On August 11, 2023 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform, reported financial results for the second quarter ended June 30, 2023 (Press release, IO Biotech, AUG 11, 2023, View Source [SID1234634274]).
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"We have made a great deal of progress during the first half of the year in the development of our novel, investigational immune-modulating cancer vaccine, IO102-IO103," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "We have achieved the important recruitment milestone of having enrolled 225 patients in our pivotal Phase 3 trial for patients with advanced melanoma. We now look forward to the interim analysis which, per the protocol, is to be conducted one year after 225 patients have been randomized. If the data from this interim analysis are supportive, we anticipate submitting a Biologics License Application for accelerated approval in the US. We are continuing to see enrollment in this trial accelerate and remain on track to reach full enrollment by the end of this year. We continue to be encouraged by the strong interest from investigators and patients in our clinical studies."
Dr. Zocca continued, "With a very strong balance sheet and executives now hired into critical roles, we are well prepared for the key activities necessary to continue progressing our lead candidate cancer vaccine, IO102-IO103, towards the market. I look forward to a very productive second half of the year."
Second Quarter 2023 and Recent Business Highlights:
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In June 2023, the company achieved a significant recruitment milestone of having enrolled 225 patients in its Phase 3 ‘IOB-013/KN-D18’ trial. The Phase 3 trial protocol calls for an interim analysis of the overall response rate one year after 225 patients have been enrolled. If the data are supportive, this interim analysis could allow for submission of a Biologics License Application for accelerated approval in the US.
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Full enrollment for the Phase 3 IOB-013/KN-D18 trial was increased from 300 to 380 patients with the aim of accelerating the time to reach the primary endpoint of progression free survival (PFS). The company expects the trial to be fully enrolled with 380 patients by the end of 2023.
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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, recurrent or metastatic head and neck cancer continued enrolling patients. The company will be closing the metastatic bladder cancer cohort of this basket trial due to the changing treatment landscape in this indication and the possibility of further exploring the safety and efficacy of IO Biotech products in this indication in a separate IIT. Data from the lung cohort of this basket trial will be presented in a mini oral presentation at the IASLC 2023 World Conference on Lung Cancer (WCLC) in September 2023 and in a poster presentation at the ESMO (Free ESMO Whitepaper) Congress in October 2023.
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Three of five investigator-initiated trials (IITs) that the company is supporting have recently started enrolling patients. These three IITs include: (1) a Phase 1 trial to investigate IO102-IO103 in combination with pembrolizumab for BCG-unresponsive or intolerant, non-muscle invasive bladder cancer (NMIBC), (NCT05843448); (2) the Phase 2 KIEO (Keytruda-IO102-IO103 Extended-pre-Operative) trial to investigate neoadjuvant pembrolizumab and IO102-IO103 prior to curative-intent surgical care for squamous cell carcinoma of the head and neck (SCCHN), (NCT05977907); and (3) a Phase 2 trial evaluating IO102-IO103 and a fixed-dose combination of nivolumab-relatlimab in treatment-naïve patients with unresectable Stage III/IV melanoma, (NCT05912244).
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The company strengthened its executive team with the appointments of Christine Richter, PhD, MBA, as Senior Vice President, Commercial and Program Lead; Qasim Ahmad, MD, as Chief Medical Officer; and the promotion of Eric Faulkner from Sr. Vice President, CMC to Chief Technical Officer.
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The Company appointed Heidi Hunter to its Board of Directors.
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On August 7, 2023, the company entered into a definitive securities purchase agreement. Under the securities purchase agreement, the investors have agreed to purchase 37,065,647 shares of the company’s common stock and accompanying warrants to purchase up to an aggregate of 37,065,647 shares of common stock, at a combined purchase price of $2.025 per share and accompanying warrant. Each accompanying warrant will represent the right to purchase one share of the company’s common stock at an exercise price of $2.47 per share. The warrants will be exercisable for a period of three years and six months following the date of issuance.
Second Quarter 2023 Financial Results
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Net loss for the three months ended June 30, 2023 was $21.2 million, compared to $18.5 million for the three months ended June 30, 2022.
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Research and development expenses were $16.5 million for the three months ended June 30, 2023, compared to $12.2 million for the three months ended June 30, 2022. The increase was primarily related to clinical trial-related activities for our IO102-IO103 product candidate, including the continued execution of our Phase 3 clinical trial. The Company recognized $0.9 million in research and development equity-based compensation for the three months ended June 30, 2023, compared to $0.5 million for the three months ended June 30, 2022.
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General and administrative expenses were $5.3 million for the three months ended June 30, 2023, compared to $5.9 million for the three months ended June 30, 2022. The decrease was related to lower professional services and consulting costs, offset by an increase in headcount. The Company recognized $0.7 million in general and administrative equity-based compensation for the three months ended June 30, 2023, compared to $0.8 million for the three months ended June 30, 2022.
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Cash and cash equivalents as of June 30, 2023 were $110.1 million, compared to $142.6 million at December 31, 2022. During the three months ended June 30, 2023, the Company used cash, cash equivalents and restricted cash of $18.3 million from operating and investing activities with an additional decrease of $0.1 million in cash due to the effects of foreign currency exchange rates.
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Cash on hand is expected to support operations into the fourth quarter of 2025.
Upcoming events
Morgan Stanley 21st Annual Global Healthcare Conference. New York City. September 11-13, 2023. Dr. Zocca and Ms. Sullivan will participate in a fireside chat and one-on-one meetings on Tuesday, September 12.
H.C. Wainwright 25th Annual Global Investment Conference. New York City. September 11-13, 2023. Dr. Zocca will present a corporate overview and Dr. Zocca and Ms. Sullivan will participate in one-on-one meetings on Wednesday, September 13.
A live audio webcast of each presentation will be available on the Investors section of the IO Biotech website at www.iobiotech.com. A webcast replay of the presentations will be available on IO Biotech’s website for 90 days following the presentation.
IASLC 2023 World Conference on Lung Cancer (WCLC). Singapore, September 9-12, 2023. One abstract has been accepted for a Mini Oral presentation.
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Abstract Title: Ph 2 Trial of IO102-IO103 Vaccine Plus Pembrolizumab: Preliminary Results for the First-line Treatment of Lung Adenocarcinoma
Session: MA15—Bringing New Discoveries into Early Phase Clinical Trials
Session Date & Time: September 12, 2023 at 10:45 AM—11:45 AM
Presenter: Jonathan Riess, MD
ESMO Congress 2023. Madrid, October 20-24, 2023. One abstract has been accepted for a poster presentation.
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Abstract Title: A Phase 2 trial of the IO102-IO103 vaccine plus pembrolizumab: preliminary analysis for first line (1L) treatment of Non-Small Cell Lung Cancer (NSCLC) and Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Presentation number: 1038P
Presenter: Jonathan Riess, MD
About IO102-IO103
IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1. The company is currently conducting a Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, and a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709).
About the IOB-013/KN-D18 Phase 3 Clinical Trial
IOB-013/KN-D18 (NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment is 380 patients from centers spread across the United States, Europe, Australia, Israel and South Africa. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains full global commercial rights to IO102-IO103.
About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial
IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line advanced cancers: non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial bladder cancer (UBC). The clinical trial is sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.