TAE Life Sciences and Kyoto University Achieve Breakthrough Preclinical Results in Boron Neutron Capture Therapy (BNCT) with Promising Implications for Cancer Treatment

On November 13, 2024 TAE Life Sciences (TLS), TAE Life Sciences, in collaboration with Kyoto University and Principal Investigator Dr. Fuyuhiko Tamanoi, reported groundbreaking preclinical results in Boron Neutron Capture Therapy (BNCT). Utilizing TAE Life Science’s novel boron-10 drugs and Kyoto University Research Reactor (KURR) neutron source has generated significant pre-clinical data that may redefine the potential of BNCT in cancer treatment (Press release, TAE Life Sciences, NOV 13, 2024, View Source [SID1234649553]).

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Recently published in the Journal of Medicinal Chemistry (J. Med. Chem. 2023, 66, 13809−13820) and complemented by a newly submitted manuscript to ACS Central Science, our
research highlights a remarkable phenomenon known as the abscopal effect. This effect, where localized radiation treatment results in the shrinkage of tumors at untreated sites, holds profound implications for treating metastatic and micro-metastatic cancer.

In a key study using immune-competent balb/c mice, BNCT treatment of subcutaneous tumors on one leg completely inhibited tumor growth when the same tumor cells were reintroduced to the opposite leg two weeks post-treatment. These results, some of the most impressive preclinical data seen to date, suggest that BNCT can stimulate an immune response capable of generating memory cells to prevent tumor recurrence at distant sites.

"In one experiment, a mouse colon tumor was grown in the leg of a mouse and a second tumor was grown in its shoulder. BNCT was applied to the tumor in the leg, while the shoulder tumor was shielded from treatment. Remarkably, the untreated shoulder tumor exhibited a 34% reduction and slower growth rate compared to the control group, highlighting a potential systemic effect of BNCT."

"While the abscopal effect is not new in radiation oncology, these results with BNCT represent a significant step forward", said Dr. Sunil Krishnan, Radiation Oncologist and Professor at the Center for Translational Cancer Research at UT Health Houston. "What’s particularly exciting is that this level of immune response and tumor control has not traditionally been observed with standard x-ray-based radiation therapy. It underscores the potential for BNCT to not only address
primary tumors but also impact metastatic disease in a way we haven’t seen before."

Further investigations are underway to explore the mechanisms behind these results, focusing on the role of dendritic cells, T-cells, and macrophages in immune memory. Additionally, TAE Life Sciences is evaluating the combination of BNCT with immune checkpoint inhibitors, such as anti-CTLA4, anti-PD1, and anti-PDL1, to enhance outcomes in tumors with both "hot" (active immune profile) and "cold" (inactive immune profile) immune phenotypes.

"We are excited to demonstrate both the vaccine effect and the abscopal effect in preclinical BNCT experiments," said Kendall Morrison, Chief Scientific Officer at TAE Life Sciences.
"This research reinforces BNCT’s potential not only as a localized therapy but also as a treatment capable of addressing metastatic cancer. Combining BNCT with immunotherapy agents could significantly transform cancer treatment outcomes."

If these preclinical results can be translated to clinical applications, it could pave the way for improved responses to immune checkpoint blockade therapies, particularly for challenging "cold" tumors.

Alentis Therapeutics Raises $181.4 Million in an Oversubscribed Series D Financing to Advance the Clinical Development of Anti-Claudin-1 ADCs in Solid Tumors

On November 12, 2024 Alentis Therapeutics ("Alentis"), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, reported that it has raised $181.4 million in Series D financing, supported by a syndicate of top-tier biotech investors (Press release, Alentis Therapeutics, NOV 12, 2024, View Source [SID1234648155]). The financing will support Alentis to develop a deep pipeline of CLDN1 targeted medicines for solid tumors.

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The funding round was led by OrbiMed with co-leads Novo Holdings and Jeito Capital. New investors Frazier Life Sciences, Longitude Capital, Catalio Capital, Piper Heartland Healthcare Capital and Avego Bioscience Capital participated in the round. Significant backing was also received from existing investor RA Capital Management, along with support from Morningside Venture Investments, BB Pureos, Bpifrance through its InnoBio 2 fund, as well as other early institutional investors, all of whom have been instrumental to Alentis’ development path.

