S-1 1 y32360sv1.htm FORM S-1 S-1
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As filed with the Securities and Exchange Commission on August 13, 2007
Registration Statement No. 333-      
 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
Form S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
 
 
 
 
NANOSPHERE, INC.
(Exact name of registrant as specified in its charter)
 
         
         
Delaware
(State or other jurisdiction of
incorporation or organization) 		  2835
(Primary Standard Industrial
Classification Code Number) 		  36-4339870
(I.R.S. Employer
Identification Number)
 
4088 Commercial Avenue
Northbrook, Illinois 60062
(847) 400-9000
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
 
 
 
 
William P. Moffitt III
President and Chief Executive Officer
Nanosphere, Inc.
4088 Commercial Avenue
Northbrook, Illinois 60062
(847) 400-9000
(Name, address, including zip code, and telephone number, including area code, of agent for service)
 
 
 
 
Copies to:
 
     
Esteban A. Ferrer, Esq.
Ann Lawrence, Esq.
Paul, Hastings, Janofsky & Walker LLP
1055 Washington Boulevard
Stamford, CT 06901
Telephone: (203) 961-7400
Facsimile: (203) 674-7716 		  William J. Whelan III, Esq.
Cravath, Swaine & Moore LLP
Worldwide Plaza
825 Eighth Avenue
New York, NY 10019
Telephone: (212) 474-1000
Facsimile: (212) 474-3700
 
 
 
 
Approximate date of commencement of proposed sale to the public:  As soon as practicable after this registration statement becomes effective.
 
 
 
 
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  o
 
If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  o
 
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  o
 
If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  o
 
 
 
 
CALCULATION OF REGISTRATION FEE
 
             
      Amount of
      Registration Fee
      Proposed Maximum
 		     
Title of Each Class of
 		    Aggregate Offering
 		     
Securities to be Registered     Price(1)(2)      
Common Stock, $0.01 par value per share
    $100,000,000     $3,070
             
 
(1) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act of 1933.
 
(2) Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price and includes the offering price of shares that the underwriters have the option to purchase to cover over-allotments, if any.
 
 
 
 
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
 

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The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
 
SUBJECT TO COMPLETION, DATED          , 2007
 
           Shares
 
 
Common Stock
 
 
 
Prior to this offering, there has been no public market for our common stock. The initial public offering price of the common stock is expected to be between $      and $      per share. We will apply to list our common stock on the NASDAQ Global Market under the symbol “NSPH”.
 
The underwriters have an option to purchase a maximum of      additional shares of common stock to cover over-allotments of shares.
 
Investing in our common stock involves risks. See “Risk Factors” beginning on page 9.
 
                         
          Underwriting
 		       
    Price to
 		    Discounts and
 		    Proceeds to
 		 
    Public     Commissions     Nanosphere, Inc.  
 
Per Share
  $           $           $        
Total
  $           $           $        
 
Delivery of the shares of common stock in book-entry form will be made on or about          , 2007.
 
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
 
 
Credit Suisse
Piper Jaffray
Leerink Swann & Company
Allen & Company LLC
 
 
The date of this prospectus is          , 2007.

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The Verigene® System Verigene® Processor Test Cartridge Verigene® Reader

 

