Retifanlimab

Presentation of interim TAMARACK Phase 2 study data: updated safety and preliminary efficacy of vobra duo in mCRPC patientsConference call scheduled for today at 4:30 p.m. ET ROCKVILLE, Md., May 09, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended March 31, 2024. “We are very encouraged by the interim updated safety and preliminary efficacy data from the TAMARACK study of vobra duo in metastatic castration-resistant prostate cancer," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We believe this interim data set helps validate our previously stated hypothesis that improved tolerability coupled with compelling biological activity could be achieved through dose reductions and a longer dosing interval. We believe vobra duo’s biological activity shown to date aligns well with the parameters we outlined at the outset of the study. Based on our evaluation of the interim data to date, we have initiated planning activities for a potential Phase 3 study that could commence next year. We anticipate sharing final safety, efficacy and durability data, including radiographic progression-free survival data, which is the primary endpoint of the study, in the second half of 2024. Furthermore, having preliminarily identified suitable vobra duo doses in mCRPC in the TAMARACK study, we have greater confidence in the molecule’s potential to help patients with a broad range of B7-H3-expressing cancers.” “The interim safety and anti-tumor activity observed to date in the TAMARACK study look very promising for patients with metastatic castration-resistant prostate cancer,” said Johann DeBono, Regius Professor of Cancer Research and Professor in Experimental Cancer Medicine at The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust. “With the limited treatment options currently available to these patients, this novel ADC molecule could potentially become the first therapy targeting B7-H3 in patients with prostate cancer and would represent an important new treatment for this population.” Updates on Proprietary Investigational Programs Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below. B7-H3-Directed Therapies •Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. •MacroGenics completed enrollment of the TAMARACK Phase 2 study of vobra duo in November 2023. TAMARACK is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W). •A new presentation of TAMARACK interim data, consisting of updated safety and preliminary efficacy data, all based on a data cut-off date of April 12, 2024, is available under "Events & Presentations" in the Investor Relations section of MacroGenics’ website or directly via this link. Below is a high-level summary of this interim data, which is subject to further updates: Vobra Duo2.0 mg/kg q4WVobra Duo2.7 mg/kg q4WPatients Enrolledn=91n=90PSA Reduction Summary: PSA Evaluable Patientsn=82n=71Any PSA Reduction ≥50%41 (50.0%)36 (50.7%)Confirmed PSA Reduction ≥50%36 (43.9%)26 (36.6%)Tumor Response Summary: RECIST Evaluable Patients with Measurable Disease at Baselinen=45n=32Disease Control Rate (CR+PR+SD)41 (91.1%)28 (87.5%)Overall Response Rate (CR+PR, confirmed only)8 (17.8%)8 (25.0%)Overall Response Rate (CR+PR, including unconfirmed)11 (24.4%)14 (43.8%)Safety Summary: Safety Populationn=90n=86Treatment-Emergent Adverse Events All Grade89 (98.9%)86 (100.0%)Treatment- Emergent Adverse Events Grade ≥349 (54.4%)44 (51.2%)TEAE Leading to Study Drug Discontinuation10 (11.1%)13 (15.1%)TEAE Leading to Study Drug Dose Reduction39 (43.3%)44 (51.2%)TEAE Leading to Study Drug Dose Interruption38 (42.2%)48 (55.8%)Five Most Common TEAE All GradeAsthenia (46.7%)Nausea (35.6%)Oedema peripheral (32.2%) Decreased appetite (28.9%) Fatigue (25.6%)Asthenia (58.1%)Decreased appetite (37.2%) Oedema peripheral (36.0%) Nausea (30.2%)Pleural effusion (29.1%)Pleural EffusionsGrade 1=8.9%Grade 2=8.9%No Grade ≥ 3 eventGrade 1=14.0%Grade 2=14.0%Grade 3=1.2%Palmar-plantar Erythrodysaesthesia SyndromeGrade 1=11.1%Grade 2=4.4%No Grade ≥ 3 eventGrade 1=12.8%Grade 2=9.3%Grade 3=1.2% • The median number of cycles of vobra duo administered was five (range of 1-10). • A total of five events with fatal outcome occurred as follows: one Grade 5 event in the 2.0 mg/kg dosing cohort: acute myocardial infarction (considered unrelated to study drug by the investigator); three Grade 5 events in the 2.7 mg/kg dosing cohort: one cardiac arrest (considered unrelated to study drug by the investigator) and two events of pneumonitis. In addition, a patient in the 2.7 