“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
Recent Corporate Highlights
- Completed Business Combination with
FS Development Corp. II: InDecember 2021 , Pardes completed its business combination withFS Development Corp. II (FSII), a special purpose acquisition company (SPAC) sponsored byForesite 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:
- 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.
Ann Kwong , Ph.D.: Pardes appointedAnn 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.Phil Tinmouth : Pardes appointedPhilippe 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: InMarch 2022 , Pardes appointedThomas 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 , theUnited States Food and Drug Administration (FDA) cleared Pardes’ Investigational New Drug (IND) application for PBI-0451.
Full Year 2021 Financial Results
Pardes reported a net loss of
Research and development expenses were
General and administrative expenses were
Pardes’ cash and cash equivalents as of
About Pardes Biosciences, Inc.
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
Investor Contact:
ir@pardesbio.com
(858) 525-2047
stephen@gilmartinir.com
Select Financial Information:
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
Year Ended | Period from (inception) through | |||||||
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 | $ | (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 | ) | $ | — |
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
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): | ||||||||
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 |
Source:
2022 GlobeNewswire, Inc., source