As filed with the Securities and Exchange Commission on March 16, 2017
November20, 2020
Registration Statement No. 333-216031333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 1 TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
ATOSSA GENETICS INC.Atossa Therapeutics, Inc.
(Exact name of registrantRegistrant as specified in its charter)
Delaware | 2834 | 26-4753208 | ||
(State or other jurisdiction incorporation or organization) | (Primary Standard Industrial Classification Code Number) | (I.R.S. Employer Identification |
107 Spring Street
Seattle, Washington 98104
Telephone: (800) 351-3902(866) 893-4927
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
Steven C. Quay
Chairman, Chief Executive Officer and President
107 Spring Street
Seattle, Washington 98104
Telephone: (800) 351-3902(866) 893-4927
(Name, address, including zip code, and telephone
number, including area code, of agent for service)
Copies to:
Ryan A. Murr Gibson, Dunn & Crutcher LLP 555 Mission Street, Suite 3000 San Francisco, CA 94105-0921 (415) 393-8373 | Kyle Guse Chief Financial Officer and General Counsel 107 Spring Street Seattle, Washington 98104 (866) 893-4927 | Barry L. Grossman |
Approximate date of commencement of proposed sale to the public: From time to time
As soon as practicable after the effective date of this Registration Statement becomes effective.Statement.
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.¨box: ☐
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.¨ ☐
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.¨ ☐
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.¨
☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company,” and “smaller reporting“emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
Emerging growth company | ☐ |
The registrant isIf an emerging growth company, as defined inindicate 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 2(a)7(a)(2)(B) of the Securities Act. This Registration Statement complies with the requirements that apply to an issuer that is an emerging growth company.☐
CALCULATION OF REGISTRATION FEE
| Title of each class of securities to be registered(1) | Proposed maximum aggregate offering price(2) | Amount of registration fee(3) | ||||||
| Common Stock, par value $0.015 per share | $ | 6,080,000 | $ | 704.67 | ||||
Title of each class of securities to be registered(1)(2) | Proposed | Amount of | ||||||
Common stock, $0.18 par value per share | ||||||||
Series C convertible preferred stock, par value $0.001 per share(4) | ||||||||
Total | $ | 14,375,000 | $ | 1,568.31 | ||||
(1) Pursuant to Rule 416(a) of the Securities Act of 1933, as amended, this Registration Statement also covers any additional shares of Common Stock which may become issuable to prevent dilution from stock splits, stock dividends and similar events.
(1) | Pursuant to Rule 416 under the Securities Act of 1933, as amended, the securities being registered hereunder include such indeterminate number of additional securities as may be issuable to prevent dilution resulting from stock splits, dividends or similar transactions. |
(2) | The proposed maximum aggregate offering price of the common stock to be sold in the offering will be reduced on a dollar-for-dollar basis on the offering price of any Series C convertible preferred sold, such that the proposed maximum aggregate offering price of the common stock and Series C convertible preferred shares (including the common stock issuable upon exercise of the Series C convertible preferred shares, if any), is $13,800,000. Such maximum aggregate offering price includes $1,875,000 in shares that may be sold pursuant to the underwriter’s over-allotment option. |
(3) | Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended. The issuer is offering a combination of Common Stock and Series C convertible preferred stock for aggregate offering proceeds of up to $14,375,000. |
(4) | Includes shares of Common Stock issuable upon conversion of Series C convertible preferred stock issued hereunder. |
(2) Pursuant to Rule 457(o) of the Securities Act of 1933, estimated solely for the purpose of calculating the registration fee. Includes offering price of shares which the underwriters have the option to purchase to cover over-allotments, if any.
(3) $463.60 of the registration fee was previously paid with the initial filing of this Registration Statement.
The registrantRegistrant 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 as amended, 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.
The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the Registration Statementregistration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting offersan offer to buy these securities in any jurisdictionstate where the offer or sale is not permitted.
PRELIMINARY PROSPECTUS, SUBJECT TO COMPLETION DATED MARCH 16, 2017
4,000,000
Shares of Common Stock
Preliminary Prospectus
This is a firm commitment publicUp to Shares of Common Stockand
Up to Shares of Series C Convertible Preferred Stock
We are offering of 4,000,000 up to shares of our Common Stock by Atossa Genetics Inc. common stock, par value $0.18 per share (the “common stock”). We are also offering to certain large investors the opportunity to purchase, in lieu of the shares of our common stock, up to shares of Series C convertible preferred stock, which is convertible into a total of shares of common stock, subject to certain beneficial ownership conversion limitations.
Our Common Stockcommon stock is listedcurrently quoted on The NASDAQNasdaq Capital Market (“Nasdaq”) under the symbol “ATOS.”“ATOS”. On March 15, 2017,, 2020, the last reported sale price per share of our Common Stockcommon stock on Nasdaq was $1.50 per share.$ . There is no trading market for the Series C convertible preferred stock and we do not currently intend to apply for listing of the Series C convertible preferred stock on any securities exchange or recognized trading system.
We are an “emerging growth company” as that term is usedInvesting in our securities involves risks. You should carefully consider the Jumpstart Our Business Startups Act of 2012 (the “JOBS ActRisk Factors ”) and, as such, have elected to comply with certain reduced public company reporting requirements for included in this prospectus and future filings.
Our business andbefore you make an investment in our securities involve a high degreesecurities.
Per-Share | Per-Share | Total | ||||||||||
Public offering price | $ | $ | $ | |||||||||
Underwriting discount (1) | $ | $ | $ | |||||||||
Proceeds, before expenses, to us | $ | $ | $ | |||||||||
(1) | See the section titled “Underwriting” for additional information regarding compensation payable to the underwriter. |
We have granted the underwriter an option to purchase up to additional shares of risk. See “Risk Factors” beginning on page 5our common stock at the public offering price, less the underwriting discount, for 45 days after the date of this prospectus for a discussion of information that you should consider before investing in our securities.prospectus.
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.
The shares will be ready for delivery on or about , 2020.
Sole Book-Running Manager
MAXIM GROUP LLC
The date of this prospectus is , 2020
| ABOUT THIS PROSPECTUS | 1 | |||||||
| 2 | ||||||||
We have granted a 45-day option to the underwriters to purchase up to additional shares of Common Stock solely to cover over-allotments, if any.
The underwriters expect to deliver the shares against payment therefor on or about , 2017.
Aegis Capital Corp.
, 2017
TABLE OF CONTENTS
Neither we nor
We have not, and the underwriters have not, authorized anyone to provide you with information that is different from that contained in this prospectus we may authorize to be delivered or made available to you. When you make a decision about whether to invest in our securities, you should not rely upon any information or to make any representations other than those containedthe information in this prospectus or in any free writing prospectus prepared bythat we may authorize to be delivered or on behalfmade available to you. Neither the delivery of us or to which we have referred you. We take no responsibility for, and can provide no assurance as tothis prospectus nor the reliabilitysale of any other informationour securities means that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under the circumstances and in the jurisdictions where it is lawful to do so. The information contained in this prospectus or in any applicable free writing prospectus is current only ascorrect after the date of its date, regardless of its time of deliverythis prospectus or any sale of shares of our Common Stock. Our business, financial condition, results of operations and prospects may have changed since that date. We aresuch free writing prospectus. This prospectus is not and the underwriters are not, making an offer to sell or the solicitation of thesean offer to buy our securities in any jurisdiction where suchcircumstances under which the offer or solicitation is not permitted.unlawful.
For investors outside the United States: Neither we norWe have not, and the underwriters have done anythingnot, taken any action that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities covered hereby and the distribution of this prospectus outside the United States.
You should read this prospectus, any applicable prospectus supplement and the information incorporated by reference in this prospectus before making an investment in the securities of Atossa Genetics Inc. See “Where You Can Find Additional Information” on page _ for more information. You should rely only on the information contained in or incorporated by reference in this prospectus or a prospectus supplement. The Company has not authorized anyone to provide you with different information. This document may be used only in jurisdictions where offers and sales of these securities are permitted. You should assume thatUnless otherwise indicated, information contained in this prospectus orconcerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity and market share, is based on information from our own management estimates and research, as well as from industry and general publications and research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we believe to be reasonable. Our management estimates have not been verified by any independent source, and we have not independently verified any third-party information. In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Cautionary Note Regarding Forward-Looking Statements.”
We further note that the representations, warranties and covenants made by us in any document incorporated by reference,agreement that is filed as an exhibit to the registration statement of which this prospectus is a part were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
Unless the context otherwise requires, references in this prospectus to “Atossa,” “the Company,” “we,” “us” and “our” refer to Atossa Therapeutics, Inc. Solely for convenience, our trademarks and tradenames referred to in this registration statement, may appear without the ® or ™ symbols, but such references are not intended to indicate in any date onway that we will not assert, to the front coverfullest extent under applicable law, our rights to these trademarks and tradenames. All other trademarks, service marks and trade names included or incorporated by reference into this prospectus or the accompanying prospectus are the property of the applicable document. Our business, financial condition, results of operations and prospects may have changed since that date.their respective owners.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Statements madeThis prospectus contains, in this prospectus that are not statements ofaddition to historical information, arecertain information, assumptions and discussions that may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”“Securities Act”). We have made these statements in reliance on the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties, which could cause actual results to differ materially from those projected or anticipated. Although we believe our assumptions underlying our forward-looking statements are reasonable as of the date of this prospectus, we cannot assure you that the forward-looking statements set out in this prospectus will prove to be accurate. We typically identify these forward-looking statements by the use of forward-looking words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or the negative version of those words or other comparable words. Forward-looking statements contained in this prospectus include, but are not limited to, statements about:
| ● | |
● | whether we can obtain approval from the U.S. Food and Drug Administration |
● | our ability to successfully initiate and complete clinical trials of our pharmaceutical candidates under development, including |
● | the success, cost and timing of our product and drug development activities and clinical trials, including whether |
● | whether we will successfully initiate and complete our clinical trial of oral Endoxifen to reduce mammographic breast density and whether the study will meet its objective; |
● | our ability to contract with third-party suppliers, manufacturers and service providers, including clinical research organizations, and their ability to perform adequately; |
● | our ability to successfully develop and commercialize new therapeutics currently in development or that we might identify in the future and in the time frames currently expected; |
● | our ability to successfully defend |
● | our ability to establish and maintain intellectual property rights covering our products; |
● | our expectations regarding, and our ability to satisfy, federal, state and foreign regulatory requirements; |
● | the accuracy of our estimates of the size and characteristics of the markets that our products and services may address; |
● | whether the final study results will vary from preliminary study results that we may announce; |
● | our expectations as to future financial performance, expense levels and capital sources; |
● | our ability to attract and retain key personnel; and |
● | our ability to raise capital. |
This prospectus also contains estimates and other statistical data provided by independent parties and by us relating to market size and growth and other industry data.
These and other forward-looking statements made in this prospectusherein are presented as of the date on which the statements are made.of this prospectus. We have included important factors in the cautionary statements included in this prospectus, particularly in the section titled “RiskRisk Factors” that we believe could cause actual results or events to differ materially from the anticipated results as set forth in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any new information, future events or circumstances that may affect our business after the date of this prospectus. Except as required by law, we do not intend to update any forward-looking statements after the date on which the statement is made, whether as a result of new information, future events or circumstances or otherwise.
The following summary of our business highlights certain of the information contained elsewhere in or incorporated by reference into this prospectus. Because this is only a summary, however, it may not contain all of the information that may be important to you. You should carefully read the following summary together with the more detailed information regarding our Company and the securities being sold in this offering, including “Risk Factors” and other information incorporated by reference herein.
Our CompanyOverview
We are a clinical-stage pharmaceuticalbiopharmaceutical company focusedseeking to discover and develop innovative medicines in areas of significant unmet medical need with a focus on the development of novel therapeutics and delivery methods for the treatment ofcoronavirus (“COVID-19”), breast cancer and other breast conditions. Our two COVID-19 drugs under development are AT-H201, to improve lung function of moderate to severely ill, hospitalized COVID-19 patients by inhalation, and AT-301, a nasal spray for COVID-19 patients for at-home use. Our drug under development for breast cancer and other breast conditions is Endoxifen which is being developed primarily in two settings: one to reduce tumor cell activity in breast cancer patients in the “window of opportunity” between diagnosis of breast cancer and surgery; and another for women with dense breast tissue to reduce the density and/or to act as an adjunct to mammography.
Summary of Leading Programs
A summary of our four leading programs is as follows:
AT-301. AT-301 is our proprietary drug candidate intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person’s immune system can more effectively fight COVID-19. We also intend to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2, with the goal that it could complement any traditional vaccine that may be developed in that a traditional vaccine may not be effective in all people and may not be taken by all people.
