Korro Bio(KRRO)

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Korro Bio(KRRO) - 2023 Q2 - Quarterly Report
2023-08-10 20:06
Financial Performance - Net loss for the three months ended June 30, 2023, was $10,796 thousand, compared to a net loss of $21,285 thousand for the same period in 2022, representing a 49.1% improvement[17]. - The company reported a comprehensive loss of $10,738 thousand for the three months ended June 30, 2023, compared to a comprehensive loss of $21,381 thousand for the same period in 2022, a reduction of 49.8%[20]. - Net loss for the six months ended June 30, 2023, was $30.3 million, a reduction of $14.3 million (32.1%) from a net loss of $44.7 million in the prior year[132]. - The basic and diluted net loss per share for the six months ended June 30, 2023, was $(0.85), down from $(1.28) for the same period in 2022[48]. - The net losses for the three and six months ended June 30, 2023, were $10.8 million and $30.3 million, respectively, with an accumulated deficit of $292.0 million as of June 30, 2023[105]. Assets and Liabilities - Total current assets decreased by 44.5% from $87,493 thousand on December 31, 2022, to $48,379 thousand on June 30, 2023[14]. - Cash and cash equivalents decreased from $51,954 thousand on December 31, 2022, to $39,712 thousand on June 30, 2023, a decline of 23.4%[14]. - Total liabilities decreased by 34.8% from $52,043 thousand on December 31, 2022, to $33,975 thousand on June 30, 2023[14]. - Total stockholders' equity decreased from $69,195 thousand on December 31, 2022, to $45,408 thousand on June 30, 2023, a decline of 34.4%[14]. - The company had cash, cash equivalents, and restricted cash of $41,672 thousand at the end of the period, down from $44,072 thousand at the same time last year[26]. Operating Expenses - Total operating expenses for the three months ended June 30, 2023, were $11.8 million, a decrease of $9.4 million compared to $21.3 million for the same period in 2022[121]. - Research and development expenses for the three months ended June 30, 2023, were $4.6 million, down from $13.3 million in the same period in 2022, reflecting a decrease of $8.7 million[121]. - General and administrative expenses for the three months ended June 30, 2023, were $7.2 million, a decrease of $0.8 million from $8.0 million in the same period in 2022[127]. - Total operating expenses for the six months ended June 30, 2023, were $32.3 million, a decrease of $12.2 million (27.4%) compared to $44.5 million in the same period of 2022[132]. - Research and development expenses totaled $15.9 million for the six months ended June 30, 2023, down $11.1 million (41.1%) from $27.1 million in 2022[133]. Cash Flow - Net cash used in operating activities for the six months ended June 30, 2023, was $22,556 thousand, compared to $30,821 thousand for the same period in 2022, a decrease of 26.9%[26]. - Cash, cash equivalents, and marketable securities totaled $46.5 million as of June 30, 2023[145]. - Interest income for the three months ended June 30, 2023, was $0.3 million, compared to $0.4 million for the same period in 2022[128]. - There was no interest expense for the three months ended June 30, 2023, compared to $0.2 million for the same period in 2022, due to loan prepayment[129]. - Interest income increased to $0.9 million for the six months ended June 30, 2023, compared to $0.5 million in the same period of 2022, reflecting changes in investment balances[140]. Workforce and Restructuring - The Company underwent a restructuring in February and May 2023, resulting in a personnel reduction of approximately 55%[28]. - The Company announced a reduction in force of approximately 55% of its workforce following the failure of the FX-322 Phase 2b study to achieve its primary efficacy endpoint[94]. - The company announced a reduction in force of approximately 55% of its workforce in February 2023, with total restructuring costs of approximately $4.3 million[149]. - The Company incurred $4,329 in restructuring-related expenses in the six months ended June 30, 2023, including $3,840 in severance and other benefit-related costs[95]. Strategic Initiatives - The Company expects to continue generating operating losses for the foreseeable future, relying on its ability to raise additional capital[29]. - The Company plans to focus on developing a product candidate for remyelination in multiple sclerosis following the discontinuation of the FX-322 and FX-345 programs[102]. - The company is focusing on pursuing strategic alternatives for its MS Program and expects research and development expenses to relate to this initiative for the remainder of 2023[112]. - The Company entered into a Merger Agreement with Korro Bio on July 14, 2023, with Korro Bio becoming a wholly owned subsidiary[98]. - Following the merger agreement on July 14, 2023, the company does not expect any further development of its product candidates or programs[151]. Terminations and Agreements - The company terminated the Astellas Agreement on April 14, 2023, with no payments or costs incurred as a result of this termination[71]. - The Company terminated the CALIBR License Agreement in April 2023 without any associated payments or costs[76]. - The Company also terminated the MEE License Agreement in April 2023, incurring no payments or costs as a result[78]. - The company terminated several license agreements, including the Astellas Agreement and the MIT License, with no associated payments or costs due to these terminations[107][108]. Market and Risk Factors - The company has not experienced any material changes to its critical accounting policies during the six months ended June 30, 2023, compared to the previous year[164]. - The company has incorporated risk factors from its Registration Statement on Form S-4 filed with the SEC on July 27, 2023[174]. - The company is classified as a smaller reporting company and is not required to provide certain disclosures under Regulation S-K[179]. - The company has not disclosed any quantitative and qualitative disclosures about market risk as it is considered a small reporting company[168].
