Anti-CD73 antibody(Peter MacCallum Cancer Institute)

SHANGHAI and HONG KONG, Aug. 23, 2024 /PRNewswire/ -- Antengene Corporation (6996.HK) today announced its interim results for the period ending June 30, 2024, along with several significant milestones achieved in recent months. Dr. Jay Mei, Antengene's Founder, Chairman, and CEO, stated, "In the first half of 2024, the company has made significant progress in both R&D and commercialization. Our four global rights assets — ATG-022 (Claudin 18.2 ADC), ATG-037 (CD73 small molecule), ATG-101 (PD-L1/4-1BB bispecific antibody), and ATG-031 (CD24 monoclonal antibody) have all advanced steadily as planned. Among them, ATG-022, currently in Phase II dose expansion stage, has demonstrated efficacy not only in gastric cancer patients with moderate-to-high Claudin 18.2 expression but also in those with low and ultra-low expression levels. This unprecedented data reinforces our belief that ATG-022 is poised to become a globally best-in-class molecule targeting Claudin 18.2. While we remain focused on building a differentiated and innovative pipeline, the company has also established a robust self-sustaining revenue-generating capability. XPOVIO® has achieved three significant milestones within the past six months, including a supplementary new drug approval (NDA) for diffuse large B-cell lymphoma (DLBCL) in the Mainland of China, National Health Insurance Service Approval for Reimbursement in South Korea, and NDA approvals for multiple myeloma (MM) in Malaysia. To date, XPOVIO® has been approved for marketing in eight countries and regions across the Asia-Pacific markets and included in the national health insurance of four of these markets, generating product revenue of RMB 60.8 million in the first half of 2024." Dr. Mei continued, "Antengene's innovative R&D capabilities, strategic approach to drug discovery and development, and rigorous cost-efficiency measures ensure the company is well positioned for sustained operations and growth in the coming years. With a cash and bank balance of RMB 1.024 billion, we have sufficient runway to provide strong support to the continuous growth, development, and operations of Antengene. We look forward to sharing more of our progress in the second half of 2024, with a key highlight being the latest research results of ATG-037, which will be presented in a mini oral presentation at the ESMO Annual Meeting on September 16." 1. Global Rights Assets with Advancing Steadily at Clinical Stage ATG-022 (Claudin 18.2 Antibody-Drug Conjugate, ADC): Currently at Phase II Dose Expansion Stage, Effectively Targeting Gastric Cancer with both High and Ultra-low Claudin 18.2 (CLDN18.2) Expression ATG-022 is a highly differentiated asset demonstrating activity across a wide range of CLDN18.2 expression levels, including both high and low/ultra-low expression level. ATG-022 has received two Orphan Drug Designations (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. The Phase I CLINCH dose escalation study was completed earlier this year, 2.4 mg/kg was selected as the recommended Phase II dose (RP2D). ATG-022 has now progressed to the Phase II monotherapy dose expansion stage. As of Aug 21st 2024, Data from the on-going Phase II CLINCH dose expansion study, shows that 21 CLDN18.2 positive gastric cancer patients have been treated with ATG-022. Among the 12 patients who at least underwent their first tumor assessment after study treatment, 5 achieved partial response (PR), resulting in an overall response rate (ORR) of 41.7% (including one patient with ultra-low CLDN18.2 expression), and a disease control rate (DCR) of 100%. The Phase II CLINCH study is currently progressing smoothly in China and Australia. ATG-037 (CD73 Small Molecule Inhibitor): Demonstrated Potential in Reversing Resistance to anti-PD-1 Therapies during Dose Escalation Inhibiting CD73 is intended to stop the production of adenosine, a key immunosuppressive molecule in the tumor microenvironment. As a small molecule inhibitor of CD73, ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with locally advanced or metastatic solid tumors. ATG-037 demonstrated an excellent safety profile during the dose escalation stage. Notably, four partial responses in patients previously treated with a checkpoint inhibitor were observed — two in melanoma patients and two in non-small cell lung cancer patients. With the Phase I dose escalation now complete, the company plans to initiate the Phase II dose-expansion of the STAMINA study in China and Australia in the third quarter of 2024. ATG-101 (PD-L1/4-1BB Bispecific Antibody): Durable Responses and Preliminary Efficacy in "Cold Tumors" Observed at Low Doses Without Off-target Liver Toxicity ATG-101's differentiated approach to targeting PD-L1 resistant cancers incorporates the conditional activation of the T-cell co-stimulatory receptor 4-1BB. The bispecific antibody utilizes high PD-L1 affinity and conditional 4-1BB activation, to reduce the risk of hepatotoxicity. ATG-101 is currently undergoing dose-escalation studies in the US, the Mainland of China, and Australia. The treatment has demonstrated excellent tolerability, with no significant liver toxicity observed to date. Encouragingly, durable stable disease has been observed even at low dose levels, as along with a partial response in a patient with microsatellite stable (MSS) colorectal cancer. The Phase I dose escalation phase is on track for completion by the first half of 2025. ATG-031 (Anti-CD24 Monoclonal Antibody): First-in-Class Macrophage Activator Targeting CD24 ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S. ATG-031 works by blocking CD24-Siglec10 and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include