AT-301 is being developed with a nasal spray delivery mechanism because many COVID-19 patients are infected via the nasal passage. Collectively, the components of AT-301 are believed to help maintain a protective mucosal like layer within the nasal cavity with both anti-viral properties and a protective mucosal like barrier that may lead to lower infectivity and reduced symptoms in COVID-19 patients due to their interference with the spike protein of the virus in the nasal cavity and upper respiratory tract. Our nasal spray formulation AT-301 is being designed to contain ingredients that can potentially block SARS-CoV-2 viral entry gene proteins in nasal epithelial cells by interfering with spike protein activation by host proteases, by masking receptor binding domains (RBD) via electrostatic mechanisms, and by providing a generalized mucoadhesive epithelial barrier.
In July 2020, we completed in vitro testing of AT-301 which showed that AT-301 inhibits SARS-CoV-2 infectivity of VERO cells in a laboratory culture.
We recently completed a Phase 1 study of AT-301 which was a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consisted of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two doses. Part B was a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two doses. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation. Dosing is complete and data output is expected in January 2021. A preliminary evaluation of the blinded data indicates that there we no serious adverse events, no discontinuations, and only one of the subjects in the study experienced adverse events that were considered moderate in severity; all other adverse events were considered mild. Our preliminary assessment is that our AT-301 nasal spray was safe and well tolerated in this study. These results support advancing this program uses our patented intraductal microcatheters which deliver pharmaceuticals through the breast ducts. We initiatedinto a Phase 2 clinical study in March 2016 using our microcatheters to deliver fulvestrant as a potential treatment of ductal carcinoma in-situ, or DCIS, and breast cancer. This study was initiated at Columbia University Medical Center Breast Cancer Programs and isstudy. We are in the process of being transferredpreparing a pre-IND meeting request with the U.S. FDA which we plan to Montefiore Medical Center.submit in December 2020.
Our second development program
AT-H201. AT-H201 is a proprietary combination of two drugs previously approved by the FDA to treat other diseases. It is intended to improve compromised lung function for endoxifen,moderate to severely ill, hospitalized COVID-19 patients by inhalation. There are five known key steps the coronavirus must take to signal the cell to open up and let the virus in. AT-H201 is being designed to function like a “chemical vaccine” by blocking all five of those steps, similar to what antibodies would be expected to do when a vaccine is administered. In May 2020, we completed in vitro testing of AT-H201 which we believe couldshowed that the components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells, which is a standard cell type being used to study infectivity of the coronavirus. The AT-H201 components were found to be a potential treatment for a varietyat least four times more potent than remdesivir and at least 20 times more potent than hydroxychloroquine. Potency was measured by microscopic examination of conditions, including for post-breast cancer therapy, preventative therapythe cytopathic effect caused by SARS-CoV-2 in VERO cells. Developing new drugs that combine drugs previously approved by the FDA typically requires pre-clinical and clinical studies of the individual components of the new drug as well as the combination of the components in the new drug. In the second quarter 2020, we requested a potential therapypre-IND meeting with the FDA to discuss the AT-201 program, including a proposed study at NYC Health + Hospitals/Metropolitan in New York City. The FDA requested that we provide, among other things, additional pre-clinical and other information on AT-H201. We also requested a pre-IND meeting with the FDA to discuss one of the components of AT-H201, to which the FDA provided guidance. We are evaluating conducting the study outside the United States. We plan to commence the initial clinical study of AT-H201 in the first quarter of 2021.
We have filed provisional patent applications on AT-H201 to treat COVID-19 patients and on AT-301 to treat patients diagnosed with, or to prevent, COVID-19 via nasal spray.
Endoxifen for MBD. Mammographic breast density (MBD) is an emerging public health issue affecting over 10 million women in the U.S. Studies conducted by others have shown that MBD increases the risk of developing breast cancer and otherthat reducing MBD can reduce the incidence of breast health conditions. cancer. In December 2019, we contracted with Stockholm South General Hospital to conduct a randomized, double-blinded, placebo-controlled study of our oral Endoxifen in pre-menopausal women with MBD who will be dosed over six months. This study will evaluate safety, tolerability and efficacy. The primary endpoint is the change of MBD after six months of daily Endoxifen treatment. We are planning for the study to be conducted in Stockholm, Sweden. The study is subject to approval by the European Medical Product Authority (MPA) which we expect to receive in December 2020.
In June 2019, we reported preliminary analysis from our Phase 2 study of proprietary daily topical Endoxifen to reduce MBD, showing significant (p=0.02) and rapid reduction in MBD at the 20mg daily dose level. MBD was reduced by an average of 14.3% in the group applying 20mg daily topical Endoxifen, which was statistically significant (p=0.02). In the lower dose group (10mg), MBD was reduced by an average of 9.0%, but was not statistically significant. Approximately 70% of participants receiving 20mg topical Endoxifen experienced a reduction in MBD, and of those, the mean reduction in MBD was 27%. Many participants in this study, however, experienced adverse skin reactions and dropped out of the study. We plan to reevaluate our development strategy for the topical form of Endoxifen once we complete the Phase 2 study of oral Endoxifen to reduce MBD.
Endoxifen for Window of Opportunity. We are currently conducting a Phase 2 study in Australia in the window of time between diagnosis of breast cancer and surgical treatment. The study will enroll up to 25 newly-diagnosed patients with ER+ and human epidermal growth factor receptor 2 negative (HER2-) stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients will receive Atossa’s proprietary oral Endoxifen for at least 14 days from the time of diagnosis up to the day of surgery. The primary endpoint is to determine if the administration of oral Endoxifen reduces the tumor activity as measured by Ki-67. The secondary endpoints are safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors. The impact on additional markers of cellular activity will also be explored.
In May 2020, we reported interim results from our window of opportunity study. A statistically significant (p=0.031) reduction of about 74% in tumor cell proliferation, as measured by Ki-67, over the 22 days of dosing was achieved in the initial patients. Ki-67 is a recognized standard measurement of breast cancer cell proliferation. The purpose of this study is to determine if Atossa’s oral Endoxifen reduces breast cancer tumor cell proliferation as measured by several biomarkers, including Ki-67. Six out of six (100%) patients experienced a significant reduction in Ki-67. A summary of these results includes:
● | Ki-67 was reduced by more than 50% in every patient in the window of opportunity between initial biopsy and surgery, with an overall relative reduction of 74%. |
● | All six patients had a Ki-67 below 25% after treatment. In a paper entitled, “Prognostic value of different cut-off levels of Ki-67 in breast cancer: a systematic review and meta-analysis of 64,196 patients,” Ki-67 was an independent prognostic value for predicting overall survival in ER+ breast cancer patients. Ki-67 levels below 25% were associated with the lowest risk of death in this systematic review and meta-analysis. |
● | Treatment ranged from 16-40 days with an average of 22 days. |
● | There were no safety or tolerability issues, including vasomotor symptoms such as hot flashes and night sweats, which are often a tolerability challenge for patients on tamoxifen. |
This study continues to be open for enrollment; however, enrollment has been slower than anticipated in part due to fewer patients undergoing breast cancer surgery in Australia as a result of the Coronavirus pandemic.
About Endoxifen
Endoxifen is an active metabolite of tamoxifen which is an FDA approvedFDA-approved drug given to treat and prevent breast cancer patientsin high risk women. Endoxifen has been studied in 70 participants in Atossa-conducted Phase 1 clinical studies. No serious adverse events were reported in any of the studies.
In May 2020, we reported that the FDA recently provided written input on our clinical path for oral Endoxifen to prevent recurrence as well asreduce MBD. The input was provided pursuant to a pre-IND meeting request which was scheduled for April 30, 2020. The input received from the occurrenceFDA was very useful and will inform our clinical trial strategy and study design both in the U.S. and in Stockholm, Sweden where we are planning a Phase 2 study to reduce MBD.
Compassionate Use of new breast cancer. Within the endoxifen program,Endoxifen
In December 2018, we began providing our initial pharmaceutical under development is oral endoxifen forEndoxifen to a pre-menopausal, estrogen-receptor positive (ER+), lacking CYP2D6 function, breast cancer patients who are refractory,patient under an FDA-approved expanded access, single patient, or resistant,"compassionate use" program. The purpose of this therapeutic approach was to tamoxifen. Certain research indicates that low endoxifen levelsreduce activity of the cancer cells prior to surgery. The patient received daily doses of our oral Endoxifen for approximately three weeks prior to surgery. There were no safety or tolerability issues and her surgery was successfully completed. The cancer cell biological activity was reduced, based on the estrogen receptor activity of the tumor cells and a 50% reduction in Ki-67. The FDA has also permitted use of our Endoxifen for this patient following her surgery, under the compassionate use program, as part of her long-term breast cancer patients takingtreatment regimen. The use of our proprietary oral tamoxifen may be correlated withEndoxifen is restricted solely to this patient. In July 2020, we reported an update on this patient, who has received Endoxifen for 18 months post-surgery. To date, the patient has not had a higher riskrecurrence of recurrence as compared to patients with adequate endoxifen levels. breast cancer, has not had treatment-related changes in periodic laboratory blood tests and the treatment has been well tolerated, including an absence of typically seen vasomotor symptoms (night sweats and hot flashes).
Research and Development Phase
We estimate that up to 50%are in the research and development phase and are not currently marketing any products. We do not anticipate generating revenue unless and until we develop and launch our pharmaceutical programs.
Impact of the one million women eligible to take tamoxifen inNovel Coronavirus
The continued spread of the COVID-19 pandemic is affecting the United States each year are refractory, meaning that they have inadequate endoxifen levels (for any numberand global economies and may affect the Company’s operations and those of reasonsthird parties on which the Company relies, including low levelscausing possible disruptions in the supply of the Company’s Endoxifen, AT-H201, AT-301 and the conduct of current and future clinical trials. In addition, the COVID-19 pandemic may affect the operations of the U.S. Food and Drug Administration and other health authorities including similar entities/agencies in Sweden and Australia, which could result in delays in meetings, reviews and approvals. The evolving COVID-19 pandemic could also directly or indirectly impact the pace of enrollment in the Company’s clinical trials for at least the next several months and possibly longer as patients may avoid or may not be able to travel to healthcare facilities and physicians’ offices except for a liver enzyme)health emergency. Such facilities and they have an increased risk for breast cancer recurrence.
We believe that, basedoffices may also be required to focus limited resources on non-clinical trial activities, including treatment of COVID-19 patients, and may not be available, in whole or in part, on a January 2017 study by Defined Health, a leading market research firm,for clinical trial activities related to the Company's products under development. Additionally, while the potential U.S. marketeconomic impact brought by, and the duration of, the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce the Company’s ability to access capital, which could negatively impact the Company’s short-term and long-term liquidity. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. The Company does not yet know the full extent of potential delays or impacts on its business, financing or clinical trial activities or on healthcare systems or the global economy as a whole. However, these effects could have a material adverse impact on the Company’s liquidity, capital resources, operations, financial position and business and those of the third parties on which we rely. As of September 30, 2020, the Company has not experienced any delay in drug supply for intraductal administrationits ongoing and planned clinical studies, including studies of fulvestrant or similar drugsEndoxifen, AT-301 and AT-H201. Currently, enrollment is open in DCIS patients is upAustralia for the Endixofen Window of Opportunity study for which enrollment continues to $800 million annually. This estimate includes treatment of DCIS patients priorbe slow due in part to surgery as well as patients who would use intraductal treatment as an alternative to surgery. We believe thatdisruption caused by COVID-19. The Company anticipates commencing the potential U.S. market for endoxifenMBD Endoxifen trial in the treatment and prevention settings is up to $1 billion annually.
We expect to complete the manufacturingfourth quarter of an initial supply of proprietary endoxifen and to initiate the endoxifen Phase 1 clinical study2020. The Company opened enrollment in the secondAT-301 trial during the third quarter of 2017.2020 and completed enrollment in the fourth quarter 2020. We plananticipate receiving regulatory approval to commence a Phase 2the initial clinical study of endoxifenone of the components of AT-H201 in the second halffirst quarter of 2017. We anticipate completing2021. The Company will continue to monitor future enrollment in studies for potential restrictions on site visits, mammograms or the fulvestrant microcatheter study by August 2017.impositions of new restrictions on trials as a result of the COVID-19 pandemic.
Corporate Information
We were incorporated in the state of Delaware in April of 2009 and2009. On January 6, 2020, we changed our Common Stock is currently quoted on The NASDAQ Capital Market under the symbol “ATOS.”
Summary of Our Clinical-Stage Programs Under Development
Delivery of Therapeutics via our Microcatheters
We believe our patented intraductal microcatheters may be useful in delivering a number of therapeutics to the ducts in the breast, the site of the majority of early breast cancers. Doing so is intended to provide a therapeutic directly to the breast tissue while at the same time reducing the delivery of the drug to healthy tissue. We must obtain FDA approval of any drug delivered via our intraductal microcatheters devices, which will require expensive and time-consuming studies. For example, we must complete clinical studies to demonstrate the safety and tolerability of fulvestrant using our delivery method. We may not be successful in completing these studies and obtaining FDA approval.
