On July 29, 2024 ImmunoPrecise Antibodies Ltd. ("IPA", "Company", "we" or "us") (NASDAQ: IPA), an artificial intelligence (AI)-driven biotherapeutic research and technology company, reported its financial results for the fiscal year ended April 30, 2024 (Press release, ImmunoPrecise Antibodies, JUL 29, 2024, View Source [SID1234645132]). All numbers are expressed in Canadian dollars unless otherwise noted.

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"IPA has achieved significant milestones this fiscal year," said Dr. Jennifer Bath, CEO and President of IPA. "We are proud to report our fifth consecutive quarter of record revenues as well as record annual revenues, which reflect strong demand for our comprehensive antibody discovery and development services. This impressive growth is driven by our B Cell Select platforms and the enhanced capacity of our manufacturing facilities. We are excited to share that our strategic investments in AI technologies are starting to pay off, as demonstrated by the progress of BioStrand in meeting significant milestones with the rollout of their LENSai software both internally and to the public. This progress highlights our commitment to innovation and positions us at well amongst AI-driven drug discovery and development."

Business Highlights and Corporate Update

ImmunoPrecise Antibodies Ltd. (IPA) has reported a record-breaking fiscal year for the Company, achieving revenues of $24.5 million, a 19% increase from $20.7 million the previous year. This growth underscores IPA’s capability to meet the rising demand for its end-to-end antibody services, including comprehensive wet lab and in silico discovery and development technologies. The Company’s financial prudence and operational efficiency are further highlighted by a notable reduction in cash burn.

Technological advancements have been pivotal in IPA’s success. We believe that BioStrand’s patented HYFT Technology has significantly enhanced the Company’s ability to solve complex biological problems, leading to major advancements in developing novel potential therapeutics against challenging targets for our clients and partners. Strategic collaborations, including with InterSystems and PGxAI, have expanded IPA’s capabilities in healthcare data processing and pharmacogenomics, respectively. Our commitment to innovation was recently recognized with the 2024 Impact Award for BioStrand’s LENSai technology and the launch of the LENSai API, offering commercial access across multiple sectors.

FY24 Enhancements to Functionality of LENSai

•
HYFT Technology Advancement: Unveiled a new approach to biological sequence retrieval, combining Natural Language Processing (NLP) and database research for improved accuracy and efficiency.
•
Advanced AI Model Introduction: Introduced an advanced Foundation AI Model in January, combining Large Language Models (LLMs) with HYFT Technology, advancing AI-driven drug discovery.
•
Healthcare Data Processing Partnership: Partnered with InterSystems Corporation in February to integrate vector search with LENSai for AI-driven drug discovery and healthcare applications, enhancing data processing and expanding market reach.
•
Electronic Health Record (EHR) Data Integration: Developed an advanced LLM for EHRs in March, improving retrieval and analysis to optimize collaboration outputs with InterSystems.

Commercialization of LENSai

•
Internal Rollout of LENSai: Successfully rolled out LENSai internally, including to IPA’s sites in Utrecht and Oss, the Netherlands, showcasing the platform’s security and utility.
•
Commercial Projects: Successfully executed end-to-end programs entirely in silico using LENSai, solving challenging therapeutic antibody programs for partners and clients, providing feedback on LENSai’s performance and resilience in solving complex biological challenges.
•
Public Commercial Launch of LENSai API: BioStrand announced the commercial launch of its LENSai API software, and is working to offer the platform, in conjunction its partner, AWS, on the AWS Marketplace, a sales channel that enables Independent Software Vendors (ISVs) and consulting partners to sell their solutions to AWS customers.
•
LENSai Rollout Success: BioStrand has initiated the public rollout of LENSai with selected pharmaceutical partners ahead of schedule. Based on client positive experience and outcomes from LENSai applications, one of our large pharmaceutical company clients has chosen to expand from initial services to a broader integration with our Software-as-a-Service (SaaS) and API solutions. This successful pilot demonstrates the platform’s capability to generate significant revenue streams through these commercially available solutions, which may support recurring revenue for BioStrand.
•
2024 Impact Award for LENSai Technology: BioStrand was awarded the prestigious 2024 Impact Award in April for their LENSai technology, recognizing the potential of our HYFT-powered platform with EHR analysis capabilities.