"This financing is a testament to the transformational potential of CLDN1 antibody-drug conjugates (ADCs) for the treatment of solid tumors," said Roberto Iacone, Chief Executive Officer of Alentis. "Let me take this opportunity to extend a warm welcome to our new investors." Dr. Iacone added, "We’re excited to execute our development strategy and deliver clinical data for our programs over the next 12-18 months."

The proceeds of the financing will be used to conduct Phase 1/2 clinical trials of two first-in-class ADCs targeting CLDN1, ALE.P02 and ALE.P03, further development of the pipeline, and general corporate purposes.

The FDA recently cleared an IND application for a Phase 1/2 clinical trial of ALE.P02 (with a tubulin inhibitor) in advanced or metastatic CLDN1+ squamous solid tumors. The clinical trial is expected to commence Q1 2025. For ALE.P03 (with a topoisomerase I inhibitor), a first-in-human trial in patients with CLDN1+ tumors is planned to start in 2025.

Luca Santarelli, Chairman of Alentis said, "I am excited about the future of Alentis, especially after this very significant financing, and would like to welcome the new Board Members that will join after the closing of the transaction."

OrbiMed Partner, Dina Chaya said, "With this financing, Alentis is now well positioned to advance its CLDN1 antibody-drug conjugates, which have the potential to be first and best-in-class therapies for the treatment of cancer."

"ADCs have shown their potential to be highly effective cancer treatments," said Naveed Siddiqi, Senior Partner at Novo Holdings, Venture Investments. "Alentis has an exciting pipeline of first-in-class ADCs and we are proud to have co-led this round. We are looking forward to seeing the data generated from the first clinical trials of ALE.P02 and ALE.P03."

Dr. Rafaèle Tordjman, Founder and CEO of Jeito Capital said, "We are excited to co-lead this major new financing round for Alentis that further validates the strength of its pipeline. We look forward to continuing to bring our expertise to support their development."

New Board of Directors Appointments
As part of the financing, three new Board Members will join the Alentis Board of Directors, further strengthening the business, science and drug development expertise at the Board level.

Dina Chaya, Partner at OrbiMed, has over 20 years of experience in healthcare investments, specializing in biopharma and medical technology.
Anna Chen, Principal at Frazier Life Sciences, where she has been involved with investing in and building many of Frazier Life Sciences’ biopharmaceutical portfolio companies over the past 7 years.
Brian Liu, Managing Director at Longitude Capital, brings more than 10 years of biopharma consulting and investing experience, focusing on transformative healthcare innovation.
About ALE.P02 and ALE.P03
ALE.P02 and ALE.P03 are first-in-class ADCs designed by linking a potent cancer drug (a tubulin and topoisomerase I inhibitor, respectively) to our antibody that specifically targets a unique CLDN1 epitope exposed on cancer cells. This combination creates a powerful new tool to fight cancer with less toxicity than traditional cancer drugs. The IND application for ALE.P02 to commence a Phase 1/2 clinical trial in advanced or metastatic CLDN1+ squamous solid tumors was recently cleared by the FDA.

FibroGen Reports Third Quarter 2024 Financial Results

On November 12, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the third quarter 2024 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 12, 2024, View Source [SID1234648171]).

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"This past quarter we transformed into a lean and more focused organization, resulting in significant cost savings that will extend into the future. Moreover, roxadustat continued its impressive performance, generating $96.6 million in net sales in China during the quarter," said Thane Wettig, Chief Executive Officer, FibroGen. "Having implemented our cost reduction plan, we are well positioned to advance FG-3246, with topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide at the University of California San Francisco (UCSF) on track for the first half of 2025, and the anticipated start of our Phase 2 monotherapy trial in the first quarter of 2025. We continue to be optimistic about our future prospects."

Recent Developments and Key Events of Third Quarter 2024:

•Meaningful progress on U.S. cost reduction plan.
o
Expected to be substantially complete by year-end 2024
•Reported topline results from the pamrevlumab arm of PanCAN Precision Promise Phase 2/3 adaptive platform trial for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), in which the trial did not meet the primary endpoint.
•Reported topline results from the LAPIS Phase 3 study of pamrevlumab in patients with locally advanced, unresectable pancreatic cancer (LAPC), in which the trial did not meet the primary endpoint.

