On November 14, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, "HOOKIPA", the "Company"), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious disease, reported financial results for the third quarter ended September 30, 2024 and provided recent business highlights, including an update on the progress of the lead clinical program, eseba-vec (Press release, Hookipa Pharma, NOV 14, 2024, View Source [SID1234648545]).

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"HOOKIPA made excellent progress across each program in our pipeline in the third quarter," said Malte Peters, MD, Chief Executive Officer of HOOKIPA. "We advanced the development of eseba-vec for HPV16+ head and neck squamous cell carcinoma (HNSCC), through the start of an investigator-initiated study in the new clinical setting of adjuvant care, and presented continued positive, updated data from our Phase 2 study in first-line recurrent/metastatic disease as a late breaking abstract at SITC (Free SITC Whitepaper) 2024. In parallel, we have made significant progress with our review of the business strategy and operations, having implemented a number of initiatives to optimize spending and ensure prioritization of resources."

Recent Developments

Oncology
Eseba-vec: Pivotal-trial ready immunotherapy for human papilloma virus type 16 positive (HPV16+) cancers, including head and neck squamous cell carcinoma (HNSCC) and oropharyngeal squamous cell carcinoma (OPSCC). HOOKIPA owns all rights to this program.

Enrollment completed in the Phase 2 H200-001 study for eseba-vec in combination with pembrolizumab in HPV+ HNSCC with 68 patients enrolled as of October 2024.
First Patients Dosed in Phase 2 Adjuvant Therapy IIT with MSKCC: On October 30, 2024, HOOKIPA announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) dosed the first patients in an investigator-initiated trial (IIT) evaluating eseba-vec in patients with minimal residual disease positive (MRD+) HPV-16+ driven, locally advanced HNSCC, following treatment for curative intent. The study could pave the way to broaden the eseba-vec HNSCC opportunity into adjuvant care.
Updated Phase 2 Data Presented as SITC (Free SITC Whitepaper) 2024 Late-Breaker: On November 9, 2024, HOOKIPA’s clinical collaborator, Alan Ho, MD, PhD, Chief of the Head and Neck Oncology Service at MSKCC, presented a late-breaking poster at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2024). The presentation provided updated results, including data from additional patients enrolled in the Phase 2 trial evaluating eseba-vec plus pembrolizumab as 1L treatment of recurring/metastatic HPV16+ HNSCC in patients with PD-L1 CPS levels of greater than or equal to 20. Eseba-vec treatment resulted in continued, durable clinical responses and antigen-specific T cell responses.
HB-700: The HB-700 program is a novel Phase 1-ready immunotherapy for KRAS-mutated cancers, including pancreatic, colorectal and lung cancer. The investigational therapy was designed to target the most prevalent KRAS mutations of these cancers in a single therapy. HOOKIPA owns all rights to this program and the Investigational New Drug Application (IND) received FDA clearance in April 2024.

Presentation of Strong Preclinical Dataset: On September 25, 2024, HOOKIPA presented the preclinical proof-of-concept dataset for HB-700 at the 6th Annual RAS-Targeted Drug Development Summit. The dataset demonstrated that HB-700 induced target-specific CD8+ T cells and target cell killing in several different animal and translational models.
Infectious Diseases
HOOKIPA is advancing two independent anti-viral programs (HB-400 for HBV and HB-500 for HIV-1) through a collaboration and license agreement with Gilead Sciences, Inc. (Gilead).

HB-400: An investigational therapeutic vaccine for the treatment of chronic hepatitis B (CHB).

Enrollment Completed in Phase 1a/1b Clinical Trial: The vaccine is being evaluated in a Phase 1a/1b clinical trial (NCT05770895) in 83 subjects to assess the safety and immune response induced by HB400 in healthy participants and in participants with CHB on oral antiviral therapy.
HB-500: An investigational therapeutic vaccine for the treatment of human immunodeficiency virus-1 (HIV-1).

Ongoing Phase 1b Clinical Trial: The vaccine is being evaluated in a Phase 1b clinical trial (NCT06430905) to assess the safety and magnitude of cellular immune response against HIV-1 induced by HB-500 in people living with HIV who are taking anti-retroviral treatment. Under the collaboration agreement with Gilead, HOOKIPA received a $5 million milestone payment associated with dosing of the first subject in this trial in July 2024.
Corporate and Financial Updates

Corporate Highlights

Board of Director Changes: On August 30, 2024, Director Julie O’Neill was appointed to be Non-Executive Chair of the Company’s Board of Directors, succeeding Jan van de Winkel, who decided to step down from the Board due to increased time commitments from other executive responsibilities. Tim Reilly also stepped down from the Board to dedicate more time to his other professional responsibilities. HOOKIPA is grateful for the years of service each Director dedicated to the Company.

