On November 13, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the third quarter ended September 30, 2023 (Press release, Leap Therapeutics, NOV 13, 2023, View Source [SID1234637546]).

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"Leap continued to make great strides this quarter including advancing into the 130 patient, randomized controlled Part B of the DeFianCe study evaluating DKN-01 plus bevacizumab and chemotherapy in second-line colorectal cancer, after exceeding our 20% overall response rate threshold in Part A. We are excited by the progress made and plan on presenting new data from Part A at a medical conference in January 2024," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "In addition, we’re focused on executing the DisTinGuish study evaluating DKN-01 plus tislelizumab and chemotherapy in first-line gastric cancer, and we expect to complete enrollment into the 160-patient, randomized controlled Part C of the trial this quarter."

DKN-01 Development Update

● Updated data from Part A of the DeFianCe Study of DKN-01 plus bevacizumab and chemotherapy in colorectal cancer patients to be presented at a medical conference in January 2024. The Company expects to present new long-term follow-up data from Part A of the DeFiance study (NCT05480306), a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced colorectal cancer who have received one prior systemic therapy for advanced disease. Initial results from Part A indicated an overall response rate (ORR) above 20% with a high disease control rate, which exceeded the benchmarks expected for this population. Subsequently, the study expanded into a 130-patient Part B randomized controlled trial.

● Part C of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients is ongoing and enrollment is expected to be completed by the end of 2023. The DisTinGuish study (NCT0436380) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma. The Company previously presented long-term follow-up data from Part A of the study in June 2023, showing 73% ORR in the modified intent-to-treat population, and 85% ORR in the PD-L1 low-subgroup. The data also demonstrated 19.5 months median overall survival and 11.3 months median progression-free survival.

Selected Third Quarter 2023 Financial Results

Net Loss was $13.7 million for the third quarter 2023, compared to $15.1 million for the same period in 2022. The decrease was primarily due to decreased research and development expenses and increased interest income.

Research and development expenses were $11.5 million for the third quarter 2023, compared to $12.1 million for the same period in 2022. The decrease in research and development expenses was primarily due to a decrease of $2.5 million in manufacturing costs related to clinical trial material and manufacturing campaigns. This decrease was partially offset by an increase of $1.1 million in clinical trial costs and an increase of $0.8 million in payroll and other related expenses due to an increase in headcount of our research and development full-time employees.

General and administrative expenses were $3.3 million for the third quarter 2023, compared to $3.2 million for the same period in 2022. The increase in general and administrative expenses was primarily due to an increase of $0.1 million in payroll and other related expenses due to an increase in headcount of our general and administrative full-time employees.

Cash and cash equivalents totaled $80.7 million at September 30, 2023. Research and development incentive receivables totaled $0.8 million at September 30, 2023.

On November 13, 2023 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and third-quarter 2023 financial results (Press release, Kronos Bio, NOV 13, 2023, View Source [SID1234637545]).

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"This quarter, we made great strides in advancing our clinical programs as well as our discovery projects and Genentech collaboration," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "At the AACR (Free AACR Whitepaper)-NCI-EORTC and CTOS conferences we shared KB-0742 data that demonstrated on-mechanism, single agent anti-tumor activity in pre-treated patients with transcriptionally addicted solid tumors. We are encouraged by the strong investigator interest in KB-0742, and the potential impact of this positive preliminary efficacy data and manageable safety profile for patients."

Dr. Bischofberger continued, "With our resource optimization and extended cash runway, I’m confident that we are well positioned to deliver on our mission to bring forward new and innovative therapies for difficult-to-treat cancers. Our team is committed to realizing the potential of drugging transcription in cancer."

Third Quarter and Recent Company Updates

•Corporate update
◦On November 2, 2023, Kronos Bio announced its plan to optimize its resource allocation, restructure, and contain costs in light of the positive preliminary safety and efficacy clinical data from its Phase 1/2 study of KB-0742.
◦This plan positions the company to maximize the potential of KB-0742 while continuing to advance the development of lanraplenib, currently in the dose escalation portion of a Phase 1b/2 study.
◦The company will also focus its discovery efforts on maturing projects and its Genentech collaboration activities.
◦Kronos Bio expects that these efforts, which include a 19% reduction in force, will extend its cash runway into 2026.

