UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
|
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2020
OR
|
☐ |
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: 001-39409
ALLOVIR, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware |
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83-1971007 |
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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139 Main Street, Suite 500 Cambridge, MA |
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02142 |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (617) 433-2605
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 |
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Common Stock, par value $0.0001 per share |
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ALVR |
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The Nasdaq Global 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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☐ |
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Accelerated filer |
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☐ |
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Non-accelerated filer |
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☒ |
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Smaller reporting company |
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☒ |
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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 November 9, 2020, the registrant had 65,106,873 shares of common stock, $0.0001 par value per share, outstanding.
Table of Contents
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Page |
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PART I. |
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Item 1. |
4 |
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4 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
5 |
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6 |
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8 |
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9 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
22 |
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Item 3. |
31 |
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Item 4. |
32 |
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PART II. |
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Item 1. |
33 |
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Item 1A. |
33 |
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Item 2. |
78 |
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Item 3. |
78 |
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Item 4. |
78 |
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Item 5. |
78 |
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Item 6. |
79 |
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80 |
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i
Summary of Material Risks Associated with Our Business
Our business is subject to numerous risks and uncertainties that you should be aware of before making an investment decision, including those highlighted in the section entitled “Risk Factors.” These risks include, but are not limited to, the following:
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• |
Our business could be adversely affected by the effects of health epidemics, including the recent COVID-19 pandemic, in regions where third parties for which we rely, as in CROs or CMOs, have significant research, development or manufacturing facilities, concentrations of clinical trial sites or other business operations, causing disruption in supplies and services. |
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• |
We are a late clinical-stage cell therapy company and we have incurred net losses since our inception. We anticipate that we will continue to incur significant losses for the foreseeable future, and may never achieve or maintain profitability. |
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• |
Our business is highly dependent on our lead product candidate, Viralym-M, and we must complete clinical testing before we can seek regulatory approval and begin commercialization of any of our product candidates. |
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• |
We depend substantially on intellectual property licensed from third parties, including BCM, and termination of any of these licenses could result in the loss of significant rights, which would harm our business. |
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• |
If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates and manufacturing process, or if the scope of the intellectual property protection is not sufficiently broad, our ability to commercialize our product candidates successfully and to compete effectively may be adversely affected. |
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• |
We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product discovery and development programs or commercialization efforts. |
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• |
We have a limited operating history, which may make it difficult to evaluate the success of our business to date and to assess our future viability. |
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• |
We are early in our development efforts and have only a small number of product candidates in clinical development. All of our other product candidates are still in preclinical development. If we or our collaborators are unable to successfully develop and commercialize product candidates or experience significant delays in doing so, our business may be materially harmed. |
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• |
Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and the inability to successfully and timely conduct clinical trials and obtain regulatory approval for our product candidates would substantially harm our business. |
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• |
The results of preclinical studies or earlier clinical trials are not necessarily predictive of future results. Our existing product candidates in clinical trials, and any other product candidate we advance into clinical trials, may not have favorable results in later clinical trials or receive regulatory approval. |
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• |
Our product candidates, the methods used to deliver them or their dosage levels may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following any regulatory approval. |
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• |
We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do. |
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• |
We and our third-party partners are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates. |
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• |
We intend to develop an efficient and highly productive manufacturing supply chain for our allogeneic, off-the-shelf single- and multi-VST cell therapies. Delays in process performance qualification to validate the drug product manufacturing process could delay regulatory approvals, our development plans and thereby limit our ability to generate revenues. |
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• |
We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. |
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• |
The trading price of our common stock may be volatile. |
The summary risk factors described above should be read together with the text of the full risk factors below, in the section entitled “Risk Factors” and the other information set forth in this Quarterly Report on Form 10-Q, including our consolidated financial statements and the related notes, as well as in other documents that we file with the SEC. The risks summarized above or described in full below are not the only risks that we face. Additional risks and uncertainties not precisely known to us, or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, results of operations and future growth prospects.
