NCC

First-in-human PET imaging study of 64Cu-PD-32766 for patients with clear cell renal cell carcinoma were initiated. By utilizing PET, the diagnostic capability of 64Cu-PD-32766 as well as the potential for therapeutic efficacy when labeled with therapeutic isotopes (radiotheranosticsNote) will be investigated. Clinical information generated in this study is expected to accelerate further clinical development in radiopharmaceuticals. KAWASAKI, Japan--(BUSINESS WIRE)-- National Cancer Center and PeptiDream Inc.: Overview The National Cancer Center (President: Hitoshi Nakagama) Hospital East (Director: Toshihiko Doi) and PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter “PeptiDream”)(Tokyo: 4587) today announced the dosing of the first patient in the human imaging study of PeptiDream’s 64Cu-PD-32766, a 64Cu-labelled radiopharmaceutical targeting Carbonic Anhydrase IX (CAIX), for patients with clear cell renal cell carcinoma (ccRCC) conducted at the National Cancer Center Hospital East (“the clinical research”). Details The clinical research, which was approved by the National Cancer Center Japan’s clinical review board in April 2024, is a first-in-human imaging study of 64Cu-PD-32766 conducted in collaboration with the National Cancer Center Japan and PeptiDream. This study is intended to evaluate the safety, pharmacokinetics, and accumulation of 64Cu-PD-32766 in tumors using PET in patients with newly diagnosed, relapsed or suspected relapsed ccRCC. Overview of Clinical Research Title Early-phase clinical trial of 64Cu-PD-32766 for the patients with clear cell renal cell carcinoma Principal Investigator Anri Inaki (National Cancer Center Hospital East) Objectives To evaluate the safety, pharmacokinetics, and exposure dose of PET/CT test with 64Cu-PD-32766 in patients with newly diagnosed, relapsed or suspected to have relapsed ccRCC. Inclusion Criteria Proven ccRCC patients with the presence of distant metastatic lesions (including distant metastatic recurrence) or local recurrence lesions from the site of removal after total nephrectomy of the diseased kidney Number of Subjects 6 Primary outcome Per-patient PET sensitivity Secondary outcomes Per-lesion PET sensitivity, safety, pharmacokinetics and estimated irradiation dose JRCT trial identifier: jRCTs031240046 CAIX is a cell surface antigen highly expressed in ~95% of ccRCC with minimal expression in normal tissues, making it a potentially ideal target for the diagnosis and treatment of ccRCC. PeptiDream discovered and developed PD-32766 using its proprietary Peptide Discovery Platform System (PDPS) technology, with in vivo imaging and efficacy studies conducted by PDRadiopharma Inc. (PeptiDream’s wholly owned subsidiary). Key advantages of this clinical research are the ability to generate early human imaging data (often referred to as a Phase 0 study) using diagnostic 64Cu agent directly in the target patient population which provides an early look at the diagnostic usefulness of the agent, the likelihood of therapeutic benefit when labeled with a therapeutic radioisotope, and additional critical information that can be used in designing subsequent clinical studies, thereby significantly accelerating clinical development. Comments of Dr. Toshihiko Doi, Director, National Cancer Center Hospital East We are delighted to report the initiation of this human imaging study, with the first administration of 64Cu-PD-32766 in patients diagnosed with ccRCC. As one of the leading cancer centers in Japan, our mission is to continuously improve healthcare in Japan, by bringing innovative life changing therapeutics to our patients in need, and we believe that combining PeptiDream’s cancer targeting peptides with the imaging and cancer killing power of radionuclides, represents a highly promising new therapeutic approach toward the diagnosis and treatment of patients with ccRCC. Comments of Dr. Patrick C. Reid, President & CEO of PeptiDream We are excited to announce that our collaborators at the National Cancer Center Japan have dosed the first patient in the human imaging study of PD-32766, our CAIX targeting macrocyclic peptide radiolabeled with 64Cu, for the potential diagnosis and treatment of patients with ccRCC. I am extremely proud of the entire PeptiDream team, and grateful to our National Cancer Center Japan collaborators, for this wonderful achievement, and we look forward to sharing the results as they become available. We are deeply committed to utilizing our peptide expertise to develop the next generation of targeted radiopharmaceuticals, which we believe will have a tremendous impact on cancer patient care. About Renal Cell Carcinoma (RCC) RCC is the 9th most common cancer in the United States, representing 2% of all global cancer diagnoses and death, with 5-year survival rates at 12% (worldwide an estimated 400,000 people were diagnosed with kidney cancer in 2020, with roughly 9 out of 10 kidney cancers being RCCs). There are largely three main types of RCC, clear cell (“ccRCC”), papillary (“pRCC-type 1 and type 2”), and chromophobe (“chRCC”), with ccRCC representing roughly 70% of RCC cases. Reference A novel Carbonic Anhydrase IX targeting radiopeptide, 64Cu-PD-32766 and 177Lu-PD32766, exhibit promising theranostic potential in ccRCC tumors. (American Association for Cancer Research (AACR) Annual Meeting 2024) Glossary (Note) Radiotheranostics Radiotheranostics refers to the use of radioisotope-labelled agents to diagnose and treat patients by using different nuclides. Theranostics integrate the diagnosis and treatment of cancer, narrow down patients who is likely to be effective in treatment and monitor the effectiveness of treatment. About National Cancer Center Hospital East At National Cancer Center Hospital East, we provide our patients with world-class cancer treatments, multidisciplinary teams consisting of various specialities coordinate the best support for each patient, delivered with utmost care. We offer advanced medical services using state-of-the art medical devices such as robot-assisted surgery, proton beam and endoscopic therapy, minimally invasive surgery limiting burdens to the patient. We also provide various drug treatments and conduct many clinical trials. URL: About PeptiDream Inc. PeptiDream Inc. (Tokyo Stock Exchange Prime Market 4587) is leading the translation of macrocyclic peptides into a whole new class of innovative medicines to address unmet medical needs and improve the quality of life of patients worldwide. In its radiopharmaceutical business, through its wholly-owned subsidiary PDRadiopharma, PeptiDream markets and