On November 14, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the third quarter ended September 30, 2024, and provided corporate updates (Press release, Sensei Biotherapeutics, NOV 14, 2024, View Source [SID1234648413]).

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"The third quarter of 2024 saw significant progress in advancing patient enrollment in the dose expansion portion of the Phase 1 study for SNS-101 across dose levels and patients with primary and acquired resistance to PD-1 inhibitors. Looking ahead, management has focused its attention on preparing for Phase 2 studies," said John Celebi, President and Chief Executive Officer. "We believe SNS-101 has disruptive potential for the treatment of a multitude of cancer indications and for this reason we are making the difficult decision to reduce our headcount to focus our resources on advancing the clinical development of SNS-101. We anticipate that these changes will extend our cash runway into the second quarter of 2026. We look forward to sharing a clinical update focused primarily on the activity profile of SNS-101 and additional details about the design of Phase 2 studies. I want to express my gratitude to all our affected employees for the contributions they have made to the Company."

Clinical Highlights and Milestones

SNS-101

SNS-101 is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors.

Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study, with approximately half of the dose expansion study enrolled. To further the Company’s objective of generating clinical data that informs both the optimal dose and patient population for Phase 2 studies, including comprehensive data from patients with both primary and acquired resistance to PD-1 inhibitors, the Company expects to report clinical data across two dose levels in multiple tumor types in the first half of 2025.
Sensei received preliminary guidance from the FDA on the dose optimization strategy for SNS-101. The Company plans to re-engage with the agency following additional data from the dose expansion portion of the Phase 1/2 clinical trial.
SNS-101 continues to be well tolerated with a best-in-class pharmacological profile among anti-VISTA antibodies.
In November, Sensei presented an overview of SNS-101 at PEGS Europe: Protein and Antibody Engineering Summit.
In November, the Company presented data on spatial proteomic profiling of VISTA and PSGL-1 interactions across cancer indications in a poster presentation at the Society of Immunotherapy Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting.
Corporate Updates

Sensei is announcing an organizational restructuring to streamline operations and focus resources on advancing the clinical development of SNS-101. The Company will close its research site in Rockville, Maryland and reduce its workforce by approximately 46 percent, with most of the headcount reductions in the Company’s preclinical research and development group. These changes are anticipated to extend cash runway into the second quarter of 2026.
In July, the Company announced the appointment of Josiah Craver as Senior Vice President, Finance. In September, Josiah was appointed as the Company’s principal financial officer and principal accounting officer.
Third Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $47.0 million as of September 30, 2024. Sensei expects its current cash balance to fund operations into the second quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were $4.6 million for the quarter ended September 30, 2024, compared to $3.8 million for the quarter ended September 30, 2023. The increase in R&D expenses was primarily attributable to higher expense associated with clinical trials, personnel costs and manufacturing related expense partially offset by lower costs for preclinical research and lower consulting fees.

General and Administrative (G&A) Expenses: G&A expenses were $3.2 million for the quarter ended September 30, 2024, compared to $3.9 million for the quarter ended September 30, 2023. The decrease in G&A expense was primarily attributable to decreased costs associated with insurance premiums as well as lower outside services expense, personnel costs and license fees.

Net Loss: Net loss was $7.3 million for the quarter ended September 30, 2024, compared to $7.1 million for the quarter ended September 30, 2023.

On November 14, 2024 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported third quarter 2024 financial results and business updates (Press release, Precigen, NOV 14, 2024, View Source [SID1234648412]).

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"The strategic reprioritization of our portfolio announced last quarter has enabled us to focus our team and allocate resources to advance PRGN-2012 as rapidly as possible. We are excited about our imminent submission of a BLA for PRGN-2012 in RRP as we have finalized our pre-BLA meetings and are aligned with the FDA on the content for all modules and plan for submission in the fourth quarter. Our commercial and manufacturing readiness campaigns for PRGN-2012 are well underway to support a potential 2025 launch," said Helen Sabzevari, PhD, President and CEO of Precigen. "Although our primary focus is on PRGN-2012, we continue to demonstrate the many advantages of the UltraCAR-T platform over conventional CAR-Ts. Our recent data presentation at SITC (Free SITC Whitepaper) for our next generation UltraCAR-T targeting CD19 reinforces the potential to be the best-in-class CD19-targeting medicine in oncology and autoimmune diseases, such as lupus nephritis. We are excited about the potential of this platform and the strategic partnership discussions that currently are underway."

