October 22, 2020
TO
FORM S-1
VICAL INCORPORATED
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Delaware (State or other jurisdiction of | 2836 (Primary Standard Industrial Classification Code Number) | 93-0948554 (I.R.S. Employer Identification |
10390 Pacific Center Court
San Diego, California 92121
(858) 646-1100
Vijay
Copies to:
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Please send copies of all communications to: | ||||||||
Daniel L. Boeglin Jonathan R. Zimmerman Faegre Drinker Biddle & Reath LLP 2200 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402 Telephone: (612) 766-7000 | Steven M. Skolnick, Esq. Sean M. Clayton, Esq. Cooley Lowenstein Sandler LLP 4401 Eastgate Mall San Diego, California 92121 (858) 550-6000 |
1251 Avenue of the Americas New York, NY 10020 Telephone: (212) 262-6700 |
Large accelerated filer ☐ | Accelerated filer ☐ | |||||
Non-accelerated filer | Smaller reporting company ☒ | |||||
Emerging growth company ☐ |
Title of each class of Securities to be Registered | Proposed Maximum Aggregate Offering Price (1) | Amount of Registration Fee | ||||||||||||
Common stock, par value $0.01 per share (2)(3)(4) | $ | 15,000,000 | — | |||||||||||
Pre-funded warrants to purchase shares of common stock and common stock issuable upon exercise thereof (2)(3)(4) | 15,000,000 | |||||||||||||
Warrants to purchase common stock and shares of common stock issuable upon exercise thereof (2)(3) | 15,000,000 | — | ||||||||||||
Total | $ | 30,000,000 | $ | 3,273 | ||||||||||
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The Registrantregistrant 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 that specifically states that this
Subject to completion, dated November 6, 2017
PRELIMINARY PROSPECTUS
VICAL INCORPORATED
10,000,000
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The offering is being underwritten on a firm commitment basis. We have granted the underwriter an option for a period of 30 days from the date ofYou should read this prospectus, to purchase up to antogether with additional 1,500,000 sharesinformation described under the headings “Information Incorporated by Reference” and “Where You Can Find More Information,” carefully before you invest in any of our common stock to cover over-allotments, if any.securities.
Per Share | Per Pre-Funded Warrant | Per Common Warrant | Total | |||||||||||||||||||||||
Public offering price | $ | $ | $ | $ | ||||||||||||||||||||||
Underwriting discounts and commissions (1) | $ | $ | $ | $ | ||||||||||||||||||||||
Proceeds to us, before expenses | $ | $ | $ | $ | ||||||||||||||||||||||
The underwriter expects to deliver the shares of common stock and any pre-funded warrants to purchasers on or about November , 2017.
H.C. Wainwright
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ABOUT THIS PROSPECTUS | |||||||||||
CAUTIONARY NOTE CONCERNING FORWARD-LOOKING STATEMENTS | |||||||||||
PROSPECTUS SUMMARY | |||||||||||
THE OFFERING | |||||||||||
RISK FACTORS | |||||||||||
USE OF PROCEEDS | |||||||||||
DILUTION | |||||||||||
DESCRIPTION OF CAPITAL STOCK | |||||||||||
DESCRIPTION OF SECURITIES WE ARE OFFERING | |||||||||||
UNDERWRITING | |||||||||||
INFORMATION INCORPORATED BY REFERENCE | |||||||||||
WHERE YOU CAN FIND MORE INFORMATION | |||||||||||
LEGAL MATTERS | |||||||||||
EXPERTS |
and “our” refer to Brickell Biotech, Inc. and our consolidated subsidiaries.
Our Company
An ongoing Phase 3 trial of ASP0113 for prevention of cytomegalovirus, or CMV, reactivation in hematopoietic stem cell transplant recipients in collaboration with Astellas Pharma Inc., or Astellas. Enrollment of the trial was completed in September 2016 withare a total of 515 subjects. Dosing in the trial was completed in April of 2017 and the one-year follow-up period was completed in September 2017. The primary endpoint of the trial is a composite of overall mortality and CMV end organ disease which will be assessed one year after transplantation. Astellas expects top-line data to be available in the first quarter of 2018. We and Astellas continue to make progress towards a Biologics License Application filing in 2018 with the U.S. Food and Drug Administration, or FDA. Astellas has indicated that, if approved, it would seek to commercialize ASP0113 in North America, Europe and Asia.
An ongoing Phase 2 trial of VCL-HB01, our therapeutic DNA vaccine for reduction of genital herpes lesion recurrences caused by herpes simplex virus type 2, or HSV-2, infection. Recruitment into the Phase 2 trial of VCL-HB01 has been completed with a total of 261 subjects enrolled at 15 U.S. clinical sites. The four-dose vaccination series was completed in July 2017, and all active subjects are currently being monitored for lesion recurrences during a 12-month follow-up period. VCL-HB01 is formulated with Vaxfectin® and encodes two full-length HSV-2 antigens gD and UL46, designed to reduce recurrences in patients with symptomatic genital HSV-2 infection. Healthy adult subjects, 18 to 50 years of age, have been randomized 2:1 to receive either vaccine or placebo to evaluate in a double-blinded fashion the efficacy and safety of the vaccine. The primary endpoint of the study is annualized lesion recurrence rate which is a clinically meaningful endpoint for both patients and treating physicians as it provides important informationclinical-stage pharmaceutical company focused on the numberdevelopment of recurrences over time in this chronic disease setting. We expect to announce top-line data during the second quarter of 2018.
A completed first-in-human Phase 1 trial of our novel antifungal VL-2397. The randomized, double-blind, placebo-controlled trial evaluated safety, tolerabilityinnovative and pharmacokinetics of single and multiple ascending doses of intravenous VL-2397 in 96 healthy volunteers. Results point to a favorable safety and pharmacokinetic profile for VL-2397. The full data set was presented as one of four presentations at the ASM Microbe 2017 conference in June. The FDA has advised us that VL‑2397 would be eligible for a Limited Use Indication, or LUI, approval assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the FDA’s advice. The final determination of whether VL-2397 is approvable will be made by the FDA after review of all relevant data. We plan to initiate a Phase 2 trialdifferentiated prescription therapeutics for the treatment of invasive aspergillosisdebilitating skin diseases. Our pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Our executive management team and board of directors bring extensive experience in acute leukemia patientsproduct development and allogeneic hematopoietic cell transplant recipientsglobal commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®.
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Risks Associated with Our BusinessHyperhidrosis is a life-altering condition of sweating beyond what is physiologically required to maintain normal thermal regulation. It is believed to be caused by an overactive cholinergic response of the sweat glands and this Offering
An investment in our securities involvesaffects an estimated 15.3 million, or 4.8%, of the population of the U.S. According to a high degree2016 update on the prevalence and severity of risk. Prior to making a decision about investing in our securities, you should carefully consider the risks describedhyperhidrosis in the section entitled “Risk Factors”U.S. by Doolittle et al., axillary (underarm) hyperhidrosis, which is the targeted first potential indication for sofpironium bromide, is the most common occurrence of hyperhidrosis, affecting approximately 65% of patients in the U.S. or an estimated 10 million individuals.
certain other Asian countries.