Leadership Changes: On July 22, 2024, the Board of Directors appointed Malte Peters, MD, as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer to lead the Company through its next phase of development and to realize the significant opportunity of HOOKIPA’s pipeline.

Board Appointment: On July 22, 2024, Sean Cassidy was appointed to the Board of Directors. Mr. Cassidy serves as the chair of the Audit Committee and as a member of the Compensation and the Nominating and Corporate Governance Committees.

Reverse Split: On July 9, 2024, the Company effected a reverse stock split of the outstanding shares of its common stock on a one-for-ten (1:10) basis. The reverse stock split is part of the Company’s plan to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.
Financial Highlights: Milestone Payments

Gilead: In July, HOOKIPA received a $5.0 million milestone payment under its collaboration and license agreement with Gilead. The success-based milestone payment was achieved in connection with the dosing of the first subject in the Phase 1b clinical trial of HB-500 for the treatment of HIV-1, initiated on July 1, 2024.
Third Quarter 2024 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2024 was $60.0 million, compared to $117.5 million as of December 31, 2023. The decrease was primarily attributable to cash used in operating activities, partially offset by cash received relating to milestone achievements under our collaboration agreements with Roche and Gilead.

Revenue: Revenue was $4.7 million for the three months ended September 30, 2024, compared to $6.9 million for the same period in 2023. The decrease was primarily due to lower partnering revenues as a result of the termination of the Roche collaboration agreement.

Research and Development Expenses: HOOKIPA’s research and development expenses were $15.6 million for the three months ended September 30, 2024, compared to $24.6 million for the same period in 2023. The primary changes in research and development expenses were lower personnel-related and laboratory-related expenses as well as lower manufacturing and research expenses resulting from the pause in development activities related to HB-300 announced in January 2024, partially offset by higher clinical study expenses for the eseba-vec program.

General and Administrative Expenses: General and administrative expenses amounted to $6.7 million for the three months ended September 30, 2024, compared to $4.9 million for the same period in 2023. The primary drivers of the increase in general and administrative expenses were an increase in personnel-related expenses and an increase in professional and consulting fees incurred in connection with management transitions during the third quarter of 2024.

Restructuring Expenses: Restructuring expenses amounted to $0.9 million for the three months ended September 30, 2024, and resulted from severance and other personnel costs as well as professional fees related to a reduction in workforce and related activities conducted in the third quarter of 2024.

Impairment Expenses: Impairment expenses amounted to $0.2 million for the three months ended September 30, 2024, and resulted from write-downs related to laboratory equipment.

Net Loss: HOOKIPA’s net loss was $13.8 million for the three months ended September 30, 2024, compared to a net loss of $19.1 million for the same period in 2023.

On November 14, 2024 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the third quarter ended September 30, 2024 and other recent business developments (Press release, Celcuity, NOV 14, 2024, View Source [SID1234648393]).

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"Enrollment in our VIKTORIA-1 study remains robust and on-track. The PIK3CA wild-type cohort is 100% enrolled, and enrollment in the PIK3CA mutant cohort is on plan," said Brian Sullivan, CEO and co-founder of Celcuity. "Based on our current forecast of reaching the event thresholds that will trigger primary analysis in both the PIK3CA wild-type and mutant cohorts, we expect to report topline data for the PIK3CA wild-type cohort sometime in late Q1 2025 or during Q2 2025 and to report topline data for the PIK3CA mutant cohort in the second half of 2025."

Third Quarter 2024 Business Highlights and Other Recent Developments

● The VIKTORIA-1 Phase 3 clinical trial expects to provide topline data for the PIK3CA wild-type cohort in late Q1 2025 or during Q2 2025 and for the PIK3CA mutant cohort in the second half of 2025.

○ VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor.
○ The PIK3CA wild-type cohort is 100% enrolled and enrollment of the PIK3CA mutant cohort is on-track relative to plan.

● The VIKTORIA-2 Phase 3 clinical trial remains on track to enroll its first patient in Q2 2025.

