As filed with the Securities and Exchange Commission on February 24, 2020June 8, 2022
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
AYTU BIOSCIENCE,BIOPHARMA, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware | 47-0883144 | |
(State or Other Jurisdiction of Incorporation or Organization) | | (I.R.S. Employer Identification No.) |
373 Inverness Parkway, Suite 206
Englewood, Colorado 80112
(720) 437-6580
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Joshua R. Disbrow
Chief Executive Officer
373 Inverness Parkway, Suite 206
Englewood, Colorado 80112
Telephone: (720) 437-6580
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)
Copies to:
Nolan S. Taylor
Anthony W. Epps
Dorsey & Whitney LLP
111 S. Main Street, Suite 2100
Salt Lake City, Utah 84111
(801) 933-7360
Approximate date of commencement of proposed sale to the public: From time to time after the effective date of this registration statement.
If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ☐
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, please check the following box. ☒
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c)462 (c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer ☐ | Smaller reporting company ☒ |
Accelerated Filer ☐ | Emerging growth company ☐ |
Non-accelerated filer ☒ | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
CALCULATION OF REGISTRATION FEE
| Title of Each Class of Securities to be Registered | Amount to be Registered(1) | Proposed Maximum Offering Price Per Share(2) | Proposed Maximum Aggregate Offering Price | Amount of Registration Fee | ||||||||||||
| Common Stock, issuable upon conversion of Series G Convertible Preferred Stock (3) | 9,805,845 | $ | 0.75 | $ | 7,354,383.75 | $ | 954.60 | |||||||||
| TOTAL | 9,805,845 | |||||||||||||||
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with sectionSection 8(a) of the Securities Act of 1933, or until thethis registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said sectionSection 8(a), may determine.
The information in this prospectus is not complete and may be changed. The selling stockholderWe may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdictionstate where thesuch offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED FEBRUARY 24, 2020JUNE 8, 2022
PROSPECTUS
PROSPECTUS
AYTU BIOSCIENCE, INC.
9,805,845Up to 867,769 Shares of Common Stock Issuable upon Conversion of Series G Convertible Preferred Stock
Warrants
This prospectus relates to the resale of 9,805,845867,769 shares of Common Stock, par value $0.0001 per share (“Common Stock”Stock”) of Aytu BioScience,BioPharma, Inc. (the “Company”“Company”) by Cerecor Inc.Avenue Venture Opportunities Fund, LP and Avenue Venture Opportunities Fund II, LP (the “Selling Stockholder”“Selling Stockholders”). The Common Stock includes 9,805,845 shares of Common Stockis issuable upon the conversionexercise of 9,805,845 shares of Series G Convertible Preferred Stock867,769 warrants (“Series G Preferred Stock”Warrants”) of the Company issued to the Selling StockholderStockholders pursuant to the asset purchaseloan and security agreement dated October 10, 2019,January 26, 2022 (the “Loan Agreement”). The Warrants have an exercise price of $1.21 per share, each subject to adjustment as amended November 1, 2019 (the “Asset Purchase Agreement”).described below. We will receive the proceeds from the exercise of the Warrants. We will not receive any proceeds from the conversion of Series G Preferred Stock or from the sale of any shares of Common Stock by the Selling StockholderStockholders pursuant to this prospectus.
Our registration of the securities covered by this prospectus does not mean that the Selling StockholderStockholders will offer or sell any of the shares of Common Stock. The Selling StockholderStockholders may sell the shares of Common Stock offered by this prospectus from time to time on terms to be determined at the time of sale through ordinary brokerage transactions or through any other means described in this prospectus under the caption “Plan of Distribution.” The shares of Common Stock may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices.
Our Common Stock is tradedlisted on the NASDAQThe Nasdaq Capital Market (“NASDAQ”) under the symbol “AYTU”.“AYTU.” On February 19, 2020,June 7, 2022, the last reported salessale price offor our Common Stock was $0.73$0.59 per share. Each prospectus supplement to this prospectus will indicate if the securities offered thereby will be listed on any securities exchange.
An investmentInvesting in our securities involves risks. SeeYou should carefully review the risks and uncertainties described under the heading “Risk Factors” beginning on page 58 of this prospectus, page 13 of our Annual Report on Form 10-K for the fiscal year ended June 30, 2019, and any updates to those risk factors or new risk factors contained in our subsequent Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC, all of which we incorporate by reference herein.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2020.
TABLE OF CONTENTS
You should rely only on the information provided in this prospectus, as well as the information incorporated by reference into this prospectus and any applicable prospectus supplement. We have not authorized anyone to provide you with different information. We are not making an offer of these securities in any jurisdiction where the offer is not permitted. You should not assume that the information in this prospectus, any applicable prospectus supplement or any related free writing prospectus, and in any documents incorporated by reference is accurate as of anyherein or therein before investing in our securities.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date other than the date of the applicable document. Since the respective dates of this prospectus and the documents incorporated by reference into this prospectus, our business, financial condition, resultsis 2022
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You should rely only on the information contained in this prospectus or in any related free writing prospectus filed by us with the Securities and Exchange Commission (“SEC”SEC”). We and the Selling StockholderStockholders have not authorized anyone to provide you with any information or to make any representation not contained in this prospectus. We and the Selling StockholderStockholders do not take any responsibility for, and can provide no assurance as to the reliability of, any information that others may provide to you. This prospectus is not an offer to sell or an offer to buy securities in any jurisdiction where offers and sales are not permitted. The information in this prospectus is accurate only as of its date, regardless of the time of delivery of this prospectus or any sale of securities. You should also read and consider the information in the documents to which we have referred you under the caption “Where You Can Find More Information” in the prospectus.
Neither we nor the Selling StockholderStockholders have done anything that would permit a public offering of the securities or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities and the distribution of this prospectus outside of the United States.
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 section titled “Where You Can Find Additional Information.”
We urge you to read carefully this prospectus, as supplemented and amended, before deciding whether to invest in any of the Common Stock being offered.
Unless the context indicates otherwise, as used in this prospectus, the terms “Aytu,” “we,” “us,” “our,” and “our business” refer to Aytu BioScience,BioPharma, Inc. and its subsidiary.subsidiaries.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We own, license,This prospectus, and the documents incorporated by reference herein, contain certain “forward-looking statements” within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995, and are based on management’s current expectations. These forward-looking statements can be identified by the use of forward-looking terminology, including, but not limited to, “believes,” “may,” “will,” “would,” “should,” “expect,” “anticipate,” “seek,” “see,” “confidence,” “trends,” “intend,” “estimate,” “on track,” “are positioned to,” “on course,” “opportunity,” “continue,” “project,” “guidance,” “target,” “forecast,” “anticipated,” “plan,” “potential” and the negative of these terms or comparable terms.
Various factors could adversely affect our operations, business or financial results in the future and cause our actual results to differ materially from those contained in the forward-looking statements, including those factors discussed under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” or otherwise have rightsdiscussed in our Annual Report on Form 10-K for the fiscal year ended June 30, 2021, our Quarterly Reports on Form 10-Q for the quarterly periods ended September 30, 2021, December 31, 2021, and March 31, 2022 and in our other filings made from time to various U.S. federal trademark registrations and applications, and unregistered trademarks and service marks, including Natesto, Poly-Vi-Flor, Tri-Vi-Flor, Karbinal, Tuzistra XR, AcipHex Sprinkle, ZolpiMist and MiOXSYS. All other trade names, trademarks and service marks appearing in this prospectus are the property of their respective owners. We have assumed that the reader understands that all such terms are source-indicating. Accordingly, such terms, when first mentioned in this prospectus, appeartime with the trade name, trademark or service mark notice and then throughoutSEC after the remainderdate of this prospectus without trade name, trademarkprospectus.
For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please see the documents that we have filed with the SEC, including our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents and reports filed from time to time with the SEC.
All subsequent forward-looking statements attributable to us or service mark notices for convenience only and should not be construed as being used in a descriptive or generic sense.
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This prospectus summary highlights selected information contained in this prospectus and does not contain all of the information that is important to you. This prospectus summary isany person acting on our behalf are expressly qualified in itstheir entirety by the more detailed information included incautionary statements contained or incorporated by reference into this prospectus. Before making your investment decision with respect to our Common Stock, you should carefully read this entire prospectus, any applicable prospectus supplement and the documents referred to in “Where You Can Find More Information”this section. We are not under any obligation to, and “Documents Incorporated by Reference.”expressly disclaim any obligation to, update or alter any forward-looking statements whether as a result of such changes, new information, subsequent events or otherwise.
The Company2
Overview
We are a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs. We have multiple approved products on the market, and we seek to build a portfolio ofcommercializing novel therapeutics that serve large medical needs, across a rangeand consumer healthcare products and developing therapeutics for rare pediatric-onset or difficult-to-treat diseases. We operate through two business segments: the BioPharma segment, consisting of conditions,five core brands promoted through our in-houseinternal commercial team. Our commercial infrastructureteam sold through third party wholesalers, and the Consumer Health segment, which consists primarilyapproximately twenty over-the-counter medicines and specialized dietary supplements sold directly to consumers. We develop and manufacture our attention deficit hyperactivity disorder (“ADHD”) products at our manufacturing facility and use third party manufacturers for our other prescription and consumer health products. We also have two product candidates in development, AR101 (enzastaurin) for the treatment of a pharmaceutical sales force calling on physicians throughoutvascular Ehlers-Danlos Syndrome (“VEDS”) and Healight (endotracheal ultraviolet light catheter) for the US. We focustreatment of severe, difficult-to-treat respiratory infections.
