On November 14, 2024 Flamingo Therapeutics ("Flamingo") reported an oral presentation at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research, RNAs as Drivers, Targets, and Therapeutics in Cancer, being held in Seattle, Washington from November 14-17, 2024 (Press release, Flamingo Therapeutics, NOV 14, 2024, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-announces-oral-presentation-at-aacr-special-conference-in-cancer-research-on-rnas-as-drivers-targets-and-therapeutics-in-cancer [SID1234648397]).

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Dr. Andrew Denker, Flamingo’s Chief Medical Officer, will deliver an oral presentation on the Company’s approach to developing RNA therapeutics against difficult-to-drug targets for cancer indications. Dr. Denker will discuss Flamingo’s novel oligonucleotide targeting the long noncoding RNA (lncRNA) MALAT1, FLM-7523, discovered by Ionis Pharmaceuticals, which has recently completed IND-enabling preclinical activities and is moving toward a Phase 1 First-in-Human trial in solid tumors. Flamingo’s lead program, danvatirsen, is an antisense oligonucleotide discovered by Ionis that selectively targets STAT3 mRNA and has shown clinical activity in HNSCC.

"I am excited that Flamingo’s approach to leveraging RNA for cancer drug development will be showcased at this important scientific meeting," commented Dr. Denker. "Long noncoding RNAs, part of the genetic ‘dark matter’, are gaining attention as potential novel targets in cancer and other diseases. The antisense oligonucleotide therapeutic modality is uniquely suited for lncRNA targets, and FLM-7523 is one of the most advanced therapeutics in development. We look forward to highlighting our approach at the AACR (Free AACR Whitepaper) Special Conference."

Oral presentation details are as follows:

Title: "Antisense Oligonucleotides as Therapeutics for Difficult-to-Drug Targets in Oncology"

Session Title: Plenary Session 6: Small RNA Therapeutics

Session Date and Time: Saturday, November 16, 2024, 3:30 pm

Presenting Author: Dr. Andrew Denker

Abstracts selected for presentation during the meeting (poster or oral) will be published as a freely available supplement in an AACR (Free AACR Whitepaper) journal on the first day of the meeting. For more information, please visit the AACR (Free AACR Whitepaper) Special Conference 2024 website.

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 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, reported financial results and recent corporate highlights for the third quarter ended September 30, 2024 (Press release, Fortress Biotech, NOV 14, 2024, View Source [SID1234648398]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "We are thrilled to have received U.S. Food and Drug Administration ("FDA") approval for Emrosi, a potential best-in-class treatment for inflammatory lesions of rosacea in adults, which is a tremendous milestone for Fortress and our partner company, Journey Medical Corporation ("Journey Medical"). This marks the first FDA approval across the Fortress portfolio, and demonstrates our ability to successfully in-license a clinical stage program and develop it through commercialization. We could achieve up to two more U.S. FDA approvals in the next nine months, and our next anticipated PDUFA goal date is December 28, 2024, for cosibelimab, an anti-PD-L1 antibody, for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC"). We have an exciting late-stage pipeline with many upcoming value creation opportunities, and we are focused on attaining our long-term strategy of building shareholder value, while bringing innovative treatment options to patients with unmet medical needs."

Recent Corporate Highlights1:

Regulatory Updates

● In November 2024, the FDA approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg), also known as DFD-29. Emrosi has the potential to be the new treatment paradigm for the millions of patients suffering from inflammatory lesions of rosacea. The treatment is expected to launch late in the first quarter or early in the second quarter of 2025 by our partner company, Journey Medical (Nasdaq: DERM).
● In July 2024, the FDA accepted the Biologics License Application ("BLA") resubmission for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation and set a PDUFA goal date of December 28, 2024. Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics (Nasdaq: CKPT) ("Checkpoint").

● In December 2023, we completed the asset transfer of CUTX-101 (copper histidinate for Menkes disease) to Sentynl Therapeutics ("Sentynl"), a wholly owned subsidiary of Zydus Lifesciences Ltd. Sentynl completed the rolling submission of the New Drug Application for CUTX-101 in the fourth quarter of 2024. Cyprium Therapeutics ("Cyprium"), our subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.

