424B2

424B2 1 d23719d424b2.htm 424B2 424B2

Filed Pursuant to Rule 424(b)(2)

File No. 333-251305

PROSPECTUS

LOGO

12,364,568 Shares of Common Stock

Offered by the Selling Stockholders

This prospectus relates to the proposed resale or other disposition of an aggregate of 12,364,568 shares of our Common Stock, $0.001 par value per share (the “Shares”), by the selling stockholders identified in this prospectus (collectively with any of the holders’ transferees, pledgees, donees or successors, the “Selling Stockholders”). The Shares covered by this prospectus consist of (i) 12,065,875 Shares that are issuable upon conversion of Series X¹ Preferred Stock that was issued in a private placement transaction dated September 14, 2020 and (ii) 298,693 Shares that are issuable upon conversion of Series X¹ Preferred Stock underlying warrants that the Company assumed in connection with the acquisition of Anelixis Therapeutics, Inc. on September 14, 2020.

The Company will not receive any proceeds from the sale by the Selling Stockholders of the Shares. We are paying the cost of registering the Shares covered by this prospectus as well as various related expenses. The Selling Stockholders are responsible for all selling commissions, transfer taxes and other costs related to the offer and sale of its shares.

Sales of the Shares by the Selling Stockholders may occur at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices. The Selling Stockholders may sell shares to or through underwriters, broker-dealers or agents, who may receive compensation in the form of discounts, concessions or commissions from the Selling Stockholders, the purchasers of the shares, or both. If required, the number of shares to be sold, the public offering price of those shares, the names of any underwriters, broker-dealers or agents and any applicable commission or discount will be included in a supplement to this prospectus, called a prospectus supplement. See the disclosure under the heading “Plan of Distribution” elsewhere in this prospectus for more information about how the Selling Stockholders may sell or otherwise dispose of their Shares hereunder.

The Company’s Common Stock is traded on The Nasdaq Capital Market under the symbol “NVUS.” On December 21, 2020, the closing sale price of our Common Stock was $17.00 per share.

Investing in our common stock involves a high degree of risk. Please read the information contained in and incorporated by reference under the heading “Risk Factors” beginning on page 6 of this prospectus, and under similar headings in the other documents that are filed after the date hereof and incorporated by reference into this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

This prospectus is dated December 22, 2020

TABLE OF CONTENTS


	Page No.
ABOUT THIS PROSPECTUS		1
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS		2
THE COMPANY		3
SELECTED FINANCIAL DATA		4
RISK FACTORS		6
USE OF PROCEEDS		7
SELLING STOCKHOLDERS		8
PLAN OF DISTRIBUTION		10
LEGAL MATTERS		13
EXPERTS		13
WHERE YOU CAN FIND MORE INFORMATION		13
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE		13

ABOUT THIS PROSPECTUS

You should read this prospectus, any applicable prospectus supplement and the information incorporated by reference in this prospectus before making an investment in the securities of Novus Therapeutics, Inc. See “Where You Can Find More Information” and “Incorporation of Certain Information by Reference” for additional information. You should rely only on the information contained in or incorporated by reference in this prospectus or a prospectus supplement. The Company has not authorized anyone to provide you with different information. This document may be used only in jurisdictions where offers and sales of these securities are permitted. You should assume that information contained in this prospectus, or in any document incorporated by reference, is accurate only as of any date on the front cover of the applicable document. Our business, financial condition, results of operations and prospects may have changed since that date.

Unless otherwise indicated, references to the terms “Novus,” “our,” “us,” “we”, or the “Company” refer to Novus Therapeutics, Inc. and its wholly-owned subsidiaries, on a consolidated basis.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus and the information incorporated by reference in this prospectus contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995, which statements involve substantial risks and uncertainties. Any statements about the Company’s future expectations, plans and prospects, including statements about its strategy, future operations, and development of its product candidates and other statements containing words such as “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “could,” “may,” and similar expressions, constitute forward-looking statements, although not all forward-looking statements include such identifying words. Forward-looking statements include, but are not limited to statements regarding:

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our short operating history and the Anelixis acquisition, which may make it difficult to evaluate the success of our business to date and to assess our future viability;

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the impact of the COVID-19 pandemic on our operations, including our ability to access capital markets;

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expectations regarding the timing for the commencement and completion of product development or clinical trials for the Company’s product candidates;

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the timing, costs, conduct and outcome of preclinical studies and clinical trials;

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meeting future clinical and regulatory milestones, such as New Drug Application (“NDA”) submissions;

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the risk that clinical trials of the Company’s product candidates may not be successful in establishing safety and tolerability or efficacy;

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the Company’s plans and timing with respect to seeking regulatory approvals and uncertainties regarding the regulatory process;

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the anticipated treatment of data by the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”) or other regulatory authorities of the Company’s product candidates;

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the rate and degree of market acceptance and clinical utility of the Company’s product candidates;

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the Company’s commercialization, marketing, and manufacturing capabilities and strategy;

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the Company’s intellectual property position and strategy;

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the Company’s ability to identify additional product candidates with significant commercial potential;

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the availability of funds and resources to pursue the Company’s research and development projects, including preclinical studies and clinical trials of its product candidates, and manufacturing activities.

