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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2024
OR
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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: 001-40522
Monte Rosa Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
84-3766197 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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321 Harrison Avenue, Suite 900 Boston, Massachusetts |
02118 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (617) 949-2643
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Name of each exchange on which registered |
Common stock, par value $0.0001 per share |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of August 5, 2024 the registrant had 61,372,824 shares of common stock, $0.0001 per share, outstanding.
Special note regarding forward-looking statements
This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, or the or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “intends”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of these terms or other comparable terminology. These statements are not guarantees of future results or performance and involve substantial risks and uncertainties. Forward-looking statements in this Quarterly Report include, but are not limited to, statements about:
•the initiation, timing, progress, results, costs, and any expectations and/or predictions of success of our current and future research and development programs and preclinical studies, including our expectations for our molecular glue degraders, or MGDs, molecules, including our GSPT1-directed MGD MRT-2359, VAV1-directed MGD MRT-6160 and NEK7-directed MGD, MRT-8102;
•the initiation, timing, progress, results, costs, and any expectations and/or predictions of success of our current and any future clinical trials, including statements regarding the nature of or the timing for when any results of any clinical trials will become available;
•our ability to continue to develop our proprietary platform, called QuEENTM, and to expand our proteomics and translational medicine capabilities;
•the potential advantages of our platform technology and product candidates;
•the extent to which our scientific approach and platform technology may target proteins that have been considered undruggable or inadequately drugged;
•our plans to submit Investigational New Drug, or IND applications to the U.S. Food and Drug Administration, or the FDA for current and future product candidates;
•the potential benefits of strategic collaborations and our ability to enter into strategic collaborations with third parties who have the expertise to enable us to further develop our biological targets, product candidates and platform technologies;
•our ability to obtain and maintain regulatory approval of our product candidates;
•our ability to maintain and expand, including through third-party vendors, our library of MGDs
•our ability to manufacture, including through third-party manufacturers, our product candidates for preclinical use, future clinical trials and commercial use, if approved;
•our ability to commercialize our product candidates, including our ability to establish sales, marketing and distribution capabilities for our product candidates;
•the rate and degree of market acceptance of our product candidates;
•the size and growth potential of the markets for our product candidates, and our ability to serve those markets;
•our ability to establish and maintain intellectual property rights covering our current and future product candidates and technologies;
•the implementation of our business model and strategic plans for our business, product candidates, and technology;
•estimates of our future expenses, revenues, capital requirements, and our needs for additional financing;
•our expected use of proceeds from sales of our common stock in "at-the-market" offerings and other offerings, and the period over which such proceeds, together with existing cash, will be sufficient to meet our operating needs;
•our ability to obtain funding for our operations necessary to complete further development and commercialization of our product candidates;
•our financial performance;
•developments in laws and regulations in the United States, or the U.S., and foreign countries;
•the success of competing therapies that are or may become available;
•our ability to attract and retain key scientific or management personnel;
•the effect of global economic uncertainty and financial market volatility caused by economic effects of rising inflation and interest rates, global health crises, geopolitical events, elections, changes in international trade relationships and military conflicts on any of the foregoing or other aspects of our business or operations; and
•other risks and uncertainties, including those listed under the section entitled “Risk factors" and those included in "Part 1, Item 1A, Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, or our 2023 Annual Report, filed with the Securities and Exchange Commission, or the SEC, on March 14, 2024.
Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events and with respect to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part II, Item 1A, “Risk Factors” and elsewhere in this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
All of our forward-looking statements are as of the date of this Quarterly Report only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the SEC could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report, even if new information becomes available in the future or if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report that modify or impact any of the forward-looking statements contained in this Quarterly Report will be deemed to modify or supersede such statements in this Quarterly Report.
We may from time to time provide estimates, projections and other information concerning our industry, the general business environment, and the markets for certain diseases, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information reflected in this Quarterly Report. Unless otherwise expressly stated, we obtained this industry, business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources, in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate.
TRADEMARKS
Solely for convenience, our trademarks and trade names in this report are sometimes referred to without the ® and symbols, but such references should not be construed as any indicator that we will not assert, to the fullest extent under applicable law, our rights thereto.