Korro Bio(KRRO) - 2023 Q1 - Quarterly Report
2023-05-12 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39062 FREQUENCY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-2324450 (State or other jur ...
Korro Bio(KRRO) - 2022 Q4 - Annual Report
2023-03-10 12:41
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Delaware 47-2324450 (State or Other Jurisdiction of Incorporation or Organization) (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39062 FREQUENCY THERAPEUTICS, INC. (Exact Name of ...
Korro Bio(KRRO) - 2022 Q3 - Quarterly Report
2022-11-08 21:16
Financial Performance - The company reported no revenue for the three months ended September 30, 2022, compared to $14,068,000 for the same period in 2021[20]. - For the nine months ended September 30, 2022, the net loss was $64,218,000, compared to a net loss of $63,186,000 for the same period in 2021, indicating a slight increase in losses year-over-year[29]. - The company reported a net loss per share of $1.83 for the nine months ended September 30, 2022, compared to $1.84 for the same period in 2021, indicating a stable loss per share[51]. - The company reported a comprehensive loss of $19,531,000 for the three months ended September 30, 2022, compared to a comprehensive loss of $25,159,000 for the same period in 2021, indicating an improvement of approximately 22%[23]. - The company reported net losses of $64.2 million and $84.7 million for the nine months ended September 30, 2022, and the year ended December 31, 2021, respectively[145]. Assets and Liabilities - Total current assets decreased from $134,748,000 on December 31, 2021, to $100,990,000 on September 30, 2022, a decline of approximately 25%[17]. - Cash and cash equivalents decreased from $79,635,000 on December 31, 2021, to $43,846,000 on September 30, 2022, a reduction of approximately 45%[17]. - The accumulated deficit increased from $180,085,000 on December 31, 2021, to $244,303,000 on September 30, 2022, reflecting a rise of about 36%[17]. - The company had total liabilities of $54,040,000 as of September 30, 2022, compared to $54,534,000 on December 31, 2021, showing a slight decrease of about 1%[17]. - Cash, cash equivalents, and restricted cash at the end of the period were $45,545,000, down from $113,760,000 at the end of the same period in 2021, indicating a significant decrease in liquidity[29]. Operating Expenses - Total operating expenses for the three months ended September 30, 2022, were $20,275,000, down from $24,990,000 in the same period of 2021, representing a decrease of about 19%[20]. - Research and development expenses for the nine months ended September 30, 2022, were $38,769,000, down from $48,169,000 for the same period in 2021, a decrease of about 19%[20]. - General and administrative expenses for the three months ended September 30, 2022, were $8.6 million, down $0.8 million from $9.3 million in 2021[187]. - Total operating expenses for the nine months ended September 30, 2022, were $64.8 million, down $11.9 million from $76.7 million in 2021[195]. - General and administrative expenses were $26.0 million for the nine months ended September 30, 2022, a decrease of $2.5 million from $28.6 million in 2021[201][202]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2022, was $42,618,000, a decrease from $58,171,000 in the prior year, reflecting improved cash flow management[29]. - The company had net cash provided by investing activities of $6,573,000 for the nine months ended September 30, 2022, a significant improvement from a net cash used of $51,479,000 in the prior year[29]. - Cash, cash equivalents, and marketable securities totaled $99.3 million as of September 30, 2022, expected to fund operations into 2024[210]. Stock and Equity - The weighted-average shares of common stock outstanding increased from 34,448,746 for the three months ended September 30, 2021, to 35,247,680 for the same period in 2022, an increase of approximately 2%[20]. - The company had 35,262,233 shares of common stock issued and outstanding as of September 30, 2022, an increase from 34,611,213 shares as of December 31, 2021[53]. - The company sold 12,767 shares of common stock under the ATM program for net proceeds of approximately $50,000 during the nine months ended September 30, 2022[58]. - The company recognized stock-based compensation of $5,994,000 for the nine months ended September 30, 2022, compared to $7,393,000 for the same period in 2021[70]. - The total unrecognized stock-based compensation expense relating to unvested stock options and restricted stock units was $23,888,000, expected to be recognized over a weighted-average period of 1.72 years[70]. Research and Development - Research and development expenses for the three months