Appointed Kemi Olugemo, M.D., FANN as Chief Medical Officer CAMBRIDGE, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (NASDAQ:KRRO), a biopharmaceutical company focused on developing a new class of genetic medicines based on editing RNA for both rare and highly prevalent diseases, today reported financial results for the first quarter of 2024 and provided an update on its recent progress and anticipated milestones. On track for regulatory filing for First-in-Human (FIH) study of KRRO-110 in ...

Financing led by Deep Track Capital with participation from other leading healthcare investors Pro-forma cash and cash equivalents of approximately $236 million before fees and expenses On track for regulatory filing for First-in-Human (FIH) study of KRRO-110 in Alpha-1 Antitrypsin Deficiency (AATD) patients anticipated in the second half of 2024Proceeds fund interim readout in the second half of 2025 and FIH study completion in 2026 for KRRO-110 CAMBRIDGE, Mass., April 18, 2024 (GLOBE NEWSWIRE) -- Korro Bi ...

Korro Reports Full Year 2023 Financial Results and Highlights Recent Progress Exhibit 99.1 - On track for regulatory filing for First-in-Human study of KRRO-110 in Alpha-1 Antitrypsin Deficiency (AATD) patients anticipated in the second half of 2024 - Demonstrated the versatility of Korro's RNA editing platform by generating de-novo protein variants via multiple targets in non-human primates (NHPs) - Demonstrated greater than 50% editing using GalNAc conjugates in the liver with subcutaneous administration ...

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, 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 Korro Bio, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organiz ...

Table of Contents As filed with the Securities and Exchange Commission on December 20, 2023 Registration No. 333-275353 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 to FORM S-3 on FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KORRO BIO, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-2324450 (Primary Standard Industrial Classification Code No.) One Kendall ...

Table of Contents to FORM S-3 on FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KORRO BIO, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) As filed with the Securities and Exchange Commission on December 20, 2023 Registration No. 333-275353 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 Delaware 2834 47-2324450 (Primary Standard Industrial Classification Code No.) One Kendall ...

Table of Contents As filed with the Securities and Exchange Commission on December 1, 2023 Registration No. 333-275353 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-3 on FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KORRO BIO, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-2324450 (Primary Standard Industrial Classification Code No.) One Kendall ...

Table of Contents As filed with the Securities and Exchange Commission on December 1, 2023 Registration No. 333-275353 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-3 on FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KORRO BIO, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-2324450 (Primary Standard Industrial Classification Code No.) One Kendall ...