mg/kg dosing cohort had a Grade 3 pleural effusion that is recorded as having a fatal outcome. The latter three deaths are being investigated, as follow-up is incomplete on this ongoing trial. • Additional data is provided in the presentation on the Company’s website and as filed with the Securities and Exchange Commission. • Based on a current evaluation of this interim data, the Company is undertaking the initial steps necessary to prepare for the potential initiation of a Phase 3 study in mCRPC in 2025. The final decision to pursue such a Phase 3 study will be based on an analysis of the final data set, including rPFS, when available. •The Company intends to share final safety, efficacy, and durability data, including the primary endpoint of radiographic progression-free survival, from the TAMARACK trial in the second half of 2024. •MacroGenics plans to expand the TAMARACK study of vobra duo by enrolling patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), melanoma, squamous cell carcinoma of the head and neck (SCCHN) and anal cancer. The Company expects to initiate dosing in these additional cohorts in mid-2024. •MacroGenics continues to enroll a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors. The Company anticipates commencing a dose expansion study of this combination in mCRPC and at least one additional indication in 2024. •MGC026 is a clinical B7-H3-targeting ADC that is site-specifically conjugated to exatecan, a topoisomerase I inhibitor payload developed by Synaffix (a Lonza company). With distinct mechanisms of action, vobra duo and MGC026 may address different cancers, tumor stages, or be used in combination with alternate agents — or potentially with one another — to enhance their clinical utility. A Phase 1 dose escalation study of MGC026 in patients with advanced solid tumors is ongoing.MGC026 preclinical data was presented recently at the American Association for Cancer Research (AACR) Annual Meeting. In preclinical studies, MGC026 was shown to have greater potency than B7-H3-directed antibodies conjugated to deruxtecan, or DXd, a topoisomerase-based payload utilized in other ADCs. In addition, the MGC026 payload has been shown to be less susceptible to multi-drug resistance (MDR) mechanisms than DXd and SN-38. •Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3. The HEAT study, an investigator-sponsored, randomized Phase 2 clinical trial being conducted by MacroGenics’ academic collaborators, is ongoing. This study is being conducted to evaluate the activity of neoadjuvant enoblituzumab given prior to radical prostatectomy in up to 219 men with high-risk localized prostate cancer. Lorigerlimab •Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART® molecule. In addition to the ongoing study of lorigerlimab in combination with vobra duo mentioned above, MacroGenics is enrolling LORIKEET, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current trial design includes a primary study endpoint of radiographic progression-free survival (rPFS). The Company anticipates completing enrollment of the study in 2024 and providing a clinical update in the first half of 2025. Emerging ADC Pipeline •MGC028 is a preclinical ADC incorporating an ADAM9-targeting antibody and represents the second MacroGenics ADC molecule that incorporates Synaffix’s novel site-specific linker and topoisomerase I inhibitor-based cytotoxic payload. ADAM9 (a disintegrin and metalloprotease domain 9) is a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers, making it an attractive target for cancer treatment. The Company currently anticipates submitting an investigational new drug (IND) application for MGC028 by the end of 2024.MGC028 preclinical data was presented recently at the AACR Annual Meeting. In preclinical studies, MGC028 demonstrated specific antitumor activity in in vivo models representing gastric, lung, pancreatic, colorectal cancer, SCCHN and cholangiocarcinoma. In addition, in a non-human primate study, MGC028 was well tolerated at high dose levels, with mild, reversible side effects and no ocular toxicity, which is often a concern with tubulin-inhibitor-based ADCs. These promising preclinical results support the continued investigation of MGC028 as a therapeutic option for treating ADAM9-expressing solid cancers. Partnered Program •MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing. MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. Under an October 2022 exclusive option and collaboration agreement, Gilead Sciences, Inc. has