According to The American Cancer Society, breast cancer is the most common cancer in American women, other than skin cancer. The American Cancer Society estimates that in 2017 there will be 252,710 new cases of breast cancer in women in the United States, in addition to 63,410 cases of carcinoma in situ. They also estimate that 40,610 women will diecorporate name from breast cancer in the United States in 2017.
Breast cancers and precancerous lesions are typically treated with systemically administered agents such as tamoxifen, Faslodex, Perjeta and Herceptin; however, these drugs can cause serious side effects which may lead to poor patient compliance with the drug regimens. Providing drug directly into the breast ducts targeting the site of the localized cancerous lesions could reduce the need for systemic anti-cancer drugs, and potentially reduce or eliminate the systemic side effects of the drugs and morbidity in such patients, and ultimately improve patient compliance and ultimately reduce mortality.
The initial drug we are studying using our microcatheters for intraductal delivery is fulvestrant. Fulvestrant is FDA-approved for metastatic breast cancer. It is administered as a monthly injection of two shots, typically into the buttocks. In 2012, a published study documented that the single dose cost of intramuscular fulvestrant was approximately $12,000.
We own several pending patent applications directed to the treatment of breast conditions, including cancer, by the intraductal administration of therapeutics including fulvestrant, and one issued patent directed to the intraductal treatment of breast conditions following a diagnosis of breast conditions using ductal fluid.
We do not yet have the FDA’s input, but based on our preliminary analysis, subject to FDA feedback, we believe that the intraductal fulvestrant program could qualify for designation under the 505(b)(2) status. This would allow us to file with only clinical data and without having to perform additional, significant clinical or pre-clinical studies. As a result, the path to market could be both faster and less expensive than a standard new drug application program.
To support this development program, we have successfully produced microcatheters for the fulvestrant Phase 2 clinical trial. The FDA has also issued a “Safe to Proceed” letter for our first Investigational New Drug application (an “IND”) for the Phase 2 study and the institutional review board approval has also been received.
In March 2016, we opened enrollment in the fulvestrant microcatheter study, which was initially being conducted by The Columbia University Medical Center Breast Cancer Program. The principal investigator for this study transferred from Columbia to Montefiore Medical Center in January 2017, and as a result we are in the process of transferring the study to Montefiore Medical Center. We expect to complete enrollment in the study by August 2017.
The study includes women with DCIS or invasive breast cancer slated for mastectomy or lumpectomy. This study will assess the safety, tolerability and distribution of fulvestrant when delivered directly into breast milk ducts of these patients compared to those who receive the same product intramuscularly. The secondary objective of the study is to determine if there are changes in the expression of Ki67 as well as estrogen and progesterone receptors between a pre-fulvestrant biopsy and post-fulvestrant surgical specimen. Digital breast imaging before and after drug administration in both groups will also be performed to determine the effect of fulvestrant on any lesions as well as breast density of the participant. Six study participants will receive the standard intramuscular fulvestrant dose of 500 mg to establish the reference drug distribution, and 24 participants will receive fulvestrant by intraductal instillation utilizing our microcatheter device. The total dose administered via our microcatheters will not exceed 500 mg.
The study was presented at the CTRC-AARC San Antonio Breast Cancer Symposium, which was held December 6-10, 2016. The study was presented in the “Ongoing Clinical Trials” category, which features studies that have not been completed and which does not permit the presentation of study results.
Additional information about the study can be found at:https://clinicaltrials.gov/ct2/show/NCT02540330?term=atossa&rank=2.
Endoxifen
Our second development program involves the drug endoxifen, which is the most active metabolite of tamoxifen, and which we believe could be a potential treatment for a variety of conditions, including for post-breast cancer therapy, preventative therapy as well as a potential therapy for breast density and other breast health conditions.
Within the endoxifen program, our initial pharmaceutical under development is oral endoxifen for breast cancer patients who are refractory to tamoxifen. Endoxifen is an active metabolite of tamoxifen, which is an FDA approved drug used by breast cancer patients to prevent recurrence as well as the occurrence of new breast cancer. Certain research indicates that low endoxifen levels in breast cancer patients taking oral tamoxifen may be correlated with a higher risk of recurrence as compared to breast cancer patients with adequate endoxifen levels. We believe that up to 50% of the one million women eligible to take tamoxifen in the United States each year are refractory, meaning that they have inadequate endoxifen levels (for any number of reasons including low levels of a liver enzyme) and they have an increased risk for breast cancer recurrence. We are also evaluating endoxifen as a potential preventive therapy for breast cancer, a potential therapy to reduce mammographic density, and other breast health conditions.
We have filed patent applications covering endoxifen and we are in the process of manufacturing an initial supply of our proprietary endoxifen drug for initial Phase 1 studies. We expect to initiate the Phase 1 study in the second quarter of 2017. We plan to conduct the Phase 1 study through a clinical research organization in Australia, pending approval from the associated ethics committee. The anticipated primary endpoint of this placebo-controlled, repeat dose study of 48 healthy female volunteers is to assess the pharmacokinetics of both an oral and topical formulation of endoxifen over 28 days. The secondary endpoint is to assess safety and tolerability.
Subject to successful completion of the Phase 1 study and other regulatory requirements, we plan to initiate a Phase 2 study of endoxifen in the second half of 2017.
We believe that the potential U.S. market for endoxifen in the treatment and prevention settings is up to $1 billion in annual sales.
Our Pre-Clinical Programs Under Development
In addition to our clinical-stage pharmaceutical programs, we are in the process of evaluating other therapeutic candidates to treat breast conditions, including breast cancer. Factors we are considering in evaluating potential drug candidates include, for example, the ability to obtain expedited regulatory approval, significance of unmet medical need, size of the patient population, intellectual property opportunities, and the anticipated pre-clinical and clinical pathway.
Our Medical Devices
Our medical devices include the ForeCYTE Breast Aspirator and the FullCYTE Breast Aspirator, which collect specimens of nipple aspirate fluid (“NAF”) for cytological testing at a laboratory, and a universal transport kit to assist with the packaging and transport of NAF samples to a laboratory. We also own the exclusive rights to manufacture and sell various medical devices (although we do not currently maintain an inventory of such devices) consisting primarily of tools to assist breast surgeons, which we acquired from Acueity Healthcare, Inc. in 2012. We are not currently commercializing our breast aspirator devices, transportation kits, tools for breast surgeons nor any NAF cytology tests.
Our patented intraductal microcatheter devices are being developed for the targeted delivery of potential pharmaceuticals and are currently being used in a Phase 2 clinical trial, as described above.
Intellectual Property
As of February 15, 2017, and based on a recent periodic review of our patent estate, we own 78 issued patents (33 in the United States and approximately 45 in foreign countries), and 11 pending patent applications (5 in the United States, and 6 international applications) directed to ForeCyte, FullCyte, and Acueity devices, various tests, intraductal treatments, and therapeutics. Excluding certain patents and applications that are no longer being maintained or prosecuted, our patent estate consists primarily of the following:
| Description | U.S. Patents Issued(1) | Expiration | U.S. Pending(1) | Foreign Patents Granted(1) | Expiration | Foreign Pending(1) | ||||||
| Intraductal Treatment Program | 0 | N/A | 3 | 2 | 2017 - 2031 | 1 | ||||||
| Therapeutics | 0 | N/A | 3 | 0 | N/A | 2 | ||||||
| ForeCyte Breast Aspirator Program | 2 | 2017 - 2031 | 0 | 12 | 2017 - 2031 | 0 | ||||||
| Fullcyte Microcatheters, Fullcyte Breast aspirator and Diagnostics/tests Programs | 29 | 2017 - 2031 | 1 | 31 | 2017 - 2031 | 3 | ||||||
| Acueity Tools | 12 | 2017 - 2024 | 0 | 0 | 2017 - 2024 | 0 |
Atossa and Atossa Genetics (stylized) are our registered trademarks.
Implications of being an Emerging Growth Company
We are an “emerging growth company,” as defined in the JOBS Act, and, for as long as we continue to be an “emerging growth company,” we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies but not to “emerging growth companies,” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an “emerging growth company” for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our annual gross revenues exceed $1 billion, (ii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our Common Stock that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter, or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three-year period. We are choosing to “opt out” of the extended transition periods available under the JOBS Act for complying with new or revised accounting standards, and intend to take advantage of the other exemptions.
Corporate Information
Our corporate website is located atwww.atossagenetics.com . Information contained on, or that can be accessed through, our website is not a part of this prospectus. We make available, free of charge through our website or upon written request, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other periodic SEC reports, along with amendments to all of those reports, as soon as reasonably practicable after we file the reports with the SEC.
Unless otherwise noted, the term “Atossa Genetics” refers to Atossa Genetics Inc., a Delaware corporation, the terms “Atossa,” the “Company,” “we,” “us,” and “our,” refer to the ongoing business operations of Atossa and the historic business of the NRLBH, whether conducted through Atossa Genetics or the NRLBH; however unless the context otherwise indicates, references to “we,” “our” or the “Company” as they relate to laboratory tests generally refers to activities conducted by the NRLBH. We were incorporated in Delaware in April 2009.Therapeutics, Inc. Our principal executive officescorporate headquarters are located at 107 Spring Street, Seattle, WA 98104, and ourWashington 98104. Our telephone number is (800) 351-3902.
Our name(206) 588-0256 and logo, Atossaour Internet website address is www.atossatherapeutics.com. We do not incorporate the information on our website into this prospectus, and Atossa Genetics (stylized) are our registered trademarks. ArgusCYTE is our registered service mark. This prospectus also includes additional trademarks, trade names and service marksyou should not consider it part of third parties, which are the property of their respective owners. this prospectus.
THE OFFERINGThe Offering
Securities Offered: |
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Underwriter Overallotment: |
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Price per share: | $ | |
Series C Convertible Preferred Stock: | Each whole share of Series C convertible preferred stock is convertible into 1,000 shares of common stock at any time so long as the | |
Common | shares of common stock. | |
Common stock outstanding after this offering: | shares of common stock, determined on | |
Use of proceeds: | We intend to use the net proceeds from this offering for | |
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Risk Factors: | Investing in our common or preferred stock involves a high degree of risk. See the information contained in or incorporated by reference under the heading “Risk Factors” and in the documents incorporated by reference and any free writing prospectus that we authorize for use in connection with this offering. | |
Market symbol and trading: | Our |
The number of shares of our common stock to be outstanding after this offering is based on shares of our common stock outstanding as of September 30, 2020 and excludes:
| ● | shares of our common stock that have been sold or may be sold in the future in connection with our current “at-the-market” offering; | |
● | 1,070,028 shares of common stock issuable upon the exercise of outstanding warrants as of September 30, 2020, at an exercise price of $4.05 per share; |
● | 7,079,831 shares of common stock issuable upon the exercise of options issued under the Company’s 2010 and 2020 Stock Option and Incentive Plans at a weighted average exercise price of $2.77 per share as of September 30, 2020; |
● | 177,562 shares of common stock issuable upon the conversion of outstanding Series B convertible preferred stock as of September 30, 2020; and |
● | 670,000 shares of common stock reserved for issuance pursuant to future equity awards under our 2020 Plan as of September 30, 2020, as well as any future increases in the number of shares of our common stock reserved for future issuance under the 2020 Plan. |
RISK FACTORSExcept as otherwise indicated herein, all information in this prospectus, including the number of shares that will be outstanding after this offering, assumes no exercise by the underwriters of their option to purchase additional securities.
A purchase of our shares of Common Stock is anRISK FACTORS
An investment in our securities and involves a high degree of risk. You should carefully consider the risks and uncertainties and all other information contained in or incorporated by reference in this prospectus, includingdescribed below as well as the riskrisks and uncertainties discussedset forth under the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016. If any2019, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which are incorporated by reference herein, before deciding whether to purchase securities. You should also refer to the other information contained in this prospectus and the documents incorporated by reference herein, including our audited consolidated financial statements and related notes and the section titled “Management’s Discussion and Analysis of these risks actually occur, our business, financial conditionFinancial Condition and resultsResults of operations would likely suffer. In that case, the market price of the Common Stock could decline, and you may lose part or all of your investmentOperations” included in our company. Additional risks of which we are not presently aware or that we currently believe are immaterial may also harm our business and results of operations.
We may not continue as a going concern.
We have not yet established an ongoing source of revenue sufficient to cover operating costs and allow us to continue as a going concern. The report issued by our independent auditors also emphasized our ability to continue as a going concern. Our ability to continue as a going concern is dependentAnnual Report on obtaining adequate capital to fund operating losses until we become profitable. If we are unable to obtain adequate capital, we may be unable to develop and commercialize our product offerings or geographic reach and we could be forced to cease operations.
