As filed with the Securities and Exchange Commission on _______, 2019
Registration No. 333-___________
SECURITIES AND EXCHANGE COMMISSION
THE SECURITIES ACT OF 1933
SCOPUS BIOPHARMA INC.
(Exact name of registrant as specified in its constitutional documents)
(State or other jurisdiction of
incorporation or organization)
(Primary Standard Industrial
Classification Code Number)
420 Lexington Avenue, Suite 300
New York, New York 10170
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
S1 biopharma ipo date
420 Lexington Avenue, Suite 300
New York, New York 10170
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Jason Simon, Esq.
Jocelyn M. Coney, Esq.
Greenberg Traurig, LLP
1750 Tysons Boulevard
McLean, Virginia 22102
Kenneth Koch, Esq.
Jeffrey Schultz, Esq.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
666 Third Avenue
New York, New York 10017
Approximate date of commencement of proposed sale to the public: As soon as practical after the date this registration statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box.
Earum IPO Date, Price, GMP, Review & Details
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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
Emerging growth company
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 to Section 7(a)(2)(B) of the Securities Act.
CALCULATION OF REGISTRATION FEE
|Title of Each Class of Security Being Registered|| Proposed |
Offering Price (1)(2)
| Amount of |
Series A Units, each consisting of one share of $0.001 par value common stock and two Series A Warrants
Common stock included in Series A Units(3)
Series A Warrants, included in the Series A Units, each issuable for one Series B Unit
Series B Units underlying Series A Warrants, each consisting of one share of common stock and one Series B Warrant
Common stock included in Series B Units(3)
|Series B Warrants, included in the Series B Units, each issuable for one share of common stock||$||11,250,000||$||1,363.50|
Common stock issuable upon exercise of all Series A Warrants and Series B Warrants issued or issuable in this offering(3)
|Common stock offered for resale(3)||$||1,200,000||$||145.44|
Estimated solely for purposes of calculating the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended (the “Act”).
|(2)||Includes securities issuable upon exercise of the underwriters’ option to purchase additional Series A Units.|
Pursuant to Rule 416 under the Securities Act of 1933, this registration statement also covers any additional securities that may be offered or issued in connection with any stock split, stock dividend or similar transaction.
No fee required under Rule 457(g) of the Act.
The registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
This Registration Statement contains two forms of prospectuses: one to be used in connection with the initial public offering of _____Series A Units (including the Series the A Units which may be issued upon exercise of the 45-day option granted to the underwriters to cover over-allotments, if any) through the underwriters named on the cover page of this prospectus (the “IPO Prospectus”) and one to be used in connection with the potential resale by certain selling stockholders of an aggregate amount up to _____________ shares of our common stock (the “Selling Stockholder Prospectus”).
The IPO Prospectus and the Selling Stockholder Prospectus will be identical in all respects except for the alternate pages for the Selling Stockholder Prospectus included herein which are labeled “Alternate Page for Selling Stockholder Prospectus.”
The Selling Stockholder Prospectus is substantively identical to the IPO Prospectus, except for the following principal points:
they contain different outside and inside front covers;
they contain different Offering sections in the Prospectus Summary section;
they contain different Use of Proceeds sections;
the Dilution section has been omitted;
a Selling Stockholder section is included in the Selling Stockholder Prospectus;
the Underwriting section from the IPO Prospectus is deleted from the Selling Stockholder Prospectus and a Plan of Distribution is inserted in its place; and
the Legal Matters section in the Selling Stockholder Prospectus deletes the reference to counsel for the underwriters.
We have included in this Registration Statement, after the financial statements, a set of alternate pages to reflect the foregoing differences of the Selling Stockholder Prospectus as compared to the IPO Prospectus.
The sales of our securities registered in the IPO Prospectus and the shares of our common stock registered in the Selling Stockholder Prospectus may result in two offerings taking place concurrently, which could affect the price and liquidity of, and demand for, our securities.
This risk and other risks are included in “Risk Factors” beginning on page 6 of the IPO Prospectus.
The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective.
This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED JUNE 18
_______ Series A Units
This is an initial public offering of our securities. We are offering ____ of our Series A Units. The offering price is $___ per Series A Unit.
Each Series A Unit consists of one share of our common stock and two Series A Warrants.
Each Series A Warrant is exercisable for one Series B Unit. Each Series B Unit consists of one share of common stock and one Series B Warrant. Each Series B Warrant is exercisable for one share of common stock.
The exercise price of the Series A Warrant is $___ and the exercise price of the Series B Warrant is $____. The Series A Warrants and Series B Warrants will be exercisable commencing on October 1, 2020 and September 1, 2021, respectively.
