8-K
false000182271100018227112022-03-292022-03-29

 

 

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 29, 2022

 

PARDES BIOSCIENCES, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

 

001-40067

 

85-2696306

(State or Other Jurisdiction

of Incorporation)

 

(Commission File Number)

 

(IRS Employer

Identification No.)

2173 Salk Avenue, Suite 250

PMB#052

Carlsbad, CA 92008

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: 415-649-8758

 

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 $0.0001 per share

 

PRDS

 

The Nasdaq Global 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).

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 7.01 Regulation FD Disclosure.

 

On March 29, 2022, Pardes Biosciences, Inc. (the “Company”) announced its financial results for the year ended December 31, 2021. The full text of the press release issued in connection with the announcement is attached 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 the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company 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.

Item 9.01 Exhibits.

 

(d) Exhibits

 

Exhibit No.

 

Description

99.1

 

Press Release by the Company dated March 29, 2022.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

1


 

SIGNATURES

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 thereunto duly authorized.

 

 

 

PARDES BIOSCIENCES, INC.

 

 

 

 

 

 

By:

/s/ Thomas G. Wiggans

 

 

Name:

Thomas G. Wiggans

 

 

Title:

Chief Executive Officer and Chair of the Board of Directors

Date: March 29, 2022

2


EX-99.1

EXHIBIT 99.1

https://cdn.kscope.io/76f94b6f108f19e812b358af0e1b32a5-img256556724_0.jpg 

 

Pardes Biosciences Reports Full Year 2021 Financial Results and Provides Business Update

CARLSBAD, Calif. March 29, 2022 (GLOBE NEWSWIRE) – Pardes Biosciences, Inc. (NASDAQ: PRDS), a clinical-stage biopharmaceutical company developing PBI-0451 as a potential stand-alone novel direct-acting, oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases (i.e., COVID-19), today reported financial results for the full year ended December 31, 2021 and provided a business update.

 

“2021 was a transformational year for Pardes, culminating in the completion of our business combination and successful financing, which positioned us well to continue working urgently to develop PBI-0451 as a potential stand-alone oral antiviral drug candidate for the treatment and prevention of COVID-19. We have seen oral antiviral treatments begin to emerge, and while they are a great starting point - there is a clear need for additional therapies, especially for those individuals with the greatest need - such as those who are older or those with co-morbid medical conditions,” said Tom Wiggans, Chief Executive Officer and Chairman of Pardes Biosciences. “We are encouraged by the observations from our First-in-Human Phase 1 study, which is pending completion, and we look forward to leveraging these insights to inform our upcoming Phase 2/3 study, which we plan to initiate in the middle of the year.”

 

Recent Corporate Highlights

Completed Business Combination with FS Development Corp. II: In December 2021, Pardes completed its business combination with FS Development Corp. II (FSII), a special purpose acquisition company (SPAC) sponsored by Foresite Capital. Gross proceeds made available to Pardes from this transaction totaled approximately $274 million, which included funds held in FSII’s trust account and the concurrent private investment in public equity (PIPE) financing.
Strengthened Leadership Team with Key Additions: Pardes has grown it’s executive and senior leadership team with several key appointments across manufacturing, research, and business development. Significant hires include:
o
Valdas Jurkauskas, Ph.D.: Pardes appointed Valdas Jurkauskas as Senior Vice President of Technical Operations. Dr. Jurkauskas brings 18 years of extensive experience in pharmaceutical manufacturing, clinical and commercial drug supply and enabling transition from clinical stage into commercialization.
o
Ann Kwong, Ph.D.: Pardes appointed Ann Kwong as Executive Vice President of Research. Dr. Kwong brings more than 30 years of experience in antiviral drug discovery and development expertise. Ann also has experience in leading an NDA team and a commercial franchise team in the biopharmaceutical industry.