Upcoming Milestones:

Roxadustat

•Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in early 2025. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca.
FG-3246 and FG-3180 (PET Imaging Agent)

•Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 1H 2025.
•Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 1Q 2025. This trial will include a sub-study of FG-3180 to enable assessment of CD46 expression and response to FG-3246.

Syros Announces Topline Data from SELECT-MDS-1 Phase 3 Trial of Tamibarotene in Higher-Risk Myelodysplastic Syndrome with RARA Gene Overexpression

On November 12, 2024 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported that the SELECT-MDS-1 Phase 3 trial evaluating tamibarotene in combination with azacitidine in newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression did not meet its primary endpoint of complete response (CR) rate (Press release, Syros Pharmaceuticals, NOV 12, 2024, View Source [SID1234648215]). Tamibarotene is Syros’ proprietary oral, selective, retinoic acid receptor alpha (RARα) agonist.

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In the first 190 enrolled patients, the CR rate by intent-to-treat (ITT) in the tamibarotene/azacitidine treatment arm was 23.8% (n=126; 95% CI: 16.7%-32.2%) compared to a CR rate of 18.8% (n=64; 95% CI: 10.1%-30.5%) in the placebo/azacitidine control arm and was not statistically significant (p-value = 0.2084). In the safety analysis of all enrolled patients (n=245), tamibarotene in combination with azacitidine (n=160) appeared to be generally well-tolerated, with an adverse event profile that was similar to that seen in earlier Syros-sponsored studies.

Syros also reported that, as previously disclosed in its filings with the SEC, the failure of the SELECT-MDS-1 trial to achieve its primary endpoint constitutes an event of default under its secured loan facility with Oxford Finance LLC.

"We are deeply disappointed by this outcome, particularly for the HR-MDS patients who are seeking a new treatment option for this challenging disease," said Conley Chee, Chief Executive Officer of Syros. "We plan to stop the study, review the clinical data more thoroughly, and evaluate the next steps. We want to express our sincere appreciation for the patients, caregivers and healthcare professionals who took part in the SELECT-MDS-1 trial and to all the employees of Syros for their exceptional work on the tamibarotene program."

About SELECT-MDS-1 Phase 3 Trial

SELECT-MDS-1 is a multinational Phase 3 randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of tamibarotene in combination with azacitidine compared to placebo and azacitidine in HR-MDS patients with RARA overexpression. The primary endpoint of the trial was the CR rate in the first 190 patients.

AstraZeneca’s 9M and Q3 2024 results

On November 12, 2024 AstraZeneca reported its 9M and Q3 2024 results (Press release, AstraZeneca, NOV 12, 2024, View Source [SID1234648230]):

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Revenue and EPS summary

9M 2024

% Change

Q3 2024

% Change

$m

Actual

CER1

$m

Actual

CER

– Product Sales

37,576

16

19

12,947

18

20

– Alliance Revenue

1,498

49

50

559

48

50

– Collaboration Revenue

108

(66)

(66)

59

(39)

(40)

Total Revenue

39,182

16

19

13,565

18

21

Reported EPS

$3.57

11

21

$0.92

4

17

Core2 EPS

$6.12

5

11

$2.08

20

27

Financial performance for 9M 2024 (Growth numbers at constant exchange rates)

Total Revenue up 19% to $39,182m, driven by a 19% increase in Product Sales and continued growth in Alliance Revenue from partnered medicines
Total Revenue growth from Oncology was 22%, CVRM 21%, R&I 24% and Rare Disease 14%
Core Product Sales Gross Margin3 of 82%
Core Operating Margin of 32%
Core Tax Rate of 20%
Core EPS increased 11% to $6.12. In the prior year period, Core EPS included gains totalling $953m from the disposal of Pulmicort Flexhaler US rights and updated contractual arrangements for Beyfortus
Guidance for FY 2024 Total Revenue and Core EPS growth at CER upgraded to high teens percentage growth
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:

"Our company has continued on its strong growth trajectory in the first nine months of 2024. Total Revenue and Core EPS were up 21% and 27% respectively in the third quarter, reflecting the increasing demand for our medicines across Oncology, BioPharmaceuticals and Rare Disease and supporting an upgrade to our full year 2024 guidance.

