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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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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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 August 14, 2024, Metagenomi, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2024 and additional business updates. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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 (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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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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Metagenomi, Inc. |
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Date: |
August 14, 2024 |
By: |
/s/ Brian C. Thomas |
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Brian C. Thomas |
Exhibit 99.1
Metagenomi Reports Business Updates and Second Quarter 2024 Financial Results
Declared development candidate MGX-001 for the treatment of hemophilia A;
plans to present 12-month NHP durability study data in September 2024
All Wave 1 Ionis collaboration programs advancing in lead optimization, unlocking potential for multiple development candidate nominations in 2025
Achieved milestone from partner Affini-T related to Metagenomi licensed technology
Well capitalized with $299.9M in cash, cash equivalents and available-for-sale marketable securities at the end of Q2 2024; cash runway anticipated to support operating plans into 2027
EMERYVILLE, Calif., August 14, 2024 -- Metagenomi, Inc. (Nasdaq: MGX) (Metagenomi), a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary, comprehensive metagenomics-derived gene editing toolbox, today provided a business update and reported second quarter 2024 financial results.
“We are progressing our pipeline while remaining laser focused on our vision to create curative genetic medicines by harnessing the power of our AI-driven metagenomics platform,” said Brian C. Thomas, PhD, CEO and Founder. “We have significantly advanced our wholly-owned program in hemophilia A, including recent positive regulatory interactions with Food and Drug Administration (FDA) and the declaration of MGX-001 as our lead development candidate. Our team has worked diligently to allow us to accelerate the data release from our 12-month nonhuman primate (NHP) durability study from the end of 2024 into September 2024. This study is an important step towards advancing MGX-001 as a potentially life-long curative treatment for both adults and children with hemophilia A, and demonstrating our ability to potentially achieve large targeted gene integration in patients using our metagenomics toolbox.”
Dr. Thomas continued, “We are also progressing our partnered programs and advancing our metagenomics-based toolbox. The foundation of our Ionis collaboration was strengthened by the addition of two high-value targets associated with cardiometabolic disease, and all collaboration programs have progressed into the lead optimization phase of development. We achieved a development milestone with Affini-T, where our team provided support for Affini-T’s regulatory filing related to Metagenomi licensed technology and current good manufacturing practices (cGMP) material supply. We continue to advance a broad range of technologies to support our goal of being able to address any disease by enabling any therapeutic genome edit in the human genome. Going forward, we remain well capitalized to execute our strategic priorities, with a cash runway into 2027.”
Second Quarter 2024 Business Updates and Key 2024-2025 Anticipated Milestones
Therapeutic Pipeline Updates
Technology Platform Updates
Other Business Updates
Upcoming Events
Metagenomi plans to participate in the following events during the third quarter of 2024:
Second Quarter 2024 Financial Results
About Metagenomi
Metagenomi is a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary, comprehensive metagenomics-derived toolbox. Metagenomi is harnessing the power of metagenomics, the study of genetic material recovered from the natural environment, to unlock four billion years of microbial evolution to discover and develop a suite of novel editing tools capable of correcting any type of genetic mutation found
anywhere in the genome. Its comprehensive genome editing toolbox includes programmable nucleases, base editors, and RNA and DNA-mediated integration systems (including prime editing systems and clustered regularly interspaced short palindromic repeat associated transposases). Metagenomi believes its diverse and modular toolbox positions the company to access the entire genome and select the optimal tool to unlock the full potential of genome editing for patients. For more information, please visit https://metagenomi.co.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions, include, but are not limited to, any statements relating to our growth strategy and product development programs, including the timing of and our ability to conduct IND-enabling studies, make regulatory filings such as INDs, statements concerning the potential of therapies and product candidates, statements concerning the timing of data presentations and publications, and any other statements that are not historical facts. Forward looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in “Risk Factors,” in our most recent Form 10-K and our most recent 10-Qs on file with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Investor Contact:
Simon Harnest - CIO, SVP Investor Relations
simon@metagenomi.co
Media Contact:
Ashlye Hodge - Communications Manager
ashlye@metagenomi.co
Condensed Financial Statements
Condensed Consolidated Balance Sheet Data
(Unaudited)
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June 30, |
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December 31, |
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(in thousands) |
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2024 |
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2023 |
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Cash, cash equivalents and available-for-sale marketable securities |
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$ |
299,921 |
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$ |
271,182 |
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Total assets |
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$ |
385,905 |
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$ |
364,842 |
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Total liabilities |
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$ |
116,486 |
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$ |
149,668 |
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Redeemable convertible preferred stock |
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$ |
— |
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$ |
350,758 |
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Total stockholders’ equity (deficit) |
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$ |
269,419 |
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$ |
(135,584 |
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Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
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$ |
385,905 |
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$ |
364,842 |
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Condensed Consolidated Statements of Operations
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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(In thousands, except share and per share data) |
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2024 |
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2023 |
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2024 |
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2023 |
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Collaboration revenue |
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$ |
20,008 |
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$ |
11,337 |
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$ |
31,167 |
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$ |
19,994 |
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Operating expenses: |
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Research and development |
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28,320 |
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22,681 |
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59,759 |
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42,811 |
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General and administrative |
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8,551 |
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6,619 |
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17,303 |
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13,084 |
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Total operating expenses |
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36,871 |
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29,300 |
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77,062 |
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55,895 |
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Loss from operations |
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(16,863 |
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(17,963 |
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(45,895 |
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(35,901 |
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Other income (expense): |
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Interest income |
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3,976 |
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3,967 |
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7,910 |
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7,970 |
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Change in fair value of long-term investments |
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— |
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2,870 |
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— |
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2,870 |
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Other income (expense), net |
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(51 |
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16 |
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(101 |
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15 |
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Total other income, net |
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3,925 |
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6,853 |
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7,809 |
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10,855 |
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Net loss before benefit (provision) for income taxes |
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(12,938 |
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(11,110 |
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(38,086 |
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(25,046 |
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Benefit (provision) for income taxes |
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2,199 |
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(1,898 |
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2,199 |
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(4,095 |
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Net loss |
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$ |
(10,739 |
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$ |
(13,008 |
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$ |
(35,887 |
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$ |
(29,141 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.29 |
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$ |
(3.82 |
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$ |
(1.24 |
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$ |
(8.56 |
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Weighted average common shares outstanding, basic and diluted |
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36,625,291 |
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3,404,585 |
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28,901,399 |
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3,404,585 |
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