Prior to this offering, there has been no public market for our units, shares of common stock or warrants. We intend to apply to have our Series A Units, Series A Warrants and shares of common stock listed on the Nasdaq Global Market, or Nasdaq, under the symbols “____”, “____” and “____”.
The shares of common stock and Series A Warrants comprising the Series A Units will begin separate trading on July 1, 2020, unless we elect to allow such separate trading at an earlier date. At such time as the Series A Warrants can be exercised, we also intend to have our Series B Units and Series B Warrants listed on Nasdaq under the symbols “____” and “____”.
We are an “emerging growth company” as defined under the federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements.
We have granted the underwriters an option to purchase up to an additional _________ Series A Units at the initial public offering price less the underwriting discount.
Investing in the securities offered by this prospectus involves a high degree of risk.
Our company is at an early stage of its development and our securities may only be appropriate for long-term investment. You should purchase our securities only if you can afford to lose your entire investment.
See “Risk Factors” beginning on page 6 of this prospectus for a discussion of information that should be considered in connection with an investment in such securities.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete.
Any representation to the contrary is a criminal offense.
|Public offering price||$||$|
|Underwriting discount (2)||$||$|
|Proceeds, before expenses, to us||$||$|
|(1)||Assumes the underwriters have not exercised their option to purchase additional Series A Units as described herein.|
|(2)||See “Underwriting” beginning on page 67 of this prospectus for a description of the compensation payable to, and other arrangements with, the underwriters.
The underwriters expect to deliver the Series A Units against payment in New York, New York on _________, 2019.
The date of this prospectus is ___________, 2019
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
Unless otherwise stated in this prospectus, “we,” “us,” “our,” “company,” “Scopus” and “Scopus BioPharma” refer to Scopus BioPharma Inc.
We have not authorized anyone to provide any information other than that contained in this prospectus or in any prospectus supplement prepared by us or on our behalf or to which we may have referred you.
We do not take any responsibility for, and cannot provide any assurance as to the reliability of, any other information that others may give you. We have not authorized any other person to provide you with different or additional information, and none of us are making an offer to sell the securities in any jurisdiction where the offer or sale thereof is not permitted.
This offering is being made solely on the basis of the information contained in this prospectus. You should assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus, regardless of the time of delivery of the prospectus or of any sale of the securities.
Form S-1 Scopus Biopharma Inc.
Our business, financial condition, results of operations and prospects may have changed since the date on the front cover of this prospectus.
For investors outside of the United States, we have not done anything that would permit the offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States.
You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus outside of the United States.
This prospectus is part of a registration statement on Form S-1 that we filed with the SEC. From time to time, we may file one or more prospectus supplements to add, update or change information included in this prospectus.
You should read both this prospectus and any applicable prospectus supplements, together with additional information described below under the caption “Where You Can Find Additional Information.” You should also carefully consider, among other things, the matters discussed in the section entitled “Risk Factors.”
Concurrently with the primary offering, we are registering shares of common stock in connection with the potential resale by certain selling stockholders of an aggregate amount up to _________ shares of our common stock.
Please read the risk factors, including the risk factor titled “Sales of our Series A Units in the primary offering will be taking place concurrently with common stock registered by selling stockholders which might affect the price, demand, and liquidity of our Series A Units” on page 25.
This summary highlights certain information appearing elsewhere in this prospectus.
For a more complete understanding of this offering, you should read the entire prospectus carefully, including the risk factors and the financial statements.
We are a biotechnology company focused on developing novel therapeutics targeting the endocannabinoid system.
This system is critical for maintaining overall human health by modulating key functions within the body, including those relating to the immune, metabolic and nervous systems.
The endocannabinoid system is comprised of chemical compounds, or cannabinoids, that interact with cannabinoid receptors which are located throughout the body.
Endogenously-produced cannabinoids are known as endocannabinoids. Cannabinoids can also be derived from the cannabis plant or can be synthetically produced. The most well-known and researched plant-derived and synthetically-produced cannabinoids are cannabidiol, or CBD, and tetrahydrocannabinol, or THC.
We intend to pursue U.S.
Food and Drug Administration, or FDA, approval, as well as other U.S. and non-U.S.
General form for registration of securities under the Securities Act of 1933
regulatory approvals, for our proprietary drug candidates. We believe that the rigorous safety and efficacy testing required to obtain FDA approval will distinguish our drugs from the proliferation of commoditized cannabinoid products in the marketplace.
