# EDGAR Filing Document

**Accession Number:** 0001786255
**File Stem:** 0001193125-23-085563
**Filing Date:** 2023-3
**Character Count:** 21143
**Document Hash:** 7b18e20be9a45baf03d7e31f47ed2310
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-085563.hdr.sgml**: 20230330

**ACCESSION NUMBER**: 0001193125-23-085563

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230330

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230330

**DATE AS OF CHANGE**: 20230330

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Icosavax, Inc.
- **CENTRAL INDEX KEY:** 0001786255
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40655
- **FILM NUMBER:** 23780863

**BUSINESS ADDRESS:**
- **STREET 1:** 1930 BOREN AVE., SUITE 1000
- **CITY:** SEATTLE
- **STATE:** WA
- **ZIP:** 98101
- **BUSINESS PHONE:** (206) 737-0085

**MAIL ADDRESS:**
- **STREET 1:** 1930 BOREN AVE., SUITE 1000
- **CITY:** SEATTLE
- **STATE:** WA
- **ZIP:** 98101

?xml version="1.0" encoding="utf-8" ? 8-K

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

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### FORM 8-K

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#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of the Securities Exchange Act of 1934

#### Date of report (Date of earliest event reported): March 30, 2023

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## ICOSAVAX, INC.

#### (Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-40655** | **82-3640549** |
| **(State or other jurisdiction of**<br> **incorporation or organization)** | **(Commission**<br> **File Number)** | **(I.R.S. Employer**<br> **Identification No.)** |

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#### 1930 Boren Avenue, Suite 1000

#### Seattle, Washington 98101

#### (Address of principal executive offices) (Zip Code)
(206) 737-0085

#### (Registrant's telephone number, include area code)

#### N/A

#### (Former Name or Former Address, if Changed Since Last Report)

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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:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading<br>Symbol(s)** | **Name of each exchange<br>on which registered** |
| Common Stock, par value $0.0001 per share | ICVX | The Nasdaq Global Select Market |

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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. ☒

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#### Item 2.02 Results of Operations and Financial Condition.
On March 30, 2023, Icosavax, Inc. issued a press release announcing its financial results for the fourth quarter and full-year ended December 31, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, 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, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.

#### Item 9.01. Financial Statements and Exhibits.
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits

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| | |
|:---|:---|
| **Exhibit**<br>**No.** | **Description** |
| 99.1 | [Press Release Issued on March 30, 2023](d481904dex991.htm) |
| 104 | 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 hereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | ICOSAVAX, INC. | ICOSAVAX, INC. |
| Date: March 30, 2023 | By: | /s/ Thomas Russo |
|  |  | Thomas Russo |
|  |  | Chief Financial Officer |

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## Exhibit 99.1

**Exhibit 99.1**![LOGO](g481904g0330181831769.jpg)

**Icosavax Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update** 

*- FDA granted Fast Track Designation for IVX-A12, a bivalent respiratory syncytial virus (RSV) and human* 

*metapneumovirus (hMPV) VLP vaccine candidate -* 

*- Completed dosing in ongoing Phase 1 study of IVX-A12; topline interim results expected in 2Q 2023 -* 

*- Initiation of IVX-A12 Phase 2 trial expected in 2H 2023 -* 

*- Cash and cash equivalents, restricted cash, and short-term investments of $219.4M at end 4Q 2022 -* 

**SEATTLE, March 30, 2023 - Icosavax, Inc. (Nasdaq: ICVX),** a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases and a vision of creating pan-respiratory vaccines for older adults, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.

"We are proud of the progress we made in 2022, which included announcing positive interim results from our Phase 1/1b IVX-121 monovalent respiratory syncytial virus trial, followed by promising durability data at the six-month timepoint. Additionally, we initiated our Phase 1 trial for IVX-A12, a bivalent respiratory syncytial virus and human metapneumovirus VLP vaccine candidate," said Adam Simpson, Chief Executive Officer of Icosavax. "We have now completed dosing and plan to announce topline data for this Phase 1 trial in 2Q 2023, followed by the planned initiation of a Phase 2 study in the second half of this year. In February, our IVX-A12 program was further boosted when it was granted Fast Track designation by the FDA. These achieved and prospective milestones, along with a 12-month durability data readout from our IVX-121 Phase 1b extension trial around mid-year, mean that 2023 is shaping up to be an exciting period for Icosavax as we continue to work towards our vision."