"Following our reprioritization and public equity offering announced in August, we remain focused on fiscal management while appropriately investing in activities necessary for the potential launch of PRGN-2012. We are making good progress on a number of potential financing options, including strategic partnerships and other transactions. We will update our investors on this progress in the coming months," said Harry Thomasian Jr., CFO of Precigen.

Key Program Highlights

PRGN-2012 AdenoVerse Gene Therapy in RRP

· PRGN-2012 is an investigational off-the-shelf AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of recurrent respiratory papillomatosis (RRP). PRGN-2012 received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). PRGN-2012 also received Orphan Drug Designation from the FDA and Orphan Drug Designation from the European Commission.

· Results from the pivotal clinical study of PRGN-2012 for the treatment of RRP were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in a late-breaking oral presentation titled, "PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients."

· Pivotal study met primary safety and efficacy endpoints.

· 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; Complete Responses have been durable beyond 12 months with median duration of follow up of 20 months as of the May 20, 2024 data cutoff.

· 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 (range: 3-10) pre-treatment to 0 (range: 0-7) post-treatment.

· PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.

· PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders.

· PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders.

· The Company has completed the pre-biologics license application (BLA) meeting with the FDA and is in full alignment on the content of the BLA, including the clinical and chemistry, manufacturing and controls (CMC) module, and the path for a fourth quarter 2024 rolling BLA submission under an accelerated approval pathway.

· The Company continues to rapidly advance its commercial and manufacturing readiness campaign in anticipation of a potential 2025 launch.

· Patient enrollment continues to advance in the confirmatory clinical trial of PRGN-2012 in accordance with the guidance from the FDA to initiate the study prior to submission of the BLA.

PRGN-2009 AdenoVerse Gene Therapy in HPV-associated cancers

· PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer are ongoing. As part of the strategic reprioritization announced earlier, the Company has paused enrollment in the cervical cancer Phase 2 clinical trial at non-NCI sites.

PRGN-3006 UltraCAR-T in AML and MDS

· The Company has completed enrollment of the Phase 1b trial for PRGN-3006 in acute myeloid leukemia (AML), which received Fast Track designation from the FDA, and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps.

PRGN-3008 UltraCAR-T Targeting CD19 in Oncology and Autoimmune Diseases

· PRGN-3008 is an autologous CD19-directed UltraCAR-T, based on Precigen’s next generation UltraCAR-T platform, which is engineered to express a CD19 chimeric antigen receptor (CAR), membrane-bound IL-15 (mbIL15) for enhanced persistence and maintenance of stem cell memory/naïve (Tscm) phenotype, an intrinsic PD-1 blockade without complex and expensive gene editing techniques to avoid exhaustion, and a safety/kill switch, all from a single non-viral transposon to ensure a homogenous cell product.

· Next generation UltraCAR-T aims to improve on conventional CAR-T through overnight manufacturing, incorporation of a safety/kill switch, built-in PD1 downregulation that avoids the need for checkpoint inhibitor combination, and the ability for repeat dosing. These advantages give Precigen’s CD19 UltraCAR-T the potential to be the best-in-class treatment for B-cell malignancies and autoimmune indications for the proven CD19 target.