FDA approval will also allow us to legally market our drugs with claims of therapeutic benefit for specific diseases and indications which cannot be done with non-FDA approved products. Finally, obtaining approval will allow us to overcome the legal obstacles that exist under state and federal laws to the marketing, selling and transportation of cannabinoids and cannabinoid associated products.
By pursuing this strategy, we hope to gain a competitive advantage over non-approved products and encourage healthcare providers to prescribe our drugs for the diseases and indications for which they are intended at higher prices when compared to non-approved products. To date, we have not submitted any investigational new drug, or IND, applications to the FDA or initiated any clinical trials. Our primary activities have been sponsoring pre-clinical research and development activities with world-renowned academic and medical research institutions for our drug candidates, none of which have been approved by the FDA at this time.
Our products will utilize synthetically-produced cannabinoids as opposed to plant-derived compounds.
We believe this will enable us to have better quality control and consistency for our products and eliminate the inherent risks associated with plant production.
Biotech IPO Calendar
We hope to also gain a competitive advantage in this regard.
Our Strategic Relationships
We are advancing four cannabinoid programs in collaboration with top researchers at The Hebrew University of Jerusalem, or Hebrew University, and at the National Institutes of Health, or NIH.
Both are leaders in cannabinoid and cannabis research.
We have contracted with these institutions believing that the experience and knowledge of their researchers will better enable us to advance our product candidates even though we may undertake our own research or utilize other third parties in the future. We trust that our current research agreements with these institutions will serve to reduce the development cycle of our prospective product candidates.
The Hebrew University of Jerusalem
Hebrew University has been a pioneer in cannabinoid and cannabis research for over 50 years.
Form S-1 Gt Biopharma, Inc.
Researchers at Hebrew University were responsible for the identification of THC and its chemical structure, as well as other phytocannabinoids such as cannabigerol, or CBG, cannabigerolic acid and cannabichromene. To better integrate and coordinate its research efforts in the area of cannabinoids and cannabis, Hebrew University established the Multidisciplinary Center for Cannabinoid Research, or MCCR, in April 2017.
The MCCR is headed by Dr. Joseph (Yossi) Tam, D.M.D., Ph.D., who is a member of our scientific advisory board, and staffed by eminent scientists and medical doctors from a variety of faculties at the Hebrew University and Hadassah University Medical Center.
Working in collaboration with researchers at the MCCR, in June 2018 we entered into two Memorandums of Understanding, or MOUs, to fund and advance research focused on the development of therapeutics targeting the endocannabinoid system.
Under one MOU, we are funding at a cost of approximately $115,000 a two-year feasibility study at Hebrew University for the development of a safe and painless pain selective anesthesia devoid of neurotoxicity by combining CBD with known anesthetics.
Under the second MOU, we are funding a two part research program at an approximate aggregate cost of approximately $245,000 at Hebrew University focused on synthesizing cannabinoid-based dual action compounds and developing novel chemical derivatives based upon the molecular structure of existing cannabinoids.
The dual action compounds are intended to create cannabinoid-based hybrid new chemical entities, or NCEs, that will improve upon the efficacy and reduce the side effects of other existing and under development drugs. The novel chemical derivatives will be evaluated for potential therapeutic benefits.
Under both MOUs, we have an exclusive right to negotiate world-wide licenses to the research results and patents that result from the research.
Historical IPO Database
To date, we have executed one license agreement.
National Institutes of Health
NIH is the United States’ medical research agency made up of 27 components called Institutes and Centers. The NIH spends approximately $39 billion annually to conduct and fund medical research seeking to enhance health, lengthen life and reduce illness and disability.
The Company has licensed a series of novel cannabinoid receptor mediating compounds from the NIH developed by Dr.
George Kunos, M.D., Ph.D., a member of our scientific advisory board. Dr.
Kunos is the Scientific Director for the National Institute on Alcohol Abuse and Alcoholism, or NIAAA, and a leading researcher on the endocannabinoid system with a focus on its role in certain fibrotic, inflammatory and metabolic diseases.
Upon execution of this license agreement we paid a license fee and reimbursed certain patent fees and expenses in an aggregate amount of approximately $121,000.
In conjunction with this license, we entered into a Cooperative Research and Development Agreement, or CRADA. Under the CRADA we are advancing the studies which Dr. Kunos has undertaken to date in connection with the potential therapeutic benefits of using MRI-1867, a licensed compound, for the treatment of systemic sclerosis.
The CRADA covers two years of research at an aggregate cost of approximately $240,000.