the option to license MGD024 at predefined decision points during the Phase 1 study. First Quarter 2024 Financial Results •Cash Position: Cash, cash equivalents and marketable securities balance as of March 31, 2024, was $184.2 million, compared to $229.8 million as of December 31, 2023. •Revenue: Total revenue was $9.1 million for the quarter ended March 31, 2024, compared to total revenue of $24.5 million for the quarter ended March 31, 2023. The decrease was primarily due to a decrease in revenue from collaborative and other agreements, including a $15.0 million milestone received from Incyte in the quarter ended March 31, 2023. •R&D Expenses: Research and development expenses were $46.0 million for the quarter ended March 31, 2024, compared to $45.9 million for the quarter ended March 31, 2023. •SG&A Expenses: Selling, general and administrative expenses were $14.7 million for the quarter ended March 31, 2024, compared to $13.5 million for the quarter ended March 31, 2023. The increase was primarily related to increased stock-based compensation expense and other professional fees. •Net Loss: Net loss was $52.2 million for the quarter ended March 31, 2024, compared to net loss of $38.0 million for the quarter ended March 31, 2023. •Shares Outstanding: Shares of common stock outstanding as of March 31, 2024 were 62,560,502. •Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $184.2 million as of March 31, 2024, in addition to projected and anticipated future payments from partners and product revenues should extend its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the Phase 2 LORIKEET study as well as MacroGenics’ other ongoing clinical and preclinical studies. Conference Call Information To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call. MACROGENICS, INC.SELECTED CONSOLIDATED BALANCE SHEET DATA(Amounts in thousands) March 31, 2024 December 31, 2023 (unaudited) Cash, cash equivalents and marketable securities$184,237 $229,805Total assets 248,285 298,418Deferred revenue 79,019 80,894Total stockholders' equity 106,154 152,613 MACROGENICS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited)(Amounts in thousands, except share and per share data) Three Months Ended March 31, 2024 2023 Revenues: Collaborative and other agreements$1,449 $16,686 Product sales, net 4,861 3,490 Contract manufacturing 2,276 3,615 Royalty revenue 160 422 Government agreements 358 283 Total revenues 9,104 24,496 Costs and expenses: Cost of product sales 270 113 Cost of manufacturing services 1,846 3,410 Research and development 46,029 45,872 Selling, general and administrative 14,709 13,527 Total costs and expenses 62,854 62,922 Loss from operations (53,750) (38,426)Interest and other income 2,693 1,073 Interest and other expense (1,133) (656)Net loss (52,190) (38,009)Other comprehensive income (loss): Unrealized gain (loss) on investments (29) 13 Comprehensive loss$(52,219) $(37,996) Basic and diluted net loss per common share$(0.84) $(0.61)Basic and diluted weighted average common shares outstanding 62,290,538 61,809,817 About MacroGenics, Inc. MacroGenics (the Company) is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, MARGENZA and DART are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, including initiation and enrollment in clinical trials, expected timing of results from clinical trials, discussions with regulatory agencies, commercial prospects of or product revenues from MARGENZA and the Company’s product candidates, if approved, manufacturing services revenue, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company, as well as future global net sales of TZIELD and the Company’s ability to achieve the milestone payments set forth under the terms of the agreement with DRI (or its successors or assigns with respect to such agreement), and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, especially with respect to vobramitamab duocarmazine; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises such as the novel coronavirus (referred to as COVID-19 pandemic); and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. CONTACTS: Jim Karrels, Senior Vice President, CFO 1-301-251-5172 info@macrogenics.com

