On March 7, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported business updates and financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Poseida Therapeutics, MAR 7, 2024, View Source [SID1234640935]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2024 looks to be a breakout year for Poseida as we build on the recent allogeneic BCMA clinical data presented at ASH (Free ASH Whitepaper), which demonstrated the potential of our high-TSCM allogeneic CAR-T therapies to offer effective, safe, and reliable treatment addressing unmet needs in multiple myeloma. We are able to achieve high levels of CAR-TSCM in our products because of our proprietary, nonviral technologies," said Kristin Yarema, Ph.D., President and Chief Executive Officer. "Over the coming months we are planning data readouts for each of our three clinical-stage CAR-T programs, all of which are manufactured at our own GMP facility and will discuss the latest progress of our gene therapy programs at our R&D Day in April."

Recent 2023 Accomplishments

Cell therapy

•
Presented positive data from the Phase 1 study of P-BCMA-ALLO1 in relapsed/refractory multiple myeloma (RRMM) at ASH (Free ASH Whitepaper): In December 2023, the Company presented data from its Phase 1 study of P-BCMA-ALLO1 at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. These early data support the Company’s belief that TSCM-rich allogeneic CAR-Ts have the potential to offer promising product response rates, safety profiles, and rapid patient access which if confirmed could provide differentiation from currently available therapies, including autologous CAR-T therapies. The study used product from 6 different CAR-T lots produced from 6 different donors with data demonstrating:

o
82% ORR in deep clinical responses, including sCRs and MRD-negative patients from off-the-shelf, allogeneic BCMA-targeted CAR-T in heavily pretreated patients receiving adequate lymphodepletion.
o
100% ORR in those patients who were not previously treated with a BCMA-targeted bispecific T-cell engaging antibody.
o
Favorable emerging safety and reliability profile, with all (100%) intent-to-treat patients receiving therapy with no use of bridging chemotherapy or other anti-myeloma bridging therapies and low incidences of CRS and neurotoxicity observed (all ≤ Grade 2).
o
Preliminary data suggest that allogeneic TSCM-rich CAR-T cells traffic to bone marrow, differentiate to cell-killing effector T cells and persist at least 6 weeks, supporting the hypothesis of cell persistence at tumor-relevant sites.
o
8 of 9 responding patients still in response at data cut off.
•
Continued enrollment of P-MUC1C-ALLO1: The Company continued enrollment in the Phase 1 clinical trial of P-MUC1C-ALLO1 for solid tumors. Drawing from insights gained in allogeneic BCMA CAR-T, it is exploring various dosing approaches, including higher lymphodepletion, cell dose, and scheduling in the MUC1C program. Data from the allogeneic BCMA CAR-T program, presented at ASH (Free ASH Whitepaper), underscored the important role of cyclophosphamide conditioning dose in CAR-T cell expansion and persistence. Patients in arms receiving higher doses (500 mg/m2 and 1,000 mg/m2) demonstrated significantly elevated P-BCMA-ALLO1 levels compared to those in the 300 mg/m2 cohort. Consequently, the Company is assessing lymphodepleting conditioning regimens with doses exceeding 300 mg/m2 in the MUC1C program.
•
Advanced programs within hematologic malignancies at all stages, in partnership with Roche, throughout 2023:
o
Previously announced the expected acceleration of achieving milestones, resulting in the receipt of a $30 million payment in the first quarter of 2024.
o
Expanded the protocol and continued to enroll patients in the Phase 1 study of P-BCMA-ALLO1, incorporating lymphodepletion learnings from ASH (Free ASH Whitepaper) 2023.
o
Continued site activation activities and initiation of enrollment for P-CD19CD20-ALLO1, the Company’s first dual, allogeneic CAR-T for B-cell malignancies.
o
Advanced research programs optioned to Roche (P-BCMACD19-ALLO1 for multiple myeloma and P-CD70-ALLO1 for AML).
o
Developed and deployed manufacturing platform improvements to all programs that delivered higher and more consistent levels of cell expansion.
Gene therapy

•
Presented proof-of-principle data supporting P-FVIII-101 as a potential treatment option for Hemophilia A at ASH (Free ASH Whitepaper): New preclinical data presented at ASH (Free ASH Whitepaper) demonstrated the capabilities of the Company’s non-viral approach in providing stable Factor VIII (FVIII) transgene expression through genomic integration. Additionally, the data highlighted re-dosing, or titrating to efficacy, along with favorable tolerability data for this approach, including 52-week durability data in an adult Hemophilia A mouse model supporting sustained and robust expression.