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  F-1
 EX-4.2: AMENDED AND RESTATED REGISTRATION RIGHTS AGREEMENT
 EX-10.1: 2000 EQUITY INCENTIVE PLAN
 EX-10.2: FORM OF 2000 EQUITY INCENTIVE PLAN NON-QUALIFIED STOCK OPTION AWARD AGREEMENT
 EX-10.3: FORM OF 2000 EQUITY INCENTIVE PLAN OPTION AWARD AGREEMENT
 EX-10.4: 2007 LONG-TERM INCENTIVE PLAN
 EX-10.5: FORM OF 2007 LONG-TERM INCENTIVE PLAN INCENTIVE STOCK OPTION AWARD AGREEMENT
 EX-10.6: FORM OF 2007 LONG-TERM INCENTIVE PLAN NON-QUALIFIED STOCK OPTION AWARD AGREEMENT
 EX-10.7: FORM OF 2007 LONG-TERM INCENTIVE PLAN OPTION AWARD AGREEMENT
 EX-10.8: EMPLOYMENT AGREEMENT
 EX-10.9: RESTRICTED STOCK PURCHASE AGREEMENT
 EX-10.10: EMPLOYMENT AGREEMENT
 EX-10.11: EMPLOYMENT AGREEMENT
 EX-10.12: EMPLOYMENT AGREEMENT
 EX-10.13: EMPLOYMENT AGREEMENT
 EX-10.14: EMPLOYMENT AGREEMENT
 EX-10.15: SEVERANCE AGREEMENT
 EX-10.18: LEASE
 EX-10.19: LOAN AND SECURITY AGREEMENT
 EX-10.20: LOAN AND SECURITY AGREEMENT
 EX-10.21: CONSULTING AND NON-COMPETITION AGREEMENT
 EX-23.1: CONSENT OF DELOITTE & TOUCHE LLP
 
You should rely only on the information contained in this document or to which we have referred you. We have not authorized anyone to provide you with information that is different. This document may only be used where it is legal to sell these securities. The information contained in this document is accurate only on the date of this document. Our business, financial condition, results of operations and prospectus may have changed since that date.
 
 
Dealer Prospectus Delivery Obligation
 
Until          , 2007 (25 days after the commencement of the offering), all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to unsold allotments or subscriptions.

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PROSPECTUS SUMMARY
 
This summary highlights selected information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our common stock. You should read this entire prospectus carefully, especially the risks of investing in our common stock discussed under “Risk Factors” beginning on page 9, and the financial statements and notes to those financial statements, before making an investment decision. Unless the context indicates otherwise, the references in this prospectus to “Nanosphere,” “we,” “us” and “our” refer to Nanosphere, Inc. Nanosphere, Inc. does not have any subsidiaries.
 
Our Company
 
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene System, that enables simple, low cost and highly sensitive genomic and protein testing on a single platform. Our proprietary nanoparticle technology simplifies molecular diagnostic testing, achieves ultra-sensitive protein detection at limits beyond current diagnostic technologies, provides the ability to multiplex, or run multiple tests at the same time on the same sample, and enables the development of a broad menu of test assays to be performed on a single platform. We are currently developing diagnostic tests for a variety of medical conditions including cancer, neurodegenerative, cardiovascular and infectious diseases, as well as pharmaco-genomics, or tests for personalized medicine.
 
Our Market Opportunity
 
According to Boston Biomedical Consultants the global in vitro diagnostics market was estimated to be $34 billion in 2006. The fastest growing segment of the in vitro diagnostics market is the $2.3 billion molecular diagnostics market which, together with the estimated market for our initial protein assays, comprises our more than $3.0 billion current market opportunity. Growth in our market will be driven by the continued conversion of traditional testing methods to molecular methods, an acceleration in the discovery of genomic biomarkers resulting in opportunities for novel tests, the emergence of tests for pharmaco-genomics, the availability of technology for more sensitive protein detection resulting in novel protein tests and the growing understanding of the inter-relationship between genetics and proteins in disease states.
 
The most widely used method for genomic testing is polymerase chain reaction, or PCR, which involves amplifying, or generating billions of copies of, the DNA sequence in question and then detecting the DNA with the use of fluorescent dyes. Due to the complexity, susceptibility to contamination and significant costs related to PCR and other amplification technologies, the molecular diagnostics market remains limited to reference laboratories, research facilities and laboratories associated with major hospitals, typically at academic teaching institutions, of which there are 200 to 300 in the United States. Moreover, due to the limited capability of many existing technologies, numerous testing platforms are required to perform even a limited menu of tests. PCR and other target amplification technologies also lack the capacity to multiplex in a cost effective manner.
 