Recent Developments
Commercial Product Update
On March 23, 2022, our commercial efforts on serving large therapeutic areas and offer products with distinct patient benefits.
We acquired exclusive U.S. rights to Natesto® (testosterone) nasal gel, a novel formulation of testosterone delivered via a discreet, easy-to-use nasal gel, and we launched Natestonewly issued US patent No. 11,166,947 for Cotempla XR-ODT was listed in the U.S. with our direct sales force in 2016. Natesto is approved by the U.S. Food and Drug Administration or FDA,(the “FDA”) publication "Approved Drug Products with Therapeutic Equivalence Evaluations", commonly known as the "Orange Book." The Cotempla XR-ODT patent covers methods of use for the effective pediatric dosing of methylphenidate for the treatment of hypogonadism (low testosterone)attention deficit hyperactivity disorder. The Orange Book listing extends the exclusivity period for Cotempla XR-ODT to 2038. Pursuant to the non-exclusive license agreement between Neos Therapeutics, Inc. (“Neos”) and Teva Pharmaceuticals USA, Inc. (“Teva”) entered into on December 21, 2018, Teva has the right to manufacture and market its generic version of Cotempla XR-ODT under its Abbreviated New Drug Application (“ANDA”) beginning on July 1, 2026, or earlier under certain circumstances. See Note 18 – License Agreements in menthe accompanying unaudited consolidated financial statements for further information.
As part of our realization of post-acquisition synergies and product prioritization, we have implemented a portfolio rationalization plan whereby we will discontinue or divest five non-core products: Cefaclor Oral Suspension, Flexichamber, Tussionex, Tuzistra XR, and Zolpimist. These products, collectively, contributed $1.7 million in net revenue and $0.6 million in gross loss during the nine months ended March 31, 2022.
Development Portfolio Updates
AR101 (enzastaurin)
On December 7, 2021, we were notified by the U.S. Food & Drug Administration (“FDA”) that AR101/Enzastaurin received Orphan Drug designation for the treatment of Ehlers-Danlos Syndrome. The treatment of vascular VEDS is captured within this designation. The FDA grants Orphan Drug designation status to drugs and biologics that are intended for the only testosterone replacement therapy,safe and effective treatment, diagnosis or TRT, delivered viaprevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug designation affords Aytu certain financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.
On December 13, 2021, we announced that the FDA has cleared the Investigational New Drug application for AR101/Enzastaurin in VEDS to enable the initiation of the AR101/Enzastaurin PREVEnt Trial in VEDS. We are in discussions with the FDA relating to clinical study design, inclusive of refinement of a nasal gel. Natesto offers multiple advantages over currently available TRTsprimary efficacy endpoint and competesexpect to begin the trial in mid-calendar year 2022.
On February 24, 2022, the European Commission granted orphan designation to AR101 for the treatment of Ehlers-Danlos Syndrome. Orphan designation in the EU is granted by the European Commission based on a positive opinion issued by the EMA COMP. To qualify, an investigational medicine must be intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU, and there must be sufficient non-clinical or clinical data to suggest the investigational medicine may produce clinically relevant outcomes. EMA orphan designation provides companies with certain benefits and incentives, including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized
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marketing authorization procedure valid in all EU member states, reduced regulatory fees and 10 years of market exclusivity.
On April 19, 2022, we were notified by the FDA that AR101 received Fast Track designation. Fast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. Fast Track addresses a broad range of serious conditions, and the request can be initiated by a pharmaceutical company at any time during the development process. FDA reviews the request and decides based on whether or not the drug fills an unmet medical need in a $1.7 billion market accounting for over 6.9 million prescriptions annually. Importantly, as Natestoserious condition. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the sponsor is delivered viaencouraged throughout the nasal mucosaentire drug development and notreview process.
Healight
In April 2022, our preclinical pilot study showed positive results that administration of our Healight ultraviolet light A (“UV-A”) endotracheal catheter delayed the skin, there is no risktime to development of testosterone transference to others,ventilator-associated pneumonia (“VAP”) in a known potential side effectnovel porcine model. VAP has a reported mortality rate approaching 50% in some patient populations, making it one of the most difficult-to-treat and black box warningdeadly infections affecting hospitalized patients. Approximately 86% of nosocomial pneumonias are associated with all other topically applied TRTs, includingmechanical ventilation and result in VAP. Between 250,000 and 300,000 VAP cases per year occur in the market leader AndroGel®.
In June 2018 we acquired an exclusive U.S. and Canadian license to ZolpiMist™. ZolpiMistUnited States alone, which is an incidence rate of 5 to 10 cases per 1,000 hospital admissions. VAP afflicts up to 15% of mechanically ventilated patients in intensive care units.
Class-Action Securities Litigation
A putative class action was filed on February 9, 2022 in the Delaware Chancery Court was brought by Rafal Aponowicz derivatively on behalf of all Aytu stockholders, challenging the grant in 2021 of certain stock option awards to directors and officers. The stockholder contends those awards were in amounts exceeding the shares available under the Company’s 2015 equity incentive plan and that the directors therefore breached their fiduciary duties and breached a purported contract between them and stockholders. The Complaint seeks rescission of the awards, unspecified damages to stockholders as a result of the awards, and attorneys’ fees. The Company does not believe there are any damages attributable to the awards and intends to file a motion to dismiss.
Commercial Prescription Products
Our prescription ADHD portfolio (the “ADHD Portfolio”), acquired in March 2021 through our merger with Neos, includes branded products marketed in the United States using our internal commercial organization.
These commercial ADHD products are extended-release (“XR”) medications formulated in patient-friendly, orally disintegrating tablet (“ODT”) or oral suspension dosage forms that utilize our microparticle modified-release drug delivery technology platform. Neos received approval from the FDA for three ADHD products and were subsequently launched as displayed below.
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Branded Product | Approved Indication | FDA Approval Date | Commercial Launch Date | ||||
Adzenys XR‑ODT (amphetamine) | | Treatment of ADHD in patients 6 years and older | | January 2016 | | May 2016 | |
Cotempla XR‑ODT (methylphenidate) | | Treatment of ADHD in patients 6 to 17 years old | | June 2017 | | September 2017 | |
Products containing amphetamine or methylphenidate are the most commonly prescribed medications in the United States for the treatment of ADHD. Adzenys XR-ODT and Cotempla XR-ODT are the first and only FDA-approved prescription product that isamphetamine and methylphenidate extended-release, orally disintegrating tablets, respectively, and they are indicated for the short-term treatment of insomniaADHD.
Our core legacy prescription pediatric portfolio includes Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions and isPoly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based multi-vitamin product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency (Karbinal ER, Poly-Vi-Flor and Tri-Vi-Flor are
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collectively the only oral spray formulation of zolpidem tartrate - the most widely prescribed prescription sleep aid in the U.S. ZolpiMist is commercially available and competes in the non-benzodiazepine prescription sleep aid category, a $1.8 billion prescription drug category with over 43 million prescriptions written annually. Thirty million prescriptions of zolpidem tartrate (Ambien®, Ambien® CR, Intermezzo®, Edluar®, ZolpiMist™, and generic forms of immediate-release, controlled release, and orally dissolving tablet formulations) are written each year in the U.S., representing almost 70% of the non-benzodiazepine sleep aid category. Approximately 2.5 million prescriptions are written for novel formulations of zolpidem tartrate products (controlled release and sublingual tablets). We intend to integrate ZolpiMist into our sales force’s promotional efforts as an adjunct product to Natesto as there is substantial overlap of physician prescribers among our primary care physician targets.
In November 2018 we acquired an exclusive commercial license from Tris Pharma to market Tuzistra® XR in the U.S. Tuzistra XR is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Tuzistra XR is a patented combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged 18 years and older. Tuzistra XR is protected by two Orange Book-listed patents extending to 2031 and multiple pending patents. According to MediMedia, the US cough cold prescription market is worth in excess of $3 billion at current brand pricing, with 30-35 million annual prescriptions. This market is dominated by short-acting treatments, which require dosing 4-6 times a day. Tuzistra XR was developed using Tris Pharma’s liquid sustained release technology, LiquiXR®, which allows for extended drug delivery throughout a 12-hour dosing period.
In November 2019 we acquired a portfolio of six commercial assets from Cerecor Inc. (the “Commercial“Pediatric Portfolio”). The Commercial Portfolio includes prescriptionThese products competing inserve established pediatric markets exceeding $8 billion in annual U.S. sales. The portfolio consists of six established, commercialized pediatric primary care products including: Karbinal® ER, Poly-Vi-Flor®, Tri-Vi-Flor™, AcipHex® Sprinkle™, Cefaclor for Oral Suspension, and Flexichamber™.
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Each product hasoffer distinct clinical features and patient-friendly benefitspatient benefits.
In 2020, to facilitate improved patient access to our ADHD products, Neos deployed a Neos-sponsored patient support program, called Neos RxConnect. This program operates through a network of approximately 1,000 pharmacies. Following the Neos merger we rebranded the program as Aytu RxConnect™, and we integrated the Pediatric Portfolio into the program during the second half of calendar 2021. With this integration of all core brands into RxConnect, our patients and their health care providers are indicatedbenefiting from this state-of-the-art patient support program. Aytu RxConnect program offers affordable and predictable copays to treat common pediatricall commercially insured patients, regardless of their individual insurance plan and seeks to significantly reduce the challenges and frustrations that health care professionals and their office staff can face when prescribing branded medications, including our medications, for their patients.