Anticipated Milestones

•
P-BCMA-ALLO1: The Company plans to present data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego. At AACR (Free AACR Whitepaper), the Company will present data on a subset of recently enrolled patients refractory to initial BCMA targeting therapy. The poster presentation, titled "Clinical Activity of P-BCMA-ALLO1, a B-cell Maturation Antigen (BCMA) Targeted Allogeneic Chimeric Antigen Receptor T-cell (CAR-T) Therapy, in Relapsed Refractory Multiple Myeloma (RRMM) Patients (pts) Following Progression on Prior BCMA Targeting Therapy," is anticipated to take place on April 8, 2024, 9:00 AM to 12:30 PM PT. Subject to coordination with Roche, the Company plans to provide an additional clinical update on this program at a scientific meeting in the second half of 2024.
•
P-MUC1C-ALLO1: The Company plans to review initial clinical findings from the Phase 1 clinical trial in solid tumors at AACR (Free AACR Whitepaper) related to cell expansion and lymphodepletion regimens. The poster presentation, titled "Solid Tumor Patients Require Higher Cyclophosphamide Dose than Multiple Myeloma Patients to Achieve Adequate Lymphodepletion (LD) Necessary to Enable Allogeneic CAR-T Expansion," is anticipated to take place on April 8, 2024, 9:00 AM to 12:30 PM PT. In addition to the AACR (Free AACR Whitepaper) presentation, the Company plans to present a more fulsome clinical update at an appropriate forum in the second half of 2024.
•
P-CD19CD20-ALLO1: Following the initiation of the Phase 1 trial targeting B-cell malignancies in late 2023, the Company expects to provide an interim data update in the second half of 2024, subject to coordination with Roche.
•
P-PSMA-ALLO1: In January 2024, Poseida announced that it expects to advance its next allogeneic solid tumor program, P-PSMA-ALLO1 in prostate cancer, into IND-enabling studies incorporating the progress and learnings of its previous autologous study and recent advancements in its allogeneic platform in 2024.
The Company believes its TSCM-rich CAR-T platform and associated proprietary technologies have strong potential to deliver new therapeutic approaches in autoimmune disease. The Company is actively developing a strategy in inflammation and autoimmune disease and will provide an update at an appropriate time.

Other Operational Updates and Upcoming Events

Poseida R&D Days

The Company plans to host two R&D Days in 2024 focusing on gene therapy and cell therapy respectively.

The Company plans to host its gene therapy specific R&D Day on April 17, 2024, which will feature presentations from gene therapy management as well as key opinion leaders. The event will highlight the Company’s progress across its proprietary non-viral gene insertion and editing technologies, an update following a strategic review of its portfolio and new preclinical data across in vivo gene therapy programs.

The Company plans to host an R&D Day focusing on cell therapy in the second half of 2024.

Evaluating Opportunities in CAR-T Beyond Oncology

The Company believes its TSCM-rich CAR-T platform and associated proprietary technologies have strong potential to deliver new therapeutic approaches in autoimmune disease. The Company is developing a strategy in inflammation and autoimmune disease and will provide an update at an appropriate time.

Leadership Updates

Alexander Chapman joined Poseida on February 26, 2024, as Senior Vice President, Investor Relations & Corporate Communications. He has over 20 years’ experience spanning a broad range of strategic roles across the biotech sector. Prior to Poseida, he was the Head of Corporate Communications & Investor Relations at Atara Biotherapeutics, the first company in the world to receive regulatory approval for an allogeneic T-cell immunotherapy. Previously, Mr. Chapman held a series of global and U.S. leadership roles at Amgen, including Corporate Affairs, Value, Access & Pricing, and U.S. Business Operations.