Advances in molecular diagnostics have led to a broad array of new tests to detect genomic markers, however, many diseases are manifested at the protein, rather than the genetic, level. The most widely used method for protein testing is enzyme-linked immunosorbent assay, or ELISA. However, ELISA is often not sufficiently sensitive to detect protein biomarkers until the disease has progressed to an advanced stage and biomarkers for several diseases have not been validated or commercialized because they exist in concentrations too low to be detected by current technologies. While mass spectrometry has emerged as an alternative approach to ELISA for protein detection due to its greater sensitivity, it is extremely costly, requires significant time and effort by highly trained personnel and is unable to detect long peptide chain proteins or misfolded proteins which are biomarkers for diseases such as transmissible spongiform encephalopathy, or mad cow, and Alzheimer’s.


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The Verigene System
 
The Verigene System is a compact, bench top molecular diagnostics workstation. It allows multiple tests to be performed on a single platform, including both genomic and protein assays, unlike most existing systems, which provide a diagnostic result for one test or specific niche. The Verigene System is comprised of a microfluidics processor, a reader, and disposable test cartridges. With a prepared sample, the Verigene System completes tests in 45 to 90 minutes and requires less than 20 minutes of technician time. The system incorporates several key features which we believe will make it attractive to a wide range of laboratories, including:
 
  •  Low Cost and Complexity.  The Verigene System is a low cost platform without the need for sophisticated instrumentation or complex reagent kits.
 
  •  On Demand Testing.  The Verigene System allows laboratories to economically run tests at the time they are ordered, unlike other systems where laboratories must wait to process patient samples in batches to control reagent and labor costs.
 
  •  Multiplexing.  The Verigene System enables high count multiplexing, or the ability to identify a large number of target molecules on the same sample in a single assay.
 
  •  Direct Genomic Detection.  The Verigene System utilizes a proprietary method to detect nucleic acids with greater specificity and without the complexity and risk of contamination inherent in the use of amplification techniques such as PCR, thereby increasing the reliability of test results.
 
  •  Ultra-Sensitive Protein Detection.  The Verigene System allows ultra-sensitive detection of proteins with at least 100 times greater sensitivity than current technologies such as ELISA. This may enable earlier detection of disease and the development of completely novel tests.
 
We believe that the Verigene System’s ease of use, rapid turnaround times, relatively low cost and ability to support a broad test menu will simplify work flow and reduce costs for laboratories already performing molecular diagnostic testing and allow a broader range of laboratories, including those operated by local hospitals, to perform molecular diagnostic testing.
 
Our Initial Test Menu
 
Earlier this year, we submitted applications to the United States Food and Drug Administration, or FDA, for 510(k) clearance of the Verigene System and our first two diagnostic tests:
 
  •  Hyper-coagulation.  This assay is for the detection of genetic mutations associated with an increased risk for the development of blood clots. Hyper-coagulation tests for mutations associated with a pre-disposition to blood clots are currently among the most frequently conducted human genetic tests. Our hyper-coagulation panel consists of a multiplex of three genetic markers associated with a pre-disposition to blood clots. We believe that our assay will enable the detection of these markers on a much simpler platform than current alternatives.
 
  •  Warfarin Metabolism.  This assay is a pharmaco-genomic test for the detection of genetic mutations that determine an individual’s ability to metabolize the oral anticoagulant warfarin, including Coumadin. Warfarin decreases blood clotting and is the most widely prescribed oral anticoagulant in North America and Europe. Because individuals metabolize warfarin differently, if administration of the drug is not managed carefully, it can lead to serious bleeding complications. There are currently no FDA approved diagnostic tests to assess warfarin metabolism. Our test panel detects three genetic markers that play a critical role in metabolizing warfarin. Through detection of these genetic markers, doctors are able to determine the appropriate dosage level in a safer and more efficient manner than current methods.
 
We are developing additional genomic assays, including tests for cystic fibrosis and for a range of infectious diseases including herpes simplex virus, Human Papillomavirus, or HPV, and respiratory viruses.