•KB-0742
◦Kronos Bio presented positive preliminary data from the phase 1 dose escalation portion of the ongoing phase 1/2 KB-0742 study at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference in October and at the Connective Tissue Oncology Society Annual Meeting in

November, where it also presented corresponding data from the pre-clinical mechanistic studies.
◦KB-0742 demonstrated on-mechanism, single agent anti-tumor activity and a manageable safety profile in pre-treated patients with transcriptionally addicted solid tumors.
◦Enrollment in two expansion cohorts is ongoing, including Cohort A for patients with MYC-dependent tumors, such as triple negative breast cancer, non-small cell lung cancer and ovarian cancer, and Cohort B for patients with transcription factor fusion-driven cancers and other transcriptionally addicted cancers, including chordomas, sarcomas and small cell lung cancer.
◦The Company plans to share data from both the ongoing dose escalation, beyond the 60 mg dose, and from the expansion portions of the Phase 1/2 KB-0742 study, in mid-2024.

•Lanraplenib
◦Lanraplenib is currently in the dose escalation portion of a Phase 1b/2 trial in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia.
◦Three patients have cleared the 28-day safety window at each of the 20 mg, 40 mg and 60 mg dose levels.
◦The Company is now enrolling at the 90 mg dose. To better understand safety, PK and PD, and to accommodate investigator and patient interest, additional patients may be enrolled at dose levels below 90 mg.
◦Kronos Bio anticipates announcing the recommended expansion phase dose in Q4 2023/Q1 2024 and plans to share data from the phase 1b/2 study in mid-2024.

Third Quarter 2023 Financial Highlights

•Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $198.4 million in cash, cash equivalents and investments as of September 30, 2023, the Company reiterates its expected cash runway into 2026.

•R&D Expenses: Research and development expenses were $25.3 million for the third quarter of 2023, which includes non-cash stock-based compensation expense of $3.2 million.

•G&A Expenses: General and administrative expenses were $9.4 million for the third quarter of 2023, which includes non-cash stock-based compensation expense of $3.1 million.

•Net Loss: Net loss for the third quarter of 2023 was $31.4 million, or $0.54 per share, including non-cash stock-based compensation expense of $6.3 million.

On November 13, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal first quarter ended September 30, 2023 and provided a corporate update (Press release, Kintara Therapeutics, NOV 13, 2023, View Source [SID1234637543]).

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RECENT CORPORATE DEVELOPMENTS

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Announced that preliminary topline results from the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study showed that VAL-083 did not perform better than the current standards of care in glioblastoma. These topline results included preliminary safety data for VAL-083 that was similar to that of the current standards of care used to treat glioblastoma. With this study outcome, Kintara is suspending the development of VAL-083 and turning its focus to its second program, REM-001. In addition to focusing on its REM-001 program, Kintara will evaluate a wide range of strategic options aimed at potentially maximizing shareholder value. (October 2023)
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Awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent for the treatment of cutaneous metastatic breast cancer (CMBC). (June 2023)

"We are looking forward to enrolling the first patient in our 15 patient REM-001 study for cutaneous metastatic breast cancer, a disease with little or no current treatment options" commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "The majority of study expenses will be covered by the $2 million National Institutes of Health grant we were awarded to support the further development of REM-001. We have undertaken efforts to significantly cut costs and are continuing to evaluate strategic options with the goal of maximizing shareholder value."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 FIRST QUARTER ENDED SEPTEMBER 30, 2023

As of September 30, 2023, Kintara had cash and cash equivalents of approximately $0.2 million. In November 2023, the Company has received net proceeds of approximately 1.0 million from the sale of common stock, primarily from its at-the-market (ATM) facility.

For the three months ended September 30, 2023, Kintara reported a net loss of approximately $3.0 million, or $1.83 per share, compared to a net loss of approximately $4.6 million, or $3.39 per share, for the three months ended September 30, 2022. The decreased net losses for the three months ended September 30, 2023 compared to the three months ended September 30, 2022 was largely due to lower research and development expenses, primarily lower clinical development costs. General and administrative costs were also lower during the same period primarily due to reduced level of staffing.

On November 13, 2023 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, reported financial results for the third quarter ended September 30, 2023 and provided a business update (Press release, Kezar Life Sciences, NOV 13, 2023, View Source [SID1234637542]).