Consumer Health
The Consumer Health segment is dedicated to being a leader in developing and commercializing safe and effective non-prescription (also known as “over the counter” or “OTC”) medicines, personal care products, and dietary supplements to improve men’s and women’s health and vitality. We focus on five core product categories including diabetes management (with a concentration on neuropathy), pain management, digestive health, sexual and urological health and general wellness for men and women. All products are intended to be used by consumers on a regular basis, and as such, we offer a monthly subscription program to allow for ongoing use and to simplify product ordering and use by patients. We acquired our consumer health division, previously known as Innovus Pharmaceuticals, Inc., in February 2020.
The division currently sells directly to consumers in both the United States and Canada through its proprietary Beyond Human Sales & Marketing platform which focuses on direct mail and newspaper advertisements, allowing consumers to purchase directly through call centers with shipment directly to their homes. We currently issue over 17 million pieces of mail annually across the United States and Canada. Additionally, products are marketed on e-commerce platforms including the division’s branded website and the Amazon.com platform. Our consumer health marketing strategies focus on search engine optimization, search marketing, and affiliate marketing. The division also sells to a small number of domestic and international distributors on both an exclusive and non-exclusive basis.
The overall strategy of Aytu Consumer Health focuses on two primary care conditions.
objectives:
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Development Portfolio
AR101
On April 12, 2021, we acquired substantially all the assets of Rumpus Therapeutics, LLC through an asset purchase agreement with Rumpus VEDS, LLC, Rumpus Therapeutics, LLC, Rumpus Vascular, LLC (together with Rumpus VEDS, LLC and Rumpus Therapeutics LLC, “Rumpus”). Upon closing the transaction, we hired Rumpus’ executive officers, Christopher Brooke and Nathaniel Massari, as employees. Pursuant to the Rumpus transaction, we acquired certain rights and other assets, including key commercial licenses, including a global license to enzastaurin (which we now refer to as AR101) for rare, inherited connective tissue disorders specifically inclusive of VEDS.
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AR101 is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K and AKT pathways. AR101 has been studied in more than 3,300 patients across a range of solid and hematological tumor types in trials previously conducted by Eli Lilly & Company. Dr. Hal Dietz developed the first preclinical model that mimics the human condition and recapitulates VEDS, and this model serves as the basis for the plausible clinical benefit and rationale for conducting a clinical trial with AR101 in VEDS. This novel knock-in model has the same genetic mutation most prevalent in VEDS patients and is representative of the human condition in both the timing and location of vascular events. The model has generated identical structural histology and mechanical characteristics, and unbiased findings demonstrated that vascular structure alone does not lead to vascular events. Objective comparative transcriptional profiling by high-throughput RNA sequencing of the aorta displayed a molecular signature for excessive PKC/ERK cell signaling that is the purported driver of disease. PKC inhibitors proved efficacious in multiple pre-clinical and murine (mice) models and indeed prevented death due to vascular rupture.
Through our transaction with Rumpus, we have secured exclusive global rights to enzastaurin/AR101 from Denovo in the fields of rare genetic pediatric onset or congenital disorders outside of oncology. AR101 is protected by a suite of pending patents being pursued in major markets globally which have been licensed from The Johns Hopkins University (“Johns Hopkins”) and have an earliest priority date of March 2017. In December 2021, the FDA granted an Orphan Drug designation to AR101 for the treatment of VEDS, allowing for seven years' marketing exclusivity in the United States. The FDA has cleared the IND application for AR101, enabling us to proceed with initiating a pivotal clinical trial for AR101. We expect to advance AR101 to a pivotal study by early-calendar year 2023.
Healight™
Our clinical-stage medical device asset, an ultraviolet-A (UV-A) light endotracheal catheter we refer to as Healight™, is being studied as a potential treatment for mechanically ventilated patients suffering from severe respiratory infections, including the infection caused by SARS-CoV-2, the virus implicated in COVID-19. In April 2020 we licensed global rights to the Healight technology platform from Cedars-Sinai Medical Center (“Cedars-Sinai”). The research team at the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai has been developing the patent-pending Healight platform since 2016 and has produced a growing body of scientific evidence demonstrating pre-clinical safety and effectiveness of the technology as a potential antiviral and antibacterial treatment. The Healight technology employs proprietary methods of administering intermittent UV-A light via a novel endotracheal medical device that, when implemented clinically, is inserted through the patient’s endotracheal tube and illuminated intermittently over a period of multiple days. Pre-clinical findings indicate the technology's effects in eradicating a wide range of viruses and bacteria, activating a key cell signaling protein, and reducing cytokine levels responsible, in part, for the ‘cytokine storm’ associated with SARS-CoV-2 infections. Those data, along with recently published clinical data from a five patient study studying SARS-CoV-2, have been the basis of discussions with regulatory bodies as we consider an efficient path to enable human use for the potential treatment of coronavirus in intubated patients in the intensive care unit. We are nearing the initiation of a clinical study with Healight whereby a leading hospital in Barcelona, Spain will study 40 SARS-CoV-2 patients who have been intubated and are on mechanical ventilation. The study will be randomized one-to-one with patients in the Healight active treatment arm receiving a twenty-minute administration of UV-A light for five consecutive days compared to patients receiving a placebo/non-operating catheter device. This study will evaluate the difference in SARS-CoV-2 viral load in endotracheal tube aspirates between the active treatment arm and sham arm. Secondary endpoints include various safety measures, improvement in clinical severity scores, SARS-CoV-2 genotyping, and various exploratory biomarkers.
Beyond the initial pursuit of a coronavirus indication, additional data suggest broader clinical applications for the technology across a range of viral and bacterial pathogens. This includes bacteria implicated in ventilator associated pneumonia (“VAP”). A randomized, controlled, placebo-controlled study is currently being planned to further evaluate Healight in SARS-CoV-2, and additional clinical applications (including VAP) are being considered. We received the first issued patent protecting Healight™ which covers methods of treating a patient for an infectious condition inside the patient's body through the insertion of a UV-light-emitting delivery tube inside a respiratory cavity of the patient at specific UV-A light wavelengths. The term of this patent extends to August of 2040.
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Our Strategy
Our goal is to become a leading pharmaceutical company that improves the lives of patients and healthcare consumers. We will do this by employing a focused approach of in-licensing, acquiring, developing and commercializing novel prescription therapeutics and consumer health products. Our primary focus is on commercializing innovative prescription products that address prevalent conditions frequently developed in childhood, including ADHD. We also commercialize consumer healthcare products through efficient direct-to-consumer and e-commerce platforms. Importantly, we are also focused on developing a late-stage pipeline of novel, promising therapeutics that address unmet medical needs, with a focus on pediatric-onset rare diseases. Our lead product candidate is a pivotal study-ready therapeutic that, if proven safe and effective and ultimately approved, would be the first and only approved treatment for VEDS.
Our strategic priorities are to continue to increase revenues from our prescription and consumer health portfolios, advance our late-stage product pipeline, expand our patient access programs for our prescription products and grow our commercial portfolio through additional in-licensing or acquisition. Specifically, we intend to:
| ● | continue to grow our commercial branded, revenue-generating products, by increasing product sales and improving patient access. Our primary commercial objective is to drive revenue growth of our ADHD and pediatric brands, with a focus on Adzenys XR-ODT, Cotempla XR-ODT, Poly-Vi-Flor, and | |
| our products; |
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| healthcare consumers and drive revenue growth; |
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On February 14, 2020, we entered into the consumer healthcare market through the consummationWe believe our history of the mergeracquiring companies and in-licensing and acquiring products and pipeline assets, along with Innovus Pharmaceuticals, Inc. (“Innovus”). Innovus Pharmaceuticals, Inc.,our success in building out commercial teams and executing product launch and growth strategies, is a specialty pharmaceutical company commercializing, licensingdistinct competitive advantage. Our transactional adeptness and developing safeexecution orientation enable us to continue to seek growth opportunities through both organic growth and effectiveopportunistic in-licensing or strategic acquisitions. Further, our commercial infrastructure and distribution capability is scalable and lends itself to additional on-market assets and future product candidates that fit within our core therapeutic focus. As such, in the near term, we may seek to leverage our commercial model and infrastructure by expanding our commercial portfolio with external product opportunities as we have done since our inception. Near to longer term, we believe our prescription and consumer health products. Through this combined entity, Aytu expands into the $40 billion consumer healthcare market with a portfolio of over thirty-five consumer products competingbusinesses will provide resources to invest in large therapeutic categories including diabetes, men's health, sexual wellness and respiratory health.develop our pediatric and rare disease asset pipeline.
In the future we will look to acquire additional commercial-stage or near-market products, including existing products we believe can offer distinct commercial advantages. Our management team’s prior experience has involved identifying primarily commercial-stage assets that can be launched or re-launched to increase value, with a focused commercial infrastructure specializing in novel, niche products.
Our management team has extensive experience across a wide range of business development activities and have in-licensed or acquired products from large, mid-sized, and small enterprises in the United States and abroad. Through an assertive product and business development approach, we expect that we will build a substantial portfolio of complementary urology products.
Corporate Information
We were incorporated as Rosewind Corporation on August 9, 2002 in the State of Colorado.