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In addition, we have an active program to develop tests based on established protein biomarkers and to validate new biomarkers where our ultra-sensitive technology may enable earlier detection of a broad range of diseases. We are conducting clinical studies to demonstrate the diagnostic value of our first two ultra-sensitive protein assays:
 
  •  Prostate Specific Antigen — Recurrent Prostate Cancer.  This assay is being developed to enable the early detection of recurrent prostate cancer in men following prostate removal. Prostate specific antigen, or PSA, is a protein produced by the cells of the prostate gland and may be found in an increased amount in those with prostate cancer. However, current technologies have limited detection capabilities and on average can only diagnose recurrence three and a half years later. We expect that our ultra-sensitive PSA detection assay will detect recurrence within a few months after surgery enabling earlier intervention and treatment.
 
  •  Cardiac Troponin I — Cardiac Risk Stratification.  This assay is being developed for the detection of cardiac troponin I in patients suspected of having cardiovascular disease. Troponin I is a protein that is found in cardiac muscle and is released when the heart is injured, for instance during a myocardial infarction. Cardiac troponin tests are used to diagnose a heart attack and evaluate mild to severe heart injury in patients experiencing heart/chest discomfort. However, limitations of current detection levels of cardiac troponin I often result in the failure to accurately diagnose all cases of cardiovascular disease. Our initial clinical tests have demonstrated the ability to reliably identify a rise in cardiac troponin I well below the current limits of detection.
 
Through our biomarker validation program, we are also working to validate novel protein targets for Alzheimer’s disease, stroke, sepsis, and kidney disease, which we believe will create new protein-based diagnostic tests.
 
Other Applications of Our Technology
 
Our technology is broadly applicable beyond the clinical diagnostics market in both research and industrial applications and we expect to continue to seek opportunities, either directly or through outlicensing arrangements, to commercialize our technology in these markets. For example, for over two years the Verigene System has been in use in research laboratories supporting collaborations and independent research in areas including ovarian cancer, mad cow disease, and HIV. In addition, we are currently working with the FDA on a joint research program to develop an H5N1 avian flu assay. In the industrial market, we have developed and delivered a biosecurity platform for the detection of various bioterrorism agents to the Technical Support Working Group, an agency affiliated with the U.S. Department of Defense.
 
Our Intellectual Property Portfolio
 
Our patent portfolio is comprised, on a worldwide basis, of 92 issued patents and 146 pending patent applications which, in either case, we own directly or for which we are the exclusive licensee. We licensed our initial core technology from the International Institute for Nanotechnology at Northwestern University in May 2000. This formed the basis for a sustained relationship with Northwestern whereby we have rights to future developments in the field of biodiagnostics. This relationship provides us with access to ongoing research and innovation which we utilize in our research and development of new applications and products.


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Our Strategy
 
Our goal is to establish a new standard in molecular diagnostics characterized by our low cost, easy to use platform for genomic and protein testing and to develop new diagnostic tests where none exist today. To achieve this objective, we intend to:
 
  •  Target Key Customer Segments.  We will focus our sales efforts on hospital laboratories, where there is significant demand for molecular diagnostic testing, but where cost, complexity and resource needs of existing technologies have limited their ability to process tests in-house.
 
  •  Employ a Direct Sales Force Model.  We will market and sell the Verigene System through our own sales and marketing organization, which is currently comprised of 18 people, including sales representatives, clinical support staff and product managers.
 
  •  Market FDA Cleared Products.  We will seek FDA clearance for all our products. We believe that there is strong market demand for FDA cleared tests because they are less complex to use and do not subject the laboratory to extensive additional regulatory requirements and risks.
 
  •  Establish a Broad Test Menu.  We are developing a broad test menu to maximize the value of the Verigene System, generate cartridge sales and support placements of systems in those laboratories that demand a broad testing menu before implementing a new testing platform.
 
  •  Validate New Biomarkers and Commercialize New Tests Using Our Ultra-Sensitive Protein Detection Methods.  We are applying our ultra-sensitive protein detection methods to the development of established protein biomarkers and the validation of novel protein targets that may lead to earlier detection of medical conditions in the area of cancer, neurodegenerative disorders including Alzheimer’s disease, sepsis and mad cow disease.
 
  •  Capitalize on Strong Intellectual Property and Development Capabilities.  We will continue to develop assays based on both our in-house and in-licensed intellectual property through our ongoing relationship with the International Institute for Nanotechnology at Northwestern University and other third parties to expand the utility of our Verigene System.
 