Loren Wagner was promoted to the role of Chief Operations Officer in February 2024. Mr. Wagner joined the Company in March 2021 and most recently served as Senior Vice President, Global Operations. He has more than 30 years of industry experience across a variety of manufacturing, quality, and engineering roles. Prior to the Company, Mr. Wagner was the Head of CAR-T Operations at Bristol Myers Squibb/Celgene. Prior to Celgene, he worked for 12 years at Allergan, where he was responsible for the production and distribution of investigational supplies globally.

Brent Warner, who has served as the Company’s President, Gene Therapy, will depart Poseida to pursue an external career opportunity effective April 1, 2024.

Financial Results for the Fourth Quarter and Full Year 2023

Revenues

Revenues were $25.0 million for the fourth quarter ended December 31, 2023, compared to $10.1 million for the same period in 2022. The increase was primarily due to revenue earned as a result of a milestone achieved in the fourth quarter under the amendment to the collaboration and license agreement with Roche and increased activity under the collaboration, offset by a decrease in revenue related to Takeda due to the termination of its collaboration agreement in the third quarter of 2023.

For the full year ended December 31, 2023, revenues were $64.7 million, compared to $130.5 million for the same period in 2022. The decrease was primarily due to initial license revenue recognized from the collaboration and license agreement with Roche, which became effective in the third quarter of 2022, offset by the revenue recognized related to the research services performed under the collaboration and license agreements with Roche and Takeda, including $8.9 million of previously deferred revenue recognized as a result of the termination of its collaboration agreement with Takeda in the third quarter of 2023.

Research and Development Expenses

Research and development expenses were $42.0 million for the fourth quarter ended December 31, 2023, compared to $33.9 million for the same period in 2022. The increase was primarily due to an increase in preclinical stage programs and other unallocated expenses due to an increase in research collaboration activity, an increase in personnel expenses as a result of increased headcount, and an increase in clinical stage allogeneic programs, partially offset by a decrease in clinical stage autologous programs driven by the wind-down of the Company’s clinical development activities for such programs.

For the full year ended December 31, 2023, research and development expenses were $156.8 million, compared to $152.9 million for the same period in 2022. The increase was primarily due to an increase in preclinical stage programs and other unallocated expenses due to an increase in research collaboration activity, an increase in personnel expenses as a result of increased headcount, an increase in clinical stage allogeneic programs, and an increase in internal costs related to facilities and other expenses, offset by a decrease in clinical stage autologous programs driven by the wind-down of the Company’s clinical development activities for such programs.

General and Administrative Expenses

General and administrative expenses were $8.9 million for the fourth quarter ended December 31, 2023, compared to $9.4 million for the same period in 2022. The decrease was primarily due to lower insurance costs.

For the full year ended December 31, 2023, general and administrative expenses were $37.4 million, compared to $37.5 million for the same period in 2022. The decrease was primarily due to lower insurance costs, offset by an increase in personnel costs due to an accelerated stock-based compensation expense in the first quarter of 2023 related to a one-time expense associated with the retirement of the Company’s former Executive Chairman.

Net Loss

Net loss was $25.3 million and $123.4 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to net loss of $33.3 million and $64.0 million for the fourth quarter and full year ended December 31, 2022, respectively.

Cash Position

As of December 31, 2023, the Company’s cash, cash equivalents and short-term investments balance was $212.2 million. The Company expects that its cash, cash equivalents and short-term investments together with the remaining near-term milestones and other payments from Roche will be sufficient to fund operations into the second half of 2025. Potential additional payments under the amended Roche collaboration and license agreement and/or potential additional business development could further extend cash runway.