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the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

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developments relating to the Company’s competitors and industry; the impact of government laws and regulations; and

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the duration over which the Company’s cash balances will fund its operations.

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the ability to develop commercially viable product formulations on a timely basis, or at all; the sufficiency of the Company’s cash resources; the ability to obtain necessary regulatory and ethics approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product; whether any such submission will receive approval from the FDA or equivalent foreign regulatory agencies and, if the Company is able to obtain such approval for an investigational product, whether it will be successfully distributed and marketed; and the duration of the COVID-19 pandemic, including economic and other impacts of the pandemic and of and actions taken in response to it by governments, businesses, and individuals. These risks and uncertainties, as well as other risks and uncertainties that could cause the Company’s actual results to differ significantly from the forward-looking statements contained herein, are described in greater detail in described under the heading “Risk Factors” in this prospectus.

THE COMPANY

Overview

Novus is a biopharmaceutical company focused on developing life-changing, targeted medicines for patients undergoing organ or cellular transplantation, as well as those living with immunological diseases. Our lead product candidate, AT-1501, is a humanized monoclonal antibody (mAb), designed to target CD40 Ligand (“CD40L,” also called CD154), a molecule expressed on the surface of human immune system T cells. The central role of CD40/CD40L signaling in generating pro-inflammatory responses makes it an attractive candidate for therapeutic intervention in autoimmune disease, induction and maintenance of transplant tolerance, and neuroinflammation. Blocking the activation of the CD40L pathway ameliorates disease progression and pathology in preclinical models of autoimmunity and prevents acute and long-term allograft transplant rejection in multiple animal species.

We currently plan to develop AT-1501 in up to 4 indications: prevention of kidney allograft rejection, prevention of islet cell allograft rejection, treatment of autoimmune nephritis, and treatment of amyotrophic lateral sclerosis (“ALS”). AT-1501 successfully completed a Phase 1 study in healthy subjects and a cohort of subjects with ALS and has received an orphan drug designation from the U.S. FDA for the treatment of ALS.

In September 2020, we acquired Anelixis Therapeutics, Inc. (“Anelixis”), the company that owned or controlled the intellectual property related to AT-1501, a humanized IgG1 anti-CD40L antibody lacking Fc effector function. AT-1501 is designed to inhibit signaling via CD40L, a costimulatory type II membrane receptor expressed on activated T cells and CD40, a receptor expressed on Antigen Presenting Cells (“APC”s). Interactions between B cell expressing CD40, and activated CD4+ “helper” T cells expressing CD40L, play a critical role in promoting germinal center formation, clonal expansion, antibody production, and secretion of pro-inflammatory cytokines that amplify immune response. The role of CD40 in B cells has been extensively characterized and has been shown to be essential for productive primary and secondary humoral immune responses to T cell dependent antigens. Anti CD40L antibodies also inhibit both CD40 as well as CD11 costimulatory receptors on antigen presenting cells, thus inhibiting the pro-inflammatory polarization of CD4+ and CD8+ lymphocytes. Blocking the ligand also polarizes CD4+ lymphocytes to FoxP3 positive Tregs, a specialized subpopulation of T cells that act to suppress immune response, which functionally secrete IL10 and other cytokines creating a more tolerogenic environment. Finally, blocking the CD-CD40L pathway has not been shown to cause systemic lymphopenia.

Our business strategy is to optimize the clinical and commercial value of AT-1501 and become a global biopharmaceutical company with a focused autoimmune franchise.

Reverse Stock Split

In October 2020, we effected a reverse stock-split of our issued and outstanding Common Stock and options for Common Stock at a ratio of one-for-eighteen (the “Reverse Stock Split”). The Reverse Stock Split reduces the number of shares of common stock issuable upon the conversion of the Company’s outstanding preferred stock and the exercise or vesting of its outstanding stock options, restricted stock units and warrants in proportion to the ratio of the reverse stock split and causes a proportionate increase in the conversion and exercise prices of such convertible notes, stock options and warrants. The par value per common share remained unchanged. Except where the context otherwise requires, share numbers in this prospectus reflect the Reverse Stock Split.

