UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On November 14, 2023, HCW Biologics Inc. issued a press release announcing its financial results for the quarter ended September 30, 2023. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth in this Item 2.02 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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HCW BIOLOGICS INC. |
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Date: |
November 14, 2023 |
By: |
/s/ Hing C. Wong |
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Hing C. Wong |
Exhibit 99.1
HCW Biologics Reports Third Quarter 2023 Financial Results
And Recent Business Highlights
Miramar, FL – November 14, 2023 – HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2023.
A human data readout from the ongoing Phase 1 clinical trial to evaluate HCW9218 in patients with chemo-refractory/chemo-resistant solid tumors was presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (“SITC”) by Melissa A. Geller, M.D., M.S., Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota, who serves as a Principal Investigator of this trial, which is sponsored by the University of Minnesota.
Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “We believe the findings we shared in the preliminary human data readout at SITC provide support for future Phase 2 studies of HCW9218 in combination with chemotherapy and/or immune checkpoint inhibitors against solid tumors in patients with ovarian cancer. We are pleased to see the consistency of results in humans with those that we saw in our preclinical animal studies. Together, we believe these findings verify the balanced bifunctional activities of HCW9218 in stimulating effector immune cells and reducing TGF-β-mediated responses.”
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Business Highlights:
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Third Quarter 2023 Financial Results:
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Financial Guidance
As of September 30, 2023, the Company held $11.2 million in cash and cash equivalents. In addition, the Company recognized prepaid expenses of $1.7 million, and a deposit for interest reserve of $5.3 million. The Company advanced $4.4 million toward its new lab and manufacturing facilities prior to drawing funds available under the 2023 Loan Agreement. With the current cash and cash equivalents and funds available to the Company under the 2023 Loan Agreement, including recouping the amounts advanced toward its new lab and manufacturing facilities, the Company believes it has adequate capital to fund operations and other commitments to the end of 2024.
On April 27, 2023, in connection with the Altor/NantCell matter, the U.S. District Court for the Southern District of Florida (the “Court”) approved the parties’ stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Altor/NantCell’s proceeding against the Company is now proceeding in arbitration before JAMS. Although adverse decisions (or settlements) may occur in arbitration, it is not possible to reasonably estimate the possible loss or range of loss, if any, associated therewith at this time. As such, no accrual for these matters has been recorded within the Company’s financial statements. In the year ahead, the Company expects to continue to incur legal expenses on its own behalf in connection with the legal proceedings brought against it by Altor/NantCell. Further, while legal expenses incurred by Dr. Wong in connection with the arbitration against him that was initiated by Altor/NantCell are covered through advancement of expenses from Altor/NantCell, under certain circumstances, the Company may be required to advance his legal fees. The Company incurred legal expenses on its own behalf in the period ended September 30, 2023, and it expects to continue to incur material costs and expenses in connection with defending itself in the foregoing legal matters through the end of 2023 and into 2024.
About HCW Biologics
HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, autoimmune diseases, as well as other conditions such as long-haul COVID-19. The Company has combined a deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ (Tissue factOr-Based fusIon) discovery platform. The Company uses its TOBITM discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The invention of HCW Biologics’ two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The Company currently has two ongoing clinical trials to evaluate HCW9218 in cancer indications. The Masonic Cancer Center, University of Minnesota, is the sponsor of a Phase 1 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant solid tumors that have progressed after prior chemotherapies (Clinicaltrials.gov: NCT05322408). The Company is the sponsored of a Phase 1b/2 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant advanced pancreatic cancer (Clinicaltrials.gov: NCT05304936). The Company’s lead molecule for its regulatory T cell expansion program, HCW9302, is currently undergoing IND-enabling studies for an autoimmune indication.
