SECURITIES AND EXCHANGE COMMISSION
FORM S-1
UNDER
THE SECURITIES ACT OF 1933
INVIVO THERAPEUTICS HOLDINGS CORP.
(Exact name of registrant as specified in its charter)
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Nevada (State or other Jurisdiction of | | | 3841 (Primary Standard Industrial Classification Code Number) | | | 36-4528166 (I.R.S. Employer Identification No.) | |
Cambridge, MA 02139
(617) 863-5500
(Address, including zip code, and telephone number, including
area code, of
President and Chief Executive Officer
InVivo Therapeutics Holdings Corp.
One Kendall Square, Suite B14402
Cambridge, MA 02139
(617) 863-5500
(Name, address, including zip code, and telephone number, including area code, of agent for service)
| Copy to: Rosemary G. Reilly, Esq. Wilmer Cutler Pickering Hale and Dorr LLP 60 State Street Boston, Massachusetts 02109 (617) 526-6000 | ||
Approximate date of commencement of proposed sale to the public:
As soon as practicable after this registration statement is declared effective.
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| | Non-accelerated filer | | | ☒ | | | Smaller reporting company | | | ☒ | |
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Common stock, $.00001 par value per share, issuable upon exercise of common stock purchase warrants Common stock, $.00001 par value per share, issuable upon exercise of placement agent's warrants to purchase common stock Total The selling stockholders acquired the warrants pursuant to a securities purchase agreement dated October 7, 2022 or an engagement letter dated August 31, 2022. DESCRIPTION OF OUR CAPITAL STOCK ” Corporate Information and preferred investment options. 5% Stockholders Entities affiliated with Sabby Volatility Warrant Master Fund, Ltd.(1) Entities affiliated with Armistice Capital Master Fund, Ltd.(2) CVI Investments, Inc.(3) Intracoastal Capital, LLC(4) Directors and Named Executive Officers Richard Toselli, M.D.(5) Richard Christopher(6) C. Ann Merrifield(7) Richard J. Roberts, Ph.D.(8) Daniel R. Marshak, Ph.D.(9) Christina Morrison(10) Robert J. Rosenthal, Ph.D.(11) All current directors and executive officers as a group (7 persons)(12) $0.00001 par value, were issued and outstanding. or more but less than a take action at a duly called $2.20. The Intracoastal Capital, LLC(2) CVI Investments, Inc.(3) Entities affiliated with Armistice Capital Master Fund Ltd.(4) Entities affiliated with Sabby Volatility Warrant Master Fund, Ltd.(5) Noam Rubinstein(6)(7) Craig Schwabe(6)(8) Michael Vasinkevich(6)(9) Charles Worthman(6)(10) Broker-dealers engaged by the Act. be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of The consolidated financial statements of InVivo Therapeutics Holdings Corp. and subsidiary as of December 31, reports, other than the portions of those documented not deemed to be filed. SEC registration fee Printing fees and expenses Legal fees and expenses Accounting fees and expenses Total Each of the amounts set forth above, other than the registration fee is an estimate. ” oCALCULATION OF REGISTRATION FEE Title of Each Class of Securities
to be Registered Amount to be
Registered(1) Proposed Maximum
Offering Price
Per Security(2) Proposed Maximum
Aggregate Offering
Price(2) Amount of
Registration Fee 1,715,240(3) $1.48 $2,538,556 $330 111,491(4) $1.48 $165,007 $22 1,826,731 $2,703,563 $352 (1)Pursuant to Rule 416(a) of the Securities Act of 1933, as amended, or the Securities Act, also covers any additional shares of common stock that may become issuable to prevent dilution from stock splits, stock dividends and similar events.(2)This estimate is made pursuant to Rule 457(c) of the Securities Act solely for purposes of calculating the registration fee. The price per share and aggregate offering price are based upon the average of the high and low prices of the Registrant's common stock on May 20, 2020, as reported on The Nasdaq Capital Market.(3)Represents shares of common stock issuable upon the exercise of warrants to purchase common stock at an exercise price of $1.62 per share issued by the Registrant in a private placement on April 17, 2020.(4)Represents shares of common stock issuable upon the exercise of warrants to purchase common stock at an exercise price of $2.1875 per share issued to designees of the placement agent on April 17, 2020.The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrantRegistrant shall file a further amendment which specifically states that this registration statementRegistration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this registration statementthe Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.May 22, 2020November 8, 2022
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1,826,7313,016,191 Shares of Common Stock1,826,731(i) up to an aggregate of 1,190,476 shares of our common stock that are issuable upon the exercise of certain outstanding warrants, or(ii) 1,714,286 shares of common stock issuable upon the exercise of certain outstanding preferred investment options and (iii) 111,429 shares of common stock issuable upon the exercise of certain outstanding placement agent preferred investment options. We refer to the warrants and the preferred investment options collectively as the warrants, and the shares issuable upon exercise thereof we refer to purchase shares of our common stock, oras the warrant shares.UponIn the event of the exercise of the warrants for all 1,826,7313,016,191 warrant shares of our common stock by payment of cash, however, we willwould receive aggregate gross proceeds of approximately $3.0$9.4 million.thesethe warrant shares. The selling stockholders will pay or assume any discounts, brokerage commissions, fees of underwriters, selling brokers and similar charges, if any, incurred for the sale of the warrant shares."Plan“Plan of Distribution"Distribution” beginning on page 1914 of this prospectus. We will not be paying any underwriting discounts or commissions in connection with any offering of warrant shares under this prospectus.Thethe Nasdaq Capital Market under the ticker symbol "NVIV."“NVIV.” On May 21, 2020,November 4, 2022, the last reported sale price per share of our common stock on the Nasdaq Capital Market was $1.62$2.20 per share.thisthe entire prospectus and any amendments or supplements carefully before you make your investment decision, together with additional information described under the headings "Incorporation“Incorporation of Certain Information by Reference"Reference” and "Where“Where You Can Find More Information,"” carefully before you invest in any of our securities."Risk Factors"“Risk Factors” beginning on page 64 of this prospectus and the section entitled "Risk Factors"“Risk Factors” included in our included in our most recent Annual Report on Form 10-K, as revised or supplemented by our subsequent Quarterly Reports on Form 10-Q,, which are incorporated herein by reference, for a discussion of information that you should consider before investing in our securities.20202022 PageNumber 1ii 21 52 64 75 97 SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 138 1611 1914 2216 EXPERTS 2217 2318 23 19 (the "SEC")or the SEC, includes exhibits that provide more detail of the matters discussed in this prospectus. You should read this prospectus, the related exhibits filed with the SEC, and the documents incorporated by reference herein before making your investment decision. You should rely only on the information provided in this prospectus and the documents incorporated by reference herein or any amendment thereto. In addition, this prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the heading "Where“Where You Can Find Additional Information."1,826,7313,016,191 shares of common stock, as described in this prospectus, in one or more offerings. This prospectus also covers any shares of common stock that may become issuable as a result of stock splits, stock dividends or similar transactions. We have agreed to pay the expenses incurred in registering these shares, including legal and accounting fees.parties'parties’ trademarks, trade dress or products is not intended to and does not imply a relationship with, or endorsements or sponsorship of, us by the trademark or trade dress owner. Solely for convenience, trademarks, tradenames and service marks referred to in this prospectus appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and trade names."Risk Factors"“Risk Factors” in this prospectus and the documents incorporated by reference and our financial statements and notes thereto that are incorporated by reference in this prospectus. Some of the statements in this prospectus and the documents incorporated by reference herein constitute