We were
We are a “smaller reporting company” as definedwebsite in Rule 12b-2deciding whether to purchase our securities and the inclusion of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and have elected to take advantage of certain of the scaled disclosure available for smaller reporting companiesour website address in this prospectus as well asis an inactive textual reference only.
Any brandrights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks appearing in this prospectusto imply a relationship with, or in documents incorporatedendorsement or sponsorship of us by, reference in this prospectus are the property of their respective owners.
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The Offering
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Common Stock to be Offered | 18,223,788 shares, based on the sale of our common stock at an assumed combined public offering price of $0.8231 per share of common stock and accompanying common warrant, which is the last reported sale price of our common stock on October 20, 2020, and no sale of any pre-funded warrants. | |||||
Pre-funded | We are also offering to certain purchasers whose purchase of shares of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if such purchasers so choose, pre-funded warrants, in lieu of shares of common stock that would otherwise result in any such purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock. Each pre-funded warrant will be exercisable for one share of our common stock. The purchase price of each pre-funded warrant and accompanying common warrant will equal the price | |||||
Common | Common warrants to purchase an aggregate of 18,223,788 shares of our common stock. Each share of our common stock and each pre-funded warrant to purchase one share of our common stock is being sold together with a common warrant to purchase one share of our common stock. Each common warrant will have an exercise price of $ _ per share, will be immediately exercisable and will expire on the fifth anniversary of the original issuance date. The shares of common stock and pre-funded warrants, and the accompanying common warrants, as the case may be, can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the common warrants. | |||||
Common Stock to be Outstanding after this |
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We estimate that the net proceeds from this offering will be approximately $13.7 million, based on an | |||||
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Risk |
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National Securities Exchange Listing | Our common stock is listed on | |||||
The number of shares of our common stock tothat will be outstanding after this offering is based on 11,547,98032,682,154 shares of common stock outstanding as of September 30, 2017October 20, 2020, and assumes the sale and issuance by us of 10,000,00018,223,788 shares of common stock (and no sale of any pre-funded warrants) in this offering and excludes, as of September 30, 2017:
1,754,281•4,743,537 shares of common stock issuable upon the exercise of options outstanding stock options,as of October 20, 2020 at a weighted-averageweighted average exercise price of $12.06$4.67 per share;
50,162•204,233 shares of common stock issuable upon the settlement of outstandingunderlying unvested restricted stock units; and
638,959•1,997,623 shares of common stock reserved for future issuance under our Amended and Restated Stockthe 2020 Omnibus Long-Term Incentive Plan or the Incentive Plan.
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Such number also excludes 1,058,487•19,556,109 shares of common stock sold underissuable upon the exercise of warrants outstanding as of October 20, 2020, of which there were warrants to purchase (i) one share of our common stock at an exercise price of $0.07 per share; (ii) 490,683 shares of our common stock at an exercise price of $10.36 per share; (iii) 9,005 shares of our common stock at an exercise price of $33.31 per share; (iv) 1,556,420 shares of our common stock at an exercise price of $1.16 per share; and (v) 17,500,000 shares of our common stock at an exercise price of $1.25 per share; and
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could prevent or cause substantial delays in our ability to seek approval for sofpironium bromide gel in the U.S. and other territories in which we maintain exclusive rights. adequately protect us from a serious disaster. the net tangible book value of the common stock you purchase in this offering. Based on an assumed combined public offering price of $0.8231 per share of common stock and accompanying common warrant being sold in this offering, and our net tangible book value as of June 30, 2020, if you purchase shares of common stock in this offering, you will suffer immediate and substantial dilution of $0.08 per share with respect to the net tangible book value of the common stock. See the section entitled “Dilution” for a more detailed discussion of the dilution you will incur if you purchase common stock in this offering. There is no established public trading market for the pre-funded warrants or common warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply to list the pre-funded warrants or common warrants on any securities exchange or nationally recognized trading system, including An investmentPriorWe urge you to making a decision about investing in our securities, you should carefully consider the risks described below, together with all of the other information included or incorporated by referencecontained in this prospectus including the risks described in the section entitled “Risk Factors” contained in our most recent quarterly report on Form 10-Q,and other information which has been filed with the SEC and ismay be incorporated by reference in this prospectus as wellprovided under “Information Incorporated by Reference.” In particular, you should consider the risk factors below, together with those under the heading “Risk Factors” in our most recent Annual Report on Form 10-K, which is incorporated by reference into this prospectus, as any updates thereto contained inthose risk factors are amended or supplemented by our subsequent filings with the SECSEC. These risks and uncertainties are not the only risks and uncertainties we face. Additional risks and uncertainties not currently known to us, or any free writing prospectus.that we currently view as immaterial, may also impair our business. If any of thesethe risks were toor uncertainties described below or in our SEC filings or any additional risks and uncertainties actually occur, our business, financial condition, or results of operations would likely suffer. In that event, the value of our securitiesand cash flow could decline,be materially and adversely affected. As a result, you could lose all or part of your investment.riskssuccessful development, regulatory approval, and uncertaintiescommercialization of sofpironium bromide requires significant additional financing and depends on a number of factors, including but not limited to the following:describecurrently anticipate and/or produce results that do not achieve the endpoints of the trials or which are ultimately deemed not to be clinically meaningful;ones facing us. Additional risksto the extent approved by these regulatory authorities (unlike with most other industries);presently knownlimited to patents and licenses.currently deem immaterial may also impaircollaborate, or regulatory authorities to interrupt, extend, modify, delay, or halt clinical trials, or even later commercialization, and could result in a more restrictive or narrower product label or the delay or denial of regulatory approval by the FDA or comparable foreign authorities, or a product recall and/or cancellation.resultsothers identify undesirable side effects, or other previously unknown problems, caused by sofpironium bromide after obtaining U.S. or foreign regulatory approval, a number of operations.Risks Relatedpotentially negativeOfferinghave broadnot receive additional milestone or other payments from Kaken if Kaken is not successful in its development, regulatory or commercial activities.inof the formulary.proceeds fromoperating loss carryforwards and other tax assets to offset future taxable income may be subject to certain limitations and it is possible that this offering may materially reduce or eliminate our net operating loss carryforwards.use them effectively.management willcorporate office is located in Boulder, Colorado, near a major flood and blizzard zone. If a disaster, power outage, computer hacking, or other event occurred that prevented us from using all or a significant portion of our office, that damaged critical infrastructure (such as enterprise financial systems, IT systems, manufacturing resource planning or enterprise quality systems), or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. Our contract manufacturers’ and suppliers’ facilities are located in multiple locations where other natural disasters or similar events, such as tornadoes, earthquakes, storms, fires, explosions or large-scale accidents or power outages, or IT threats, could severely disrupt our operations, could expose us to liability and could have broad discretiona material adverse effect on our business, financial condition, operating results, and prospects. In addition, acts of terrorism and other geo-political unrest or labor unrest, or natural disasters, or global developments like the coronavirus outbreak, could cause disruptions in our business or the