In the year to date we have announced the results for multiple positive high-value trials and are working to bring these new options to patients as quickly as possible. Additionally, the quality and impact of our scientific research was well recognised this quarter with data for AstraZeneca medicines featuring in an unprecedented five Presidential Plenary sessions at the two major oncology conferences in September.

We are highly encouraged by the broad-based underlying momentum we are seeing across our company in 2024, and growth looks set to continue through 2025, providing a solid foundation to deliver on our 2030 ambition.

Finally, we take the matters in China very seriously. If requested we will fully cooperate with the authorities. We remain committed to delivering innovative life-changing medicines to patients in China."

Key milestones achieved since the prior results announcement

Positive read-outs for Tagrisso plus Orpathys in EGFRm NSCLC with high levels of MET overexpression and/or amplification (SAVANNAH), Calquence in combination with venetoclax, with or without obinutuzumab in previously untreated CLL (AMPLIFY), and the next generation propellant for Breztri. Koselugo in adult patients with NF1-PN (KOMET), Tezspire in severe chronic rhinosinusitis with nasal polyps (WAYPOINT)
US approvals for Tagrisso in unresectable, Stage III EGFRm NSCLC (LAURA) and Imfinzi plus chemotherapy in resectable early-stage NSCLC (AEGEAN) and FluMist for self-administration. EU approvals for Imfinzi plus chemotherapy followed by Imfinzi alone in mismatch repair deficient endometrial cancer (DUO-E), Imfinzi plus chemotherapy followed by Lynparza and Imfinzi in mismatch repair proficient endometrial cancer (DUO-E) and Fasenra for EGPA (MANDARA). China approvals for Enhertu in unresectable, locally advanced or metastatic HER2-mutated NSCLC (DESTINY-Lung02, DESTINY-Lung05), Enhertu in locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma (DESTINY-Gastric06), and Fasenra for severe eosinophilic asthma (MIRACLE)
Guidance

Given the strength of underlying Product Sales and Alliance Revenue, as well as increased confidence in achieving certain sales-based milestones, the Company raises its Total Revenue and Core EPS guidance for FY 2024 at CER.

Total Revenue is expected to increase by a high teens percentage (previously a mid teens percentage)

Core EPS is expected to increase by a high teens percentage (previously a mid teens percentage)

Other elements of the Income Statement are expected to be broadly in-line with the indications issued in the Company’s H1 2024 earnings statement
The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.

Currency impact

If foreign exchange rates for October 2024 to December 2024 were to remain at the average rates seen in September 2024, it is anticipated that FY 2024 Total Revenue would incur a low single-digit percentage adverse impact compared to the performance at CER (unchanged from previous guidance), and Core EPS would incur a mid single-digit percentage adverse impact (unchanged from previous guidance). The Company’s foreign exchange rate sensitivity analysis is provided in Table 17.

China

As previously disclosed, the Company is aware of a number of individual investigations by the Chinese authorities into current and former AstraZeneca employees. To the best of the Company’s knowledge, the investigations include allegations of medical insurance fraud, illegal drug importation and personal information breaches. Recently Leon Wang, EVP International and AstraZeneca China President was detained. The Company has not received any notification that it is itself under investigation. If requested, AstraZeneca will fully cooperate with the Chinese authorities.

Table 1: Key elements of Total Revenue performance in Q3 2024

% Change

Revenue type

$m

Actual %

CER %

Product Sales

12,947

18

20

Alliance Revenue

559

48

50

* $49m Beyfortus (Q3 2023: $17m)

* $361m Enhertu (Q3 2023: $266m)

* $123m Tezspire (Q3 2023: $74m)

Collaboration Revenue

59

(39)

(40)

* $56m Beyfortus (Q3 2023: $71m)

Total Revenue

13,565

18

21

Therapy areas

$m

Actual %

CER %

Oncology

5,569

19

22

* Tagrisso up 14% (17% at CER), Calquence up 24% (25% at CER), Enhertu Total Revenue up 50% (55% at CER)