Table of Contents
Part I ─ Financial Information
Item 1. Financial Statements
Monte Rosa Therapeutics, Inc.
Condensed consolidated balance sheets (unaudited)
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(in thousands, except share and per share amounts) |
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June 30, |
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December 31, |
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(unaudited) |
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2024 |
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2023 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
108,847 |
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$ |
128,101 |
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Marketable securities |
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153,358 |
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104,312 |
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Accounts receivable |
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9,000 |
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— |
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Other receivables |
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842 |
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505 |
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Prepaid expenses and other current assets |
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5,849 |
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3,294 |
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Total current assets |
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277,896 |
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236,212 |
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Property and equipment, net |
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33,250 |
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33,803 |
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Operating lease right-of-use assets |
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27,893 |
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28,808 |
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Restricted cash |
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4,866 |
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4,580 |
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Other long-term assets |
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209 |
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352 |
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Total assets |
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$ |
344,114 |
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$ |
303,755 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
6,473 |
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$ |
11,152 |
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Accrued expenses and other current liabilities |
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12,759 |
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14,600 |
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Current deferred revenue |
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19,645 |
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17,678 |
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Current portion of operating lease liability |
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3,471 |
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3,162 |
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Total current liabilities |
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42,348 |
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46,592 |
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Deferred revenue, net of current |
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33,596 |
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32,323 |
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Defined benefit plan liability |
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2,614 |
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2,713 |
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Operating lease liability |
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40,885 |
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42,877 |
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Total liabilities |
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119,443 |
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124,505 |
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Commitments and contingencies (Note 8) |
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Stockholders’ equity |
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Preferred stock, $0.0001 par value, 10,000,000 shares authorized |
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— |
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— |
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Common stock, $0.0001 par value; 500,000,000 shares authorized, 61,333,597 shares issued and 61,328,282 shares outstanding as of June 30, 2024; and 50,154,929 shares issued and 50,140,233 shares outstanding as of December 31, 2023 |
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6 |
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5 |
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Additional paid-in capital |
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655,501 |
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547,857 |
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Accumulated other comprehensive loss |
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(2,670 |
) |
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(2,724 |
) |
Accumulated deficit |
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(428,166 |
) |
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(365,888 |
) |
Total stockholders’ equity |
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224,671 |
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179,250 |
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Total liabilities and stockholders’ equity |
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$ |
344,114 |
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$ |
303,755 |
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See accompanying notes to the condensed consolidated financial statements.
Monte Rosa Therapeutics, Inc.
Condensed consolidated statements of operations and comprehensive loss (unaudited)
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|
|
|
|
|
|
|
|
|
|
|
(in thousands, except share and per share amounts) |
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
(unaudited) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Collaboration revenue |
|
$ |
4,695 |
|
|
$ |
— |
|
|
$ |
5,759 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
28,055 |
|
|
|
29,076 |
|
|
|
55,081 |
|
|
|
55,831 |
|
General and administrative |
|
|
9,282 |
|
|
|
8,145 |
|
|
|
18,267 |
|
|
|
15,649 |
|
Total operating expenses |
|
|
37,337 |
|
|
|
37,221 |
|
|
|
73,348 |
|
|
|
71,480 |
|
Loss from operations |
|
|
(32,642 |
) |
|
|
(37,221 |
) |
|
|
(67,589 |
) |
|
|
(71,480 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2,637 |
|
|
|
2,302 |
|
|
|
5,079 |
|
|
|
4,739 |
|
Foreign currency exchange gain (loss), net |
|
|
(53 |
) |
|
|
(93 |
) |
|
|
567 |
|
|
|
(178 |
) |
Gain on disposal of fixed assets |
|
|
— |
|
|
|
24 |
|
|
|
— |
|
|
|
24 |
|
Loss on sale of marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(131 |
) |
Total other income |
|
|
2,584 |
|
|
|
2,233 |
|
|
|
5,646 |
|
|
|
4,454 |
|
Net loss before income taxes |
|
|
(30,058 |
) |
|
|
(34,988 |
) |
|
|
(61,943 |
) |
|
|
(67,026 |
) |
Provision for income taxes |
|
|
(252 |
) |
|
|
(190 |
) |
|
|
(335 |
) |
|
|
(190 |
) |
Net loss |
|
$ |
(30,310 |
) |
|
$ |
(35,178 |
) |
|
$ |
(62,278 |
) |
|
$ |
(67,216 |
) |
Net loss per share—basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.71 |
) |
|
$ |
(0.95 |
) |
|
$ |
(1.36 |
) |
Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted |
|
|
71,233,992 |
|
|
|
49,431,922 |
|
|
|
65,695,095 |
|
|
|
49,389,931 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(30,310 |
) |
|
$ |
(35,178 |
) |
|
$ |
(62,278 |
) |
|
$ |
(67,216 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Provision for pension benefit obligation |
|
|
35 |
|
|
|
14 |
|
|
|
70 |
|
|
|
28 |
|
Unrealized gain (loss) on available-for-sale securities |
|
|
(12 |
) |
|
|
(261 |
) |
|
|
(16 |
) |
|
|
84 |
|
Comprehensive loss |
|
$ |
(30,287 |
) |
|
$ |
(35,425 |
) |
|
$ |
(62,224 |
) |
|
$ |
(67,104 |
) |
See accompanying notes to the condensed consolidated financial statements.