Pelareorep advancing to registration-enabling studies Preparations underway for Type C meeting with the FDA to establish registrational pathway in HR+/HER2- metastatic breast cancer Overall survival data from BRACELET-1 breast cancer study expected in H2 2024 Cash position of $29.6 million provides runway through critical milestones into 2025 Management hosting conference call and webcast today at 4:30 p.m. ET SAN DIEGO and CALGARY, AB, May 9, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced recent operational highlights and financial results for the first quarter ended March 31, 2024. All dollar amounts are expressed in Canadian currency unless otherwise noted. "Our 2024 is off to an exciting start as we have been granted a Type C meeting with the FDA to discuss our planned registration-enabling study in breast cancer. With respect to our GOBLET study, we expanded enrollment in the anal cancer cohort and expect to begin enrolling patients this quarter into our new pancreatic cancer cohort investigating modified FOLFIRINOX/pelareorep with or without atezolizumab," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "This new GOBLET study activity represents an opportunity to significantly expand pelareorep's impact on gastrointestinal cancers. Our 2024 milestones are driven by a robust clinical database from two positive randomized studies in HR+/HER2- metastatic breast cancer, multiple cohorts from our GOBLET study, especially in pancreatic and anal cancers, and consistent translational data across several indications. Together, these studies have repeatedly demonstrated the potential benefits of pelareorep treatment and support its mechanism of action as a differentiated immunotherapeutic agent." Dr. Coffey continued, "Looking ahead, Oncolytics is focused on advancing pelareorep towards registration-enabling studies in breast and pancreatic cancer that will lead to the broad adoption of pelareorep as a treatment for cancer. We are optimistic about the potential for pelareorep to improve the care of cancer patients and look forward to updating investors with our progress on these important milestones." First Quarter and Subsequent Highlights FDA Type C meeting granted to discuss plans for breast cancer. Oncolytics has been granted a meeting with the FDA to discuss the Company's planned registration-enabling study for pelareorep in HR+/HER2- metastatic breast cancer. Aligning with the FDA on the design and objectives of a registrational trial for pelareorep in metastatic breast cancer is a key near-term milestone and a critical step towards bringing this innovative treatment to patients. Encouraging data from two randomized studies (BRACELET-1 and IND-213) showing a meaningful benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy, in addition to translational data from the AWARE-1 study, form the basis for Oncolytics' registrational program. Ongoing dialogue with clinical collaborators and potential partners, as well as prior FDA guidance, has helped the Company shape its thinking on the optimal registration pathway, which is reflected in the briefing document that was submitted to the FDA in advance of the upcoming Type C meeting. Initiated enrollment expansion of the GOBLET anal cancer cohort. Enrolling additional patients into this cohort was initiated as a result of compelling clinical data. These data, presented at a medical meeting last fall, showed that the combination of pelareorep and atezolizumab yielded a 37.5% objective response rate in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA), including one patient who had a complete response ongoing at 12 months. These data compare favorably to historical clinical results, which showed that patients with second-line or later anal carcinoma experienced response rates of 10-14%1-3 when treated with checkpoint inhibitor monotherapy. The addition of 18 evaluable patients could further validate the impressive results reported to date and potentially advance pelareorep toward a future registration in another indication (link to the PR). Received German regulatory and ethics approval to begin enrolling patients in a new pancreatic cancer cohort supported by PanCAN. As part of the Company's strategy to improve treatment options for pancreatic ductal adenocarcinoma (PDAC) patients, pelareorep will be evaluated in a new cohort of the GOBLET study. This cohort will include pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX), one of the most widely used therapies in this indication, with or without atezolizumab. The Pancreatic Cancer Action Network (PanCAN) awarded Oncolytics US$5 million to fund this cohort as a result of being selected to receive PanCAN's Therapeutic Accelerator Award, which is granted to accelerate the development of new treatments for pancreatic cancer. Oncolytics is also continuing to develop pelareorep