•
Collaboration with PGxAI: This commercial collaboration represents a strategic move in the growing trend of AI-to-AI collaborations, a burgeoning strategy within the industry. By fostering enhanced interactions between AI systems, this approach is driving significant advancements, particularly in precision medicine. Following the launch of the LENSai API, IPA signed a collaboration with PGxAI to develop an AI model for pharmacogenomics, further solidifying its position at the forefront of AI-driven healthcare solutions.

Growth of Discovery and Development Service Offerings

•
Expansion of Oss Laboratory Facilities: The Company expanded its laboratory facilities at its Oss, the Netherlands, site in February 2024. This increased lab space has enabled enhanced service offerings and additional equipment, such as the Carterra LSA, to support the high throughput needs from the downstream outputs of LENSai. These new services are already in high demand.
IPA’s ongoing efforts to expand its technological and service capabilities, including the acquisition of additional laboratory space and equipment, forecast continued robust growth. The expansion of its B Cell Select platforms and advancements in VHH antibody discovery technologies further bolster its position as a leader in biotherapeutic research and development. Overall, these strategic initiatives have improved IPA’s financial performance and technological prowess.

Fourth Quarter 2024 Financial Results

Revenue was $6.5 million for the three months ended April 30, 2024, compared to $5.6 million for the three months ended April 30, 2023.

Research and development (R&D) expenses were $1.3 million for the three months ended April 30, 2024, compared to $0.9 million for the three months ended April 30, 2023. This increase was primarily driven by increased R&D activities at BioStrand.

Selling and marketing expenses were $0.9 million for the three months ended April 30, 2024, compared to $0.9 million for the three months ended April 30, 2023.

General and administrative expenses were $4.8 million for the three months ended April 30, 2024, compared to $5.0 million for the three months ended April 30, 2023.

Net loss was $18.0 million for the three months ended April 30, 2024, including a $15 million impairment expense related to BioStrand’s goodwill and intangible assets. This compares to the net loss of $5.1 million for the three months ended April 30, 2023, including a $2.5 million impairment expense related to BioStrand.

Full Year 2024 Financial Results

Revenue was $24.5 million for the fiscal year 2024, marking an increase from $20.7 million in the previous year fiscal 2023. We attribute this growth to the successful implementation of our strategic initiatives, including the expansion of our B Cell Select platforms and the ongoing development of our VHH antibody discovery technologies.

Research and development expenses were $4.0 million, down from $14.1 million in fiscal 2023, reflecting the transition of Talem assets from R&D build to the focus of revenue generation.

Sales and marketing expenses were $3.5 million, compared to $3.6 million in fiscal 2023, down slightly year over year as we managed our expenses, even with achieving record revenue growth.

General and administrative expenses were $15.6 million, compared to $15.4 million in fiscal 2023, flat year over year as the company grew.  

The Company recorded an impairment charge of $15 million related to BioStrand’s goodwill and intangible assets. This adjustment reflects a rise in the discount rate and delays in expected cash flows. Despite this change in accounting valuation, IPA remains committed to its strategic investments and long-term growth plans. The Company recorded an impairment charge of $2.5 million related to BioStrand in fiscal 2023.

Net loss for the fiscal year was $27.2 million, or $(1.07) per share on a basic and diluted basis, compared to a net loss of $26.6 million or $(1.06) on a basic and diluted basis in fiscal 2023, for an increase of $0.6 million. However, the impairment recognized in fiscal 2024 was $12.5 million higher than fiscal 2023.