Vyrix Pharmaceuticals, Inc., or Vyrix, was incorporated under the laws of the State of Delaware on November 18, 2013 and was wholly owned by Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), or Ampio, immediately prior to the completion of the Merger (defined below). Vyrix was previously a carve-out of the sexual dysfunction therapeutics business, including the late-stage men’s health product candidates, Zertane and Zertane-ED, from Ampio, that carve-out was announced in December 2013. Luoxis Diagnostics, Inc., or Luoxis, was incorporated under the laws of the State of Delaware on January 24, 2013 and was majority owned by Ampio immediately prior to the completion of the Merger. Luoxis was initially focused on developing and advancing the RedoxSYS System. The MiOXSYS System was developed following the completed development of the RedoxSYS System.
On March 20, 2015, Rosewind formed Rosewind Merger Sub V, Inc. and Rosewind Merger Sub L, Inc., each a wholly-owned subsidiary formed for the purpose of the Merger, and on April 16, 2015, Rosewind Merger Sub V, Inc. merged with and into Vyrix and Rosewind Merger Sub L, Inc. merged with and into Luoxis, and Vyrix and Luoxis became subsidiaries of Rosewind. Immediately thereafter, Vyrix and Luoxis merged with and into Rosewind with Rosewind as the surviving corporation (herein referred to as the Merger). Concurrent with the closing of the Merger, Rosewind abandoned its pre-merger business plans, and we now solely pursue the specialty healthcare market, focusing on urological related conditions, including the business of Vyrix and Luoxis. When we discuss our business in this prospectus, we include the pre-Merger business of Luoxis and Vyrix.
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On June 8, 2015, we (i) reincorporated as a domestic Delaware corporation under Delaware General Corporate Law and changed our name from Rosewind Corporation to Aytu BioScience, Inc., and (ii) effected a reverse stock split in which each Common Stock holder received one share of Common Stock for each 12.174 shares outstanding. At our annual meeting of stockholders held on May 24, 2016, our stockholders approved (1) an amendment to our Certificate of Incorporation to reduce the number of authorized shares of Common Stock from 300.0 million to 100.0 million, which amendment was effective on June 1, 2016, and (2) an amendment to our Certificate of Incorporation to affect a reverse stock split at a ratio of 1-for-12 which became effective on June 30, 2016. At our special meeting of stockholders held on July 26, 2017, our stockholders approved an amendment to our Certificate of Incorporation to affect a reverse stock split at a ratio of 1-for-20 which became effective on August 25, 2017. In addition, at our annual meeting of stockholders held on June 27, 2018, our stockholders approved an amendment to our Certificate of Incorporation to affect a reverse stock split at a ratio of up to 1-for-20, which reverse stock split became effective at a ratio of 1-for-20 on August 10, 2018. All share and per share amounts in this prospectus have been adjusted to reflect the effect of these four reverse stock splits.
Our principal executive offices are located at 373 Inverness Parkway, Suite 206, Englewood, Colorado 80112, and our phone number is (720) 437-6580. Our corporate website address is http://www.aytubio.com. The information
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contained on, connected to or that can be accessed via our website is not part of this prospectus. We have included our website address in this prospectus as an inactive textual reference only and not as an active hyperlink.
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The Offering
We are registering the resale of 9,805,845 shares of Common Stock issuable upon the conversion of 9,805,845 shares of Series G Preferred Stock issued pursuant to the Purchase Agreement.
Unless otherwise indicated, all information in this prospectus excludes as of February 14, 2020:
An investmentInvesting in our securities involves risks and uncertainties. Youa risk of loss. Before investing in our securities, you should carefully consider carefully the risksrisk factors described below, those beginning on page 13 ofunder “Risk Factors” in our Annual Report on Form 10-K filed with the SEC for the fiscalmost recent year, ended June 30, 2019,in any applicable prospectus supplement and any updates to those risk factors or new risk factors contained in our subsequent Annual Reports on Form 10-K,filings with the SEC, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filedtogether with the SEC, all of which we incorporate by reference herein, as well as the other information included in this prospectus and any applicable prospectus supplement before making an investment decision. Any of the risk factors could significantly and negatively affect our business, financial condition, results of operations, cash flows, and prospects and the trading price of our securities.
Our Amendedother information incorporated by reference herein and Restated Bylaws provides thattherein. These risks are not the Court of Chancery of the State of Delaware is the exclusive forum for certain litigation that may be initiated by our stockholders, including claims under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our Amended and Restated Bylaws provides that the Court of Chancery of the State of Delaware shall, to the fullest extent permitted by law, be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim for breach of a fiduciary duty owed by any of our directors, officers, employees or agentsonly ones facing us. Additional risks not currently known to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporationthat we currently deem immaterial also may impair or our bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine. The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, employees or agents, which may discourage such lawsuits against us and our directors, officers, employees and agents. Stockholders who do bring a claim in the Court of Chancery could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near the State of Delaware. The Court of Chancery may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments or results may be more favorable to us than to our stockholders. Alternatively, if a court were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affectharm our business and financial condition. Notwithstanding the foregoing, the exclusive provision shall not precluderesults. Statements in or contract the scopeportions of exclusive federal or concurrent jurisdiction for actions brought under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended, or the respective rules and regulations promulgated thereunder.
This prospectus includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts containeda future document incorporated by reference in this prospectus, including, statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as “may,” “will,” “should,” “forecast,” “could,” “expect,” “suggest,” “believe,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology.
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including without limitation, the risks describedthose relating to risk factors, may update and supersede statements in “Risk Factors” inand portions of this prospectus andor such incorporated documents. Please also refer to the documents incorporated by reference herein. These risks are not exhaustive. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, 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. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We assume no obligation to update or supplement forward-looking statements, except as may be required under applicable law.section entitled “Special Note Regarding Forward-Looking Statements.”
All of the shares of Common Stock offered by the Selling StockholderStockholders pursuant to this prospectus will be sold by the Selling StockholderStockholders for its own account. We will not receive any of the proceeds from these sales.
We will receive up to an aggregate of approximately $1.05 million from the exercise of the Warrants, assuming the exercise in full of all of the Warrants for cash. We expect to use the net proceeds from the exercise of the Warrants for general corporate purposes.
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DESCRIPTION OF SECURITIESTRANSACTION
The following summaryOn January 26, 2022, we entered into the Loan Agreement. Pursuant to the Loan Agreement, the Avenue Capital Lenders (i) provided a term loan (the “Avenue Capital Loan”) in the principal amount of $15 million, at an interest rate of the materialgreater of prime and 3.25%, plus 7.4%, with a three-year term, consisting of 18 monthly payments of interest only followed by equal monthly payments of principal and accrued interest (with interest-only period being extended up to 36 months contingent upon the Obligors achieving certain milestones) and (ii) permitted the Avenue Capital Loan proceeds to be used towards the full repayment of the Obligors’ obligations (the “Deerfield Debt Obligations”) under that certain Facility Agreement, dated as of May 11, 2016 and as thereafter amended (the “Deerfield Facility Agreement”), by and among the Aytu Obligors, Aytu Consumer Health, Inc., the Neos Obligors and Deerfield Private Design Fund III, L.P. and Deerfield Partners, L.P., as the lenders thereunder. In connection with entering into the Avenue Capital Agreement (i) the Obligors granted a security interest in substantially all of their assets in favor of the Avenue Capital Agent on behalf of itself and the Avenue Capital Lenders in support of the repayment of the Avenue Capital Loan and related obligations, (ii) Avenue Capital Agent and Avenue Capital Lenders consent to the first priority liens granted by the Neos Obligors in favor of Eclipse Lender (as defined below) in support of the repayment of the Eclipse Loan (defined below) and (iii) the Deerfield Debt Obligations have been repaid and performed in full (other than contingent indemnification obligations that expressly survive the termination thereof).
As consideration for entering into the Avenue Capital Agreement, Aytu issued the Warrants to the Selling Stockholder exercisable for $1,050,000 shares of our Common Stock at per share exercise price equal to $1.21. Under the terms of our securities isthe warrants, the Selling Stockholders may not intendedexercise the Warrants to bethe extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to beneficially own a complete summarynumber of the rights and preferences of such securities. We urge you to read our certificate of incorporation in its entirety for a complete description of the rights and preferences of our securities.
General
We are authorized to issue up to 100,000,000 shares of Common Stock $0.0001which would exceed 19.99% of our then outstanding Common Stock following such exercise, excluding for purposes of such determination shares of Common Stock issuable upon exercise of the Warrants which have not been exercised. The Warrants were immediately exercisable and expire on January 31, 2027. The Warrants were issued in reliance upon the exemption from the registration requirements in Section 4(a)(2) of the Securities Act of 1933, as amended.
In connection with the issuance of the Warrants, we entered into a Registration Rights Agreement dated January 26, 2022 providing for the registration of shares of our Common Stock issuable upon conversion of the Warrants issued to the Avenue Capital Lenders. The Registration Rights Agreement provides that the Company will use its best efforts to cause a registration statement to be declared effective under the Securities Act of 1933, as amended (the “Securities Act”) within 243 days of the date of the Registration Rights Agreement (or, in the event of a full review by the Securities and Exchange Commission, within 273 days) and shall and shall use its best efforts to keep such registration statement continuously effective under the Securities Act until the date that all registrable securities covered by such registration statement have been sold.
