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GSK Announces the COiMMUNITY Initiative to Help Achieve Higher Adult Vaccination Rates in the US

• Grant funding will be provided to support national, state, and local non-profit organizations and community-based groups focused on adult immunization and health equity

• Increased data transparency and information on adult immunization trends will be available through enhanced Vaccine Track capabilities and collaborations to better inform public health efforts

• New resources and tools will help implement tangible solutions and further operationalize adult vaccination to help set a new precedent for adult immunization rates and close longstanding inequities in uptake

PHILADELPHIA–(BUSINESS WIRE)–
GSK plc (LSE/NYSE: GSK) today announced the launch of the COiMMUNITY Initiative to help reduce health inequities and set a new precedent for adult immunization rates in the US, which continue to remain below pre-pandemic levelsⁱ. The initiative is a multipronged effort to address long-standing barriers to adult immunization in the US with funding, increased data transparency through enhanced Vaccine Track capabilities and collaborations, and resource-sharing opportunities.

Judy Stewart, Senior Vice President, Head of US Vaccines, GSK said “This is a critical moment for public health. While there is a heightened level of awareness of the importance of vaccines to prevent infectious diseases, too often, adults miss the opportunity to prioritize vaccination, despite being increasingly susceptible to immune decline and infectious diseases. Our industry can do more by investing in local interventions to help create healthier communities and sustain best practices from the pandemic. We believe this initiative will contribute to a more equitable and resilient public health infrastructure and bolster existing partner efforts—leading to more vaccinated adults.”

The launch of the COiMMUNITY Initiative builds on recent US regulatory and industry developments that improve adult vaccine availability, coverage, and access. These include the 2023 policy changes within the Inflation Reduction Act of 2022 (IRA) that expand and improve adult vaccine coverage for Medicare and Medicaid beneficiaries, investments in community-level vaccine infrastructure during the COVID-19 pandemic, and innovations in adult vaccine development.

The COiMMUNITY Initiative includes the following components:

• Funding: GSK is committing up to $1 million USD in grant funding to support national, state and local non-profit organizations and community-based groups focused on adult immunization and health equity. This program is in addition to existing funding opportunities GSK provides to support the critical work of partner organizations within the immunization ecosystem. GSK recognizes the pivotal leadership demonstrated by these types of groups, particularly at the state and local levels, during the pandemic and the need to sustain their incredibly important work as patient advocates. Eligible organizations should respond to the Request for Proposal (RfP) with programming that aligns with the COiMMUNITY Initiative mission to reduce health inequities and help set a new precedent for adult immunization rates in the US. Grant proposals will be reviewed and approved on a rolling basis according to set principles and criteria until mid-November of 2023. The grant application process is now open on www.gskfunding.com. In your request, please address the COiMMUNITY Initiative.

• Data transparency and collaborations: GSK aims to strengthen data transparency and access to immunization trends to inform public health efforts. GSK will continue to make adult vaccination claims data available via Vaccine Track on a quarterly basis, and enhance the platform’s capabilities by further segmenting ​Medicaid data (e.g., Fee for Service vs. Managed Care) to improve the understanding of claims trends within these populations, as well as considering additional social determinants of health (e.g., urban vs rural, education, household income). GSK is also opening the platform to public and private stakeholders, welcoming the opportunity to potentially integrate and host additional data and viewpoints on adult vaccination trends. Data integration is subject to a Data Licensing Agreement.

  The most recent data published by Vaccine Track indicates that the average monthly claims through 2022 for recommended vaccines (excluding flu) show some improvements compared to 2021; however, they remain below 2019 levels. According to the data, on average, vaccination claims in 2022 are 14% lower than 2019, with 43 states and Washington, DC still facing claims reductions for recommended vaccinations for adults (excluding flu).​ The data also suggest that most of the adult vaccinations took place during the flu season, indicating additional pressure exerted on health systems in the flu months as well as missed vaccination opportunities year-round.

• Resource-sharing opportunities: GSK will share new resources, tools and best practices in adult vaccine confidence and delivery to help stakeholders implement tangible solutions for addressing adult immunization gaps. Resources include:
  • An infographic on year-round adult vaccination, which will support operationalizing the US adult immunization schedule, leveraging Vaccine Track data that shows missed opportunities throughout the year for non-seasonal vaccination. With new innovation in adult vaccination and the ability to protect against more diseases, further focus is needed on sequencing vaccine administration throughout the year to ensure adults stay up to date with recommended vaccinations.
  • “Optimizing Adult Immunizations in the U.S. – Building on Recent Coverage Expansions U.S. Vaccine Coverage 2023,” a recently commissioned whitepaper from CapView Strategies, LLC that outlines the current vaccine coverage landscape in the US and tangible solutions for addressing adult immunization gaps. The paper explores three immediate, actionable steps to boost adult immunization rates:
    • Address Seasonality and Operationalize the Adult Immunization Schedule

    • Ensure “No Wrong Door” to Vaccine Receipt—Making Access Easier

    • Embed an Equity Focus Across Adult Immunization Efforts

  • Disease education materials, to further demonstrate GSK’s commitment to science-driven disease education and its investments in new programs to spotlight adult immunization.

