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): August 31, 2020

 

 

Pandion Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   001-39381   83-3015614
(State or Other Jurisdiction
of Incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

134 Coolidge Avenue

Watertown, Massachusetts

  02472
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 393-5925

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))

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    PAND    Nasdaq Global Select 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 2.02

Results of Operations and Financial Condition.

On August 31, 2020, Pandion Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2020. The full text of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 2.02, including Exhibit 99.1 attached hereto, 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 a filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

The following exhibit is furnished herewith:

 

99.1    Press Release issued by the Company on August 31, 2020


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.

 

   

PANDION THERAPEUTICS, INC.

Date: August 31, 2020     By:  

/s/ Rahul Kakkar

     

Name:

 

Rahul Kakkar

     

Title:

 

Chief Executive Officer

EX-99.1

Exhibit 99.1

Pandion Reports Second Quarter 2020 Financial Results and Provides

Business Update

- Completed successful IPO providing approximately $153 million in gross proceeds; cash runway

extended through first half of 2024

- Expanded executive team with appointment of John S. Sundy, M.D., Ph.D. as Chief Medical

Officer

- Announced issuance of U.S. patent for bifunctional molecules derived from TALON platform

WATERTOWN, Mass. – August 31, 2020 - Pandion Therapeutics, Inc. (Nasdaq: PAND), a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients suffering from autoimmune diseases, today reported financial results for the second quarter ended June 30, 2020 and provided a recent business update.

“The second quarter was marked by significant foundation-building milestones, including the growth of our team, followed by the completion of our IPO in July. We believe our platform enables a truly innovative approach to address autoimmune disease with modular proteins and bifunctional antibodies, and we look forward to advancing our pipeline as rapidly as possible,” said Rahul Kakkar, M.D., Chief Executive Officer of Pandion Therapeutics. “The capital raised from our IPO will enable the continued development of our lead product candidate, PT101, into and through Phase 1b/2a trials in ulcerative colitis, as well as allow us to advance earlier stage candidates into the clinic and continue the progression of our TALON discovery programs. We continue to look forward to reporting top-line Phase 1a data for PT101 in the first half of 2021. We are extremely proud of what our team has accomplished, and we aim to continue to innovate as we work towards our mission of developing and commercializing therapeutics for patients suffering from autoimmune diseases.”

Second Quarter & Recent Business Updates

 

   

Completed Initial Public Offering (IPO), raising approximately $153 million in gross proceeds. In July 2020, Pandion completed its IPO, selling approximately 8.5 million shares of common stock at a public offering price of $18.00 per share, which includes 994,166 shares issued in August 2020 pursuant to the partial exercise of the underwriter’s option to purchase additional shares. In connection with the IPO, Pandion converted from a Delaware limited liability company to a Delaware corporation.

 

   

Appointed John S. Sundy, M.D., Ph.D. as Chief Medical Officer. In May 2020, Pandion announced the appointment of John S. Sundy, M.D., Ph.D. as Chief Medical Officer. Dr. Sundy brings deep expertise in translational medicine and innovative drug development from his previous leadership role at Gilead.

 

   

Announced issuance of U.S. patent for bifunctional molecules derived from TALON platform. In June 2020, Pandion announced the U.S. Patent and Trademark Office issued U.S. Patent No. 10,676,516 with claims covering bifunctional molecules that target IL-2


 

muteins to tissues in the gut. The bifunctional molecules protected under this patent were developed using Pandion’s proprietary TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform that enables Pandion to create bifunctional product candidates designed to concentrate immune effector modulators within a target organ. Additional patent applications are pending in the U.S. and globally covering various immune effectors, tissue-targeted tethers, and combinations thereof.

Financial Results for Second Quarter of 2020:

 

   

Cash Position: Cash and cash equivalents were $105.7 million as of June 30, 2020 as compared to $16.0 million as of December 31, 2019. The June 30, 2020 cash balance does not include the proceeds from the company’s IPO which closed in the third quarter of 2020 and raised approximately $153 million in gross proceeds.