CVRM

3,159

18

20

* Farxiga up 25% (27% at CER), Lokelma up 40% (42% at CER)

R&I

1,959

26

29

* Breztri up 56% (57% at CER). Saphnelo up 63% (64% at CER), Tezspire up >2x, Symbicort up 27% (31% CER)

V&I

460

48

49

* Beyfortus Total Revenue up 73% (72% at CER), FluMist up 34% (31% at CER)

Rare Disease

2,148

9

11

* Ultomiris up 33% (35% at CER), partially offset by decline in Soliris of 22% (18% at CER), Strensiq up 20% (21% at CER) and Koselugo up 37% (39% at CER)

Other Medicines

270

(12)

(8)

Total Revenue

13,565

18

21

Regions

$m

Actual %

CER %

US

6,008

23

23

Emerging Markets

3,423

15

23

– China

1,671

15

15

– Ex-China Emerging Markets

1,752

16

31

Europe

2,875

22

22

Established RoW

1,260

(1)

4

Total Revenue

13,565

18

21

Key alliance medicines

Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $2,729m in 9M 2024 (9M 2023: $1,844m).
Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to $843m in 9M 2024 (9M 2023: $438m).
Table 2: Key elements of financial performance in Q3 2024

Metric

Reported

Reported change

Core

Core
change

Comments4

Total Revenue

$13,565m

18% Actual 21% CER

$13,565m

18% Actual 21% CER

* See Table 1 and the Total Revenue section of this document for further details

Product Sales Gross Margin

76%

-5pp Actual -4pp CER

81%

Stable Actual and CER

* Variations in Product Sales Gross Margin can be expected between periods, due to product seasonality (e.g. FluMist and Beyfortus sales are weighted to the second half of the year), foreign exchange fluctuations and other effects

‒ Reported Product Sales Gross Margin impacted by PAAGR5 inventory related restructuring charges taken in the quarter

R&D

expense

$3,115m

21% Actual 21% CER

$3,068m

23% Actual 24% CER

+ Increased investment in the pipeline

* Core R&D-to-Total Revenue ratio of 23%
(Q3 2023: 22%)

SG&A expense

$5,143m

7% Actual 8% CER

$3,605m

8% Actual 9% CER

+ Market development for recent launches and pre-launch activities

* Core SG&A-to-Total Revenue ratio of 27%
(Q3 2023: 29%)

Other operating income and expense6

$25m

-65% Actual -61% CER

$24m

-65% Actual -61% CER

Operating Margin

16%

-1pp Actual Stable CER

32%

+1pp Actual +2pp CER

* See commentary above on Gross Margin, R&D, SG&A and Other operating income and expense

Net finance expense

$274m

-6% Actual -15% CER

$329m

46% Actual 35% CER

+ New debt issued at higher interest rates

+ Higher level of Net debt

Tax rate

22%

+5pp Actual +5pp CER

19%

Stable Actual and CER

* Variations in the tax rate can be expected between periods

EPS

$0.92

4% Actual 17% CER

$2.08

20% Actual 27% CER

* Further details of differences between Reported and Core are shown in Table 12

Table 3: Pipeline highlights since prior results announcement

Event

Medicine

Indication / Trial

Event

Regulatory approvals and other regulatory actions

Tagrisso

Unresectable, Stage III EGFRm NSCLC (LAURA)

Regulatory approval (US)

Imfinzi

Primary advanced or recurrent endometrial cancer with mismatch repair deficiency (DUO-E)

Regulatory approval (EU)

Imfinzi + Lynparza

Primary advanced or recurrent endometrial cancer with mismatch repair proficiency (DUO-E)

Regulatory approval (EU)

Imfinzi

Resectable early-stage (IIA-IIIB) NSCLC (AEGEAN)

Regulatory approval (US)

Enhertu

Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma (DESTINY-Gastric06)

Regulatory approval (CN)

Enhertu

Unresectable locally advanced or metastatic HER2m NSCLC (DESTINY-Lung02, DESTINY-Lung05)

Regulatory approval (CN)

Fasenra

EGPA (MANDARA)

Regulatory approval (US, EU)