Monte Rosa Therapeutics, Inc.
Condensed consolidated statements of stockholders’ equity (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except share amounts) (unaudited) |
|
Shares |
|
|
Amount |
|
|
Additional paid-in capital |
|
|
Accumulated other comprehensive loss |
|
|
Accumulated deficit |
|
|
Total Stockholders’ equity |
|
Balance—January 1, 2023 |
|
|
49,323,531 |
|
|
$ |
5 |
|
|
$ |
503,696 |
|
|
$ |
(1,752 |
) |
|
$ |
(230,536 |
) |
|
$ |
271,413 |
|
Restricted common stock vesting |
|
|
33,192 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Exercise of common stock options |
|
|
4,261 |
|
|
|
— |
|
|
|
18 |
|
|
|
— |
|
|
|
— |
|
|
|
18 |
|
Provision for pension benefit obligation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14 |
|
|
|
— |
|
|
|
14 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
3,974 |
|
|
|
— |
|
|
|
— |
|
|
|
3,974 |
|
Unrealized gain on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
345 |
|
|
|
— |
|
|
|
345 |
|
Net Loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(32,038 |
) |
|
|
(32,038 |
) |
Balance—March 31, 2023 |
|
|
49,360,984 |
|
|
$ |
5 |
|
|
$ |
507,688 |
|
|
$ |
(1,393 |
) |
|
$ |
(262,574 |
) |
|
$ |
243,726 |
|
Restricted common stock vesting |
|
|
32,185 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Exercise of common stock options |
|
|
147,333 |
|
|
|
— |
|
|
|
897 |
|
|
|
— |
|
|
|
— |
|
|
|
897 |
|
Provision for pension benefit obligation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14 |
|
|
|
— |
|
|
|
14 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
4,153 |
|
|
|
— |
|
|
|
— |
|
|
|
4,153 |
|
Unrealized loss on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(261 |
) |
|
|
— |
|
|
|
(261 |
) |
Issuance of shares under employee stock purchase plan |
|
|
51,977 |
|
|
|
— |
|
|
|
303 |
|
|
|
— |
|
|
|
— |
|
|
|
303 |
|
Net Loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(35,178 |
) |
|
|
(35,178 |
) |
Balance—June 30, 2023 |
|
|
49,592,479 |
|
|
$ |
5 |
|
|
$ |
513,041 |
|
|
$ |
(1,640 |
) |
|
$ |
(297,752 |
) |
|
$ |
213,654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance—January 1, 2024 |
|
|
50,140,233 |
|
|
$ |
5 |
|
|
$ |
547,857 |
|
|
$ |
(2,724 |
) |
|
$ |
(365,888 |
) |
|
$ |
179,250 |
|
Restricted common stock vesting |
|
|
4,691 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Exercise of common stock options |
|
|
45,108 |
|
|
|
— |
|
|
|
246 |
|
|
|
— |
|
|
|
— |
|
|
|
246 |
|
Provision for pension benefit obligation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
35 |
|
|
|
— |
|
|
|
35 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
4,873 |
|
|
|
— |
|
|
|
— |
|
|
|
4,873 |
|
Unrealized loss on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(4 |
) |
|
|
— |
|
|
|
(4 |
) |
Issuance of common stock pursuant to the at-the-market sales agreement |
|
|
10,272 |
|
|
|
— |
|
|
|
87 |
|
|
|
— |
|
|
|
— |
|
|
|
87 |
|
Net Loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(31,968 |
) |
|
|
(31,968 |
) |
Balance—March 31, 2024 |
|
|
50,200,304 |
|
|
$ |
5 |
|
|
$ |
553,063 |
|
|
$ |
(2,693 |
) |
|
$ |
(397,856 |
) |
|
$ |
152,519 |
|
Restricted common stock vesting |
|
|
85,249 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Exercise of common stock options |
|
|
190,160 |
|
|
|
— |
|
|
|
422 |
|
|
|
— |
|
|
|
— |
|
|
|
422 |
|
Provision for pension benefit obligation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
35 |
|
|
|
— |
|
|
|
35 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
4,502 |
|
|
|
— |
|
|
|
— |
|
|
|
4,502 |
|
Unrealized loss on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(12 |
) |
|
|
— |
|
|
|
(12 |
) |