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General
This prospectus describes the general terms of our capital stock. For a more detailed description of our capital stock, you should read the applicable provisions of the Delaware General Corporation Law, or DGCL, and our charter and bylaws.
Our certificate of incorporation provides that we may issue up to 200,000,000 shares of common stock, par value $0.0001 per share, and up to 50,000,000 shares of preferred stock, $0.0001 par value $0.0001 per share.
Excludingshare, and permits our board of directors, without stockholder approval, to amend the Series G Preferred Stock, ascharter to increase or decrease the aggregate number of February 14, 2020, a totalshares of 26,828,490stock or the number of shares of stock of any class or series that we have authority to issue. As of June 3, 2022, there were 38,574,875 shares of our Common Stock were issued and outstanding, 400,000 shares of our Series D Preferred Stock were issued and outstanding and 10,000 shares of our Series F Preferred Stock and 1,997,902 Series H Preferred Stock were issued and outstanding. There were no shares of our Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock,preferred stock outstanding. Under Delaware law, stockholders generally are not personally liable for our debts or Series E Preferred Stock issued or outstanding.obligations solely as a result of their status as stockholders.
Common Stock
The holdersHolders of our Common Stock are entitledgenerally have no preference, conversion, exchange, sinking fund, redemption or appraisal rights and have no preemptive rights to one vote per share. Our Certificatesubscribe for any of Incorporation does not expressly prohibit cumulative voting. The holdersour securities. Holders of our Common Stock are entitled to receive ratably such dividends if any, as may be declaredwhen authorized by the Boardour board of Directorsdirectors out of assets legally available funds. Uponfor the payment of dividends. They are also entitled to share ratably in our assets legally available for distribution to our stockholders in the event of our liquidation, dissolution or winding-up,winding up, after payment of or adequate provision for all of our known debts and liabilities. These rights are subject to the preferential rights of any other class or series of our stock. The outstanding shares of Common Stock are, and any shares offered by this prospectus will be when issued and paid for, fully paid and nonassessable.
Each outstanding share of Common Stock entitles the holder to one vote on all matters submitted to a vote of stockholders, including the election of directors. Except as provided with respect to any other class or series of stock, the holders of our Common Stock will possess the exclusive voting power. In uncontested elections, directors are entitledelected by a majority of all of the votes cast in the election of directors, and in contested elections, directors are elected by a plurality of all of the votes cast in the election of directors.
Preferred Stock
Our board of directors has the authority, without stockholder approval, to share ratablyissue, at any time and from time to time, up to 50,000,000 shares of our preferred stock in all assets that are legally available for distribution.one or more classes or series. Each such class or series shall have such preferences, conversion or other rights, voting powers, restrictions, limitations as to dividends or other distributions, qualifications and terms or conditions of redemption as shall be determined by our board of directors and set forth in articles supplementary relating to such class or series. The rights of the holders of our Common Stock have no preemptive, subscription, redemption or conversion rights.
The rights, preferences and privileges of holders of our Common Stock arewill be subject to, and may be adversely affected by, the rights of holders of any preferred stock that may be issued in the future. Such rights may include voting and conversion rights which could adversely affect the holders of the Common Stock. Satisfaction of any dividend or liquidation preferences of outstanding preferred stock would reduce the amount of funds available, if any, for the payment of dividends or liquidation amounts on Common Stock.
A prospectus supplement, relating to any offered class or series of preferred stock, which may be designated solely by actionwill specify the following terms of the Board of Directors and issued in the future.
Outstanding Preferred Stock
Our Certificate of Incorporation provides our Board of Directors with the authority to divide the preferred stock intosuch class or series, and to fix and determine the rights and preferences of the shares of any series of preferred stock established to the full extent permitted by the laws of the State of Delaware and the Certificate of Incorporation. Our preferred stock consists of the following::
as applicable:
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| preferred stock, |
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| preferred stock offered, the liquidation preference per share and the offering price of such class or series of preferred stock, |
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| ● | whether dividends on such class or series of preferred stock are | |
| preferred stock shall accumulate, |
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| preferred stock, |
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| preferred stock, |
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| preferred stock on any securities exchange, |
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| preferred stock, |
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Terms of Series G Preferred Stock
Conversion. Each share of Series G Preferred Stock, assuming approval of the Conversion Proposal, and subject to other conversion restrictions,preferred stock will be initially convertible under certain circumstances into one share of common stock, which conversion ratio will be subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations.
Fundamental Transaction. In the event we consummate a merger or consolidation with or into another person or other reorganization event in which our common stock is converted or exchanged for securities, cash or other property, or we sell, lease, license, assign, transfer, convey or otherwise dispose of all or substantially all of our assets or we or another person acquires 50% or more of our outstanding shares of common stock, then following such event, the holders of the Series G Preferred Stock will be entitled to receive upon conversion of such Series G Preferred Stock the same kind and amount of securities, cash or property which the holders would have received had they converted their Series G Preferred Stock immediately prior to such fundamental transaction. Any successor to Aytu or surviving entity shall assume the obligations under the Series G Preferred Stock.
Liquidation Preference. In the event of a liquidation, the holders of Series G Preferred Stock will be entitled to participate on an as-converted-to-common-stock basis with holders of our common stock in any distribution of our assets to the holders of the common stock.
Voting Rights. With certain exceptions, as described in the certificate of designation, the Series G Preferred Stock will have no voting rights. However, as long as any shares of Series G Preferred Stock remain outstanding, the certificate of designation provides that we shall not, without the affirmative vote of holders of a majority of the then-outstanding shares of Series G Preferred Stock: (a) alter or change adversely the powers, preferences or rights given to the Series G Preferred Stock or alter or amend the certificate of designation, (b) amend our certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders, (c) increase the number of authorized shares of Series G Preferred Stock or (d) enter into any agreement with respect to any of the foregoing.
Dividends. The certificate of designation provides, among other things, that we shall not pay any dividends on shares of common stock (other than dividends in the form of our common stock) unless and until such time as we pay dividends on each share of Series G Preferred Stock on an as-converted basis. Other than as set forth in the previous sentence, the certificate of designation provides that no other dividends shall be paid on shares of Series G Preferred Stock and that we shall pay no dividends (other than dividends in the form of our common stock) on shares of common stock unless we simultaneously comply with the previous sentence.
Exchange Listing. The Series G Preferred Stock is not listed on any securities exchange or other trading system.
Outstanding Warrants
As of February 14, 2020, we had outstanding warrants to purchase an aggregate of 24,459,663 shares of our Common Stock, consisting of:
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Outstanding Options
On June 1, 2015, our stockholders approved the 2015 Stock Option and Incentive Plan (the “2015 Plan”), which provides for the award of stock options, stock appreciation rights, restricted stock and other equity awards for up to an aggregate of 3,000,000 shares of Common Stock. The shares of Common Stock underlying any awards that are forfeited, canceled, reacquired by us prior to vesting, satisfied without any issuance of stock, expire or are otherwise terminated (other than by exercise) under the 2015 Plan will be added back to the shares of Common Stock available for issuance under the 2015 Plan. On February 14, 2020, our stockholders approved an amendment to the 2015 Plan to increase the aggregate number of shares issuable under the 2015 Plan by 2,000,000 shares.
As of February 14, 2020, we had outstanding options to purchase an aggregate of 13,937 shares of our Common Stock at a weighted average exercise price of $34.69 per share. Of these, an aggregate of 13,937 are exercisable.
The 2015 Plan is administered by our Board or a committee designated by the Board (as applicable, the Administrator). The Administrator has full power to select, from among the individuals eligible for awards, the individuals to whom awards will be granted, to make any combination of awards to participants, and to determine the specific terms and conditions of each award, subject to the provisions of the 2015 Plan. The Administrator may delegate to our Chief Executive Officer the authority to grant stock options and other awards to employees who are not subject to the reporting and other provisions of Section 16 of the Exchange Act and not subject to Section 162(m) of the Code, subject to certain limitations and guidelines.
Persons eligible to participate in the 2015 Plan are full or part-time officers, employees, non-employee directors, directors and other key persons (including consultants and prospective officers) of our company and its subsidiaries as selected from time to time by the Administrator in its discretion. Approximately 35 individuals are currently eligible to participate in the 2015 Plan, which includes officers, employees who are not officers, non-employee director, former employees and other individuals who are primarily consultants.
The 2015 Plan provides that upon the effectiveness of a “sale event” as defined in the 2015 Plan, except as otherwise provided by the Administrator in the award agreement, all stock options, stock appreciation rights and other awards will be assumed or continued by the successor entity and adjusted accordingly to take into account the impact of the transaction. To the extent, however, that the parties to such sale event do not agree that all stock options, stock appreciation rights or any other awards shall be assumed or continued, then such stock options and stock appreciation rights shall become fully exercisable and the restrictions and conditions on all such other awards with time-based conditions will automatically be deemed waived. Awards with conditions and restrictions relating to the attainment of performance goals may become vested and non-forfeitable in connection with a sale event in the Administrator’s discretion. In addition, in the case of a sale event in which our stockholders will receive cash consideration, we may make or provide for a cash payment to participants holding options and stock appreciation rights equal to the difference between the per share cash consideration and the exercise price of the options or stock appreciation rights in exchange for the cancellation thereto.
Quotation on the NASDAQ Capital Market
Our Common Stock is quoted on the NASDAQ Capital Market under the symbol “AYTU”. We have two series of warrants quoted on the OTCQB under the symbols “AYTUW” and “AYTUZ”.