applicationbusinesses of our partners, manufacturers, or the economy as a whole. All of the net proceeds from this offering, including foraforementioned risks may be further increased if we do not implement a disaster recovery plan or our partners’ or manufacturers’ disaster recovery plans prove to be inadequate. To the extent that any of the purposes describedabove should result in delays in the section entitled “Useregulatory approval, manufacture, distribution, or commercialization of Proceeds,sofpironium bromide, this could expose us to liability, and our business, financial condition, operating results, and prospects would suffer.youother applicable government agencies may change quickly, and new or additional statutes or government laws or regulations may be enacted, including at federal, state, and local levels, or case law may issue, which can differ by geography and could prevent or delay regulatory approval of our product candidates or further restrict or regulate post-approval activities, including commercial efforts. We cannot predict the likelihood, nature or extent of adverse government regulations that may arise from future legislation or administrative action, or judicial outcomes based on litigation, either in the U.S. or abroad. If we are not able to achieve and maintain regulatory or other legal compliance, we may not be permitted to commercialize our product candidates, which would adversely affect our ability to generate revenue and achieve or maintain profitability.opportunity as partpotential economic impact brought by and the duration of your investment decisionthe pandemic may be difficult to assess whetheror predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting from the net proceeds are being used appropriately. Becausespread of the numbercoronavirus could materially and variability of factors that will determineadversely affect our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. Our management may not apply the net proceeds from this offering in ways that ultimately increasebusiness and the value of your investment. our common stock.failureultimate impact of the current pandemic, or any other health epidemic, is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole. However, these effects could have a material adverse effect on our business, financial condition and results of operations and cash flows.managementbusiness plan.apply these funds effectivelyaffect important bodily functions and processes. Any side effects, manufacturing defects, misuse or abuse associated with our product candidates could result in actual or perceived injury to a patient that may or may not be reversible or potentially even cause death. We cannot offer any assurance that we will not face product liability or other similar suits in the future or that we will be successful in defending them, nor can we assure that our insurance coverage will be sufficient to cover our liability under any such cases.business. Pending their use,business, financial condition, operating results, and prospects.investcollaborate may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.net proceedsrisk that our employees, officers, directors, independent contractors, principal investigators, other clinical trial staff, consultants, advisors, vendors, CROs and any partners with which we may collaborate may engage in fraudulent or other illegal or unethical activity. Misconduct by these persons could include intentional, reckless, gross or negligent misconduct or unauthorized activity that violates: laws or regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA or foreign regulatory authorities; product sampling; manufacturing standards; federal, state and foreign healthcare fraud and abuse laws and data privacy; anticorruption laws, anti-kickback and Medicare/Medicaid rules, debarment laws, promotional laws, securities laws, and/or laws that require the true, complete and accurate reporting of financial information or data, books and records. If any such or similar actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative and punitive penalties, damages, monetary fines, possible exclusion from this offeringparticipation in short-term, investment-grade, interest-bearing securities. These investmentsMedicare, Medicaid, and other federal or state healthcare programs, debarments, contractual damages, reputational harm, diminished profits and future earnings, injunctions, and curtailment or cessation of our operations, any of which could expose us to liability and adversely affect our business, financial condition, operating results, and prospects.not yieldbe subject to risks related to pre-approval promotion or off-label use, or unauthorized direct-to-consumer advertising of our product candidates.favorable returnproduct’s indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.stockholders.product candidates. If we do not investlawfully promote our products once they have received regulatory approval, we may become subject to such litigation and, if we are not successful in defending against such actions, those actions could expose us to liability and could have a material adverse effect on our business, financial condition, operating results, and prospects and even result in having an independent compliance monitor assigned to audit our ongoing operations at our cost for a lengthy period of time.net proceedsexclusion from participation in federal and state healthcare programs, individual imprisonment or corporate criminal liability, or the curtailment or restructuring of our operations, and injunctions, any of which could expose us to liability and could adversely affect our business, financial condition, operating results, and prospects.offering in waysstrategy depends partly on our ability to identify and select promising pharmaceutical product candidates and products, negotiate licensing or acquisition agreements with their current owners, and finance these arrangements.enhance stockholder value,are never completed, or we may fail to achieve expected financial results,realize the anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates on terms that we find acceptable or at all.causesignificantly harm our business, financial condition, operating results, and prospects.decline.the The Nasdaq Capital Market. Without an active market, the liquidity of the pre-funded warrants or common warrants will be limited.
Holders of pre-funded warrants or common warrants purchased in this offering will have no rights as common stockholders until such holders exercise their pre-fundedsuch warrants and acquire our common stock.
Until holders of pre-funded warrants or common warrants acquire shares of our common stock upon exercise of the pre-fundedsuch warrants, holders of pre-funded warrants or common warrants will have no rights with respect to the shares of our common stock underlying such pre-funded warrants. Upon exercise of the pre-funded warrants or common warrants, the holders will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.
There may be future salesWe will have broad discretion in the use of our securitiesexisting cash and cash equivalents, including the proceeds from this offering, and may invest or other dilutionspend our cash in ways with which you do not agree and in ways that may not increase the value of your investment.
We are generally not restrictednet proceeds from issuing additional common stock, including any securities that are convertible into or exchangeable for, or that represent the right to receive, common stock. The market price of our common stock could decline as a result of sales of common stock or securities that are convertible into or exchangeable for, or that represent the right to receive, common stock after this offering orfor research and development, including clinical trials, working capital and general corporate purposes. Our failure to apply the perception that such sales could occur.
Even ifnet proceeds from this offering is successful,effectively could compromise our ability to pursue our growth strategy and we will need to raise additional capital in the future to continue operations, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
To date, we have not sold, or received approval to sell, any pharmaceutical products. We do not expect to sell any pharmaceutical products for at least the next several years. Our net losses were approximately $9.0 million, $9.2 million and $16.5 million for the years ended December 31, 2016, 2015 and 2014, respectively. As of December 31, 2016, we had incurred cumulative net losses totaling approximately $413.9 million. Moreover, we
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expect that our net losses will continue and may increase for the foreseeable future. We maymight not be able to achieve projected resultsyield a significant return, if we generate lower revenues or receive lowerany, on our investment income than expected, or we incur greater expenses than expected, or all of these net proceeds. You will not have the above. Currentlyopportunity to influence our revenues are largely dependentdecisions on manufacturing and research services performed underhow to use our license agreement with Astellas. That revenue may decrease once the ASP0113 trials are complete or in the event that the development of the ASP0113 program ceases. We may never generate sufficient product revenue to become profitable. We also expect to have quarter-to-quarter fluctuations in revenues, expenses, and losses, some of which could be significant.
net proceeds from this offering.