On March 7, 2024 Portage Biotech presented its corporate presentation (Presentation, Portage Biotech, MAR 7, 2024, View Source [SID1234640934]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On March 7, 2024 BioCentriq, Inc., a global cell therapy Contract Development and Manufacturing Organization (CDMO), reported a significant enhancement to its partnership with Pluristyx Inc., an early stage, privately held biotechnology company specializing in Induced Pluripotent Stem Cell (iPSC) products (Press release, panCELLa, MAR 7, 2024, View Source [SID1234640933]). Through BioCentriq’s process development services, their strategic collaboration now includes seamless access to Pluristyx’s proprietary iPSC lines to help lower the barrier to entry, provide a swift translation to clinic, and ensure the best path to commercialization for the next generation of iPSC-derived treatments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pluristyx’s unique clinical-grade iPSC lines, derived from regulatory-compliant starting material and reprogrammed using proprietary mRNA technology, represent a breakthrough in cell therapy development, providing stability, scalability, and customization potential for enhanced therapeutic outcomes. Building upon the existing research agreement, BioCentriq will extend its capabilities by incorporating Pluristyx’s iPSC lines into its cell therapy development and manufacturing processes. This expansion aims to facilitate an integration of Pluristyx’s proprietary iPSC lines, further optimizing the activation, expansion rate, and manufacturability of iPSC-derived NK cells.

"Expanding our collaboration with Pluristyx to include access to iPSC lines is a significant leap forward for BioCentriq and our clients," said Alex Klarer, Vice President of Business Strategy and Innovation at BioCentriq. "This capability enhancement underscores BioCentriq’s commitment to providing our clients with state-of-the-art resources to accelerate the development and manufacture of innovative cell-based therapies including next-generation iPSC-derived treatments."

"Pluristyx is excited to expand our relationship with BioCentriq to provide streamlined access to our research- and clinical-grade iPSC lines and accelerate the development of next generation therapeutics," states Dr Benjamin Fryer, Chief Executive Officer and Co-Founder of Pluristyx. "Our best-in-class iPSC lines offer a simplified path to commercialization, and are made available pre-edited with our exclusive FailSafe and iACT Stealth Cells platform technologies to provide unparalleled safety and cloaking capabilities to overcome the inherent challenges of iPSC-derived therapies."

On March 7, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a business update and provided fourth quarter and full year 2023 financial results (Press release, Oncternal Therapeutics, MAR 7, 2024, View Source [SID1234640932]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged by the progress in our clinical programs and their potential to address significant unmet needs in advanced prostate cancer and aggressive B-cell malignancies. Our Phase 1 study of ONCT-534 in patients with R/R mCRPC is progressing through the initial dose escalation portion of the study according to plan and we look forward to an initial clinical readout in the second quarter of this year that will include response readouts from patients dosed at potentially therapeutic levels. We continue to believe that the novel mechanism of action of ONCT-534 and the wealth of preclinical data we generated underpins its potential to address the needs of prostate cancer patients who progress after treatment with approved AR pathway inhibitors," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Our ROR1 CAR T program showed encouraging initial response results and we believe that the protocol amendments will further ensure patient safety as we investigate the optimal dose of ONCT-808 for patients with relapsed or refractory aggressive B cell lymphoma, including patients who have relapsed after CD19 CAR T treatment."

Recent Highlights

In January 2024, we announced that two patients with metastatic castration-resistant prostate cancer (mCRPC) were enrolled into the third dosing cohort (160 mg daily) in the Phase 1/2 dose escalation/dose expansion study of ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI). The third cohort is now fully enrolled.
In December 2023, we updated the status of our dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating our ROR1-targeting autologous CAR T cell therapy ONCT-808 for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment.
Encouraging response signal at the initial dose of 1×106 CAR T cells per kg, with two of the three patients achieving complete metabolic response (CMR) and the third achieving a partial response (PR) by FDG PET-CT.
Common adverse events in the initial dosing cohort included decreased blood counts, pneumonia and Grade 1-2 cytokine release syndrome (CRS) as of a 4 December 2023 data cutoff.
The first patient treated at the second dose level of 3×106 CAR T cells per kg, an 80-year-old with bulky disease who had received four previous lines of therapy including CD19 CAR T, experienced a Grade 5 (fatal) serious adverse event consistent with CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). No evidence of his lymphoma was found histologically, based on the patient’s initial autopsy report.
In alignment with the U.S. Food and Drug Administration, the company decided to implement protocol changes that include modified eligibility criteria and testing lower doses for future patients in the study.
In January 2024, we announced a 1-for-20 reverse stock split of our common stock and regained compliance with Nasdaq’s minimum bid price requirement.
Expected Upcoming Milestones