Our Drug Candidates
CBD-mediated, Opioid-sparing Anesthetics
In collaboration with Dr. Alexander Binshtok of Hebrew University, we are evaluating the effects of delivering approved anesthetics in combination with CBD as an opioid-sparing treatment for the management of pain. Under our sponsored research program, Dr.
Binshtok has demonstrated in an in vivo “proof of concept” feasibility experiment in mice that CBD, a TRPV1 and TRPA1 channel activator, used in combination with chloroprocaine, an approved anesthetic, results in painless selective long-term pain relief without paralytic, autonomic or neurotoxic side effects.
We believe our proprietary combinations of CBD with approved anesthetics would be applicable in multiple clinical settings including:
|opioid-sparing post-operative pain management|
|nerve block anesthesia|
|epidural anesthesia during childbirth (i.e., pain relief while retaining the ability to “push”)|
|spinal anesthesia, particularly in patients susceptible to low blood pressure (e.g., the elderly)|
|inflammatory, cancer and neuropathic pain|
We also believe that our proprietary combinations of CBD with approved anesthetics may be eligible for the FDA’s 505(b)2 development pathway, which could significantly reduce the future time and costs associated with clinical development.
We plan to file an IND in the second half of 2020 to commence human clinical trials.
Synthesis of Cannabinoids
In collaboration with Dr. Dmitry Tsvelikhovsky of Hebrew University, we are pursuing two programs seeking to synthesize novel cannabinoids: cannabinoid-based dual-action compounds and novel chemical derivatives based upon the molecular structure of existing cannabinoids.
Cannabinoid-based Dual-action Compounds
Our first program seeks to create new dual-action, cannabinoid-based hybrid NCEs which improve upon the efficacy, side effects or a combination of both compared to FDA-approved drugs and other promising drug candidates currently under development.
Our initial strategy is to focus on indications that have been proven to be responsive to cannabinoids and cannabinoid therapeutics such as certain metabolic, autoimmune and inflammatory diseases.
Once we have completed the synthesis portion of our research and development program, we will contract with third-party clinical research organizations, or CROs, to perform in vitro receptor binding assays, which we plan to commence in the second half of 2019, to determine which indications these compounds may address. Based on the results of these receptor binding assays, we will decide which compounds to advance into in vivo testing and which compounds would benefit from further chemical refinement.
Novel Chemical Derivatives of Existing Cannabinoids
Our second program seeks to create novel derivatives of two cannabinoids that are found in the cannabis plant, CBG (which is a precursor to CBD and THC) and tetrahydrocannabivarin, or THCV, which we plan to evaluate for their potential therapeutic benefits.
The fact that CBG and THCV already demonstrate biological activity gives us reason to believe that their derivatives will also be biologically active. Since these derivatives are NCEs, however, they may also demonstrate different biological activity than their respective parent compounds.
CBG is a non-psychoactive cannabinoid that is believed to be responsible for regulating mood, sleep and appetite, as well as potentially having therapeutic benefits in the areas of pain management, inflammatory diseases and central nervous system, or CNS, diseases.
CBG is also believed to be a possible inhibitor of the psychoactive effects of THC.
THCV is a psychoactive cannabinoid that is believed to suppress appetite making it a popular research target for weight loss and diabetes drugs. It may also possess anti-inflammatory, anti-anxiety and anti-seizure properties, as well as being effective at treating certain CNS conditions such as amyotrophic lateral sclerosis, or ALS, and Parkinson’s and Alzheimer’s disease.
Further, in vitro receptor binding assays will be performed, which we plan to commence in the second half of 2019, in order to determine the best potential indications for further development of these novel chemical derivatives of CBG and THCV.
Cannabinoid Receptor Mediating Compounds for the Treatment of Systemic Sclerosis
In collaboration with Dr. Kunos of the NIH, we are developing MRI-1867, our lead cannabinoid receptor mediating compound, for the treatment of systemic sclerosis, or SSc.
SSc is a chronic, systemic autoimmune disease characterized by a thickening of the skin and internal organs, such as the heart, lungs, kidneys and gastrointestinal tract, caused by a proliferation of connective tissue, or fibrosis, and small blood vessels.
It is estimated that SSc affects approximately 90,000 patients in the United States and Europe, the majority of which are female (80%) and adults (average age of onset is 46 years old). Currently, there are no FDA-approved treatments for SSc.
This fact coupled with the size of the patient population qualifies SSc as an orphan indication.
MRI-1867 is a dual-action, hybrid small molecule NCE that is an inverse agonist of the CB1 receptor of the endocannabinoid system and inhibitor of inducible nitric oxide synthase.
