ZSAN Zosano Pharma Corporation

 

 

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): September 28, 2015

 

 

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))

 

 

 

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Item 1.02

Termination of a Material Definitive Agreement.

On September 28, 2015, we terminated the Collaboration, Development and License Agreement dated as of November 21, 2014, or Collaboration Agreement, between Eli Lilly and Company, or Lilly, and our wholly owned subsidiary, ZP Opco, Inc. We terminated the Collaboration Agreement in accordance with its terms following our determination that it is commercially unreasonable to pursue one of the critical success factors under the Collaboration Agreement, relating to worldwide regulatory approval of Daily ZP-PTH by 2019.

The Collaboration Agreement provided for the development of one or more microneedle patch products to administer ZP-PTH, our proprietary formulation of teriparatide, a synthetic form of parathyroid hormone (PTH 1-34) for the treatment of severe osteoporosis, with the initial product candidate being Daily ZP-PTH, a daily administration of ZP-PTH. Under the Collaboration Agreement, we granted to Lilly an exclusive, worldwide license to commercialize ZP-PTH in all dosing frequencies, and we would have been eligible to receive non-refundable milestone payments from Lilly totaling up to $300 million upon achievement of certain regulatory approvals of Daily ZP-PTH and up to $125 million upon achievement of certain sales milestones for Daily ZP-PTH. We also would have been eligible to receive royalties on sales of Daily ZP-PTH in major markets and reimbursement of manufacturing costs for commercial supplies of Daily ZP-PTH. Lilly would have been responsible, pending successful clinical trial outcomes and regulatory approval, for commercialization of Daily ZP-PTH.

As a result of the termination of the Collaboration Agreement, the exclusive, worldwide license that we granted to Lilly terminated and reverted to us, and we will no longer be eligible to receive any milestone or other payments from Lilly. If, prior to August 19, 2019, we decide to resume development of Daily ZP-PTH, then we will be required to notify Lilly and offer to reinstate the Collaboration Agreement on the same terms or on other mutually agreeable terms.

Lilly beneficially owns more than ten percent of our outstanding common stock, which it acquired in connection with the Collaboration Agreement.

On September 28, 2015, we issued a press release, a copy of which is attached hereto as Exhibit 99.1, announcing the termination of the Collaboration Agreement.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

Exhibit		Description
99.1		Press release dated September 28, 2015, entitled “Zosano Pharma Resumes Development of Weekly ZP-PTH Treatment for Severe Osteoporosis.”

 

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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: September 28, 2015		By:		/s/ Vikram Lamba
				Name: Vikram Lamba
				Title: President and Chief Executive Officer

 

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EXHIBIT INDEX

 

Exhibit		Description
99.1		Press release dated September 28, 2015, entitled “Zosano Pharma Resumes Development of Weekly ZP-PTH Treatment for Severe Osteoporosis.”

 

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Exhibit 99.1

 

FOR IMMEDIATE RELEASE

ZOSANO PHARMA RESUMES DEVELOPMENT OF WEEKLY ZP-PTH TREATMENT

FOR SEVERE OSTEOPOROSIS

Company announces discontinuation of development of Daily ZP-PTH and

terminates collaboration with Eli Lilly and Company

Zosano to host webcast and conference call today at 5:00 p.m. ET

FREMONT, CA, September 28, 2015 – Zosano Pharma Corporation (NASDAQ: ZSAN) announced today that the company has decided to discontinue development of its Daily ZP-PTH treatment for severe osteoporosis and to resume development of its Weekly ZP-PTH product.

Zosano’s decision to discontinue development of Daily ZP-PTH is driven by recent feedback from Japanese regulatory authorities, which would have required additional studies that would have likely delayed commercialization in Japan by approximately one year, as well as an overall assessment and prioritization of company resources towards the most promising commercial opportunities. After discussions with Lilly, the companies agreed to terminate the collaboration agreement that they signed in 2014.

Zosano will resume its efforts to develop a Weekly ZP-PTH product, as the company had been doing prior to its collaboration with Lilly. In early 2014, Zosano completed a Phase 1 clinical trial of Weekly ZP-PTH in Australia and in July 2014 held a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to discuss the clinical trial design for a planned Phase 2 and Phase 3 trial of Weekly ZP-PTH. Zosano is now planning to initiate a Phase 2 trial of Weekly ZP-PTH in the first half of 2016.

“While we have received positive feedback from the FDA and were on track to initiate a Phase 3 trial of Daily ZP-PTH in the U.S., we believe that committing significant capital and other resources to development of Daily ZP-PTH is not a prudent investment given the recent feedback received from Japanese regulatory authorities and the significant milestone payments associated with approval in Japan. Although we have made the decision to terminate our contract with Lilly due to business reasons, we are extremely thankful for their support and collaboration,” said Vikram Lamba, Zosano’s Chief Executive Officer. “Our Weekly ZP-PTH patch has strong clinical data and is well-differentiated compared to competitive products. As we finalize our plans for further development of Weekly ZP-PTH, we look forward to announcing results from a Phase 2 trial of our ZP-Glucagon product within the next few weeks and results from a Phase 1 trial of our ZP-Triptan product before the end of 2015.”

Webcast and Conference Call

Zosano management will host a webcast and conference call to discuss this announcement at 5:00 p.m. ET today. The live call may be accessed by dialing 1-866-410-5537 for domestic callers and 1-704-908-0329 for international callers. The conference ID is 49587251. A live webcast of the call will be available from the investor relations section of the company’s website at ir.zosanopharma.com, and will be archived there for 30 days.

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About Zosano Pharma

Zosano Pharma Corporation is a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of a variety of indications. Zosano’s microneedle patch system offers rapid onset, consistent drug delivery, improved ease of use and room-temperature stability, benefits that the company believes often are unavailable using oral formulations or injections. Zosano’s microneedle patch system has the potential to deliver numerous medications for a wide variety of indications in commercially attractive markets. It has been tested in more than 400 patients with over 30,000 patches successfully applied to humans in Phase 1 and Phase 2 clinical studies. 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 Zosano Pharma’s 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 Annual Report on Form 10-K for the year ended December 31, 2014 filed with Securities and Exchange Commission on March 26, 2015. Although the company believes that the expectations reflected in these forward-looking statements are reasonable, it 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:

Vikram Lamba

Chief Executive Officer

510-745-1200

Investor Contact:

Patti Bank

Westwicke Partners

415-513-1284

patti.bank@westwicke.com

Media Contact:

Jamie Lacey-Moreira

PressComm PR, LLC

410-299-3310

jamielacey@presscommpr.com

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