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): March 28, 2018

 

 

ALPINE IMMUNE SCIENCES, INC.

(Exact name of registrant as specified in its Charter)

 

 

 

Delaware   001-37449   20-8969493

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

201 Elliott Avenue West, Suite 230

Seattle, WA 98119

(Address of principal executive offices)

Registrant’s telephone number including area code: (206) 788-4545

(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))

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 2.02 Results of Operations and Financial Condition.

On March 28, 2018, Alpine Immune Sciences, Inc. issued a press release providing a corporate update and reporting its full year 2017 financial results. A copy of the press release is furnished herewith as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.    Description
99.1   

Press Release dated March 28, 2018.

The information furnished in this Current Report under Item 2.02 and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.


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.

 

Date: March 28, 2018    

ALPINE IMMUNE SCIENCES, INC.

    By:  

/s/ Paul Rickey

   

Name:

 

Paul Rickey

   

Title:

 

Senior Vice President and Chief Financial Officer

EX-99.1

Exhibit 99.1

 

LOGO

Alpine Immune Sciences Provides Corporate Update and

Reports Full Year 2017 Financial Results

New preclinical data on ALPN-202 program to be presented at 2018 American Association for Cancer Research Annual Meeting

SEATTLE, WA – March 28, 2018 — Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a company focused on discovering and developing innovative, protein-based immunotherapies targeting the immune synapse to treat cancer, autoimmune, and inflammatory diseases, today provided a corporate update and reported financial results for the year ended December 31, 2017.

“We are pleased with the progress we have made and look forward to having two programs entering clinical trials from our proprietary Variant Immunoglobulin Domain (vlgD) technology. The preclinical data we have generated supports the biologic rationale of our approach and we believe Alpine is at the forefront of next-generation therapeutics capable of both inhibiting and/or activating multiple human immune system proteins simultaneously,” said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. “We expect to file an IND in the fourth quarter of 2018 for our lead autoimmune/inflammatory program ALPN-101, a potential first-in-class dual ICOS/CD28 antagonist, and an IND in 2019 for our lead oncology program ALPN-202, a dual PD-L1/CTLA-4 antagonist with CD28 costimulation.”

Alpine will present a poster at the upcoming 2018 American Association for Cancer Research (AACR) Annual Meeting. The poster will show data from preclinical experiments in the ALPN-202 program, which is based on a single vIgD protein capable of modulating multiple immune system targets for the treatment of cancer. Alpine’s CD80 vIgD-Fc fusion proteins are capable of antagonizing both PD-L1 and CTLA-4, while providing T cell costimulation via CD28:

 

  Poster Title: CD80 vlgD-Fc proteins combine checkpoint antagonism and costimulatory signaling for potent antitumor immunity
  Session Category: Clinical Research
  Session Title: Immune Checkpoints 4
  Session Date and Time: Tuesday, April 17, 2018 – 1:00 PM – 5:00 PM
  Location: McCormick Place South, Exhibit Hall A, Poster Section 25
  Poster Board #: 5

2017 Highlights

Completion of Preferred Financing and Merger with Nivalis Therapeutics: On July 24, 2017, Alpine closed its merger with Nivalis Therapeutics. The combined company, named Alpine Immune Sciences, Inc., began trading on the NASDAQ Global market on July 25, 2017 under the ticker symbol “ALPN”. Upon completion of the merger, Alpine had approximately $90 million in cash, cash equivalents, and short-term investments. This included $17.0 million in proceeds from the purchase of Alpine convertible preferred shares immediately prior to the merger from current Alpine investors OrbiMed Advisors, Frazier Healthcare Partners, and Alpine BioVentures at a purchase price of $12.74 per share.


American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP): Alpine’s poster at the 2017 ACR/ARHP Annual Meeting disclosed preclinical studies evaluating ALPN-101 program dual ICOS/CD28 antagonists generated by Alpine’s directed evolution platform. ICOSL vIgD-Fc fusion proteins demonstrated potent activity in an animal model of rheumatoid arthritis and in a humanized mouse model of graft vs. host disease (GvHD), suggesting ALPN-101 candidates could have potential clinical utility in multiple inflammatory diseases.

American Society of Hematology (ASH): At the 59th Annual ASH Meeting & Exposition, Alpine’s poster disclosed results from a preclinical study of the Company’s lead program, ALPN-101, in a humanized model of graft vs. host disease (GvHD). Results showed Alpine’s ICOSL vlgD-Fc fusion proteins demonstrated therapeutic efficacy, reducing GvHD disease activity and improving survival.

San Antonio Breast Cancer Symposium (SABCS): Alpine’s poster at the 40th Annual SABCS disclosed preclinical data combining vIgDs generated by its novel directed evolution platform with the monoclonal antibody trastuzumab. Alpine scientists fused a costimulatory ICOS/CD28 vIgD to trastuzumab with the goal of activating T cells against HER2-positive tumors in the tumor microenvironment. Results showed these trastuzumab-ICOSL “V-mAbs” promoted T cell proliferation and cytokine secretion.

Society for the Immunotherapy of Cancer (SITC): At the SITC 32nd Annual Meeting, Alpine’s poster disclosed distinct preclinical data from multiple novel immuno-oncology programs, all also generated from its vlgD technology. Multiple formats of vIgD-based proteins were functionally active, utilizing multiple mechanisms of action. Some suppressed tumors in an animal model. The demonstrated versatility of the scientific platform suggests it has the potential to contribute to the next generation of immuno-oncology therapeutics.

