UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. Results of Operations and Financial Condition.
On November 12, 2024, Korro Bio, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2024. The full text of the press release is being furnished as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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Press Release issued by Korro Bio, Inc., dated November 12, 2024 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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KORRO BIO, INC. |
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Date: November 12, 2024 |
By: |
/s/ Ram Aiyar |
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Name: Ram Aiyar |
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Title: President and Chief Executive Officer |
Exhibit 99.1
Korro Reports Third Quarter 2024 Financial Results and Provides Business Updates
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Submitted regulatory filing for first-in-human clinical study of KRRO-110 in patients with alpha-1 antitrypsin deficiency (AATD) |
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Formed Clinical Advisory Board (CAB) of leading lung and liver experts and strengthened leadership team |
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Partnered with Novo Nordisk to develop up to two targets for cardiometabolic diseases leveraging Korro’s proprietary OPERATM platform |
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Ended third quarter of 2024 with $169.1 million in cash, cash equivalents and marketable securities |
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Cash runway into the second half of 2026 expected to fund KRRO-110 through completion of a Phase 1/2 clinical study and progress additional pipeline candidates |
CAMBRIDGE, Mass., Nov. 12, 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 third quarter of 2024 and provided an update on its recent progress and anticipated milestones.
“Korro is delivering across key scientific, regulatory and business objectives, highlighted by our first regulatory filing submission, formation of a Clinical Advisory Board, and collaboration agreement with Novo Nordisk,” said Ram Aiyar, PhD, CEO and President of Korro. “Driven by the dedicated efforts of our employees and growing leadership team, our clinical efforts are well underway, and we expect to dose the first participant in our Phase 1/2 clinical study of KRRO-110 in the first quarter of 2025, pending regulatory approval. With a strong balance sheet and cash runway into the second half of 2026, we are well-positioned to execute multiple meaningful inflection points for KRRO-110 and to advance our wholly owned and partnered pipeline programs.”
Pipeline and Business Updates:
Upcoming Milestones:
Third Quarter 2024 Financial Results:
Cash Position: Cash, cash equivalents and marketable securities were $169.1 million as of September 30, 2024, compared to $166.1 million as of December 31, 2023. Korro expects its cash, cash equivalents and marketable securities will fund operating expenses and capital expenditure requirements into the second half of 2026.
Research and Development (R&D) Expenses: R&D expenses were $16.0 million for the three months ended September 30, 2024, as compared to $14.0 million for the same period in 2023. The increase was driven primarily by increases in discovery, preclinical and contract manufacturing costs, personnel related expenses, consulting fees and other costs.
General and Administration (G&A) Expenses: G&A expenses were $7.3 million for the three months ended September 30, 2024, as compared to $5.1 million for the same period in 2023. The increase was primarily due to increased personnel costs and professional services, information technology, insurance and other costs attributable to build-out of the G&A function and compliance costs as a public company.
Net Loss: Korro’s net loss was $21.0 million for the three months ended September 30, 2024, as compared to $18.5 million for the same period in 2023.
About Alpha-1 Antitrypsin Deficiency (AATD) and KRRO-110
AATD is a genetic disorder most commonly caused by a single missense mutation (G-to-A) in the SERPINA1 gene. Affected adult individuals experience pulmonary emphysema and/or hepatic cirrhosis, as well as end organ manifestations. KRRO-110 is the first RNA editing oligonucleotide product candidate from Korro’s proprietary RNA editing platform, Oligonucleotide Promoted Editing of RNA (OPERA™). KRRO-110 is designed to co-opt an endogenous enzyme, Adenosine Deaminase Acting on RNA’s (ADAR), to edit the
“A” variant on SERPINA1 RNA, repair an amino acid codon, and restore secretion of normal AAT protein. This repair of the endogenous protein has the potential to clear protein aggregates from within liver cells to create a potentially clinically differentiated benefit for liver function and to preserve lung function by providing an adequate amount of normal AAT protein.