four renowned cancer centers in the United States: MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center. In the Phase I PERFORM study, 19 late-stage cancer patients have been treated with early low doses in the dose escalation segment, with no dose-limiting toxicities (DLTs) observed. Observations include stable disease (SD), objective tumor shrinkage, and clinical improvements among enrolled patients. The company targets a Phase I data readout in the first half of 2025. Promising Pre-clinical Programs: Antengene is committed to advancing its proprietary "2+1" T-cell engager platform, AnTenGagerTM. T cell engagers developed from this platform are designed to induce disease-associated antigen (DAA)-dependent T-cell binding and activation, delivering strong therapeutic activity while minimizing the risk of cytokine release syndrome (CRS). The development of preclinical candidates, including ATG-042, a selective PRMT5 inhibitor targeting MTAP-null tumors, and ATG-201, a CD19 x CD3 T-cell engager, is ongoing. 2. Expanding APAC Presence with Inclusion in Multiple National Health Insurance Programs In June 2024, South Korea's National Health Insurance Service (NHIS) has approved the reimbursement of XPOVIO®, effective from July 1, 2024. This marks the fourth Asia-Pacific market, following the Mainland of China, Australia, and Singapore, where the company has secured reimbursement/insurance coverage for XPOVIO®. The company is actively working to secure health insurance inclusion for XPOVIO® in more Asia-Pacific markets. In July 2024, XPOVIO® received approval for a new indication in the Mainland of China, offering a new treatment option for patients with DLBCL. This is the second indication approved for XPOVIO® in the Mainland of China, following its approval for relapsed/refractory multiple myeloma (R/R MM). In August 2024, XPOVIO® was officially approved for marketing in Malaysia. To date, XPOVIO® has received multiple new drug approvals across eight countries and regions in the Asia-Pacific market (the Mainland of China, Taiwan, Hong Kong, Macau, Australia, South Korea, Malaysia, and Singapore). The company has also submitted NDA for XPOVIO® in other ASEAN markets such as Thailand and Indonesia, with approvals expected later this year. Since being included in the National Reimbursement Drug List (NRDL) in December 2023, XPOVIO® has shown impressive revenue performance in the first half of 2024. As of June 30, 2024, XPOVIO® sales revenue has reached RMB 60.8 million. 3. Strong Cash and Bank Balance to Support Strategic Objectives As of June 30, 2024, the company held RMB 1.024 billion in cash and bank balance. The steady growth in revenue, strong cash and bank balance coupled with careful spending, will provide strong support to the continuous growth, development, and operations of Antengene. For more details on the 2024 interim financial results, please refer to the full announcement available in the "Investor Relations" section of the company's official website. About Antengene Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited

Early Results from Soquelitinib Phase 1 Randomized Trial in Atopic Dermatitis Demonstrate Clinical Activity and Corresponding Changes in Cytokine Levels Consistent with ITK Inhibition Mechanism of Action Soquelitinib Registration Phase 3 Trial in Peripheral T Cell Lymphoma (PTCL) Advancing Toward Initial Enrollment in Q3 2024; New Complete Response Achieved in Ongoing Phase 1/1b Clinical Trial Conference call today at 4:30 p.m. ET / 1:30 p.m. PT BURLINGAME, Calif., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the second quarter ended June 30, 2024. “We have seen growing evidence supporting the central role of ITK in T cell biology and the significant potential of ITK inhibition as a new mechanism to treat a broad range of immune diseases and cancers,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “This includes early data from our Phase 1 clinical trial of soquelitinib in atopic dermatitis and our ongoing preclinical work exploring ITK inhibition in autoimmunity and inflammation. Based on this, we are increasingly optimistic that our ITK platform has the potential to improve clinical outcomes for a range of indications as an oral medication with an attractive tolerability profile. We have leveraged our experience in T cell lymphomas which has allowed us to gain a deeper understanding of the role of ITK in T cell biology that we can now apply to immune diseases. We remain on track to initiate a Phase 3 registrational trial in PTCL in the third quarter.” Business Update and Strategy Prioritized Program: Soquelitinib (formerly CPI-818, Corvus’ selective ITK inhibitor) Soquelitinib for Immune Diseases Corvus continues to enroll patients at multiple clinical sites in its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis. The trial is planned to enroll 64 patients that have failed at least one prior therapy across four different 28-day dosing regimens of soquelitinib compared to a placebo group. The endpoints include safety and improvement in Eczema Area and Severity Index. Patients and physicians will be blinded to treatment assignment. Initial results, as of July 31, 2024, from three evaluable patients in the first cohort of the trial that completed the 28-day dosing regimen and follow-up visit demonstrated signs of clinical activity and corresponding changes in serum cytokine levels that are consistent with soquelitinib’s mechanism of action. These patients received a dose of 100 mg two-times a day, the lowest dose level planned for the study. Corvus anticipates interim data from the Phase 1 clinical trial will be presented in the fourth quarter of 2024. Recent published data from