ONCT-534, our dual-action androgen receptor inhibitor
Initial clinical data update in the second quarter of 2024
Additional clinical data readouts in the fourth quarter of 2024
ONCT-808, our autologous ROR1-targeted CAR T cell therapy
Clinical data update in mid-2024
Additional clinical data readouts in the fourth quarter of 2024

On March 7, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, reported recent operational highlights and financial results for the fourth quarter and year ended December 31, 2023 (Press release, Oncolytics Biotech, MAR 7, 2024, View Source [SID1234640931]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Positive 2023 data further de-risked pelareorep and re-defined Oncolytics as a late-stage cancer company. Data from the randomized BRACELET-1 breast cancer trial in HR+/HER2- metastatic patients, reported in June using a March 3, 2023 cut-off date, nearly tripled response rates in the test arm compared to the control arm. Additionally, median progression-free survival was 50% higher in the test arm, and the hazard ratio was 0.29. In the coming months, we expect to report overall survival results from the BRACELET-1 study and define a registrational path that will focus on patients with metastatic HR+/HER2- disease and utilize a pelareorep/paclitaxel combination. Productive, ongoing discussions with our clinical collaborators and potential strategic partners have sharpened and enriched our thinking on the design of this study," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.

"Our gastrointestinal-focused GOBLET Phase 1/2 study showed that pelareorep combinations provided clinically impactful improvements in objective response rates compared to historical controls, especially in the pancreatic and anal cancer cohorts, and with no toxicity concerns. With these results in hand, we have expanded enrollment in the anal cancer cohort, and, in pancreatic cancer, we intend to initiate an adaptive trial in first-line patients this year. This registration-enabled study will be a landmark achievement for Oncolytics and evaluate the GOBLET pancreatic cohort treatment regimen that was granted Fast Track designation by the FDA. Additionally, the planned PanCAN-supported trial utilizing a modified FOLFIRINOX (mFOLFIRINOX)-pelareorep combination could expand our pancreatic cancer program to include both of the most widely used treatment backbones, which may result in broad adoption of pelareorep as a therapeutic solution in this indication.

New translational data in breast and pancreatic cancer reported in the fourth quarter continued to highlight pelareorep’s role in stimulating tumor-directed immune responses and shaping the tumor microenvironment, affirming its immunotherapeutic mechanism of action (MOA). These studies also point to the potential use of tumor-infiltrating lymphocytes, or TILs, as a clinical biomarker for future studies and patient care based on a positive association with tumor responses. We are optimistic about the potential for pelareorep to provide improved outcomes for cancer patients and look forward to updating investors and our key stakeholders on our registrational readiness and progress as the year unfolds," concluded Dr. Coffey.

Fourth Quarter and Subsequent Highlights

Expansion of enrollment in the GOBLET anal carcinoma cohort. Cohort 4 of the GOBLET study evaluates pelareorep in combination with atezolizumab (Tecentriq) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The cohort was expanded (link to the PR) based on positive preliminary data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC), showing that the combination of pelareorep and atezolizumab provided a 37.5% objective response rate, including one patient with a long-lasting complete response, and good overall tolerability (link to the PR, link to the poster). These data represent a meaningful contrast to recent clinical trial results, which showed that second-line or later anal carcinoma patients treated with checkpoint inhibitor monotherapy experienced response rates of 10-14%1-3. With a modest expansion of fewer than 20 patients, there could be a sufficient efficacy signal to move to a registrational study.