○ The VIKTORIA-2 study is a global Phase 3 open-label randomized clinical trial evaluating the efficacy and safety of gedatolisib in combination with fulvestrant plus a CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to fulvestrant plus a CDK4/6 inhibitor as a first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant.
○ Prior to the initiation of the Phase 3 portion of the trial, a safety run-in study will be conducted in 12-36 participants to assess the safety profile of gedatolisib in combination with ribociclib and fulvestrant.
○ Site qualification activities to support activation of up to 200 sites across North America, Europe, Latin America, and Asia are on track.

● The Phase 1b/2 clinical trial, evaluating gedatolisib in combination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), is ongoing and expected to report preliminary data in Q2 2025.

● Overall survival data from the B2151009 Phase 1b clinical trial will be presented at the San Antonio Breast Cancer Symposium (SABCS), taking place December 10-13, 2024. Details of the poster presentation are as follows:

○ Abstract Title: Overall survival in patients with HR+/HER2- advanced breast cancer treated in a phase 1b trial evaluating gedatolisib in combination with palbociclib and endocrine therapy (SESS-1510)
○ Presentation Number: P4-08-25
○ Date/Time: Thursday, December 12, 5:30 PM CST

● Additional nonclinical data further characterizing the mechanism of action of gedatolisib and its effect on breast cancer cell metabolic functions will also be presented at the SABCS.

○ Abstract Title: Mechanism of action of gedatolisib in combination with fulvestrant and/or palbociclib in estrogen receptor positive breast cancer models (SESS-989)
○ Abstract Title: Different effects of gedatolisib versus single-node PI3K/AKT/mTOR pathway inhibitors on breast cancer cell metabolic functions (SESS-997)
● In October, Cancers published results of nonclinical studies in gynecological cancer cell line models highlighting the differences between single-node inhibitors of the PI3K/AKT/mTOR pathway and gedatolisib. The published manuscript is available online and on the publications section of Celcuity’s website.

Third Quarter 2024 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2024, compared to the third quarter ended September 30, 2023.

Total operating expenses were $30.1 million for the third quarter of 2024, compared to $18.9 million for the third quarter of 2023.

Research and development (R&D) expenses were $27.6 million for the third quarter of 2024, compared to $17.5 million for the prior-year period. Of the approximately $10.1 million increase in R&D expenses, $6.3 million primarily related to activities supporting the VIKTORIA-1 Phase 3 trial, the Phase 1b/2 trial and the initiation of the VIKTORIA-2 Phase 3 trial, and $3.8 million was related to increased employee and consulting expenses.

General and administrative (G&A) expenses were $2.5 million for the third quarter of 2024, compared to $1.4 million for the prior-year period. Employee and consulting related expenses accounted for $0.9 million of the increase. Professional fees and other administrative expenses accounted for the remaining increase of approximately $0.2 million.

Net loss for the third quarter of 2024 was $29.8 million, or $0.70 loss per share, compared to a net loss of $18.4 million, or $0.83 loss per share, for the third quarter of 2023. Non-GAAP adjusted net loss for the third quarter of 2024 was $27.6 million, or $0.65 loss per share, compared to non-GAAP adjusted net loss of $17.3 million, or $0.78 loss per share, for the third quarter of 2023. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the third quarter of 2024 was $20.6 million, compared to $12.7 million for the third quarter of 2023.

At September 30, 2024, Celcuity reported cash, cash equivalents and short-term investments of $264.1 million.

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

•
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

•
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

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

•
Design imparts potential for earlier interim readouts and study completion

•
Design presents potential for reduced execution costs

•
Amended IND (updated design) submitted November 2024

•
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.

•
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.

On November 14, 2024 TriSalus Life Sciences Inc., (Nasdaq: TLSI), an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported its financial results for the third quarter ended September 30, 2024, and provided a business update (Press release, TriSalus Life Sciences, NOV 14, 2024, View Source [SID1234648426]).

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"We enter the final quarter of 2024 with great momentum, both commercially and clinically, and we are positioned well for an even greater 2025," stated Mary Szela, President and Chief Executive Officer of TriSalus Life Sciences. "Commercially, we enjoyed a strong third quarter highlighted by 42% revenue growth. We recently launched the TriNav LV system to address patients with larger vessels, an opportunity we believe will meaningfully expand our addressable market and provide full access to the $375 million liver embolization market."

