter due to timing of settlements. Expectations for the full year Core tax rate are unchanged at 18-22%
Core EPS increased 21% to $2.49
Five positive Phase III readouts and 13 approvals in major regions since the prior results
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:

"Our strong growth momentum has continued into 2025 and we have now entered an unprecedented catalyst-rich period for our company.

Already this year we have announced five positive Phase III study readouts, including most recently the highly anticipated DESTINY-Breast09 for Enhertu, as well as SERENA-6 for camizestrant and MATTERHORN for Imfinzi; the latter two of these will feature in the ASCO (Free ASCO Whitepaper) 2025 plenary sessions, reflecting the significance of these data to the oncology community.

Our company is firmly committed to investing and growing in the US and we continue to benefit from our broad-based source of revenue and global manufacturing footprint, including eleven production sites in the US covering small molecules, biologics as well as cell therapy. Additionally, we have even greater US investment in manufacturing and R&D planned, leveraging our two large R&D sites in Gaithersburg MD and Cambridge MA.

Overall, we are making excellent progress toward our ambition of eighty billion dollars in Total Revenue by 2030."

See Table 1 for details of clinical trial results since the prior earnings announcement, including DESTINY-Breast09, MATTERHORN, and SERENA-6.

See Note 4 for the locations of the eleven US manufacturing sites.

Guidance

AstraZeneca reiterates its Total Revenue and Core EPS guidance5 for FY 2025 at CER, based on the average foreign exchange rates through 2024.

Total Revenue is expected to increase by a high single-digit percentage

Core EPS is expected to increase by a low double-digit percentage

– The Core Tax rate is expected to be between 18-22%

– If foreign exchange rates for April 2025 to December 2025 were to remain at the average rates seen in March 2025, it is anticipated that compared to the performance at CER, FY 2025 Total Revenue would incur a low single-digit percentage adverse impact (unchanged from prior guidance), and Core EPS would incur a low single-digit percentage adverse impact (previously mid single-digit).

Results highlights

Table 1. Milestones achieved since the prior results announcement

Phase III and other registrational data readouts

Medicine

Trial

Indication

Event

Enhertu

DESTINY-Gastric04

HER2-positive gastric/GEJ cancer (2nd-line)

Primary endpoint met

Enhertu

DESTINY-Breast09

HER2-positive metastatic breast cancer (1st line)

Primary endpoint met for combination arm

Imfinzi

MATTERHORN

Resectable gastric/GEJ cancer

Primary endpoint met

camizestrant

SERENA-6

HR+ HER2- metastatic breast cancer (1st line switch on emergence of ESR1m)

Primary endpoint met

eneboparatide

CALYPSO

Chronic hypoparathyroidism

Primary endpoint met, trial continues to 52 weeks

Regulatory approvals

Medicine

Trial

Indication

Region

Calquence

ACE-LY-004

Relapsed/refractory MCL

EU

Calquence

ChangE

CLL/SLL

CN

Datroway

TROPION-Breast01

HR+ HER2- breast cancer (2nd-line)

EU

Enhertu

DESTINY-Breast06

HER2-low and -ultralow HR+ breast cancer (2nd-line+)

EU

Imfinzi

AEGEAN

Resectable early-stage (IIA-IIIB) NSCLC

EU, CN

Imfinzi

NIAGARA

MIBC

US

Imfinzi ± Imjudo

ADRIATIC

SCLC (limited-stage)

EU, JP

Truqap

CAPItello-291

Biomarker-altered HR+ HER2- metastatic breast cancer

CN

Wainzua

NEURO-TTRansform

ATTRv-PN

EU

Beyonttra (acoramidis)

NCT04622046

ATTR-CM

JP

Ultomiris

CHAMPION-MG

gMG

CN

Regulatory submissions or acceptances* in major regions

Medicine

Trial

Indication

Region

Enhertu

DESTINY-Breast06

HER2-low and -ultralow HR+ breast cancer (2nd-line+)

CN

Imfinzi

PACIFIC-5

Locally advanced NSCLC

CN

Imfinzi + Imjudo

HIMALAYA

Unresectable HCC

CN

Imfinzi

HIMALAYA

Unresectable HCC

CN

Imfinzi

DUO-E

Primary advanced or recurrent endometrial cancer with mismatch repair deficiency

CN

Fasenra

MANDARA

EGPA

CN

Tezspire

WAYPOINT

CRSwNP

US, EU, JP, CN

Koselugo

KOMET

NF1-PN (adults)

US, CN

* US, EU and China regulatory submissions denotes filing acceptance

Other pipeline updates

For recent trial starts and anticipated timings of key trial readouts, please refer to the Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations.html.