forward-looking statements that involve risks and uncertainties. See information set forth under the section "Special“Special Note Regarding Forward-Looking Statements."” Except where the context otherwise requires, the terms "we," "us," "our," "InVivo"“we,” “us,” “our,” “InVivo” or "the Company"“the Company” refer to the business of InVivo Therapeutics Holdings Corp., a Nevada corporation, and its wholly-ownedwholly owned subsidiary.mission is to redefine the life of the SCI patient, and we seek to develop treatment options intended to provide meaningful improvement in patient outcomes following SCI. Our approach to treating acute SCIs is based on our investigational Neuro-Spinal ScaffoldTMScaffold™ implant, a bioresorbable polymer scaffold that is designed for implantation at the site of injury within a spinal cord and is intended to treat acute SCI. The Neuro-Spinal Scaffold implant incorporates intellectual property licensed under an exclusive, worldwide license from Boston Children'sChildren’s Hospital, or BCH, and the Massachusetts Institute of Technology, or MIT. We also plan to evaluate other technologies and therapeutics that may be complementary to our development of the Neuro-Spinal Scaffold implant, such as stem cells, therapeutics or electrical stimulation, including in combination with learnings applied from our Neuro-Spinal Scaffold implant or technologies that offer the potential to bring us closer to our goal of redefining the life of the SCI patient. The current standard of care for acute management of spinal cord injuries focuses on preventing further injury to the spinal cord. However, the current standard of care does not address repair of the spinal cord. For additional information regarding our business, see the section entitled "Business" included in ourAnnual Report on Form 10-K for the fiscal year ended December 31, 2019, as well as the sections entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our financial statements and the related notes thereto included in ourAnnual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, each of which is incorporated by reference into this prospectus.Our Clinical Program We currently have one clinical development program for the treatment of acute SCI. Our Neuro-Spinal Scaffold implant is an investigational bioresorbable polymer scaffold that is designed for implantation at the site of injury within a spinal cord. The Neuro-Spinal Scaffold implant is intended to promote appositional, or side-by-side, healing by supporting the surrounding tissue after injury, minimizing expansion of areas of necrosis, and providing a biomaterial substrate for the body's own healing/repair processes following injury. We believe this form of appositional healing may spare white matter, increase neural sprouting, and diminish post-traumatic cyst formation. TheNeuro-Spinal Scaffold implant is composed of two biocompatible and bioresorbable polymers that are cast to form a highly porous investigational product:•Poly lactic-co-glycolic acid, a polymer that is widely used in resorbable sutures and provides the biocompatible support forNeuro-Spinal Scaffold implant; and•Poly-L-Lysine, a positively charged polymer commonly used to coat surfaces in order to promote cellular attachment. Because of the complexity of SCIs, it is likely that multi-modal therapies will be required to maximize positive outcomes in SCI patients. In the future, we may attempt to further enhance the performance of our Neuro-Spinal Scaffold implant through multiple combination strategies involving electrostimulation devices, additional biomaterials, drugs approved by the U.S. Food and Drug Administration, or FDA, or growth factors. We expect the Neuro-Spinal Scaffold implant to be regulated by the FDA as a Class III medical device.INSPIRE 2.0 Study Our Neuro-Spinal Scaffold implant has been approved to be studied under our approved Investigational Device Exemption, or IDE, in the INPSIRE 2.0 Study, which is titled the "Randomized, Controlled, Single-blind Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care." The purpose of the INSPIRE 2.0 Study is to assess the overall safety and probable benefit of the Neuro-Spinal Scaffold for the treatment of neurologically complete thoracic traumatic acute SCI. The INSPIRE 2.0 Study is designed to enroll 10 subjects into each of the two study arms, which we refer to as the Scaffold Arm and the Comparator Arm. Patients in the Comparator Arm will receive the standard of care, which is spinal stabilization without dural opening or myelotomy. The INSPIRE 2.0 Study is a single blind study, meaning that the patients and assessors are blinded to treatment assignments. The FDA approved the enrollment of up to 35 patients in this study so that there would be at least 20 evaluable patients (10 in each study arm) at the primary endpoint analysis, accounting for events such as screen failures or deaths that would prevent a patient from reaching the primary endpoint visit. We estimate that enrollment in the INSPIRE 2.0 Study will be complete in the fourth quarter of 2020, with the final patient enrolled in the INSPIRE 2.0 study reaching their six-month primary endpoint visit in the second quarter of 2021. The primary endpoint is defined as the proportion of patients achieving an improvement of at least one AIS grade at six months post-implantation. Assessments of AIS grade are at hospital discharge, three months, six months, 12 months and 24 months. The definition of study success for INSPIRE 2.0 is that the difference in the proportion of subjects who demonstrate an improvement of at least one grade on AIS assessment at the six-month primary endpoint follow-up visit between the Scaffold Arm and the Comparator Arm must be equal to or greater than 20%. In one example, if 50% of subjects in the Scaffold Arm have an improvement of AIS grade at the six-month primary endpoint and 30% of subjects in the Comparator Arm have an improvement, then the difference in the proportion of subjects who demonstrated an improvement is equal to 20% (50% minus 30% equals 20%) and the definition of study success would be met. In another example, if 40% of subjects in the Scaffold Arm have an improvement of AIS grade at the six-month primary endpoint and 30% of subjects in the Comparator Arm have an improvement, then the difference in the proportion of subjects who demonstrated an improvement is equal to 10% (40% minus 30% equals 10%) and the definition of study success would not be met. Additional endpoints include measurements of changes in NLI, sensory levels and motor scores, bladder, bowel and sexual function, pain, Spinal Cord Independence Measure, and quality of life. Although The INSPIRE Study is structured with the an Objective Performance Criterion, or OPC, as the primary component for demonstrating probable benefit, the OPC is not the only variable thatthe FDA would evaluate when reviewing a future HDE application. Similarly, while our INSPIRE 2.0 Study is structured with a definition of study success requiring a minimum difference between study arms in the proportion of subjects achieving improvement, that success definition is not the only factor that the FDA would evaluate in the future HDE application. Approval is not guaranteed if the OPC is met for our prior clinical trial, The INSPIRE Study, or the definition of study success is met for the INSPIRE 2.0 Study, and even if the OPC or definition of study success are not met, the FDA may approve a medical device if probable benefit is supported by a comprehensive review of all clinical endpoints and preclinical results, as demonstrated by the sponsor's body of evidence. In 2016, the FDA accepted our proposed HDE modular shell submission and review process for theNeuro-Spinal Scaffold implant. The HDE modular shell is comprised of three modules: a preclinical studies module, a manufacturing module, and a clinical data module. As part of its review process, the FDA reviews each module, which are individual sections of the HDE submission, on a rolling basis. Following the submission of each module, the FDA reviews and provides feedback, typically within 90 days, allowing the applicant to receive feedback and potentially resolve any deficiencies during the review process. Upon receipt of all three modules, which constitutes the complete HDE submission, the FDA makes a filing decision that may trigger the review clock for an approval decision. We submitted the first module in March 2017 and received feedback in June 2017. We submitted an updated first module in the fourth quarter of 2019. The HDE submission will not be complete until the manufacturing and clinical modules are also