If we do not raise additional capital, we anticipate liquidity issues in the next two to four months.
ForForm 10-K for the year ended December 31, 2016, we incurred a net loss2019, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which are incorporated by reference herein. Our business, financial condition, results of $6,368,885operations and we had an accumulated deficitprospects could be materially and adversely affected by any of $57,303,748. Asthese risks or uncertainties. In any such case, the trading price of the dateour common stock could decline, and you could lose all or part of filing this prospectus, we expect that our existing resources will be sufficient to fund our planned operations for at least the next two to four months. We have not yet established an ongoing source of revenue sufficient to cover our operating costs and allow us to continue as a going concern. Our ability to continue as a going concern is dependent on obtaining adequate capital to fund operating losses until we become profitable. The revenue we have generated to date consisted of mainly laboratory services; however, we sold our laboratory business on December 16, 2015 and we currently have no other products and services approved for commercialization. Although the terms of the agreement governing this sale provide that we will receive royalties of 6% of laboratory revenue starting December 2016, we have not received any payments to date and may not receive any in the future. We may not receive or maintain regulatory clearance for our products and other sources of capital may not be available when we need them or on acceptable terms. If we are unable to raise in a timely fashion the amount of capital we anticipate needing, we will be forced to curtail or cease operations.your investment.
Risks Related to this Offering
We estimate that the net proceeds fromIf you purchase our issuance and sale of 4,000,000 shares of Common Stocksecurities in this offering, willyou may incur immediate and substantial dilution in the book value of your shares.
The public offering price per share may be approximately $ million (or approximately $ million ifsubstantially higher than the underwriters exercise their optionnet tangible book value per share of our common stock immediately prior to purchase additionalthe offering. After giving effect to the assumed sale of shares from usof common stock (determined on an as-converted basis) in full), assuming athis offering, at an assumed public offering price of $ per share, which was the last reported sale price of our Common Stock on The NASDAQ Capital Market on February , 2017,and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
A $1.00 increase or decreaseus, purchasers of our common stock in the assumed publicthis offering pricewill incur immediate dilution of $ per share would increasein the net tangible book value of the common stock they acquire. For a further description of the dilution that investors in this offering may experience, see “Dilution.” In addition, to the extent that outstanding stock options or decreasewarrants have been or may be exercised or other shares issued, you may experience further dilution.
You may experience future dilution as a result of future equity offerings.
In order to raise additional capital, we may at any time, including during the pendency of this offering, offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock at prices that may not be the same as the price per share in this offering (including in our current “at-the-market” offering in which we are offering shares of our common stock pursuant to a prospectus supplement filed by the Company with the SEC on September 25, 2020 (Registration No. 333-248555)). We may sell shares or other securities in any other offering at a price per share that is less than the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by investors in this offering
We have broad discretion in the use of our cash and cash equivalents, including the net proceeds we receive in this offering, and may not use them effectively.
Our management has broad discretion to use our cash and cash equivalents, including the net proceeds we receive in this offering, to fund our operations and could spend these funds in ways that do not improve our results of operations or enhance the value of our common stock, and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. The failure by our management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock to decline and delay the development of our product candidates. Pending their use to fund our operations, we may invest our cash and cash equivalents, including the net proceeds from this offering, in a manner that does not produce income or that loses value.
Because we do not intend to declare cash dividends on our shares of common stock in the foreseeable future, stockholders must rely on appreciation of the value of our common stock for any return on their investment.
We have never declared or paid cash dividends on our common stock. We currently anticipate that we will retain future earnings, if any, for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends in the foreseeable future. In addition, the terms of any existing or future debt agreements may preclude us from paying dividends. As a result, we expect that only appreciation of the price of our common stock, if any, will provide a return to investors in this offering for the foreseeable future.
There is no public market for the Series C Convertible Preferred Stock in this offering.
There is no established public trading market for the Series C convertible preferred stock, and we do not expect a market to develop. In addition, we do not currently intend to apply for listing of the Series C convertible preferred stock on any securities exchange or recognized trading system. The ability to convert the Series C convertible preferred stock to common stock will be subject to a beneficial ownership conversion limit, which may further impair the liquidity of this investment.
We estimate that the net proceeds to us from the sale of the securities offered by this prospectus in this offering will be approximately $ million and(or $ million respectively, assumingif the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, andunderwriters fully exercise their overallotment option) after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. An increase (decrease) by shares in the number of shares offered by us would increase (decrease) the net proceeds to us from this offering by approximately $ million ($ million), assuming that the public offering price remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We do not expect that a change in the public offering price or the number of shares by these amounts would have a material effect on our anticipated uses of the net proceeds from this offering, although it may accelerate the time at which we will need to seek additional capital.
We anticipate that we willcurrently intend to use the net proceeds from this offering for working capital and general corporate purposes.purposes, including clinical studies of our products under development. We may also use a portion of the net proceeds from this offering for the acquisitionacquisitions of businesses, products, technologies or investment in,licenses that are complementary to our business, products, or technologies, although we have no present commitments or agreements to do so.
The allocation of the net proceeds of the offering set forth above represents our estimates based upon our current plans and assumptions regarding industry and general economic conditions, our future revenues and expenditures. The amounts and timing of our actual expenditures may vary significantly and will depend on numerous factors, regulatory requirements, cash used by our operations, the extent to which we receive project funding from government grants and other third party collaborators and other business developments and opportunities that may arise. We may find it necessary or advisable to use portions of the proceeds from this offering for any specific acquisitionsother purposes.
We believe that the net proceeds of this offering, together with cash on hand, will be sufficient to fund our operations for at least the next 12-18 months. Additional capital may not be available on terms favorable to us, or investments. at all. If we raise additional funds by issuing equity securities, including in our current at-the-market offering program, our stockholders may experience dilution. Debt financing, if available, may involve restrictive covenants or additional security interests in our assets. Any additional debt or equity financing that we complete may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or products or grant licenses on terms that are not favorable to us. If we are unable to raise adequate funds, we may have to delay, reduce the scope of, or eliminate some or all of, our development programs or liquidate some or all of our assets.
Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment grade, interest bearing instruments and U.S. government securities
These expected uses of the net proceeds from this offering represent our intentions based upon our current financial condition, results of operations, business plans, and conditions. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the closing of this offering or the amounts that we will actually spend on the uses set forth above. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering.securities.
We have not declared any dividendsnever, and do not anticipate that we will, declare or pay a cash dividend. We expect to retain future earnings, if any, for our business and do not anticipate paying dividends on common stock or our Series C convertible preferred stock at any time in the foreseeable future. Because we do not anticipate paying dividends in the foreseeable future; rather, we intendfuture, the only opportunity for our stockholders to retain any future earnings forrealize the developmentcreation of the business. Paymentvalue in our common stock or our Series C convertible preferred stock will likely be through a sale of future cash dividends, if any, will be at the discretionthose shares.
Purchasers of our Boardcommon stock will experience an immediate dilution of Directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs, outstanding indebtedness and plans for expansion and restrictions imposed by lenders, if any.
DILUTION
If you invest in our Common Stock, your interest will be diluted immediately to the extent of the difference between the public offering price per share of Common Stock and the adjusted net tangible book value per share of our Common Stock after this offering.
Thecommon stock. Our net tangible book value as of September 30, 2020 was approximately $ , or $ per share of common stock (based upon shares of our Common Stock ascommon stock then outstanding (calculated on an as-converted basis) and assuming no exercise of December 31, 2016, was approximately $2,456,666, or approximately $0.65 per share.the underwriter’s overallotment option). Net tangible book value per share represents the amount ofis equal to our total tangible assets excluding goodwill and intangible assets, less our total liabilities, divided by the total number of shares of our Common Stock outstanding.outstanding common stock (calculated on an as-converted basis).
Dilution per share to new investors representsof common stock equals the difference between the amountoffering price per share paid by purchasers for each share of Common Stock in this offering and the net tangible book value per share of our Common Stockcommon stock immediately following the completion ofafter this offering.
After giving effect toBased on the sale by us of 4,000,000 shares of Common Stock offered by this prospectus supplementcommon stock (calculated on an as-converted basis) at an offering price of $1.50$ per share which was the closing price on The Nasdaq Capital Market on March 15, 2017, in connection with this offering and after deducting the estimated underwriting discounts and offering expenses and underwriter fees and expenses payable by us, our pro forma net tangible book value as of December 31, 2016September 30, 2020 would have been approximately $8,456,666$ , or approximately $1.09$ per share. This represents an immediate increase in net tangible book value of approximately $0.44 per share to our existing stockholders and an immediate dilution in pro forma net tangible book value to existing stockholders of $ per share and an immediate dilution to purchasers in the rights offering of $ per share. The following table illustrates this per-share dilution:
Offering price per share | $ | |||||||
Tangible book value per common share as of September 30, 2020 | $ | |||||||
Increase in tangible book value per common share attributable to this offering | $ | |||||||
As adjusted tangible book value per common share after this offering | $ | |||||||
Dilution in tangible book value per common share to new investors | $ |
A $0.50 increase (decrease) in the assumed offering price of $ per share would increase (decrease) our as adjusted tangible book value per share after this offering by approximately $0.41$ , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the underwriting discounts and estimated offering expenses payable by us.
If the underwriters’ option to purchase additional shares is exercised in full, the pro forma tangible book value per share after giving effect to this offering would be approximately $ per share, and the dilution in pro forma as adjusted tangible book value per share to purchasers of shares of Common Stockinvestors in this offering as illustrated by the following table:
| Offering price per share | $ | 1.50 | ||
| Net tangible book value per share as of December 31, 2016 | $ | 0.65 | ||
| Increase per share attributable to the offering | $ | 0.44 | ||
| As adjusted net tangible book value per share after this offering | $ | 1.09 | ||
| Dilution per share to new investors | $ | (0.41 | ) |
The discussion of dilution, and the table quantifying it, assumes no exercise of any outstanding options or warrants or the issuance of other potentially dilutive securities. The exercise of potentially dilutive securities having an exercise price less than the offering price would increase the dilutive effect to new investors.be approximately $ per share.
The number of shares of Common Stock shown above to be outstanding after this offeringdiscussion and table is based on 3,786,913 shares outstanding as of December 31, 2016,September 30, 2020, and excludes shares of Common Stock issuable in connection with future option grants as well as the following as of December 31, 2016:excludes:
● | 1,070,028 shares of common stock issuable upon the exercise of outstanding warrants as of September 30, 2020, at an exercise price of $4.05 per share; |
● | 7,079,831 shares of common stock issuable upon the exercise of options issued under the Company’s 2010 and 2020 Stock |
● | 177,562 shares of common stock issuable upon the conversion of outstanding Series B convertible preferred stock as of September 30, 2020; and |
● | 670,000 shares of common stock reserved for issuance pursuant to future equity awards under our 2020 Plan as of September 30, 2020, as well as any future increases in the number of shares of our |
Common Stock
The terms and provisions of our common stock are incorporated by reference to Exhibit 4.16 (Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934) of our Annual Report on Form 10-K for the year ended December 31, 2019.
Series C Convertible Preferred Stock.
The terms and provisions of our Series C convertible preferred stock are:
Conversion. Each share of Series C convertible preferred stock is convertible into 1,000 shares of our common stock at any time so long as the holder, together with its affiliates, and any other person acting as a group together with the holder or any of its affiliates, does not own excess of 4.99% of the number of shares of our common stock outstanding immediately after giving effect to its exercise. In addition, the conversion ratio is subject to adjustment for stock dividends, distributions, subdivisions, combinations or reclassifications of the underlying common stock.
Fundamental Transactions. In the event we effect certain mergers, consolidations, sales of substantially all of our assets, tender or exchange offers, reclassifications or share exchanges in which our common stock is effectively converted into or exchanged for other securities, cash or property, we consummate a business combination in which another person acquires 50% of the outstanding shares of our common stock, or any person or group becomes the beneficial owner of 50% of the aggregate ordinary voting power represented by our issued and outstanding common stock, then, upon any subsequent conversion of the Series C convertible preferred stock, the holders of the Series C convertible preferred stock will have the right to receive any shares of the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of common stock then issuable upon conversion in full of the Series C convertible preferred stock.
Dividends. Holders of Series C convertible preferred stock shall be entitled to receive dividends (on an as-if-converted-to-common-stock basis) in the same form as dividends actually paid on shares of the common stock when, as and if such dividends are paid on shares of common stock.
Voting Rights. Except as otherwise provided in the certificate of designation or as otherwise required by law, the Series C convertible preferred stock has no voting rights.
Liquidation Preference. Upon our liquidation, dissolution or winding-up, whether voluntary or involuntary, holders of Series C convertible preferred stock will be entitled to receive out of our assets, whether capital or surplus, the same amount that a holder of common stock would receive if the Series C convertible preferred stock were fully converted (disregarding for such purpose any conversion limitations under the certificate of designation) to common stock, which amounts shall be paid pari passu with all holders of common stock.
Redemption Rights. We are not obligated to redeem or repurchase any shares of Series C convertible preferred stock. Shares of Series C convertible preferred stock are not otherwise entitled to any redemption rights, or mandatory sinking fund or analogous provisions.
Aegis Capital Corp. is acting as the representative of the underwriters and the sole book-running manager in this offering. We have entered into an underwriting agreement dated with Maxim Group LLC as the representative.sole representative of the underwriters (“Maxim” or the “Representative”), with respect to the shares being offered. Maxim is the sole book running manager for the offering. Subject to the terms and conditions of thean underwriting agreement between us and Maxim, we have agreed to sell to each underwriter named below, and each underwriter named below has severally and not jointly agreed to purchase, from us, at the public offering price per share less the underwriting discounts and commissions set forth on the cover page of this prospectus, the number of shares of Common Stock listedcommon stock and Series C convertible preferred shares next to its name in the following table:
Name of Underwriter | Number of Common Shares | Number of Series C Preferred Shares | ||
Maxim Group LLC | ||||
Total |
The underwriters are committed to purchase all the shares of Common Stockcommon stock and Series C convertible preferred shares (the “shares”) offered by us other than those covered by the option to purchase additional shares described below,this prospectus if they purchase any shares. The obligationsunderwriting agreement also provides that if an underwriter defaults, the purchase commitments of thenon-defaulting underwriters may be terminated uponincreased or the occurrence of certain events specified inoffering may be terminated. The underwriters are not obligated to purchase the underwriting agreement. Furthermore, pursuant to the underwriting agreement,shares covered by the underwriters’ obligations are subject to customary conditions and representations and warranties contained in the underwriting agreement, such as receipt by the underwriters of officers’ certificates and legal opinions.
We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the underwriters may be required to make in respect thereof.
over-allotment option described below. The underwriters are offering the shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel, and other conditions specifiedcontained in the underwriting agreement.agreement, such as the receipt by the underwriters of officer’s certificates and legal opinions. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.
Over-allotment Option.Over-Allotment Option
We have granted to the underwriters an over-allotment option. This option, which is exercisable for up tono later than 45 calendar days after the date of this prospectus, permits the underwritersunderwriting agreement, to purchase a maximum ofup to an additional shares (15% of the shares sold in this offering) from us to cover over-allotments, if any. If the underwriters exercise all or part of this option, they will purchase shares covered by the optioncommon stock at the public offering price per share,listed on the cover page of this prospectus, less the underwriting discounts and commissions. If thiscommissions, solely for the purpose of covering over-allotments. To the extent the option is exercised in full,and the total offering priceconditions of the underwriting agreement are satisfied, we will be obligated to sell to the publicunderwriters, and the underwriters will be $obligated to purchase, these additional shares.
Discounts and the total net proceeds, before expenses, to us will be $ .Commissions; Expenses
Discounts, Commissions and Non-Accountable Expense Allowance.The following table shows the public offering price, underwriting discount non-accountable expense allowance and proceeds, before expenses, to us. The information assumes either no exercise or full exercise by the underwritersRepresentative of theirthe over-allotment option.
Per Share (Common Stock) | Per Share (Preferred Stock) | Total Without Over-Allotment Option | Total With FullOver- Allotment | |||||||||
Public offering price | $ | $ | $ | $ | ||||||||
Underwriting discount | $ | $ | $ | $ | ||||||||
Proceeds, before | $ | $ | $ | $ | ||||||||
The underwriters propose to offer the shares offered by us to the public at the public offering price per share set forth on the cover of this prospectus. In addition, the underwriters may offer some of the shares to other securities dealers at such price less a concession of up to $ per share. If all ofAfter the shares offered by us are not sold atinitial offering, the public offering price per share,and concession to dealers may be changed.
We have paid an expense deposit of $25,000 to the underwriters may changeRepresentative, which will be applied against the offering price per share and other selling termsaccountable expenses that will be paid by meansus to the Representative in connection with this offering.
We have also agreed to payreimburse the representative a nonaccountable expense allowance of % of the aggregate offering proceeds (excluding the over-allotment option),Representative for reasonable out-of-pocket legal and audit fees and expenses not to reimburse certain of the representative’s out of pocket expenses, including the fees of underwriters’ counsel, up to a total of $79,500.
exceed $75,000 without our prior written consent. We estimate that the total expenses of the offering payable by us excludingin connection with this offering, other than the total underwriting discounts, commissions, and non-accountable expense allowancediscount, will be approximately $ .
Lock-Up Agreements.Agreements
We and each of our executive officers and directors have agreed, with the representative that we will not offer or sell any securities for a period of 90 days from the closing date of this offering, subject to certain exceptions. In addition, all of our directors and executive officers have entered into lock up agreements with the representative prior to the commencement of this offering pursuant to which each of these persons, for a period of 90 days from the closing date of this offering, without the prior written consent of the representative, agreeexceptions, not to (1) offer, pledge,issue, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell,encumber, grant any option right or warrant to purchase, lend,for the sale of or otherwise transfer or dispose of directly or indirectly, any shares of our securitiescommon stock or anyother securities convertible into or exercisable or exchangeable for common shares owned or acquired on or prior to the closing date of this offering (including any common shares acquired after the closing date of this offering upon the conversion, exercise or exchange of such securities); (2) file or caused to be filed any registration statement relating to the offering of any shares of our capital shares;common stock for a period of 90 days after this offering is completed without the prior written consent of Maxim. The foregoing does not prohibit (a) the Company from granting options or (3) enter into any swapequity awards to the Company’s Directors and executive officers pursuant to equity compensation arrangements approved or other arrangement that transferssubject to another, in whole or in part, anyapproval by the stockholders of the economic consequences of ownership of common shares, whether any such transaction described in clause (1), (2), or (3) aboveCompany and (b) commencing 60 days after the offering is completed transactions under trading plans pursuant to be settled by delivery of common shares or such other securities, in cash or otherwise, except for certain exceptions and limitations.SEC Rule 10b5-1.
The lock-up period describedMaxim may in the preceding paragraph will be automatically extended if: (1) during the last 17 daysits sole discretion and at any time without notice release some or all of the shares subject to lock-up period, we issue an earnings release or announce material news or a material event; or (2)agreements prior to the expiration of the lock-up period, we announce that we willperiod. When determining whether or not to release earnings results during the 16-day period beginning on the last day ofshares from the lock-up period, in which caseagreements, the restrictions described inRepresentative will consider, among other factors, the preceding paragraph will continue to apply untilsecurity holder’s reasons for requesting the expiration ofrelease, the 18-day period beginning on the date of the earnings release.
Electronic Offer, Sale and Distribution of Securities. A prospectus in electronic format may be made available on the websites maintained by one or more of the underwriters or selling group members, if any, participating in this offering and one or more of the underwriters participating in this offering may distribute prospectuses electronically. The representative may agree to allocate a number of shares for which the release is being requested and warrantsmarket conditions at the time.
Indemnification
We have agreed to underwriters and selling group members for sale to their online brokerage account holders. Internet distributions will be allocated byindemnify the underwriters and selling group members that will make internet distributions on the same basis as other allocations. Other than the prospectus in electronic format, the information on these websites is not part of, nor incorporated by reference into, this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us or any underwriter in its capacity as underwriter, and should not be relied upon by investors.
NASDAQ Capital Market Listing. Our Common Stock is listed on The NASDAQ Capital Marketagainst certain liabilities, including liabilities under the symbol “ATOS.”Securities Act, and to contribute to payments that the underwriters may be required to make for these liabilities.
Stabilization.Price Stabilization, Short Positions, and Penalty Bids
In connection with this offering, the underwriters may engage in stabilizing transactions over-allotment transactions, syndicate-covering transactions, penalty bids and purchases to cover positions created by short sales. Stabilizing transactions permit bids to purchase shares so long asthat stabilize, maintain or otherwise affect the stabilizing bids do not exceed a specified maximum, and are engaged in for the purpose of preventing or retarding a decline in the market price of the shares while the offering is in progress.
Over-allotment transactions involve sales byour common stock. Specifically, the underwriters may over-allot in connection with this offering by selling more shares than are set forth on the cover page of shares in excess of the number of shares the underwriters are obligated to purchase.this prospectus. This creates a syndicate short position thatin our common stock for its own account. The short position may be either a covered short position or a naked short position. In a covered short position, the number of shares common stock over-allotted by the underwriters is not greater than the number of shares of common stock that they may purchase in the over-allotment option. In a naked short position, the number of shares of common stock involved is greater than the number of shares common stock in the over-allotment option. To close out a short position, the underwriters may elect to exercise all or part of the over-allotment option. The underwriters may close outalso elect to stabilize the price of our common stock or reduce any short position by exercising their over-allotment option and/orbidding for, and purchasing, sharescommon stock in the open market.
Syndicate covering transactions involve purchases of sharesThe underwriters may also impose a penalty bid. This occurs when a particular underwriter or dealer repays selling concessions allowed to it for distributing a security in this offering because the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close out the short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared with the price at which they may purchase shares through exercise of the over-allotment option. If the underwriters sell more shares than could be covered by exercise of the over-allotment option and, therefore, have a naked short position, the position can be closed out only by buying shares in the open market. A naked short position is more likely to be created if the underwriters are concernedunderwriter repurchases that after pricing there could be downward pressure on the price of the shares in the open market that could adversely affect investors who purchase in the offering.
Penalty bids permit the representative to reclaim a selling concession from a syndicate member when the shares originally sold by that syndicate member are purchasedsecurity in stabilizing or syndicateshort covering transactions.
Finally, the underwriters may bid for, and purchase, shares of our common stock in market making transactions, to cover syndicate short positions.including “passive” market making transactions as described below.
These stabilizing transactions, syndicate covering transactions and penalty bidsactivities may have the effect of raisingstabilize or maintainingmaintain the market price of our shares or Common Stock or preventing or retardingcommon stock at a decline in the market price of our shares or Common Stock. As a result,that is higher than the price of our Common Stock in the open market may be higher than it wouldthat might otherwise beexist in the absence of these transactions. Neither we nor theactivities. The underwriters makeare not required to engage in these activities, and may discontinue any representation or prediction as to the effect that the transactions described above may have on the price of our Common Stock.these activities at any time without notice. These transactions may be effected on The NASDAQ Capital Market,Nasdaq, in the over-the-counter market, or otherwise and, if commenced, may be discontinued at any time.otherwise.
Passive market making.In connection with this offering, the underwriters and selling group members, if any, or their affiliates may engage in passive market making transactions in our Common Stock on The NASDAQ Capital Marketcommon stock immediately prior to the commencement of sales in this offering, in accordance with Rule 103 of Regulation M under the Exchange Act,Act. Rule 103 generally provides that:
● | a passive market maker may not effect transactions or display bids for our common stock in excess of the highest independent bid price by persons who are not passive market makers; |
● | net purchases by a passive market maker on each day are generally limited to 30% of the passive market maker’s average daily trading volume in our common stock during a specified two-month prior period or 200 shares, whichever is greater, and must be discontinued when that limit is reached; and |
● | passive market making bids must be identified as such. |
Electronic Distribution
A prospectus in electronic format may be made available on a period beforewebsite maintained by the commencementrepresentatives of offersthe underwriters and may also be made available on a website maintained by other underwriters. The underwriters may agree to allocate a number of shares to underwriters for sale to their online brokerage account holders. Internet distributions will be allocated by the representatives of the underwriters to underwriters that may make Internet distributions on the same basis as other allocations. In connection with the offering, the underwriters or syndicate members may distribute prospectuses electronically. No forms of electronic prospectus other than prospectuses that are printable as Adobe® PDF will be used in connection with this offering.
The underwriters have informed us that they do not expect to confirm sales of shares offered by this prospectus to accounts over which they exercise discretionary authority.
Other than the sharesprospectus in electronic format, the information on any underwriter’s website and extending through the completionany information contained in any other website maintained by an underwriter is not part of the distribution. A passive market maker must displayprospectus or the registration statement of which this prospectus forms a part, has not been approved and/or endorsed by us or any underwriter in its bid at a pricecapacity as underwriter and should not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid, then that bid must then be lowered when specified purchase limits are exceeded.relied upon by investors.
Certain Relationships
The underwriters and their affiliates have provided, or mayMaxim is acting as our sales agent in an “at-the-market” offering pursuant to a prospectus supplement filed by the future provide, various investment banking, commercial banking, financial advisory, brokerage, and other services to us and our affiliates for which services they have received, and may inCompany with the future receive, customary fees and expense reimbursement.SEC on September 25, 2020 (Registration No. 333-248555).