Transfer Agent
and Registrar
The transfer agent of our Common Stock is Issuer Direct Corporation. Their address is 500 Perimeter Park Drive, Suite D, Morrisville, NC 27560.
Delaware Anti-Takeover Law and Provisions of Our Certificate of Incorporation and Bylaws
Delaware Anti-Takeover Law. We are subject to Section 203 of the Delaware General Corporation Law. Section 203 generally prohibits a public Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:
Section 203 defines a “business combination” to include:
In general, Section 203 defines an “interested stockholder” as any person that is:
Under specific circumstances, Section 203 makes it more difficult for an “interested stockholder” to effect various business combinations with a corporation for a three-year period, although the stockholders may, by adopting an amendment to the corporation’s certificate of incorporation or bylaws, elect not to be governed by this section, effective 12 months after adoption.
Our certificate of incorporation and bylaws do not exclude us from the restrictions of Section 203. We anticipate that the provisions of Section 203 might encourage companies interested in acquiring us to negotiate in advance with our board of directors since the stockholder approval requirement would be avoided if a majority of the directors then in office approve either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder.
Certificate of Incorporation and Bylaw. Provisions of our certificate of incorporation and bylaws may delay or discourage transactions involving an actual or potential change of control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our Common Stock. Among other things, these provisions include:
On October 10, 2019, the Company entered into the Asset Purchase Agreement with Cerecor, whereby the Company agreed to purchase certain assets and assume certain liabilities relating to the Products Business (the “Acquisition”). As consideration for the Acquisition, the Company agreed to pay aggregate consideration of approximately $32 million to Cerecor consisting of (i) cash consideration in the amount of $4.5 million by wire transfer of immediately available funds; (ii) Series G Preferred Stock valued at $12.5 million; and (iii) the Company’s assumption of obligations owed by Cerecor to Deerfield CSF, LLC totaling approximately $16.575 million, including any guaranteed interest payments with respect thereto (i.e., interest is due through January 2021 even if the note is paid in full prior to its maturity).
The Acquisition closed on October 31, 2019, at which time the Company paid to Cerecor $4.5 million by wire transfer of immediately available funds and issued to Cerecor 9,805,845 million shares of Series G Preferred Stock.
In connection with the Acquisition, we entered into a registration rights agreement, providing for the registration of the shares of common stock issuable upon conversion of the Series G Preferred Stock issued to Cerecor under the Asset Purchase Agreement. The registration rights agreement provides that we use our reasonable best efforts to cause a registration statement to be declared effective as promptly as possible following the effectiveness of our registration statements associated with the Offering and with our announced merger with Innovus Pharmaceuticals, Inc. and we shall use our reasonable best efforts to keep such registration statement continuously effective under the Securities Act until the date that all registrable securities (as defined in the Asset Purchase Agreement) covered by such registration statement (i) have been sold, thereunder or pursuant to Rule 144, or (ii) may be sold without volume or manner-of-sale restrictions pursuant to Rule 144 and without the requirement for the Company to be in compliance with the current public information requirement under Rule 144.
STOCKHOLDERS
The Common Stock being offered by the Selling Stockholderselling stockholders are those previously issued to the selling stockholders, and those issuable to the Selling Stockholder,selling stockholders, upon exercise of the Series G Preferred Stock.warrants. For additional information regarding the issuances of those shares of Common Stock and warrants, see “Description of Debt Financing” above. We are registering the shares of Common Stock in order to permit the Selling Stockholderselling stockholders to offer the shares for resale from time to time. For additional information regardingExcept for the issuanceownership of the Series G Preferredshares of Common Stock see “The Acquisition” above. Except as disclosed inand the footnotes,warrants, the Selling Stockholderselling stockholders have not had any material relationship with us within the past three years.
The table below lists the Selling Stockholderselling stockholders and other information regarding the beneficial ownership of the shares of common stockCommon Stock by each of the Selling Stockholder.selling stockholders. The second column lists the number of shares of common stockCommon Stock beneficially owned by each Selling Stockholder,selling stockholder, based on its ownership of the shares of Common Stock and warrants, as of February 14, 2020,June 3, 2022, assuming the conversionexercise of the Series G Preferred Stockwarrants held by the Selling Stockholderselling stockholders on that date, without regard to any limitations on exercises.
The third column lists the shares of Common Stock being offered by this prospectus by the Selling Stockholder.selling stockholders.
In accordance with the terms of a registration rights agreement with the selling stockholders, this prospectus generally covers the resale of the sum of (i) the number of shares of Common Stock issued to the selling stockholders in the “Private Placement of Shares of Common Stock and Warrants” described above and (ii) the maximum number of shares of Common Stock issuable upon exercise of the related warrants, determined as if the outstanding warrants were
| Name of Selling Stockholder | Number of shares of Common Stock Owned Prior to Offering | Maximum Number of shares of Common Stock to be Sold Pursuant to this Prospectus | Number of shares of Common Stock Owned After Offering | |||||||||
| Cerecor Inc.(*) | 9,805,845 | 9,805,845 | 0 | |||||||||
| Total | 9,805,845 | 9,805,845 | 0 | |||||||||
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exercised in full as of the trading day immediately preceding the date this registration statement was initially filed with the SEC, each as of the trading day immediately preceding the applicable date of determination and all subject to adjustment as provided in the registration right agreement, without regard to any limitations on the exercise of the warrants. The fourth column assumes the sale of all of the shares offered by the selling stockholders pursuant to this prospectus.
Under the terms of the warrants, a selling stockholder may not exercise the warrants to the extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to beneficially own a number of shares of Common Stock which would exceed 19.99% of our then outstanding Common Stock following such exercise, excluding for purposes of such determination shares of Common Stock issuable upon exercise of the warrants which have not been exercised. The number of shares in the second column does not reflect this limitation. The selling stockholders may sell all, some or none of their shares in this offering. See “Plan of Distribution.”
Name of Selling |
| Number of shares of |
| Maximum Number of shares |
| Number of shares of Common Stock |
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Avenue Venture Opportunities Fund, LP (1) | | 0 | | 347,108 | | 0 | |
Avenue Venture Opportunities Fund II, LP (1) | | 0 | | 520,661 | | 0 | |
Total | | 0 | | 867,769 | | 0 | |
| (2) | Consists solely of shares of Common Stock issuable upon exercise of the Warrants. |
TheEach Selling Stockholder of the securities and any of itstheir pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered hereby on the principal Trading Market or any other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. TheA Selling Stockholder may use any one or more of the following methods when selling securities:
| ● | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| ● | block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
| ● | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| ● | an exchange distribution in accordance with the rules of the applicable exchange; |
| ● | privately negotiated transactions; |
| ● | settlement of short sales; |
| ● | in transactions through broker-dealers that agree with the Selling |
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| ● | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| ● | a combination of any such methods of sale; or |
| ● | any other method permitted pursuant to applicable law. |
The Selling StockholderStockholders may also sell securities 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.
Broker-dealers engaged by the Selling Stockholderselling stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholderselling stockholders (or, if any broker-dealer acts as agent for the purchaser of securities,our Common Stock, 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 Financial Industry Regulatory Authority, or FINRA, Rule 2440;5110; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440.Rule 2121.
In connection with the sale of the securities or interests therein, the Selling StockholderStockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The Selling StockholderStockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The Selling StockholderStockholders 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 securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The Selling StockholderStockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.
The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities. The Company has agreed to indemnify the Selling StockholderStockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
We agreed to keep this prospectus effective until the earlierdate that all shares of Common Stock covered by this propsectus (i) the date on which the securitieshave been sold, thereunder or pursuant to Rule 144, or (ii) may be resold by the Selling Stockholdersold without registration and without regard to any volume or manner-of-sale limitations by reason ofrestrictions pursuant to Rule 144 and without the requirement for the Company to be in compliance with the current public information requirement under Rule 144, underas determined by the Securities Act or any other rule of similar effect or (ii) all ofcounsel to the securities have been soldCompany pursuant to this prospectus or Rule 144 undera written opinion letter to such effect, addressed and acceptable to the Securities Act or any other ruleTransfer Agent and the affected holders The Company shall telephonically request effectiveness of similar effect.a Registration Statement as of 5:00 p.m. (New York City time) on a Trading Day. The resale 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 resale 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.
Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling StockholderStockholders will 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 common stock by the Selling StockholderStockholders or any other person. We will make copies of this prospectus available to the Selling Stockholder Stockholders
13
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 validityAt the time a particular offer of securities is made, if required, a prospectus supplement will be distributed that will set forth the number of securities being offered and the terms of the offering, including the name of any underwriter, dealer or agent, the purchase price paid by any underwriter, any discount, commission and other item constituting compensation, any discount, commission or concession allowed or reallowed or paid to any dealer, and the proposed selling price to the public.
Certain legal matters in connection with the offered securities covered by this prospectus has beenwill be passed upon for us by Dorsey & Whitney LLP, Salt Lake City, Utah. Any underwriters or agents will be represented by their own legal counsel, who will be identified in the applicable prospectus supplement.
The consolidated financial statements of Aytu BioScience,BioPharma, Inc. at June 30, 20192021 and 2018,2020, and for each of the two years in the period ended June 30, 20192021 have been audited by Plante & Moran, PLLC, (successor to EKS&H LLLP), independent registered public accounting firm. Such financial statements have been incorporated herein by reference in reliance on the report of such firm given upon their authority as experts in accounting and auditing.