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"During the third quarter, we made important progress in streamlining our operations and sharpening our focus on the zetomipzomib and KZR-261 programs," said Christopher Kirk, Ph.D., co-founder and Chief Executive Officer of Kezar. "Our progress has been bolstered by a strategic collaboration and license agreement with Everest Medicines to develop and commercialize zetomipzomib in China, South Korea and Southeast Asia. Looking ahead, our strategic realignment and strong balance sheet provide cash runway to reach and extend beyond important clinical inflection points over the next three years for both our immunology and oncology programs."

Corporate Update

Christopher Kirk, Ph.D. was appointed and began serving as Kezar’s Chief Executive Officer on November 7, 2023. Dr. Kirk is a co-founder and member of the Board of Directors and previously served as Kezar’s President and Chief Scientific Officer. John Fowler, co-founder and departing CEO, will continue serving as a member of the Board of Directors. In addition, Kezar recently announced a strategic restructuring to prioritize long-term growth and focus resources on its clinical-stage programs. Actions to prioritize clinical programs and implement cost saving measures are expected to extend Kezar’s cash runway into late 2026. These measures will focus resources on achieving important clinical data readouts for zetomipzomib in lupus nephritis (LN) and autoimmune hepatitis and KZR-261 in solid tumors. All research and drug discovery activities have been paused, and Kezar is exploring strategic alternatives for its protein secretion platform and preclinical programs. Kezar anticipates initial data from its KZR-261 Phase 1 clinical trial in 2024, topline data from its PORTOLA Phase 2a clinical trial in mid-2025 and topline data from its PALIZADE Phase 2b clinical trial mid-2026.

Zetomipzomib: Selective Immunoproteasome Inhibitor

Collaboration with Everest Medicines:

In September 2023, Kezar entered into a collaboration and license agreement with Everest Medicines to develop and commercialize zetomipzomib in Greater China, South Korea and Southeast Asia. Everest Medicines is joining Kezar on PALIZADE, a global, placebo-controlled Phase 2b clinical trial evaluating zetomipzomib in patients with active LN, and will contribute their local regulatory and clinical trial expertise to potentially accelerate enrollment in these geographies. In addition to PALIZADE, Kezar and Everest Medicines have the opportunity to collaborate on future clinical trials and indications for the continued development of zetomipzomib.

Clinical Development:

PALIZADE – Phase 2b clinical trial of zetomipzomib in patients with active LN (ClinicalTrials.gov: NCT05781750)

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PALIZADE is a global, placebo-controlled, randomized, double-blind Phase 2b clinical trial evaluating the efficacy and safety of two dose-levels of zetomipzomib in patients with active LN. Target enrollment will be 279 patients, randomly assigned (1:1:1) to receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or placebo subcutaneously once weekly for 52 weeks, in addition to standard background therapy. Background therapy can, but will not be mandated to, include standard induction therapy. Over the initial 16 weeks, there will be a mandatory corticosteroid taper to 5 mg per day or less. End-of-treatment assessments will occur at Week 53. The primary efficacy endpoint is the proportion of patients who achieve a complete renal response (CRR) at Week 37, including a urine protein-to-creatine ratio (UPCR) of 0.5 or less without receiving rescue or prohibited medications.
PORTOLA – Phase 2a clinical trial of zetomipzomib in patients with autoimmune hepatitis (AIH) who have not benefited from standard-of-care treatment (ClinicalTrials.gov: NCT05569759)

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PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed. Target enrollment will be 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background corticosteroid therapy for 24 weeks, with a protocol-mandated steroid taper by Week 14. The primary efficacy endpoint will measure the proportion of patients who achieve a complete response measured as normalization of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels with a successful corticosteroid taper by Week 24.
PRESIDIO Open-Label Extension (OLE) – Dr. Rohit Aggarwal, M.D., an investigator at the University of Pittsburgh, will present results from the OLE portion of the Phase 2 PRESIDIO trial in patients with dermatomyositis (DM) and polymyositis (PM) showing zetomipzomib demonstrates long-term safety and tolerability without signs of immunosuppression at the upcoming American College of Rheumatology (ACR) Convergence 2023, which is taking place November 10 – 15, 2023, in San Diego, Calif.

MISSION – Kezar will present an encore poster presentation of the results from the open-label Phase 2 MISSION trial of zetomipzomib in LN at the upcoming 25th Asia-Pacific League of Associations for Rheumatology (APLAR) Congress, which is taking place December 7 – 11, 2023 in Thailand.

KZR-261: Broad-SpectrumSec61 Translocon Inhibitor

KZR-261-101 – Phase 1 clinical trial of KZR-261 in patients with locally advanced or metastatic solid malignancies (ClinicalTrials.gov: NCT05047536)

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The Phase 1 clinical trial of KZR-261 is being conducted in two parts: dose escalation and dose expansion in tumor-specific solid tumors. The study is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, identify a recommended Phase 2 dose and to explore the preliminary anti-tumor activity of KZR-261 in patients with locally advanced or metastatic disease.
•
The KZR-261 trial is currently enrolling Cohort 8 (60 mg/m2). Previously, Cohort 1 (1.8 mg/m2) through Cohort 7 (40 mg/m2) enrolled a total of 29 patients and completed rapid dose escalation without significant safety concerns.
•
To date, KZR-261 has shown dose-proportional exposure and no signs of accumulation or altered pharmacokinetics with repeated dosing.
Protein Secretion Platform

Kezar presented results around the quantitative proteomic profiling of KZR-540, an oral small molecule inhibitor that selectively blocks PD-1 expression via inhibition of the Sec61 translocon, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting which took place November 1– 5, 2023 in San Diego, CA. KZR-540 demonstrates that the Sec61 translocon can be selectively inhibited for specific anti-tumor effects and validates Sec61 inhibition as a platform for selective down-regulation of high-value targets. The poster presentation was made by David Bade, Ph.D., Senior Scientist at Kezar.

Financial Results

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Cash, cash equivalents and marketable securities totaled $218.2 million as of September 30, 2023, compared to $276.6 million as of December 31, 2022. The decrease was primarily attributable to cash used in operations to advance clinical-stage programs and preclinical research and development.
•
Revenue for the third quarter of 2023 was $7.0 million resulting from the upfront payment under the collaboration and license agreement with Everest Medicines.
•
Research and development expenses for the third quarter of 2023 increased by $9.8 million to $23.7 million compared to $13.9 million in the third quarter of 2022. This increase was primarily due to advancing the zetomipzomib clinical program in multiple indications and the KZR-261 clinical program and an increase in compensation and personnel related expenses, including non-cash stock-based compensation expense, as a result of an increase in headcount.
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General and administrative (G&A) expenses for the third quarter of 2023 increased by $3.7 million to $8.8 million compared to $5.1 million in the third quarter of 2022. The increase was primarily due to an increase in legal and professional service expense in connection with the collaboration and license agreement with Everest and an increase in compensation and personnel related expenses, including non-cash stock-based compensation, as a result of an increase in headcount.
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Net loss for the third quarter of 2023 was $23.1 million, or $0.32 per basic and diluted common share, compared to a net loss of $17.8 million, or $0.25 per basic and diluted common share, for the third quarter of 2022.
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Total shares of common stock outstanding were 72.7 million shares as of September 30, 2023. Additionally, there were options to purchase 13.3 million shares of common stock at a weighted-average exercise price of $2.76 per share and 0.3 million restricted stock units outstanding as of September 30, 2023.

On November 13, 2023 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win technology platform, reported financial results for the third quarter ended September 30, 2023 (Press release, IO Biotech, NOV 13, 2023, View Source [SID1234637541]).

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"Our focus for 2023 has been to successfully execute multiple clinical trials for our novel, investigational therapeutic cancer vaccine, IO102-IO103. We recently achieved several milestones, completion of enrollment in our pivotal Phase 3 trial in patients with advanced melanoma, the presentation of encouraging preliminary data from the Phase 2 basket trial of IO102-IO103 at WCLC and ESMO (Free ESMO Whitepaper), and expanding into earlier stages of melanoma treatment with the initiation of an additional Phase 2 basket study in the neoadjuvant/adjuvant setting," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "With our strengthened balance sheet as a result of our $75 million private placement and key additions to both our management team and board of directors, we are in a strong position as we work diligently to bring our lead therapeutic cancer vaccine candidate, IO102-IO103, toward the market, potentially as early as 2025."