submitted.wholly-ownedwholly owned subsidiary.TableImplications of ContentsBeing a Smaller Reporting CompanyCommon Stock offered by the Selling Stockholders:1,826,731 shares.Use of proceedsWe will not receive any proceeds from the sale of common stock in this offering.Nasdaq Capital Market symbolOur common stock is listed on the Nasdaq Capital Market under the symbol "NVIV."Contentscommon stock issuable upon the exercise of pre-funded warrants, 1,714,286 shares of common stock issuable upon the exercise of preferred investment options and 111,429 shares of common stock issuable upon the exercise of placement agent preferred investment options."Risk Factors"“Risk Factors” included in ourmost recent Annual Report on Form 10-K, as revised or supplemented by our subsequent Quarterly Reports on Form 10-Q,, which are incorporated herein by reference, and other filings we make with the Securities and Exchange Commission, or SEC from time to time, which are incorporated by reference herein in their entirety, together with the other information in this prospectus and the information incorporated by reference herein and in any free writing prospectus that we may authorize for use in connection with this offering. If any of these risks actually occurs, our business, financial condition, results of operations or cash flow could suffer materially. In such event, the trading price of our common stock could decline and you might lose all or part of your investment."forward-looking statements"“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements include statements made regarding our commercialization strategy, future operations, cash requirements and liquidity, capital requirements, and other statements on our business plans and strategy, financial position, and market trends. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "should," "believe," "plan," "intend," "anticipate," "target," "estimate," "expect,"“may,” “might,” “will,” “should,” “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect,” and other similar expressions. These forward-looking statements are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements, including factors such as our ability to raise substantial additional capital to finance our planned operations and to continue as a going concern; our ability to execute our strategy and business plan; our ability to obtain regulatory approvals for our products, including theNeuro-Spinal Scaffold; our ability to successfully commercialize our current and future product candidates, including theNeuro-Spinal Scaffold; the progress and timing of our development programs; market acceptance of our products; our ability to retain management and other key personnel; our ability to promote, manufacture, and sell our products, either directly or through collaborative and other arrangements with third parties; and other factors detailed under "Risk Factors"“Risk Factors” in this prospectus and in the section entitled "Risk Factors"“Risk Factors” included in ourmost recent Annual Report on Form 10-K, as revised or supplemented by our subsequent Quarterly Reports on Form 10-Q,, which are incorporated herein by reference, and other filings we make with the SEC from time to time, which are incorporated herein by reference. These forward-looking statements are only predictions, are uncertain, and involve substantial known and unknown risks, uncertainties, and other factors which may cause our actual results, levels of activity, or performance to be materially different from any future results, levels of activity, or performance expressed or implied by these forward-looking statements. Such factors include, among others, the following:•••• implant;• implant;•the impact of the COVID-19 pandemic on our business;•••••••cannot guarantee future results, levels of activity,may not actually achieve the plans, intentions or performance. Youexpectations disclosed in our forward-looking statements, and you should not place undue reliance on theseour forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-lookingwhich speak only as of the respective dates as of which they were made. You are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are referenced in the section of this prospectus entitled "Risk Factors."we make. You should also carefully review the risk factors and cautionary statements described in the other documents we file from time to time with the SEC that are incorporated herein by reference, specifically our most recent Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. ExceptOur forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or enter into.law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events.law."Selling Stockholders"“Selling Stockholders” to resell such shares of common stock issuable upon exercise of such pre-funded warrants or the warrant shares.warrantwarrants shares sold pursuant to this prospectus and we will not receive any proceeds from the resale of any warrantwarrants shares offered by this prospectus by the selling stockholders.uponin the event of full exercise of the pre-funded warrants for 1,826,731 shares of our common stockand preferred investment options by payment of cash, we will receive aggregate gross proceeds of approximately $3.0$9.4 million. Any proceeds from the exercise of the pre-funded warrants and preferred investment options will be used for working capital, business development activities, and general corporate purposes. We cannot predict when or if the pre-funded warrants and preferred investment options will be exercised, and it is possible that the pre-funded warrants and preferred investment options may expire and never be exercised.warrantwarrants shares covered by this prospectus, but the selling stockholders will pay all discounts, commissions or brokers'brokers’ fees or fees of similar securities industry professionals and transfer taxes, if any, attributable to sales of the warrantwarrants shares.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The following table sets forth certain information as of April 30, 2020 with respect to the beneficial ownership of our common stock by:•each person or group of affiliated persons known by us to be the beneficial owner of more than 5% of our common stock;•each of our directors;•each of our named executive officers; and•all of our current executive officers and directors as a group. Unless otherwise indicated in the footnotes to the following table, each person named in the table has sole voting and investment power, and his or her address is c/o InVivo Therapeutics Holdings Corp., One Kendall Square, Suite B14402, Cambridge, MA 02139. Shares of our common stock subject to options or warrants currently exercisable or exercisable within 60 days of April 30, 2020 are deemed outstanding for computing the share ownership and percentage of the person holding such options and warrants, but are not deemed outstanding for computing the percentage of any other person. The percentage ownership of our common stock of each person or entity named in the following table is based on 4,847,370 shares of our common stock outstanding as of April 30, 2020. Number of Shares
of Common Stock
Beneficially Owned Percentage of
Common Stock
Beneficially
Owned 1,394,429 22.3 % 1,458,061 24.1 % 497,221 9.3 % 305,715 5.9 % 10,072 * 9,856 * 7,360 * 443 * 85 * 68 * — — 27,884 * *Percentage of shares beneficially owned does not exceed one percent.(1)Consists of 1,394,429 shares of common stock underlying warrants that are exercisable as of April 30, 2020, which are held directly by Sabby Volatility Warrant Master Fund, Ltd. ("SVWMF"). Certain of the warrants are subject to a beneficial ownership limitation of 4.99%, which does not permit SVWMF to exercise that portion of the warrants that would result in SVWMF and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The amounts and percentages in the table do not give effect to the beneficial ownership limitation. Hal Mintz is the manager of Sabby Management, LLC, which acts as the investment managerof SVWMF. As a result, Mr. Mintz may be deemed to beneficially own the securities held by SVWMF. The address of each of SVWMF, Sabby Management LLC and Mr. Mintz is c/o Sabby Management, LLC, 10 Mountainview Road, Suite 205, Upper Saddle River, New Jersey 07458.