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 9, 2023, Evoke Pharma, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2023. 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.
(d) Exhibits
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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 hereunto duly authorized.
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EVOKE PHARMA, INC. |
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Date: |
November 9, 2023 |
By: |
/s/ Matthew J. D'Onofrio |
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Name: Matthew J. D'Onofrio |
Evoke Pharma Reports Third Quarter 2023 Financial Results
38% Revenue Increase Compared to Q2 2023; 88% Increase Year-Over-Year
Seventh Straight Prescription Fill Increase Since Q1 2022
21% Increase Compared to Q2 2023; 95% Increase Year-Over-Year
“Superiority of Nasal Spray Compared to Orally Administered Metoclopramide in Reducing Healthcare Costs in Treating Diabetic Gastroparesis Patients” Presented at The American College of Gastroenterology (ACG) 2023 Annual Meeting
SOLANA BEACH, CA., November 9, 2023 -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced its financial results for the third quarter ended September 30, 2023, and recent corporate developments.
“Our execution across the business in the third quarter continues to improve and gain momentum. The perseverance and diligent efforts of our commercial team resulted in record net product sales of $1.6 million, an 88% year-over-year increase. We continue to see solid growth across our key sales metrics, including prescription fills, new prescription enrollments, and cumulative prescribers. As of September 30, there were a total of 1,572 prescribers, almost double from Q3 2022. In line with other metrics, our patient enrollment rate was up approximately 5% from the previous quarter. Prescription fills in Q3 2023 were also up 21% from Q2 2023,” commented David A. Gonyer, R.Ph., Chief Executive Officer of Evoke Pharma.
“Only since May of this year, we began sharing insights from our healthcare resource utilization data which provides a real world look at the merits of GIMOTI (nasal metoclopramide) over oral metoclopramide within the healthcare environment. Last month, at ACG, we were thrilled to expand upon the initial set of data and present to health care providers and key opinion leaders within the gastroenterology community a resulting cost savings of $15,000 per patient in their first 6 months of GIMOTI treatment that underscores the financial advantages of GIMOTI usage for patients and payers compared to oral metoclopramide. Additive to these conversations have been the popularity around GLP-1 agonist prescription therapies for diabetes and the frequency that our targeted health care providers see gastroparesis in these patients. Given the growing usage of GLP-1 agonists, we remain committed to ensuring that healthcare providers and patients are aware of the availability and beneficial use of GIMOTI for treating diabetic gastroparesis in adults." Mr. Gonyer continued.
“In addition, as the volume of inbound GIMOTI prescriptions continues to increase, the Company recently transitioned the prescription intake system service from vitaCare to ASPN Pharmacies effective November 6, 2023. Under the prior intake system, a meaningful number of approved prescriptions were unable to be filled due to narrow PBM pharmacy networks which precluded delivery of GIMOTI. ASPN currently has an extensive network of partners with broader PBM agreements which should drive increased GIMOTI revenue by maximizing our ability to fill prescriptions across various insurer pharmacy networks and ensure more eligible patients receive GIMOTI when needed.”
“Based on recent industry data, the Company believes that the GIMOTI prescription demand is much larger than what is currently being directed to our specialty pharmacy. Therefore, we are implementing additional retail pharmacy messaging programs to recapture prescriptions sent to retail pharmacies and properly guide them to be adjudicated and delivered directly to patients. As part of our patient-centric mindset as a company, we are always evaluating ways to improve GIMOTI’s patient accessibility. Taken together, with 2023 coming to a close, we believe we will be favorably positioned for 2024 to achieve our growth plan,” Mr. Gonyer concluded.
Third Quarter 2023 Developments and Recent Progress
Continued Presentations and Abstract Acceptances at Renowned Medical Meetings
Operational Changes
Third Quarter 2023 Financial Review
For the third quarter of 2023, net product sales were $1,562,860 compared to $832,100 during the third quarter of 2022. We attribute the increase in net sales to the continuously increasing educational and promotional activities of the EVERSANA sales force.
For the third quarter of 2023, selling, general and administrative expenses were approximately $3.1 million compared to $2.6 million for the third quarter of 2022. The increases were due to higher professional fees and reimbursement and profit-sharing activity with EVERSANA.
Total operating expenses for the third quarter of 2023 were approximately $3.2 million compared to $2.7 million for the same period in 2022.