GSK will coordinate regular convenings with external stakeholders and harness existing forums to share best practices in adult vaccine confidence and delivery, empowering public health organizations and communities with actionable models to help bring successful adult immunization efforts to scale.

About Vaccine Track

Vaccine Track is a comprehensive platform provided by GSK, in collaboration with IQVIA, for use by public health officials, industry leaders, and medical professionals to strengthen vaccination data transparency, raise awareness and publicly share vaccination trends. Containing comprehensive claims data about routine adult (age 19+) vaccines, Vaccine Track currently spans information from January 2019 to December 2022 and will be updated on a quarterly basis. Information is sourced from medical claims data and longitudinal prescription data; both datasets are de-identified for research purposes. Medical claims data is collected from services performed in physicians’ offices; longitudinal prescription data sourced from retail and mail pharmacies, as well as long-term care facilities. Vaccines administered in institutional or hospital settings, as well as through certain other settings or programs, are not accounted for in projections.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D ‘Risk factors” in the company’s Annual Report on Form 20-F for 2022, and Q1 Results for 2023 and any impacts of the COVID-19 pandemic.

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References

_________________________

ⁱ VaccineTrack.com

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HASI Upsizes Revolving Credit Facility to $840 Million, Increasing Liquidity to Fund Growth

ANNAPOLIS, Md.–(BUSINESS WIRE)–
Hannon Armstrong Sustainable Infrastructure Capital, Inc. (“HASI,” “we”, “our”, or the “Company”) (NYSE: HASI), a leading investor in climate solutions, today announced that it has amended its revolving credit facility effective immediately, increasing the committed line under the revolving credit facility by $240 million to $840 million. The amendment also expands the accordion feature under the revolving credit facility by $420 million, resulting in total capacity of up to $1.26 billion subject to certain terms and conditions. The applicable margin remains unchanged at 1.875% for Term SOFR Rate-based loans.

“This upsize along with our recent successful equity offering will enable the continued growth of our portfolio,” said Marc Pangburn, HASI Chief Financial Officer. “Our diversified funding platform and strong relationships provide ongoing access to capital to profitably invest in the energy transition.”

The bank group is led by JPMorgan Chase Bank, N.A. as administrative agent, sustainability structuring agent, lead arranger and bookrunner. Bank of America, N.A., Barclays Bank PLC, Citibank, N.A., Morgan Stanley Bank, N.A., RBC Capital Markets, Sumitomo Mitsui Banking Corporation and Wells Fargo Bank, N.A., are documentation agents. The lead arranger and all documentation agents are either joining the facility or increasing their respective commitments as part of this amendment.

Fitch Ratings has also revised its outlook for the Company to positive.

About HASI

HASI (NYSE: HASI) is a leading climate positive investment firm that actively partners with clients to deploy real assets that facilitate the energy transition. With more than $10 billion in managed assets, our vision is that every investment improves our climate future. For more information, please visit hasi.com.

Forward-Looking Statements

Some of the information in this press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, words such as “believe,” “expect,” “anticipate,” “estimate,” “plan,” “continue,” “intend,” “should,” “may,” “target,” or similar expressions, are intended to identify such forward-looking statements. Forward-looking statements are subject to significant risks and uncertainties. Investors are cautioned against placing undue reliance on such statements. Forward-looking statements are not predictions of future events. Actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause actual results to differ materially from those described in the forward-looking statements include those discussed under the caption “Risk Factors” included in the Company’s Annual Report on Form 10-K (as supplemented by our Form 10-K/A) for the Company’s fiscal year ended December 31, 2022, which was filed with the SEC, as well as in other reports that the Company files with the SEC.

Forward-looking statements are based on beliefs, assumptions and expectations as of the date of this press release. The Company disclaims any obligation to publicly release the results of any revisions to these forward-looking statements reflecting new estimates, events or circumstances after the date of this press release.