Total cash, cash equivalents, and marketable securities, including restricted cash, were $3.5 million as of April 30, 2024, reflecting the focus on managing operational costs while investing in R&D and capital equipment. The Company used cash in operating activities of $4.2 million in fiscal 2024, compared to $19.8 million in 2023. Equipment purchases were $1.4 million in fiscal 2024 and $1.5 million in fiscal 2023. To offset these uses of cash, net funds of $2.4 million were raised in fiscal 2024 versus $0.7 million in fiscal 2023.

Subsequently, on July 16, 2024, the Company agreed to sell and issue to A II PN, Ltd., an investment fund managed by Yorkville Advisors Global, LP ("Yorkville"), U.S.$3.0 million of convertible debentures in two tranches and at a purchase price of 95% of the aggregate principal amount.

(in thousands, CAD$)

Q4 FY24

Q4 FY23

FY24

FY23

Revenue

$6,459

$5,620

$24,518

$20,665

Gross Profit

3,108

3,341

12,053

11,563

Research & Development Expense

1,260

912

4,043

14,101

Sales & Marketing Expense

910

933

3,543

3,608

General & Administrative Expense

4,821

4,963

15,592

15,383

Impairment Expense

15,031

2,460

15,031

2,460

Net Loss

(18,045)

(5,129)

(27,177)

(26,560)

Conference Call and Webcast

IPA will host a live conference call and webcast to discuss these results and provide a corporate update on July 29, 2024, at 10:30 AM ET. The conference call will be webcast live and available for replay via a link provided in the Events section of the Company’s IR pages at IPA Events and Presentations.

Conference Call

Event Title: ImmunoPrecise Reports Financial Results and Recent Business Highlights for Full Fiscal Year 2024

Event Date: July 29th, 2024

Time: 10:30 AM (GMT-04:00) Eastern Time (US and Canada)

Participant Dial-In Details

Participants call one of the allocated dial-in numbers (below) and advise the Operator of either the Conference ID 9236374 or Conference Name.

North America Toll-Free: (888) 550-5658

North America Toll: (646) 960-0289

International Toll: +1(646) 960-0289

Webcast Details

Attendee URL:

View Source

On July 29, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the U.S. Food and Drug Administration (FDA) has approved the company’s Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease (Press release, Guardant Health, JUL 29, 2024, View Source [SID1234645131]). It is the first blood test to be approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield in a manner similar to all non-invasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage.1

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Colorectal cancer is the second-leading cause of cancer-related death in the U.S., even though it is highly treatable if caught early.2 The American Cancer Society estimates that more than 150,000 people will be diagnosed with CRC in 2024 and the disease will be responsible for more than 53,000 deaths.3 More than three out of four individuals who die from CRC are not up to date with their screening.4 Early detection is critical. When colon cancer is found at an early stage before it has spread, the five-year relative survival rate is 91%. If the cancer has spread to distant parts of the body, the five-year relative survival rate is 14%.5

The CRC screening rate in the U.S. is only about 59%, which falls well below the National Colorectal Cancer Roundtable’s goal of 80% for eligible individuals.6 More than one out of three eligible Americans – over 50 million people – do not complete CRC screening, often due to the perception that other available options, such as colonoscopy or stool-based tests, are invasive, unpleasant or inconvenient.7

"The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people," said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. "The FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved."

The Shield blood test is the result of over 10 years of research and development, including collaboration between Guardant Health and leading health organizations globally. Since the commercial introduction of the LDT (laboratory developed test) version in May 2022, the overall adherence rate for the Shield test has been more than 90%, meaning more than 90% of patients who were prescribed the test in a real-world clinical setting completed it.8 In contrast, studies show only 28-71% of patients who are prescribed other screening methods, such as colonoscopy or a stool test, complete them.9-12 Primary care physicians can have patients complete a Shield test with a simple blood draw during a routine office visit, providing a convenient and more pleasant alternative screening method that doesn’t require the special preparation, dietary changes, time and discomfort associated with colonoscopy or the unpleasantness of handling stool.