About Korro
Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to affect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro is based in Cambridge, Massachusetts. For more information, visit korrobio.com.
Korro intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Korro’s Investor Relations website, in addition to following Korro’s press releases, SEC filings, public conference calls, presentations, and webcasts.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, but are not limited to, express or implied statements regarding expectations, hopes, beliefs, intentions or strategies of Korro regarding the future including, without limitation, express or implied statements regarding: Korro’s ability to develop up to two therapeutic candidates for cardiometabolic diseases under the collaboration with Novo Nordisk; Korro’s cash runway, including its ability to complete a Phase 1/2 clinical study of KRRO-110 for AATD; approval by the Australian Bellberry Human Research Ethics Committee of Korro’s regulatory filing to commence a Phase 1/2 clinical study of KRRO-110 for AATD; the timing of Korro dosing the first participant, interim data readout and completion of the Phase 1/2 clinical study; KRRO-110’s potential to provide a clinically differentiated benefit; Korro’s ability to advance its wholly owned and partnered pipeline programs and the strength of its balance sheet to support completion; and Korro’s ability to expand the reach of genetic medicines; among others. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including risks inherent in biopharmaceutical development; risks associated with pre-clinical studies and clinical studies; and other risks associated with obtaining regulatory approvals and protecting intellectual property; as well as risks associated with
general economic conditions; and other risks and uncertainties indicated from time to time in Korro’s filings with the SEC, including Part II Item 1A. “Risk Factors” in Korro’s Quarterly Report on Form 10-Q filed with the SEC on the date hereof, as such may be amended or supplemented by its other filings with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Except as required by law, Korro does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Korro.
Korro Bio Contact Information
Investor & Media Contact
Tim Palmer
IR@korrobio.com
Korro Bio, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
15,964 |
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$ |
14,008 |
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$ |
46,674 |
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$ |
41,828 |
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General and administrative |
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7,328 |
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5,140 |
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22,196 |
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15,813 |
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Total operating expenses |
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23,292 |
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19,148 |
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68,870 |
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57,641 |
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Loss from operations |
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(23,292 |
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(19,148 |
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(68,870 |
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(57,641 |
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Other income: |
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Other income, net |
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2,284 |
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656 |
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6,526 |
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1,922 |
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Total other income, net |
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2,284 |
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656 |
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6,526 |
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1,922 |
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Loss before provision for income taxes |
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(21,008 |
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(18,492 |
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(62,344 |
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(55,719 |
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Provision for income taxes |
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9 |
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— |
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(38 |
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(27 |
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Net loss |
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$ |
(20,999 |
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$ |
(18,492 |
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$ |
(62,382 |
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$ |
(55,746 |
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Other comprehensive income: |
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Unrealized gain on available-for-sale marketable securities |
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$ |
593 |
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$ |
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$ |
614 |
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$ |
5 |
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Foreign currency translation adjustments, net |
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$ |
(40 |
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$ |
— |
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$ |
(40 |
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$ |
— |
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Comprehensive loss |
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$ |
(20,446 |
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$ |
(18,492 |
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$ |
(61,808 |
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$ |
(55,741 |
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Net loss per share, basic and diluted |
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$ |
(2.26 |
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$ |
(65.08 |
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$ |
(7.11 |
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$ |
(200.94 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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9,303,218 |
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284,156 |
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8,771,743 |
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277,433 |
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Korro Bio, Inc.
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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September 30, |
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December 31, |
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Cash, cash equivalents and marketable securities |
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$ |
169,112 |
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$ |
166,150 |
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Working capital (1) |
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139,173 |
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153,245 |
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Total assets |
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243,543 |
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221,663 |
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Total liabilities |
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63,911 |
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51,752 |
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Total stockholders' equity |
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179,632 |
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169,911 |
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(1) Working capital is defined as current assets less current liabilities. |
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