researchers at Cornell University demonstrated that ITK controls the fate of inflammatory Th17 cells. When ITK is inhibited by soquelitinib, the Th17 cells convert or switch to Treg cells that suppress inflammation. Soquelitinib treatment in an asthma model of mice with allergic airway inflammation significantly reduced the percentage of Th17 cells in the lung resulting in an increase in the ratio of Treg to Th17 cells. These studies confirm our understanding of the role of specific ITK inhibition in inflammation and are relevant to many immune diseases.Corvus continues to advance its next-generation ITK inhibitor preclinical product candidates, which were designed to deliver precise T-cell modulation that is optimized for specific immunology indications. The next-generation ITK inhibitor candidates are part of the Company’s ongoing business development efforts to maximize the potential of the Company’s ITK inhibitor programs in immune diseases and cancers. Soquelitinib for T Cell Lymphoma Corvus continues to follow patients with relapsed T cell lymphoma in its Phase 1/1b clinical trial (no longer enrolling new patients) evaluating single agent therapy with soquelitinib. Updated interim data as of July 16, 2024: A total of 25 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose and meet the eligibility criteria for the planned registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies, including 23 evaluable patients.For the 23 evaluable patients, objective responses (complete response, CR plus partial response, PR) were seen in nine patients (39%), including six CRs (26%) and three PRs. Compared to the prior data reported as of May 3, 2024, one patient with continued tumor regression achieved a CR that previously had a PR at the first follow up visit. See waterfall plot below.Disease control (CR, PR and stable disease) was seen in 14 of 23 patients (61%). The stable disease group included five patients who achieved tumor reductions that did not meet the criteria for a PR. Corvus anticipates initiating a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL in the third quarter of 2024. There are currently no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma. Recently, the Company received a Pediatric Waiver from the FDA indicating that it would not be required to conduct clinical trials in a pediatric population for this indication.As recently announced, soquelitinib has received Fast Track designation for treatment of adult patients with relapsed or refractory peripheral T cell lymphoma after at least 2 lines of systemic therapy. Waterfall Plot for Patients in the 200 mg Dose Cohort of the Soquelitinib Phase 1/1b Clinical Trial for Peripheral T Cell Lymphoma. The plot shows the best percent change in tumor volume in the 23 evaluable patients (eligible patient population), as of July 16, 2024, that were measurable by CT scan or by Modified Severity-Weighted Assessment Tool (mSWAT) for patients with cutaneous involvement. PTCL-NOS, peripheral T cell lymphoma not otherwise specified; CTCL, cutaneous T cell lymphoma of either Sezary or mycosis fungoides type; NKTCL, natural killer cell T cell lymphoma; ALCL, anaplastic large cell lymphoma; AITL, angioimmunoblastic T cell lymphoma. Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor) Corvus is collaborating with the Kidney Cancer Research Consortium in a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The efficacy endpoint for the trial is deep response rate, defined as CR plus PRs of greater than 50% tumor volume reduction. The clinical trial is expected to enroll up to 60 patients and as of May 31, 2024 a total of 32 patients were enrolled in the trial. The protocol defined, interim pre-specified statistical threshold for efficacy is a 50% increase above the 32% deep response rate seen with previous ipilimumab/nivolumab combination trials in RCC conducted by investigators at the Kidney Cancer Research Consortium. As of May 31, 2024, the interim analysis of the clinical trial has met the threshold for efficacy and therefore enrollment continues.In July 2024, a new U.S. patent was issued (United States Patent No. 12,023,337) by the U.S. Patent and Trademark Office that covers the use of ciforadenant for the treatment of cancer; foreign counterparts are pending. Partner Led Program: Mupadolimab (anti-CD73) Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in an expansion cohort of a Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC). In this clinical trial, patients will receive mupadolimab monotherapy. Financial Results As of June 30, 2024, Corvus had cash, cash equivalents and marketable securities of $47.2 million as compared to $27.1 million as of December 31, 2023. During the quarter ended June 30, 2024, the Company completed a registered direct offering in which it sold shares of common stock, pre-funded warrants and common warrants, generating $30.3 million in net proceeds. Corvus expects full year 2024 net cash used in operating activities to be between approximately $24 million and $27 million, resulting in a projected cash balance of between approximately $31 million and $34 million at December 31, 2024. Based on its current plans, Corvus expects its cash to fund operations into the fourth quarter of 2025. Research and development expenses for the three months ended June 30, 2024 totaled $4.1 million compared to $4.0 million for the same period in 2023. The increase of $0.1 million was primarily due to higher clinical trial costs associated with the development of soquelitinib. The net loss for the three months ended June 30, 2024 was $4.3 million compared to a net loss of $6.5 million for the same period in 2023. Total stock compensation expense for the three