PART I. FINANCIAL INFORMATION This section presents the company's unaudited financial statements, management's discussion, and related disclosures [Item 1. Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20%28Unaudited%29) Unaudited Q3 2023 financials show reduced assets, liabilities, and net loss, driven by restructuring and debt repayment [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Total assets and liabilities significantly decreased by September 30, 2023, primarily due to lower cash and debt repayment Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $41,723 | $51,954 | | Total current assets | $42,500 | $87,493 | | Total assets | $46,349 | $121,238 | | **Liabilities & Equity** | | | | Total current liabilities | $9,612 | $21,026 | | Total liabilities | $9,612 | $52,043 | | Total stockholders' equity | $36,737 | $69,195 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Net loss significantly narrowed for Q3 and nine months 2023, driven by reduced research and development expenses Consolidated Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,560 | $11,715 | $18,509 | $38,769 | | General and administrative | $10,105 | $8,560 | $26,498 | $26,037 | | Loss from operations | $(12,665) | $(20,275) | $(45,007) | $(64,806) | | Net loss | $(11,614) | $(19,547) | $(41,953) | $(64,218) | | Net loss per share | $(0.31) | $(0.55) | $(1.17) | $(1.83) | [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Cash flows for nine months 2023 show reduced operating cash burn, increased investing cash, and cash used in financing Cash Flow Summary for Nine Months Ended September 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(27,358) | $(42,618) | | Net cash provided by investing activities | $31,528 | $6,573 | | Net cash (used in) provided by financing activities | $(14,133) | $256 | | **Net decrease in cash, cash equivalents and restricted cash** | **$(9,963)** | **$(35,789)** | [Notes to Unaudited Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes detail corporate events including the Korro Bio merger, program discontinuation, debt repayment, and restructuring charges - On July 14, 2023, the company entered into a Merger Agreement with **Korro Bio, Inc.**, which will become a wholly owned subsidiary[29](index=29&type=chunk) - The company announced a restructuring in February 2023, discontinuing its hearing program and reducing its workforce by approximately **55%**, followed by another **55%** reduction in May 2023[29](index=29&type=chunk) - On April 3, 2023, the company prepaid the remaining **$11.7 million** due under its Loan Agreement with **Silicon Valley Bank**[47](index=47&type=chunk) - During 2023, the company terminated its collaboration agreement with Astellas and license agreements with MIT, MEE, and CALIBR, with no resulting payments or costs[72](index=72&type=chunk)[76](index=76&type=chunk)[80](index=80&type=chunk) - The company incurred **$4.3 million** in restructuring-related expenses in the nine months ended September 30, 2023, primarily from severance and benefit costs[96](index=96&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strategic shifts, including program discontinuation, workforce reductions, and their impact on expenses and liquidity - In February 2023, the company discontinued its FX-322 and FX-345 hearing development programs after the FX-322-208 study failed to meet its primary endpoint[101](index=101&type=chunk) - The company executed multiple workforce reductions in 2022 and 2023 to align with its new strategic focus and preserve capital[102](index=102&type=chunk) - As of September 30, 2023, the company had an **accumulated deficit** of **$303.6 million** and cash, cash equivalents, and marketable securities of **$41.7 million**[105](index=105&type=chunk)[147](index=147&type=chunk) - Following the merger with **Korro Bio**, the business of the combined company will focus on **Korro Bio's** programs, and Frequency does not expect further development of its own product candidates[106](index=106&type=chunk)[153](index=153&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Operating expenses significantly decreased for Q3 and nine months 2023, driven by reduced R&D offset by higher G&A Comparison of Operating Expenses (in thousands) | Expense Category | Q3 2023 | Q3 2022 | Change | Nine Months 2023 | Nine Months 2022 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,560 | $11,715 | $(9,155) | $18,509 | $38,769 | $(20,260) | | General and administrative | $10,105 | $8,560 | $1,545 | $26,498 | $26,037 | $461 | | **Total operating expenses** | **$12,665** | **$20,275** | **$(7,610)** | **$45,007** | **$64,806** | **$(19,799)** | - The decrease in R&D costs is directly attributed to the discontinuation of the FX-322 and FX-345 programs in Q1 2023[124](index=124&type=chunk)[125](index=125&type=chunk) - The increase in G&A expenses was primarily due to higher professional service fees, particularly legal fees[128](index=128&type=chunk)[141](index=141&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is supported by $41.7 million in cash, with key events including debt prepayment and ATM program termination - Cash, cash equivalents and marketable securities totaled **$41.7 million** as of September 30, 2023[147](index=147&type=chunk) - In April 2023, the company prepaid the remaining **$11.7 million** on its term loan[148](index=148&type=chunk) - The company's ATM Program was terminated on September 26, 2023. No shares were sold under the program in 2023[149](index=149&type=chunk) - Restructuring in February 2023 related to program discontinuation and a **55%** staff reduction incurred costs of approximately **$4.3 million**[151](index=151&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This disclosure is not required as the company is a smaller reporting company - The company is a smaller reporting company and is **not required** to provide this information[171](index=171&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of September 30, 2023, with no material changes to internal controls - Management concluded that as of September 30, 2023, the company's disclosure controls and procedures were **effective at a reasonable assurance level**[173](index=173&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[174](index=174&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and other required disclosures [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 15 of the financial statements for legal contingencies - For information on legal proceedings, the report directs readers to Note 15, "Commitments and contingencies – Legal Contingencies"[176](index=176&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company incorporates prospectus risk factors by reference, highlighting its history of significant losses and anticipated unprofitability - The company has incurred **significant losses** since inception and had an **accumulated deficit** of **$303.6 million** as of September 30, 2023[178](index=178&type=chunk) - Frequency is a preclinical-stage company that is **not profitable** and expects to continue incurring **significant operating losses** for the foreseeable future[178](index=178&type=chunk)[179](index=179&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) No material change in the use of net proceeds from the October 2019 IPO was reported - There has been **no material change** in the use of the approximately **$79.7 million** in net proceeds from the company's October 2019 IPO[181](index=181&type=chunk)[182](index=182&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None reported - **None reported** [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - **Not applicable** [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) Not applicable - **Not applicable** [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including the Korro Bio merger agreement and officer certifications

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].