Toggle SGML Header (+)


Section 1: 8-K (FORM 8-K)

dffn20191115_8k.htm

 



UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 


FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 


Date of Report (Date of earliest event reported): November 15, 2019

 


 

DIFFUSION PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

 

Delaware

000-24477

30-0645032

(State or other jurisdiction of

incorporation)

(Commission File

Number)

(I.R.S. Employer

Identification No.)

 

1317 Carlton Avenue, Suite 200

Charlottesville, Virginia

 

22902

(Address of principal executive offices)

(Zip Code)

 

(434) 220-0718

(Registrant’s telephone number, including area code)

 

Not applicable

(Former name 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 communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐     Pre-commencement 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 Stock, par value $0.001 per share

DFFN

NASDAQ Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company 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. 

 

 

 

 

Item 8.01.

 

Other Events.

 

On November 15, 2019, Diffusion Pharmaceuticals Inc. (the “Company”) issued a press release announcing that the Company had closed its previously announced public offering of 5,104,429 shares of its common stock, par value $0.001 per share (the “Common Stock”), 6,324,143 pre-funded warrants each to purchase one share of Common Stock, together with common warrants to purchase up to 22,857,144 shares of Common Stock. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

 

Item 9.01.

 

Financial Statements and Exhibits.

 

(d) Exhibits

 
   

Exhibit No.

Description

Exhibit 99.1

Press release issued November 15, 2019

 

 

 

 

SIGNATURES

 

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

 

 

 

Dated: November 15, 2019 

DIFFUSION PHARMACEUTICALS INC.

 

 

 

 

 

 

 

 

 

 

By:

/s/ David G. Kalergis

 

 

Name:

David G. Kalergis

 

 

Title:

Chief Executive Officer

 

 

           

(Back To Top)

Section 2: EX-99.1 (EXHIBIT 99.1)

ex_165115.htm

Exhibit 99.1

 

 

Diffusion Pharmaceuticals Announces Closing of $4.0 Million Public Offering

 


Charlottesville, Va. (November 15, 2019) – Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) (“Diffusion,” the “Company,” “we,” “our” or “us”) a clinical-stage biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it is needed most, today announced the closing of its previously announced public offering of an aggregate of 11,428,572 shares of common stock (or common stock equivalents) of the Company, together with accompanying common warrants, at a public offering price of $0.35 per share and associated warrants. Each share of common stock (or common stock equivalent) sold in the offering was sold collectively with (i) a common warrant to purchase one share of common stock expiring eighteen months from the date of issuance and (ii) a common warrant to purchase one share of common stock expiring five years from the date of issuance. Each common warrant has an exercise price of $0.35.

 

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

 

The gross proceeds to Diffusion from this offering are $4.0 million, before deducting the placement agent’s fees and other estimated offering expenses payable by Diffusion, and assuming none of the common warrants issued in this offering are exercised.

 

Diffusion anticipates using the net proceeds from the offering to fund research and development of its lead product candidate, transcrocetinate sodium, also known as trans sodium crocetinate (TSC), including clinical trial activities, and for general corporate purposes.

 

The securities described above were offered by the Company pursuant to a registration statement (File No. 333-234234) previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on November 13, 2019. A prospectus relating to the securities being offered was filed with the SEC on November 15, 2019 and is available on the SEC’s website at http://www.sec.gov. Electronic copies of the final prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at http://www.sec.gov.

 

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation or sale is unlawful. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.

 

About Diffusion Pharmaceuticals Inc.

 

Diffusion Pharmaceuticals Inc. is an innovative biotechnology company developing new treatments that improve the body’s ability to bring oxygen to the areas where it is needed most, offering new hope for the treatment of life-threatening medical conditions.

 

Diffusion’s lead drug, TSC, was originally developed in conjunction with the Office of Naval Research, which was seeking a way to treat hemorrhagic shock caused by massive blood loss on the battlefield.

 

 

 

 

Evolutions in research have led to Diffusion’s focus today: Fueling Life by taking on some of medicine’s most intractable and difficult-to-treat diseases, including stroke and GBM brain cancer. In each of these diseases, hypoxia – oxygen deprivation of essential tissue in the body – has proved to be a significant obstacle for medical providers and the target for TSC’s novel mechanism.

 

Its on-ambulance PHAST-TSC acute stroke protocol has begun patient enrollment. In July 2019 the Company reported favorable safety data in a 19-patient dose-escalation run-in study to its Phase 3 INTACT program, using TSC to target inoperable GBM brain cancer. Additional preclinical data supports the potential use of TSC as a treatment for other conditions where hypoxia plays a major role, such as myocardial infarction, respiratory diseases such as COPD, peripheral artery disease, and neurodegenerative conditions such as Alzheimer’s and Parkinson’s disease.

 

In addition, RES-529, the Company’s PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes, is in preclinical testing for GBM.

 

Diffusion is headquartered in Charlottesville, Virginia – a hub of advancement in the life science and biopharmaceutical industries – and is led by CEO David Kalergis, a 30-year industry veteran and company co-founder.

 

Forward-Looking Statements

 

To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the company's plans, objectives, expectations  and intentions with respect to future operations and products, the potential of the company's technology and product candidates, the anticipated timing of future clinical trials, and other statements that are not historical in nature, particularly those that utilize terminology such as "would," "will," "plans," "possibility," "potential," "future," "expects," "anticipates," "believes," "intends," "continue," "expects," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause the Diffusion’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include: the use of proceeds of this offering; the difficulty of developing pharmaceutical products; obtaining regulatory and other approvals and achieving market acceptance; general business and economic conditions; the company's need for and ability to obtain additional financing or partnering arrangements; and the various risk factors (many of which are beyond Diffusion’s control) as described under the heading “Risk Factors” in Diffusion’s filings with the United States Securities and Exchange Commission. All forward-looking statements in this news release speak only as of the date of this news release and are based on management's current beliefs and expectations. Diffusion undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 

 

Contacts:

David Kalergis, CEO

Diffusion Pharmaceuticals Inc.

(434) 220-0718

[email protected]

 

LHA Investor Relations

Kim Sutton Golodetz

(212) 838-3777

[email protected] 

(Back To Top)