"The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable," said AmirAli Talasaz, Guardant Health co-CEO. "We are now getting ready to launch this test in the near future and are very excited to empower physicians with a viable blood-based screening option to tailor the screening regimen to the unique needs of their patients."

The FDA decision follows a strong recommendation for approval by an Advisory Committee panel in May 2024. The approval was based on results of ECLIPSE, a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults. Designed to reflect the diverse population of the U.S., the study was conducted at more than 200 clinical trial sites in rural and urban communities across 37 states. Results from the study, published in the March 14, 2024, issue of The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.13

"In addition to performance, a screening test’s value should be measured by how accessible it is, and how likely people are to use it," said Michael Sapienza, CEO of the Colorectal Cancer Alliance. "Guardant Health’s Shield test checks all three of these boxes and is truly a welcomed addition to the screening options currently available. Giving people choice, and offering a blood test that can reach those in harder-to-screen communities, will undoubtedly be a huge step forward in our battle against colorectal cancer."

"This is a promising step toward making more convenient tools available to detect colorectal cancer early while it is more easily treated," said William M. Grady, MD, a gastroenterologist at Fred Hutchinson Cancer Center. "The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options."

"Most people in my situation know we’re supposed to get screened for colon cancer," said Dennis Barnes, a 55-year-old attorney whose physician had recommended a colonoscopy. But despite his best intentions, he had never scheduled one. "It’s hard to find the time to schedule it if you have a busy life and a demanding job," he said. When his doctor told him about Shield, he agreed to have the blood test and was fortunate to have the result come back normal. "I realized I had taken quite a risk by waiting so long to screen. The Shield test is a much more pleasant way to screen, and the convenience of it makes getting screened pretty much a no-brainer."

"I was in for a routine physical and my doctor asked when I had my last colonoscopy," said John Gormly, a 77-year-old business executive in Newport Beach, California. "I said it’s been a long time, so he offered to give me the Shield blood test. A few days later the result came back positive, so he referred me for a colonoscopy. It turned out I had stage II colon cancer. The tumor was removed, and I recovered very quickly. Thank God I had taken that blood test."

Shield is available for eligible individuals by prescription through a doctor or other healthcare professional and is expected to be covered for eligible Medicare beneficiaries. Commercial insurance coverage for patients eligible for CRC screening will continue to expand following anticipated future guideline inclusion by the American Cancer Society and the U.S. Preventive Services Task Force (USPSTF).

For complete product information about the Shield blood test for CRC screening, including full safety information, visit ShieldCancerScreen.com.

Webcast Details

Guardant Health will host an investor conference call and webcast Monday, July 29, at 8:30 a.m. ET / 5:30 a.m. PT to discuss the FDA approval for Shield. A link to live audio of the webcast will be available on the "Investors" section of the company website at investors.guardanthealth.com or directly at this link. The webcast will be archived and available for replay after the event.

On July 29, 2024 GSK plc (LSE/NYSE: GSK) and Flagship Pioneering (Flagship), the bioplatform innovation company, reported they have entered a collaboration with the goal of discovering and developing a portfolio of future transformational medicines and vaccines, starting in respiratory and immunology (Press release, GlaxoSmithKline, JUL 29, 2024, View Source [SID1234645130]).

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This alliance brings together GSK’s disease area expertise and development capability with Flagship’s ecosystem of bioplatform companies, inclusive of its novel modalities and technologies, to make major advances in healthcare.

GSK and Flagship will initially fund up to $150 million upfront to support an exploration phase to identify the most promising concepts for further research and development with Flagship’s bioplatform companies. From these explorations, the collaboration aims to identify a portfolio of up to 10 novel medicines and vaccines which will each be subject to an exclusive option by GSK for further clinical development. Under the terms of the agreement, Flagship and its bioplatform companies will be eligible to receive up to $720 million in upfront, development and commercial milestones from GSK, as well as preclinical funding and tiered royalties, for each acquired programme.

