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:
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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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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 March 30, 2022, Metacrine, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended December 31, 2021. A copy of the press release is attached hereto as Exhibit 99.1.
The information contained under 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, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
Item 9.01 Financial Statements and Exhibits.
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(d) |
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The following exhibit is furnished with this Current Report. |
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Exhibit Number |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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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 thereunto duly authorized.
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Metacrine, Inc. |
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Date: March 30, 2022 |
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By: |
/s/ Patricia Millican |
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Patricia Millican |
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Chief Financial Officer |
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Exhibit 99.1
METACRINE REPORTS FOURTH-QUARTER 2021 RESULTS
SAN DIEGO – March 30, 2022 - Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with gastrointestinal diseases, today reported its fourth-quarter 2021 financial results.
“We continue to devote all of our development effort to bringing expanded therapeutic options to people living with ulcerative colitis (UC),” said Preston Klassen, M.D., MHS, CEO, Metacrine. “We have generated preclinical data that supports moving our MET642 program into clinical testing in UC during the next few months. In addition, by reducing our organizational footprint as part of our recently implemented restructuring plan, we expect that our cash runway will fund operations through 2023 as we evaluate a range of ways to generate value from our discovery programs, product candidates and financial assets.”
Recent News & Outlook
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Phase 2 clinical trial in ulcerative colitis remains on track - Metacrine received authorization in February 2022 from the U.S. Food and Drug Administration (FDA) to proceed with its Phase 2 trial evaluating MET642 in subjects with UC and expects to begin the study in the second quarter of 2022. |
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Restructuring plan implemented to reduce expenses - To support ongoing clinical development of MET642 in UC, the Company implemented a restructuring plan in February 2022 to significantly reduce expenses associated with its operations in order to preserve cash. The restructuring included a staff reduction of approximately 50% primarily consisting of the Company’s research organization. Metacrine also discontinued preclinical development of its hydroxysteroid dehydrogenase (HSD) program. |
Fourth-Quarter 2021 Financial Results
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Cash Balance - Cash, cash equivalents and short-term investments were $76.4 million as of December 31, 2021. Metacrine believes it has sufficient capital to fund its current operating plan through 2023. |
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R&D Expenses - Research and development expenses were $9.2 million for the three months ended December 31, 2021, as compared to $6.8 million for the prior-year period. The increase was primarily driven by higher clinical development costs related to the advancement of the Company’s MET409 and MET642 programs. |
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G&A Expenses - General and administrative expenses were $3.9 million for the three months ended December 31, 2021, as compared to $3.8 million for the same period in the prior year. The increase was attributable to higher employee-related costs and expenses associated with operating as a publicly traded company. |
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Net Loss - Net loss was $13.5 million for the three months ended December 31, 2021, as compared to $10.8 million for prior-year quarter. |
About Metacrine
Metacrine, Inc. is a clinical-stage biopharmaceutical company developing differentiated therapies to treat gastrointestinal diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold, which has demonstrated an improved therapeutic profile in clinical trials. To learn more, visit www.metacrine.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements about the design, progress, timing, scope and results of clinical trials; plans for initiating future clinical trials and studies; statements regarding the therapeutic potential of MET642; the expected benefits of Metacrine’s restructuring plans; anticipated drivers of value; and Metacrine’s belief that it has sufficient capital to fund its current operating plan through 2023. Words such as “may,” “will,” “expect,” “plan,” “aim,” “projected,” “likely, ”anticipate,” “estimate,” “intend,” “potential,” “prepare,” “perceived,” “believes” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Metacrine’s expectations and assumptions that may never materialize or prove to be incorrect. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks and uncertainties regarding regulatory approvals for MET642; potential delays in initiating, enrolling or completing any clinical trials; potential adverse side effects or other safety risks associated with MET642; competition from third parties that are developing products for similar uses; Metacrine’s ability to obtain, maintain and protect its intellectual property; and Metacrine’s ability to successfully reduce expenses in connection with the restructuring plan. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Metacrine’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2022, and in Metacrine’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as required by law, Metacrine assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Investor & Media Contact
Investor Relations
Metacrine, Inc.
investors@metacrine.com
Metacrine, Inc.
Unaudited Condensed Consolidated Statements of Operations
(In thousands)
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Three Months Ended December 31, |
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Years Ended December 31, |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
9,177 |
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$ |
6,817 |
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$ |
45,474 |
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$ |
26,790 |
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General and administrative |
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3,910 |
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3,813 |
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15,605 |
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9,900 |
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Total operating expenses |
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13,087 |
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10,630 |
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61,079 |
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36,690 |
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Loss from operations |
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(13,087 |
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(10,630 |
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(61,079 |
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(36,690 |
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Total other income (expense) |
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(439 |
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(186 |
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(1,128 |
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(614 |
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Net loss |
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$ |
(13,526 |
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$ |
(10,816 |
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$ |
(62,207 |
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$ |
(37,304 |
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Metacrine, Inc.
Unaudited Condensed Consolidated Balance Sheets
(In thousands)
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December 31, |
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2021 |
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2020 |
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Assets |
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Current assets: |
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Cash, cash equivalents, and short-term investments |
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$ |
76,427 |
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$ |
96,176 |
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Prepaid expenses and other current assets |
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2,313 |
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5,847 |
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Total current assets |
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78,740 |
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102,023 |
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Property and equipment, net |
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347 |
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634 |
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Operating lease right-of-use asset |
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902 |
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1,579 |
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Total assets |
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$ |
79,989 |
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$ |
104,236 |
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Liabilities, Preferred Stock, and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
368 |
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$ |
334 |
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Accrued and other current liabilities |
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7,392 |
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3,692 |
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Total current liabilities |
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7,760 |
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4,026 |
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Long-term debt, net of debt discount |
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13,303 |
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9,372 |
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Other long-term liabilities |
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1,571 |
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1,559 |
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Stockholders’ equity |
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57,355 |
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89,279 |
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Total liabilities, preferred stock, and stockholders’ equity |
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$ |
79,989 |
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$ |
104,236 |
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Document and Entity Information |
Mar. 30, 2022 |
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| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Entity Registrant Name | Metacrine, Inc. |
| Document Period End Date | Mar. 30, 2022 |
| Entity Central Index Key | 0001634379 |
| Entity File Number | 001-39512 |
| Entity Incorporation State Country Code | DE |
| Entity Tax Identification Number | 47-2297384 |
| Entity Address, Address Line One | 3985 Sorrento Valley Blvd. |
| Entity Address, Address Line Two | Suite C |
| Entity Address, City or Town | San Diego |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 92121 |
| City Area Code | (858) |
| Local Phone Number | 369-7800 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Entity Emerging Growth Company | true |
| Entity Ex Transition Period | true |
| Security 12b Title | Common Stock, par value $0.0001 per share |
| Trading Symbol | MTCR |
| Security Exchange Name | NASDAQ |