Fulcrum Therapeutics(US:FULC)2021-08-09 16:00Financial Performance - The company reported net losses of $19.6 million and $36.6 million for the three and six months ended June 30, 2021, respectively, compared to $15.7 million and $34.1 million for the same periods in 2020, with an accumulated deficit of $258.3 million as of June 30, 2021[133]. - Net loss for Q2 2021 was $19.6 million, compared to a net loss of $15.7 million in Q2 2020, reflecting an increase of $4.0 million[159]. - Net cash used in operating activities was $34.0 million during the six months ended June 30, 2021 compared to $29.3 million during the same period in 2020[180]. - Net cash used in investing activities was $13.9 million during the six months ended June 30, 2021, a decrease of $42.7 million compared to $56.6 million in the same period in 2020[181]. - Net cash provided by financing activities was $47.7 million for the six months ended June 30, 2021, down from $65.0 million for the same period in 2020[182]. - The company expects substantial operating losses and negative operating cash flows for the foreseeable future due to increased expenses related to research and development activities[183]. Cash and Funding - As of June 30, 2021, the company had $125.6 million in cash, cash equivalents, and marketable securities, expected to fund operations into Q1 2023[137]. - Existing cash, cash equivalents, and marketable securities of $125.6 million as of June 30, 2021, are projected to fund operating expenses into the first quarter of 2023[184]. - The company will rely on additional financing to achieve business objectives, with potential funding sources including equity offerings and debt financings[188]. - The company funded operations primarily with $357.0 million from various financing activities, including public offerings and collaboration agreements[174]. Research and Development - The Phase 2b ReDUX4 trial for losmapimod did not meet its primary endpoint, but showed clinically relevant benefits in secondary and exploratory endpoints at 48 weeks[117]. - In the ongoing Phase 1 clinical trial of FTX-6058, the 10 mg dose demonstrated a mean 4.5-fold induction in HBG mRNA and a mean 4.2-fold increase in F-reticulocytes at the safety follow-up, indicating increased HbF protein expression[124]. - The company plans to initiate enrollment in a Phase 1b clinical trial in sickle cell patients in Q4 2021, with a treatment period of up to three months[129]. - The Phase 1 clinical trial of FTX-6058 is designed to evaluate safety, tolerability, and pharmacokinetics, with no serious adverse events reported to date[123]. - The company anticipates initiating a clinical trial in non-SCD hemoglobinopathies in 2022, with an IND submission planned by year-end 2021[130]. - The company anticipates significant increases in research and development expenses as it advances product candidates into later stages of clinical development[155]. - Research and development expenses for Q2 2021 were $17.4 million, an increase of $4.6 million compared to $12.8 million in Q2 2020[159]. - Total research and development expenses increased by $6.5 million from $27.3 million for the six months ended June 30, 2020 to $33.7 million for the six months ended June 30, 2021[169]. - Research and development expenses included $18.993 million in external research and development costs for the six months ended June 30, 2021[169]. Revenue and Collaboration - Collaboration revenue for Q2 2021 was $4.4 million, an increase of $2.4 million from $2.0 million in Q2 2020[159]. - The company recognized $2.0 million of collaboration revenue under the MyoKardia Collaboration Agreement for Q2 2021[146]. - The company recognized $4.9 million and $4.2 million of collaboration revenue under the Acceleron and MyoKardia Collaboration Agreements, respectively, for the six months ended June 30, 2021[168]. - Collaboration revenue increased by $6.4 million from $2.8 million for the six months ended June 30, 2020 to $9.2 million for the six months ended June 30, 2021[167]. - The company expects to receive up to $436.5 million in milestone payments under the Acceleron Collaboration Agreement[140]. - As of June 30, 2021, the company recorded $4.0 million of deferred revenue associated with the Acceleron Collaboration Agreement[142]. - The company has recorded unbilled accounts receivable of $0.6 million related to reimbursable research and development costs under the Acceleron Collaboration Agreement[142]. Operating Expenses - Total operating expenses for Q2 2021 were $24.1 million, up $6.1 million from $17.9 million in Q2 2020[159]. - General and administrative expenses for Q2 2021 were $6.7 million, rising by $1.5 million from $5.1 million in Q2 2020[159]. - General and administrative expenses increased by $2.0 million from $10.2 million for the six months ended June 30, 2020 to $12.2 million for the six months ended June 30, 2021[170]. Other Financial Information - Other income, net decreased by $0.5 million from $0.6 million for the six months ended June 30, 2020 to less than $0.1 million for the same period in 2021[173]. - There were no material changes to contractual obligations during the three and six months ended June 30, 2021[189]. - The company has no off-balance sheet arrangements as of the periods presented[190]. - Interest income is sensitive to changes in interest rates; however, a 10% change would not materially affect the fair market value of the investment portfolio[195]. - The company is exposed to foreign currency exchange rate fluctuations but does not currently hedge this risk[196]. - Inflation has not had a material effect on the company's business or financial condition during the reported periods[197].