Tony Wood, Chief Scientific Officer, GSK, said: "Together with Flagship, we will use science and technology to deliver best-in-class innovation at pace. We look forward to partnering with the talented team at Flagship, and their ecosystem of bioplatform companies, to further accelerate our pipeline and discover practice-changing medicines and vaccines for patients."

Paul Biondi, General Partner, Flagship Pioneering and President, Pioneering Medicines, said: "Flagship and GSK have a shared focus on delivering breakthrough medicines for patients. This collaboration is the latest example of Flagship’s Innovation Supply Chain Partnership model, which is designed to generate transformational medicines together with our pharma partners by leveraging our ecosystem of first-in-category bioplatforms to create a sustainable source of treatments for patients with the greatest unmet needs."

On July 29, 2024 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended June 30, 2024 (Press release, Corcept Therapeutics, JUL 29, 2024, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-2 [SID1234645129]).

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Financial Results

Revenue of $163.8 million, a 39 percent increase over the same period in 2023
Increase in 2024 revenue guidance to $640 – $670 million, from $620 – $650 million
Net income per common share of $0.32 (diluted), compared to $0.25 in second quarter 2023
Cash and investments of $492.5 million as of June 30, 2024
"Once again, we had a record number of new Korlym prescribers and a record number of patients receiving Korlym this quarter. Physicians are increasingly aware that hypercortisolism is much more prevalent than was previously assumed, so they are screening more patients for the disorder," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "From the launch of Korlym, we implemented a unique system of patient and physician support and have invested in multiple refinements over the past 12 years. Hypercortisolism is a complicated disease and the expertise we have developed is critical to the life-changing impact for patients who receive Korlym treatment."

Corcept’s second quarter 2024 revenue was $163.8 million, compared to $117.7 million in the second quarter of 2023. Second quarter operating expenses were $128.2 million, compared to $88.1 million in the second quarter of 2023, due to increased spending on clinical trials and sales and marketing activities and to support the expansion of our commercial and clinical development teams. Net income was $35.5 million in the second quarter of 2024 compared to $27.5 million in the same period last year. Cash and investments were $492.5 million at June 30, 2024 compared to $451.0 million at March 31, 2024.

The company increased its 2024 revenue guidance to $640 – $670 million.

Clinical Development

"During the second quarter we presented the results from our GRACE and CATALYST trials. GRACE’s positive results are a welcome development for patients with hypercortisolism and constitute a significant step toward our new drug application for relacorilant, which we expect to submit in the fourth quarter. In addition, the results from the prevalence phase of our CATALYST study establish that hypercortisolism is a driving biological force in patients with diabetes refractory to treatment. We expect data from the treatment phase of the CATALYST study, as well as our other late-stage studies, GRADIENT, ROSELLA and DAZALS, by the end of this year," added Dr. Belanoff.

Cushing’s Syndrome

GRACE – Phase 3 trial of relacorilant in 152 patients with all etiologies of hypercortisolism – primary endpoint achieved in randomized withdrawal phase; open-label phase demonstrated clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognitive impairment and quality of life
Relacorilant New Drug Application (NDA) – NDA submission for Cushing’s syndrome expected in the fourth quarter
GRADIENT – Phase 3 trial of relacorilant in 137 patients with Cushing’s syndrome caused by adrenal adenomas – enrollment completed; results expected in the fourth quarter
CATALYST – Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – in the first 1,055 patients enrolled, 24% were found to have hypercortisolism; 136 patients with hypercortisolism entered a randomized, double-blind, placebo-controlled study of Korlym – treatment phase results expected in the fourth quarter
"Relacorilant has demonstrated tremendous promise as a treatment for patients with Cushing’s syndrome. Patients in GRACE’s open-label phase experienced significant improvements across a broad range of clinically meaningful endpoints, without significant safety burden. In the randomized withdrawal phase, GRACE met its primary endpoint and demonstrated that patients who remained on relacorilant maintained these improvements while those who received placebo saw a significant worsening in their signs and symptoms of hypercortisolism," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

"Our Phase 4 CATALYST trial is the largest and most rigorous study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. The prevalence results from CATALYST confirm there are considerably more patients with Cushing’s syndrome than was previously assumed. CATALYST is poised to become the landmark study that guides physicians toward expanded screening for hypercortisolism and will result in better health outcomes for many patients who are struggling today," said Dr. Guyer.

