Business
Half-year Report
Half-year Report.
About this update from Ondine Biomedical, Inc.
[{"type":"text","content":"\n\n25 September 2023\nONDINE BIOMEDICAL INC.\n \n(\"Ondine Biomedical\", \"Ondine\" or the \"Company\")\n \nInterim results for the six months to 30 June 2023\n \nSignificant operational progress\n \nOndine Biomedical Inc (AIM: OBI), the Canadian life sciences company developing non-antibiotic photodisinfection therapies to prevent and treat healthcare-associated and drug-resistant infections announces its unaudited results for the six months that ended 30 June 2023 and provides an update on commercial progress in approved markets and next steps for its planned Phase 3 study being finalised to seek US regulatory approval.\n \n Unless otherwise specified, all financial figures throughout this interim report are in Canadian dollars.\n \nOperating results for the first half year were in line with management expectations despite a challenging economic backdrop and unfavorable stock markets which contributed to the deferral of 2023 fundraising plans. The Company has made solid progress toward its two key 2023 corporate objectives:\n· Preparing for the upcoming Phase 3 clinical study-a critical component for US market approval of the Company's nasal photodisinfection. ( Steriwave)\n· Advancing commercial efforts and geographic footprint into the Canadian, British, Spanish, and Mexican markets.\n \nFinancial highlights\n· Loss from operations in H1 2023 of $8.03 million (H1 2022: $8.41 million), a 7% loss decrease year-over-year. This loss largely comprises the costs associated with clinical and regulatory efforts for the US market, public company-related costs, and expanding commercialization reach.\n· Total revenues in H1 2023 were $0.43 million (H1 2022: $0.26 million) a 63% increase during the period, reflecting the additional hospital clinical deployments.\n· Cash, cash equivalents and restricted cash of $4.59 million as at 30 June 2023 (31 December 2022: $13.27 million).\n \nOther advances (including post-period) \nI. Clinical & regulatory\n· Submission of pivotal Phase 3 file to FDA for review.\n· Review meeting held with the FDA on September 22, 2023 confirmed that the Company has satisfied the FDA's pre-clinical and saf...