We may need to raise more money to continue the research and development necessary to bring our products to market and to establish marketing and additional manufacturing capabilities. We may seek additional funds through public and private stock offerings, government contracts and grants, arrangements with corporate collaborators, borrowings under lines of credit or other sources. We currently have on file a shelf registration statement that allows us to raise proceeds from the sale of common stock, preferred stock, debt securities and/or warrants subject to applicable rules under the Securities Act of 1933, as amended, or Securities Act. However, we may not be able to raise additional funds on favorable terms, or at all. Conditions in the credit markets and the financial services industry may make equity and debt financing more difficult to obtain, and may negatively impact our ability to complete financing transactions. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants, such as limitations on our ability to incur additional indebtedness and other operating restrictions that could adversely impact our ability to conduct our business.
In October 2016, we also entered into an At-The-Market Issuance Sales Agreement, or the ATM Agreement, with IFS Securities, Inc. (doing business as Brinson Patrick, a division of IFS Securities, Inc.), or BP, under which we may issue and sell up to $10.0 million of shares of our common stock from time to time. As of November 6, 2017, we had sold 1,509,370 shares of our common stock under the ATM Agreement and have received gross proceeds of approximately $4.3 million. BP is not obligated to sell any shares that we may request to be sold, and any attempt to sell shares under this facility, if made, may not be successful or generate sufficient proceeds to meet our capital requirements.
If we are unable to obtain additional funds, we may have to scale back our development of new products, reduce our workforce or license to others products or technologies that we otherwise would seek to commercialize ourselves. The amount of money we may need would depend on many factors, including:
The progress of our research and development programs;
The scope and results of our preclinical studies and clinical trials;
The amount of our legal expenses and any settlement or damages payments associated with litigation; and
The time and costs involved in: obtaining necessary regulatory approvals; filing, prosecuting and enforcing patent claims; scaling up our manufacturing capabilities; and the commercial arrangements we may establish.
We may be unable to maintain compliance with the Nasdaq Marketplace Rules which could cause our common stock to be delisted from the Nasdaq Capital Market. This could result in the lack of a market for our common stock, cause a decrease in the value of an investment in us, and adversely affect our business, financial condition and results of operations.
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Our common stock is currently listed on the Nasdaq Capital Market. To maintain the listing of our common stock on the Nasdaq Capital Market, we are required to meet certain listing requirements, including, among others, either: (i) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors and 10% or more stockholders) of at least $1 million and stockholders’ equity of at least $2.5 million; or (ii) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors and 10% or more stockholders) of at least $1 million and a total market value of listed securities of at least $35 million. As of November 3, 2017, the closing sale price per share of our common stock was $2.11, the total market value of our publicly held shares of our common stock (excluding shares held by our executive officers, directors and 10% or more stockholders) was approximately $22.0 million and the total market value of our listed securities was approximately $26.6 million. There is no assurance that we will continue to meet the minimum closing price requirement and other listing requirements. As of September 30, 2017, we had stockholders’ equity of approximately $37.7 million. Although Nasdaq may provide us with a compliance period in which to regain compliance with the listing requirements, we cannot assure you that we would be able to regain compliance within the period provided by Nasdaq .
In the event that our common stock is delisted from Nasdaq and is not eligible for quotation or listing on another market or exchange, trading of our common stock could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference herein contain forward-looking statements. The forward-looking statements are contained principally in the sections entitled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business” in this prospectus or the documents incorporated herein by reference. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
the success, cost and timing of our product development activities and clinical trials;
our estimates regarding anticipated operating losses, capital requirements and needs for additional funds;
our ability to obtain funding for our operations beyond this offering when needed and to continue our research and development programs;
our plans to develop and commercialize our product candidates;
our ability to attract collaborators with development, regulatory and commercialization expertise;
the safety and efficacy of our product candidates;
the anticipated regulatory pathways for our product candidates;
our ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of our product candidates and commercialize any approved products on our expected timeframes or at all;
the content and timing of submissions to and decisions made by the FDA and other regulatory agencies;
our ability to leverage the experience of our management team;
our ability to attract and keep management and other key personnel;
the capacities and performance of our contract research organizations, medical institutions, contract laboratories and other third parties over whom we have limited control;
the actions of our competitors and success of competing drugs that are or may become available;
our expectations with respect to future growth and investments in our infrastructure, and our ability to effectively manage any such growth;
the size and potential growth of the markets for any of our product candidates, and our ability to capture share in or impact the size of those markets;
the benefits of our product candidates;
market and industry trends;
the outcome of any litigation in which we or any of our officers or directors may be involved;
the effects of government regulation and regulatory developments, and our ability and the ability of the third parties with whom we engage to comply with applicable regulatory requirements;
the accuracy of our estimates regarding future expenses, revenues, capital requirements and needs for additional financing;
our expectations regarding future planned expenditures;
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our expectations regarding our ability to obtain, maintain and adequately maintain sufficient intellectual property protection of any of our products and product candidates;
our expected use of the net proceeds from this offering; and
our ability to operate our business without infringing the intellectual property rights of others.
In some cases, you can identify these statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this prospectus and are subject to risks and uncertainties. We discuss many of these risks in greater detail in the documents incorporated by reference herein, usually under the heading “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
You should carefully read this prospectus, the documents that we incorporate by reference into this prospectus and the documents we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements by these cautionary statements.
Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information, future events or otherwise. For all forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
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We estimate that we will receive net proceeds of approximately $19.3 million (or approximately $22.3 million if the underwriter’s over-allotment option is exercised in full) from the sale of the securities offered by us in this offering, based on the assumedcombined public offering price of $2.11$0.8231 per share (the last reported sale price of ourand accompanying common stock on the Nasdaq Capital Market on November 3, 2017), and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us and excluding the proceeds, if any, from the exercise of the pre-funded warrants issued pursuant to this offering.
A $0.10 increase (decrease) in the assumed public offering price of $2.11 per sharewarrant would increase (decrease)or decrease the expected net proceeds to us from this offering by approximately $0.9$1.7 million, 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 estimated underwriting discounts and commissions and estimated offering expenses payable by us and excluding the proceeds, if any, from the exercise of the pre-funded warrants issued pursuant to this offering.
Similarly, a one1.0 million share increase (decrease)or decrease in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase (decrease)or decrease the net proceeds to us by approximately $2.0$0.8 million, assumingbased on the assumed combined public offering price of $2.11$0.8231 per share remainsand accompanying common warrant remaining the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us and excluding the proceeds, if any, from the exerciseus.
