8-K - NVNO - Equibles

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORM8-K

CURRENTREPORT

Pursuantto Section 13 or 15(d) of the

SecuritiesExchange Act of 1934

Dateof Report (Date of earliest event reported): February 12, 2021 (February 9, 2021)

HancockJaffe Laboratories, Inc.

(Exactname of registrant as specified in its charter)

Delaware	001-38325	33-0936180
(State or other jurisdiction	(Commission	(I.R.S. Employer
of incorporation)	File Number)	Identification No.)

70Doppler

Irvine,California 92618

(Addressof principal executive offices) (Zip Code)

(949)261-2900

(Registrant’stelephone number, including area code)

N/A

(Formername or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common<br> Stock, par value $0.00001 per share	HJLI	The<br> NASDAQ Stock Market LLC
Warrant<br> to Purchase Common Stock	HJLIW	The<br> NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 pursuant to Section 13(a) of the Exchange Act. ☒

Item1.01 Entry into a Material Definitive Agreement.

On February 11, 2021, Hancock Jaffe Laboratories, Inc., a Delaware corporation (the “Company”), closed a firm commitment public offering of its securities for gross proceeds of approximately $41.4 million, including the exercise in full and closing of the over-allotment option granted to the underwriters in the offering (the “Offering”). The Offering was completed pursuant to an Underwriting Agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co. Inc., as representative of the several underwriters named therein (the “Underwriters”), dated February 9, 2021. In accordance with the terms of the Underwriting Agreement, the Underwriters purchased an aggregate of 5,914,284 units (the “Units”), consisting of (i) 5,914,284 shares of common stock (including 771,428 shares of common stock issued upon exercise of the Underwriters over-allotment option, the “Shares”) and (ii) warrants to purchase up to 2,957,142 shares of common stock (including warrants to purchase 385,714 shares of common stock issued upon exercise of the Underwriters over-allotment option the “Warrants”), at a public offering price of $7.00 per Unit.

The Warrants have an initial exercise price of $7.00 per share, subject to customary adjustments, and will expire five years from the date of issuance. The Warrants are exercisable immediately following closing. In connection with the issuance of the Warrants, the Company entered into a Warrant Agent Agreement (the “Warrant Agent Agreement”), with VStock Transfer, LLC, as warrant agent.

The Underwriting Agreement contains customary representations, warranties, covenants, agreements, and indemnification, including for liabilities under the Securities Act of 1933, as amended. In addition, pursuant to the terms of the Underwriting Agreement, the Company’s officers and directors agreed with the Underwriters to be subject to a lock-up period of 90 days and the Company also agreed to similar lock-up restrictions on the issuance and sale of Company securities for 90 days following the closing date of the Offering, in each case subject to customary exclusions.

The total discounts and expenses of the Offering are estimated to be approximately $3.3 million. The Company intends to use the net proceeds from the Offering for the continued development of its two lead products, VenoValve and the CoreoGraft, and for general corporate purposes, including working capital and investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies.

The foregoing summaries of the Underwriting Agreement, the Warrants and the Warrant Agent Agreement do not purport to be complete and are qualified in their entirety by reference to the form of Underwriting Agreement attached to the Registration Statement as Exhibit 1.1 and the form of Warrant and Warrant Agent Agreement attached to the Registration Statement as Exhibit 4.20.

The Offering of the Units was pursuant to a registration statement on Form S-1, as amended (File No. 333- 251528), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on February 8, 2021 and a registration statement on Form S-1 (File No. 333-252874) filed pursuant to Rule 462(b) of the Securities Act of 1933, as amended, which became effective on February 8, 2021. The final prospectus relating to the Offering has been filed with the SEC.

Item8.01 Other Events

The Company issued press releases announcing the pricing and closing of the Offering, which have been filed as Exhibits 99.1 and 99.2, respectively, to this Current Report.

Item9.01 Financial Statements and Exhibits.

(d)	Exhibits.

Exhibit Number	Description
99.1	Press Release, dated February 9, 2021
99.2	Press Release, dated February 11, 2021

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	HANCOCK JAFFE LABORATORIES, INC.
Dated:<br> February 12, 2021	/s/ Robert A. Berman
	Robert<br> A. Berman
	Chief<br> Executive Officer

Exhibit99.1

HancockJaffe Laboratories Announces Pricing of Upsized

$36Million Offering

IRVINE,California, February 9, 2021 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI), a developer of medical devices that restore cardiac and vascular health, today announced the pricing of its upsized underwritten public offering of units for gross proceeds of approximately $36 million, prior to deducting underwriting discounts and commissions and offering expenses payable by the company.

The public offering is comprised of 5,142,856 units, priced at a public offering price of $7.00 per unit, consisting of an aggregate of 5,142,856 shares of common stock and warrants to purchase 2,571,428 shares of common stock. The warrants have an exercise price of $7.00 per share and are exercisable for five years. The securities comprising the units are immediately separable and will be issued separately.

The closing of the public offering is expected to take place on or about February 11, 2021, subject to the satisfaction or waiver of customary closing conditions.

Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager in connection with the public offering.

In addition, the company has granted the underwriter a 45-day option to purchase up to 15% of the shares of common stock and/or additional warrants to cover over-allotments, if any, at the public offering price per share and per warrant, less the underwriting discounts and commissions.

The securities were offered pursuant to a registration statement on Form S-1, as amended (File No. 333- 251528), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on February 8, 2021 and a registration statement on Form S-1 (File No. 333-252874) filed pursuant to Rule 462(b) of the Securities Act of 1933, as amended, which became effective on February 8, 2021.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to the offering will be filed by the company with the SEC. When available, copies of the final prospectus can be obtained at the SEC’s website at www.sec.gov or from Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th floor, New York, NY 10019 or by email at prospectus@ladenburg.com.

AboutHancock Jaffe Laboratories, Inc.

HJLI specializes in developing and manufacturing bioprosthetic (tissue-based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. HJLI currently has two lead product candidates: the VenoValve, a porcine based valve that is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency; and the CoreoGraft, a bovine tissue-based off the shelf conduit intended to be used for coronary artery bypass surgery. For more information, please visit www.HancockJaffe.com.

CautionaryNote on Forward-Looking Statements

HJLIPress Contacts:

Nicole Martin

Tel: 949-261-2900

Email: info@hancockjaffe.com

SOURCE: Hancock Jaffe Laboratories, Inc.

Exhibit99.2

HancockJaffe Completes $41 Million Public Offering

CapitalRaise to Fund VenoValve U.S. Pivotal Trial

IRVINE,California, February 11, 2021 – HancockJaffe Laboratories, Inc. (Nasdaq: HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has successfully completed a public offering of its securities generating approximately $41.4 million of gross proceeds, prior to deducting underwriting discounts and commissions, and expenses. The Company sold 5,914,284 shares of common stock and warrants to purchase 2,971,142 common shares in the public offering.

Proceeds from the offering will be used for general working capital purposes, including funding of the company’s proposed U.S. pivotal trial for theVenoValve, a novel treatment for lower limb Chronic Venous Insufficiency (CVI) of the deep vein system.

“We believe that the capital from this financing should be more than sufficient to fund the VenoValve U.S. pivotal trial, and support the company into 2023,” said Hancock Jaffe CEO Robert Berman. “The current standard of care for deep venous CVI sufferers is ineffective and only treats symptoms, rather than the underlying structural valve issues. We developed the VenoValve to fill this large unmet medical need. With this funding, we expect to make substantial progress toward our goal of helping millions of CVI patients throughout the world.”

CVI is a debilitating condition that can make everyday tasks such as bathing, sleeping and walking extremely difficult for patients. CVI occurs when valves inside the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and venous hypertension. This results in leg swelling, pain, open sores (venous ulcers) and reduced mobility for patients. The current standard of care for deep venous CVI sufferers consists of compression garments and leg elevation.

One-year results from the first-in-man trial for the VenoValve, released in December 2020, demonstrated significant improvement in all study endpoints, including reflux, venous clinical severity scores (disease manifestations), and visual analog scale scoring for chronic pain, with a good safety profile. Interim results from the study were recently published online in the Journal of Vascular Surgery.

Last month, Hancock Jaffe had a successful pre-IDE meeting with the U.S. Food and Drug Administration (FDA) about the VenoValve and expects to file its application with the FDA in the first quarter of 2021 seeking IDE approval for commencing the VenoValve U.S. pivotal trial.

Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Estimates indicate that direct medical costs from CVI in the U.S. exceed $38 billion each year. There are currently no FDA-approved devices or effective treatments for deep venous CVI.

Ladenburg Thalmann & Co. Inc. acted as sole book-running manager in connection with the public offering. The securities were offered pursuant to a registration statement on Form S-1, as amended (File No. 333- 251528), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on February 8, 2021 and a registration statement on Form S-1 (File No. 333-252874) filed pursuant to Rule 462(b) of the Securities Act of 1933, as amended, which became effective on February 8, 2021.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to the offering was filed by the company with the SEC on February 10, 2021. Copies of the final prospectus can be obtained at the SEC’s website at www.sec.gov or from Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th floor, New York, NY 10019 or by email at prospectus@ladenburg.com.

AboutHancock Jaffe Laboratories, Inc.

Hancock Jaffe Laboratories (Nasdaq: HJLI) specializes in developing and manufacturing bioprosthetic (tissue-based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. HJLI currently has two lead product candidates: the VenoValve®, a porcine-based valve which is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency, and the CoreoGraft®, a bovine tissue-based off-the-shelf conduit intended to be used for coronary artery bypass surgery.

CautionaryNote on Forward-Looking Statements

This press release and any statements of stockholders, directors, employees, representatives and partners of Hancock Jaffe Laboratories, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to our liquidity and future cash position, the timing of filing of our IDE application and beginning patient enrollment, and the VenoValve’s ability to fill the unmet medical needs of CVI sufferers) may differ significantly from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

MEDIACONTACT:

Michelle McAdam, Chronic Communications, Inc.

michelle@chronic-comm.com

(310) 902-1274