Issuance of shares under employee stock purchase plan |
|
|
93,859 |
|
|
|
— |
|
|
|
298 |
|
|
|
— |
|
|
|
— |
|
|
|
298 |
|
Issuance of common stock pursuant to the at-the-market sales agreement, net of issuance costs of $89 |
|
|
120,234 |
|
|
|
— |
|
|
|
797 |
|
|
|
— |
|
|
|
— |
|
|
|
797 |
|
Issuance of common stock pursuant to the Underwritten Public Offering, net of issuance cost of $3,290 |
|
|
10,638,476 |
|
|
|
1 |
|
|
|
46,709 |
|
|
|
— |
|
|
|
— |
|
|
|
46,710 |
|
Issuance of pre-funded warrant, net of issuance costs of $290 |
|
|
— |
|
|
|
— |
|
|
|
49,710 |
|
|
|
— |
|
|
|
— |
|
|
|
49,710 |
|
Net Loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(30,310 |
) |
|
|
(30,310 |
) |
Balance—June 30, 2024 |
|
|
61,328,282 |
|
|
$ |
6 |
|
|
$ |
655,501 |
|
|
$ |
(2,670 |
) |
|
$ |
(428,166 |
) |
|
$ |
224,671 |
|
See accompanying notes to the condensed consolidated financial statements
Monte Rosa Therapeutics, Inc.
Condensed consolidated statements of cash flows (unaudited)
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Six months ended June 30, |
|
(unaudited) |
|
2024 |
|
|
2023 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(62,278 |
) |
|
$ |
(67,216 |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
|
Stock-based compensation expense |
|
|
9,375 |
|
|
|
8,127 |
|
Depreciation |
|
|
3,957 |
|
|
|
2,542 |
|
Net accretion of discounts/premiums on marketable securities |
|
|
(1,163 |
) |
|
|
(2,680 |
) |
Loss on sale of marketable securities |
|
|
— |
|
|
|
131 |
|
Gain on disposal of property and equipment |
|
|
— |
|
|
|
(24 |
) |
Changes in operating assets and liabilities |
|
|
|
|
|
|
Accounts receivable |
|
|
(9,000 |
) |
|
|
— |
|
Other receivables |
|
|
(337 |
) |
|
|
1,858 |
|
Prepaid expenses and other current assets |
|
|
(2,412 |
) |
|
|
547 |
|
Accounts payable |
|
|
(4,676 |
) |
|
|
(696 |
) |
Accrued expenses and other current liabilities |
|
|
(1,842 |
) |
|
|
(520 |
) |
Defined benefit plan liability |
|
|
(29 |
) |
|
|
— |
|
Right-of-use assets and operating lease liabilities |
|
|
(768 |
) |
|
|
9,201 |
|
Deferred revenue |
|
|
3,241 |
|
|
|
— |
|
Net cash used in operating activities |
|
$ |
(65,932 |
) |
|
$ |
(48,730 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(3,406 |
) |
|
|
(15,693 |
) |
Proceeds from the sale of property and equipment |
|
|
— |
|
|
|
62 |
|
Purchases of marketable securities |
|
|
(130,027 |
) |
|
|
(67,824 |
) |
Proceeds from sale of marketable securities |
|
|
— |
|
|
|
45,631 |
|
Proceeds from maturities of marketable securities |
|
|
82,128 |
|
|
|
76,700 |
|
Net cash provided by (used in) investing activities |
|
$ |
(51,305 |
) |
|
$ |
38,876 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
Proceeds from sale of common stock pursuant to the at-the-market sales agreement, net of underwriter's discount of $29 |
|
|
944 |
|
|
|
— |
|
Proceeds from underwritten public offering cost, net of underwriter's discount of $3,000 |
|
|
47,001 |
|
|
|
— |
|
Proceeds from the issuance of pre-funded warrants |
|
|
50,000 |
|
|
|
— |
|
Payment of common stock and pre-funded warrant issuance costs |
|
|
(641 |
) |
|
|
— |
|
Proceeds from exercise of employee stock options |
|
|
667 |
|
|
|
915 |
|
Proceeds from employee stock purchase plan |
|
|
298 |
|
|
|
303 |
|
Net cash provided by financing activities |
|
$ |
98,269 |
|
|
$ |
1,218 |
|
Net decrease in cash, cash equivalents and restricted cash |
|
$ |
(18,968 |
) |
|
$ |
(8,636 |
) |
Cash, cash equivalents and restricted cash—beginning of period |
|
|
132,681 |
|
|
|
60,190 |
|
Cash, cash equivalents and restricted cash—end of period |
|
$ |
113,713 |
|
|
$ |
51,554 |
|