**Fourth Quarter 2022 and Subsequent Highlights** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Completed enrollment in Phase 1 clinical trial of IVX-A12 (RSV/hMPV).** During the quarter, Icosavax completed dosing in the Phase 1 clinical trial of IVX-A12, a combination bivalent RSV and hMPV VLP vaccine candidate, in older adults. IVX-A12 is comprised of IVX-121, Icosavax's RSV prefusion F protein VLP vaccine candidate, and IVX-241, Icosavax's hMPV
prefusion F protein VLP vaccine candidate. The company expects to report topline interim results for this study in 2Q 2023.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Granted FDA Fast Track Designation for IVX-A12.** In February,
Icosavax announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IVX-A12, a bivalent RSV and hMPV VLP vaccine candidate, in older adults 60 years of age and above.
Icosavax plans to utilize the benefits of this important regulatory milestone in its efforts to optimize the IVX-A12 development plan.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Reported Positive Durability Data for IVX-121 (RSV) at Six-Month Timepoint**. In December, the company provided a six-month immunogenicity update from its Phase 1/1b trial of IVX-121 against RSV. In these data, IVX-121 showed sustained immunologic response at six months, with geometric mean titers (GMT) against RSV-A through day 180 persisting at 64-98% of the GMTs at day 28 in older adults.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Appointed Jennifer Raymond as Senior Vice President, Technical Operations.** In January,
Icosavax appointed Jennifer Raymond as SVP, Technical Operations. Jennifer is a pharmaceutical executive with more than 20 years in biologics manufacturing including vaccines and monoclonal antibodies. She joins Icosavax most recently from
GreenLight Biosciences, where she was SVP of CMC and Manufacturing, having previously served in roles of increasing responsibility at GSK, Novartis Vaccines and Diagnostics, Elan Pharmaceuticals, and Merck.

**Near-Term Milestone Expectations** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• IVX-A12 (RSV+hMPV) Phase 1 topline interim data expected in 2Q 2023

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• IVX-121 (RSV) Phase 1b extension, 12-month immunogenicity data expected in mid-2023

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• IVX-A12 (RSV+hMPV) Phase 2 initiation expected in 2H 2023

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Flu program candidate selection expected in 2023

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• COVID-19 bivalent candidate selection expected in 2023

**Fourth Quarter and Full Year 2022 Financial Results** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Cash, cash equivalents, restricted cash, and short-term investments** as of December 31,
2022 was $219.4 million, compared to $280.7 million as of December 31, 2021. The amount as of December 31, 2022 includes $9.4 million of net proceeds from the issuance of common shares under Icosavax's at-the-market (ATM) program. Icosavax currently expects its cash balance to be sufficient to fund operations through at least 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Research and development (R&D) expenses** for the three and twelve months ended
December 31, 2022 were $16.2 million and $65.4 million, respectively, compared to $14.1 million and $38.8 million for the same periods in 2021, respectively. The increases were primarily driven by increased clinical
development activity, increased preclinical development and manufacturing activity, and increased personnel related expenses and stock-based compensation expense. Research and development expenses include non-cash stock-based compensation expense of $2.2 million and $8.1 million for the three and twelve months ended December 31, 2022, respectively.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **General and administrative (G&A) expenses** for the three and twelve months ended
December 31, 2022 were $8.9 million and $30.2 million, respectively, compared to $6.2 million and $34.9 million for the same periods in 2021, respectively. The twelve months ended December 31, 2021 included
$21.0 million in one-time, non-cash stock-based compensation expense from the acceleration of options in connection with the death of Icosavax's former co-founder and Chairman (Tachi Yamada) in 2021. Increases in G&A expenses were primarily due to increased personnel costs, increased professional services and insurance costs, and other operating expenses
primarily related to facilities costs to support the company's growth. General and administrative expenses include non-cash stock-based compensation expense of $4.0 million and $13.6 million for
the three and twelve months ended December 31, 2022, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Net loss** for the three and twelve months ended December 31, 2022 was
$23.6 million and $91.8 million, respectively, or a basic and diluted net loss per share attributable to common stockholders of $0.59 and $2.31, respectively. This includes non-cash stock-based
compensation expense of $6.2 million and $21.7 million for the three and twelve months ended December 31, 2022, respectively. Net loss for the same periods in 2021 was $18.2 million and $67.0 million, respectively, or a
basic and diluted net loss per share attributable to common stockholders of $0.46 and $3.73, respectively.

**About Icosavax** 

Icosavax is a biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases and a vision for combination and pan-respiratory vaccines. Icosavax's VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Icosavax's lead program is a combination vaccine candidate targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), and its pipeline includes additional programs in influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases. Icosavax is located in Seattle.

For more information, visit <u>www.icosavax.com</u>.