Risk Factors
 
Our ability to execute our strategy and capitalize on our advantages is subject to a number of risks discussed more fully in the “Risk Factors” section and elsewhere in this prospectus. The principal risks facing our business include, among others:
 
History of Losses.  We have a history of losses, our losses are likely to increase significantly and we may never achieve or maintain profitability.
 
Acceptance of Verigene System.  Our financial results depend on commercial acceptance of the Verigene System, its array of tests, and the development of additional tests. If we do not achieve significant product revenue, we may not be able to meet our cash requirements without obtaining additional capital from external sources, and if we are unable to do so, we may have to curtail or cease operations.
 
Intellectual Property.  Third parties may claim we are infringing their intellectual property rights, which could prevent us from selling or commercializing our products unless we obtain a license from such third party. Our products could infringe patent rights of others, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages or limit our ability to commercialize our products.
 
Competition.  We face increasing competition from current and potential competitors, some of which have greater name recognition, more substantial intellectual property portfolios and longer operating histories.
 
Government Regulation.  Our products are subject to regulation by the FDA and numerous other federal and state governmental authorities. We may incur significant expenses to comply with, and experience delays in our product commercialization as a result of, these regulations.


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Corporate Information
 
We were founded in September 1998 as Nanosphere LLC, an Illinois limited liability company, by Dr. Robert L. Letsinger and Dr. Chad A. Mirkin, two Professors of Chemistry at Northwestern University. We established Nanosphere, Inc. in December 1999 as a Delaware corporation, into which we merged Nanosphere LLC in January 2000. Our executive offices are located at 4088 Commercial Avenue, Northbrook, IL 60062. Our telephone number at that address is (847) 400-9000 and our website is www.nanosphere.us. The information contained on, or that can be accessed through, our website is not incorporated by reference into this prospectus and should not be considered to be part of this prospectus.
 
         
Clearread, Verigene, and the
  (LOGO)   logo are our registered trademarks.
 
Ruggid, Valid and Biobarcode are the subject of pending trademark applications owned by us.
 
We also have registrations or pending applications for registration of some of our trademarks in other jurisdictions, including Europe, People’s Republic of China, Hong Kong, Japan, Republic of Korea, Taiwan, Canada, Malaysia, and Singapore. All other trademarks, trade names, and service marks appearing in this prospectus are the trademarks of their respective owners.


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The Offering
 
Issuer Nanosphere, Inc.
 
Common stock offered           shares
 
Common stock to be outstanding after this offering           shares, or          shares if the underwriters exercise their over-allotment option in full.
 
Use of Proceeds We estimate that the net proceeds to us in the offering will be approximately $           million, assuming an initial public offering price of $           per share, which is the midpoint of the range listed on the cover page of this prospectus, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We expect to use approximately $50 million of the net proceeds of this offering to finance ongoing research and development and approximately $40 million to fund additional sales and marketing personnel and initiatives. We expect to use the remainder of the net proceeds for additional working capital and general corporate purposes.
 
Dividend Policy We have never declared or paid any cash dividends on our capital stock and do not expect to pay any dividends for the foreseeable future.
 
Proposed NASDAQ Global Market symbol NSPH
 
Unless we specifically state otherwise, all information in this prospectus assumes no exercise by the underwriters of their over-allotment option; if the underwriters exercise their over-allotment in full, the number of shares of our common stock outstanding after this offering will be          .
 
The number of shares of common stock to be outstanding upon completion of this offering is based on the following (all as of June 30, 2007): 23,316,156 shares of common stock, 17,007 shares of Series B Convertible Preferred Stock, 10,050,007 shares of and 16,666 warrants to purchase Series C Convertible Preferred Stock, 128,825,044 shares of and 3,438,687 warrants to purchase Series C-2 Convertible Preferred Stock, and 168,392,966 shares of and 32,694,562 warrants to purchase Series D Convertible Preferred Stock, and excludes as of that date:
 
  •  79,338,700 shares of common stock issuable upon exercise of options outstanding as of June 30, 2007, at a weighted average exercise price of $0.20 per share; and
 
  •  7,661,300 shares of common stock reserved for future issuance under our long-term incentive plan as of June 30, 2007.
 