(2)Consists of (a) 254,597 shares of common stock and (b) 1,203,464 shares of common stock underlying warrants that are exercisable as of April 30, 2020, which are held directly by Armistice Capital Master Fund Ltd. ("Armistice Fund"). Certain of the warrants are subject to a beneficial ownership limitation of 4.99%, which does not permit Armistice Fund to exercise that portion of the warrants that would result in Armistice Fund and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The amounts and percentages in the table do not give effect to the beneficial ownership limitation. Steven Boyd is the Managing Member of Armistice Capital, LLC, which acts as the investment manager of Armistice Fund. As a result, Mr. Boyd may be deemed to beneficially own the securities held by Armistice Fund. The address of Armistice Fund is c/o dms Corporate Services ltd., 20 Genesis Close, P.O. Box 314, Grand Cayman KY1-1104, Cayman Islands, and the address of each of Armistice Capital LLC and Mr. Boyd is 510 Madison Avenue, 7th Floor, New York, NY 10022.(3)Consists of 497,221 shares of common stock underlying warrants held by CVI Investments, Inc. ("CVI") that are exercisable as of April 30, 2020. Certain of the warrants are subject to a beneficial ownership limitation of 4.99%, which does not permit CVI to exercise that portion of the warrants that would result in CVI and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The amounts and percentages in the table do not give effect to the beneficial ownership limitation. Heights Capital Management, Inc. ("Heights"), the authorized agent of CVI, has discretionary authority to vote and dispose of the shares held by CVI and may be deemed to be the beneficial owner of these shares. Martin Kobinger, in his capacity as Investment Manager of Heights, may also be deemed to have investment discretion and voting power over the shares held by CVI. Mr. Kobinger disclaims any such beneficial ownership of the shares. CVI's address is c/o Heights Capital Management, Inc., 101 California Street, Suite 3250, San Francisco, CA 94111.(4)Consists of 305,715 shares of common stock underlying warrants that are exercisable as of April 30, 2020, which are held directly by Intracoastal Capital, LLC ("Intracoastal"). The warrants are subject to a beneficial ownership limitation of 9.99%, which does not permit Intracoastal to exercise that portion of the warrants that would result in Intracoastal and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The amounts and percentages in the table do not give effect to the beneficial ownership limitation. Mitchell P. Kopin and Daniel B. Asher, each of whom are managers of Intracoastal, have shared voting control and investment discretion over the securities reported herein that are held by Intracoastal. As a result, each of Mr. Kopin and Mr. Asher may be deemed to beneficially own the securities held by Intracoastal. The address of each of Mr. Kopin and Intracoastal is 245 Palm Trail, Delray Beach, Florida 33483. The address of Mr. Asher is 111 W. Jackson Boulevard, Suite 2000, Chicago, Illinois 60604.(5)Consists of (a) 3,769 shares of common stock owned by Dr. Toselli, (b) 317 shares of common stock underlying options held by Dr. Toselli that are exercisable as of April 30, 2020 or will become exercisable within 60 days after such date, (c) 3,636 shares of common stock underlying warrants held by Dr. Toselli that are exercisable as of April 30, 2020, (d) 50 shares of restricted stock units granted to Dr. Toselli that will vest withinTable of Contents60 days after April 30, 2020, and (e) 2,300 shares of restricted common stock granted to Dr. Toselli.(6)Consists of (a) 3,636 shares of common stock owned by Mr. Christopher, (b) 1,000 shares of common stock underlying options held by Mr. Christopher that are exercisable as of April 30, 2020 or will become exercisable within 60 days after such date, (c) 3,636 shares of common stock underlying warrants held by Mr. Christopher that are exercisable as of April 30, 2020, and (d) 1,584 shares of restricted common stock granted to Mr. Christopher.(7)Consists of (a) 3,639 shares of common stock owned by Ms. Merrifield, (b) 85 shares of common stock underlying options held by Ms. Merrifield that are exercisable as of April 30, 2020 or will become exercisable within 60 days after such date, and (c) 3,636 shares of common stock underlying warrants held by Ms. Merrifield that are exercisable as of April 30, 2020.(8)Consists of (a) 290 shares of common stock owned by Dr. Roberts and (b) 153 shares of common stock underlying options held by Dr. Roberts that are exercisable as of April 30, 2020 or will become exercisable within 60 days after such date.(9)Consists solely of shares of common stock underlying options held by Dr. Marshak that are exercisable as of April 30, 2020 or will become exercisable within 60 days after such date.(10)Consists solely of shares of common stock underlying options held by Ms. Morrison that are exercisable as of April 30, 2020 or will become exercisable within 60 days after such date.(11)Mr. Rosenthal does not own any shares of common stock the Company.(12)Consists of (a) 11,334 shares of common stock owned by all current executive officers and directors as a group (b) 1,708 shares of common stock underlying options that are exercisable as of April 30, 2020 or will become exercisable within 60 days after such date, (c) 10,908 shares of common stock underlying warrants that are exercisable as of April 30, 2020, (d) 50 shares of restricted stock units that will vest within 60 days after April 30, 2020, and (e) 3,884 shares of restricted common stock."NRS"“NRS”), our articles of incorporation, as amended, and our amended and restated bylaws and, which are filed as exhibits to the registration statement of which this prospectus forms a part.Authorized Capital16,666,667250,000,000 shares of common stock, par value $0.00001 per share. As of April 30, 2020, 4,847,370share, and 1,000,000 shares of commonpreferred stock, were outstanding.par value $0.00001 per share. Our common stock is registered under Section 12(b) of the Exchange Act.Nevada'sNevada’s control share laws. A corporation is subject to Nevada'sNevada’s control share law if it has more than 200 stockholders, at least 100 of whom are stockholders of record and residents of Nevada, and if the corporation does business in Nevada, including through an affiliated corporation. This control share law may have the effect of discouraging corporate takeovers. We currently have less than 100 stockholders of record who are residents of Nevada."controlling“controlling interest,"” which means the ownership of outstanding voting shares that would be sufficient, but for the operation of the control share law, to enable the acquiring person to exercise the following proportions of the voting power of the corporation in the election of directors: (1) one-fifth or more but less than one-third; (2) one-thirdstockholder'sstockholder’s shares."interested stockholders"“interested stockholders” for two years after the interested stockholder first becomes an interested stockholder, unless the corporation'scorporation’s board of directors approves the combination in advance. For purposes of Nevada law, an interested stockholder is any person who is: (a) the beneficial owner, directly or indirectly, of 10% or more of the voting power of the outstanding voting shares of the corporation, or (b) an affiliate or associate of the corporation and at any time within the previous two years was the beneficial owner, directly or indirectly, of 10% or more of the voting power of the then-outstanding shares of the corporation. The definition of "business combination"“business combination” contained in the statute is sufficiently broad to cover virtually any kind of transaction that would allow a potential acquirer to use the corporation'scorporation’s assets to finance the acquisition or otherwise to benefit its own interests rather than the interests of the corporation and its other stockholders.Nevada'sNevada’s business combination law is to potentially discourage parties interested in taking control of the Company from doing so if it cannot obtain the approval of our board of directors.stockholders'stockholders’ meeting. Our amended and restated bylaws provide that stockholders may not call a special meeting of stockholders. Rather, only the Chairman of our board of directors, the President, or the board of directors pursuant to a resolution approved by a majority of the entire board of directors are able to call special meetings of stockholders. These provisions may discourage another person or entity from making a tender offer, even if it acquired a majority of our outstanding voting stock, because the person or entity could onlystockholders'stockholders’ meeting relating to the business specified in the notice of meeting and not by written consent.stockholders'stockholders’ meeting, and the amendment provisions in our bylaws make such provisions difficult to change."NVIV."