· Preclinical data for PRGN-3008 were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting in a poster presentation titled, "Non-viral engineered next generation CD19 UltraCAR-T with membrane bound IL-15 (mbIL15) and PD-1 blockade preserves stem cell memory/naïve phenotype and enhances anti-tumor efficacy."

o Preclinical data showed that in in vivo tumor models, a single administration of PRGN-3008 enhanced expansion and persistence, produced robust antitumor efficacy with complete tumor clearance, and demonstrated significantly longer survival compared to conventional CD19 CAR-T cells.

o In a simulation of tumor relapse in the in vivo model, PRGN-3008 demonstrated persistence and long-term antitumor immunity extending overall survival without additional PRGN-3008 treatment.

· In a humanized mouse model of lupus nephritis, additional preclinical data for PRGN-3008 in an autoimmune setting presented at the 2024 Cell and Gene Meeting on the Mesa showed complete elimination of B-cells as well as a decrease in antibodies to double-stranded DNA (dsDNA), a specific marker of lupus.

Financial Highlights

· The Company closed a public offering of its common stock in August 2024, resulting in net proceeds of approximately $30.9 million (after deducting underwriting discounts, fees and other underwriting expenses).

· In August 2024, the Company began a strategic prioritization of its clinical portfolio and streamlining of its resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of PRGN-2012.

Third Quarter 2024 Financial Results Compared to Prior Year Period

SG&A expenses increased by $0.6 million, or 7%, compared to the three months ended September 30, 2023. As a result of the Company’s increased focus on PRGN-2012, commercial readiness costs increased in the current quarter versus the prior year period. In addition, the third quarter of 2024 included severance costs incurred related to the Precigen workforce reduction. These increases were partially offset by a reduction in insurance expenses due to decreasing rates and professional fees incurred related to general corporate matters compared to the same period in 2023.

Research and development expenses decreased by $0.2 million, or 2%, compared to the three months ended September 30, 2023. The decrease was primarily the result of the Company’s portfolio reprioritization, which included a $2.0 million decrease in costs associated with ActoBio resulting from the shutdown of operations during the second quarter of 2024 as well as lower costs of $0.7 million incurred at contract research organizations for other programs compared to the same period in 2023. These decreases were offset by increased costs of approximately $2.5 million associated with PRGN-2012 in advance of the Company’s planned BLA submission and the Company’s ongoing confirmatory trial, as well as severance costs incurred related to the Precigen workforce reduction in the third quarter of 2024.

Other income (expense), net, decreased by $3.8 million compared to the three months ended September 30, 2023. This decrease was primarily due to the reclassification of cumulative translation losses of $2.9 million as a result of the final closing of the ActoBio facilities in the third quarter of 2024, as well as a reduction in interest income compared to the same period in 2023.

Total revenues decreased $0.4 million, or 31%, compared to the three months ended September 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar.

Net loss was $24.0 million, or $(0.09) per basic and diluted share, compared to net loss of $19.8 million, or $(0.08) per basic and diluted share, in the three months ended September 30, 2023.

First Nine months 2024 Financial Results Compared to Prior Year Period

SG&A expenses increased by $0.1 million, or 1%, compared to the nine months ended September 30, 2023. As a result of the Company’s increased focus on PRGN-2012, commercial readiness costs increased versus the prior year period. In addition, the second and third quarter of 2024 included higher severance costs associated with the suspension of ActoBio’s operations and the 2024 Precigen workforce reduction. These increases were partially offset by a decrease in stock compensation and insurance expenses due to decreasing rates in 2024 compared to the same period in 2023.

Research and development expenses increased $5.7 million, or 16%, compared to the nine months ended September 30, 2023, primarily as a result of the Company’s increased focus on PRGN-2012. There were $4.4 million of increased costs associated with PRGN-2012 in advance of the Company’s planned BLA submission, including the start of the PRGN-2012 confirmatory clinical trial and close out of the PRGN-2012 pivotal clinical trial activities and professional fees incurred related to the Company’s manufacturing facility. Additionally, personnel costs increased by $3.0 million due to an increase in the hiring of employees related to the advancement of PRGN-2012 in the third and fourth quarters of 2023 and severance charges incurred related to the Precigen workforce reduction in the third quarter of 2024. These increases were offset by lower costs incurred at contract research organizations for other programs compared to the prior year period as well as a reduction in total ActoBio operating expenses compared to the nine months ended September 30, 2023.

