2022 Q3 Form 10-Q Financial Statement

#000095017022017398 Filed on August 15, 2022

View on sec.gov

Income Statement

Concept 2022 Q3 2022 Q2 2022 Q1

Balance Sheet

Concept 2022 Q3 2022 Q2 2022 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $6.589M $8.895M
YoY Change -75.28% -75.49%
Cash & Equivalents $6.600M $8.900M
Short-Term Investments
Other Short-Term Assets $9.897M $11.30M
YoY Change 494.41% 409.1%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $16.49M $20.20M
YoY Change -41.79% -47.55%
LONG-TERM ASSETS
Property, Plant & Equipment $930.0K $1.048M
YoY Change -48.07% -43.04%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $123.0K $123.0K
YoY Change -28.9% 2.5%
Total Long-Term Assets $1.325M $1.535M
YoY Change -32.54% -21.68%
TOTAL ASSETS
Total Short-Term Assets $16.49M $20.20M
Total Long-Term Assets $1.325M $1.535M
Total Assets $17.81M $21.73M
YoY Change -41.19% -46.3%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.271M $3.082M
YoY Change -9.92% 7.01%
Accrued Expenses $2.870M $1.687M
YoY Change -42.32% -56.41%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $4.904M $4.893M
YoY Change
Total Short-Term Liabilities $10.43M $10.12M
YoY Change 33.71% 49.87%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change -100.0% -100.0%
Other Long-Term Liabilities $3.645M $0.00
YoY Change 968.91% -100.0%
Total Long-Term Liabilities $3.645M $0.00
YoY Change -64.34% -100.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $10.43M $10.12M
Total Long-Term Liabilities $3.645M $0.00
Total Liabilities $14.07M $10.12M
YoY Change -21.91% -40.39%
SHAREHOLDERS EQUITY
Retained Earnings -$266.7M -$258.3M
YoY Change 19.38%
Common Stock $270.4M $269.9M
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $3.741M $11.62M
YoY Change
Total Liabilities & Shareholders Equity $17.81M $21.73M
YoY Change -41.19% -46.3%