Additional positive data from the gastrointestinal cancer Phase 1/2 GOBLET study. Pancreatic and colorectal cancer data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. Additional data were reported from Pancreatic Ductal Adenocarcinoma (PDAC) patients in cohort 1, including median progression-free survival and interim median overall survival rates that exceed historical control results (link to the PR, link to the poster). Third-line metastatic colorectal cancer patients receiving pelareorep, atezolizumab, and trifluridine/tipiracil (Cohort 3) recorded a 40% disease control rate and met the pre-specified success criteria according to the Simon two-stage methodology (link to the PR, link to the poster). All three GOBLET study cohorts that have completed Stage 1 met the pre-specified success criteria.

Filed amendment to initiate Phase 1/2 pancreatic cancer study with support from PanCAN. Cohort 5 of the GOBLET study will evaluate pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed PDAC patients. Having filed the amendment to the GOBLET study, the Paul Ehrlich Institute (Germany’s regulatory body) must approve this change before patient enrollment in this cohort can begin (link to the PR). The study is being supported by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer.

Positive translational data from further analysis of the AWARE-1 breast cancer and GOBLET studies. AWARE-1 data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting and the San Antonio Breast Cancer Symposium (SABCS) 2023 underscored pelareorep’s MOA as an immunotherapeutic agent. These data showed the expansion of T cell populations in both the tumor and blood in patients treated with pelareorep. Importantly, translational data from pancreatic cancer patients reported at ESMO (Free ESMO Whitepaper) showed a correlation between tumor response and the expansion of TIL clones in the blood. This expansion of tumor resident T cells demonstrates that pelareorep treatment can increase the population of presumed tumor-reactive inflammatory cells and could become an informative biomarker of clinical outcomes to be used in future clinical studies and guide patient care.

Addition of new Director, Pat Andrews. Pat Andrews joined the Oncolytics Board of Directors and brings experience navigating registrational trials in oncology and completing significant business development agreements. Her addition expands the strategic expertise of the Board, helping to accelerate the company’s registrational plans and transformational mindset as a late-stage oncology company.

Financial Highlights

•As of December 31, 2023, the Company reported $34.9 million in cash and cash equivalents, with a projected cash runway for at least 12 months.

•Net cash used in operating activities for the twelve months ended December 31, 2023 was $28.4 million, compared to $23.4 million for the twelve months ended December 31, 2022. The change reflected higher net operating activities.

•General and administrative expenses for the fourth quarter of 2023 were $4.2 million, compared to $3.7 million for the fourth quarter of 2022. The increase was primarily due to higher investor relations activities and changes in personnel costs.

•Research and development expenses for the fourth quarter of 2023 were $4.7 million, compared to $4.8 million for the fourth quarter of 2022. The decrease was primarily due to lower GOBLET and BRACELET-1 study costs, as well as reduced clinical and safety data management. The decrease was partly offset by higher manufacturing expenses related to the preparation and start of a production run.

•The net loss for the fourth quarter of 2023 was $3.9 million, compared to a net loss of $8.6 million for the fourth quarter of 2022. The basic and diluted loss per share was $0.05 in the fourth

quarter of 2023, compared to a basic and diluted loss per share of $0.14 in the fourth quarter of 2022. The net loss for the fourth quarter of 2023 included a $4.8 million gain mainly related to the change in fair value of the warrants issued as part of our 2023 public offering.

Anticipated Milestones

•H1 2024: Guidance on the registration path for HR+/HER2- mBC (metastatic breast cancer)
•H1 2024: Initiation of the Phase 1/2 PDAC trial incorporating pelareorep/mFOLFIRINOX +/- atezolizumab and supported by PanCAN
•2024: Initiation of the adaptive registration-enabling trial for pelareorep in first-line metastatic PDAC
•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, March 7, 2024. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International), and if needed, provide Conference ID: 6244-5815. 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) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 445-815#.