We currently intend to use the net proceeds from this offering for general corporate purposes, including clinical trial expenses, research and development, expenses,including clinical trials, working capital and general and administrative expenses, manufacturing expenses, and potential acquisitions of companies and technologies that complement our business.corporate purposes. See “Risk Factors” for a discussion of certain risks that may affect our intended use of the net proceeds from this offering.
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Assumed combined public offering price per share and accompanying common warrant | $ | 0.8231 | ||||||||||||
Historical net tangible book value per share as of June 30, 2020 | $ | 0.75 | ||||||||||||
Increase in as adjusted net tangible book value per share attributable to this offering | 0.00 | |||||||||||||
As adjusted net tangible book value per share after giving effect to this offering | 0.75 | |||||||||||||
Dilution per share to new investors in this offering | $ | 0.08 |
The following summary describes the material terms of our capital stock. The description of capital stock is qualified by referenceoutstanding and warrants outstanding to our restated certificate of incorporation and our amended and restated bylaws, which are exhibits to this prospectus.
Common Stock
The descriptionpurchase (i) one share of our common stock contained inat an exercise price of $0.07 per share; (ii) 490,683 shares of our Registration Statementcommon stock at an exercise price of $10.36 per share; (iii) 9,005 shares of our common stock at an exercise price of $33.31 per share; (iv) 17,500,000 shares of our common stock at an exercise price of $1.25 per share; and (v) 1,556,420 shares of our common stock at an exercise price of $1.16 per share. As of October 20, 2020, we also had (i) 4,743,537 options issued and outstanding to purchase our common stock at a weighted average exercise price of $4.67 per share and (ii) 204,233 shares of common stock underlying unvested restricted stock units outstanding. As of October 20, 2020, we had 1,997,623 shares remaining available for future grant under the 2020 Omnibus Long-Term Incentive Plan. If the holders of our outstanding stock options and warrants exercise their rights to acquire our common stock, the percentage ownership of our stockholders existing prior to the exercise of such rights will be diluted.
Preferred Stock
Under our restated certificate of incorporation, our board of directors is authorizedout of funds legally available for such dividends. In the event of a liquidation, dissolution or winding up of our company, the holders of our common stock would be entitled to issue additionalshare ratably in all assets remaining after payment of liabilities and the satisfaction of any liquidation preferences granted to the holders of any outstanding shares of preferred stock.
the number of shares constituting each class or series;
voting rights;
have no preemptive rights and terms ofno conversion rights or other subscription rights. There are no redemption includingor sinking fund provisions;
dividend rights and rates;
terms concerningprovisions applicable to our common stock. All the distribution of assets;
conversion or exchange terms;
redemption prices; and
liquidation preferences.
We currently have on file a shelf registration statement that allows us to raise proceeds from the saleoutstanding shares of common stock preferred stock, debt securities and/or warrantsare, and our restated certificate of incorporation authorizes us to issue up to 5,000,000all shares of preferred stock.common stock offered, when issued and paid for, will be validly issued, fully paid and nonassessable. The issuance of preferred stock could adversely affect the voting powerrights, preferences and privileges of holders of our common stock are subject to, and reducemay be adversely affected by, the likelihood that our common stockholders will receive dividend payments and payments upon liquidation. The issuancerights of preferred stock could also decrease the market priceholders of any shares of our common stock, or have terms and conditions that could discourage a takeover or other transaction that might involve a premium price for our shares or that our stockholders might believe to be in their best interests.
preferred stock.
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•prior to the date of the transaction, the board of directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;
•the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding (a) shares owned by persons who are directors and also officers of the corporation and (b) shares issued under employee stock plans under which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
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•any merger or consolidation involving the corporation and the interested stockholder;
•any sale, lease, exchange, mortgage, pledge, transfer pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation;
•subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
•any transaction involving the corporation that has the effect of increasing the proportionate share of its stock owned by the interested stockholder; or
•the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.
•provide for a board comprised of three classes of directors with each class serving a staggered three-year term;
•authorize our board of directors to issue preferred stock from time to time, in one or more classes or series, without stockholder approval;
•require the approval of at least two-thirds of our outstanding voting stock to amend specified provisions of our restated certificate of incorporation;
•require the approval of at least two-thirds of our total number of authorized directors, or two-thirds of our outstanding voting stock, to amend our amended and restated bylaws;
•provide that special meetings of our stockholders may be called only by our Chief Executive Officer, or by our board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors;
•do not include a provision for cumulative voting for directors (under cumulative voting, a minority stockholder holding a sufficient percentage of a class of shares may be able to ensure the election of one or more directors).
In addition, in August 2016, we completed a private placement of our common stock to AnGes MG, Inc., or AnGes, immediately following which AnGes owned approximately 18.6% of our outstanding shares. In connection with the
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private placement, AnGes agreed to vote all of its shares in accordance with the recommendations of our board of directors on any matter brought before our stockholders for a vote, subject to certain limitations. This voting provision may also discourage or prevent attempts by other stockholders to replace members of our board of directors or engage in acquisition activities that our board of directors does not determine to be in the best interests of our stockholders.
Our common stock is listed on the The Nasdaq Capital Market under the symbol “VICL.“BBI.”
Transfer Agent and Registrar
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We are offering 10,000,000(i) 18,223,788 shares of our common stock or pre-funded warrants to purchase shares of our common stock and (ii) common warrants to purchase up to an aggregate of 18,223,788 shares of our common stock. Each share of common stock or pre-funded warrant is being sold together with a common warrant to purchase one share of our common stock. The shares of common stock or pre-funded warrants and accompanying common warrants will be issued separately. We are also registering the shares of common stock issuable from time to time upon exercise of the pre-funded warrants and common warrants offered hereby.
Common Stock
The material terms and provisions of our common stock and each other class of our securities, which qualify or limit our common stock are described under the caption “Description of Capital Stock” in this prospectus.
Pre-Funded Warrants
The following summary of certain terms and provisions of pre-funded warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the pre-funded warrant, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of pre-funded warrant for a complete description of the terms and conditions of the pre-funded warrants.
Duration and Exercise Price. Each pre-funded warrant offered hereby will have an initial exercise price per share equal to $0.01.$0.001. The pre-funded warrants will be immediately exercisable and may be exercised at any time until the pre-funded warrants are exercised in full. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise price.
Exercisability. The pre-funded warrants will be issued separately from the accompanying common warrants and may be transferred separately immediately thereafter.
Cashless Exercise.Exercise. If, at the time a holder exercises its pre-fundedcommon warrants, a registration statement registering the issuance of the shares of common stock underlying the pre-fundedcommon warrants under the Securities Act is not then effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the pre-fundedcommon warrants.