Reconciliation of cash, cash equivalents and restricted cash |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
108,847 |
|
|
$ |
47,027 |
|
Restricted cash |
|
|
4,866 |
|
|
|
4,527 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
113,713 |
|
|
$ |
51,554 |
|
Supplemental disclosure of noncash items |
|
|
|
|
|
|
Reduction of right-of-use assets for lease incentives receivable |
|
$ |
— |
|
|
$ |
4,644 |
|
Purchases of property and equipment in accounts payable and accrued expenses |
|
$ |
235 |
|
|
$ |
1,438 |
|
See accompanying notes to the condensed consolidated financial statements.
Monte Rosa Therapeutics, Inc.
Notes to the condensed consolidated financial statements
(unaudited)
1. Description of business and liquidity
Business
Monte Rosa Therapeutics, Inc. is a biotechnology company developing a portfolio of novel small molecule precision medicines that employ the body’s natural mechanisms to selectively degrade therapeutically-relevant proteins. As used in these condensed consolidated financial statements, unless the context otherwise requires, references to the Company or Monte Rosa refer to Monte Rosa Therapeutics, Inc. and its wholly owned subsidiaries Monte Rosa Therapeutics AG, or Monte Rosa AG, and Monte Rosa Therapeutics Securities Corp. Monte Rosa Therapeutics AG, a Swiss operating company, was incorporated under the laws of Switzerland in April 2018. Monte Rosa Therapeutics, Inc. was incorporated in Delaware in November 2019. The Company is headquartered in Boston, Massachusetts with research operations in both Boston and Basel, Switzerland.
Liquidity considerations
Since inception, the Company has devoted substantially all its efforts to business planning, research and development, recruiting management and technical staff, and raising capital and has financed its operations primarily through issuance and sale of convertible promissory notes, convertible preferred stock, public offerings of common stock, registered direct offerings, and through a collaboration with Roche.
The Company’s continued discovery and development of its product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
As of June 30, 2024, the Company had an accumulated deficit of $428.2 million. The Company has incurred losses and negative cash flows from operations since inception, including net losses of $62.3 million and $67.2 million for the six months ended June 30, 2024 and 2023, respectively. The Company expects that its operating losses and negative cash flows will continue for the foreseeable future as the Company continues to develop its product candidates. The Company currently expects that its cash, cash equivalents, and marketable securities of $262.2 million as of June 30, 2024 will be sufficient to fund operating expenses and capital requirements for at least 12 months from the date the second quarter interim condensed consolidated financial statements are issued. However, additional funding will be necessary to fund future discovery research, pre-clinical and clinical activities. The Company will seek additional funding through public financings, debt financings, collaboration agreements, strategic alliances and licensing arrangements. Although it has been successful in raising capital in the past, there is no assurance that the Company will be successful in obtaining such additional financing on terms acceptable to it, if at all, and the Company may not be able to enter into collaborations or other arrangements. If the Company is unable to obtain funding, it could be forced to delay, reduce or eliminate its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect the Company’s business prospects, even the ability to continue operations.