“NVIV.” On May 21, 2020,November 4, 2022, the reported closing price per share of our common stock on the Nasdaq Capital Market was $1.62.April 15, 2020,October 7, 2022, we entered into acertain securities purchase agreementagreements, or the Purchase Agreements, with certain institutional and accredited investors,Armistice Capital Master Fund Ltd. or Armistice, pursuant to which we agreed to issue and sell and issue,to Armistice, in a registered direct offering offered pursuantprivate placement priced at-the-market under Nasdaq rules, (i) pre-funded warrants to an effective shelf registration statement on Form S-3, an aggregatepurchase up to 1,190,476 shares of 1,715,240 shares ofthe Company’s common stock, for aggregate gross proceedsa purchase price of approximately $3.0 million, before deducting fees to the placement agents$5.2499 per unregistered pre-funded warrant and other offering expenses payable by us. In a concurrent private placement, pursuant to the purchase agreement, we offeredassociated preferred investment option and sold to the investors common stock purchase warrants(ii) preferred investment options to purchase an aggregate of 1,715,240up to 1,714,286 shares of our common stock or theand (iii) preferred investment options to purchase warrants. Theup to 523,810 shares of our common stock. In a concurrent registered offering, we also sold to Armistice 154,000 share of our common stock and pre-funded warrants to purchase warrants have an exercise price per share equalup to $1.62, are immediately exercisable and expire on October 17, 2025. Pursuant to a letter agreement dated as369,810 shares of April 15, 2020, or the engagement letter, we engaged H.C. Wainwright & Co., LLC, or Wainwright, to act as the exclusive placement agent inour common stock.registered direct and private placement transaction. We issued placement agentof the pre-funded warrants and preferred investment options, we entered into a registration rights agreement with Armistice, pursuant to purchase an aggregate of 111,491which we agreed to register for resale the shares of our common stock orissuable upon exercise of the placement agent warrants. The placement agent warrants have an exercise price of $2.1875 per share, are immediately exercisable and expire April 15, 2025. The shares of common stock underlying the placement agentunregistered pre-funded warrants and the purchase warrants are referred to collectively as the warrant shares. Pursuant to the securities purchase agreement and the engagement letter, wepreferred investment options. We agreed to file the registration statement with respect to the resale of such shares within 30 days after the date of the registration rights agreement. The registration rights agreement includes customary indemnification rights in connection with the registration statement. The registration statement of which this prospectus is a part has been filed in accordance with the registration rights agreement.coveramend certain existing warrants to purchase up to 80,139 shares of common stock that were previously issued to Armistice in March 2020, April 2020 and October 2020, with exercise prices of $68.75, $40.50 and $20.00 per share, respectively, in consideration for the purchase of our securities in the offering. Under the warrant amendment agreement, we agreed to (i) lower the exercise price of such existing warrants to $5.05 per share and (ii) extend the original expiration date of such existing warrants to five and one-half years following the closing of the offerings.underlying the warrants and to keep such registration statement effective until the date that is six months after no selling stockholder owns any warrants. We are registering the resale of the warrant shares to permit each of the selling stockholders identified below to resell or otherwise dispose of the warrant shares in the manner contemplated under "Plan of Distribution" in this prospectus (as may be supplemented and amended). The term "selling stockholders" includes donees, pledgees, assignees, transferees or other successors-in-interest selling shares received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other non-sale related transfer. Throughout this prospectus, when we refer to the shares of our common stock being registered on behalf of the selling stockholders, we are referring to the warrant shares, and when we refer to the selling stockholders in this prospectus, we are referring to the purchasers of the warrants and holders of the placement agent warrants. The selling stockholders may sell some, all or none of their warrant shares. We do not know how long the selling stockholders will hold the warrant shares before selling them, and we currently have no agreements, arrangements or understandings with the selling stockholders regarding the sale or other disposition of any of the warrant shares. The warrant shares covered hereby may be offered from time to time by the selling stockholders.following table sets forth the name of each selling stockholder,second column lists the number and percentage of our outstanding shares of common stock beneficially owned by the selling stockholders, based on its ownership of the shares underlying the pre-funded warrants and preferred investment options, as of April 30, 2020,November 4, 2022, assuming exercise of the numberpre-funded warrants and preferred investment options held by the selling stockholders on that date, without regard to any limitations on exercises. The percentages of warrant shares that may be offered under this prospectus, and the number and percentage of our outstanding shares of common stock beneficially owned by the selling stockholders assuming all of the warrant shares covered hereby are sold. Beneficial ownership is determined in accordance with the rules of the SECprior to and includes voting or investment power with respect to our common stock. Generally, a person "beneficially owns" shares of our common stock if the person has or shares with others the right to vote those shares or to dispose of them, or if the person has the right to acquire voting or disposition rights within 60 days. The number of shares in the column "Shares of Common Stock being Offered" represents all of the warrant shares that a selling stockholder may offer and sell from time to time under this prospectus. All information contained in the table below and the footnotes thereto is based upon information provided to us by the selling stockholders. The selling stockholders may have sold or transferred, intransactions exempt from the registration requirements of the Securities Act, some or all of their warrant shares or other securities since the date on which the information in the table below if presented. Information about the selling stockholders may change over time. The percentage of shares owned after the offering isare based on 4,847,3701,914,970 shares of common stock outstanding as of April 30, 2020. Beneficial Ownership After this Offering(1) Shares of
Common Stock
Beneficially
Owned Prior to
this Offering Shares of
Common Stock
Offered
Hereby Number of
Shares % 305,715 305,715 — — 497,221 457,143 40,078 * 1,458,061 476,191 981,870 17.6 1,394,429 476,191 918,238 16.4 92,016 35,120 56,896 1.2 5,418 3,763 1,655 * 187,374 71,493 115,881 2.3 6,851 1,115 5,736 * *Less than one percent(1)AssumesNovember 4, 2022, which includes the exercise in full of the warrants and sale of all warrant shares registered pursuant to this prospectus, although the selling stockholders are under no obligation known to us to sell any shares of common stock atoffered by this time.(2)Before offering includes purchase warrants to purchase 305,715prospectus.which are held directlythe shares offered by Intracoastal Capital, LLC ("Intracoastal"). The purchase warrants are subjectthe selling stockholders pursuant to a beneficial ownership limitation of 9.99%, which does not permit Intracoastal to exercise that portionthis prospectus.purchasepre-funded warrants, thatthe selling stockholders may not exercise the pre-funded warrants to the extent such exercise would result in Intracoastal andcause such selling stockholders, together with its affiliates owning, after exercise,and attribution parties, to beneficially own a number of shares of common stock which would exceed 4.99% or 9.99%, as applicable, of our then outstanding common stock following such exercise, excluding for purposes of such determination shares of common stock issuable upon exercise of such pre-funded warrants which have not been exercised. The number of shares in excessthe second and fourth columns do not reflect this limitation. The selling stockholders may sell all, some or none of their shares in this offering. See “Plan of Distribution.”