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Arrowhead Hosts R&D Day Highlighting Its Pipeline of RNAi Therapeutics

– New Clinical Data on ARO-RAGE Show Continued Dose Response with Single Inhaled Dose of 184 mg Achieving Mean Knockdown of 90% and Max of 95%

– Adipose Delivery Platform Achieved Single Dose Target Gene Silencing of Greater than 90% with Six Months of Duration in Non-human Primates

– Improved Hepatic Dimer Platform Achieves Equivalent or Better Knockdown of Two Target Genes with Longer Duration than Monomer Mixture in Non-human Primates

– TRiM™ Platform Now has Potential to Address Multiple Cell Types Including Liver, Solid Tumors, Lung, Central Nervous System, Skeletal Muscle, and Adipose

PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) is hosting a Research & Development (R&D) Day today beginning at 9:00 a.m. ET to discuss progress towards the company’s “20 in 25” goal to grow its pipeline of RNAi therapeutics that leverage the proprietary Targeted RNAi Molecule (TRiM™) platform to a total of 20 clinical stage or marketed products in the year 2025.

A webcast link may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website and the presentation materials will be posted following conclusion of the event.

Christopher Anzalone, Ph.D., President and CEO at Arrowhead, said: “In 2017 we had optimized the TRiM™ platform for hepatocyte delivery, but we had yet to advance any candidates into clinical studies. By the end of 2023, just 6 years later, we expect to have advanced 18 drug candidates into clinical studies ​addressing multiple cell types, including liver, solid tumor, pulmonary, CNS, and skeletal muscle, with three candidates currently in Phase 3 studies. This has been an enormously productive period for Arrowhead, which we intend to continue as we make progress towards our 20 in 25 goal to have 20 clinical stage or marketed products that utilize the TRiM™ platform in the year 2025. We are excited about the progress we’ve achieved to date and by what lies ahead, as we continue to expand the platform into systemic delivery to the CNS that crosses the blood brain barrier, delivery to adipose tissue, and delivery of dimers that can knock down two separate genes.”

The R&D Day will feature presentations by three key opinion leaders: Michael Benatar, M.D., Ph.D. (University of Miami Miller School of Medicine), who will discuss amyotrophic lateral sclerosis (ALS) caused by superoxide dismutase 1 (SOD1) mutations; Matthias Salathe, M.D. (University of Kansas Medical Center), who will discuss the muco-obstructive and inflammatory pulmonary disease landscape; and Ira Goldberg, M.D. (NYU Langone Medical Center), who will discuss the unmet medical need in treating patients with hypertriglyceridemia and mixed dyslipidemia in atherosclerotic cardiovascular disease (ASCVD). Drs. Benatar, Salathe, and Goldberg will be available to answer questions following their presentations.

The R&D Day will also feature presentations by the Arrowhead team who will provide updates on multiple programs, in the following order:

Central nervous system (CNS):

• Development of the TRiM™ platform for intrathecal administration for CNS delivery demonstrates 90-95% dose-dependent mRNA knockdown in disease-relevant spinal cord and cortex brain regions in non-human primates​.

• ARO-SOD1 for treatment of patients with ALS caused by SOD1 mutations. A CTA filing is planned for the third quarter of 2023.

TRiM™ platform expansion progress:

• TRiM™ platform for systemic administration delivered siRNA across the blood brain barrier and achieved knockdown in non-human primates in all brain regions, including deep brain​.

• TRiM™ platform for adipose tissue delivery achieved up to 98% knockdown and maintained greater than 85% knockdown over 31 weeks.

• TRiM™ dimer platform for delivery to hepatocytes achieved equivalent or better knockdown of two separate target genes with longer duration than monomer mixture.

Pulmonary programs:

• ARO-RAGE for the treatment of patients with asthma is currently in a Phase 1/2 study.
  • New clinical data demonstrate continued dose response with single inhaled dose of 184 mg achieving mean knockdown of 90% and maximum knockdown of 95%.

  • New clinical data also show ARO-RAGE achieved serum sRAGE reductions in asthma patients consistent with effects seen in healthy volunteers at the 44 mg dose, the only dose level currently available in asthma patient cohorts​.

• ARO-MUC5AC for the treatment of patients with muco-obstructive pulmonary diseases is currently in a Phase 1/2 study.

• ARO-MMP7 for the treatment of patients with idiopathic pulmonary fibrosis is currently in a Phase 1/2 study.

Early clinical stage liver targeted programs:

• ARO-C3 for treatment of patients with various complement mediated diseases is currently in a Phase 1/2 study.

• ARO-PNPLA3 for treatment of patients with non-alcoholic steatohepatitis is currently in a Phase 1/2 study.

Cardiometabolic programs:

• ARO-APOC3 for the treatment of patients with familial chylomicronemia syndrome, severe hypertriglyceridemia, and mixed dyslipidemia in atherosclerotic cardiovascular disease is currently in a Phase 3 study and multiple Phase 2b studies.