sells a number of approved radiopharmaceuticals and radiodiagnostics in Japan, as well as leveraging its proprietary Peptide Discovery Platform System (PDPS) technology to discover and develop a deep pipeline of innovative targeted radiotherapeutics and radiodiagnostics, spanning both wholly-owned internal programs and globally partnered programs. In its non-radiopharmaceutical business, PeptiDream is similarly leveraging PDPS to discover and develop a broad and diverse pipeline of investigational peptide therapeutics, peptide drug conjugates (PDC) and multi-functional peptide conjugates (MPC) across an extensive global network of discovery and development partners. PeptiDream is headquartered in Kawasaki, Japan. For more information about our company, science and pipeline, please visit . View source version on businesswire.com: Contacts Inquiries • Study Inquiries / For patients Anri Inaki Department of Diagnostic Radiology, National Cancer Center Hospital East / Division of Functional Imaging, EPOC (Exploratory Oncology Research & Clinical Trial Center) E-mail: ainaki@east.ncc.go.jp • Media Inquiries National Cancer Center Japan Office of Public Relations, Strategic Planning Bureau E-mail: ncc-admin@ncc.go.jp PeptiDream Inc. Contact: Yuko Okimoto, IR & Public Affairs Email: info@peptidream.com Source: PeptiDream Inc. 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CHARLOTTESVILLE, Va., Oct. 28, 2021 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals (NASDAQ: DFFN) (“Diffusion” or the “Company”), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, will participate in the 2021 Alliance Global Partners Biotech & Specialty Pharma Conference taking place November 10, 2021. Diffusion will also be participating in one-on-one meetings. Interested investors can schedule meetings with management from 8:30 a.m. to 5:00 p.m. on November 10. Those who wish to request a meeting with Diffusion should contact their Alliance Global Partners salesperson. About Diffusion Pharmaceuticals Inc. Diffusion Pharmaceuticals Inc. is an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most. Diffusion’s lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions. In addition to TSC, Diffusion’s product candidate DFN-529, a novel, allosteric PI3K/Akt/mTOR Pathway inhibitor, is in early-stage development. For more information, please visit us at . Forward-Looking Statements This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The Company may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although the Company believes that it has a reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control, and as a result, the Company’s actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risk and uncertainties include, among other things, those related the factors discussed under the heading “Risk Factors” in the Company’s filings most recent Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified) and, except as required by applicable law, rule, or regulation, the Company undertakes no obligation to update any such statements after the date hereof. Contacts Investors: Tiberend Strategic Advisors, Inc. Maureen McEnroe, CFA / Lisa Sher mmcenroe@tiberend.com / lsher@tiberend.com Media: Kate Barrette RooneyPartners (212) 223-0561 Kbarrette@rooneypartners.com

CHARLOTTESVILLE, Va., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (“Diffusion” or the “Company”), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, today announced that Robert Cobuzzi, Jr., Ph.D., Chief Executive Officer, will present at the H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021. The prerecorded presentation will be available starting at 7 a.m. ET on September 13, 2021 and will be accessible via the conference’s virtual platform by registered conference attendees. The presentation will be archived and available for viewing for 90 days, following the conference. Dr. Cobuzzi will provide an overview of Diffusion’s business highlights and recent corporate and clinical achievements, as well as anticipated milestones in the clinical programs for trans sodium crocetinate (TSC), Diffusion’s lead product candidate. Diffusion has completed the first of three Oxygenation Trials, which are intended to guide the selection of indications and doses to be pursued for future development of TSC. Diffusion plans to select the initial indication by year-end 2021, and initiate a Phase 2 trial in that indication in the first half of 2022. Additionally, Dr. Cobuzzi and members of the Diffusion management team will be participating in virtual one-on-one meetings with registered investors and pharmaceutical company executives. Details of the presentation are as follows: Following the conclusion of the event, a recording of Dr. Cobuzzi’s presentation will be available under “Presentations” in the Investors section of the Company’s website at . About Diffusion Pharmaceuticals Inc. Diffusion Pharmaceuticals Inc. is an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most. Diffusion’s lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions. In addition to TSC, Diffusion’s product candidate DFN-529, a novel, allosteric PI3K/Akt/mTOR Pathway inhibitor, is in early-stage development. For more information, please visit us at . Forward-Looking Statements This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s near-term strategic priorities and the potential therapeutic value of TSC. The Company may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although the Company believes that it has a reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control, and as a result, the Company’s actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risk and uncertainties include, among other things, those related to: the Company’s ability to design, initiate, enroll, execute, and complete its ongoing and planned studies evaluating TSC; the optimal doses and dosing regimens of TSC in connection with the potential treatment of any particular disease or indication; general economic, political, business, industry, and market conditions, including the ongoing COVID-19 pandemic; and the other factors discussed under the heading “Risk Factors” in the Company’s filings most recent Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified) and, except as required by applicable law, rule, or regulation, the Company undertakes no obligation to update any such statements after the date hereof. ContactsInvestors:Tiberend Strategic Advisors, Inc. Maureen McEnroe, CFA / Lisa Sher mmcenroe@tiberend.com / lsher@tiberend.com Media:Kate BarretteRooneyPartners(212) 223-0561Kbarrette@rooneypartners.com