 

   

Research and Development (R&D) Expenses: R&D expenses were $8.9 million for the quarter ended June 30, 2020, compared to $4.9 million for the quarter ended June 30, 2019. The increase was primarily due to higher consulting services and development activities outsourced to Contract Research Organizations. The company also had a $1.2 million increase in personnel related costs and a $0.5 million increase in facility and equipment costs.

 

   

General and Administrative (G&A) Expenses: G&A expenses were $2.3 million for the quarter ended June 30, 2020, compared to $0.8 million for the quarter ended June 30, 2019. The increase was primarily due to a $1.0 million increase in professional services and $0.3 million in personnel-related costs.

 

   

Net Loss: Net loss attributable to common shareholders was $11.9 million, or a net loss of $10.15 per basic and diluted share, for the quarter ended June 30, 2020, compared to $6.7 million, or a net loss of $6.30 per basic and diluted share, for the quarter ended June 30, 2019.

About Pandion Therapeutics

Pandion Therapeutics is developing novel therapeutics designed to address the unmet needs of patients suffering from autoimmune diseases. Pandion’s TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform enables the company to create a pipeline of product candidates using immunomodulatory effector modules, with the ability to also combine an effector module with a tissue-targeted tether module in a bifunctional format. Pandion’s lead product candidate PT101, a combination of an interleukin-2 mutein effector module with a protein backbone, is designed to selectively expand regulatory T cells systemically, without activating proinflammatory cells, such as conventional T cells and natural killer cells, is currently in a Phase 1a clinical trial. Pandion is continuing to develop and expand its library of effector and tether modules as part of its earlier-stage research and discovery pipeline. For more information, please visit www.pandiontx.com.


Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy and clinical development plans, timelines and prospects, the timing of availability of clinical trial data and the Company’s ability to fund its operations through the first half of 2024, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Pandion’s ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; initiate preclinical studies and clinical trials of PT101 and its other product candidates; advance PT101 and its other product candidates in preclinical research and clinical trials; replicate in clinical trials positive results found in preclinical studies; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.


Condensed Consolidated Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2020      2019      2020      2019  

Revenue

   $ 1,955      $ —        $ 3,956      $ —    

Operating Expenses

           

Research and development

     8,860        4,934        15,802        10,019  

General and administrative

     2,297        840        3,863        1,614  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total operating expenses

     11,157        5,774        19,665        11,633  
  

 

 

    

 

 

    

 

 

    

 

 

 

Loss from operations

     (9,202      (5,774      (15,709      (11,633

Interest income

     4        89        45        143  

Interest expense

     (39      —          (82      —    

Fair value adjustments to convertible note

     —          —          89        —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Net Loss

     (9,237      (5,685      (15,657      (11,490

Change in redemption value of redeemable convertible preferred shares

     (2,712      (982      (4,245      (1,936
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss attributable to common shareholders

     (11,949      (6,667      (19,902      (13,426
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss per common share, basic and diluted

   $ (10.15    $ (6.30    $ (17.23    $ (13.19
  

 

 

    

 

 

    

 

 

    

 

 

 

Weighted-average number of shares outstanding used in computing net loss per common share, basic and diluted

     1,177,479        1,057,617        1,154,856        1,018,254  
  

 

 

    

 

 

    

 

 

    

 

 

 

Condensed Balance Sheet Data

(in thousands)

 

     June 30
2020
     December 31,
2019
 
     (unaudited)         

Cash and cash equivalents

   $ 105,725      $ 15,970  

Total assets

     113,514        21,019  

Total liabilities

     23,400        16,841  

Total members’ deficit

     (62,482      (42,789

Contacts

Media:

Kathryn Morris

The Yates Network

914-204-6412

kathryn@theyatesnetwork.com

Investors:

Sarah McCabe

Stern Investor Relations, Inc.

212-362-1200

Sarah.mccabe@sternir.com