months ended June 30, 2024 was $0.8 million compared to $0.5 for the same period in 2023 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.6 million for the three months ended June 30, 2024 compared to a loss of $1.3 million for the same period in 2023. In addition, the Company recorded a non-cash gain of $1.8 million from the change in fair value of its warrant liability during the three months ended June 30, 2024 due to the warrants issued in the registered direct offering. Conference Call DetailsCorvus will host a conference call and webcast today, Tuesday, August 6, 2024, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2024 financial results. The conference call can be accessed by dialing 1- 800-717-1738 (toll-free domestic) or 1- 646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days. About Corvus PharmaceuticalsCorvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com. About SoquelitinibSoquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company plans to initiate a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL. Soquelitinib also is now being investigated in a randomized placebo controlled phase 1 clinical trial in patients with atopic dermatitis. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and inhibition of Th2 and Th17 cells. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. About Peripheral T Cell LymphomaPeripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. First line treatment for these diseases is typically combination chemotherapy, however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the three to four month range and overall median survival of six to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials. PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. About Atopic DermatitisAtopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes. About CiforadenantCiforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2a receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies. About MupadolimabMupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes. About Angel PharmaceuticalsAngel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with U.S.-based Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – soquelitinib, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49.7% equity stake in Angel Pharmaceuticals excluding 7% of Angel’s equity reserved for issuance under the Angel ESOP, and Corvus has designated three individuals on Angel’s five-person Board of Directors. For more information, visit www.angelpharma.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib, ciforadenant and mupadolimab; the potential use of soquelitinib to treat a variety of hematological cancers and autoimmune diseases; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1 clinical trial for atopic dermatitis with soquelitinib; the timing of and the Company’s ability to launch clinical trials, including the soquelitinib registrational Phase 3 clinical trial for PTCL; the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, expected number of sites and certain other product development milestones, including in regards to the Phase 1 clinical trial for atopic dermatitis with soquelitinib; the availability and timing of clinical and preclinical data announcements and clinical readouts, including early data from the Phase 1 clinical trial for atopic dermatitis with soquelitinib and preclinical data supporting the broad potential of ITK inhibition in immune and inflammatory disease; the estimated amount of net cash used in operating activities for 2024 and its ability to fund operations into the fourth quarter of 2025. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2024, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of soquelitinib and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the amount of net cash used in operating activities for 2024 and cash on hand providing funding into the fourth quarter of 2025 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The Company’s results for the quarter ended June 30, 2024 are not necessarily indicative of its operating results for any future periods. CORVUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 (unaudited) (unaudited)Operating expenses: Research and development $4,114 $3,968 $8,189 $8,562 General and administrative 1,821 1,654 3,999 3,634 Total operating expenses 5,935 5,622 12,188 12,196 Loss from operations (5,935) (5,622) (12,188) (12,196)Interest income and other expense, net 434 403 750 779 Change in fair value of warrant liability 1,816 — 1,816 — Sublease income - related party — — — 56 Loss from equity method investment (577) (1,284) (341) (3,015)Net loss $(4,262) $(6,503) $(9,963) $(14,376)Net loss per share, basic and diluted $(0.07) $(0.14) $(0.18) $(0.31)Shares used to compute net loss per share, basic and diluted 59,710,265 47,497,414 54,374,423 47,029,396 CORVUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) June 30, December 31, 2024 2023 (unaudited) Assets Cash, cash equivalents and marketable securities $47,246 $27,149 Operating lease right-of-use asset 578 1,149 Other assets 1,333 1,132 Investment in Angel Pharmaceuticals 15,404 16,123 Total assets $64,561 $45,553 Liabilities and stockholders' equity Accounts payable and accrued liabilities and other liabilities $5,517 $5,495 Operating lease liability 700 1,374 Warrant liability 7,118 — Stockholders' equity 51,226 38,684 Total liabilities and stockholders' equity $64,561 $45,553 INVESTOR CONTACT:Leiv LeaChief Financial OfficerCorvus Pharmaceuticals, Inc.+1-650-900-4522llea@corvuspharma.com MEDIA CONTACT:Sheryl SeapyReal Chemistry+1-949-903-4750sseapy@realchemistry.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a451d560-a41c-4487-99ca-cd7de11e4274