The abbreviated financial statements of the Pediatrics Product Portfolio of Cerecor Inc. at September 30, 2019 and December 31, 2018, and for the nine-month period ended September 30, 2019 and for the year ended December 31, 2018, incorporated by reference in Aytu BioScience, Inc.’s Current Report on Form 8-K/A dated January 10, 2020 have been audited by Ernst & Young LLP, independent auditors, as set forth in their report thereon incorporated by reference therein, and incorporated herein by reference. Such abbreviated financial statements are incorporated herein by reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing.
The financial statements of Innovus incorporated by reference in Aytu BioScience Inc.’s Current Report on Form 8-K dated February 14, 2020 have been audited by Hall & Company, an independent registered public accounting firm, as stated in their reports. Such financial statements have been included in reliance upon the reports of such firm given upon their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and othercurrent reports, proxy statements and other information with the SEC. OurYou may obtain such SEC filings are available to the public over the Internet atfrom the SEC’s website at http://www.sec.gov. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q,Copies of our periodic and Current Reports on Form 8-K, including any amendments to thosecurrent reports and otherproxy statements, may be obtained, free of charge, on our website at https://irdirect.net/AYTU/sec_filings. This reference to our Internet address is for informational purposes only and the information thatcontained on or accessible through such Internet address is not and shall not be deemed to be incorporated by reference into this prospectus.
As permitted by SEC rules, this prospectus does not contain all of the information we have included in the registration statement and the accompanying exhibits and schedules we file with or furnishthe SEC. You may refer to the SEC pursuant to Section 13(a) or 15(d) ofregistration statement, exhibits and schedules for more information about us and the Exchange Act can also be accessed free of chargesecurities. The registration statement, exhibits and schedules are available through the Internet. These filings will be available as soon as reasonably practicable after we electronically file such material with,SEC’s website or furnish it to, the SEC. We also maintain a website at http://www.aytubio.com, at which you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. The information contained in, or that can be accessed through, our website is not part of this prospectus.its public reference room.
DOCUMENTS INCORPORATEDINCORPORATION BY REFERENCE
The SEC allows us toIn this prospectus, we “incorporate by reference” into this prospectus the documentscertain information that we file with the SEC, which means that we can disclose important information to you by referring you to those documents.that information. The information incorporatedwe incorporate by reference is considered to bean important part of this prospectus. We incorporateprospectus, and later information that we file with the SEC will automatically update and supersede this information. The following documents or information have been filed by us with the SEC and are incorporated by reference into this prospectus the following documents:
(other than, in each case, documents or information that are or are deemed to have been furnished rather than filed in accordance with SEC rules, including disclosure furnished under Items 2.02 or 7.01 of Form 8-K):
| ● | our | |
| April 7, 2022; |
| ● | our Annual Report onForm 10-K for the fiscal year ended June 30, | |
| Form 10-K/A filed on February 22, 2022; |
| ● | our Quarterly | |
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| ● | our Current Reports on Form 8-K filed with the SEC onJuly 2, 2021, August | |
| ● | the description of our Common Stock contained in our Registration Statement onForm 8-A, | |
All documents |
We also incorporate by reference any future filings (other than information furnished under Items 2.02 or 7.01 of any Current Reports on Form 8-K and exhibits filed on such formreports that are related to such items unless such Form 8-K expressly provides to the contrary) madewe file with the SEC pursuant(other than, in each case, documents or information that are or are deemed to have been furnished rather than filed in accordance with SEC rules) under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act afterof 1934, as amended, which we refer to in this prospectus as the “Exchange Act,” from the date of this prospectus until the initial registration statement and prior to effectivenesscompletion of the registration statement, excluding,offering under this prospectus shall be deemed to be incorporated by reference into this prospectus. Unless specifically stated to the contrary, none of the information we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K that we may from time to time furnish to the SEC will be incorporated by reference into, or otherwise included in, each case,this prospectus. The information contained on or accessible through any websites, including https://irdirect.net/AYTU/sec_filings, is not and shall not be deemed furnished and not filed.to be incorporated by reference into this prospectus.
You may request a copy of these filings, other than an exhibit to these filings unless we have specifically included or incorporated that exhibit by reference into the filing, at no cost, by writing or telephoning us at the following address:
Aytu BioPharma, Inc.
373 Inverness Parkway, Suite 206
Englewood, Colorado 80112
(720) 437-6580
Any statement contained in this prospectus, or in a document incorporated or deemed to be incorporated by reference herein, shallinto this prospectus will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained herein,in this prospectus, any prospectus supplement, or in any other subsequently filed document that also is incorporated or deemed to be incorporated by reference herein,into this prospectus modifies or supersedes suchthe statement. Any statement so modified or superseded shallwill not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
You may obtain copies of these documents, at no cost to you, from our website (www.aytubio.com), or by writing or telephoning us at the following address:
Aytu BioScience, Inc.
373 Inverness Parkway, Suite 206
Englewood, CO 80112
Tel: (720) 437-6580
9,805,845 Shares of Common Stock Issuable upon Conversion of Series G Convertible Preferred Stock
, 2020
15
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Information Not Required in Prospectus
ITEM 14. Other Expenses of Issuance and Distribution
The following table sets forth the costs and expenses payable by us in connection with the offeringissuance and distribution of the securities being registered all of which will be paid by Aytu BioScience, Inc.pursuant to this registration statement. All the amounts shown are estimates except the Securities and Exchange Commission (the “SEC”) registration fee.estimates.
| Amount | ||||||||
| | | | | ||||
| SEC registration fee | $ | 954.60 |
| $ | 43 |
| ||
| Printing and engraving expenses | -- | |||||||
| Legal fees and expenses | 10,000 | | | 10,000 | | |||
| Accounting fees and expenses | 10,000 | | | 10,000 | | |||
| Transfer agent and registrar fees and expenses | 5,000 | |||||||
| Miscellaneous | 15,000 | | | 2,000 | | |||
| Total | $ | 40,954.62 | | $ | 22,043 | | ||
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
We are incorporated under the laws of the State of Delaware. Section 145 of the Delaware General Corporation Law provides that a Delaware corporation may indemnify any persons who are, or are threatened to be made, parties to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person was an officer, director, employee or agent of such corporation, or is or was serving at the request of such person as an officer, director, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided that such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his conduct was illegal. A Delaware corporation may indemnify any persons who are, or are threatened to be made, a party to any threatened, pending or completed action or suit by or in the right of the corporation by reason of the fact that such person was a director, officer, employee or agent of such corporation, or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit provided such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests except that no indemnification is permitted without judicial approval if the officer or director is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him against the expenses which such officer or director has actually and reasonably incurred. Our certificate of incorporation and bylaws provide for the indemnification of our directors and officers to the fullest extent permitted under the Delaware General Corporation Law.
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Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director, except for liability for any:
| ● | transaction from which the director derives an improper personal benefit; |
| ● | act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
| ● | unlawful payment of dividends or redemption of shares; or |
| ● | breach of a director’s duty of loyalty to the corporation or its stockholders. |
Our certificate of incorporation includes such a provision. Expenses incurred by any officer or director in defending any such action, suit or proceeding in advance of its final disposition shall be paid by us upon delivery to us of an undertaking, by or on behalf of such director or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified by us.
As permitted by the Delaware General Corporation Law, we have entered into indemnity agreements with each of our directors and executive officers. These agreements, among other things, require us to indemnify each director and officer to the fullest extent permitted by law and advance expenses to each indemnitee in connection with any proceeding in which indemnification is available.
We have an insurance policy covering our officers and directors with respect to certain liabilities, including liabilities arising under the Securities Act of 1933, as amended, or the Securities Act, or otherwise.