Except as otherwise indicated, all of the information in this prospectus assumes:
 
  •  no exercise of the underwriters’ option to purchase additional shares;
 
  •  adoption of our amended and restated certificate of incorporation and amended and restated by-laws to be effective prior to the closing of this offering;
 
  •  the conversion on a one-for-2.45 basis of our Series B Convertible Preferred Stock into common stock to be effected prior to the closing of this offering;
 
  •  the conversion on a one-for-one basis of our Series C, Series C-2 and Series D Convertible Preferred Stock into common stock to be effected prior to the closing of this offering;
 
  •  the exercise of all outstanding Series C, Series C-2 and Series D Convertible Preferred Stock warrants for an aggregate of           shares of common stock (based on an offering price of $      per share, the midpoint of the estimated price range shown on the cover page of this prospectus) to be effected prior to the closing of this offering; and
 
  •  a one-for           stock split of our common stock to be effective prior to the closing of this offering.


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Summary Financial Data
 
The following statements of operations data for each of the years ended December 31, 2004, 2005 and 2006 and the balance sheet data as of December 31, 2005 and 2006 have been derived from our audited financial statements and related notes which are included elsewhere in this prospectus. The statements of operations data for the three months ended March 31, 2006 and 2007 and the balance sheet data as of March 31, 2007 have been derived from our unaudited financial statements and related notes which are included elsewhere in this prospectus. In the opinion of management, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments necessary for the fair presentation of our financial position and results of operations for these periods. The summary financial data set forth below should be read in conjunction with our financial statements, the related notes, “Risk Factors,” “Use of Proceeds,” “Capitalization,” “Selected Financial Data,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in the document. The historical results are not necessarily indicative of the results to be expected for any future period. The accompanying financial statements for the years ended December 31, 2004, 2005, and 2006 have been restated. See Note 11 to the financial statements.
 
                                         
          Three Months
 		 
    Years Ended December 31,     Ended March 31,  
Statements of Operations Data:
  2004     2005     2006     2006     2007  
    (As Restated)     (As Restated)     (As Restated)              
 
Revenue:
                                       
Grant and contract revenue
  $ 2,768,125     $ 1,777,667     $ 1,006,351     $ 67,640     $ 223,258  
Product sales
    —       136,850       131,660       11,700       46,645  
                                         
Total revenue
    2,768,125       1,914,517       1,138,011       79,340       269,903  
                                         
Costs and expenses:
                                       
Cost of product sales
    —       125,118       31,049       —       15,179  
Research and development
    10,366,473       13,244,872       17,447,227       3,853,071       4,927,651  
Sales, general and administrative
    3,093,082       4,367,160       5,166,594       1,187,771       2,161,319  
                                         
Total costs and expenses
    13,459,555       17,737,150       22,644,870       5,040,842       7,104,149  
                                         
Loss from operations
    (10,691,430 )     (15,822,633 )     (21,506,859 )     (4,961,502 )     (6,834,246 )
Change in fair value of convertible derivative liability
    —       —       (2,916,822 )     —       —  
Interest expense - related party
    (204,335 )     (37,919 )     (146,550 )     (129,500 )     —  
Interest expense
    —       —       (7,506 )     —       (259,908 )
Interest income
    40,963       69,376       1,415,001       18,480       384,078  
                                         
Net loss
    (10,854,802 )     (15,791,176 )     (23,162,736 )     (5,072,522 )     (6,710,076 )
Accumulated convertible preferred stock dividends
    —       —       (4,413,591 )     —       (1,490,517 )
Convertible preferred stock redemption value adjustment
    (9,983,718 )     (2,898,787 )     (16,285,714 )     —       (608,940 )
                                         
Net loss attributable to common stock
  $ (20,838,520 )   $ (18,689,963 )   $ (43,862,041 )   $ (5,072,522 )   $ (8,809,533 )
                                         
Net loss per common share: