Financial Performance - As of March 31, 2024, the company had cash and cash equivalents of approximately $8.2 million and an accumulated deficit of approximately $32.8 million[105]. - The company incurred net losses of approximately $8.5 million for the three months ended March 31, 2024, compared to $2.4 million for the same period in 2023, representing an increase of 253%[105][121]. - The total operating expenses for the three months ended March 31, 2024, were $3.45 million, an increase of $1.19 million from $2.27 million in the same period in 2023[121]. - General, administrative and other expenses increased to $2.5 million for the three months ended March 31, 2024, compared to $1.8 million for the same period in 2023, reflecting a $0.7 million increase primarily due to changes in fair value of liability instruments[124]. - Net cash used in operating activities was $4.3 million for the three months ended March 31, 2024, compared to $2.0 million for the same period in 2023, driven by net losses of $8.5 million[133]. - Net cash provided by financing activities was approximately $3.3 million for the three months ended March 31, 2024, compared to $14.6 million for the same period in 2023[135]. - The effective income tax rate was 0.0% for all periods, with a full valuation allowance recorded against net deferred tax assets[129]. - The company has incurred operating losses and negative cash flows since inception, raising substantial doubt about its ability to continue as a going concern[138]. Research and Development - Research and development expenses increased to $1.0 million for the three months ended March 31, 2024, from $0.5 million in the same period in 2023, reflecting a 100% increase[123]. - The company plans to initiate a Phase 1/2 clinical trial for CYWC628 in Australia in 2025, with results expected in the third quarter of 2025[99]. - In pre-clinical studies, CYWC628 demonstrated an 83.8% reduction in wound area after the fourth administration compared to a 55.2% reduction for the untreated saline control group, indicating statistically significant improvement[108]. - The company has received IND clearance from the FDA for CybroCell™ to conduct a Phase 1 study for patients with degenerative disc disease[101]. - Future funding requirements will depend on the progress and costs associated with clinical trials and regulatory approvals for product candidates[139]. Funding and Revenue - The company expects to incur significant losses for the foreseeable future and will require substantial additional funding to support its operations and growth strategy[106][107]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[113]. - The company has no products approved for sale and does not expect to generate meaningful revenue until regulatory approval is obtained for current or future product candidates[136]. Commitments and Obligations - Material contractual obligations include future minimum lease payments under non-cancellable leases totaling approximately $1.9 million as of March 31, 2024[142]. - The commitment fee expense was $1.9 million for the three months ended March 31, 2024, with a $2 million fee becoming payable to GEM upon completion of the Direct Listing in January 2024[125]. Operational Plans - The company plans to complete a technology transfer of its cell manufacturing processes to a CDMO by the end of 2024[112].
FibroBiologics(FBLG) - 2024 Q1 - Quarterly Report