ended September 30, 2022, were $11.7 million, a decrease of $3.9 million from $15.7 million in 2021[180]. - The company incurred $2.9 million in costs related to FX-322 for the three months ended September 30, 2022, primarily for clinical costs associated with ongoing trials[183]. - FX-322, the Company's lead product candidate, showed a statistically significant improvement in word recognition scores in a Phase 1/2 clinical trial with 23 subjects[133]. - In the Phase 2a clinical trial, four weekly injections of FX-322 did not demonstrate improvements in hearing measures versus placebo, attributed to uncontrolled bias[134]. - The safety profile of FX-322 has been favorable across multiple clinical trials, with no treatment-related serious adverse events reported[136]. Future Outlook - The company expects to continue generating operating losses for the foreseeable future, emphasizing the need for additional capital to finance operations[33]. - The company plans to reduce its workforce by approximately 30% to align with business needs and focus on R&D programs[142]. - The prolonged COVID-19 pandemic may adversely impact the company's ability to raise additional capital and conduct clinical trials[149]. - The company is unable to estimate potential losses related to ongoing legal proceedings, including class action lawsuits filed against it[123].
Korro Bio(KRRO) - 2022 Q2 - Quarterly Report
2022-08-09 20:17
Financial Performance - Revenue for the three months ended June 30, 2022, was $0, compared to $9,417,000 for the same period in 2021, indicating a 100% decrease[19]. - The company had no revenue for the six months ended June 30, 2022, compared to $14,068,000 for the same period in 2021, indicating a 100% decrease[19]. - Net loss for the six months ended June 30, 2022, was $44,671,000, compared to a net loss of $38,031,000 for the same period in 2021, reflecting an increase in loss of approximately 17.5%[23]. - The net loss for the three months ended June 30, 2022, was $21,285, compared to a net loss of $17,656 for the same period in 2021, reflecting a year-over-year increase of approximately 9.2%[50]. - For the six months ended June 30, 2022, the net loss was $44,671, up from $38,031 in the same period of 2021, representing an increase of about 17.4%[50]. Assets and Cash Flow - Total assets decreased from $185,358,000 on December 31, 2021, to $149,658,000 on June 30, 2022, representing a decline of approximately 19.2%[17]. - Cash and cash equivalents decreased from $79,635,000 on December 31, 2021, to $42,373,000 on June 30, 2022, a reduction of about 46.8%[17]. - The company reported a net cash used in operating activities of $30,821,000 for the six months ended June 30, 2022, compared to $43,148,000 for the same period in 2021, a reduction of about 28.5%[29]. - Cash, cash equivalents, and marketable securities totaled $111.0 million as of June 30, 2022, expected to fund operations into 2024[209]. Operating Expenses - Total operating expenses for the three months ended June 30, 2022, were $21,273,000, down from $26,900,000 in the same period of 2021, a decrease of approximately 21.1%[19]. - Total operating expenses decreased to $44.5 million for the six months ended June 30, 2022, down from $51.8 million in 2021, representing a reduction of $7.2 million[193]. - Research and development expenses totaled $27.1 million for the six months ended June 30, 2022, a decrease of $5.5 million from $32.5 million in 2021[196]. - General and administrative expenses were $17.5 million for the six months ended June 30, 2022, down $1.8 million from $19.3 million in 2021[200]. Stockholder Equity and Shares - Stockholders' equity decreased from $130,824,000 on December 31, 2021, to $95,853,000 on June 30, 2022, a decline of approximately 26.7%[17]. - The weighted-average shares of common stock outstanding increased from 34,238,394 for the three months ended June 30, 2021, to 34,976,409 for the same period in 2022, an increase of approximately 2.2%[19]. - The company has authorized 200,000,000 shares of common stock, with 34,976,409 shares issued and outstanding as of June 30, 2022[54]. Research and Development - The company is focused on developing FX-322 to treat sensorineural hearing loss (SNHL), with a goal to help millions of people[127]. - In the Phase 1/2 clinical trial (FX-322-201), 23 subjects showed a statistically significant improvement in word recognition scores, with 34% achieving a 10% or greater absolute improvement[128][130]. - The Phase 2a clinical trial (FX-322-202) did not demonstrate improvements in hearing measures compared to placebo, raising concerns about the reliability of baseline scores[129]. - The company expects research and development expenses to continue to increase