Table 2: Key elements of financial performance in Q1 2025

Item

Reported

Change

Core

Change

$m

Act

CER

$m

Act

CER

Product Revenue

13,514

7

10

13,514

7

10

■ See Tables 3 and 24 for medicine details of Product Revenue, Alliance Revenue and Product Sales

Collaboration Revenue

74

64

64

74

64

64

■ See Table 4 for details of Collaboration Revenue

Total Revenue

13,588

7

10

13,588

7

10

■ See Tables 5 and 6 for Total Revenue by Therapy Area and by region

Gross Margin (%)

84

+1pp

84

+1pp

+ Fluctuations in foreign exchange rates

− Pricing adjustments, for example to sales reimbursed by the Medicare Part D programme in the US

■ See ‘Reporting changes’ below for the definition of Gross Margin6

■ Variations in Gross Margin can be expected between periods, due to fluctuations in foreign exchange rates, product seasonality, Collaboration Revenue, and other effects

R&D expense

3,159

13

15

3,088

14

16

■ Core R&D: 23% of Total Revenue

+ Positive data read-outs for high value pipeline opportunities that have ungated late-stage trials

+ Investment in platforms, new technology and capabilities to enhance R&D capabilities

SG&A expense

4,492

3

3,457

1

4

■ Core SG&A: 25% of Total Revenue

Other operating income and expense7

113

71

71

115

79

78

+ Upfront receipt on a divestment

Operating Margin (%)

27

+2pp

+2pp

35

+1pp

Net finance expense

265

(12)

(11)

215

(12)

(11)

+ Debt issued in 2024 at higher interest rates

− Adjustment relating to tax settlements (see below)

Tax rate (%)

14

-8pp

-8pp

16

-6pp

-6pp

− Updates to estimates of prior period tax liabilities following settlements with tax authorities

EPS ($)

1.88

34

32

2.49

21

21

For monetary values the unit of change is percent; for Gross Margin, Operating Margin and Tax rate the unit of change is percentage points.

In the expense commentary above, the plus and minus bullets denote the directional impact of the item being discussed, e.g. a ‘+’ symbol beside an R&D expense comment indicates that the item resulted in an increase in the R&D spend relative to the prior year.

China

In April 2025, there are following developments in relation to the China investigations:

First, in relation to the illegal drug importation allegations, AstraZeneca received an Appraisal Opinion from the Shenzhen City Customs Office regarding suspected unpaid importation taxes amounting to $1.6 million. To the best of AstraZeneca’s knowledge, the importation taxes referred to in the Appraisal Opinion relate to Enhertu. A fine of between one and five times the amount of unpaid importation taxes may also be levied if AstraZeneca is found liable.

Second, in relation to the personal information infringement allegation, AstraZeneca received a Notice of Transfer to the Prosecutor from the Shenzhen Bao’an District Public Security Bureau (the ‘PSB’) regarding suspected unlawful collection of personal information. The Company has been informed that there was no illegal gain to the Company resulting from personal information infringement.

AstraZeneca continues to fully cooperate with the Chinese authorities.

Corporate and business development

FibroGen
In February 2025, FibroGen announced the sale of FibroGen China to AstraZeneca.

Under the terms of the agreement, FibroGen will receive an enterprise value of $85m plus FibroGen net cash held in China at closing, estimated at the date of signing to be approximately $75m, totalling approximately $160m. The transaction is expected to close by mid-2025, pending customary closing conditions, including regulatory review in China.

Upon closing, AstraZeneca will obtain all rights to roxadustat in China, including manufacturing in China.

EsoBiotec
In March 2025, AstraZeneca entered into a definitive agreement to acquire EsoBiotec, a biotechnology company pioneering in vivo cell therapies that has demonstrated promising early clinical activity. The EsoBiotec Engineered NanoBody Lentiviral (ENaBL) platform could offer many more patients access to transformative cell therapy treatments delivered in minutes rather than the current process which takes weeks.

AstraZeneca will acquire all outstanding equity of EsoBiotec for a total consideration of up to $1bn, on a cash and debt-free basis. This will include an initial payment of $425m on deal closing, and up to $575m in contingent consideration based on development and regulatory milestones. The transaction is expected to close in the second quarter of 2025, subject to customary closing conditions and regulatory clearances.