Transferability.Transferability. Subject to applicable laws, a pre-fundedcommon warrant in book entry form may be transferred at the option of the holder through the facilities of the Depository Trust Company and common warrants in physical form may be transferred upon surrender of the pre-fundedcommon warrant to usthe warrant agent together with the appropriate instruments of transfer. Pursuant to a warrant agency agreement between us and American Stock Transfer & Trust Company, LLC, as warrant agent, the common warrants initially will be issued in book-entry form and will be represented by one or more global certificates deposited with The Depository Trust Company (“
Exchange Listing.Listing We. There is no established public trading market for the common warrants, and we do not expect a market to develop. In addition, we do not intend to list the pre-fundedcommon warrants on any securities exchange or nationally recognized trading system. Without an active trading market, the liquidity of the common warrants will be limited.
Right as a Stockholder.Stockholder. Except as otherwise provided in the pre-fundedcommon warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the pre-fundedcommon warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their pre-fundedcommon warrants.
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Number of Shares of Common Stock | Number of Pre-Funded Warrants | Number of Common Warrants | ||||||||||||||||||
Oppenheimer & Co. Inc. | ||||||||||||||||||||
Lake Street Capital Markets, LLC | ||||||||||||||||||||
Total |
A copy
We have beenunderwriters has advised by the underwriterus that it proposes initially to offer the shares of common stock and/or pre-funded warrants directlyand accompanying common warrants to purchase shares of common stock to the public at the public offering price per share or pre-funded warrant set forth on the cover page of this prospectus. Any shares of common stock and/or pre-funded warrants sold by the underwriterprospectus and to securities dealers will be sold at the public offeringa price per share or pre-funded warrant less a selling concession not in excess of $ per share.
The underwriting agreement provides thatshare and accompanying common warrant or $ per pre-funded warrant and accompanying common warrant, based on the underwriter’s obligation to purchase shares ofcombined public offering price per share and accompanying common stock and/warrant or pre-funded warrants we are offering is subjectwarrant and accompanying common warrant, to conditions contained in the underwriting agreement. The underwriter is obligated to purchasebrokers and pay for all ofdealers. After the shares of common stock and/or pre-funded warrants offered by this prospectus if any ofand accompanying common warrants are released for sale to the securities are purchased.
No action has been taken by us orpublic, the underwriter that would permit a publicrepresentative may change the offering ofprice, the common stock and/or the pre-funded warrants in any jurisdiction where action for that purpose is required. None of the shares or pre-funded warrants included in this offering may be offered or sold, directly or indirectly, nor may this prospectus or anyconcession, and other offering material or advertisements in connection with the offer and sales of any of the shares or pre-funded warrants be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons who receive this prospectus are advised to inform themselves about and to observe any restrictions relating to this offering of the common stock and/or the pre-funded warrants and the distribution of this prospectus. This prospectus is neither an offer to sell nor a solicitation of any offer to buy the common stock and/or the pre-funded warrants in any jurisdiction where that would not be permitted or legal.
The underwriter has advised us that it does not intend to confirm sales to any accounts over which it exercises discretionary authority.
Underwriting Discounts, Commissions and Expenses
The following table showsprovides information regarding the public offering price and underwritingamount of the discounts and commissions payableto be paid to the underwriterunderwriters by us, in connection with this offering.
Per Share | Per | Per Common Warrant | Total Per | Total Per | |||||||||||||||||||||||||||||||||||||||
Public offering price | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||||||
Underwriting discounts and commissions | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||||||
Proceeds, before expenses, to us | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||||||
Tail
We have also agreed to a tail fee equal to the cash compensation in this offering if any investor to which the underwriter contacted or introduced us with respect to this offering during the term of its engagement provides us with further capital in a public or private offering or capital raising transaction, with certain exceptions, during the 5-month period following termination of our engagement of the underwriter.
Option to Purchase Additional Shares
We have granted to the underwriter an option, exercisable not later than 30 days after the date of this prospectus, to purchase up to an additional 1,500,000 shares of common stock at the public offering price, less the underwriting discounts and commissions, set forth onwill be approximately $425,000, which includes the cover pagefees and expenses for which we have agreed to
Nasdaq Capital Market Listing
Our stock is currently traded on the Nasdaq Capital Marketunderwriters against certain liabilities, including liabilities under the symbol “VICL.” On November 3, 2017, the closing price ofSecurities Act.
Lock-up Agreements
Our officers and directors have agreed to a 90-day “lock-up” with the underwriterrespect to beshares of our common stock and other of our securities that they beneficially own, including securities that are convertible into shares of common stock and securities that are exchangeable or exercisable for shares of common stock. This means that, subject to certain exceptions, for a lock-up period of 90 days following the date of this prospectus. This means that, during the applicable lock-up period,prospectus, we and such persons may not offer, for sale, contract to sell, sell, distribute, grant any option, right or warrant to purchase, pledge hypothecate or otherwise dispose of directly or indirectly, anythese securities without the prior written consent of Oppenheimer & Co. Inc. Notwithstanding the foregoing, the “lock-up” with respect to our sale of shares of our common stock or any securities convertible into, or exercisable or exchangeable for, shares(a) to Lincoln Park pursuant to the Purchase Agreement, dated February 17, 2020, between us and Lincoln Park, will be limited to a period of our common stock. Certain limited transfers are permitted during the lock-up period if the transferee agrees to these lock-up restrictions. We have also agreed, in the underwriting agreement, to similar lock-up restrictions on the issuance and sale of our securities for 9060 days following the closingdate of this offering, although weprospectus and (b) pursuant to the At Market Issuance Sales Agreement, dated April 14, 2020, between us and Oppenheimer & Co., Inc., will be permittedlimited to issue stock optionsa period of 60 days following the date of this prospectus.
Stabilization, Short Positions and Penalty Bids
The underwriterthe shares is completed. However, the underwriters may engage in syndicate coveringthe following activities in accordance with the rules:
Syndicate covering transactions involve•Penalty bids - if the representative purchases of securitiesshares in the open market afterin a stabilizing transaction or syndicate covering transaction, it may reclaim a selling concession from the distribution has been completedunderwriter and selling group members who sold those shares as part of this offering.
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These syndicate covering transactions, stabilizing transactions and penalty bidsour common stock may have the effect of raising or maintaining the market pricesprice of our securitiescommon stock or preventing or retardingmitigating a decline in the market pricesprice of our securities.common stock. As a result, the price of the shares of our common stock may be higher than the price that might otherwise exist in the open market. The imposition of a penalty bid might also have an effect on the price of the shares if it discourages resales of the shares.
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transactions described above may have on the price of our common stock.the shares. These transactions may be effectedoccur on theThe Nasdaq Capital Market in the over-the-counter market or on any other trading market and, ifotherwise. If such transactions are commenced, they may be discontinued without notice at any time.