Recent Business Highlights and Anticipated Milestones

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The company completed enrollment of 380 patients in its pivotal Phase 3 trial (IOB-013/KN-D18) in November 2023. The primary endpoint of the pivotal Phase 3 trial is progression free survival (PFS). The PFS analysis is event-driven and will be conducted when 226 events have occurred in the trial, which the company estimates will take place in the second half of 2025. Additionally, there is a per-protocol interim analysis of overall response rate (ORR) planned when the first 225 randomized patients reach one year of treatment in June 2024. The outcome of this analysis is expected in the third quarter of 2024.

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The Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer, or recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) also continued to enroll patients. Encouraging preliminary data from this basket trial were presented at the IASLC 2023 World Conference on Lung Cancer (WCLC) in September 2023 and at the ESMO (Free ESMO Whitepaper) Congress in October 2023. [https://bit.ly/3uhelje; https://bit.ly/3MxPWwg]

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The company presented three posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting. Non-clinical data presented demonstrate the clear impact of therapeutic vaccines targeting IDO1 and PD-L1 on several tumoral immune escape mechanisms in the tumor microenvironment leading to enhanced anti-tumor effect and support the clinical observations observed to date with the company’s lead therapeutic vaccine candidate, IO102-IO103. [https://bit.ly/469Lvyy]

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On August 7, 2023, the company completed a $75 million private placement with participation from both new and existing healthcare-dedicated investors, extending the company’s cash runway into the fourth quarter of 2025. [https://bit.ly/3QSyaXl]

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The company appointed a new member, Helen Collins, MD, to the company’s board of directors. Dr. Collins is currently the Chief Medical Officer at Enliven Therapeutics. Prior to joining Enliven, Helen served as Chief Medical Officer and Executive Vice President at Five Prime Therapeutics, a clinical-stage biotechnology company focused on oncology that was acquired by Amgen, Inc. She serves as a member of the board of directors of Kura Oncology. [Link to Press Release]

Third Quarter 2023 Financial Results

The company ended the third quarter with approximately $165.5 million in cash and cash equivalents, which is expected to fund the company’s operations into the fourth quarter of 2025.

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Net loss for the three months ended September 30, 2023, was $21.7 million, compared to $15.7 million for the three months ended September 30, 2022.

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Research and development expenses were $17.7 million for the three months ended September 30, 2023, compared to $10.0 million for the three months ended September 30, 2022. The increase was primarily related to clinical trial-related activities for our IO102-IO103 therapeutic vaccine candidate, including the continued execution of our Phase 3 clinical trial. The company recognized $2.1 million in research and development equity-based compensation for the three months ended September 30, 2023, compared to $1.0 million for the three months ended September 30, 2022.

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General and administrative expenses were consistent at $5.8 million for the three months ended September 30, 2023 and 2022, respectively. The company recognized $0.9 million in general and administrative equity-based compensation for the three months ended September 30, 2023, compared to $1.4 million for the three months ended September 30, 2022.

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Cash and cash equivalents as of September 30, 2023, were $165.5 million, compared to $142.6 million at December 31, 2022. During the three months ended September 30, 2023, the company used cash, cash equivalents and restricted cash of $16.0 million from operating and investing activities, obtained $71.9 million in estimated net cash proceeds from our private placement and incurred an additional decrease of $0.5 million in cash due to the effects of foreign currency exchange rates.

Upcoming Events

Jefferies London Healthcare Conference from November 14-16, 2023 in London. Mai-Britt Zocca, PhD, President and CEO, and Amy Sullivan, CFO, will participate in one-on-one meetings on Wednesday, November 15.

Piper Sandler 35th Annual Healthcare Conference from November 28-30, 2023 in New York. Dr. Zocca will present a corporate overview and Dr. Zocca and Ms. Sullivan will participate in one-on-one meetings on Wednesday, November 29.

About IO102-IO103

IO102-IO103 is an investigational immune-modulating therapeutic cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1). The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced non-small cell lung cancer and squamous cell cancer of the head and neck (SCCHN), and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) evaluating IO102-IO103 plus pembrolizumab as a perioperative treatment in solid tumors including melanoma and SCCHN.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.