Oncology

ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – enrollment completed; results expected in the fourth quarter
Open-label, Phase 1b trial of relacorilant plus pembrolizumab in 14 patients with advanced adrenal cancer with cortisol excess – improvement in Cushing’s syndrome signs and symptoms observed; no change in tumor progression
Randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer in collaboration with the University of Chicago – enrollment continues
"Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer. If our pivotal ROSELLA trial replicates the positive results from our large, controlled, Phase 2 study, it will constitute a major medical advance. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – Randomized, double-blind, placebo-controlled, Phase 2 trial of dazucorilant in 249 patients with ALS – enrollment completed; results expected in the fourth quarter
"Dazucorilant showed great promise in an animal model of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We expect data by the end of this year and are hopeful that the trial results will create a much-needed advance for patients with ALS," said Dr. Guyer.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant with a cohort of patients with biopsy-confirmed MASH and a second cohort of patients with presumed MASH based on non-invasive diagnostic tests – enrollment continues
"In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures, and was well-tolerated. We look forward to building on these promising results in our MONARCH study," said Dr. Guyer. "Miricorilant has the potential to greatly benefit the millions of patients with MASH."

Conference Call

We will hold a conference call on July 29, 2024, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. Additionally, a listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.

On July 29, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a Phase 1 trial for COM503, a potential first-in-class, high affinity anti-IL-18 binding protein antibody licensed to Gilead Sciences, Inc. (Gilead) (Press release, Compugen, JUL 29, 2024, View Source [SID1234645128]). The IND clearance triggered a $30 million milestone payment from Gilead and Compugen is on track to initiate the Phase 1 trial in solid tumors, in the fourth quarter of 2024.

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"We are thrilled to receive FDA IND clearance for COM503 which triggers a $30 million milestone payment from our partner Gilead, and the initiation of a Phase 1 trial will keep us on track to expedite COM503 development," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "We are excited about the potential of COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics which we discovered through our computational discovery work at Compugen."

Dr. Cohen-Dayag added, "This achievement reflects our track record in execution and diversity in our pipeline, adding another clinical program discovered through our predictive computational discovery engine. In addition, it further strengthens our balance sheet with an expected cash runway sufficient to take us into 2027. We look forward to the initiation of the Phase 1 trial in the fourth quarter of this year, for which our preparation is well-advanced."

About COM503 Phase 1 trial
The Phase 1 trial is a first-in-human, dose escalation and dose expansion trial to assess the safety and tolerability of COM503 as a monotherapy and in combination with Gilead’s anti-PD-1, zimberelimab in participants with advanced or metastatic solid tumors globally.

About the Compugen-Gilead license agreement
In 2023, Compugen and Gilead entered into a license agreement, pursuant to which Gilead was granted exclusive rights to develop and commercialize anti-IL-18 binding protein antibodies, including the COM503 drug candidate. Compugen is responsible for preclinical development and the anticipated first- in-human Phase 1 trial evaluating the safety and tolerability of COM503. Gilead will have the sole right to develop and commercialize COM503 thereafter. Gilead provided Compugen with a $60 million upfront payment and will make a $30 million payment for achievement of the milestone of IND clearance of COM503, the subject of this press release. Compugen will be eligible to receive up to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of up to $848 million. Compugen will also be eligible to receive single- digit to low double-digit tiered royalties on worldwide net sales.