Owned Prior to Offering
Common Stock to
Being Offered
Owned After Offering(1) Name of Selling Stockholder Number Percentage Number Percentage 2,984,901 60.5% 2,904,762 80,139 1.6% 78,950 1.6% 71,454 7,496 0.2% 54,139 1.1% 35,100 19,039 0.4% 4,136 0.1% 3,761 375 — 1,233 — 1,114 119 — the beneficial ownership limitation. Mitchell P. Kopin and Daniel B. Asher, each of whom are managers of Intracoastal, have shared voting control and investment discretion over the securities reported herein that are held by Intracoastal. As a result, each of Mr. Kopin and Mr. Asher may be deemed to beneficially own the securities held by Intracoastal.those limitations. The address of each of Mr. Kopin and Intracoastal is 245 Palm Trail, Delray Beach, Florida 33483. The address of Mr. Asher is 111 W. Jackson Boulevard, Suite 2000, Chicago, Illinois 60604.(3)Before offering includes (i) purchase warrants to purchase 457,143 shares of common stock and (ii) other warrants to purchase 40,078 shares of common stock, all of which are directly held by CVI Investments, Inc. ("CVI"). Certain of the warrants are subject to a beneficial ownership limitation of 4.99%, which does not permit CVI to exercise that portion of the warrants that would result in CVI and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The amounts and percentages in the table do not give effect to the beneficial ownership limitation. Heights Capital Management, Inc. ("Heights"), the authorized agent of CVI, has discretionary authority to vote and dispose of the shares held by CVI and may be deemed to be the beneficial owner of these shares. Martin Kobinger, in his capacity as Investment Manager of Heights may also be deemed to have investment discretion and voting power over the shares held by CVI. Mr. Kobinger disclaims any such beneficial ownership of the shares. CVI's address is c/o Heights Capital Management, Inc., 101 California Street, Suite 3250, San Francisco, CA 94111.(4)Before offering includes (i) 254,597 shares of common stock, (ii) purchase warrants to purchase 476,191 shares of common stock and (iii) other warrants to purchase 727,273 shares of commonstock, all of which are held directly by Armistice Capital Master Fund Ltd. ("Armistice Fund"). Certain of the warrants are subject to a beneficial ownership limitation of 4.99%, which does not permit Armistice Fund to exercise that portion of the warrants that would result in Armistice Fund and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The amounts and percentages in the table do not give effect to the beneficial ownership limitation. Steven Boyd is the Managing Member of Armistice Capital, LLC, which acts as the investment manager of Armistice Fund. As a result, Mr. Boyd may be deemed to beneficially own the securities held by Armistice Fund. The address of Armistice Fund is c/o dms Corporate Services ltd., 20 Genesis Close, P.O. Box 314, Grand Cayman KY1-1104, Cayman Islands, and the address of each of Armistice Capital, LLC, and Mr. Boyd is 510 Madison Avenue, 7th Floor, New York, NY 10022.(5)Before offering includes (i) purchase warrants to purchase 476,191 shares of common stock and (ii) other warrants to purchase 918,238 shares of common stock, all of which are held directly by Sabby Volatility Warrant Master Fund, Ltd. ("SVWMF"). Certain of the warrants are subject to a beneficial ownership limitation of 4.99%, which does not permit SVWMF to exercise that portion of the warrants that would result in SVWMF and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The amounts and percentages in the table do not give effect to the beneficial ownership limitation. Hal Mintz is the manager of Sabby Management, LLC, which acts as the investment manager of SVWMF. As a result, Mr. Mintz may be deemed to beneficially own the securities held by SVWMF. The address of each of SVWMF, Sabby Management LLC and Mr. Mintz is c/o Sabby Management, LLC, 10 Mountainview Road, Suite 205, Upper Saddle River, New Jersey 07458.(6)affiliateassociated person of Wainwright, a registered broker-dealer.broker-dealer and has sole voting and dispositive power over the securities held. The selling stockholder acquired the preferred investment options in the ordinary course of business and, at the time the preferred investment options were acquired, the selling stockholder had no agreement or understanding, directly or indirectly, with any person to distribute such securities.(7)35,1207,496 shares of common stock and otherplacement agent preferred investment options to purchase 71,454 shares of common stock. The address of Mr. Vasinkevich is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022.56,89619,039 shares of common stock and placement agent preferred investment options to purchase 35,100 shares of common stock. The address of Mr. Rubinstein is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd3rd Floor, New York, New York 10022.(8)reflectsincludes placement agent warrants to purchase 3,763375 shares of common stock and other warrantsplacement agent preferred investment options to purchase 1,6553,761 shares of common stock. The address of Mr. Schwabe is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd3rd Floor, New York, New York 10022.(9)reflectsincludes placement agent warrants to purchase 71,493119 shares of common stock and other warrantsplacement agent preferred investment options to purchase 115,881 shares of common stock. The address of Mr. Vasinkevich is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022.(10)Before the offering reflects placement agent warrants to purchase 1,115 shares of common stock and other warrants to purchase 5,7361,114 shares of common stock. The address of Mr. Worthman is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd3rd Floor, New York, New York 10022.Other Relationships withPLAN OF DISTRIBUTION Messrs. Rubinstein, Schwabe, Vasinkevich, and Worthman, selling stockholders, are each affiliated with Wainwright, which acted as the placement agent in the concurrent private placement of the purchase warrants for which we are registering the underlying shares in the registration statement of which this prospectus forms a part,securities and received the placement agent warrants for which we are registering the underlying shares in the registration statement of which this prospectus forms a part as compensation in connection therewith. From time to time, Wainwright may provide in the future various advisory, investment and commercial banking and other services to us in the ordinary course of business, for which they have received and may continue to receive customary fees and commissions. Wainwright acted as exclusive financial advisor for our November 2019 public offering and March 2020 public offering, for which it received compensation. Except with respect to the foregoing, none of the selling stockholders has, or within the past three years has had, any position, office or other material relationship with us, other than as a result of the ownership of our shares or other securities. We are registering the warrant shares issuable to the selling stockholders to permit the resale of these shares of common stock by the selling stockholders from time to time from after the date of this prospectus. We will not receive any of the proceeds from the sale by the selling stockholders of the warrant shares. We will bear the feestheir pledgees, assignees and expenses incident to our obligation to register the shares of common stock, however the selling stockholders will bear legal and advisor fees, commissions and discounts, if any, attributable to their respective sales of the warrant shares. Each selling stockholdersuccessors-in-interest may, from time to time, sell any or all of its warrant sharestheir securities covered hereby on The Nasdaq Capitalthe principal Trading Market or any other stock exchange, market or trading facility on which the shares can besecurities are traded or in private transactions. These sales may be at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or privately negotiated prices. A selling stockholderSelling Stockholder may use any one or more of the following methods when selling shares:•sharessecurities as agent but may position and resell a portion of the block as principal to facilitate the transaction;••••underwritten transactions;•toentered into after the