1
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements, including but not limited to, statements about:
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• |
the success, cost, timing and potential indications of our product development activities and clinical trials, including the ongoing clinical trials of Viralym-M, ALVR106 and ALVR109; |
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• |
the timing of our planned Investigational New Drug (IND) submissions to the FDA for our product candidates, including ALVR106, ALVR109, ALVR107 and ALVR108; |
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• |
the timing of the initiation, enrollment and completion of planned clinical trials; |
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• |
our plans to research, develop and commercialize our product candidates, including Viralym-M, ALVR106, ALVR109, ALVR107 and ALVR108; |
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• |
the outcomes of our preclinical studies; |
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• |
the costs of development of any of our product candidates or clinical development programs and our ability to obtain funding for our operations, including funding necessary to complete the clinical trials of any of our product candidates; |
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• |
our ability to successfully manufacture and distribute Viralym-M and ALVR106 or any other future product or product candidate, including under the Development and Manufacturing Services Agreement with ElevateBio BaseCamp, Inc.; |
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• |
the potential benefits of and our ability to maintain our collaboration with our existing collaborators, including BCM, and establish or maintain future collaborations or strategic relationships or obtain additional funding; |
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• |
the ability to maintain our existing license agreements, including BCM, and to license additional intellectual property relating to any future product candidates and to comply with our existing license agreements; |
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• |
our ability to attract and retain collaborators with development, regulatory and commercialization expertise; |
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• |
risks associated with the COVID-19 pandemic, which may adversely impact our business and clinical trials; |
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• |
the size of the markets for our VST product candidates, and our ability to serve those markets; |
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• |
whether the results of our clinical trials will be sufficient to support domestic or foreign regulatory approvals for any of our product candidates; |
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• |
our ability to successfully commercialize our product candidates, including Viralym-M and ALVR106; |
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• |
the rate and degree of market acceptance of our product candidates, including Viralym-M and ALVR106; |
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• |
our ability to obtain and maintain regulatory approval of our product candidates in any of the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of any approved product we develop; |
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• |
our ability to develop and maintain sales and marketing capabilities, whether alone or with potential future collaborators; |
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• |
regulatory developments in the United States and foreign countries with respect to our product candidates or our competitors’ products and product candidates; |
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• |
our reliance on third-party contract manufacturers and the performance of our third-party suppliers and manufacturers to manufacture and supply our product candidates for us; |
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• |
the success of competing therapies that are or become available; |
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• |
our ability to attract and retain key scientific or management personnel; |
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• |
our expectation about the period of time over which our existing capital resources will be sufficient to fund our operating expenses and capital expenditures; |
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• |
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; |
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• |
our financial performance; |
2
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• |
developments and projections relating to our competitors or our industry; |
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• |
the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and |
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• |
our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others. |
In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.
You should read the section titled “Risk Factors” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
You should read this Quarterly Report on Form 10-Q, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
3
Item 1. Financial Statements (unaudited)
ALLOVIR, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
|
(in thousands, except share and per share amounts) |
|
September 30, 2020 |
|
|
December 31, 2019 |
|
||
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Assets |