Other income (expense), net, decreased $4.3 million, or 166%, compared to the nine months ended September 30, 2023. This decrease was primarily due to the reclassification of cumulative translation losses of $2.9 million resulting from the final closing of the ActoBio facilities in the third quarter of 2024, as well as a reduction in net interest income compared to the same period in 2023.

In conjunction with the suspension of ActoBio’s operations, the Company recorded $34.5 million of impairment charges related to goodwill and long-lived assets in the second quarter of 2024, as well as a related tax benefit of $1.7 million.

Total revenues decreased $2.3 million, or 45%, compared to the nine months ended September 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar.

Net loss was $106.5 million, or $(0.41) per basic and diluted share, compared to net loss of $62.8 million, or $(0.26) per basic and diluted share, in the nine months ended September 30, 2023.

On November 14, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer, autoimmune and rare diseases, reported plans to share progress across its clinical- and earlier-stage pipeline of differentiated T stem cell memory cells (TSCM)-rich allogeneic CAR-T therapies in oncology and autoimmune diseases during a virtual R&D Day to be held today at 10:00am ET /7:00am PT (Press release, Poseida Therapeutics, NOV 14, 2024, View Source [SID1234648411]).

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"We believe Poseida is well positioned to be a cell therapy leader based on the unique capabilities of our proprietary non-viral technology platform and our allogeneic TSCM-rich CAR-T approach," said Kristin Yarema, Ph.D., President and Chief Executive Officer of Poseida Therapeutics. "We are organizing our pipeline around three pillars – hematologic malignancies, solid tumors and autoimmune diseases – with multiple candidates in each that give us a wide range of opportunities. In the emerging field of cell therapy for autoimmune diseases, we are optimistic that our platform can build upon the early success seen with autologous CAR-T by offering an off-the-shelf option that would expand accessibility and address the potential drivers of relapse with more complete B cell depletion."

"Building on the advantages of our non-viral allogeneic TSCM-rich approach, we are implementing several advanced technologies aimed at bringing the benefits of CAR-T therapy to patients with solid tumors," said Devon J. Shedlock, Ph.D., Chief Scientific Officer, Cell Therapy at Poseida Therapeutics. "This includes our collaboration with Astellas, which brings together the unique technologies from both companies to create a new class of CAR-T, convertibleCARs, which employs multi-antigen targeting and other enhancements to improve CAR-T potency and persistence."

The event will feature presentations by members of Poseida’s management team and will include a fireside chat with Peter Sandor, M.D., EVP and Head of Corporate Strategy at Astellas Pharma, that will cover the research collaboration and license agreement between Xyphos Biosciences, Inc., (a wholly owned subsidiary of Astellas, "Xyphos") and Poseida to develop novel convertibleCAR programs by combining the innovative cell therapy platforms from each of the companies. Poseida management will participate in a Q&A session at the end of the program.

Cell therapy technology platform: Poseida has built a full set of non-viral capabilities to design and develop allogeneic, TSCM-rich CAR-T therapies. TSCM cells are considered ideal for CAR-T therapy because they are long-lived, multi-potent and self-replicating, with the potential for an improved safety and efficacy profile. This compares to other approaches, which either use a different cell type or drive T cell differentiation (and therefore less stemness) as part of the process to manufacture the CAR-T cells. The key elements of Poseida’s approach include:

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Non-viral, transposon-based gene insertion system preferentially integrates genes into naïve and TSCM cells, with a high cargo capacity that allows for adding multiple genes to enhance functionality and add safety features

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Cas-CLOVER gene editing system preserves the TSCM cell type and operates effectively in resting T cells. It offers approximately 25-times greater fidelity than CRISPR-Cas9, supporting improved safety and quality