As of September 30, 2023, cash and cash equivalents were approximately $6.0 million. We believe, based on our current operating plan, that our existing cash and cash equivalents, as well as future cash flows from net product sales of GIMOTI, will be sufficient to fund our operations into at least the first quarter of 2024.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis.
Visit www.EvokePharma.com for more information.
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Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: Evoke’s cash runway; GIMOTI’s potential to reduce healthcare
resource utilization by diabetic gastroparesis patents; and Evoke’s belief that GIMOTI can improve treatment of diabetic gastroparesis. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain, maintain and successfully enforce intellectual property protection for GIMOTI; EVERSANA has the right to terminate its commercialization agreement in certain circumstances; the results of market research studies may not predict acceptance by patients, healthcare providers or payors; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke is entirely dependent on the success of GIMOTI; Evoke’s dependence on third parties for the manufacture of GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor Contact:
Daniel Kontoh-Boateng
DKB Partners
Tel: 862-213-1398
dboateng@dkbpartners.net
Evoke Pharma, Inc.
Condensed Balance Sheets
Evoke Pharma, Inc |
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Condensed Balance Sheets |
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September 30, |
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December 31, |
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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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$ |
5,964,826 |
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$ |
9,843,699 |
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Accounts receivable, net |
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1,233,904 |
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624,832 |
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Prepaid expenses |
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37,855 |
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952,954 |
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Inventory, net |
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504,925 |
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289,378 |
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Other current assets |
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98,094 |
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11,551 |
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Total current assets |
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7,839,604 |
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11,722,414 |
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Operating lease right-of-use asset |
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13,370 |
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129,074 |
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Total assets |
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$ |
7,852,974 |
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$ |
11,851,488 |
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Liabilities and stockholders' equity |
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Current Liabilities: |
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Accounts payable and accrued expenses |
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$ |
1,397,442 |
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$ |
934,312 |
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Accrued compensation |
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829,669 |
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591,158 |
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Operating lease liability |
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13,370 |
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129,074 |
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Total current liabilities |
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2,240,481 |
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1,654,544 |
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Long-term liabilities |
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Note payable |
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5,000,000 |
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5,000,000 |
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Accrued interest payable |
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1,486,268 |
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1,112,295 |
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Total long-term liabilities |
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6,486,268 |
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6,112,295 |
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Total liabilities |
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8,726,749 |
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7,766,839 |
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Stockholders' equity (deficit): |
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Common stock, $0.0001 par value; authorized shares - 50,000,000; |
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334 |
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334 |
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Additional paid-in capital |
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120,577,928 |
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119,731,458 |
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Accumulated deficit |
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(121,452,037 |
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(115,647,143 |
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Total stockholders' equity (deficit) |
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(873,775 |
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4,084,649 |
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Total liabilities and stockholders' equity (deficit) |
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$ |
7,852,974 |
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$ |
11,851,488 |
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Evoke Pharma, Inc.
Condensed Statements of Operations
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Net product sales |
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$ |
1,562,860 |
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$ |
832,100 |
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$ |
3,504,636 |
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$ |
1,712,275 |
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Operating expenses: |
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Cost of goods sold |
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34,908 |
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89,775 |
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142,855 |
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180,310 |
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Research and development |
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- |
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40,388 |
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159,347 |
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273,582 |
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Selling, general and administrative |
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3,131,389 |
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2,614,488 |
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8,745,407 |
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7,334,738 |
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Total operating expenses |
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3,166,297 |
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2,744,651 |
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9,047,609 |
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7,788,630 |
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Loss from operations |
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(1,603,437 |
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(1,912,551 |
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(5,542,973 |
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(6,076,355 |
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Other income (expense): |
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Interest income |
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35,558 |
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24,714 |
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112,052 |
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29,419 |
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Interest expense |
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(126,028 |
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(126,027 |
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(373,973 |
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(373,973 |
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Total other (expense) |
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(90,470 |
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(101,313 |
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(261,921 |
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(344,554 |
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Net loss |
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$ |
(1,693,907 |
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$ |
(2,013,864 |
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$ |
(5,804,894 |
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$ |
(6,420,909 |
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Net loss per share of common stock, basic and diluted |
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$ |
(0.51 |
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$ |
(0.60 |
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$ |
(1.74 |
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$ |
(2.09 |
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Weighted-average shares used to compute basic and diluted net loss per share |
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3,343,070 |
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3,343,070 |
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3,343,070 |
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3,077,145 |
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