Full Year 2017 Financial Results

As of December 31, 2017, Alpine had cash, cash equivalents, and short-term investments totaling $81.2 million. Net cash used in operating activities for the year ended December 31, 2017 was $16.6 million compared to $3.8 million for the year ended December 31, 2016. Alpine recorded a net loss of $7.8 million and $1.2 million for the years ended December 31, 2017 and 2016, respectively.

Collaboration revenue for the year ended December 31, 2017 was $1.7 million compared to $2.9 million for the year ended December 31, 2016. The decrease was primarily attributable to the timing of revenue recognized under Alpine’s collaboration agreement with Kite Pharma, Inc., a Gilead (NASDAQ:GILD) company. As previously announced, under the terms of this research collaboration and license agreement, Alpine received upfront payments of $5.5 million, which were initially recorded as deferred revenue and expensed over the period of the research term. The research term of the agreement with Kite was extended in October 2017.

Research and development expenses for the year ended December 31, 2017 were $10.6 million compared to $3.0 million for the year ended December 31, 2016. The increase was primarily attributable to an increase in direct research, contract manufacturing, and process development activities to support ALPN-101, plus increases in research personnel related to expanding research and discovery programs and associated overhead and facility costs.

General and administrative expenses for the year ended December 31, 2017 were $6.1 million compared to $1.1 million for the same period in 2016. The increase was primarily attributable to professional and legal service fees to support the merger with Nivalis and operating as a public company, in addition to personnel-related expenses and costs associated with expanding the company’s operations as it accelerates preclinical activity.

The excess of the estimated fair value of net assets acquired over the acquisition consideration paid for Nivalis resulted in a bargain purchase gain to the statement of operations. This is a non-cash item.

Cash Guidance

The company expects to have cash to fund operations into 2020, including the clinical advancement of its lead autoimmune/inflammatory program, ALPN-101, and its lead oncology program, ALPN-202.

Alpine Immune Sciences, Inc. is focused on developing novel protein-based immunotherapies using its proprietary variant Ig Domain (vIgD) technology. vIgDs are designed to interact with multiple targets, including many present in the immune synapse. Alpine’s vIgDs are developed using its directed evolution platform, which produces proteins capable of either enhancing or diminishing an immune response and thereby may potentially apply therapeutically to cancer, autoimmune, and inflammatory diseases. Alpine has also developed Transmembrane Immunomodulatory Protein (TIP) technology, based on vIgDs, to potentially enhance engineered cellular therapies. For more information, visit www.alpineimmunesciences.com.


Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding Alpine’s platform technology, potential therapies, potential milestone and royalty payments, future development plans, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash to fund operations into 2020, expectations regarding the plans of its collaborator, and expectations regarding the potential efficacy and commercial potential of Alpine’s and its collaborator’s product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions among others. These forward-looking statements are based on current assumptions involving risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: Alpine’s discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products on a timely or cost-effective basis or at all; Alpine may not achieve additional milestone payments pursuant to its collaborations; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof, Alpine undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

“Transmembrane Immunomodulatory Protein,” “TIP,” “Variant Ig Domain,” “vIgD,” and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions. All other trademarks belong to their respective owners.

 

Alpine Immune Sciences, Inc.

     

Selected Condensed Consolidated Balance Sheet Data

     

(In thousands)

     
     December 31,  
     2017      2016  

Cash and cash equivalents

   $ 8,000      $ 11,819  

Short-term investments

     73,240        —    

Total current assets

     82,548        11,855  

Total assets

     85,222        12,595  

Total current liabilities

     1,895        2,404  

Total stockholders’ equity (deficit)

     78,917        (1,457

Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

     85,222        12,595  


Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) Data

      
(In thousands, except share and per share amounts)    Years Ended December 31,  
     2017     2016     2015  

Collaboration revenue

   $ 1,731     $ 2,950     $ 492  

Operating expenses:

      

Research and development

     10,626       2,989       422  

General and administrative

     6,079       1,149       441  
  

 

 

   

 

 

   

 

 

 

Total operating expenses

     16,705       4,138       863  
  

 

 

   

 

 

   

 

 

 

Loss from operations

     (14,974     (1,188     (371

Other income (expense):

      

Bargain purchase gain

     6,601       —         —    

Interest expense

     (152     —         —    

Interest and other income

     542       22       2  
  

 

 

   

 

 

   

 

 

 

Loss before taxes

     (7,983     (1,166     (369

Income tax benefit (expense)

     200       (66     —    
  

 

 

   

 

 

   

 

 

 

Basic and diluted net loss attributable to common stockholders

   $ (7,783   $ (1,232   $ (369
  

 

 

   

 

 

   

 

 

 

Comprehensive loss:

      

Unrealized loss on investments

     (59     —         —    
  

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (7,842   $ (1,232   $ (369
  

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per share applicable to common stockholders

   $ (1.20   $ (2.18   $ (0.74
  

 

 

   

 

 

   

 

 

 

Weighted-average shares used to compute basic and diluted net loss per share attributable to common stockholders

     6,481,665       564,816       496,900  
  

 

 

   

 

 

   

 

 

 

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