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|
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|
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Current assets: |
|
|
|
|
|
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|
|
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Cash and cash equivalents |
|
$ |
142,250 |
|
|
$ |
61,084 |
|
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Short-term investments |
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|
236,238 |
|
|
|
64,993 |
|
|
Accrued interest |
|
|
423 |
|
|
|
262 |
|
|
Unbilled grant receivables |
|
|
169 |
|
|
|
298 |
|
|
Prepaid expenses and other current assets |
|
|
4,861 |
|
|
|
676 |
|
|
Total current assets |
|
|
383,941 |
|
|
|
127,313 |
|
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Property and equipment |
|
|
295 |
|
|
|
350 |
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Operating lease right-of-use assets |
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|
9,474 |
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|
|
11,759 |
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Total assets |
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$ |
393,710 |
|
|
$ |
139,422 |
|
|
Liabilities, convertible preferred stock and stockholders’ equity (deficit) |
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|
|
|
|
|
|
|
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Current liabilities: |
|
|
|
|
|
|
|
|
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Accounts payable |
|
$ |
1,843 |
|
|
$ |
630 |
|
|
Accrued expenses |
|
|
7,849 |
|
|
|
5,163 |
|
|
Operating lease liability, current |
|
|
3,188 |
|
|
|
3,067 |
|
|
Amount due to related party |
|
|
641 |
|
|
|
246 |
|
|
Total current liabilities |
|
|
13,521 |
|
|
|
9,106 |
|
|
Operating lease liability, long term |
|
|
6,286 |
|
|
|
8,692 |
|
|
Total liabilities |
|
|
19,807 |
|
|
|
17,798 |
|
|
Series B preferred stock, $0.0001 par value: 0 and 14,877,697 shares authorized, issued and outstanding at September 30, 2020 and December 31, 2019, respectively |
|
|
— |
|
|
|
120,923 |
|
|
Series A preferred stock, $0.0001 par value: 0 and 64,520,653 shares authorized at September 30, 2020 and December 31, 2019, respectively; 0 and 44,520,653 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively |
|
|
— |
|
|
|
52,204 |
|
|
Stockholders’ equity (deficit): |
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value: 10,000,000 shares authorized at September 30, 2020 and 0 at December 31, 2019; 0 issued and outstanding at September 30, 2020 and December 31, 2019, respectively |
|
|
— |
|
|
|
— |
|
|
Common stock, $0.0001 par value: 150,000,000 and 90,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 65,106,873 and 6,502,929 issued at September 30, 2020 and December 31, 2019, respectively; 61,659,533 and 2,099,740 outstanding at September 30, 2020 and December 31, 2019, respectively |
|
|
7 |
|
|
|
— |
|
|
Additional paid-in capital |
|
|
473,841 |
|
|
|
3,748 |
|
|
Accumulated other comprehensive (loss) income |
|
|
(41 |
) |
|
|
68 |
|
|
Accumulated deficit |
|
|
(99,904 |
) |
|
|
(55,319 |
) |
|
Total stockholders’ equity (deficit) |
|
|
373,903 |
|
|
|
(51,503 |
) |
|
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) |
|
$ |
393,710 |
|
|
$ |
139,422 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
UNAUDITED
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
(in thousands, except share and per share amounts) |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
||||
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
165 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
17,182 |
|
|
|
5,655 |
|
|
|
32,906 |
|
|
|
9,561 |
|
|
General and administrative |
|
|
6,718 |
|
|
|
2,823 |
|
|
|
12,987 |
|
|
|
7,800 |
|
|
Total operating expenses |
|
|
23,900 |
|
|
|
8,478 |
|
|
|
45,893 |
|
|
|
17,361 |
|
|
Loss from operations |
|
|
(23,900 |
) |
|
|
(8,478 |
) |
|
|
(45,893 |
) |
|
|
(17,196 |
) |
|
Total other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
112 |
|
|
|
781 |
|
|
|
735 |
|
|
|
1,400 |
|
|
Other income, net |
|
|
174 |
|
|
|
427 |
|
|
|
573 |
|
|
|
700 |
|
|
Net loss |
|
$ |
(23,614 |
) |
|
$ |
(7,270 |
) |
|
$ |
(44,585 |
) |
|
$ |
(15,096 |
) |
|
Net loss per share — basic and diluted |
|
$ |
(0.58 |
) |
|
$ |
(4.97 |
) |
|
$ |
(2.93 |
) |
|
$ |
(13.67 |
) |
|
Weighted-average common shares outstanding — basic and diluted |
|
|
40,465,705 |
|
|
|
1,463,421 |
|
|
|
15,195,000 |
|
|
|
1,104,454 |
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(23,614 |
) |
|
$ |
(7,270 |
) |
|
$ |
(44,585 |
) |
|
$ |
(15,096 |
) |
|
Other comprehensive (loss) income, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on available-for-sale securities |
|
|
(125 |
) |
|
|
(27 |
) |
|
|
(83 |
) |
|
|
102 |
|
|
Unrealized (loss) gain on foreign currency translation |
|
|
(26 |
) |
|
|
— |
|
|
|
(26 |
) |
|
|
— |
|
|
Total other comprehensive (loss) income |
|
|
(151 |
) |
|
|
(27 |
) |
|
|
(109 |
) |
|
|
102 |
|
|
Comprehensive loss |
|
$ |
(23,765 |
) |
|
$ |
(7,297 |
) |
|
$ |
(44,694 |
) |
|
$ |
(14,994 |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
UNAUDITED
|
|
|
Series B Preferred Stock |
|
|
Series A Preferred Stock |
|
|
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total Stockholders’ |
|
|||||||||||||||||||
|
(in thousands, except share amounts) |
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income |
|
|
Deficit |
|
|
Deficit |
|
||||||||||
|
Balance at December 31, 2018 |
|
|
— |
|
|
$ |
— |
|
|
|
42,066,666 |
|
|
$ |
52,204 |