2. Summary of significant accounting policies
Basis of presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP, and are stated in U.S. dollars. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification and Accounting Standards Updates, or ASUs, of the Financial Accounting Standards Board, or FASB. All intercompany balances and transactions have been eliminated in consolidation.
Unaudited Financial Information
The Company’s condensed consolidated financial statements included herein have been prepared in conformity with GAAP and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. In the Company’s opinion, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the financial position and results of operations for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are
issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period.
Recently issued accounting pronouncements
The Company has elected to use the extended transition period for complying with new or revised accounting standards as available under the Jumpstart Our Business Startups Act, or the JOBS Act.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources. These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment. The standard is effective for years beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024 and early adoption is permitted. The Company is currently in the process of evaluating the impact of this pronouncement on our related disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024 and early adoption is permitted. The impact of the adoption of this standard will be immaterial to the accompanying condensed consolidated financial statements.
3. Fair value measurements
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2024 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Current assets |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
108,209 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
108,209 |
|
Pension plan assets |
|
|
— |
|
|
|
8,977 |
|
|
|
— |
|
|
|
8,977 |
|
Corporate debt securities |
|
|
— |
|
|
|
73,618 |
|
|
|
— |
|
|
|
73,618 |
|
U.S Treasury securities |
|
|
— |
|
|
|
79,740 |
|
|
|
— |
|
|
|
79,740 |
|
Total assets measured at fair value |
|
$ |
108,209 |
|
|
$ |
162,335 |
|
|
$ |
— |
|
|
$ |
270,544 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2023 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Current assets |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
122,791 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
122,791 |
|
Pension plan assets |
|
|
— |
|
|
|
9,317 |
|
|
|
— |
|
|
|
9,317 |
|
Corporate debt securities |
|
|
— |
|
|
|
79,816 |
|
|
|
— |
|
|
|
79,816 |
|
U.S Treasury securities |
|
|
— |
|
|
|
24,496 |
|
|
|
— |
|
|
|
24,496 |
|
Total assets measured at fair value |
|
$ |
122,791 |
|
|
$ |
113,629 |
|
|
$ |
— |
|
|
$ |
236,420 |
|
Money market funds are highly liquid investments and are actively traded. The pricing information on the Company’s money market funds are based on quoted prices in active markets for identical securities. This approach results in the classification of these securities as Level 1 of the fair value hierarchy.
The fair value of pension plan assets has been determined as the surrender value of the portfolio of active insured members held within the Columna Collective Foundation Group investment fund and are classified within Level 2 of the fair value hierarchy.
Marketable securities consist of corporate debt securities and U.S. Treasury securities which are classified as available-for-sale pursuant to ASC 320, Investments—Debt and Equity Securities. Marketable securities are classified within Level 2 of the fair value hierarchy because pricing inputs are other than quoted prices in active markets. The fair values of these investments are estimated by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities based on historical data and other observable inputs.
There were no transfers among Level 1, Level 2 or Level 3 categories in the six months ended June 30, 2024 and 2023.
4. Marketable Securities
Marketable securities as of June 30, 2024 consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
Description |
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
$ |
73,655 |
|
|
$ |
6 |
|
|
$ |
(43 |
) |
|
|
73,618 |
|
U.S Treasury securities |
|
|
79,771 |
|
|
|
1 |
|
|
|
(32 |
) |
|
|
79,740 |
|
Total |
|
$ |
153,426 |
|
|
$ |
7 |
|
|
$ |
(75 |
) |
|
$ |
153,358 |
|
Market securities as of December 31, 2023 consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
Description |
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
$ |
79,870 |
|
|
$ |
4 |
|
|
$ |
(58 |
) |
|
|
|