Alteogen Inc
In March 2025, AstraZeneca and Alteogen Inc. entered into an exclusive license agreement for ALT-B4, a novel hyaluronidase utilising Hybrozyme platform technology. Under the terms of the agreement, AstraZeneca has acquired worldwide rights to use ALT-B4 to develop and commercialise subcutaneous formulations of several oncology assets. Alteogen will be responsible for clinical and commercial supply of ALT-B4 to AstraZeneca. AstraZeneca has made an upfront payment to Alteogen and may make additional payments, conditional on achievement of specific development, regulatory and sales-related milestones. Additionally, Alteogen will receive royalties on the sales of the commercialised products.

Beijing R&D centre
In March 2025, AstraZeneca announced it will establish its sixth global strategic R&D centre, to be located in Beijing, China. It will be AstraZeneca’s second R&D centre in China, following the opening of the Shanghai R&D centre, and will advance early-stage research and clinical development, enabled by a state-of-the-art artificial intelligence and data science laboratory. The new R&D centre will be located near leading biotech companies, research hospitals, and the National Medical Products Administration in the Beijing International Pharmaceutical Innovation Park (BioPark).

Harbour BioMed
In March 2025, AstraZeneca executed a global strategic collaboration with Harbour BioMed to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. The strategic collaboration includes an option to license multiple programs utilizing Harbour BioMed’s proprietary fully human antibody technology platform in multiple therapeutic areas, together with an equity investment in Harbour BioMed, which closed in April 2025. Upfront payments for the collaboration and equity investment total $175m. AstraZeneca may incur additional fees and contingent milestones for each program it elects to license, along with tiered royalties on future net sales.

BioKangtai
In March 2025, BioKangtai and AstraZeneca entered into a strategic partnership to establish a joint venture that focus on researching, developing, and producing innovative vaccines.

The joint venture will serve as AstraZeneca’s first and only vaccine production hub in China, with a registered capital of RMB 345m (approx. $50m) and a total investment of approx. $400m (RMB 2.76bn). BioKangtai and AstraZeneca will each hold 50% equity in the venture.

Syneron Bio
In March 2025, AstraZeneca executed a strategic collaboration with Syneron Bio to develop potential first-in-class macrocyclic peptides for the treatment of chronic diseases. Under this collaboration, AstraZeneca will gain access to Syneron Bio’s innovative macrocyclic peptide drug research and development platform to support research programmes exploring possible future treatments of chronic diseases, including rare, autoimmune, and metabolic disease. AstraZeneca will pay an upfront payment of $55m, with option exercise fees and contingent milestones of over $3bn if all programs are optioned, along with tiered royalties on future net sales. AstraZeneca will also make an equity investment in Syneron Bio.

Tempus AI and Pathos AI
In April 2025, AstraZeneca, Tempus AI, Inc. (Tempus) and Pathos AI, Inc. (Pathos) entered into a series of agreements regarding the development of a foundational large multimodal model in the field of oncology. The model will be used to gather biological and clinical insights, discover novel drug targets, and develop therapeutics. AstraZeneca will pay Tempus a fee, and a syndicate of investors, including AstraZeneca, will contemporaneously execute a stock purchase agreement with Pathos.

Sustainability highlights

In preparation for new reporting regulations, AstraZeneca combined its 2024 sustainability and annual reporting into one integrated publication. Details of performance against targets can be found in the 2024 Sustainability Data Annex.

AstraZeneca published its first Taskforce on Nature-related Financial Disclosures report, and its Sustainable use and sourcing of raw materials report.

Reporting calendar

The Company intends to publish its H1 and Q2 2025 results on 29 July 2025.

Conference call

A conference call and webcast for investors and analysts will begin today, 29 April 2025, at 11:45 UK time. Details can be accessed via astrazeneca.com.

2025 1Q Earnings

On April 29, 2025 Hanmi reported first quarter 2025 financial results (Presentation, Hanmi, APR 29, 2025, View Source [SID1234654043]).

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iBio Raises $6.2 Million Through Warrant Inducement Transaction

On April 29, 2025 iBio, Inc. (Nasdaq: IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody therapies, announces reported that it has entered into an agreement with institutional investors that are existing holders of warrants to purchase shares of common stock of the Company for cash (the "Existing Warrants"), wherein the investors agreed to exercise the Existing Warrants to purchase 5,626,685 shares of common stock at a reduced exercise price of $1.11 per share, resulting in gross proceeds of approximately $6.2 million, before deducting advisory fees and certain other expenses (Press release, iBioPharma, APR 29, 2025, View Source [SID1234652310]). The Company intends to use the net proceeds for working capital and other general corporate purposes.

