Form 8-K - Current report
January 13 2025 - 7:18AM
Edgar (US Regulatory)
NASDAQ false 0001703647 0001703647 2025-01-13 2025-01-13
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 13, 2025
Korro Bio, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-39062 |
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47-2324450 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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60 First Street, 2nd Floor, Suite 250 Cambridge, MA |
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02141 |
(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (617) 468-1999
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common stock, par value $0.001 per share |
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KRRO |
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The Nasdaq Capital Market |
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. ☐
On January 13, 2025, Korro Bio, Inc. issued a press release announcing that it has dosed the first participants in its REWRITE Phase 1/2a clinical study of KRRO-110 for Alpha-1 Antitrypsin Deficiency and provided a pipeline update. A copy of the press release is filed as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.
Korro Bio, Inc. also updated its corporate presentation for use in meetings with investors, analysts and others. A copy of certain updated slides is filed as Exhibit 99.2 to this current report on Form 8-K and is incorporated herein by reference.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
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: January 13, 2025 |
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By: |
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/s/ Ram Aiyar |
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Name: |
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Ram Aiyar |
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Title: |
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President and Chief Executive Officer |
Exhibit 99.1
Korro Bio Announces Dosing of First Participants in REWRITE Phase 1/2a Study of KRRO-110 for Alpha-1 Antitrypsin Deficiency and Provides Pipeline Update
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KRRO-110 is the first product candidate from Korros proprietary
RNA editing OPERATM platform |
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Interim readout from REWRITE expected in the second half of 2025 |
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Korro to advance additional pipeline programs towards clinical development |
CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a clinical-stage biopharmaceutical company focused on
developing a new class of genetic medicines based on editing RNA for both rare and highly prevalent diseases, today announced the initiation of dosing in its REWRITE study investigating KRRO-110 as a potential
treatment for individuals with Alpha-1 Antitrypsin Deficiency (AATD).
KRRO-110 is designed to restore therapeutic M-AAT protein levels in
individuals with at least one Z allele by leveraging the bodys endogenous ADAR enzyme. The swift initiation of the REWRITE study for AATD is a testament to our collective strength and focused execution at Korro, said Kemi Olugemo, MD,
Chief Medical Officer at Korro. We are encouraged by our preclinical data, which demonstrates rapid restoration of functional AAT protein levels and durable editing. Our goal is to create a clinically differentiated, disease-modifying
treatment to address both lung and liver manifestations of AATD. We look forward to evaluating the therapeutic potential of KRRO-110 and sharing interim data in the second half of this year.
REWRITE is a two-part single and multiple dose-escalating study that will evaluate the safety and tolerability of KRRO-110 in up to 64 participants, including healthy adults and clinically stable AATD patients with the PiZZ genotype. Secondary and exploratory endpoints include pharmacokinetic and pharmacodynamic parameters that
will guide optimal dose selection for later stage studies. Interim data from Part 1 (single ascending doses in healthy volunteers and individuals with AATD) is expected in the second half of 2025, and completion of the study is anticipated in 2026.
For additional information about the REWRITE study, visit ClinicalTrials.gov (NCT06677307).
In addition to advancing
KRRO-110, Korro is progressing a pipeline of wholly owned programs and a Novo Nordisk partnered program in a cardiometabolic indication towards the clinic.
We have evolved from a research organization to a clinical-stage drug development organization with our first participant in the REWRITE study recently
dosed with KRRO-110. We have taken time to build our pipeline to demonstrate the versatility of RNA editing, building on data from other oligonucleotide programs, said Ram Aiyar, PhD, President and CEO.
Over the next three years, we expect to take three product candidates into the clinic, in two tissue types with a single modular platform. This will be the crux of our
3-2-1 strategy through 2027. I am excited about the prospect that RNA editing holds beyond the treatment of rare genetic disease and applying our platform to highly
prevalent diseases.
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 adults experience pulmonary emphysema and/or hepatic cirrhosis, as well as end organ manifestations.