In connection with this offering,Electronic Delivery of Prospectus: A prospectus in electronic format may be delivered to potential investors by the underwriter also may engage in passive market making transactions in our common stock in accordance with Regulation M during a period before the commencement of offers or sales of shares of our common stockunderwriters participating in this offering and extending through the completion of the distribution. In general, a passive market maker must display its bid at a price notoffering. The prospectus in excess of the highest independent bid for that security. However, if all independent bids are lowered below the passive market maker’s bid that bid must thenelectronic format will be lowered when specific purchase limits are exceeded. Passive market making may stabilize the market price of the securities at a level above that which might otherwise prevail in the open market and, if commenced, may be discontinued at any time.
Neither we nor the underwriter make any representation or prediction asidentical to the directionpaper version of such prospectus. Other than the prospectus in electronic format, the information on any underwriter’s website and any information contained in any other website maintained by an underwriter is not part of this prospectus or magnitudethe registration statement of any effect that the transactions described above may have on the prices of our securities. In addition, neither we nor the underwriter make any representation that the underwriter will engage in these transactions or that any transactions, once commenced, will not be discontinued without notice.
Indemnification
We have agreed to indemnify the underwriter against certain liabilities, including certain liabilities arising under the Securities Act, or to contribute to payments that the underwriter may be required to make for these liabilities.
Other Relationships
which this prospectus forms a part.
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restrictions will cause the recipient and the Company to be in violation of the Belgian securities laws.
The validityThis document constitutes an “exempt offering document” as defined in and for the purposes of applicable Canadian securities laws. No prospectus has been filed with any securities commission or similar regulatory authority in Canada in connection with the offer and sale of the securities described herein (the “Securities”). No securities commission or similar regulatory authority in Canada has reviewed or in any way passed upon this document or on the merits of the Securities and any representation to the contrary is an offence.
The financial statements of Vical Incorporated at December 31, 2016 and 2015, and for each of the three years in the period ended December 31, 2016, incorporated by reference in this Preliminary Prospectus and Registration Statement have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon incorporated by reference elsewhere herein, and are incorporated by reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We have filed with the SEC a registration statement on Form S-1 under the Securities Act, with respectdeemed to be modified or superseded to the securities being offered by this prospectus. This prospectus does not contain all of the information in the registrationextent that a statement and its exhibits. For further information with respect to us and the securities offered by this prospectus, we refer you to the registration statement and its exhibits. Statements contained in this prospectus as to the contents of any contract or any othersubsequently filed supplement to this prospectus, or document referreddeemed to arebe incorporated by reference into this prospectus, modifies or supersedes such statement. Any statements so modified or superseded shall not necessarily complete, and in each instance, we refer yoube deemed, except as so modified or superseded, to the copyconstitute a part of the contract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by this reference.
You can read our SEC filings, including the registration statement, over the Internet at the SEC’s website at www.sec.gov. prospectus.
the following address:
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. 000-21088):
ourBrickell Biotech, Inc. appearing in Brickell Biotech, Inc.’s Annual Report on Form 10-K(Form 10-K) for the year ended December 31, 2016, which was2019, have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon included therein, and incorporated herein by reference. Such financial statements are, and audited financial statements to be included in subsequently filed documents will be, incorporated herein in reliance upon the reports of Ernst & Young LLP pertaining to such financial statements (to the extent covered by consents filed with the SECSEC) given on March 10, 2017;
our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2017, June 30, 2017 and September 30, 2017, which were filed with the SEC on May 15, 2017, August 8, 2017 and October 24, 2017, respectively;
our Current Reports on Form 8-K, which were filed with the SEC on April 4, 2017, June 1, 2017 and October 2, 2017;
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our definitive proxy statement relating to our 2017 Annual Meeting of Stockholders, which was filed with the SEC on April 7, 2017; and
the description of our common stock contained in the Registration Statement on Form 8-A, which was filed with the SEC on January 8, 1993.
In addition, all documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the termination of the offering (excluding any information furnished rather than filed) shall be deemed to be incorporated by reference into this prospectus.
You may request a free copy of any of the documents incorporated by reference in this prospectus by writing or telephoning us at the following address:
Vical Incorporated
10390 Pacific Center Court
San Diego, California 92121
(858) 646-1100
Attention: Investor Relations
In accordance with Rule 412 of the Securities Act, any statement contained in a document incorporated by reference herein shall be deemed modified or superseded 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.
VICAL INCORPORATED
10,000,000
H.C. Wainwright
November , 2017
The date of this prospectus is , 2020. | ||
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Amount to be paid | |||||||||||
SEC registration fee | $ | 3,273 |
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FINRA filing fee | 5,000 |
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Printing and mailing expenses | 5,000 | ||||||||||
Legal fees and expenses | 300,000 |
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Accounting fees and expenses | 35,000 |
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Miscellaneous | 76,727 |
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Total expenses | $ | 425,000 |
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•for any breach of the director’s duty of loyalty to the corporation or its stockholders;
II-1
•for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;
•for acts related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or
•for any transaction from which the director derived an improper personal benefit.
Our
Set forth below is information regarding securities issued by us since January 1, 2014 that were not registered under
On March 24, 2015, we entered into a license agreement with Astellas Pharma Inc., or Astellas, granting us an exclusive, worldwide license to develop and commercialize VL-2397. In connection with the equity payments contemplated by the license agreement, on March 24, 2015, we entered into a separate stock purchase agreement with Astellas, or the Stock Purchase Agreement. Pursuant to the Stock Purchase Agreement pursuant to which, Lincoln Park purchased, and we issuedsold, (i) an aggregate of 86,121 unregistered950,000 shares of our common stock (the “
On August 1, 2016,change of control transaction. In connection with the enrollment of the first patient in our Cardigan I Study in the U.S., on October 9, 2020, we entered into a stock purchase agreement with AnGes, pursuantissued to which AnGes purchased 1,841,420 unregisteredBodor 480,769 shares of our common stock, at abased on the closing price of $1.04 per share price of $4.2448, or the AnGes Stock Purchase Agreement. The shares of our common stock on October 8, 2020, as required by the Amended and Restated License Agreement. Such issuance was exempt from registration under Section 4(a)(2) of the Securities Act.
Item 16. Exhibits and Financial Statement Schedules.
(a) Exhibits.
Seesecurities, the Exhibit Index attachedundersigned registrant hereby undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, whichregardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
(b) Financial Statement Schedules.
No financialin the registration statement schedules are provided becauseshall 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
Item 17. Undertakings.
The undersigned Registrant hereby undertakestime it was declared effective; and
initial
bona fide offering thereof.II-2
advised that in the opinion of the SEC 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 Registrantregistrant of expenses incurred or paid by a director, officer or controlling person of the Registrantregistrant 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 Registrantregistrant 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 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.
The undersigned Registrant hereby undertakes:
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrantregistrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized in the City of San Diego, California,Boulder, State of Colorado, on the 6th day of November, 2017.