substantially as it conducts ongoing clinical trials and develops additional product candidates[162]. Financing and Capital Needs - The company expects to continue generating operating losses for the foreseeable future, emphasizing the need for additional capital to finance operations[32]. - Additional financing will be necessary to support ongoing operations, as the company does not expect to generate significant revenue from product sales in the foreseeable future[141]. - The company has raised approximately $378.3 million to date, including from grants and option exercises[209]. Legal and Compliance - The company intends to vigorously defend against ongoing class action lawsuits alleging violations of securities laws, with no accruals recorded as of June 30, 2022[119][123]. - The company has recorded a valuation allowance against its deferred tax assets due to uncertainty around utilizing these tax attributes[175]. Workforce and Operational Changes - The company announced a reduction in force of approximately 30% of its workforce to align with near-term business needs and focus on research and development for its lead candidates FX-322 and FX-345[137]. - The company announced a reduction in force of approximately 30% of its workforce to better align resources with business needs, with estimated costs of $1.2 million related to severance[212].
Korro Bio(KRRO) - 2022 Q1 - Quarterly Report
2022-05-04 20:45
Financial Performance - The company had a net loss of $23,386,000 for the three months ended March 31, 2022, compared to a net loss of $20,375,000 for the same period in 2021, representing an increase in loss of approximately 15%[20]. - The Company reported a net loss of $23,386,000 for the three months ended March 31, 2022, compared to a net loss of $20,375,000 for the same period in 2021, representing an increase in loss of approximately 14.8%[53]. - Revenue for the three months ended March 31, 2022 was $0, a decrease of $4.7 million compared to $4.7 million for the same period in 2021, attributed to the conclusion of revenue recognition from the Astellas Agreement[181]. - Total operating expenses for the three months ended March 31, 2022 were $23.3 million, a decrease of $1.6 million from $24.9 million in the same period in 2021[180]. - Net loss for the three months ended March 31, 2022 was $23.4 million, compared to a net loss of $20.4 million for the same period in 2021, reflecting an increase in losses of $3 million[180]. - Research and development expenses totaled $13.8 million for the three months ended March 31, 2022, down from $15.1 million in the same period in 2021, a decrease of $1.3 million[183]. Assets and Liabilities - As of March 31, 2022, Frequency Therapeutics reported total assets of $164,939,000, a decrease of 11% from $185,358,000 as of December 31, 2021[18]. - Cash and cash equivalents decreased to $49,830,000 as of March 31, 2022, down 37% from $79,635,000 at the end of 2021[18]. - The accumulated deficit increased to $203,471,000 as of March 31, 2022, compared to $180,085,000 at the end of 2021[18]. - The company had total liabilities of $52,269,000 as of March 31, 2022, a slight decrease from $54,534,000 at the end of 2021[18]. - Cash, cash equivalents, and marketable securities totaled $124.8 million as of March 31, 2022, expected to fund operations into 2024[196]. Stock and Shares - The weighted-average shares of common stock outstanding increased to 34,810,676 in Q1 2022 from 34,115,682 in Q1 2021, reflecting an increase of approximately 2%[20]. - The weighted-average shares of common stock outstanding increased to 34,810,676 as of March 31, 2022, from 34,115,682 in the prior year, reflecting a growth of about 2.0%[53]. - The Company has authorized 200,000,000 shares of common stock, with 34,976,409 shares issued and outstanding as of March 31, 2022, up from 34,611,213 shares as of December 31, 2021[57]. - The Company sold 12,767 shares of common stock under its ATM program for net proceeds of approximately $50,000 during the three months ended March 31, 2022[59]. - The total grant date fair value of options vested during the three months ended March 31, 2022, was $5,097,000, compared to $4,284,000 for the same period in 2021, an increase of approximately 18.9%[64]. Operating Activities - The company had a net cash used in operating activities of $17,343,000 for Q1 2022, a decrease from $25,474,000 in Q1 2021[29]. - Net cash used in operating activities for the three months ended March 31, 2022 was $17.3 million, a decrease from $25.5 million in the same period in 2021[201]. - The company incurred $12.7 million in net cash used in investing activities for the three months ended March 31, 2022, primarily due to $20.8 million in purchases of