**Forward-Looking Statements** 

Statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on the company's current beliefs and expectations and include, but are not limited to: the company's expectation regarding the opportunities for, and the prophylactic and commercial potential of, its vaccine candidates and technology platform; the company's ability to advance its development program and achieve the noted development milestones in 2023; and the sufficiency of the company's current cash, cash equivalents, and investments to fund its operations through at least 2024. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the company's business, including, without limitation: the early stage of the company's development efforts; the company's approach to the development of vaccine candidates, including its plan to develop a combination bivalent RSV/hMPV VLP vaccine candidate, which is a novel and unproven approach; potential delays in the development process including without limitation in candidate development, IND submission, the commencement,

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enrollment, conduct of, and receipt of data from, clinical trials; unexpected adverse side effects or inadequate immunogenicity or efficacy of the company's vaccine candidates that may limit their development, regulatory approval, and/or commercialization; results from preclinical studies or early clinical trials not necessarily being predictive of future results; the company's dependence on third parties in connection with manufacturing, research, and clinical testing; the potential for challenges encountered in the manufacturing and scale up process, including without limitation challenges that reduce drug product stability or potency; competing approaches limiting the commercial value of the company's vaccine candidates; regulatory developments in the United States and other countries; the company's ability to obtain and maintain intellectual property protection for its vaccine candidates and maintain its rights under intellectual property licenses; the company's ability to fund its operating plans with its current cash, cash equivalents, and investments; and other risks described in the company's prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2022 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

**Media Contact:** 

Jessica Yingling, Ph.D.,

Little Dog Communications Inc.

<u>jessica@litldog.com</u>

858.344.8091 **Investor Contact:** 

Laurence Watts

Gilmartin Group, LLC

<u>laurence@gilmartinir.com</u>

619.916.7620 ------

**ICOSAVAX, INC.** 

**Balance Sheets** 

(in thousands)

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| | | |
|:---|:---|:---|
|  | **December 31,** | **December 31,** |
|  | **2022** | **2021** |
|  **Assets** |  |  |
|  Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Cash and cash equivalents | $58846 | $279082 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Restricted cash | 1061 | 1642 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Short-term investments | 159461 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Prepaid expenses and other current assets | 4545 | 5829 |
|  Total current assets | 223913 | 286553 |
|  Right-of-use assets – operating leases | 3247 |  |
|  Property and equipment, net | 11517 | 1076 |
|  Total assets | $238677 | $287629 |
|  **Liabilities and stockholders' equity** |  |  |
|  Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Accounts payable | $2892 | $3899 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Accrued and other current liabilities | 8759 | 4757 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Current portion of operating lease liabilities | 2137 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Deferred revenue |  | 582 |
|  Total current liabilities | 13788 | 9238 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Operating lease liabilities, net of current portion | 6658 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Other noncurrent liabilities | 69 | 171 |
|  Total liabilities | 20515 | 9409 |
|  Stockholders' equity: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Common stock | 6 | 5 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Additional paid-in capital | 404386 | 372284 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Accumulated other comprehensive loss | (403) |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Accumulated deficit | (185827) | (94069) |
|  Total stockholders' equity | 218162 | 278220 |
|  Total liabilities and stockholders' equity | $238677 | $287629 |

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**ICOSAVAX, INC.** 

**Condensed Statements of Operations and Comprehensive Loss** 

(in thousands, except share and per share data)

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended<br>December 31,** | **Three Months Ended<br>December 31,** | **Year Ended<br>December 31,** | **Year Ended<br>December 31,** |
|  | **2022** | **2021** | **2022** | **2021** |
|  | **(Unaudited)** | **(Unaudited)** | | |
|  Grant revenue | $— | $2070 | $582 | $7802 |
|  Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Research and development | 16193 | 14063 | 65410 | 38776 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; General and administrative | 8938 | 6218 | 30230 | 34887 |
|  Total operating expenses | 25131 | 20281 | 95640 | 73663 |
|  Loss from operations | (25131) | (18211) | (95058) | (65861) |
|  Other income (expense): |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Change in fair value of embedded derivative liability |  |  |  | (205) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Loss on extinguishment of convertible promissory note |  |  |  | (754) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Interest and other | 1518 | 29 | 3300 | (151) |
|  Total other income (expense) | 1518 | 29 | 3300 | (1110) |
|  Net loss | $(23613) | $(18182) | $(91758) | $(66971) |
|  Comprehensive loss: |  |  |  |  |
|  Unrealized losses on available-for-sale debt securities | 206 |  | (403) |  |
|  Comprehensive loss | $(23407) | $(18182) | $(92161) | $(66971) |
|  Net loss per share, basic and diluted | $(0.59) | $(0.46) | $(2.31) | $(3.73) |
|  Weighted-average common shares outstanding, basic and diluted | 39811323 | 39139724 | 39725131 | 17965894 |

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