Cashflow Statement

Concept 2022 Q3 2022 Q2 2022 Q1

Facts In Submission

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<p style="text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;line-height:1.0685416666666667;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">1. Nature of Business</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">Allena Pharmaceuticals, Inc. (the “Company”) is a clinical stage company focused on developing non-absorbed oral enzyme therapeutics to treat metabolic conditions including hyperuricemia and gout. The Company was incorporated under the laws of the State of Delaware on June 24, 2011. The Company’s headquarters are in Sudbury, Massachusetts.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.0685416666666667;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">The Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations, reliance on third party manufacturers, ability to transition from pilot-scale manufacturing to large-scale production of products and the need to obtain adequate additional financing to fund the development of its product candidates.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="margin-left:2.267%;text-indent:0.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:6.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Liquidity and Going Concern</span></p><p style="text-indent:5.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">The Company had an accumulated deficit of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">266.7</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million at June 30, 2022 and will require substantial additional capital to fund operations. The future success of the Company is dependent on its ability to identify and develop its product candidates and ultimately upon its ability to attain profitable operations. At June 30, 2022, the Company had $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">6.6</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million of cash and cash equivalents. <br/></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:5.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">The Company’s available cash and cash equivalents as of June 30, 2022 are not sufficient to fund the Company’s current operating plan for at least the next twelve months following the filing of this Quarterly Report. The Company requires additional capital to sustain its operations, including its ALLN-346 development program. Management is exploring opportunities to secure additional funding through equity or debt financings or through collaborations, licensing transactions or other sources. In January 2022, the Company initiated a process to explore a range of strategic and financing alternatives to maximize stockholder value and has engaged the investment bank Stifel, Nicolaus &amp; Company, Inc. ("Stifel") to act as strategic advisor for this process. Potential strategic alternatives that may be evaluated include a partnership or sale of ALLN-346, a sale or merger of the Company, or securing additional financing to enable further development of the Company's ALLN-346 program. There can be no assurance that this strategic review process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed. If the Company is unable to complete a transaction, it may be required to seek an in-court or out-of-court restructuring of its liabilities.<br/></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:5.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">As part of the strategic process, the Compensation Committee of the Board of Directors approved a retention plan on January 28, 2022, available to all employees (the "Retention Plan"). Employees were required to execute retention agreements to receive payments and other considerations offered by the Retention Plan. Employees who executed a retention agreement received a salary adjustment equal to </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">6.5</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">% retroactive to January 1, 2022, a restricted stock unit ("RSU") grant and a lump sum retention payment. A total of </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">2,998,500</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> RSUs were granted on February 1, 2022 under the Retention Plan. Lump sum retention payments totaling $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">3.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million were made to employees in February 2022. If an employee resigns from the Company or is terminated for cause prior to June 30, 2022, the employee would be required to fully repay the lump sum retention payment received. If an employee resigns from the Company or is terminated for cause between July 1, 2022 and September 30, 2022, the employee would be required to repay </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">50</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">% of the lump sum retention payment received. <br/></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:5.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">During the first quarter of 2022, the Company made voluntary principal repayments of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">5.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million of the $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">10.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million that was outstanding as of December 31, 2021 under the loan and security agreement with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P. (together “Pontifax”) (the “Pontifax Agreement”). The Company made an additional voluntary principal repayment of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">0.5</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million in August 2022. The outstanding principal balance as of the filing date of this Quarterly Report is $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">4.5</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million. The Company also purchased Directors' &amp; Officers' run-off insurance for $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">6.8</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million in March 2022. <br/></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:5.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">On March 18, 2022, the Company announced that it was terminating its URIROX-2 study and reloxaliase program and initiated the process of closing the URIROX-2 study with the CRO, investigative sites, patients and business partners. In connection with the termination of the reloxaliase program, the Company completed a workforce reduction of approximately</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">40</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">% on March 31, 2022. In accordance with the terms of the Retention Plan, the employees terminated by the Company on March 31, 2022 were not required to repay any portion of their lump sum retention payments originally received in February 2022.</span></p><p style="text-indent:5.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">During the first quarter of 2022, the Company issued and sold </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">6,804,888</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> shares of its common stock under an At-Market Issuance Sales Agreement with B. Riley Securities, Inc. at a weighted average price of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">0.62</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> per share for net proceeds of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">3.9</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:5.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">On May 3, 2022, the Company entered into a securities purchase agreement with an investor, pursuant to which the Company agreed to issue, in a registered direct offering, an aggregate of </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">2,872.1376</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> shares of Preferred Stock (split evenly between the Series D Convertible Preferred Stock, par value $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">0.001</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> per share (“Series D Preferred Stock”), and Series E Convertible Preferred Stock, par value $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">0.001</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> per share (“Series E Preferred Stock” and together with the Series D Preferred Stock, the “Preferred Stock”)). The Company received net proceeds of approximately $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">2.3</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million from the issuance and sale of the Preferred Stock, after deducting offering expenses and placement agent fees. The shares of Preferred Stock have a stated value of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">1,000</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> per share and are convertible, following the date of the issuance thereof, into an aggregate of </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">8,975,430</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> shares of common stock of the Company upon the conversion of the Series D Preferred Stock and into an aggregate of </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">8,975,430</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> shares of common stock of the Company upon the conversion of the Series E Preferred Stock, in each case, at a conversion price of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">16.00</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> per share. H.C. Wainwright &amp; Co., LLC (“HCW”) was the exclusive placement agent for this offering. On May 5, 2022, the Preferred Stock investor converted all of its Series D Preferred Stock into </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">8,975,430</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> shares of common stock, and on May 9, 2022, the Preferred Stock investor converted all of its Series E Preferred Stock into </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">8,975,430</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> shares of common stock.</span></p><p style="text-indent:5.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">In a concurrent private placement, the Company also issued to the Preferred Stock investor unregistered warrants (the “2022 Common Warrants”) to purchase up to an aggregate of </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">22,438,575</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> shares of the Company’s common stock, at an exercise price of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">0.1694</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> per share. The 2022 Common Warrants will become exercisable six months after the date of issuance, and will have a term of </span><span style="font-size:10.0pt;font-family:Times New Roman;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">five years</span></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> from the initial exercise date. The Company also issued to designees of HCW, in a concurrent private placement, warrants to purchase up to </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">1,256,561</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> shares of Common Stock (the “HCW Warrants”). The HCW Warrants are exercisable for $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">0.20</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> per share and will be exercisable six months after the date of issuance and have a term of </span><span style="font-size:10.0pt;font-family:Times New Roman;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">five years</span></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> from the commencement of sales pursuant to the registered direct offering.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">The Company entered into an At Market Offering Agreement with H.C. Wainwright &amp; Co., LLC (“HCW ATM Agreement”) on July 8, 2022. Since that time and through the filing date of this Quarterly Report, the Company issued and sold </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">14,358,057</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> shares of its common stock under the HCW ATM Agreement at a weighted average price of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">0.14</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> per share for net proceeds of approximately $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">1.9</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> million.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="margin-left:2.267%;text-indent:0.0%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:6.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Reverse Stock Split</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">At a special meeting of stockholders held on August 4, 2022, the Company’s stockholders approved an amendment to the Company’s amended and restated certificate of incorporation, as amended, to, at the discretion of the Company’s board of directors, effect a reverse stock split with respect to its issued and outstanding Common Stock, par value $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">0.001</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> per share, including any Common Stock held by the Company as treasury shares, at any time prior to December 31, 2022, at a ratio of 1-for-10 to 1-for-100 (the “Range”). The Range and timing of the reverse stock split will be determined by the Company’s board of directors without further approval or authorization of the Company’s stockholders and included in a public announcement once determined.</span></p>
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