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Forward Looking Statements:
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, without limitation, statements regarding completion of Phase 1/1b clinical studies in cancer; potential of HCW9218 to treat other aging-associated diseases beyond cancer; potential of HCW9218 as a combination therapy with checkpoint inhibitors and of HCW9218’s mechanism of action; timing of completion for trials; the Company’s cash runway; the Company’s expectations regarding future purchases by Wugen; timing of submission of INDs; duration of the supply of the Company’s lead molecules; and timing and outcome of the Altor/NantCell arbitration and the Company’s liability related thereto. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2023, the Form 10-Q filed with the SEC on November 14, 2023, and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
Company Contact:
Rebecca Byam
CFO
HCW Biologics Inc.
rebeccabyam@hcwbiologics.com
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HCW Biologics Inc.
Condensed Statements of Operations
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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2022 |
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2023 |
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2022 |
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2023 |
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Revenues: |
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Revenues |
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$ |
1,809,025 |
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$ |
853,102 |
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$ |
5,380,570 |
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$ |
1,517,792 |
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Cost of revenues |
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(1,447,220 |
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(678,325 |
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(3,062,496 |
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(1,210,077 |
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Net revenues |
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361,805 |
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174,777 |
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2,318,074 |
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307,715 |
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Operating expenses: |
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Research and development |
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2,648,794 |
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1,667,442 |
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6,408,353 |
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5,539,919 |
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General and administrative |
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1,732,666 |
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3,585,215 |
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5,321,262 |
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9,716,765 |
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Total operating expenses |
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4,381,460 |
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5,252,657 |
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11,729,615 |
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15,256,684 |
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Loss from operations |
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(4,019,655 |
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(5,077,880 |
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(9,411,541 |
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(14,948,969 |
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Interest expense |
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(32,184 |
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(95,514 |
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(32,184 |
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(284,465 |
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Other (expense) income, net |
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137,645 |
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234,753 |
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(38,237 |
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919,688 |
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Net loss |
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$ |
(3,914,194 |
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$ |
(4,938,641 |
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$ |
(9,481,962 |
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$ |
(14,313,746 |
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Net loss per share, basic and diluted |
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$ |
(0.11 |
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$ |
(0.14 |
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$ |
(0.26 |
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$ |
(0.40 |
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Weighted average shares outstanding, basic and diluted |
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35,835,135 |
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35,926,921 |
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35,809,216 |
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35,907,123 |
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HCW Biologics Inc.
Condensed Balance Sheets
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December 31, |
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September 30, |
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2022 |
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2023 |
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Unaudited |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
22,326,356 |
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$ |
11,220,793 |
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Short-term investments |
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9,735,930 |
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— |
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Accounts receivable, net |
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417,695 |
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710,078 |
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Prepaid expenses |
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1,394,923 |
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1,742,341 |
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Other current assets |
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196,015 |
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174,881 |
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Total current assets |
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34,070,919 |
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13,848,093 |
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Investments |
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1,599,751 |
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1,599,751 |
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Property, plant and equipment, net |
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10,804,610 |
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14,780,872 |
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Deposit for interest reserve |
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— |
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5,250,000 |
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Other assets |
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333,875 |
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137,626 |
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Total assets |
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$ |
46,809,155 |
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$ |
35,616,342 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Liabilities |
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Current liabilities: |
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Accounts payable |
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$ |
1,226,156 |
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$ |
3,153,834 |
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Accrued liabilities and other current liabilities |
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1,730,325 |
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2,262,839 |
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Total current liabilities |
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2,956,481 |
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5,416,673 |
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Debt, net |
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6,409,893 |
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6,332,736 |
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Other liabilities |
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14,275 |
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— |
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Total liabilities |
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9,380,649 |
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11,749,409 |
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Commitments and contingencies (Note 8) |
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Stockholders’ equity: |
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Common stock: |
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Common, $0.0001 par value; 250,000,000 shares authorized |
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3,588 |
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3,593 |
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Additional paid-in capital |
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82,962,964 |
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83,715,133 |
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Accumulated deficit |
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(45,538,046 |
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(59,851,793 |
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Total stockholders’ equity |
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37,428,506 |
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23,866,933 |
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Total liabilities and stockholders’ equity |
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$ |
46,809,155 |
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$ |
35,616,342 |
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7