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Exhibit No. | Description | Registrant’s | Date | Exhibit | Filed | |||||
5.1 | X | |||||||||
10.2# | 8-K/A | 6/08/15 | 10.4 | |||||||
10.3# | 8-K/A | 6/08/15 | 10.5 | |||||||
10.4 | ||||||||||
10.5# | 8-K/A | 6/08/15 | 10.7 | |||||||
10.6# | 8-K/A | 6/08/15 | 10.8 | |||||||
10.7# | 8-K/A | 6/08/15 | 10.9 | |||||||
10.8# | 8-K | 5/27/15 | 10.14 | |||||||
10.9 | Promissory Note issued by Ampio to the Registrant on April 16, 2015 | 8-K | 4/22/15 | 10.11 | ||||||
10.10 | Subscription Agreement between the Registrant and Ampio, dated April 16, 2015 | 8-K | 4/22/15 | 10.12 | ||||||
10.11 | ||||||||||
10.12 | 8-K | 5/27/15 | 10.14 | |||||||
10.13 | Form of Note Purchase Agreement for 2015 Convertible Note Financing | 8-K | 7/24/15 | 10.1 | ||||||
10.14 | 8-K | 10/07/15 | 10.18 | |||||||
10.15 | 8-K | 10/13/15 | 10.19 | |||||||
10.16 | Form of Subscription Agreement for January 2016 common stock purchases | 8-K | 1/20/16 | 10.1 |
ITEM 16. EXHIBITS
EXHIBITS
Exhibit No. | | Description | | Registrant’s | | Date | | Exhibit | | Filed |
| | | | | | | | | | |
3.1 | | | 8-K | | 06/09/15 | | 3.1 | | | |
| | | | | | | | | | |
3.2 | | Certificate of Amendment of Certificate of Incorporation effective June 1, 2016. | | 8-K | | 06/02/16 | | 3.1 | | |
| | | | | | | | | | |
3.3 | | Certificate of Amendment of Certificate of Incorporation, effective June 30, 2016. | | 8-K | | 07/01/16 | | 3.1 | | |
| | | | | | | | | | |
3.4 | | | 8-K | | 08/16/17 | | 3.1 | | | |
| | | | | | | | | | |
3.5 | | Certificate of Amendment of Certificate of Incorporation, effective August 25, 2017. | | 8-K | | 08/29/17 | | 3.1 | | |
| | | | | | | | | | |
3.6 | | | S-1/A | | 02/27/18 | | 3.6 | | | |
| | | | | | | | | | |
3.7 | | Certificate of Amendment to the Restated of Certificate of Incorporation, effective August 10, 2018. | | 8-K | | 08/10/18 | | 3.1 | | |
| | | | | | | | | | |
3.8 | | | 10-Q | | 02/07/19 | | 10.4 | | | |
| | | | | | | | | | |
3.9 | | | 8-K | | 10/15/19 | | 3.1 | | | |
| | | | | | | | | | |
3.10 | | | 8-K | | 110/4/19 | | 3.1 | | | |
| | | | | | | | | | |
3.11 | | Certificate of Amendment to the Restated Certificate of Incorporation, effective December 7, 2020. | | 8-K | | 12/08/20 | | 3.1 | | |
| | | | | | | | | | |
3.12 | | | 8-K | | 03/22/21 | | 3.1 | | | |
| | | | | | | | | | |
3.13 | | | 8-K | | 05/9/22 | | 3.1 | | | |
| | | | | | | | | | |
4.1 | | Form of Placement Agent Warrant issued in 2015 Convertible Note Financing. | | 8-K | | 07/24/15 | | 4.2 | | |
| | | | | | | | | | |
4.2 | | | 8-K | | 05/06/16 | | 4.1 | | | |
| | | | | | | | | | |
4.3 | | | S-1 | | 09/21/16 | | 4.5 | | | |
| | | | | | | | | | |
4.4 | | | 8-K | | 11/2/16 | | 4.1 | | | |
| | | | | | | | | | |
4.5 | | Form of Amended and Restated Underwriters’ Warrant (May 2016 Financing). | | 8-K | | 03/1/17 | | 4.1 | | |
| | | | | | | | | | |
4.6 | | Form of Amended and Restated Underwriters’ Warrant (October 2016 Financing). | | 8-K | | 03/1/17 | | 4.2 | | |
| | | | | | | | | | |
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4.7 | | Form of Common Stock Purchase Warrant issued on August 15, 2017. | | 8-K | | 08/16/17 | | 4.1 | | |
| | | | | | | | | | |
4.8 | | Form of Common Stock Purchase Warrant for March 2018 Offering. | | S-1 | | 02/27/18 | | 4.8 | | |
| | | | | | | | | | |
4.9 | | | 8-K | | 03/13/20 | | 4.1 | | | |
| | | | | | | | | | |
4.10 | | | 8-K | | 03/13/20 | | 4.2 | | | |
| | | | | | | | | | |
4.11 | | | 8-K | | 03/13/20 | | 4.1 | | | |
| | | | | | | | | | |
4.12 | | | 8-K | | 03/13/20 | | 4.2 | | | |
| | | | | | | | | | |
4.13 | | | 8-K | | 03/20/20 | | 4.1 | | | |
| | | | | | | | | | |
4.14 | | | 8-K | | 03/20/20 | | 4.2 | | | |
| | | | | | | | | | |
4.15 | | | 8-K | | 07/02/20 | | 4.1 | | | |
| | | | | | | | | | |
4.16 | | | 8-K | | 12/14/20 | | 4.1 | | | |
| | | | | | | | | | |
4.17 | | | 10-Q | | 02/14/22 | | 10.6 | | | |
| | | | | | | | | | |
4.18 | | | 8-K | | 03/4/22 | | 4.1 | | | |
| | | | | | | | | | |
4.19 | | | 8-K | | 03/4/22 | | 4.2 | | | |
| | | | | | | | | | |
10.1 | | Registration Rights Agreement dated January 26, 2022 between Aytu and the selling stockholders. | | 10-Q | | 02/14/22 | | 10.5 | | |
| | | | | | | | | | |
5.1 | | | | | | | | | X | |
| | | | | | | | | | |
23.1 | | Consent of Dorsey & Whitney LLP (to be included in Exhibit 5.1). | | | | | | | | X |
| | | | | | | | | | |
23.2 | | Consent of Plante & Moran, PLLC relating to Aytu’s financial statements. | | | | | | | | X |
| | | | | | | | | | |
24.1 | | | | | | | | | X | |
| | | | | | | | | | |
107 | | | | | | | | | X | |
| | | | | | | | | | |
| Exhibit No. | Description | Registrant’s Form | Date Filed | Exhibit Number | Filed Herewith | |||||
10.17 | 8-K | 4/25/16 | 10.1 | |||||||
10.18 | 8-K | 4/25/16 | 10.2 | |||||||
10.19 | 8-K | 5/16/16 | 10.1 | |||||||
10.20 | 8-K | 7/28/16 | 10.1 | |||||||
10.21 | 8-K | 7/28/16 | 10.2 | |||||||
10.22† | 8-K | 4/18/17 | 10.1 | |||||||
10.23† | 8-K | 4/18/17 | 10.2 | |||||||
10.24 | 10-Q | 5/11/17 | 10.1 | |||||||
10.25# | Merger Agreement, dated May 3, 2017, between Nuelle, Inc. and Aytu BioScience, Inc. | 10-K | 8/31/2017 | 10.25 | ||||||
10.26† | 8-K | 6/19/17 | 10.1 | |||||||
10.27† | 2015 Stock Option and Incentive Plan, as amended on July 26, 2017. | 8-K | 7/27/17 | 10.1 | ||||||
10.28 | 8-K | 8/16/17 | 10.1 | |||||||
10.29 | 8-K | 8/16/17 | 10.2 | |||||||
10.30 | 8-K | 3/28/18 | 10.1 | |||||||
10.31 | 10-K | 09/06/18 | 10.31 | |||||||
10.32 | 8-K | 11/29/18 | 10.1 | |||||||
10.33 | 10-Q | 2/7/19 | 10.6 | |||||||
10.34 | 10-Q | 2/7/19 | 10.5 | |||||||
10.35 | 10-Q | 2/7/19 | 10.3 | |||||||
10.36 | License, Development, Manufacturing and Supply Agreement, dated November 2, 2018 | 10-Q | 2/7/19 | 10.2 | ||||||
10.37 | 8-K | 4/26/19 | 10.1 | |||||||
10.38 | 8-K | 5/2/19 | 10.1 | |||||||
10.39 | 10-Q | 5/14/19 | 10.3 |
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ITEM 17. UNDERTAKINGS
| (a) |
| (i) | To include any prospectus required by Section 10(a)(3) of |
| (ii) | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed |
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| To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
(a) The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act;
(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Securities and Exchange Commission (the “Commission”) pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
provided, however, that:
Paragraphsthat paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the Registrantregistrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 as amended (the “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.
| (2) | That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment 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. |
| (3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
| (4) | That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser: |
| (i) | Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
| (ii) | Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by |
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| reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
| (5) | That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities of the undersigned registrant pursuant to the registration statement, regardless 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: |
| (i) | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
| (ii) | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
| (iii) | The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
| (iv) | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
| (b) | That, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) 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. |
| (c) | Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933 and will be governed by the final adjudication of such issue. |
(2) That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment 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 initialbona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the Securities Act to any purchaser:
(i) Each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
(ii) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initialbona fide offering thereof.Provided,however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
(5) That, for purposes of determining any liability under the Securities Act, each filing of the Registrant’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’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 initialbona fide offering thereof.
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Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the city of Englewood, Colorado on February 24, 2020.June 8, 2022.
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| AYTU BIOPHARMA, INC. | |
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| /s/ Joshua R. Disbrow | |
| Name: | Joshua R. Disbrow |
| Title: | Chairman and Chief Executive Officer |
POWER OF ATTORNEY
KNOW ALL BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Joshua R. Disbrow and David A. GreenMark Oki as his true and lawful attorneys-in-fact and agents, each with the full power of substitution, for him and in his name, place or stead, in any and all capacities, to sign any and all amendments to this registration statement (including post-effective amendments), and to file the same, with exhibits thereto and other documents in connection therewith, with the SEC, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities indicated and on the dates indicated.
Signature | Capacity in Which Signed | Date | ||
| | | | |
/s/ Joshua R. Disbrow
| | Chairman and Chief Executive Officer | | June 8, 2022 |
Joshua R. Disbrow | | (Principal Executive Officer) | | |
| | | | |
/s/
| | Chief Financial Officer | | June 8, 2022 |
Mark Oki | | (Principal Financial and Accounting Officer) | | |
| | | | |
/s/
| | Director | | June 8, 2022 |
Michael E. Macaluso | | | | |
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/s/ Gary V. Cantrell | | Director | | June 8, 2022 |
Gary V. Cantrell | |
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/s/ Carl C. Dockery | | Director | | June 8, 2022 |
Carl C. Dockery | |
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/s/ John A. Donofrio, Jr. | | Director | | June 8, 2022 |
John A. Donofrio, Jr. | |
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