8-K

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): May 15, 2018

ZOSANO PHARMA CORPORATION

(Exact name of registrant as specified in its charter)

Delaware	001-36570	45-4488360
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

34790 Ardentech Court

Fremont, CA 94555

(Address of principal executive offices) (Zip Code)

(510) 745-1200

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 (see General Instruction A.2. below):

☐ 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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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 2.02 Results of Operations and Financial Conditions.

On May 15, 2018, we issued a press released titled “Zosano Pharma Reports First Quarter 2018 Financial Results and Operational Update.” The press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 2.02.

The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit	Description
99.1	Press release dated May 15, 2018, titled “Zosano Pharma Reports First Quarter 2018 and Financial Results and Operational Update”

2

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.

	ZOSANO PHARMA CORPORATION
Dated: May 15, 2018	By:	/s/ John Walker
		Name: John Walker
		Title:   President and Chief Executive Officer

3

EX-99.1

Exhibit 99.1

Zosano Pharma Reports First Quarter 2018 Financial Results and Operational Update

• Completion of follow on offering netting $45.7 million

• Issuance of new US patent

• Long-term safety study now has 250 subjects enrolled

FREMONT, CA, May 15, 2018 - Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”) a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using its proprietary Adhesive Dermally-Applied Microarray (“ADAM™”) technology, today announced financial results for the first quarter ended March 31, 2018.

“We successfully completed an offering of 10 million shares of common stock at five dollars per share and passed the 250th mark in subjects enrolled in our long-term safety study, noting that the pain freedom and pain relief scores observed are consistent with the high degree of efficacy we achieved with M207 in our pivotal study”, stated John Walker Chairman and CEO. “With the newly issued IP protecting M207 through 2037, we are increasingly convinced that, if approved, M207 will be an important contributor to the treatment of migraines.”

Recent Business Highlights and Clinical Update

• In March 2018, Zosano announced that US patent 9,918,932 was issued. This will provide patent protection through the early part of 2037.

• Also in March 2018, we announced that the 100th patient had been enrolled in our long-term safety study of M207. To date, we have successfully enrolled 250 patients in the study and, importantly, over 1,000 migraines have been treated with observed pain freedom scores at two hours of 42% and pain relief scores at two hours of 85%.

• In April 2018, Zosano announced the closing of the public offering of 10 million shares of its common stock at a price of five dollars per share. The net proceeds to Zosano from this offering were $45.7 million after deducting underwriting discounts and commissions.

Financial Results for the First Quarter Ended March 31, 2018

• Zosano reported a net loss for the first quarter of 2018 of $8.2 million, or $4.16 per share on a basic and diluted basis, compared with a net loss of $7.0 million, or $6.89 per share on a basic and diluted basis, for the same quarter in 2017.

• Research and development (R&D) expenses for the first quarter of 2018 were $5.8 million, compared with $4.6 million for the same quarter in 2017. The increase was primarily attributable to an increase in clinical trial costs for the long-term safety study and to additional payroll costs resulting from new employees hired to support the long-term safety study.

• General and administrative (G&A) expenses for the first quarter of 2018 were $2.3 million, compared with $2.1 million for the same quarter in 2017. The increase was primarily attributable to increases in legal and tax expenses.

• As of March 31, 2018, we had cash and cash equivalents of $3.5 million, debt of $5.2 million, and approximately 2.0 million of common shares outstanding. In April 2018, Zosano announced the completion of a public offering of 10 million shares of common stock that generated aggregate net proceeds of $45.7 million.

About Migraine

Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine symptoms can include moderate to severe headache pain combined with nausea and vomiting, or abnormal sensitivity to light and sound. According to the Migraine Research Foundation, migraine affects 30 million men, women and children in the United States. Most migraines last between four and 24 hours, but some last as long as three days. According to published studies, 63% of migraine patients experience between one and four migraines per month. According to Decision Resources, prescription drug sales for migraine in the top seven countries were estimated to be $3.3 billion in 2015, and are expected to grow to over $10.0 billion in 2025. Triptans, a family of tryptamine-based drugs first sold in the 1990s, account for almost 75% of anti-migraine therapies prescribed at office visits.

About M207

M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano’s proprietary ADAM technology. Zosano’s ADAM technology consists of titanium microprojections coated with drug, and in the case of M207, our formulation of zolmitriptan. Our ADAM technology delivers drug by abrading the stratum corneum and allowing drug to be absorbed into the microcapillary system of the skin. In February 2017, the Company announced statistically significant results from the ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. In November 2017, the Company announced the initiation of its long-term safety study evaluating M207 and expects to file an NDA for M207 in the fourth quarter of 2019.

About Zosano Pharma

Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using our proprietary ADAM technology. The Company previously announced positive results from our ZOTRIP study that evaluated M207, which is our proprietary formulation of zolmitriptan delivered via our ADAM technology, as an acute treatment for migraine, and is currently conducting a long-term safety study of M207. Zosano is focused on developing products where rapid administration of established molecules with known safety and efficacy profiles provides an increased benefit to patients, for markets where patients remain underserved by existing therapies. The Company anticipates that its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” “unaudited,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

Zosano Contact:

John Walker

Chief Executive Officer and Chairman of the Board

510-745-1200

ZOSANO PHARMA CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(unaudited; in thousands, except per share amounts)

	Three Months Ended March 31,
	2018			2017
Revenue	$	—		$	—
Operating expenses:
Research and development		5,806			4,626
General and administrative		2,260			2,122
Total operating expenses		8,066			6,748
Loss from operations		(8,066	)		(6,748	)
Other expense:
Interest expense, net		(141	)		(247	)
Other income (expense), net		1			(2	)
Loss before provision for income taxes		(8,206	)		(6,997	)
Provision for income taxes		—			—
Net loss	$	(8,206	)	$	(6,997	)
Net loss per common share – basic and diluted	$	(4.16	)	$	(6.89	)
Weighted-average shares used in computing net loss per common share – basic and diluted		1,973			1,016

ZOSANO PHARMA CORPORATION

SELECTED CONDENSED BALANCE SHEET DATA

(in thousands)

	March 31,			December 31,
	2018			2017
	(unaudited)
Cash and cash equivalents	$	3,537		$	11,651
Total current assets		5,507			13,393
Total assets		10,372			18,000
Secured promissory note		5,160			6,687
Total liabilities		11,391			10,952
Stockholders’ (deficit) equity		(1,019	)		7,048

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