KRRO-110 is the first RNA editing oligonucleotide product candidate from Korros 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
(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 clinical-stage 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
bodys natural RNA editing process, enabling 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 Korros Investor Relations website, in addition to following Korros 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: the timing of the interim data readout and completion of the Phase 1/2a clinical
study of KRRO-110 for AATD (REWRITE), including Korros ability to complete the Phase 1/2a clinical study; KRRO-110s potential to treat individuals with AATD;
KRRO-110s ability to restore therapeutic M-AAT protein levels; KRROs potential as a clinically differentiated, disease-modifying treatment to address both
lung and liver manifestations of AATD; Korros ability to progress a pipeline of programs towards the clinic; the timing of, and Korros ability to, deliver three product candidates in two tissue types with a single modular platform by the
end of 2027; 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 managements control including
risks of conducting a first-in-human clinical study; challenges with addressing any regulatory concerns necessary to proceed with enrollment and dosing; risks associated
with enrolling sufficient participants and other risks inherent in biopharmaceutical development; risks associated with conducting pre-clinical studies and clinical
studies and risks of replicating results from pre-clinical studies in 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 Korros filings with the SEC, including Part II Item 1A. Risk Factors
in Korros most recent Quarterly Report on Form 10-Q filed with the SEC, 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
Disclaimers Forward-Looking Statements
Certain statements in this presentation 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 Bio, Inc. (Korro) regarding the future including, without limitation, express or implied statements regarding: the benefits of Korro’s
OPERA platform and its potential to develop transformative genetic medicines; the timing of the interim data readout and completion of the Phase 1/2a clinical study for KRRO-110; Korro’s ability to grow and create value in 2025 and beyond; the
timing and nomination of a second development candidate in the liver with GalNac delivery; expanding Korro’s wholly owned pipeline with multiple genetically validated targets; the 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 1/2a clinical study of KRRO-110 for AATD and advance other pipeline programs; the timing of and ability to
advance three drug candidates to the clinic, two with clinical data and nominate an extra-hepatic drug candidate; KRRO-110’s potential as a best-in-class drug candidate for AATD; KRRO-110’s ability to restore therapeutic AAT levels in
PiZZ patients and reduce lung and liver risk in patients; KRRO-110’s potential to provide a therapeutic benefit for patients and achieve therapeutic M-AAT levels in humans by its third single ascending dose; and the clinical advancement of
KRRO-110, including Korro's plans to expand its Phase 1/2a clinical study to the US and other geographies; 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; the possibility that Korro may be adversely affected by other economic,
business, and/or competitive factors; other risks and uncertainties indicated from time to time in Korro’s filings with the SEC, including Item 1A. “Risk Factors” in Korro’s most recent Quarterly Report on Form 10-Q filed
with the SEC, as such may be amended or supplemented by its other filings with the SEC. Nothing in this presentation 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 presentation, 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 their
expectations or in the events, conditions or circumstances on which any such statement is based. This presentation does not purport to summarize all of the conditions, risks and other attributes of an investment in Korro. Industry and Market Data
Certain information contained in this presentation relates to or is based on studies, publications, surveys and Korro’s own internal estimates and research. In this presentation, Korro relies on, and refers to, publicly available information
and statistics regarding market participants in the sector in which Korro competes and other industry data. Any comparison of Korro to any other entity assumes the reliability of the information available to Korro. Korro obtained this
information and statistics from third-party sources, including reports by market research firms and company filings. In addition, all of the market data included in this presentation involve a number of assumptions and limitations, and there can be
no guarantee as to the accuracy or reliability of such assumptions. Finally, while Korro believes its internal research is reliable, such research has not been verified by any independent source and Korro has not independently verified the
information. Trademarks This presentation may contain trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade
names and copyrights referred to in this presentation may be listed without the TM, SM © or ® symbols, but Korro will assert, to the fullest extent under applicable law, the rights of the applicable owners, if any, to these trademarks,
service marks, trade names and copyrights. Exhibit 99.2
CONCEPT PROGRAM / INDICATION DELIVERY
DISCOVERY PRECLINICAL DEVELOPMENT PHASE 1 PHASE 2 PHASE 3 Repairing a pathogenic variant KRRO-110 AATD LNP (IV) De novo protein to inhibit degradation Rare metabolic disorder GalNAc (SC) De novo protein to overcome LoF and GoF 1 Amyotrophic lateral
sclerosis Undisclosed De novo protein to modulate currents Subsets of pain Undisclosed Repairing a pathogenic variant Parkinson's disease Undisclosed Undisclosed Cardiometabolic Undisclosed AAT Phase 1/2a - Interim data in 2H '25 Undisclosed DC in
'25 TDP43 Robust Pipeline with Multiple High-Value Targets Up to 2 Targets LRRK2 1De Novo protein variant to prevent toxic gain of function (GoF) with TDP43 aggregation, and still continue STMN2 signaling by overcoming toxic Loss-of-function (LOF)
KRRO-110 program with first participant dosed in January ‘25 Nav1.7
SERPINA1 Surrogate Editors Demonstrate
Good Translation to Higher Species 2mg/kg (single dose) Surrogate SERPINA1 design: KB-1494-GVT KRRO-110 site E342K KB-1494-GVT site (few bases away) SERPINA1 mRNA Observations for KB–1494-GVT in PiZ C57BL/6 and Cyno KB-1494-GVT edits at
~2x in Cynos relative to PiZ mouse at same dose
v3.24.4
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Jan. 13, 2025 |
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