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Wholly-owned, onsite GMP manufacturing facility positioned to serve discovery through commercial needs across the Company’s pipeline. The Company’s Booster Molecule has enabled a scalable, lower cost manufacturing approach with the proven ability to generate cell yield up to over 100 doses per batch

Emerging leadership in allogeneic CAR-T for hematologic malignancies: Poseida will provide an overview of recently reported interim Phase 1 results for P-BCMA-ALLO1, its lead CAR-T program targeting BCMA for the treatment of multiple myeloma. New preclinical data suggest that P-BCMA-ALLO1 effectively targets mutations that are known to arise in patients with relapse after prior anti-BCMA therapies. P-BCMA-ALLO1 is part of Poseida’s collaboration with Roche and is currently enrolling a Phase 1b dose expansion study, which will be outlined in the presentation. In addition, the Company will highlight its emerging pipeline programs for hematologic malignancies:

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P-CD19CD20-ALLO1 is the Company’s first dual CAR-T program targeting CD19 and CD20 for the treatment of B-cell malignancies in collaboration with Roche. New preclinical data demonstrate that P-CD19CD20-ALLO1 delivers high in vitro potency and strong in vivo antitumor activity for either CD19 or CD20 single-positive target cells, as well as double-positive targets. A Phase 1 clinical trial is enrolling patients with selected B-cell malignancies, with initial clinical data anticipated in 2025. Additional information about the trial is available at www.clinicaltrials.gov using identifier: NCT06014762.

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Beyond hematologic malignancies, preclinical data also demonstrate robust in vitro activity against patient-derived B cells across multiple autoimmune diseases

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P-CD70-ALLO1 is a preclinical program targeting CD70 for the treatment of diseases including acute myeloid leukemia (AML). New preclinical data demonstrate P-CD70-ALLO1’s robust anti-AML effect, with no toxicity to hematopoietic stem cells. In addition, there is a growing body of clinical and preclinical evidence that targeting CD70 with cell therapy may be an effective treatment for solid tumors. Roche has an option to add this as a potential new program to the collaboration

Expanding allogeneic TSCM-rich CAR-T to autoimmune disease: Poseida’s cell therapy technology platform has the potential to create CAR-T therapies designed to address the challenges with existing emerging approaches to applying cell therapy to autoimmune disease, including autologous CAR-T, in vivo CAR-T and T cell engagers. The Company’s lead program for autoimmune disease is P-BCMACD19-ALLO1, a dual CAR-T targeting BCMA and CD19. New preclinical data demonstrate P-BCMACD19-ALLO1’s potential in both autoimmune disease and oncology:

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Demonstrated robust in vitro killing of patient-derived B cells across multiple autoimmune diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and multiple sclerosis (MS), which collectively affect more than 5 million people in the U.S.

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Achieved dose-dependent depletion of primary human B cells in a humanized mouse model generated with human CD34+ cells

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Effectively eliminated primary human CD81+CD19+ multiple myeloma progenitor cells from patient bone marrow samples, addressing cells associated with relapse where BCMA-only targeted therapies were ineffective

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Demonstrated ability of P-BCMACD19-ALLO1 and P-BCMA-ALLO1 to kill tumor cells expressing known mutant forms of BCMA, which are linked to relapse in patients treated with autologous CAR-T and bispecific T cell engager therapies directed at BCMA

Poseida is conducting IND-enabling studies for P-BCMACD19-ALLO1 and plans to file one or more INDs for an autoimmune disease indication with the U.S. Food and Drug Administration.