extent permitted by law;effective date of the registration statement of which this prospectus is a part;•selling stockholdersSelling Stockholders to sell a specified number of such sharessecurities at a stipulated price per share;security;••through the distribution of the common stock by any selling stockholder to its partners, members or stockholders;••selling stockholdersSelling Stockholders may also sell the shares of common stocksecurities under Rule 144 or any other exemption from registration under the Securities Act of 1933, as amended (the “Securities Act”), if available, rather than under this prospectus. If underwriters are used in the sale, the shares of common stock will be acquired by the underwriters for their own account and may be resold from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or at varying prices determined at the time of sale. In connection with any such underwritten sale of shares of common stock, underwriters may receive compensation from the selling stockholders, for whom they may act as agents, in the form of discounts, concessions or commissions. If the selling stockholders use an underwriter or underwriters to effectuate the sale of shares of common stock, we and/or they will execute an underwriting agreement with those underwriters at the time of sale of those shares of common stock. To the extent required by law, the names of the underwriters will be set forth in a prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes the prospectus supplement and the accompanying prospectus used by the underwriters to sell those securities. The obligations of the underwriters to purchase those shares of common stock will be subject to certainconditions precedent, and unless otherwise specified in a prospectus supplement, the underwriters will be obligated to purchase all the shares of common stock offered by such prospectus supplement if any of such shares of common stock are purchased. Any public offering price and any discounts or concessions allowed or re-allowed or paid to dealers may be changed from time to time.selling stockholdersSelling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the selling stockholdersSelling Stockholders (or, if any broker-dealer acts as agent for the purchaser of shares,securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus,Prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.shares of common stocksecurities or interests therein, the selling stockholdersSelling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the shares of common stocksecurities in the course of hedging the positions they assume. The selling stockholdersSelling Stockholders may also sell the shares of common stocksecurities short and deliver these securities to close out their short positions, or to return borrowed shares in connection with such short sales, or loan or pledge the shares of common stocksecurities to broker-dealers that in turn may sell these securities. The selling stockholdersSelling Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares of common stocksecurities offered by this prospectus, which sharessecurities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).selling stockholdersSelling Stockholders and any broker-dealers or agents that are involved in selling the shares of common stocksecurities may be deemed to be "underwriters"“underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such selling stockholders, broker-dealers or agents and any profit on the resale of the sharessecurities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each Selling stockholders who are "underwriters" withinStockholder has informed the meaning of Section 2(11) ofCompany that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the Securities Act will be subject to the prospectus delivery requirements of the Securities Act and may be subject to certain statutory liabilities of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act of 1934, as amended, or the Exchange Act. We aresecurities.usthe Company incident to the registration of the shares of common stock of the selling stockholders. We have alsosecurities. The Company has agreed to indemnify the selling stockholders holding purchase warrantsSelling Stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act, with respect to the registration statement of which this prospectus forms a part. The selling stockholders will be subject to the prospectus delivery requirements of the Securities Act, including Rule 172 thereunder, unless an exemption therefrom is available.cause the registration statement of whichkeep this prospectus is a part to remain effective until the earlier of (i) the date on which no selling stockholder ownsthe securities may be resold by the Selling Stockholders without registration and without regard to any purchase warrantsvolume or common stock issuable upon exercise thereof.manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information requirement under Rule 144 under the Securities Act or any other rule of similar effect or (ii) the date on which all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The shares of common stockresale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the shares of common stockresale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.shares of common stockresale securities may not simultaneously engage in market making activities with respect to the shares of common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the selling stockholdersSelling Stockholders willshares ofthe common stock by the selling stockholdersSelling Stockholders or any other person. We will make copies of this prospectus available to the selling stockholdersSelling Stockholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act). The selling stockholders may decide not to sell any or all of the shares of common stock we registered on behalf of the selling stockholders pursuant to the registration statement of which this prospectus forms a part. Once sold under the registration statement of which this prospectus forms a part, the shares of common stock will be freely tradable in the hands of persons other than our affiliates. �� EXPERTS20192021 and 20182020 and for the years then ended incorporated in this Prospectus by reference from the InVivo Therapeutics Holdings Corp.'s ’s Annual Report on Form 10-K for the year ended December 31, 20192021 have been audited by RSM US LLP, an independent registered public accounting firm, as stated in their report thereon, (which report expresses an unqualified opinion and includes an explanatory paragraph relating to InVivo Therapeutics Holdings Corp.'s ability to continue as a going concern), incorporated herein by reference, and have been incorporated in this Prospectus and Registration Statement in reliance upon such report and upon the authority of such firm as experts in accounting and auditing.SEC'sSEC’s Internet site. Copies of certain information filed by us with the SEC are also available on our website atwww.invivotherapeutics.com. The information on our Internet website is not incorporated by reference in this prospectus.SEC'sSEC’s Internet site."filed"“filed” under the Exchange Act in accordance with the Exchange Act and applicable SEC rules.terminationsale of all the offering made herebyshares covered by this prospectus are incorporated by reference in this prospectus as of the respective filing dates of these documents and reports.(1)2019,2021, filed with the SEC on February 20, 2020;March 7, 2022 including the information specifically incorporated by reference into the Annual Report on Form 10-K from our definitive proxy statement for the 2022 Annual Meeting of Stockholders;(2)ReportReports on Form 10-Q for the quarterquarterly periods ended March 31, 20202022, June 30, 2022 and September 30, 2022, filed with the SEC on May 13, 2020;10, 2022, August 8, 2022 and November 7, 2022, respectively;(3)January 16, 2020,January 24, 2020,February 3, 2020,February 11, 2020,February 24, 2020,March 2, 2020;March 11, 2020, andApril 16, 202014, 2022,April 26, 2022,May 13, 2022,May 26, 2022,June 2, 2022,July 12, 2022,September 13, 2022 and October 11, 2022; and(4)
One Kendall Square, Suite B14402
Cambridge, Massachusetts 02139
Attn: Investor Relations
(617) 863-5500
1,826,7313,016,191 Shares of Common Stock2020("SEC"(“SEC”) registration fee.
