On May 16, 2022 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported financial results for the quarter ended March 31, 2022 (Press release, IO Biotech, MAY 16, 2022, View Source [SID1234614642]).
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"During our first quarter and in recent weeks we continued to advance our promising pipeline of immune-modulating cancer therapies, highlighted by the initiation of our IOB-022 / KN-D38 Phase 2 Trial," said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. "This trial will evaluate IOB102-103 with KEYTRUDA (pembrolizumab) in previously untreated patients with three different tumor types in the first line setting, and we look forward to expanding our data set in these additional indications. We were also pleased to see the presentation of updated efficacy data and subgroup analyses from our MM1636 Phase 1/2 clinical trial evaluating IO102-IO103 as investigational agents in metastatic melanoma at the AACR (Free AACR Whitepaper) annual meeting in April. These data further demonstrate the three-year survival probability of 73% for 3% for IO102-IO103 in combination with nivolumab for these patients, and we are encouraged by the clinical activity demonstrated in this trial. As previously disclosed, we expect to provide guidance regarding the timing for the interim readout for our IOB-013/KN-D18 Phase 3 trial towards the middle of this year. We believe our platform and product candidates may represent a paradigm shift in the management of cancer, and with a solid balance sheet we have a substantial cash runway to carry us through multiple data readouts into mid-2024."
Highlights for First Quarter 2022 and Recent Weeks
Hosted Part 1 of Key Opinion Leader Webinar Series: A New Way to Kill Tumors–IO102-IO103 Phase 3 Trial in Combination with Anti-PD-1 in Advanced Melanoma
Announced initiation and dosing of first patient in Phase 2 IOB-022 / KN-D38 trial (NCT05077709)
New data from MM1636 Phase 1/2 Clinical Trial presented at 2022 AACR (Free AACR Whitepaper) Annual Meeting
Three-year Survival Probability of 73%
Subgroup analyses including patients with poor prognosis
David V. Smith Appointed to Board of Directors
First Quarter Financial Results
Net loss for the three months ended March 31, 2022 was $17.2 million, compared to $3.7 million for the quarter ended March 31, 2021.
Research and development expenses were $10.3 million for the three months ended March 31, 2022, compared to $2.8 million for the three months ended March 31, 2021. The increase of $7.5 million was primarily related to an increase in costs for chemistry, manufacturing and control, or CMC, activities of $2.3 million, an increase in personnel costs of $2.4 million primarily related to an increase in headcount and related recruiting costs and an increase in clinical trial-related activities for our IO102-IO103 product candidate, including the completion of our Phase 1/2 clinical studies, of $2.4 million.
General and administrative expenses were $6.7 million for the three months ended March 31, 2022, compared to $1.0 million for the three months ended March 31, 2021. The increase of $5.7 million was primarily related to an increase in professional services of $1.4 million related primarily to corporate legal fees and audit and tax fees and other consulting costs in support of our growth as well as an increase in personnel costs of $1.6 million primarily related to an increase in headcount and related recruiting costs and an increase in consultants and other costs of $2.7 million.
Cash and cash equivalents at March 31, 2022 were $187.9 million, compared to $211.5 million at December 31, 2021. Cash on hand is expected to support operations through anticipated data readouts into mid-2024.
About the IOB-013 / KN-D18 Clinical Trial
IOB-013 / KN-D18 (Clinical Trials.gov: 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 will be 300 patients from centers spread across Europe, Australia, and the United States. Biomarker analyses will also be conducted. IO Biotech will sponsor the Phase 3 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
About IOB-022 / KN-D38
IOB-022 / KN-D38 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 indications: NSCLC, SCCHN, and mUBC. The clinical trial will be sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.
About IO102-IO103
IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dehydrogenase (IDO) and PD-L1.