Fasenra

Fasenra (MIRACLE)

Regulatory approval (CN)

FluMist

Self-administration

Regulatory approval (US)

Regulatory submissions
or acceptances*

Tagrisso

EGFRm NSCLC (Stage III

unresectable) (LAURA)

Regulatory submission (EU, JP, CN)

Imfinzi

Muscle-invasive bladder

Cancer (NIAGARA)

Regulatory submission (EU)

Imfinzi

NSCLC (neoadjuvant) AEGEAN

Regulatory submission (JP)

Imfinzi

SCLC (limited stage) (ADRIATIC)

Regulatory submission (US, EU, JP, CN)

Calquence

Mantle cell lymphoma (1st-line) (ECHO)

Regulatory submission (US, EU, JP)

Calquence

CLL (ELEVATE-TN)

Regulatory submission (CN)

Lynparza

mCRPC (PROpel)

Regulatory submission (CN)

Enhertu

HER2-low breast cancer

(2nd-line) (DESTINY-Breast06)

Regulatory submission (US, EU, JP)

Wainua

Hereditary transthyretin-mediated amyloid polyneuropathy (NEURO-TTRansform)

Regulatory submission (CN)

Breztri and HFO1234ze

Moderate to severe COPD

Regulatory submission (EU)

Sipavibart

Prevention of COVID-19

(SUPERNOVA)

Regulatory submission (JP)

Ultomiris

NMOSD (CHAMPION-NMOSD)

Regulatory submission (CN)

Phase III / registrational data readouts and other developments

Tagrisso + Orpathys

EGFRm NSCLC with high levels of MET overexpression and/or amplification (SAVANNAH)

Clinically meaningful ORR

Calquence fixed duration

Chronic lymphocytic leukaemia (AMPLIFY)

Primary endpoint met

Fasenra

Eosinophilic chronic rhinosinusitis with nasal polyps (ORCHID)

Primary endpoint not met

Tezspire

Severe chronic rhinosinusitis with nasal polyps (WAYPOINT)

Primary endpoint met

Koselugo

Adults with NF1-PN (KOMET)

Primary endpoint met

*US, EU and China regulatory submission denotes filing acceptance

Upcoming pipeline catalysts

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.

Corporate and business development

In October 2024, AstraZeneca entered into an exclusive license agreement with CSPC Pharmaceutical Group Ltd (CSPC) to advance the development of an early stage, novel small molecule Lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidaemia. This further strengthens the company’s cardiovascular portfolio to help address the major risk factors driving chronic cardiovascular disease. Under the terms of the agreement, AstraZeneca will receive access to CSPC’s pre-clinical candidate small molecule, YS2302018, an oral Lp(a) disruptor, with the aim of developing this as a novel lipid-lowering therapy with potential in a range of cardiovascular disease indications alone or in combination, including with AstraZeneca’s oral small molecule PCSK9 inhibitor, AZD0780. CSPC will receive an upfront payment of $100 million from AstraZeneca. CSPC is also eligible to receive up to $1.92 billion for further development and commercialisation milestones plus tiered royalties.

In October 2024, AstraZeneca entered into an agreement to out-license ALXN1840 (bis-choline tetrathiomolybdate), a drug candidate for Wilson disease to Monopar Therapeutics Inc (Monopar). Monopar will be responsible for all future global development and commercialisation activities. AstraZeneca will have a 9.9% beneficial ownership interest in Monopar upon issuance as well as an upfront cash payment of $4.0 million. AstraZeneca is also eligible to receive milestones and royalties.

Sustainability highlights

In September, AstraZeneca had a significant presence at Climate Week NYC and the 79th Session of the UN General Assembly in New York, with a delegation led by Pam Cheng, Executive Vice President of Global Operations and IT and Chief Sustainability Officer and the company’s US leadership. A programme of more than 50 engagements with governments, media, NGOs and the private sector focused on the interconnected issues of the climate crisis, health equity and health system resilience and the Company’s commitment to contribute to more sustainable, resilient and equitable health systems.

Conference call

A conference call and webcast for investors and analysts will begin today, 12 November 2024, at 14:00 UK time. Details can be accessed via astrazeneca.com.