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In consideration for the exercise of the Existing Warrants for cash, the investors received new warrants (the "New Warrants") to purchase up to an aggregate of 11,253,370 shares of common stock. The New Warrants are exercisable at $0.86 per common share, and expire five years from the issuance date. The closing of the warrant inducement transaction is expected to occur on or about April 30, 2025, subject to satisfaction of customary closing conditions.

Chardan acted as the exclusive financial advisor in connection with the transaction.

The securities in this private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. iBio granted registration rights to the purchasers of the New Warrants, and has agreed to file a registration statement with the Securities and Exchange Commission registering the shares of common stock issuable upon exercise of the New Warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Innovent Announces First Patient Dosed in Phase 1 Study of IBI3020, Global First-in-class Dual Payload CEACAM5 ADC, in Patients with Advanced Malignancies

On April 29, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported completion of the first patient dosing for IBI3020, its first-in-class dual-payload CEACAM5 ADC, in Phase 1 clinical trial for the treatment of patients with advanced solid tumors (Press release, Innovent Biologics, APR 29, 2025, View Source;in-patients-with-advanced-malignancies-302441146.html [SID1234652331]). IBI3020 is the first dual-payload ADC developed from Innovent’s proprietary DuetTx dual-payload ADC platform and the first dual-payload ADC globally known in the same class to complete the first-in-human dosing.

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The study is an open-label, multi-regional Phase 1 study evaluating the safety, tolerability, and preliminary efficacy of IBI3020 in participants with advanced solid tumors, as well as determining the recommended Phase 2 dose (RP2D). The study has received IND approval in the U.S. recently and will be conducted in both China and the U.S.

As a global first-in-class ADC candidate, IBI3020 is generated from Innovent’s proprietary DuetTx dual-payload ADC platform. The internationalization of the CEACAM5-dependent ADC occurs after IBI3020 selectively binds to CEACAM5-expressing tumor cells, followed by lysosomal degradation. This process releases two types of cytotoxic payloads, leading to cell killing of tumor cells.

In preclinical studies, IBI3020 has demonstrated robust antitumor activity across various tumor-bearing pharmacology models, with a notable bystander killing effect. Additionally, IBI3020 has shown favorable safety characteristics in preclinical models, with an overall manageable safety profile.

Professor Yu Jinming, Shandong Cancer Hospital, stated:" Carcinoembryonic antigen (CEA), also known as CEACAM5, is a glycosylphosphatidylinositol-anchored cell-surface glycoprotein involved in cell adhesion, invasion, and metastasis of cancer cells. There is a significant clinical need for effective therapies in advanced colorectal cancer, non-squamous lung cancer, gastric cancer, pancreatic cancer, and others. CEACAM5 is overexpressed in these solid tumors but shows limited expression in healthy tissues, making it a potentially safe and promising therapeutic target. The dual payload of IBI3020 consists of two types of payloads that have been clinically validated. This dual-payload design has demonstrated enhanced tumor-killing effects in preclinical studies. We look forward to observing the clinical profiles and potential breakthrough of IBI3020 in terms of safety, tolerability, and efficacy in clinical trials."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to announce the successful dosing of the first patient dose with IBI3020. We will continue to advance the global development of IBI3020, aiming to offer better treatment options for patients with advanced solid tumors. Innovent possesses innovative ADC technology platforms with independent intellectual property rights. Multiple ADC molecules have clinically validated their differentiated competitiveness. IBI3020, Innovent’s first dual-payload ADC, has successfully entered clinical trials and is the first dual-payload ADC globally known in the same class to complete the first-in-human dosing, marking a breakthrough in Innovent’s ADC technology. We will continue our "IO+ADC" strategy, focusing on next-generation innovations with global potential to benefit cancer patients worldwide."

About IBI3020

IBI3020 is a global first-in-class ADC candidate developed from Innovent’s proprietary DuetTx dual-payload ADC platform. The CEACAM5 dependent ADC internalization occurs after IBI3020 selectively binds to the CEACAM5-expressing tumor cells, followed by the lysosomal degradation. This process releases two types of cytotoxic payloads, leading to tumor cell killing.

The multi-regional Phase 1 study of IBI3020, initiated in China, assesses the safety, tolerability, and preliminary efficacy of IBI3020 in patients with advanced solid tumors and aims to determine the recommended Phase 2 dose (RP2D). The study has also received IND approval in the U.S. recently and will be conducted in China and the U.S.