"With the successful completion of our Phase 1 dose escalation study enrollment in UM-LM, we are actively pursuing a strategic partnership for nelitolimod," continued Ms. Szela. "This follows the successful presentation of positive Phase 1 results from our PERIO-01 dose escalation study in UM-LM at SITC (Free SITC Whitepaper). Additionally, by mid-2025, we anticipate data from our Phase 1 study in locally advanced pancreatic cancer, which will guide our next steps."

"Our clinical development efforts for the TriNav system have expanded with the launch of the DELIVER program, starting with the PROTECT registry trial for patients with multinodular goiter. There is significant potential to broaden our addressable market by $400 million, and we are committed to providing further updates on PROTECT and additional programs within the DELIVER initiative."

"Finally, we are initiating 2025 guidance that calls for greater than 50% revenue growth, a greater than 20% reduction in operating expenses, positive full-year EBITDA, and positive cash flow in the second half of the year," concluded Ms. Szela.

Third Quarter Business Update

TriNav System Large Vessel Launch

TriSalus recently expanded its portfolio of Pressure-Enabled Drug Delivery (PEDD) devices with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter to optimize therapeutic delivery for patients with larger vessels. The TriNav LV system is suitable for patients with vessels sized between 3.5 and 5.0 mm and is expected to allow the Company to meaningfully expand its addressable liver embolization market. The TriGuide Guiding Catheter has a larger inner diameter, lubricious inner lining, and reverse curve design to support femoral access for the TriNav LV system, which the Company believes will enhance procedural efficiency. These new products are eligible for the same HCPCS reimbursement codes as existing TriNav products, enabling seamless integration into current billing structures.

DELIVER and PROTECT Updates

During the quarter, TriSalus advanced the DELIVER clinical program, a series of clinical trials designed to demonstrate enhanced safety and efficacy across a broad spectrum of complex, difficult-to-treat patients through investigator-initiated studies, further underscoring the impact of PEDD technology. A key focus of the DELIVER program is to investigate the potential of combining use of the TriNav system with these therapies to enhance effectiveness and address resistance mechanisms in challenging cancers.

The first of these is a registry study called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease), which has been initiated, and TriSalus intends to enroll 100 patients across five leading academic sites. It is estimated that approximately 5% of adults have multinodular goiters, and the prevalence in adults over 50 is estimated to be up to 50%. The Company estimates that this could expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity and putting the Company’s total addressable market at more than $1 billion in the U.S. This new procedure utilizing the TriNav system is also eligible for the same Healthcare Common Procedure Coding System (HCPCS) reimbursement code allowing for seamless integration into current billing approaches.

The Company anticipates opening additional DELIVER studies in the first half of 2025 and will provide more details as those studies commence.

PERIO Trial Update

TriSalus presented Phase 1 results from the PERIO-01 clinical trial at the recent SITC (Free SITC Whitepaper) meeting. This dose escalation trial investigated the use of the PEDD method of nelitolimod in patients with UM-LM. The results suggested that PEDD-administered nelitolimod, combined with immune checkpoint inhibitors, provides promising clinical benefits and durable survival in heavily pretreated patients with UM-LM and a favorable safety profile. The Company is actively exploring strategic partnerships to advance this indication further.

The Company also completed enrollment of 13 patients in its PERIO-03 Phase 1 dose escalation study of nelitolimod in locally advanced pancreatic cancer. Evidence gathered thus far supports a strong safety profile and further exploration of nelitolimod combined with the TriNav pancreatic infusion technology. The Company will outline the next steps once the final data are available in mid-2025.

Financial Results for Q3 2024

Revenue, all from the sale of the TriNav system, was $7.3 million and $21.2 million, respectively, for the three and nine months ended September 30, 2024. These were up 42% and 66%, respectively, compared to the same periods in 2023. Revenue growth was driven primarily by increased selling resources and increased market share.

Gross margins were 86% and 86% for the three and nine months ended September 30, 2024, respectively, compared to 89% and 84%, respectively, for the same periods in 2023. The year-to-date improvement is due to increased factory volumes and improved operational efficiency.

Operating losses were $8.7 million and $28.6 million, respectively, for the three and nine months ended September 30, 2024, respectively, compared to losses of $18.6 million and $40.2 million, respectively, for the same periods in 2023. These amounts include non-cash stock compensation and depreciation expenses of $1.6 million and $4.3 million for the three- and nine-month periods in 2024 and $0.4 million and $0.9 million for the same periods in 2023. Current year reductions in operating losses are due to increased sales, reduced general and administrative expenses due to non-recurrence of prior year costs related to becoming a public company, and reduced research and development spending associated with the ramp-down of clinical trial spending.