Addressing historical barriers for CAR-T in solid tumors through a broad array of bold, innovative technologies enabled by the Company’s platform: There are currently no CAR-T therapies approved for solid tumors, with several key factors believed to be roadblocks: 1) antigen heterogeneity; 2) differing lymphodepletion needs compared to hematologic malignancies to enable CAR-T cell engraftment, tracking, and infiltration; 3) on-target off-tumor toxicity; and 4) hostile tumor microenvironment. Poseida is approaching these challenges with a suite of technologies across multiple solid tumor programs:

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P-MUC1C-ALLO1 is Poseida’s lead solid tumor CAR-T program targeting MUC1-C, a membrane protein overexpressed in many epithelial cancers. A Phase 1 clinical trial is enrolling patients with treatment-resistant breast, ovarian, colorectal and other solid tumors, with ongoing exploration of P-MUC1C-ALLO1 dosing and lymphodepletion regimens. A clinical data update is planned for the European Society for Medical Oncology Immuno-Oncology Congress 2024 (ESMO-IO) taking place in Geneva December 11-13, 2024. A patient case study from the Phase 1 trial demonstrated a 42% decrease in paraesophageal lymph node size with prolonged stable disease for nearly a year in a heavily pretreated appendiceal carcinoma patient. New preclinical data suggest adding low-dose methotrexate to standard lymphodepletion may enhance CAR-T expansion and persistence

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P-PSMA-ALLO1 is a preclinical program targeting PSMA for prostate cancer. In preclinical models, P-PSMA-ALLO1’s dual CAR format showed superior in vivo anti-tumor activity and cytotoxicity compared to single and tandem binder CAR-Ts

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Poseida and Xyphos are developing allogeneic convertibleCARs for solid tumors, combining Poseida’s allogeneic CAR-TSCM platform with Xyphos’ ACCEL technology to create controlled, long lasting, and highly active CAR-T therapies. New preclinical data shows positive results for an allogeneic convertibleCAR-TSCM targeting universal inert natural killer group 2 member D receptor (iNKG2D), paired with a solid tumor antigen-targeting MicAbody. Poseida and Xyphos are working to optimize this convertibleCAR and MicAbody pairing, and other platform technologies designed to maximize potency and persistence

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Poseida will highlight its allogeneic CAR-TCR-T cells to address antigen heterogeneity in solid tumors. The Company recently presented new preclinical data demonstrating enhanced potency to better target solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting. Preclinical data highlight the potential of a combination of CAR-TCR-T cell treatment followed by a T cell engager (TCE). In this model, MUC1C-CAR and NY-ESO-1-TCR T cells effectively controlled a primary tumor (MUC1C+/NY-ESO-1+/CD70-), and later were reactivated and re-directed by a CD70 TCE to control challenge by a secondary tumor (MUC1C-/NY-ESO-1-/CD70+)

LOGO

In-house manufacturing to support Poseida’s broad cell therapy pipeline: the Company will highlight the capabilities of its GMP facility and team, including:

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New data demonstrated high-purity apheresis across different healthy donors, with consistency in CAR-T manufacturing (cellular expansion, gene editing, final phenotype) across collections from the same donor

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Future manufacturing platform enhancement opportunities including AI-assisted donor screening to improve efficiency; improving electroporation unit operations to improve gene editing efficiency and subsequent cell health; and leveraging dynamic bioreactor environments to increase yields

Video Webcast and Replay

This virtual event and access to the live webcast is available through the following registration link: View Source

Registration for this virtual event and access to a replay of the live webcast will be available on the Investors & Media section of www.poseida.com. A replay of the webcast will be available for approximately 90 days following the presentation.

On November 14, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biotechnology company exploring new pathways towards a cancer-free future by using its INTASYL siRNA gene silencing technology designed to make the body’s immune cells more effective in killing cancer cells reported its financial results for the quarter ended September 30, 2024 and provided a business update (Press release, Phio Pharmaceuticals, NOV 14, 2024, View Source [SID1234648410]).

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Recent Corporate Updates

The Phase 1b dose escalation clinical trial for our lead product candidate, PH-762, previously received a positive safety recommendation to advance to the next highest dose from the Safety Monitoring Committee (SMC) for the first cohort. The second cohort is fully enrolled, and screening for the 3rd cohort will open on 10 Dec 2024. Each enrolled subject receives four (4) intratumoral (IT) doses of PH-762. The currently enrolled patients were diagnosed with cutaneous squamous cell carcinoma (6 patients) and metastatic melanoma (1 patient). Two of the three patients in the second cohort have completed the treatment and the follow-up phase.