in combination with atezolizumab and gemcitabine/nab-paclitaxel, another commonly used therapy for PDAC patients. This combination has already proven to exceed historical outcomes and resulted in a Fast Track designation from the FDA. Therefore, a compelling efficacy signal for pelareorep in combination with mFOLFIRINOX could lead to another registration-enabling study in PDAC (link to the PR). Upcoming presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Oncolytics will share updates on cohort 5 of the GOBLET study in which the combination of pelareorep and mFOLFIRINOX +/- atezolizumab will be evaluated, and on pelareorep's ability to drive TIL expansion in pancreatic, breast, and colon cancer (link to the PR). Financial Highlights As of March 31, 2024, the Company reported $29.6 million in cash and cash equivalents, with a projected cash runway through critical milestones and into 2025. Net cash used in operating activities for the three months ended March 31, 2024 was $7.5 million, compared to $7.8 million for the three months ended March 31, 2023. The change reflected higher net operating activities and non-cash working capital changes. General and administrative expenses for the first quarter of 2024 were $3.0 million, compared to $3.2 million for the first quarter of 2023. The decrease was primarily due to lower public-company related expenses associated with lower investor relations activities and lower directors and officers liability insurance premiums. Research and development expenses for the first quarter of 2024 were $5.7 million, compared to $3.5 million for the first quarter of 2023. The increase was primarily due to higher manufacturing expenses associated with completing a cGMP production run and the related batch testing. We also started preparations for an upcoming product fill. The net loss for the first quarter of 2024 was $6.9 million, compared to a net loss of $6.4 million for the first quarter of 2023. The basic and diluted loss per share was $0.09 in the first quarter of 2024, compared to a basic and diluted loss per share of $0.10 in the first quarter of 2023. Anticipated Milestones Mid 2024: Guidance on the registration path for HR+/HER2- mBC (metastatic breast cancer) Q2 2024: Initiation of the GOBLET PDAC cohort investigating pelareorep/mFOLFIRINOX +/- atezolizumab and supported by PanCAN H2 2024: Overall survival results from the BRACELET-1 trial Webcast and Conference Call Management will host a conference call for analysts and investors at 4:30 p.m. ET today, May 9, 2024. To access the call, please dial (800) 836-8184 (North America) or (289) 819-1350 (International), and if needed, provide Conference ID: 77797. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 77797#. References Rao S, et al. Phase II study of retifanlimab in patients (pts) with squamous carcinoma of the anal canal (SCAC) who progressed following platinum-based chemotherapy. Annals of Oncology. 2020 September. doi: . Marabelle A, et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4. Lonardi S, et al. Randomized phase II trial of avelumab alone or in combination with cetuximab for patients with previously treated, locally advanced, or metastatic squamous cell anal carcinoma: the CARACAS study. J Immunother Cancer. 2021 November;9(11):e002996. doi: 10.1136/jitc-2021-002996. PMID: 34815354; PMCID: PMC8611452. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; this new GOBLET study activity represents an opportunity to significantly expand pelareorep's impact in gastrointestinal cancers ; our focus on advancing pelareorep towards registration-enabling studies in breast and pancreatic cancer that will lead to the broad adoption of pelareorep as a treatment for cancer; our optimism about the potential for pelareorep to improve the care of cancer patients; our 2024 milestones, including aligning with the FDA on the design and objectives of a registrational trial for pelareorep in metastatic breast cancer, initiation of the PDAC cohort incorporating pelareorep/mFOLFIRINOX +/- atezolizumab and supported by PanCAN; and release of overall survival results from the BRACELET-1 trial and the anticipated timing for each; our belief that the addition of 18 evaluable patients could further validate study results in SCCA; our belief that a compelling efficacy signal for pelareorep in combination with mFOLFIRINOX could lead to another registration-enabling study in PDAC; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Logo - SOURCE Oncolytics Biotech® Inc.