o
Phil Tinmouth: Pardes appointed Philippe Tinmouth as Chief Business and Strategy Officer. Mr. Tinmouth brings more than 25 years of experience in strategic leadership, business development and alliance management in the biopharmaceutical industry.
Appointed Thomas G. Wiggans to CEO and Chairman of the Board: In March 2022, Pardes appointed Thomas G. Wiggans to assume the role of Chief Executive Officer and Chair of the Board of Directors. Mr. Wiggans brings over 40 years of biopharmaceutical industry experience, including chief executive leadership roles with multiple successful acquisitions. In parallel, Uri A. Lopatin, M.D. --who founded Pardes and led it from inception through its public listing via SPAC transaction – will remain part of the company as a Board member and transition to a Scientific and Strategic Advisor role.
First-in-Human PBI-0451 Phase 1 Trial completion: PBI-0451 has completed dosing in a comprehensive First-in-Human study and has showed favorable tolerability over a duration of exposure in excess of intended treatment duration. Moreover, PBI-0451 administered as a stand-alone agent achieved and maintained pharmacokinetics (PK) exposures that has potential to provide potent antiviral activity against SARS-CoV-2. Interim PK and safety data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (CROI) 2022 and the 35th International Conference On Antiviral Research (ICAR) 2022. Dose selection for Pardes’ planned global Phase 2/3 study is in progress.
Announced FDA Clearance of IND Application for PBI-0451: In January 2022, the United States Food and Drug Administration (FDA) cleared Pardes’ Investigational New Drug (IND) application for PBI-0451.

 

About Pardes Biosciences, Inc.

Pardes Biosciences is a clinical-stage biopharmaceutical company created to help solve pandemic-sized problems, starting with COVID-19. We are applying modern reversible-covalent chemistry as a starting point to discover and develop novel oral drug candidates. For more information, please visit www.pardesbio.com.
 

About PBI-0451

PBI-0451 is an orally administered direct-acting antiviral (DAA) that inhibits the coronavirus (CoV) main protease (Mpro), including the SARS-CoV-2 that causes COVID-19. Inhibition of Mpro prevents the liberation and assembly of the viral replication complex of the viral replication complex within infected cells that is required to produce more viral RNA and virions. Safety and pharmacokinetic (PK) data from the first-in-human study (Study PBI-0451-0001, NCT 05011812) support that PBI-0451, administered twice daily (BID) as a stand-alone agent has the potential to yield substantial antiviral activity against SARS-CoV-2 clinically. This is supported by favorable tolerability and safety data from oral administration of PBI-0451.

 

Availability of Other Information about Pardes Biosciences

Pardes Biosciences intends to use the Investors page of its website (https://ir.pardesbio.com) as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD (Fair Disclosure). Accordingly, investors should monitor Pardes Biosciences’ Investors website, in addition to following Pardes’ press releases, Securities and Exchange Commission filings, public conference calls, presentations and webcasts.

 

 


Investor Contact:

ir@pardesbio.com

 

Stephen Jasper

Gilmartin Group

(858) 525-2047

stephen@gilmartinir.com

 


Select Financial Information:

Pardes Biosciences, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except share and per share amounts)

 

 

 

Year Ended December 31,

 

 

Period from February 27, 2020 (inception) through December 31,

 

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

28,152

 

 

$

4,563

 

General and administrative

 

 

10,336

 

 

 

750

 

Total operating expenses

 

 

38,488

 

 

 

5,313

 

Loss from operations

 

 

38,488

 

 

 

5,313

 

Other income (expense):

 

 

 

 

 

 

Interest expense, net

 

 

(30

)

 

 

 

Change in fair value of SAFE liability

 

 

 

 

 

(7,693

)

Total other expense, net

 

 

(30

)

 

 

(7,693

)

Net loss and comprehensive loss

 

$

(38,518

)

 

$

(13,006

)

Weighted-average number of common shares —basic and diluted

 

 

3,800,506

 

 

 

 

Net loss per share — basic and diluted

 

$

(10.13

)

 

$

 

 

 


Pardes Biosciences, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

 

 

December 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

268,678

 

 

$

3,410

 

Prepaid expenses and other current assets

 

 

6,581

 

 

 

194

 

Total current assets

 

 

275,259

 

 

 

3,604

 

Total assets

 

$

275,259

 

 

$

3,604

 

Liabilities and stockholders' equity (deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,385

 

 

$

1,394

 

Accrued expenses

 

 

6,580

 

 

 

408

 

Simple agreements for future equity (SAFE)

 

 

 

 

 

14,808

 

Total current liabilities

 

 

8,965

 

 

 

16,610

 

Total liabilities

 

 

8,965

 

 

 

16,610

 

 

 

 

 

 

 

 

Stockholders' equity (deficit):

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

6

 

 

 

 

Additional paid-in capital

 

 

317,812

 

 

 

 

Accumulated deficit

 

 

(51,524

)

 

 

(13,006

)

Total stockholders' equity (deficit)

 

 

266,294

 

 

 

(13,006

)

Total liabilities and stockholders' equity (deficit)

 

$

275,259

 

 

$

3,604