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Robert B. Brown Chief Executive Officer |
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Exhibit Number | Description of Exhibit | ||||
Form of Underwriting Agreement. | |||||
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed with the SEC on September 1, 2020). | |||||
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020). | |||||
Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-8 filed with the SEC on September 10, 2019). | |||||
Form of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-1 filed with the SEC on October 13, 2020). | |||||
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1 filed with the SEC on October 13, 2020). | |||||
Form of Warrant Agency Agreement (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-1 filed with the SEC on October 13, 2020). | |||||
Form of Warrant Agency Agreement between Brickell Biotech, Inc. and American Stock Transfer & Trust Company, LLC in connection with the Company’s June 2020 offering (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-1/A filed with the SEC on June 17, 2020). | |||||
Form of Warrant to Purchase Common Stock issued in connection with the Company’s June 2020 offering (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-1/A filed with the SEC on June 17, 2020). | |||||
Form of Pre-Funded Warrant to Purchase Common Stock issued in connection with the Company’s June 2020 offering (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1/A filed with the SEC on June 8, 2020). | |||||
Opinion of Faegre Drinker Biddle & Reath LLP. | |||||
License, Development and Commercialization Agreement, dated March 31, 2015, including certain amendments, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd. (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Amendment to License, Development and Commercialization Agreement, dated February 24, 2016, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-1/A filed with the SEC on June 8, 2020). | |||||
Amendment No. 2 to License, Development and Commercialization Agreement, dated October 6, 2017, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd., including Right of First Negotiation Agreement, as amended, dated October 6, 2017, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd. (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Clinical Supply Agreement, dated as of July 30, 2019, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd., and First Amendment to Clinical Supply Agreement, dated as of October 18, 2019 (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1/A filed with the SEC on June 8, 2020). | |||||
Letter Agreement for Supply of API, dated as of April 26, 2020, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd. (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1/A filed with the SEC on June 8, 2020). |
Letter Agreement, dated as of September 3, 2020, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd. (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1 filed with the SEC on October 13, 2020). | |||||
Amended and Restated License Agreement, dated February 17, 2020, by and among Brickell Biotech, Inc., Brickell Subsidiary, Inc., Bodor Laboratories, Inc. and Dr. Nicholas S. Bodor (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 18, 2020). | |||||
Settlement Agreement, dated February 17, 2020, by and among Brickell Biotech, Inc., Brickell Subsidiary, Inc., Bodor Laboratories, Inc. and Dr. Nicholas S. Bodor (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on February 18, 2020). | |||||
License Agreement, as amended, dated June 26, 2012, by and between Brickell Biotech, Inc. and the UAB Research Foundation (incorporated by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Second Restated License Agreement, dated November 23, 2015, by and between Orca Pharmaceuticals LLC and New York University, as further assigned by Orca Pharmaceuticals LLC to Brickell Biotech, Inc. (incorporated by reference to Exhibit 10.7 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Asset Purchase Agreement, dated November 23, 2015, by and between Brickell Biotech, Inc., Orca Pharmaceuticals LLC, and Orca Pharmaceuticals Limited (incorporated by reference to Exhibit 10.8 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Asset Purchase Agreement, dated January 30, 2015, by and between Brickell Biotech, Inc. and Panmira Pharmaceuticals, LLC (incorporated by reference to Exhibit 10.9 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Lease, as amended, dated August 4, 2016, by and between Brickell Biotech, Inc. and BMC Properties, LLC (incorporated by reference to Exhibit 10.10 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Employment Agreement, dated November 16, 2018, by and between Brickell Biotech, Inc. and Robert Brown (incorporated by reference to Exhibit 10.11 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Consulting Agreement, dated as of December 18, 2017, by and between Brickell Biotech, Inc. and Michael Carruthers; Amendment No. 1 to Consulting Agreement, dated as of March 1, 2019, by and between Brickell Biotech, Inc. and Michael Carruthers; and Amendment No. 2 to Consulting Agreement, dated as of December 23, 2019, by and between Brickell Biotech, Inc. and Michael Carruthers (incorporated by reference to Exhibit 10.14 to the Company’s Registration Statement on Form S-1/A filed with the SEC on June 8, 2020). | |||||
Second Amended and Restated Employment Agreement, dated November 27, 2018, by and between Brickell Biotech, Inc. and Andrew Sklawer (incorporated by reference to Exhibit 10.12 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
First Amended and Restated Employment Agreement, dated September 1, 2020, by and between Brickell Biotech, Inc. and Deepak Chadha (incorporated by reference to Exhibit 10.17 to the Company’s Registration Statement on Form S-1 filed with the SEC on October 13, 2020). | |||||
Brickell Biotech, Inc. Letter Agreement, dated July 10, 2018, by and between Brickell Biotech, Inc. and Jose Breton (incorporated by reference to Exhibit 10.14 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Employment Agreement, dated July 1, 2019, and Amendment to Employment Agreement, dated August 27, 2019, by and between Brickell Biotech, Inc. and David R. McAvoy (incorporated by reference to Exhibit 10.15 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019). | |||||
Settlement and Termination Agreement, dated November 25, 2019, by and between Brickell Subsidiary, Inc., Brickell Biotech, Inc. and NovaQuest Co-Investment Fund X, L.P. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 25, 2019). | |||||
Securities Purchase Agreement, dated February 17, 2020, by and between Brickell Biotech, Inc. and Lincoln Park Capital Fund, LLC (schedules omitted) (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed with the SEC on February 18, 2020). | |||||
Series A Warrant issued by Brickell Biotech, Inc. to Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-3 filed with the SEC on February 28, 2020). | |||||
Series B Warrant issued by Brickell Biotech, Inc. to Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-3 filed with the SEC on February 28, 2020). | |||||
Purchase Agreement, dated February 17, 2020, by and between Brickell Biotech, Inc. and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.6 to the Company’s Current Report on Form 8-K filed with the SEC on February 18, 2020). | |||||
Registration Rights Agreement, dated February 17, 2020, by and between Brickell Biotech, Inc. and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.7 to the Company’s Current Report on Form 8-K filed with the SEC on February 18, 2020). | |||||
At Market Issuance Sales Agreement, dated April 14, 2020, by and between Brickell Biotech. Inc. and Oppenheimer & Co. Inc. (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 14, 2020). | |||||
Brickell Biotech, Inc. 2020 Omnibus Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 1, 2020). | |||||
Amended and Restated Stock Incentive Plan of Vical Incorporated (incorporated by reference to Exhibit 99.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 1, 2017). | |||||
Amended and Restated 2009 Equity Incentive Plan of Brickell Biotech, Inc. (incorporated by reference to Exhibit 99.2 to the Company’s Registration Statement on Form S-8 filed with the SEC on September 10, 2019). | |||||
List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2019). | |||||
Consent of Ernst & Young LLP. | |||||
Consent of Faegre Drinker Biddle & Reath LLP (included as part of Exhibit 5.1). | |||||
Power of Attorney (included on the signature page to the Company’s Registration Statement on Form S-1 filed with the SEC on October 13, 2020). |