Corporate Information

We were incorporated under the laws of the State of Delaware on March 26, 2004 under the name Tokai Pharmaceuticals, Inc. and we changed our name to Novus Therapeutics on May 9, 2017. Our principal executive offices are located at 19900 MacArthur Boulevard, Suite 550, Irvine, California 92612, and our telephone number is (949) 238-8090. Our website address is novustherapeutics.com. The information contained in, or accessible through, our website does not constitute part of this prospectus. We have included our website address in this prospectus solely as an inactive textual reference.

SELECTED FINANCIAL DATA

The following selected financial data has been derived from our audited consolidated financial statements included in our Annual Report on Form 10-K filed with the SEC on March 17, 2020, and our unaudited consolidated financial statements included in our Quarterly Reports on Form 10-Q filed with the SEC on May 15, 2020, and August 14, 2020, as adjusted to reflect the Reverse Stock Split for all periods presented. Our unaudited consolidated financial statements included in our Quarterly Report on Form 10-Q filed with the SEC on November 16, 2020 gave retroactive effect to the reverse stock-split for all periods presented. Our historical results are not indicative of the results that may be expected in the future and results of interim periods are not indicative of the results for the entire year. In addition, the below presented historical results do not present the pro forma impact of the acquisition of Anelixis, as presented in the unaudited pro forma financial statements and accompanying notes for the six months ended June 30, 2020 and the fiscal year ended December 31, 2019 contained in the Company’s definitive proxy statement on Schedule 14A dated November 20, 2020 as Annex D thereto and incorporated herein by reference.

AS REPORTED


(in thousands, except share and per share amounts)	Years Ended December 31,
	2019			2018
Net loss and comprehensive loss	$	(16,011	)	$	(14,065	)
Net loss per share, basic and diluted	$	(1.36	)	$	(1.56	)
Weighted-average common shares outstanding, basic and diluted		11,799,468			9,005,352
Common shares outstanding at year end		12,967,338			9,422,143

	Three Months Ended March 31,
	2020			2019
	(Unaudited)
Net loss and comprehensive loss	$	(8,177	)	$	(4,881	)
Net loss per share, basic and diluted	$	(0.47	)	$	(0.52	)
Weighted-average common shares outstanding, basic and diluted		17,267,123			9,427,073
Common shares outstanding at period end		16,069,562			9,447,361

	Three Months Ended June 30,
	2020			2019
	(Unaudited)
Net loss and comprehensive loss	$	(2,586	)	$	(4,093	)
Net loss per share, basic and diluted	$	(0.15	)	$	(0.35	)
Weighted-average common shares outstanding, basic and diluted		16,981,540			11,751,110
Common shares outstanding at period end		19,379,562			12,974,923

	Six Months Ended June 30,
	2020			2019
	(Unaudited)
Net loss and comprehensive loss	$	(10,763	)	$	(8,974	)
Net loss per share, basic and diluted	$	(0.63	)	$	(0.85	)
Weighted-average common shares outstanding, basic and diluted		17,124,331			10,595,511
Common shares outstanding at period end		19,379,562			12,974,923

AS ADJUSTED FOR ONE-FOR-EIGHTEEN REVERSE STOCK SPLIT


(unaudited, in thousands, except share and per share amounts):	Years Ended December 31,
	2019			2018
	(Unaudited)
Net loss and comprehensive loss	$	(16,011	)	$	(14,065	)
Net loss per share, basic and diluted	$	(24.42	)	$	(28.11	)
Weighted-average common shares outstanding, basic and diluted		655,526			500,297
Common shares outstanding at year end		720,407			523,452

	Three Months Ended March 31,
	2020			2019
	(Unaudited)
Net loss and comprehensive loss	$	(8,177	)	$	(4,881	)
Net loss per share, basic and diluted	$	(8.52	)	$	(9.32	)
Weighted-average common shares outstanding, basic and diluted		959,285			523,726
Common shares outstanding at period end		892,753			524,853

	Three Months Ended June 30,
	2020			2019
	(Unaudited)
Net loss and comprehensive loss	$	(2,586	)	$	(4,093	)
Net loss per share, basic and diluted	$	(2.74	)	$	(6.27	)
Weighted-average common shares outstanding, basic and diluted		943,419			652,839
Common shares outstanding at period end		1,076,642			720,829

	Six Months Ended June 30,
	2020			2019
	(Unaudited)
Net loss and comprehensive loss	$	(10,763	)	$	(8,974	)
Net loss per share, basic and diluted	$	(11.31	)	$	(15.25	)
Weighted-average common shares outstanding, basic and diluted		951,352			588,640

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SEC Form 4 filed