|
|
|
|
747,231 |
|
|
$ |
— |
|
|
$ |
858 |
|
|
|
— |
|
|
$ |
(31,480 |
) |
|
$ |
(30,622 |
) |
|
Issuance of common stock, upon vesting of restricted stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
140,106 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
231 |
|
|
|
— |
|
|
|
— |
|
|
|
231 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,524 |
) |
|
|
(2,524 |
) |
|
Balance at March 31, 2019 |
|
|
— |
|
|
$ |
— |
|
|
|
42,066,666 |
|
|
$ |
52,204 |
|
|
|
|
887,337 |
|
|
$ |
— |
|
|
$ |
1,089 |
|
|
$ |
— |
|
|
$ |
(34,004 |
) |
|
$ |
(32,915 |
) |
|
Issuance of Series B Preferred Stock, net of $330 issuance costs |
|
|
14,877,697 |
|
|
$ |
120,923 |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock, upon vesting of restricted stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
510,876 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Unrealized gain on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
129 |
|
|
|
— |
|
|
|
129 |
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
1,441 |
|
|
|
— |
|
|
|
— |
|
|
|
1,441 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,302 |
) |
|
|
(5,302 |
) |
|
Balance at June 30, 2019 |
|
|
14,877,697 |
|
|
$ |
120,923 |
|
|
|
42,066,666 |
|
|
$ |
52,204 |
|
|
|
|
1,398,213 |
|
|
$ |
— |
|
|
$ |
2,530 |
|
|
$ |
129 |
|
|
$ |
(39,306 |
) |
|
$ |
(36,647 |
) |
|
Issuance of common stock, upon vesting of restricted stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
211,198 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Unrealized gain on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(27 |
) |
|
|
— |
|
|
|
(27 |
) |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
596 |
|
|
|
— |
|
|
|
— |
|
|
|
596 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,270 |
) |
|
|
(7,270 |
) |
|
Balance at September 30, 2019 |
|
|
14,877,697 |
|
|
|
120,923 |
|
|
|
42,066,666 |
|
|
|
52,204 |
|
|
|
|
1,609,411 |
|
|
|
— |
|
|
|
3,126 |
|
|
|
102 |
|
|
|
(46,576 |
) |
|
|
(43,348 |
) |
6
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
UNAUDITED
|
|
|
Series B Preferred Stock |
|
|
Series A Preferred Stock |
|
|
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total Stockholders’ |
|
|||||||||||||||||||
|
(in thousands, except share amounts) |
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income |
|
|
Deficit |
|
|
Equity (Deficit) |
|
||||||||||
|
Balance at December 31, 2019 |
|
|
14,877,697 |
|
|
$ |
120,923 |
|
|
|
44,520,653 |
|
|
$ |
52,204 |
|
|
|
|
2,099,740 |
|
|
$ |
— |
|
|
$ |
3,748 |
|
|
$ |
68 |
|
|
$ |
(55,319 |
) |
|
$ |
(51,503 |
) |
|
Issuance of common stock, upon vesting of restricted stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
292,644 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Unrealized gain available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
176 |
|
|
|
— |
|
|
|
176 |
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
646 |
|
|
|
— |
|
|
|
— |
|
|
|
646 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(9,339 |
) |
|
|
(9,339 |
) |
|
Balance at March 31, 2020 |
|
|
14,877,697 |
|
|
$ |
120,923 |
|
|
|
44,520,653 |
|
|
$ |
52,204 |
|
|
|
|
2,392,384 |
|
|
$ |
— |
|
|
$ |
4,394 |
|
|
$ |
244 |
|
|
$ |
(64,658 |
) |
|
$ |
(60,020 |
) |
|
Issuance of common stock, upon vesting of restricted stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
409,475 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Unrealized loss available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(134 |
) |
|
|
— |
|
|
|
(134 |
) |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
492 |
|
|
|
— |
|
|
|
— |
|
|
|
492 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(11,632 |
) |
|
|
(11,632 |
) |
|
Balance at June 30, 2020 |
|
|
14,877,697 |
|
|
$ |
120,923 |
|
|
|
44,520,653 |
|
|
$ |
52,204 |
|
|
|
|
2,801,859 |
|
|
$ |
— |
|
|
$ |
4,886 |
|
|
$ |
110 |
|
|
$ |
(76,290 |
) |
|
$ |
(71,294 |
) |
|
Issuance of common stock, upon vesting of restricted stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
311,035 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Initial public offering, net of underwriting discounts, commissions and offering costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
18,687,500 |
|
|
|
2 |
|
|
|
291,973 |
|
|
|
— |
|
|
|
— |
|
|
|
291,975 |
|
|
Conversion of convertible preferred stock into common stock upon initial public offering |
|
|
(14,877,697 |
) |
|
|
(120,923 |
) |
|
|
(44,520,653 |
) |
|
|
(52,204 |
) |
|
|
|
39,859,139 |
|
|
|
5 |
|
|
|
173,122 |
|
|
|
— |
|
|
|
— |
|
|
|
173,127 |
|
|
Unrealized loss available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(125 |
) |
|
|
— |
|
|
|
(125 |
) |
|
Unrealized loss on foreign currency translation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(26 |
) |
|
|
— |
|
|
|
(26 |
) |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
3,860 |
|
|
|
— |
|
|
|
— |
|
|
|
3,860 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(23,614 |
) |
|
|
(23,614 |
) |
|
Balance at September 30, 2020 |
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
|
|
61,659,533 |
|
|
$ |
7 |
|
|
$ |
473,841 |
|
|
$ |
(41 |
) |
|
$ |
(99,904 |
) |
|
$ |
373,903 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
7
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
UNAUDITED
|
|
|
Nine Months Ended September 30, |
|
|||||
|
(in thousands) |
|
2020 |
|
|
2019 |
|
||
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(44,585 |
) |
|
$ |
(15,096 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
55 |
|
|
|
— |
|
|
Accretion of discounts on short-term investments |
|
|
92 |
|
|
|
||