TheCertain of the underwriters and their affiliates may provide, from time to time, engage in transactions withinvestment banking and performfinancial advisory services forto us in the ordinary course of their business, for which they may receive customary fees and reimbursement of expenses. In the ordinary course of their various business activities, the underwriters and their affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own accountscommissions.
Notice to Prospective Investors in Canada
This prospectus constitutes an “exempt offering document” as defined in and for the accountspurposes of their customers, and such investment andapplicable Canadian securities activities may involve securities and/or instruments of our company. The underwriters and their affiliates may also make investment recommendations and/or publish or express independent research views in respect of such securities or instruments and may at any time hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.
Offer Restrictions Outside the United States
Other than in the United States, no actionlaws. No prospectus has been taken by usfiled with any securities commission or the underwriters that would permit a public offering of the securities offered by this prospectussimilar regulatory authority in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisementsCanada in connection with the offer and sale of any suchthe shares. No securities be distributedcommission or publishedsimilar regulatory authority in Canada has reviewed or in any way passed upon this prospectus or on the merits of the shares and any representation to the contrary is an offence.
Canadian investors are advised that this prospectus has been prepared in reliance on section 3A.3 of National Instrument 33-105 Underwriting Conflicts (“NI 33-105”). Pursuant to section 3A.3 of NI 33-105, this prospectus is exempt from the requirement that the Company and the underwriter(s) provide Canadian investors with certain conflicts of interest disclosure pertaining to “connected issuer” and/or “related issuer” relationships that may exist between the Company and the underwriter(s) as would otherwise be required pursuant to subsection 2.1(1) of NI 33-105.
Resale Restrictions
The offer and sale of the shares in Canada is being made on a private placement basis only and is exempt from the requirement that the Company prepares and files a prospectus under applicable Canadian securities laws. Any resale of shares acquired by a Canadian investor in this offering must be made in accordance with applicable Canadian securities laws, which may vary depending on the relevant jurisdiction, exceptand which may require resales to be made in accordance with Canadian prospectus requirements, pursuant to a statutory exemption from the prospectus requirements, in a transaction exempt from the prospectus requirements or otherwise under circumstances that will result in compliance witha discretionary exemption from the prospectus requirements granted by the applicable rules and regulationslocal Canadian securities regulatory authority. These resale restrictions may under certain circumstances apply to resales of that jurisdiction. Persons into whose possession this prospectus comes are advisedthe shares outside of Canada.
Representations of Purchasers
Each Canadian investor who purchases shares will be deemed to inform themselves abouthave represented to the Company, the underwriters and to observe any restrictions relatingeach dealer from whom a purchase confirmation is received, as applicable, that the investor is (i) purchasing as principal, or is deemed to be purchasing as principal in accordance with applicable Canadian securities laws, for investment only and not with a view to resale or redistribution; (ii) an “accredited investor” as such term is defined in section 1.1 of National Instrument 45-106 Prospectus Exemptions or, in Ontario, as such term is defined in section 73.3(1) of the offeringSecurities Act (Ontario); and the distribution(iii) is a “permitted client” as such term is defined in section 1.1 of National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations.
Taxation and Eligibility for Investment
Any discussion of taxation and related matters contained in this prospectus. This prospectus does not constitute an offerpurport to sellbe a comprehensive description of all of the tax considerations that may be relevant to a Canadian investor when deciding to purchase the shares and, in particular, does not address any Canadian tax considerations. No representation or warranty is hereby made as to the tax consequences to a solicitationresident, or deemed resident, of Canada of an offerinvestment in the shares or with respect to buy any securities offeredthe eligibility of the shares for investment by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.
DESCRIPTION OF SECURITIES TO BE REGISTEREDinvestor under relevant Canadian federal and provincial legislation and regulations.
Our authorized capital stock consistsRights of 75,000,000 shares of Common Stock, $0.015 par value per share, and 10,000,000 shares of preferred stock, $0.001 par value per share.Action for Damages or Rescission
Common Stock
HoldersSecurities legislation in certain of Common Stock are entitledthe Canadian jurisdictions provides certain purchasers of securities pursuant to receive ratably dividends outan offering memorandum (such as this prospectus), including where the distribution involves an “eligible foreign security” as such term is defined in Ontario Securities Commission Rule 45-501Ontario Prospectus and Registration Exemptions and in Multilateral Instrument 45-107 Listing Representation and Statutory Rights of funds legally available, ifAction Disclosure Exemptions, as applicable, with a remedy for damages or rescission, or both, in addition to any other rights they may have at law, where the offering memorandum, or other offering document that constitutes an offering memorandum, and when declared from timeany amendment thereto, contains a “misrepresentation” as defined under applicable Canadian securities laws. These remedies, or notice with respect to timethese remedies, must be exercised or delivered, as the case may be, by our Board of Directors. We have never paid any cash dividends on our Common Stock and our Board of Directors does not anticipate that we will pay cash dividends in the foreseeable future. The future payment of dividends, if any, on our Common Stock ispurchaser within the discretion of the Board of Directorstime limits prescribed under, and will depend upon earnings, capital requirements, financial conditions, and other relevant factors. Holders of Common Stock are entitled to one vote for each share held on each matter to be voted on by stockholders. There is no cumulative voting in the election of directors. In the event of liquidation, dissolution or winding up of the affairs of us, holders of Common Stock are to share in all assets remaining after the payment of liabilities and any preferential distributions payable to preferred stockholders, if any. The holders of Common Stock have no preemptive or conversion rights and are not subject to further calls or assessments. There are no redemption or sinking fund provisions applicable to the Common Stock. The rights of the holders of the Common Stock are subject to limitations and defenses under, applicable Canadian securities legislation. In addition, these remedies are in addition to and without derogation from any rights that may be fixed for holders of preferred stock, if any. All ofother right or remedy available at law to the outstanding shares of Common Stock are fully paid and non-assessable.
Certificate of Incorporation
Under our certificate of incorporation, as amended, our Board of Directors, without further action by our stockholders, currently has the authority to issue up to 10,000,000 shares of preferred stock and to fix the rights (including voting rights), preferences, and privileges of these “blank check” preferred shares. Such preferred stock may have rights, including economic rights, senior to our Common Stock. As a result, the issuance of the preferred stock could have a material adverse effect on the price of our Common Stock and could make it more difficult for a third party to acquire a majority of our outstanding Common Stock.
Anti-Takeover Devices
Our certificate of incorporation and bylaws include a number of provisions that may have the effect of delaying, deferring or preventing another party from acquiring control of us and encouraging persons considering unsolicited tender offers or other unilateral takeover proposals to negotiate with our Board of Directors rather than pursue non-negotiated takeover attempts. These provisions include the items described below.investor.
Board Composition and Filling Vacancies. In accordance with our certificateLanguage of incorporation, our BoardDocuments
Upon receipt of Directors is divided into three classes serving staggered three-year terms, with one class being electedthis document, each year. Our certificate of incorporation also providesCanadian investor hereby confirms that directors may only be removed from office for cause and only byit has expressly requested that all documents evidencing or relating in any way to the affirmative vote of holders of 75% or moresale of the outstanding shares of capital stock then entitled to vote at an election of directors. Furthermore,securities described herein (including for greater certainty any vacancy on our Board of Directors, however occurring, includingpurchase confirmation or any vacancy resulting from an increasenotice) be drawn up in the size of the board, may only be filled by the affirmative vote ofEnglish language only. Par la réception de ce document, chaque investisseur canadien confirme par les présentes qu’il a majority of our directors then in office even if less than a quorum. The classification of directors, together with the limitations on removal of directors and treatment of vacancies, has the effect of making it more difficult for stockholders to change the composition of our Board of Directors.
Undesignated Preferred Stock.expressément exigé que tous les documents faisant foi ou se rapportant de quelque manière que ce soit à la vente des valeurs mobilières décrites aux présentes (incluant, pour plus de certitude, toute confirmation d’achat ou tout avis) soient rédigés en anglais seulement. Our certificate of incorporation authorizes “blank-check” preferred stock, which means that our Board of Directors has the authority to designate one or more series of preferred stock without stockholder approval. These series of preferred stock may have superior rights, preferences and privileges over our Common Stock, including dividend rights, voting rights, and liquidation preferences. The ability of our Board of Directors to issue shares of our preferred stock without stockholder approval could deter takeover offers and make it more difficult or costly for a third party to acquire us without the consent of our Board of Directors.
Section 203 of the Delaware General Corporation Law. In addition, our certificate of incorporation does not opt out of Section 203 of the Delaware General Corporation Law, which protects a corporation against an unapproved takeover by prohibiting a company from engaging in any business combination with any interested stockholder (defined as a stockholder owning more than 15% of the outstanding shares) for a period of three years from the time such stockholder became a 15% holder unless approved by our Board of Directors.
Stockholder Rights Agreement. On May 19, 2014, the Company adopted a stockholder rights agreement which provides that all stockholders of record on May 26, 2014 received a non-taxable distribution of one preferred stock purchase right for each share of our Common Stock held by such stockholder. Each right is attached to and trades with the associated share of Common Stock. The rights will become exercisable only if one of the following occurs: (1) a person becomes an “Acquiring Person” by acquiring beneficial ownership of 15% or more of our Common Stock (or, in the case of a person who beneficially owned 15% or more of our Common Stock on the date the stockholder rights agreement was executed, by acquiring beneficial ownership of additional shares representing 2.0% of our Common Stock then outstanding (excluding compensatory arrangements)); or (2) a person commences a tender offer that, if consummated, would result in such person becoming an Acquiring Person. If a person becomes an Acquiring Person, each right will entitle the holder, other than the Acquiring Person and certain related parties, to purchase a number of shares of our Common Stock with a market value that equals twice the exercise price of the right. The initial exercise price of each right is $15.00, so each holder (other than the Acquiring Person and certain related parties) exercising a right would be entitled to receive $30.00 worth of our Common Stock. If the Company is acquired in a merger or similar business combination transaction at any time after a person has become an Acquiring Person, each holder of a right (other than the Acquiring Person and certain related parties) will be entitled to purchase a similar amount of stock of the acquiring entity.
Transfer Agent and Registrar
We have appointed VStock Transfer, LLC, 18 Lafayette Place, Woodmere, New York 11598 (Telephone: (212) 828-8436; Facsimile (646) 536-3179) as our transfer agent and registrar.
Listing
Our Common Stock is listed on The NASDAQ Capital Market under the symbol “ATOS.”
ContentsDISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIESInsofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers, and controlling personsTable of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.LEGAL MATTERSCertain legal matters relating to the validity of the Common Stock offered by this prospectus will be passed upon for us by Gibson, Dunn & Crutcher LLP, San Francisco, California. Certain legal matters will passed upon for the underwriters by Ellenoff Grossman & Schole LLP, New York, New York.
The consolidated financial statements as of December 31, 20162019 and 20152018 and for each of the two years in the period ended December 31, 20162019 incorporated by reference in this Prospectus have been so includedincorporated in reliance on the report of BDO USA, LLP, an independent registered public accounting firm (the report on the consolidated financial statements contains an explanatory paragraph regarding the Company’s ability to continue as a going concern) which is, incorporated herein by reference, in the Prospectus, given on the authority of said firm as experts in auditing and accounting.
Certain legal matters relating to the validity of the securities offered by this prospectus will be passed upon for us by Gibson, Dunn & Crutcher LLP, San Francisco, California. The underwriters are being represented by Ellenoff Grossman & Schole LLP, New York, New York.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We are required to fileThe Company files annual, quarterly and special reports, proxy statements and other information with the SEC. You may readThe SEC maintains an Internet site that contains all reports and other information that we file electronically with the SEC. The address of that website is www.sec.gov.
Statements contained in this prospectus as to the contents of any contract or other document are not necessarily complete, and in each instance we refer you to the copy anyof the contract or document filed by us at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. Our filings with the SEC are also availableas an exhibit to the public at the SEC’s Internet web site athttp://www.sec.gov .registration statement, each such statement being qualified in all respects by such reference.
We maintain a website at www.atossatherapeutics.com. Information contained in or accessible through our website does not constitute a part of this prospectus. We have filed a registration statement, of whichincluded our website address in this prospectus is a part, coveringsolely as an inactive textual reference.
For further information with respect to us and the securities offered hereby. As allowed by SEC rules,we are offering under this prospectus, does not include all of the information contained inwe refer you to the registration statement and the included exhibits financial statements and schedules. You are referred toschedules filed as a part of the registration statement (or incorporated by reference). Neither we nor the included exhibits, financial statementsunderwriter has authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and schedules for further information.can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is qualifiedan offer to sell only the shares offered hereby, but only under the circumstances and in the jurisdictions where it is lawful to do so. The information contained in this prospectus or in any applicable free writing prospectus is current only as of its entirety bydate, regardless of its time of delivery or any sale of shares. Our business, financial condition, results of operations and prospects may have changed since that date. We are not, and the underwriter is not, making an offer of these securities in any jurisdiction where such other information.offer is not permitted. See “About this Prospectus.”