• ARO-ANG3 for the treatment of patients with familial hypercholesterolemia is currently in multiple Phase 2b studies.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects, or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

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Ivonescimab Updated Data to be Featured at ASCO 2023

Summit Therapeutics is Currently Enrolling in a Phase III Study with Additional Phase III Study Planned for Third Quarter 2023 for Ivonescimab

MENLO PARK, Calif.–(BUSINESS WIRE)–
Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. The poster with updated clinical data from Phase II clinical trials will be displayed on Sunday June 4 from 8:00 to 11:00am Central Time during the Lung Cancer – Non-Small Cell Metastatic Poster Session.

The poster, which is presented by Dr. Li Zhang, Sun Yat-Sen University Cancer Center¹ with data generated and analyzed by our collaboration and licensing partner, Akeso, Inc. (HKEX Code: 9926.HK), provides updated results from the Phase II study (NCT04736823) centered around the cohort of patients in which ivonescimab is combined with chemotherapy (n=135) for first line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in patients without actionable genomic alterations (i.e., positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)). The poster provides updated data supporting promising anti-tumor activity of ivonescimab in first line advanced or metastatic NSCLC, while displaying that ivonescimab may have an acceptable safety profile in combination with platinum-doublet chemotherapy for patients with squamous or non-squamous advanced or metastatic NSCLC in this clinical study.

Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. There is higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal, healthy tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) with over 10 fold increased binding affinity to PD-1 in the presence of VEGF in vitro in tumor cells.² This tetravalent structure, the intentional design of the molecule, and bringing these two targets into a single bispecific antibody have the potential to steer ivonescimab to the tumor tissue versus healthy tissue, which are intended to improve side effects and safety concerns associated with these targets and have the potential to focus the antitumor activity of both targets. Over 750 patients have been treated with ivonescimab across multiple clinical studies in different indications in China and Australia.

Summit has begun its clinical development of ivonescimab in two NSCLC indications:

• Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (HARMONi trial or AK112-301)

• Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (HARMONi-3 trial)

In May 2023, the first patient was treated in Summit’s licensed territories in the Phase III HARMONi clinical trial. Summit intends to dose patients in the HARMONi-3 trial during the second half of 2023. Lung cancer is believed to impact approximately 238,000³ people in the United States each year and approximately 477,000⁴ in Europe. NSCLC is the most prevalent type of lung cancer and represents approximately 80% to 85% of all incidences.⁵ Among patients with non-squamous NSCLC, approximately 15% have EGFR-sensitizing mutations in the United States and Europe.⁶ Patients with squamous histology represent approximately 25% to 30% of NSCLC patients.⁷

About the ASCO Poster

Poster Title: Phase II results of Ivonescimab (AK112/SMT112) a novel PD-1/VEGF bispecific in combination with chemotherapy for first line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) in EGFR/ALK

ASCO Abstract No.:9087

ASCO Poster Session: Lung Cancer – Non-Small Cell Metastatic Poster Session.

Session Date & Time: Sunday June 4, 8:00 to 11:00am CT

Summit Therapeutics’ Mission Statement

To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate.

We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders.

About Summit Therapeutics

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Menlo Park, California, and we have additional offices in Oxford, UK.

For more information, please visit https://www.smmttx.com and follow us on Twitter @summitplc.

About Ivonescimab

Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan (Summit’s license territories), and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials in China. Summit has begun its clinical development of ivonescimab in NSCLC, enrolling the first patient in its license territory in 2023, with multiple Phase III clinical trials intended to be initiated in 2023. Over 750 patients have been treated with ivonescimab in clinical studies in China and Australia.

Summit Forward-looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the impact of the COVID-19 pandemic on the Company’s operations and clinical trials, potential acquisitions and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for SMT112, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, including the coronavirus COVID-19 outbreak, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of SMT112. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

¹ Poster Authors: Li Zhang, Wenfeng Fang, Yuanyuan Zhao, Yunpeng Yang, Ningning Zhou, Likun Chen, Yan Huang, Jianhua Chen, Li Zhuang, Yingying Du, Qitao Yu, Wu Zhuang, Yanqiu Zhao, Ming Zhou, Weidong Zhang, Yu Zhang, Yixin Wan, Weifeng Song, Michelle Xia

² Zhong et al, SITC 2022

³ American Cancer Society: Lung Cancer Statistics | How Common is Lung Cancer?

⁴ World Health Organization: 908-europe-fact-sheets.pdf (iarc.fr)

⁵ Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiology, Biomarkers & Prevention. (2019).

⁶About EGFR-Positive Lung Cancer | Navigating EGFR (lungevity.org)

⁷ Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiology, Biomarkers & Prevention. (2019).

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