be Paid SEC registration fee $ 731.26 Printing fees and expenses 10,000 Legal fees and expenses 50,000 Accounting fees and expenses 15,000 Total $ 75,731.26 Amount to
be Paid $ 352 10,000 25,000 12,500 $ 47,852 ("NRS"(“NRS”) Sections 78.7502 and 78.751 provide us with the power to indemnify any of our directors, officers, employees and agents. The person entitled to indemnification must have conducted himself in good faith, and must reasonably believe that his conduct was in, or not opposed to, our best interests. In a criminal action, the director, officer, employee or agent must also not have had reasonable cause to believe that his conduct was unlawful. In addition, any of our directors, officers, employees or agents are entitled to indemnification if such person is successful on the merits or otherwise in defense of any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative against actual and reasonable expenses incurred in connection with defending such action.director'sdirector’s or officer'sofficer’s fiduciary duties; and (ii) such breach involved intentional misconduct, fraud or a knowing violation of law. These provisions may be sufficiently broad to indemnify such persons for liabilities arising under the Securities Act of 1933, as amended, in which case such provisions are against public policy as expressed such Act and are therefore unenforceable."Securities“Securities Act.""April“April 2020 Purchase Agreement"Agreement”) with certain institutional investors (the "April“April 2020 Purchasers"Purchasers”), pursuant to which we issued an aggregate of 1,715,240 of our common stock in a registered direct offering (the "April“April 2020 Registered Offering"Offering”). Pursuant to the April 2020 Purchase Agreement, in a concurrent private placement, we also issued to the April 2020 Purchasers warrants (the "Series“Series C Warrants"Warrants”) to purchase up to 1,715,240 shares of our common stock (the "Private Placement"“Private Placement” and together with the April 2020 Registered Offering, the "April“April 2020 Offering"Offering”). The Series C Warrants have an exercise price of $1.62 per share, are immediately exercisable and expire on October 17, 2025. H. C. Wainwright & Co., LLC ("Wainwright") acted as placement agent for the April 2020 Offering."April“April 2020 Placement Agent Warrants"Warrants”) to purchase an aggregate of 111,491 shares of common stock. The April 2020 Placement Agent Warrants have an exercise price of $2.1875 per share, are immediately exercisable and expire April 15, 2025."March“March 2020 Offering"Offering”) of common stock, Series A Warrants to purchase common stock and Series B Pre-funded Warrants to purchase common stock, we issued to designees of Wainwright placement agent warrants (the "March“March 2020 Placement Agent Warrants"Warrants”) to purchase an aggregate of 165,455 shares of common stock. The March 2020 Placement Agent Warrants have an exercise price of $3.4375 per share, are immediately exercisable and expire March 6, 2025."2019 Offering"“2019 Offering”) of our common stock, we agreed to issue to Wainwright, or its designees, placement agent warrants (the "2019“2019 Placement Agent Warrants"Warrants”) to purchase On September 25, 2019, pursuant to the terms of our 2015 Equity Incentive Plan (the "Plan"), we granted 2,300 shares of our restricted common stock to Richard Toselli, our Chief Executive Officer, and 1,584 shares of our restricted common stock to Richard Christopher, our Chief Financial Officer, in consideration of Dr. Toselli's and Mr. Christopher's service as officers. These shares of restricted stock were issued under the Plan. We filed a registration statement on Form S-8 (File No. 333-234630) to register these shares of restricted common stock for resale on November 12, 2019. On January 14, 2019, we granted to Mr. Christopher, as our new Chief Financial Offer, a stock option to purchase 3,000 shares of our common stock with an exercise price of $45.90 per share. The option was granted as an inducement grant made outside of the Plan in accordance with Nasdaq Listing Rule 5635(c)(4) and in reliance upon the exemption from the registration requirements of the Securities Act. The option has a ten-year term. We filed a registration statement on Form S-8 (File No. 333-230644) to register the shares of Common Stock underlying the option on April 1, 2019. On January 25, 2018, we entered into a purchase agreement, or the Purchase Agreement, with Lincoln Park Capital Fund, LLC, or Lincoln Park, which provided that, upon the terms and subject tothe conditions and limitations set forth in the Purchase Agreement, Lincoln Park committed to purchase up to an aggregate of $15 million of shares of our common stock over the 24-month term of the Purchase Agreement. We terminated the Purchase Agreement on May 9, 2019. We issued 574 shares of common stock to Lincoln Park in consideration for entering into the Purchase Agreement, and from January 2018 through the date of termination, we sold 8,561 shares of common stock under the Purchase Agreement, generating net proceeds of approximately $3.1 million. On August 10, 2017, we issued an aggregate of 2,696 shares of common stock to certain holders of warrants, dated May 9, 2014, in exchange for their warrants to purchase an aggregate of 771 shares of common stock.+"Securities Act"“Securities Act”);"Calculation“Calculation of Registration Fee"Fee” table in the effective registration statement; and"Exchange Act"“Exchange Act”), that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.registrant'sregistrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan'splan’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.May 22, 2020. INVIVO THERAPEUTICS HOLDINGS CORP.Date: May 22, 2020
President and Chief Executive Officer (Principal Executive Officer) Date: May 22, 2020
Chief Financial Officer and Treasurer (Principal
Financial and Accounting Officer) Signature Title SignatureTitleDate
Date
/s/ President and Chief Executive Officer (Principal Executive Officer) and Director May 22, 2020 November 8, 2022 SignatureTitleDate
Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer) May 22, 2020November 8, 2022
Director
DirectorMay 22, 2020 November 8, 2022
Director
DirectorMay 22, 2020 November 8, 2022
Director
DirectorMay 22, 2020 November 8, 2022
Director
DirectorMay 22, 2020 November 8, 2022
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DirectorMay 22, 2020 November 8, 2022