In pre-clinical testing conducted by the NIH, MRI-1867 demonstrated, in relevant animal models, that, when compared to a placebo, it slowed the progression of fibrosis and also attenuated pre-existing fibrosis in the liver, lung and skin.
Importantly, these pre-clinical animal studies also demonstrated that MRI-1867 did not cross the blood brain barrier, eliminating the potential for adverse CNS side effects that can present when cannabinoids bind to receptors in the brain. Further, MRI-1867 exhibited sufficient bioavailability with oral delivery and supported once daily dosing.
We are currently conducting IND-enabling work to support an IND filing with the FDA, which we plan to file in the first half of 2021.
We believe that an effective anti-fibrotic, anti-inflammatory drug that can be orally administered would address a significant unmet medical need in SSc with the potential for a multi-billion-dollar treatment market using conservative estimates for patient populations and annual treatment costs.
Our Scientific Advisory Board
We have assembled a team of recognized experts in drug development, cannabinoids and the endocannabinoid system and clinical medicine encompassing multiple clinical specialties and conditions.
These experts serve on our scientific advisory board, which is distinct from our board of directors, and provide us with advice on product development, clinical trial design and implementation and unmet clinical needs in a variety of clinical specialties. For additional information please refer to the section “Management – Our Scientific Advisory Board.”
We were incorporated in the State of Delaware on April 18, 2017 under the name Project18 Inc.
On December 11, 2017, we changed our name to Scopus BioPharma Inc. Our principal executive offices are located at 420 Lexington Avenue, New York, New York 10170. We also maintain offices in Tel Aviv and Jerusalem in Israel. Our corporate telephone number is (212) 479-2513.
Securities being offered by the company
________ Series A Units at $____ per unit.
Securities underlying Series A Units
One share of common stock, and
Two Series A Warrants; each exercisable for one Series B Unit at an exercise price of $____ per Series A Warrant.
|Securities underlying Series B Units|
One share of common stock, and
One Series B Warrant; each exercisable for one share of common stock at an exercise price of $________ per Series B Warrant.
Securities outstanding prior to this offering
12,359,855 shares of common stock.
1,140,145 warrants issued in private placements (“Private Placement Warrants”).
Securities outstanding after this offering
__________ shares of common stock.
__________ Series A Warrants.
Separation of Units
The shares of common stock and Series A Warrants underlying our Series A Units and the shares of common stock and Series B Warrants underlying the Series B Units will become eligible for trading separately on July 1, 2020 and April 1, 2021, respectively, unless we elect to allow such separate trading at an earlier date.
Terms of Series A Warrants
Exercisable beginning on October 1, 2020.
The Series A Warrants will expire on October 1, 2025.
Terms of Series B Warrants
Exercisable beginning on September 1, 2021.
The Series B Warrants will expire on September 1, 2026.
Redemption of Series A and Series B Warrants
Commencing on October 1, 2021 and September 1, 2022, the Series A Warrants and Series B Warrants, respectively, shall be subject to redemption, at our option, in whole or in part, at a price of $0.001 per warrant upon a minimum of 30 days prior notice if, and only if, the volume weighted price per share of our common stock for the 20 trading days ending two trading days prior to the date of notice equals or exceeds $____ for the Series A Warrants and $____ for the Series B Warrants, respectively, but only if there is a current registration statement in effect for the shares of common stock underlying these warrants.
The Company reserves the right to require exercise on a cashless basis upon notice of redemption.
Proposed trading symbols
Prior to this offering, there has been no public market for our units, shares of common stock or warrants. We intend to have our Series A Units, Series A Warrants and shares of common stock listed on Nasdaq under the symbols “______”, “____” and “___”.
At such time as the Series A Warrants can be exercised, we also plan to have our Series B Units and Series B Warrants listed on Nasdaq
under the symbols “___” and “__”. See “Underwriting.”
Use of proceeds
We estimate that the net proceeds to us from the offering, after deducting the underwriting discount and other estimated offering expenses payable by us, will be $_______.
The net proceeds available to us will be used as set forth in Use of Proceeds on page 28.
Prospective investors should carefully consider the Risk Factors beginning on page 6 before investing in the Series A Units offered hereby.
Summary CONSOLIDATED Financial Data
The following table sets forth a summary of our historical consolidated financial data as of, and for the periods ended on, the dates indicated.
The summary consolidated financial data was derived from our audited and unaudited consolidated financial statements, and should be read in conjunction with the consolidated financial statements and the accompanying notes, which are included elsewhere in this prospectus.
In addition, the summary consolidated financial data should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations, also included elsewhere in this prospectus.
|For the Period|
April 18, 2017
|For the Year|
|Three Months Ended|