At Day 36 (tumor excision), while each patient in the first cohort had stable disease, the following results were described for two patients who have completed treatment in the second cohort:

· Complete response (100% tumor clearance) reported for 1 patient with cutaneous squamous cell carcinoma
· Partial response (90% tumor clearance) reported for 1 patient with cutaneous squamous cell carcinoma

A sixth clinical trial site, Paradigm Clinical Research Centers in San Diego, CA, was selected for the Phase 1b study of PH-762 and will join the other five sites engaged in the study: Banner MD Anderson Cancer Center in Gilbert, Arizona. The George Washington University-Medical Faculty Associates in Washington, D.C; The University of Pittsburgh Medical Center (UPMC) Department of Dermatology; Integrity Research Clinical Associates in Delray Beach, Florida; and Centricity Research in Dublin Ohio.

Cancer Immunology, Immunotherapy, a peer reviewed journal, highlighted the INTASYL compound PH-804. The article, issued on Oct 3, 2024, was authored by M Maxwell et al. entitled "INTASYL Self-Delivering RNAi Decreases TIGIT Expression, Enhancing NK Cell Cytotoxicity: A Potential Application to Increase the Efficacy of NK-Adoptive Cell Therapy Against Cancer".

Presented new data on Phio’s INTASYL self-delivering siRNA technology applications for immuno-oncology therapy at several conferences:

· 9th Annual CAR-TCR Summit held on Sept 17th showcased INTASYL siRNA technology-an innovative and flexible solution designed specifically to enhance cell potency and improve overall yield for adoptive cell therapy.
· 20th Annual Oligonucleotide Therapeutics Society (OTS) held on October 8th showcased INTASYL’s role in helping immune cells target and kill cancer cells.
· The American Society of Gene and Cell Therapy’s 2024 Advancing Cancer Conference held Oct 16-17 reported on INTASYL Compound PH-894: A potent and specific silencing of BRD4 in NK Cells.
· 39th Annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held November 9th reported on new clinical data from the Phase 1b clinical trial for its INTASYL Compound PH-762.

Phio Pharmaceuticals is currently participating in the Renmark Financial Virtual Non-Deal Roadshow series that features Phio’s CEO and Chairman of the Board, Robert Bitterman, presentation on its INTASYL technology. The presentations are directed to the retail investor communities including those in the Chicago, Denver, Dallas, Atlanta, and Boston areas. These roadshows have been on-going since late August 2024.

Financial Results

Cash Position

At September 30, 2024, the Company had cash of $5.4 million as compared with $8.5 million at December 31, 2023.

In July 2024, the Company entered into inducement letter agreements with certain holders of the Company’s existing warrants to purchase up to an aggregate of 545,286 shares of common stock at a reduced exercise price of $5.45 per share. In consideration for the immediate exercise of the existing warrants, the Company agreed to issue five and one-half year term Series C warrants to purchase up to 583,098 shares of common stock and eighteen month term Series D warrants to purchase up to 507,474 shares of common stock, both at an exercise price of $5.45. The net proceeds to the Company were approximately $2.6 million, after deducting placement agent fees and offering expenses.

Research and Development Expenses

Research and development expenses were $0.6 million for the three months ended September 30, 2024 as compared with $1.8 million for the three months ended September 30, 2023, a decrease of 64%. The decrease was primarily driven by non-recurring clinal program direct start-up costs in the 3rd Quarter 2023 and reductions in research compensation attributable to reductions in headcount of participants during the 3rd Quarter 2024.

General and Administrative Expenses

General and administrative expenses were $0.95 million for the three months ended September 30, 2024 as compared with $0.97 million for the three months ended September 30, 2023, a decrease of 2%. The decrease was primarily due to decreases in salary-related expenses compared to the prior year period.

Net Loss

Net loss was $1.5 million for the three months ended September 30, 2024 as compared with $2.8 million for the three months ended September 30, 2023. The decrease in net loss was primarily due to the changes in research and development expenses, as described above.