Net losses available to common stockholders were $2.4 million and $19.9 million, respectively, for the three and nine months ended September 30, 2024, compared to losses of $1.4 million and $23.7 million, respectively, for the same periods in 2023. Net losses in 2024 include non-cash related gains on change in fair value of various derivatives of $7.3 million and $10.5 million, respectively, for the three and nine months ended September 30, 2024, compared to gains of $17.1 million and $16.4 million, respectively, for the same periods in 2023. The basic and diluted loss per share for the three and nine months ended September 30, 2024, were $0.12 and $0.91, respectively, compared to $0.14 and $5.72 for the three and nine months ended September 30, 2023, respectively.

On September 30, 2024, cash and cash equivalents totaled $11.3 million. The Company expects existing liquidity sources and $25 million of available capacity on the OrbiMed debt facility to provide sufficient cash runway throughout 2025. In addition, the company expects to be EBITDA positive for 2025 and achieve positive cash flow by the second half of 2025, extending total cash runway beyond 2025.

2025 Guidance

The Company is providing guidance for 2025 for the first time, including:

Sales are expected to grow by more than 50% in 2025, driven by further market share increases in the TriNav system, the commercial launch of the TriNav LV system, and the TriNav target market expansion driven by the DELIVER program.
Operating expenses are expected to decline greater than 20% in 2025 due to reductions in R&D associated with completing the PERIO Phase 1 trials and reductions in G&A expenses due to the non-recurrence of certain costs related to becoming a public Company.
The Company expects to achieve positive full-year EBITDA and positive cash flow in the second half of the year.
Conference Call

TriSalus will host a webcast to discuss its third quarter 2024 financial results and business highlights on November 14, 2024, at 9:00 a.m. EST. The webcast can be accessed on the investor relations section of TriSalus’ website at View Source Following the conclusion of the event, a webcast replay will be available on the website. Interested parties participating by phone will need to register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number and a personal pin.

On November 14, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of cancer and autoimmune disease, reported a business and financial update for the third quarter of 2024 (Press release, Cue Biopharma, NOV 14, 2024, View Source [SID1234648394]).

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Recent Business Highlights

•
Presented positive updated data from the Phase 1 trials of CUE-101 and CUE-102 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 39th Annual Meeting (SITC 2024) November 6-10
Updated data from Phase 1 trial of CUE-101 in combination with KEYTRUDA (pembrolizumab) continued to demonstrate enhanced benefit versus historical studies with pembrolizumab alone. Key findings included an objective response rate (ORR) of 46%, 12-month overall survival (OS) of 91.3% and a median overall survival (mOS) of 21.8 months in first line (1L) HPV+ R/M HNSCC patients, as well as an ORR of 50% in the subset of 1L patients with low PD-L1 expression (combined positive score (CPS) 1-19)
Updated data from Phase 1 monotherapy trial of CUE-102 included evidence of selective expansion of WT1-specific T cells and anti-tumor activity, as well as a favorable tolerability profile with no dose limiting toxicities (DLTs) in patients with Wilms’ Tumor 1 (WT1)-expressing colorectal, gastric, ovarian and pancreatic cancers
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Demonstrated disease control rate (DCR) of 67% in late-stage pancreatic cancer patients treated with CUE-102 monotherapy, including an unconfirmed partial response (PR) with a 40% decrease in tumor burden
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Announced pricing of $12.0 million public offering
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Appointed industry veteran Lucinda Warren as Chief Business Officer
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Continued advancement of preclinical programs, CUE-401 for induction and expansion of regulatory T cells, in collaboration with Ono Pharmaceutical, and CUE-501 for B cell depletion, positioning both programs towards drug candidate selection

"We are very pleased with the validating updated clinical data from our Phase 1 trials for both CUE-101 and CUE-102," said Daniel Passeri, chief executive officer of Cue Biopharma. "Importantly, we believe the maturing data further supports and strengthens our competitive differentiation and positioning for selective modulation of disease-specific T cells. This data further bolsters our confidence that the CUE-100 series, exemplified by CUE-101 and CUE-102, represents the potential of establishing a new standard of care for cancer patients. We are also very pleased with the continued progress of our preclinical autoimmune programs, both of which have moved closer towards drug candidate selection."