Clinical Updates

● In October 2024, clinical data were presented at the 44th Fall Clinical Dermatology Conference assessing the dermal and systemic pharmacokinetics of Emrosi versus oral doxycycline 40 mg capsules (Oracea) in healthy subjects. With its extended-release formulation, Emrosi provides higher dermal concentration than doxycycline from day 1 onward at a similar dose, expected to translate into a clinically meaningful impact for treating patients with rosacea, and as demonstrated in Emrosi’s Phase 3 clinical trials.
● In September 2024, we presented longer-term data from our pivotal trial of cosibelimab in locally advanced and metastatic cSCC during the European Society for Medical Oncology ("ESMO") Congress 2024. The longer-term results for cosibelimab demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses.

Other Updates

● In July 2024, we announced a collaboration to explore the combined therapeutic potential of cosibelimab with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer ("CIK") T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells.
● Also in July 2024, our majority owned and controlled subsidiary company, Urica Therapeutics ("Urica"), entered into an asset purchase agreement, royalty agreement and related agreements with Crystalys Therapeutics ("Crystalys"). Urica transferred rights to dotinurad, its URAT1 inhibitor product candidate in development for the treatment of gout, and related intellectual property, licenses and agreements to Crystalys. In return, Crystalys issued to Urica shares of its common stock equal to 35% of Crystalys’ outstanding equity and granted Urica a securitized 3% royalty on future net sales of dotinurad.

Commercial Product Updates

● Journey Medical’s net product revenues for the third quarter ended September 30, 2024 were $14.6 million, compared to net product revenues of $14.9 million for the second quarter ended June 30, 2024.

General Corporate:

● In July 2024, Checkpoint raised $12 million in a registered direct offering priced at-the-market under Nasdaq rules.
● In July 2024, Fortress’ Board of Directors paused the payment of dividends on the Company’s 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (the "Series A Preferred Stock") until further notice. The Company believes pausing the dividend is in the best interest of the Company and its stakeholders to maintain financial flexibility ahead of potentially significant inflection points. Dividends on the Series A Preferred Stock accrue in accordance with their terms; the pausing of these dividends will defer approximately $0.7 million in cash dividend payments each month. The Board intends to revisit its decision regarding the monthly dividend regularly and will assess the profitability and cash flow of the Company to determine whether and when the suspension should be lifted.
● Also in July 2024, Fortress reduced its total debt by entering into a new loan agreement maturing in July 2027 with funds managed by Oaktree Capital Management, L.P. ("Oaktree"), a leading global investment firm. The Company received an initial tranche of $35 million and is eligible to draw an additional $15 million with Oaktree’s consent. In connection with the new loan agreement, the Company repaid its prior term loan with Oaktree of $50 million resulting in an outstanding debt reduction of approximately $15 million of debt excluding accrued interest and prepayment fees.

● In September 2024, Fortress raised $8 million in a registered direct offering and concurrent private placements.
● In October 2024, Mustang Bio raised $4 million in gross proceeds from the exercise of existing warrants.
● In November 2024, Checkpoint received $9.2 million in gross proceeds through the exercise of existing warrants.
Financial Results:

● As of September 30, 2024, Fortress’ consolidated cash and cash equivalents totaled $58.9 million, compared to $76.2 million as of June 30, 2024, and compared to $80.9 million as of December 31, 2023, a decrease of $17.3 million during the quarter and a decrease of $22.0 million year-to-date.
● Fortress’ consolidated cash and cash equivalents, totaling $58.9 million as of September 30, 2024, includes $25.6 million attributable to Fortress and the private subsidiaries, $2.6 million attributable to Avenue, $4.7 million attributable to Checkpoint, $3.5 million attributable to Mustang Bio and $22.5 million attributable to Journey Medical.
o Fortress’ consolidated cash and cash equivalents totaled $80.9 million as of December 31, 2023, which included $40.6 million attributable to Fortress and private subsidiaries, $1.8 million attributable to Avenue, $4.9 million attributable to Checkpoint, $6.2 million attributable to Mustang Bio and $27.4 million attributable to Journey Medical.
● Fortress’ consolidated net revenue totaled $14.6 million for the third quarter ended September 30, 2024, all of which was generated from our marketed dermatology products. This compares to consolidated revenue totaling $34.8 million for the third quarter of 2023, which included $15.3 million in revenue generated from our marketed dermatology products and an upfront license agreement payment of $19 million.
● Consolidated research and development expenses including license acquisitions totaled $9.4 million for the third quarter ended September 30, 2024, compared to $20.3 million for the third quarter ended September 30, 2023.
● Consolidated selling, general and administrative costs were $22.0 million for the third quarter ended September 30, 2024, compared to $21.7 million for the third quarter ended September 30, 2023.
● Consolidated net loss attributable to common stockholders was $(15.0) million, or $(0.76) per share, for the third quarter ended September 30, 2024, compared to net loss attributable to common stockholders of $(7.1) million, or $(0.94) per share for the third quarter ended September 30, 2023.

On November 14, 2024 Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with cancer and chronic immune-related diseases, reported financial results for the quarter ended September 30, 2024 and provided recent business highlights (Press release, Shattuck Labs, NOV 14, 2024, View Source [SID1234648414]).

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"Last month we announced a strategic shift to focus on the development of SL-325, a first-in-class DR3 blocking antibody designed to achieve a more complete blockade of the clinically validated TL1A/DR3 signaling pathway. We are underway with IND-enabling, non-human primate studies to evaluate the safety, pharmacokinetic and pharmacodynamic profile of SL-325," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "As of this month, we have substantively completed our restructuring plans to focus on the development of SL-325 and are well-positioned to fund our planned operations into 2027."

Upcoming Events

•Shattuck plans to attend the following investor conferences. Details will be included on the Events & Presentations section of the Company’s website.
◦Piper Sandler & Co. 36th Annual Healthcare Conference (New York City, NY), December 3–5, 2024. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs will participate in a presentation on December 3, 2024.
◦Evercore ISI 7th Annual HealthCONx Conference (Miami, FL), December 3–5, 2024. The Company’s management will participate in a fireside chat on December 4, 2024.

Third Quarter 2024 Financial Results

•Cash and Cash Equivalents and Investments: As of September 30, 2024, cash and cash equivalents and investments were approximately $90.1 million, as compared to $101.1 million as of September 30, 2023.
•Research and Development (R&D) Expenses: R&D expenses were $16.3 million for the quarter ended September 30, 2024, as compared to $24.2 million for the quarter ended September 30, 2023.
•General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the quarter ended September 30, 2024, as compared to $5.1 million for the quarter ended September 30, 2023.
•Net Loss: Net loss was $16.7 million for the quarter ended September 30, 2024, or $0.33 per basic and diluted share, as compared to a net loss of $27.5 million for the quarter ended September 30, 2023, or $0.65 per basic and diluted share.

Financial Guidance

Shattuck has effectuated its restructuring plan to prioritize the development of the DR3 program and align the Company’s cost and workforce structure with the its current goals and clinical development strategy. The Company has substantially completed the reduction in force associated with the discontinuation of SL-172154.

Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its planned operations into 2027, beyond results from its Phase 1 clinical trial of SL-325. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from potential business development transactions, and/or additional costs associated with additional development activities that may be undertaken.

About SL-325

SL-325 is a first-in-class Death Receptor 3 (DR3) antagonist antibody designed to achieve a more complete blockade of the clinically validated TL1A/DR3 pathway. Shattuck’s preclinical studies demonstrate high affinity binding, superior efficacy over TL1A antibodies, and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. SL-325 is currently being evaluated in a GLP toxicology study in non-human primates, with an IND filing expected in the third quarter of 2025.

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 [SID1234648399]).

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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.