On November 14, 2024 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported a business update and announced financial results for the third quarter of 2024 (Press release, PDS Biotechnology, NOV 14, 2024, View Source [SID1234648409]).

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"Since our last update in August, we have been actively engaged with investors and clinicians to discuss our strategy and funding requirements for our VERSATILE-003 Phase 3 trial of Versamune HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell cancer (HNSCC)," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. Dr. Bedu-Addo further noted that "based on investor feedback, discussions with key opinion leaders involved with the study and other experts, we have made minor modifications to the VERSATILE-003 trial design to reduce the overall cost and time required to achieve an interim data readout and trial completion."

With submission of the updated Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) this week, the Company expects the FDA clearance decision by mid-December, allowing the Company to initiate site activation in the first quarter of 2025.

"Elsewhere in our pipeline, we were pleased with the data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune HPV with chemoradiation to treat locally advanced cervical cancer presented at the American Society for Radiation Oncology (ASTRO) annual meeting. The presented data demonstrated promising clinical activity and a compelling safety profile. Based on continued research in various HPV-positive cancers conducted by PDS Biotech and independent researchers who recognize its potential, Versamune HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with favorable toxicity. We are exploring the next steps in the development of Versamune HPV for cervical cancer," concluded Dr. Bedu-Addo.

Recent Developments

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Update to Phase 3 VERSATILE-003 Trial Design in HPV16-positive first-line recurrent and/or metastatic HNSCC

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Updated trial design to include approximately 350 patients

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VERSATILE-002 results have shown broadly improving clinical responses across multiple parameters with increases in patient size and duration of patient follow up over the last year, demonstrating durability of the anti-tumor responses

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The design, which is informed by the observed durability of the clinical responses, retains statistical power and remains within the confines of our agreement with the FDA on registrational design

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Design maintains 2:1 randomization and median overall survival as primary endpoint

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Design imparts potential for earlier interim readouts and study completion

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Design presents potential for reduced execution costs

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Amended IND (updated design) submitted November 2024

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In September 2024, we provided updated results from our VERSATILE-002 Phase 2 clinical trial in recurrent and/or metastatic HPV16-positive HNSCC patients treated with the combination of Versamune HPV and pembrolizumab presented at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 by Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial. Press release here.

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In October 2024, we provided updated results from our IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune HPV and chemoradiotherapy presented at the ASTRO Annual Meeting by Adam Grippin, M.D., Ph.D., The University of Texas MD Anderson Cancer Center. Press release here.

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Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National Institutes of Health presented the rationale and design of recurrent prostate cancer trial combining Xtandi + PDS01ADC vs Xtandi alone during an oral presentation at the 12th Annual Meeting of the International Cytokine and Interferon Society, October 2024. Press release here .

Third Quarter 2024 Financial Results
Reported net loss was approximately $10.7 million, or $0.29 per basic share and diluted share, for the three months ended September 30, 2024, compared to a net loss of $10.8 million, or $0.35 per basic share and diluted share, for the three months ended September 30, 2023. The decrease was primarily due to lower operating expenses.

Research and development expenses increased to approximately $6.8 million for the three months ended September 30, 2024, from $6.4 million for the three months ended September 30, 2023. The increase of $0.4 million was primarily attributable to higher manufacturing expenses, partially offset by lower clinical costs and personnel expenses.

General and administrative expenses decreased to approximately $3.4 million for the three months ended September 30, 2024, from approximately $4.1 million for the three months ended September 30, 2023. The decrease of $0.7 million was primarily attributable to lower personnel costs and professional fees.

Total operating expenses decreased to approximately $10.2 million for the three months ended September 30, 2024, from $10.5 million for the three months ended September 30, 2023.

Net interest expenses increased to approximately $0.5 million for the three months ended September 30, 2024, from $0.3 million for the three months ended September 30, 2023.

Cash and cash equivalents as of September 30, 2024 totaled approximately $49.8 million.