INCORPORATION OF CERTAIN INFORMATION INCORPORATED BY REFERENCE
The SEC allows usthe Company to “incorporate by reference” the information from other documents that we fileis filed by the Company with it,the SEC, which means that wethe Company can disclose important information to you by referring you to those documents. The informationdocuments incorporated by reference is considered to be part of this prospectus. Information in this prospectus supersedes information incorporated by reference that we filed with the SEC prior to the date of this prospectus.
We incorporate by reference into this prospectus and the registration statement of which this prospectus is a part the information or documents listed below that we have filed with the SEC (Commission File No. 001-35610):are:
1. | The Company’s Annual Report on Form 10-K for the fiscal year ended December 31, |
2. | The Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020 and September 30, 2020; |
3. | The Company’s Definitive Proxy Statement on Schedule 14A, filed with the SEC on |
4. | The Company’s Current Reports on Form 8-K, filed with the SEC in 2020 on the following dates: January 7, February 10, April 13, May 19, and September 25; |
5. | The description of the Company’s common stock contained in the registration statement on Form 8-A filed with the Commission on July 24, 2012 pursuant to Section 12 of the Exchange Act, including any amendment or report filed for the purpose of updating that description; and |
We also elect to incorporate by reference information filed after the effective date of this prospectus. All documents subsequently filed by us pursuant to Section 13(a), 13(c) and 14 or 15(d) of the Exchange Act, prior to the termination date of the offering set forth herein shall be deemed incorporated by reference to this prospectus.
We will furnish without charge to you, on written or oral request, a copy of any or all of the documents incorporated by reference, including exhibits to these documents. You should direct any requests for documents to Kyle Guse, Chief Financial Officer, Atossa Genetics Inc., 107 Spring Street, Seattle, Washington, 98104, telephone: (800) 351-3902. Copies of the above reports may also be accessed from our web site atwww.atossagenetics.com.
6. | All documents filed by the Company pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act, after the date of the original Registration Statement and prior to effectiveness of the registration statement of which this prospectus is a part, provided that all documents “furnished” by the Company to the SEC and not “filed” are not deemed incorporated by reference herein. |
Any statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus willherein shall be deemed to be modified superseded, or replacedsuperseded for purposes of this prospectusregistration statement to the extent that a statement contained herein or in any other subsequently filed document which also is or is deemed to be incorporated by reference herein modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this registration statement. Under no circumstances will any information filed under items 2.02 or 7.01 of Form 8-K be deemed to be incorporated by reference unless such Form 8-K expressly provides to the contrary.
The Company will provide, without charge, to each person, including any beneficial owner, to whom a copy of this prospectus is delivered, upon such person’s written or oral request, a copy of any and all of the information incorporated by reference in this prospectus, modifies, supersedes, or replacesother than exhibits to such statement.documents, unless such exhibits are specifically incorporated by reference into the information that this prospectus incorporates. Requests should be directed to the Secretary at Atossa Therapeutics, Inc., 107 Spring Street, Seattle, Washington, 98104, phone (866) 893-4927. You may also find these documents in the “Investor Relations” section of our website, www.atossatherapeutics.com. The information on our website is not incorporated into this prospectus.
Up to Shares of Common Stock and
Up to Shares of Series C Convertible Preferred Stock
Prospectus
Sole Book-Running Manager
Maxim Group LLC
, 2020
4,000,000 Shares
INFORMATION NOT REQUIRED IN PROSPECTUS The following Registration Fee—Securities and Exchange Commission FINRA filing fee Accountants Fees and Expenses Legal Fees and Expenses Miscellaneous Total * To be filed in a pre-effective amendment. Section 145 of the Delaware General Corporation Law, or the DGCL, authorizes a corporation to indemnify its directors and officers against liabilities arising out of actions, suits and proceedings to which they are made or threatened to be made a party by reason of the fact that they have served or are currently serving as a director or officer to a corporation. The indemnity may cover expenses (including attorneys’ fees) judgments, fines and amounts paid in settlement actually and reasonably incurred by the director or officer in connection with any such action, suit or proceeding. Section 145 permits corporations to pay expenses (including attorneys’ fees) incurred by directors and officers in advance of the final disposition of such action, suit or proceeding. In addition, Section 145 provides that a corporation has the power to purchase and maintain insurance on behalf of its directors and officers against any liability asserted against them and incurred by them in their capacity as a director or officer, or arising out of their status as such, whether or not the corporation would have the power to indemnify the director or officer against such liability under Section 145. We have adopted provisions in our certificate of incorporation and bylaws that limit or eliminate the personal liability of our directors to the fullest extent permitted by the DGCL, as it now exists or may in the future be amended. Consequently, a director will not be personally liable to us or our stockholders for monetary damages or breach of fiduciary duty as a director, except for liability for: ● any breach of the director’s duty of loyalty to us or our stockholders; ● any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; ● any unlawful payments related to dividends or unlawful stock purchases, redemptions or other distributions; or ● any transaction from which the director derived an improper personal benefit. These limitations of liability do not alter director liability under the federal securities laws and do not affect the availability of equitable remedies such as an injunction or rescission. In addition, our bylaws provide that: ● we will indemnify our directors, officers and, in the discretion of our Board of Directors, certain employees to the fullest extent permitted by the DGCL, as it now exists or may in the future be amended; and ● we will advance reasonable expenses, including attorneys’ fees, to our directors and, in the discretion of our Board of Directors, to our officers and certain employees, in connection with legal proceedings relating to their service for or on behalf of us, subject to limited exceptions. We have entered into indemnification agreements with each of our directors and certain of our executive officers. These agreements provide that we will indemnify each of these directors and executive officers to the fullest extent permitted by Delaware law. We will advance expenses, including attorneys’ fees, judgments, fines and settlement amounts, to each indemnified director, executive officer or affiliate in connection with any proceeding in which indemnification is available and we will indemnify our directors and officers for any action or proceeding arising out of that person’s services as an officer or director brought on behalf of the Company or in furtherance of our rights. We maintain general liability insurance that covers certain liabilities of our directors and officers arising out of claims based on acts or omissions in their capacities as directors or officers, including liabilities under the Securities Act. Exhibit No. Description Date Amended and Restated Certificate of Incorporation of Atossa Therapeutics, Inc. 3.8** Form of Certificate of Designations of Preference, Rights and Limitations of Series C Convertible Preferred Stock ** Amended and Restated Certificate of Incorporation of Atossa Therapeutics, Inc. Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 5.1** Opinion of Gibson, Dunn & Crutcher LLP ** ** To be filed by amendment # Indicates management contract or compensatory plan, contract or agreement. †† Schedules and exhibits omitted pursuant to Item ITEM 17. Undertakings Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the The undersigned registrant hereby undertakes that: (1) For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance on Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be a part of this registration statement as of the time it was declared effective. (2) For purposes of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Pursuant to the requirements of the Securities Act of 1933, as amended, the Atossa By: Steven C. Quay, M.D., Ph.D. Chairman, Chief Executive Officer and President KNOW ALL PERSONS BY THESE PRESENTS that each individual whose signature appears below constitutes and appoints Steven C. Quay and Kyle Guse as his or her true and lawful attorney-in-fact and agent, with full power of substitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign this registration statement and any and all amendments thereto, including post-effective amendments, and to file the same, with all exhibits thereto, any related registration filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all the said attorney-in-fact and agent or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Act of 1933, as amended, this Signature Office(s) Date Chairman, Chief Executive November 20, 2020 Steven C. Quay, M.D., Ph.D. Officer and President (Principal Executive Officer) Chief Financial Officer, General Counsel and Secretary November 20, 2020 Kyle Guse (Principal Financial and Accounting Officer) Director November 20, 2020 Shu-Chih Chen, Ph.D. Director November 20, 2020 Richard November 20, 2020 Stephen J. Galli, M.D. Director November 20, 2020 H. Lawrence Remmel Director November 20, 2020 Gregory L. Weaver 16Table of Common Stock ContentsPROSPECTUSAegis Capital Corp. 14ItemITEM 13. Other Expenses of Issuance and Distribution.Distributiontable sets forthare the costs andestimated expenses payable by the Company in connection with the registration and sale of the Common Stock being registered. Alldistribution of the Shares registered hereunder on Form S-1 (the amounts set forth above are estimatesestimate, except the SEC registration fee.Registration Fee: $ 1,568.31 $ * $ * $ * $ * $ * SEC registration fee $ 705 Printing expense $ 5,000 Legal fees and expenses $ 40,000 Accounting fees and expenses $ 30,000 Transfer Agent Fees $ 1,000 Miscellaneous Fees $ 3,295 Total $ 80,000 ItemITEM 14. Indemnification of Directors and Officers.Officers·····These limitations of liability do not alter director liability under the federal securities laws and do not affect the availability of equitable remedies such as an injunction or rescission.··II-1Item 15. Recent Sales of Unregistered Securities.ITEM 16. Exhibit IndexThe Company has sold the following securities within the past three years which were not registered under the Securities Act:On April 1, 2014, the Company issued options to purchase 300,000 shares of its Common Stock, exercisable at $1.69 per share which was the fair market value on the date of grant, to Ben Chen as an inducement grant for the employment of Mr. Chen as the Company’s Sr. Vice President of Global Regulatory Affairs and Quality Assurance. This transaction was exempt from registration under Section 4(a)(2) of the Securities Act, as a transaction by an issuer not involving any public offering.On June 2, 2014, the Company issued options to purchase 200,000 shares of its Common Stock, exercisable at $1.41 per share which was the fair market value on the date of grant, to John Sawyer as an inducement grant for the employment of Mr. Sawyer as the Company’s Sr. Vice President of Global Regulatory Affairs and Quality Assurance. This transaction was exempt from registration under Section 4(a)(2) of the Securities Act, as a transaction by an issuer not involving any public offering.On September 2, 2014, the Company issued options to purchase 200,000 shares of its Common Stock, exercisable at $1.86 per share which was the fair market value on the date of grant, to Scott Youmans as an inducement grant for the employment of Mr. Youmans as the Company’s Sr. Vice President of Operations. This transaction was exempt from registration under Section 4(a)(2) of the Securities Act, as a transaction by an issuer not involving any public offering.On December 15, 2014, the Company issued options to purchase 200,000 shares of its Common Stock, exercisable at $0.96 per share which was the fair market value on the date of grant, to Pieter Van der Poel as an inducement grant for the employment of Mr. Van der Poel as the Company’s Vice President of European Commercial Operations. This transaction was exempt from registration under Section 4(a)(2) of the Securities Act, as a transaction by an issuer not involving any public offering.From March 4, 2015 to March 31, 2015 we sold 2,653,199 shares of Common Stock to Aspire Capital under the November 8, 2013 agreement with them, with total gross proceeds to the Company of $4,292,349.On May 4, 2015, the Company issued options to purchase 200,000 shares of its Common Stock, exercisable at $1.44 per share which was the fair market value on the date of grant, to Cindy Atha as an inducement grant for the employment of Ms. Atha as the Company’s Vice President of Sales and Marketing. This transaction was exempt from registration under Section 4(a)(2) of the Securities Act, as a transaction by an issuer not involving any public offering.On May 26, 2015 