marketable securities[203]. - Net cash used in investing activities for Q1 2021 was $26.2 million, primarily from the purchase of marketable securities totaling $25.7 million[207]. - Net cash provided by financing activities for Q1 2021 was $0.6 million from the exercise of stock options[208]. Future Outlook and Funding - The company expects to continue generating operating losses for the foreseeable future, with future viability dependent on raising additional capital[33]. - Anticipated operating expenses are expected to increase substantially due to the expansion of product development programs, necessitating additional financing[143][144]. - Future funding requirements will depend on the progress and costs associated with clinical development of FX-322 and other product candidates, as well as regulatory requirements[211]. - The company may finance cash needs through public or private equity or debt financings, which could dilute ownership interests[212]. - Existing cash, cash equivalents, and marketable securities are projected to fund operating expenses and capital requirements into 2024, although this estimate is subject to change[210]. Clinical Trials and Product Development - FX-322, the lead product candidate, showed a statistically significant improvement in word recognition scores in a Phase 1b trial, with 34% of subjects achieving a 10% or greater absolute improvement[133]. - The Phase 2a trial of FX-322 did not demonstrate improvements in hearing measures compared to placebo, attributed to uncontrolled bias and limitations in baseline measures[132]. - The company plans to file an investigational new drug application for FX-345 in the second half of 2022, aiming to expand treatment opportunities for different types of sensorineural hearing loss[137]. - The company is focused on advancing its progenitor cell activation approach to potentially treat multiple sclerosis, with a preclinical compound FREQ-162 showing promising results in remyelination[138]. - The company is actively engaged in clinical trials, including a Phase 2b study of FX-322, with the primary endpoint being speech perception in subjects with noise-induced or sudden sensorineural hearing loss[136]. Collaborations and Agreements - Astellas paid the company an upfront payment of $80,000, with potential development milestone payments up to $230,000 and commercialization milestones of up to $315,000 under the collaboration agreement[81]. - The collaboration with Astellas is governed by a joint steering committee, with both parties responsible for development and commercialization activities in their respective territories[80]. - The company has a license agreement with MIT, which includes potential milestone payments up to $2,900 for each Licensed Product or Licensed Process[94]. - The Company is required to make milestone payments up to $26,000 for each Category of CALIBR Licensed Products, with a $1,000 initial license fee payment[101]. - The Company has entered into a license agreement with CALIBR for exclusive rights to certain patent rights for the treatment of multiple sclerosis[99]. Workforce and Operational Changes - Approximately 30% of the workforce was reduced to better align with business needs and focus capital resources on research and development programs, with estimated future cash outlays of $1.2 million related to severance costs[127][139]. - The company announced a reduction in force of approximately 30% of its workforce, with estimated future cash outlays of $1.2 million related to severance costs[200]. Accounting and Compliance - The company is classified as an emerging growth company, allowing it to take advantage of an extended transition period for compliance with new accounting standards[216]. - There were no material changes to critical accounting policies during the three months ended March 31, 2022, compared to the previous annual report[214].
Korro Bio(KRRO) - 2021 Q4 - Annual Report
2022-03-15 11:42
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39062 FREQUENCY THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 47-2324450 (State or other jurisdi ...
Korro Bio(KRRO) - 2021 Q3 - Quarterly Report
2021-11-15 12:42
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39062 (Address of principal executive offices) (Zip Code) (781) 315-4600 (Registrant's telephone number, including area code) ...
Korro Bio(KRRO) - 2021 Q2 - Quarterly Report
2021-08-12 14:26
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39062 FREQUENCY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorpor ...
Korro Bio(KRRO) - 2021 Q1 - Quarterly Report
2021-05-13 11:44
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39062 FREQUENCY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorpo ...