National Institute of Medical Science

In ASPEN-03 and ASPEN-04 trials, efficacy data do not support advancing evorpacept in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), into a registrational study Company remains confident in continuing to pursue evorpacept in multiple clinical trials, based on the different mechanism of evorpacept in combination with anti-cancer antibodies, as evidenced by durable clinical response and consistent safety data in prior clinical trials SOUTH SAN FRANCISCO, April 25, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced topline data from its Phase 2 ASPEN-03 and ASPEN-04 clinical trials. The company’s investigational CD47-blocker evorpacept, when added to Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) with or without chemotherapy, did not meet the primary endpoints in the ASPEN-03 and ASPEN-04 trials of improved objective response rates (ORR) as compared to historical controls of pembrolizumab alone and pembrolizumab with chemotherapy, respectively, as a first-line treatment in patients with advanced head and neck squamous cell carcinoma (HNSCC). The combination of evorpacept and pembrolizumab with or without chemotherapy in ASPEN-03 and ASPEN-04 demonstrated a manageable safety profile and was consistent with what has been previously reported for pembrolizumab and chemotherapy in this setting. Although the company will no longer pursue evorpacept in combination with pembrolizumab in HNSCC, multiple clinical trials of evorpacept in combination with anti-cancer antibodies will continue based on established proof-of-concept. Evorpacept blocks the ‘don’t eat me’ signal transmitted by CD47 on the surface of cancer cells that these cells use to evade detection by the immune system. As its primary mechanism of action, evorpacept is uniquely designed to stimulate macrophages to selectively attack cancer cells and not healthy cells, when combined with active anti-cancer antibodies. This mechanism has translated into durable clinical responses and a well-tolerated safety profile in HER2-positive gastric and HER2-positive breast cancer clinical trials. To further explore the benefit in this setting, evorpacept is currently being evaluated in combination with various anti-cancer antibodies in colorectal cancer, breast cancer, non-Hodgkin lymphoma and multiple myeloma. In the ASPEN-03 and ASPEN-04 clinical trials, evorpacept was combined with pembrolizumab with or without chemotherapy to investigate a second and distinct mechanism of action. This discrete approach explored the concept that evorpacept may enhance T-cell priming by activating dendritic cells and stimulating the adaptive immune system. The trial outcomes were not sufficiently supportive of advancing evorpacept in combination with pembrolizumab in HNSCC into a registrational trial. “While there were encouraging trends in ASPEN-03 in ORR versus the historical and internal control, we've decided not to pursue evorpacept and pembrolizumab in head and neck cancer in light of our prioritization of the more established anti-cancer antibody combination program based on multiple positive studies,” said Alan Sandler, M.D., Chief Medical Officer at ALX Oncology. “We are disappointed that these studies did not meet their primary endpoints, most importantly for the patients for whom current standard-of-care treatment approaches fall short, and we thank all who participated in the trials.” “Moving forward, we are continuing to rapidly advance our clinical program combining evorpacept with anti-cancer antibodies supported by robust clinical data across trials in multiple tumor types. Evorpacept has demonstrated response rates and durability beyond what is expected from standard of care across several studies when combined with HERCEPTIN®, zanidatamab and RITUXAN®,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Based on the positive data and strong mechanistic rationale, we maintain our confidence in the evorpacept clinical development program and intend to deliver on that promise with additional clinical data in breast cancer and colorectal cancer in the near-term. With evorpacept and ALX2004, our novel EGFR-targeted antibody-drug conjugate, we continue our commitment to bringing forth meaningful therapies for patients living with cancer.” Detailed findings from the ASPEN-03 and ASPEN-04 trials will be submitted to a future medical meeting. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About ASPEN-03 and ASPEN-04 Clinical Trials ASPEN-03 and ASPEN-04 are randomized, multi-center, international Phase 2 trials evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated proprietary Fc domain, in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The ASPEN-03 trial (NCT04675294) is evaluating evorpacept in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) against pembrolizumab alone for the treatment of patients whose HNSCC is PD-L1 positive. The ASPEN-04 trial (NCT04675333) is evaluating evorpacept in combination with pembrolizumab and chemotherapy against pembrolizumab and chemotherapy alone in patients with HNSCC, regardless of PD-L1 status. Patient characteristics in the trials (N=346) were generally well-balanced across arms. The primary endpoints for the ASPEN-03 and ASPEN-04 trials is ORR compared to historical control. Key secondary endpoints for both trials are safety, duration of response (DOR), progression-free survival (PFS) and overall survival (OS). About Head and Neck Squamous Cell Carcinoma (HNSCC) HNSCC is a serious and life-threatening disease that originates in the squamous cells lining the mucosal surfaces of the head and neck, including the mouth, throat, voice box, sinuses and nasal cavity. HNSCC is the seventh most common cancer worldwide and the incidence of HNSCC is expected to increase 30% by 2030. Despite current standard-of-care therapies and recent advancements in diagnosis and treatment, people with HNSCC face a poor prognosis, particularly when diagnosed at advanced stages. Further, the survival rate for HNSCC has only modestly improved in recent years, even with the availability of new treatment modalities, underscoring a need for improved therapeutics. About Evorpacept ALX Oncology's lead therapeutic candidate, evorpacept, is a highly differentiated potential best- and first-in-class CD47 checkpoint inhibitor and one of the most advanced checkpoint inhibitors to target and activate the innate immune system. Evorpacept was intentionally designed to maximize the clinical potential of blocking CD47, while reducing the toxicities associated with previous approaches to CD47 blockade. In clinical studies across a wide spectrum of tumor types in more than 700 patients to date, evorpacept has demonstrated potential to enhance the therapeutic activity of many of the most important cancer therapies available today, contributing an additional, differentiated immuno-oncology mechanism. Based on this potential, ALX Oncology is advancing a robust clinical program evaluating evorpacept in a wide range of cancer indications, prioritizing its combination with anti-cancer antibodies in breast, gastric and colon cancers. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and is anticipated to enter Phase 1 trials mid-2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Cautionary note regarding forward-looking statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations Contact: Elhan Webb, CFA, IR Consultant ewebb@alxoncology.com Media Contact: Audra Friis, Sam Brown, Inc. audrafriis@sambrown.com (917) 519-9577

From digital twin technology to leveraging AI in tackling obesity, the NUHS Scientific & Innovation Summit is a congregation of the brightest minds in cutting-edge medicine – with patients' utmost care at heart SINGAPORE, Aug. 3, 2024 /PRNewswire/ -- Hepatocellular carcinoma (HCC) is one of the most lethal cancers, but Mr Ang Chin Chay, 70, was in the dark about his dire condition, until he experienced a bout of fever following a vacation to Vietnam. He quickly sought medical attention for what turned out to be a Hepatitis A infection, transmitted through contaminated food he had consumed overseas. Continue Reading Themed “Tomorrow’s Health Today – Predictive, Precise and Personalised”, the NUHS Scientific and Innovation Summit 2024 showcases innovations that aim to improve health outcomes for patients and the population at large. The opening was officiated by Guest of Honour Prof Tan Chorh Chuan, Permanent Secretary for National Research and Development, and Public Sector Science and Technology Policy and Plans Office, Prime Minister’s Office (middle; seventh from left). It was a fortuitous encounter, as routine tests revealed abnormal liver function results. Mr Ang subsequently underwent scans, which uncovered HCC, a largely asymptomatic cancer in its early stages. This was unexpected as Mr Ang was known to have fatty liver, but not cirrhosis, the most advanced form of liver scarring. "Patients with fatty liver – but without cirrhosis – are not routinely recommended to undergo liver cancer screening," Dr Huang explained. "But in reality, we have discovered that nearly 40 percent of HCC cases related to fatty liver occur in the absence of cirrhosis." Mr Ang's prognosis would have been poor if his condition had not been detected early, as patients who are diagnosed at a late stage have an overall five-year survival rate of less than 20 percent. Improving the screening process for patients like Mr Ang through non-invasive tests and advanced imaging is the crux of Dr Huang's work that he will be presenting at the NUHS Scientific & Innovation Summit, on 3 August 2024. "We aim to risk stratify people with fatty liver into those who have a high risk of liver cancer and those who do not, and to pre-emptively develop better ways to identify these people early so that they can receive some form of curative treatment," Dr. Huang explained. Personalising care with the digital twin Another project pushing the frontiers of medicine with digital innovations, is the Digital Twin programme led by Dr Gao Yujia, Assistant Group Chief Technology Officer, National University Health System. The digital twin, which is based on imaging and other data from a patient's own tests, is a virtual 3D anatomical replica of a patient's organs, like the liver. The digital twin will allow clinicians to transform what is usually a static scan image (such as an MRI scan), into a dynamic model that precisely recreates the shape and structural behaviour of the organ it replicates, enabling enhanced pre-surgery planning and more accurate intra-operative navigation. Together with Holomedicine, which is a mixed reality (MR) based technology, this represents a significant leap forward in the surgeons' ability to predict how organs will behave during a surgery, and predict how internal structures will move and change as the surgery is being performed. "Holomedicine leverages mixed reality to interact with virtual objects superimposed onto the real world, allowing for unparalleled accuracy in pre-surgical planning," explained Dr Gao, who will be presenting his work in mixed reality technology at the NUHS Scientific & Innovation Summit. With this near-pinpoint precision, surgeons can minimise the risk of injuring other structures, thereby reducing potential complications and operating time, ultimately improving the patient's overall recovery outcomes. Tackling diseases with precision Dr Anand Jeyasekharan, a senior consultant at the Department of Haematology-Oncology in the National University Cancer Institute, Singapore (NCIS), likens the human body's reaction to cancer cells, to an intense battle between two warring armies. It was a battle that became personal in 2023 for Mr Soegianto Nagaria, Dr Jeyasekharan's patient. He had a large tumour in his liver excised by surgeons in Taiwan. Initially thought to be liver cancer, the reports indicated it to be a Stage 4 diffuse large B-cell lymphoma instead. The situation worsened when the doctors discovered the presence of a second lymphoma in his bone marrow. Diagnosing and treating two concurrent cancers presented significant challenges, requiring precise and coordinated medical intervention. It was important to know if the two cancers were related, as the treatment would be very different if they were. Upon recommendations by his cousins, who are doctors, Mr Nagaria decided to continue the rest of his treatment at NCIS, under Dr Jeyasekharan's care. Mr Nagaria flew to Singapore in September 2023, and underwent a molecular profiling under an NUHS programme for precision oncology (IMAC - integrated molecular analysis of cancer) to get his tumour sequenced. Following the sequencing, the NCIS team discovered that the two lymphomas were not related and drew up the vital treatment plans, providing life-saving ammunition in the cancer battle. Mr Nagaria completed multiple rounds of chemotherapy over six months, and is now on close monitoring while in remission. Besides sequencing, which Mr Nagaria underwent, Dr Jeyasekharan is developing a new tool in his arsenal of weapons against deadly cancers – spatial phenotyping, where advanced imaging equipment is used to analyse cancer with high molecular detail. Spatial phenotyping represents the next frontier of cancer research, and is especially useful for solid tumours. "We are trying to draw [battle] maps of cancer at a high resolution and in great detail, in order to understand how to fight it," Dr Jeyasekharan explained. "Spatial phentoyping's ability to dive deep into molecular detail allows us to be more precise in diagnostics, treatment and care." With cancer being a leading cause of death globally, spatial phenotyping can mean a world of difference for patients afflicted with cancer. "We are never happy with just delivering standard treatment, because standard treatment simply isn't good enough," Dr Jeyasekharan said. "Some people get cured, some people don't – we are trying to understand what we can do to improve the chances of curing more people." For A/Prof Su Xinyi, who is a senior consultant with the Department of Ophthalmology at NUH, precision medicine may be the key to restoring the vision of patients suffering from currently untreatable and blinding retinal diseases. "Every patient with retinal disease has a unique gene mutation, so the treatment that we provide is tailored specifically to the mutations that they have," A/Prof Su explained. Besides gene therapy, A/Prof Su also explores innovations in cell therapy, which are last options for patients with end-stage age-related macular degeneration (AMD) – the third leading cause of blindness globally. In AMD, retinal pigment epithelium (RPE) cells in the retina degenerate with age. By growing these cells in a petri dish, and then injecting them into the eye, they can replace lost cells and help patients regain vision. While this method of treatment is not new, what makes it unique is the source of cells A/Prof Su uses in its development – cells derived from the umbilical cord. By doing so, this greatly reduces the chance of rejection or the need to use immunosuppressants. Predicting risk factors, a step ahead Predictive care affords patients and clinicians the precious gift of time, in preventing the onset, or minimising the severity, of diseases. For Dr Jocelyn Chew, who is an assistant professor at the NUS Alice Lee Centre for Nursing Studies and Yong Loo Lin School of Medicine (NUS Medicine), adopting a predictive approach to tackling a person's dietary triggers can curb overeating and obesity. Dr Chew has been working on an app called the Eating Trigger-Response Inhibition Program (eTRIP), which is designed to help patients identify moments where they are prone to overeating. These include emotional eating, or even ingrained habits such as over-ordering during family gatherings. eTRIP will be used in tandem with Adipoview, an AI-based dashboard that Dr Chew has created with the team from the NUHS Group Chief Technology Office. Adipoview will gather patient data throughout NUHS to generate insights, such as the diagnosis rate of obesity and treatment rate, to proactively predict who may need further support. At the summit of innovation More than 60 clinician-scientists will be presenting their work at the NUHS Scientific & Innovation Summit, which will be graced by guest-of-honour Professor Tan Chorh Chuan, Permanent Secretary for National Research and Development as well as for Public Sector Science and Technology Policy and Plans Office, Prime Minister's Office. Themed "Tomorrow's Health Today – Predictive, Precise and Personalised", the summit will bring together over 500 international and local healthcare experts, opinion leaders and scientists to shape the future of healthcare. Over the past decade, the NUHS academic health system has secured more than $1 billion in competitive grants (cumulative from FY2011 to FY2021). These funds have fuelled scientific innovations in predictive, precise and personalised care, ensuring improved health outcomes for patients now and in the future. For media enquiries, please contact: TOH Wei Shi Senior Assistant Manager Group Communications National University Health System Email: [email protected] Mobile: 9753 9619 About National University Health System The National University Health System (NUHS) is an integrated Academic Health System and Regional Health System in Singapore that delivers value-driven, innovative, and sustainable healthcare. As Singapore's only academic health system, we are uniquely positioned to draw on the academic, research and creative capabilities residing within the National University of Singapore (NUS). This collaboration allows us to develop solutions for existing and emerging health and healthcare needs of the Singapore population. We also work in close collaboration with community hospitals, general practitioners, family medicine clinics, nursing homes and other community and social partners to provide integrated care to the wider community. With member institutions ranging from community hospitals to academic centres, NUHS creates synergies as a fully integrated cluster to provide seamless care, develop solutions for Singapore's healthcare challenges and nurture the next generation of healthcare professionals. SOURCE National University Health System (NUHS)

Single Infusion of ANX005 Demonstrated Significant Improvements Across Multiple Functional and Prognostic Measures That Expedited Recovery in GBS Patients ANX005 Has Potential to be the First Targeted Therapy Approved for the Treatment of GBS BRISBANE, Calif., June 18, 2024 (GLOBE NEWSWIRE) --Annexon, Inc., (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced the Company will have several presentations on the Company’s ANX005 Guillain-Barré Syndrome (GBS) program at the 2024 Peripheral Nerve Society (PNS) Annual Meeting being held June 22-25, 2024 at the Palais des congrès de Montréal in Montréal, Canada. Pivotal Phase 3 clinical results of ANX005 in GBS, including further analyses of early and durable treatment effects on measures important to patients and the medical community, will be highlighted as part of a plenary clinical presentation, as well as discussed in an Annexon sponsored lunch symposium, a flash oral presentation, and two poster presentations. Details of the presentations are as follows: Oral Presentation: “Design of a Phase 3 Study Evaluating ANX005 in Patients with Guillain-Barré Syndrome” Abstract #: O 442 Session: The Richard A.C. Hughes Symposium: Clinical Highlights Presenter: Dr. Quazi Deen Mohammad, National Institute of Neuroscience, Bangladesh Date/Time: Tuesday, June 25, 2024, 4:59 – 5:12 p.m. EDT Location: Main Plenary Hall Annexon Lunch Symposium: “Annexon Biosciences Breaking New Ground in the GBS Treatment Landscape” Presenters: Dr. David Cornblath, Johns Hopkins University School of Medicine, USA; Dr. Bart Jacobs, Erasmus MC, Netherlands; Dr. Luis Querol, Hospital de la Santa Creu i Sant Pau, Spain; Dr. Jeff Allen, University of Minnesota, USA; Lisa Butler, GBS|CIDP Foundation International, USA Time and date: Tuesday, June 25, 2024, 1:15 – 2:15 p.m. EDT Location: Room 710b Flash Oral Presentation: “Comparative Efficacy: ANX005's Potential Advantage over Intravenous Immunoglobulin in Guillain-Barré Syndrome” Abstract #: 83890 Session: Inflammatory Neuropathy Consortium (INC) Concurrent SIG – INC Flash Presentations Presenter: Dr. Henk-André Kroon, Annexon Biosciences, USA Time and date: Sunday, June 23, 2024, 4:25 – 4:30 p.m. EDT Location: Room 517d Poster Presentation: “Coexistence of Acute Motor Axonal Neuropathy and Acute Inflammatory Demyelinating Polyneuropathy in Guillain-Barré Syndrome” Abstract #: P 238 Session: Poster Session II Presenter: Dr. Henk-André Kroon, Annexon Biosciences, USA Date/Time: Monday, June 24, 2024, 2:15 – 3:15 p.m. EDT Location: Poster Hall Poster Presentation: “Development of a Framework to Compare Outcomes Between Diverse GBS Populations” Abstract #: P 305 Session: Poster Session I Presenter: Dr. Eveline J.A. Wiegers, Erasmus MC, Netherlands Date/Time: Sunday, June 23, 2024, 2 – 3 p.m. EDT Location: Main Plenary Hall Additional details are available on the 2024 PNS Annual Meeting website here. About ANX005 Annexon’s lead investigational therapy, ANX005, is a first-of-its kind selective, targeted and rapid-acting agent designed to reduce inflammation and nerve damage by fully stopping C1q activity in the peripheral and central nervous systems. In GBS, ANX005 seeks out C1q and selectively blocks it from binding to its target on peripheral nerves. ANX005 is administered intravenously and has been observed to act almost immediately. In GBS, the aim is to rapidly stop the autoimmune damage of nerve cells, allowing patients to regain muscle strength sooner to regain independence and return to pre-illness activities. ANX005 has received both fast track and orphan drug designations from the U.S. Food and Drug Administration as well as orphan drug designation by the European Medicines Agency for the treatment of GBS. About Guillain-Barré Syndrome (GBS) GBS is a severe disease resulting from an acute autoantibody attack on peripheral nerves that generally occurs post-infection in otherwise healthy persons following activation of C1q and the classical complement cascade. It is a rapid and acute neurological disease with a narrow therapeutic window that results in hospitalization of over 22,000 people annually in the U.S. and Europe. The peripheral nerve damage progresses rapidly, causing acute neuromuscular paralysis, and may lead to significant morbidity, disability and mortality. Currently, there are no approved treatments for GBS in the U.S. The long-term disease burden associated with GBS has led to a multi-billion-dollar annual economic cost to the U.S. healthcare system alone. About Annexon Annexon Biosciences (Nasdaq: ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Annexon’s novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring their potential treatments to patients as quickly as possible. To learn more visit annexonbio.com. Forward Looking Statements 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. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: ability of ANX005 to stop C1q activity; the clinical and regulatory status of ANX005; the potential of ANX005 to be the first approved treatment for GBS; the potential therapeutic benefit of ANX005 on GBS; potential benefit of ANX005, if approved, compared to existing therapies; the potential benefits from treatment with anti-C1q therapy; and Annexon’s ability to rigorously advance mid-to late-stage clinical trials and continue development of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the potential for any final clinical trial results to differ from preliminary or topline results; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Joyce Allaire LifeSci Advisors, LLC jallaire@lifesciadvisors.com Media Contact: Sheryl Seapy Real Chemistry 949-903-4750 sseapy@realchemistry.com