Company entered into a stock purchase agreement with Aspire Capital Fund, LLC, which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was committed to purchase up to an aggregate of $25 million of shares of our Common Stock over the 30-month term of the agreement. Under the agreement, on May 26, 2015, Aspire Capital was issued 375,000 shares of Common Stock as a commitment fee. These transactions were exempt from registration under Section 4(a)(2) of the Securities Act, as transactions by an issuer not involving any public offering.On May 26, 2015, the Company issued options to purchase 100,000 shares of its Common Stock, exercisable at $1.49 per share which was the fair market value on the date of grant, to Dr. Gerald Engley as an inducement grant for the employment of Mr. Engley as the Company’s Sr. Director of Medical Affairs. This transaction was exempt from registration under Section 4(a)(2) of the Securities Act, as a transaction by an issuer not involving any public offering.On October 12, 2015, the Company issued options to purchase 200,000 shares of its Common Stock, exercisable at $0.79 per share which was the fair market value on the date of grant, to Janet Rea as an inducement grant for the employment of Ms. Rea as the Company’s Vice President of Regulatory Affairs and Quality. This transaction was exempt from registration under Section 4(a)(2) of the Securities Act, as a transaction by an issuer not involving any public offering.On November 11, 2015, Company entered into a stock purchase agreement with Aspire Capital Fund, LLC, which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was committed to purchase up to an aggregate of $25 million of shares of our Common Stock over the 30-month term of the agreement. This transaction was exempt from registration under Section 4(a)(2) of the Securities Act, as a transaction by an issuer not involving any public offering.In the first quarter of 2016, Ensisheim Partners LLC, which is under sole ownership and control by Steven Quay, CEO, President and Chairman of the Board, and Shu-Chih Chen, Director, purchased a total of 5,333 shares of Common Stock directly from the Company in at-the-market transactions which were approved by the Company’s audit committee at purchase prices of $3.30 to $7.95 per share. The issuances of the shares were exempt from registration under the Securities Act, pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder.Incorporated by Reference Herein Form Registration Statement on Form S-1, as Exhibit 3.2 Current Report on Form 8-K, as Exhibit 4.1 Registration Statement on Form S-1, as Exhibit 3.4 Current Report on Form 8-K, as Exhibit 3.1 Current Report on Form 8-K, as Exhibit 3.1 Current Report on Form 10-Q, as Exhibit 3.1 Amendment No.1 to Registration Statement on Form S-1, as Exhibit 4.1 ** II-2 Current Report on Form 8-K, as Exhibit 3.1 Current Report on Form 8-K, as Exhibit 3.2 3.11 Certificate of Amendment to Amended and Restated Certificate of Incorporation of Atossa Therapeutics, Inc. Current Report on Form 8-K, as Exhibit 4.1 April 23, 2018 Registration Statement on Form S-1, as Exhibit 4.1 Current Report of Form 8-K, as Exhibit 4.1 Current Report on Form 8-K, as Exhibit 4.1 Current Report on Form 8-K, as Exhibit 4.2 Amendment No.1 to Registration Statement on Form S-1, as Exhibit 4.2 Amendment No.1 to Registration Statement on Form S-1, as Exhibit 4.3 Current Report on Form 10K, as Exhibit 4.16 Registration Statement on Form S-3, as exhibit 4.1 September 2, 2020 ** On May 25, 2016 the Company entered into the Aspire Purchase Agreement, which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was committed to purchase up to an aggregate of $10.0 million of shares of our Common Stock over the 30-month term of the agreement. This transaction was exempt from registration under Section 4(a)(2) of the Securities Act, as a transaction by an issuer not involving any public offering.16. Exhibits and Financial Statement Schedules.See Exhibit Index set forth on page II-6 to this Registration Statement.Item 17. Undertakings.The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.The undersigned registrant hereby undertakes that:601 of Regulation S-K.(a) For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective. (b) For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. (c) For purposes of determining any liability under the Securities Act, each filing of the registrant's annual report pursuant to section 13(a) or section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan's annual report pursuant to section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.SECSecurities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.II-3registrantCompany certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-1 and has duly caused this Registration Statement on Form S-1registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Seattle, State of Washington, on March 16, 2017.November 20, 2020. GeneticsTherapeutics, Inc. /s/Steven C. Quay II-4Registration Statementregistration statement on Form S-1 has been signed by the following persons in the capacities and on the dates indicated. /s/Steven C. Quay Officer and President March 16, 2017 /s/Kyle Guse March 16, 2017 *DirectorMarch 16, 2017/s/Shu-Chih Chen Ph.D. *DirectorMarch 16, 2017Stephen J. Galli, M.D.*DirectorMarch 16, 2017H. Lawrence Remmel*DirectorMarch 16, 2017Gregory L. Weaver / *s/Richard Steinhart DirectorMarch 16, 2017I. Steinhart /s/Stephen J. Galli * By: /s/ Kyle GuseAttorney-in-factDirector II-5 Incorporated by Reference Herein Exhibit No. Description Form Date 1.1Underwriting Agreement between the Company and Aegis Capital Corp., dated August 30, 2016Current Report on Form 8-K, as Exhibit 1.1September 2, 20162.1††Agreement and Plan of Reorganization, dated September 30, 2012, by and among the Company, Acueity Healthcare, Inc., and Ted Lachowicz, as Stockholder RepresentativeRegistration Statement on Form S-1, as Exhibit 2.1October 4, 20123.1Amended and Restated Certificate of Incorporation of Atossa Genetics Inc.Registration Statement on Form S-1, as Exhibit 3.2June 11, 20123.2Certificate of Amendment to Amended and Restated Certificate of Incorporation of Atossa Genetics Inc.Current Report on Form 8-K, as Exhibit 4.1August 26, 2016 3.2Bylaws of Atossa Genetics Inc.Registration Statement on Form S-1, as Exhibit 3.4June 11, 20123.3Amendment to Bylaws of Atossa Genetics Inc.Current Report on Form 8-K, as Exhibit 3.1December 20, 20123.4Certificate of Designations, Preferences and Rights of Series A Junior Participating Preferred StockCurrent Report on Form 8-K, as Exhibit 3.1May 22, 20144.1Specimen Common Stock CertificateRegistration Statement on Form S-1, as Exhibit 4.1May 21, 20124.2Form of Warrant from 2011 private placementRegistration Statement on Form S-1, as Exhibit 4.2October 4, 20124.3Form of Placement Agent Warrant from 2011 private placementRegistration Statement on Form S-1, as Exhibit 4.3October 4, 20124.4Form of Warrant dated September 30, 2012Registration Statement on Form S-1, as Exhibit 4.4October 4, 20124.5Form of Warrant Agreement from January 2014 Public OfferingCurrent Report on Form 8-K, as Exhibit 4.1January 20, 20144.6Form of Warrant issued to Dawson James Securities Inc. in January 2014 Current Report on Form 8-K, as Exhibit 4.2January 20, 20144.7Rights Agreement between the Company and VStock Transfer, LLC, dated May 19, 2014Current Report on Form 8-K, as Exhibit 3.1May 22, 20144.8Form of Pre-Funded Warrant from June 5, 2015 offeringCurrent Report on Form 8-K, as Exhibit 4.1June 10, 20154.9Registration Rights Agreement between the Company and Aspire Capital Fund, LLC, dated May 25, 2016Current Report on Form 8-K, as Exhibit 4.1May 27, 20165.1Opinion of Gibson, Dunn & Crutcher, LLPPreviously filed 10.1#/s/H. Lawrence RemmelRestated and Amended Employment Agreement with Steven QuayRegistration Statement on Form S-1, as Exhibit 10.3February 14, 2012 10.2#Restated and Amended Employment Agreement with Shu-Chih ChenRegistration Statement on Form S-1, as Exhibit 10.4February 14, 2012II-610.3Form of Indemnification AgreementRegistration Statement on Form S-1, as Exhibit 10.5May 21, 201210.4#Atossa Genetics Inc. 2010 Stock Option and Incentive Plan, as amendedQuarterly Report on Form 10-Q, as Exhibit 10.3November 14, 201610.5#Form of Incentive Stock Option AgreementRegistration Statement on Form S-1, as Exhibit 10.7June 11, 201210.6#Form of Non-Qualified Stock Option Agreement for EmployeesRegistration Statement on Form S-1, as Exhibit 10.8June 11, 201210.7#Form of Non-Qualified Stock Option Agreement for Non-Employee DirectorsRegistration Statement on Form S-1, as Exhibit 10.9June 11, 201210.8Form of Subscription AgreementRegistration Statement on Form S-1, as Exhibit 10.10February 14, 201210.9Patent Assignment Agreement by and between the Company and Ensisheim Partners, LLCRegistration Statement on Form S-1, as Exhibit 10.12April 6, 201210.10#Form of Restricted Stock Award AgreementRegistration Statement on Form S-1, as Exhibit 10.13June 11, 201210.11Office Lease with Sander Properties, LLC, dated March 4, 2011Registration Statement on Form S-1, as Exhibit 10.20April 6, 201210.12Office Lease with Sander Properties, LLC, dated July 8, 2011Registration Statement on Form S-1, as Exhibit 10.21April 6, 201210.13Office Lease with Sander Properties, LLC, dated September 20, 2011Registration Statement on Form S-1, as Exhibit 10.22April 6, 201210.14Sublease with Fred Hutchinson Cancer Research Center, dated December 9, 2011Registration Statement on Form S-1, as Exhibit 10.23April 6, 201210.15†Purchase Agreement between the Company and Hologic Inc., dated May 11, 2011 Registration Statement on Form S-1, as Exhibit 10.28June 25, 201210.16†Supply and Distribution Agreement, dated as of September 21, 2012, between the Company and Diagnostics Test Group LLCRegistration Statement on Form S-1, as Exhibit 10.31October 4, 201210.17Amended and Restated Employment Agreement between the Company and Kyle Guse dated May 18, 2016#Current Report on Form 8-K, as Exhibit 10.1May 20, 201610.18Purchase Agreement, dated as of March 27, 2013, by and between the Company and Aspire Capital Fund, LLCAnnual Report on Form 10-K, as Exhibit 10.30March 28, 201310.19Purchase Agreement, dated as of November 8, 2013, by and between the Company and Aspire Capital Fund, LLCQuarterly Report on Form 10-Q, as Exhibit 10.2November 12, 201310.20OwnerChip Program Agreement dated September 1, 2013, by and between The National Reference Laboratory for Breast Health, Inc. and Affymetrix, Inc.Quarterly Report on Form 10-Q, as Exhibit 10.1November 12, 201310.21License and Services Agreement dated June 10, 2013, between Atossa Genetics and A5 Genetics KFTAnnual Report on Form 10-K, as Exhibit 10.32March 27, 201410.22Office Space Lease dated July 18, 2013 between Alexandria (ARE) and the CompanyAnnual Report on Form 10-K, as Exhibit 10.33March 27, 2014II-710.23Lab and Office Space Lease Agreement dated March 24, 2014 between Alexandria (ARE) and the CompanyAnnual Report on Form 10-K, as Exhibit 10.35March 27, 201410.24Offer Letter Agreement dated March 20, 2014 between the Company and Ben Chen#Post-Effective Amendment No. 1 to Registration Statement on Form S-1, as Exhibit 10.34April 28, 201410.25#Offer Letter Agreement dated May 23, 2013 between the Company and with Peter CarbonaroQuarterly Report on Form 10-Q, as Exhibit 10.1May 14, 201410.26#Offer Letter Agreement dated November 12, 2012 between the Company and Chris DestroQuarterly Report on Form 10-Q, as Exhibit 10.2May 14, 201410.27Office Space Assignment and Assumption of Lease and Consent to Assignment dated August 8, 2014 between Legacy Group, Inc. and the CompanyQuarterly Report on Form 10-Q, as Exhibit 10.1August 12, 201410.28#Offer Letter Agreement dated May 23, 2014 between the Company and with John SawyerAnnual Report on Form 10-K, as Exhibit 10.30March 30, 201510.29Intellectual Property License Agreement dated May 14, 2015 between the Company and Besins Healthcare Luxembourg SARLCurrent Report on Form 8-K, as Exhibit 10.1May 18, 201510.30Placement Agent Agreement dated June 5, 2015 among the Company, Roth Capital Partners, LLC and Dawson James Securities, Inc.Current Report on Form 8-K, as Exhibit 10.1June 10, 201510.31Form of Subscription Agreement from June 5, 2015 offering.Current Report on Form 8-K, as Exhibit 10.2June 10, 201510.32Stock Purchase Agreement, between the Company, National Reference Laboratory For Breast Health and the NRL Investment Group, LLC, dated as of December 16, 2015Current Report on Form 8-K, as Exhibit 10.1December 16, 201610.33Office Lease Agreement dated October 1, 2015 between Hughes-Northwest, Inc. and the Company.Annual Report on Form 10-K, as Exhibit 22.1March 30, 201610.34Employment Separation Agreement and Release dated February 3, 2016 between Scott Youmans and the Company.Current Report on Form 8-K, as Exhibit 10.1February 8, 201610.35Common Stock Purchase Agreement, between the Company and Aspire Capital Fund, LLC, dated as of May 25, 2016Current Report on Form 8-K, as Exhibit 10.1May 27, 201610.36Settlement and Termination of License Agreement between Besins Healthcare Luxembourg SARL and its Affiliates and Atossa Genetics, Inc. dated August 4, 2016 Current Report on Form 8-K, as Exhibit 10.1 August 5, 2016 21.1List of SubsidiariesAnnual Report on Form 10-K, as Exhibit 22.1March 16, 201723.1Consent of BDO USA, LLP.Filed herewith /s/Gregory L. Weaver 23.2 Consent of Gibson, Dunn & Crutcher, LLP Registration Statement on Form S-1, as Exhibit 5.1February 13, 2017 24.1Powers of AttorneyRegistration Statement on Form S-1, Part IIFebruary 13, 2017II-4#Indicates management contract or compensatory plan, contract or agreement.†Confidential treatment has been granted for portions of this exhibit. These portions have been omitted from this Registration Statement and submitted separately to the Securities and Exchange Commission.††Schedules and exhibits omitted pursuant to Item 601 of Regulation S-K.II-8