Pardes Biosciences, Inc. (NASDAQ: PRDS), a clinical-stage
biopharmaceutical company developing pomotrelvir as a potential
stand-alone novel direct-acting, oral antiviral drug candidate for
the treatment of COVID-19, today reported financial results for the
fourth quarter and full year ended December 31, 2022 and provided a
business update.
“We are greatly encouraged by the progress made
in our ongoing Phase 2 study evaluating pomotrelvir for the
treatment of COVID-19, and we continue to believe in its potential
to fulfill the unmet demand for a stand-alone, oral antiviral
treatment that is safe, easy-to-prescribe, and designed for broad
patient use, including those facing challenges with currently
available therapies,” said Thomas G. Wiggans, Chief Executive
Officer and Chair of the Board of Directors for Pardes Biosciences.
“We are excited and remain on track to share the results from this
study in the coming weeks and feel well positioned to rapidly
advance this program into its next stage of development and to
patients in need.”
Fourth Quarter and Full Year 2022 Financial
Results
Pardes reported a net loss of $24.2 million and
$96.6 million for the three months and full year ended December 31,
2022, respectively, as compared to a net loss of $14.3 million and
$38.5 million for the three months and full year ended December 31,
2021, respectively. Net loss for the reporting period was driven by
an increase in research and development expenses, as well as
increased costs related to the infrastructure needed to support
Pardes’ growth and transition to operating as a public company.
Research and development expenses were $19.4
million for the quarter ended December 31, 2022, compared to $10.4
million for the quarter ended December 31, 2021, an increase of
$9.0 million. Research and development expenses were $70.4 million
for the full year ended December 31, 2022, compared to $28.2
million for the full year ended December 31, 2021, an increase of
$42.2 million. These increases were primarily driven by increased
costs related to advancing our lead product candidate, pomotrelvir,
into the clinic and higher personnel costs, including stock-based
compensation, as we have grown our organization.
General and administrative expenses were $6.7
million for the quarter ended December 31, 2022, compared to $3.9
million for the quarter ended December 31, 2021, an increase of
$2.8 million. General and administrative expenses were $29.5
million for the full year ended December 31, 2022, compared to
$10.3 million for the full year ended December 31, 2021, an
increase of $19.2 million. These increases were due to increased
personnel costs, including stock-based compensation, increased
professional fees related to legal, pre-commercial planning and
consulting services, and costs associated with being a public
company, including directors’ and officers’ insurance and
compliance fees.
Pardes’ cash, cash equivalents and short-term
investments as of December 31, 2022, were $197.3 million compared
to $209.1 million as of September 30, 2022. The company expects
that the cash and cash equivalents and short-term investments on
hand as of December 31, 2022, will be sufficient to fund operating
expenses and capital expenditures for the next twelve months.
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 dedicated to discovering and developing potent and
easy-to-prescribe oral antiviral drug candidates so that patients
everywhere can get well sooner. For more information, please visit
www.pardesbio.com.
About Pomotrelvir
Pomotrelvir (formerly known as PBI-0451) is a
potential stand-alone, novel, direct-acting oral antiviral drug
candidate for the treatment of COVID-19 that is in Phase 2 clinical
development (NCT 05543707). Pomotrelvir was developed to inhibit
the main cysteine protease (Mpro) of all known coronaviruses,
including SARS-CoV-2. Inhibiting Mpro prevents the liberation and
assembly of the viral replication complex, blocking replication
before it begins. The potent antiviral activity observed across
SARS-CoV-2 variants in preclinical in vitro studies as well as the
favorable safety and tolerability data from Pardes Biosciences’
Phase 1 clinical trials support continued clinical development of
pomotrelvir, which we believe has the potential to be a safe,
effective and easy-to-prescribe oral antiviral for treating
COVID-19 in adult and pediatric patients, including patients unable
or unwilling to take currently authorized or approved
therapies.
About COVID-19
COVID-19 has resulted in an unprecedented and
persistent global health emergency. Over three years into the
pandemic, COVID-19 remains a leading cause of death in the U.S.,
with greater than 6.8 million deaths worldwide and millions of
newly documented cases monthly1. As the long-term implications of
on-going waves, repeated SARS-CoV-2 infection and “long COVID”
become increasingly clear, the infectivity and mutability of
SARS-CoV-2 represents a substantial clinical and economic burden
for years to come. New therapeutics are urgently needed to address
future variants and provide options for the millions of patients
unable or unwilling to take currently authorized or approved
therapeutics. Existing treatment options are unfortunately being
eliminated or falling short due to lack of efficacy against new
variants, safety concerns, significant drug-drug interactions, risk
of viral rebound, limited access, and other factors. Notably, the
most commonly prescribed oral therapy in the U.S. is
contraindicated with dozens of common medications, leaving millions
of patients with high unmet medical need vulnerable to disease
progression. Over 80% of adults over 60 are on at least 1 other
medicine and over 30% are taking at least 5 other medicines.2 Many
of these common, contraindicated drug classes should not be paused
(e.g., blood thinners, antipsychotics, antidepressants and
antiarrhythmics). These patients are at high risk of severe disease
and left with unacceptable alternatives. New therapeutics are
urgently needed to address this need, prepare for future variants,
and advance care for all patients.
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. Accordingly,
investors should monitor Pardes Biosciences’ Investors website, in
addition to following Pardes Biosciences’ press releases,
Securities and Exchange Commission (SEC) filings, public conference
calls, presentations and webcasts.
1
https://www.kff.org/coronavirus-covid-19/issue-brief/global-covid-19-tracker/
2 https://www.cdc.gov/nchs/data/databriefs/db347-h.pdf
Forward Looking Statements
This press release contains statements that
relate to future events and expectations and, as such, constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. When or if used in this
press release, the words “anticipate,” “believe,” “could,”
“estimate,” “expect,” “intend,” “may,” “outlook,” “plan,”
“possible,” “predict,” “should,” “will,” and similar expressions
and their variants, as they relate to Pardes Biosciences (Pardes),
may identify forward-looking statements. All statements that
reflect Pardes’ expectations, assumptions or projections about the
future, other than statements of historical fact, are
forward-looking statements, including, without limitation,
statements regarding the company’s future financial or business
performance, conditions, plans, prospects, trends or strategies and
other financial and business matters, including expectations that
its current cash and cash equivalents and short-term investments on
hand as of December 31, 2022, will be sufficient to fund operating
expenses and capital expenditures for the next twelve months;
pomotrelvir’s potential as a safe, well-tolerated and easy to
prescribe COVID-19 oral antiviral treatment for all patients; the
potential advancement of pomotrelvir into later staged clinical
trials; and the timing on the availability of data from the Phase 2
clinical trial. Forward-looking statements reflect Pardes’ current
beliefs, expectations, and assumptions regarding the future of its
business, its future plans and strategies, its development plans,
its preclinical and clinical results, future conditions and other
factors Pardes believes are appropriate in the circumstances.
Although Pardes believes the expectations and assumptions reflected
in such forward-looking statements are reasonable, Pardes can give
no assurance that they will prove to be correct. Forward-looking
statements are not guarantees of future performance and are subject
to risks, uncertainties and changes in circumstances that are
difficult to predict, which could cause Pardes’ actual activities
and results to differ materially from those expressed in any
forward-looking statement. Such risks and uncertainties include,
but are not limited to: (i) risks and uncertainties related to
Pardes’ ability to advance, obtain regulatory approval of and
ultimately commercialize its product candidates; (ii) the timing
and results of preclinical studies and clinical trials; (iii)
Pardes’ ability to maintain financial resources necessary to
continue its clinical trials and fund development goals and
business operations; (iv) the impact of the COVID-19 pandemic on
Pardes’ business, clinical trials, financial condition, liquidity
and results of operations; (v) Pardes’ ability to protect its
intellectual property; and (vi) other risks and uncertainties
described under the heading “Risk Factors” in Pardes’ Annual Report
on Form 10-K for the year ended December 31, 2022 and other SEC
filings. Accordingly, readers are cautioned not to place undue
reliance on these forward-looking statements. The statements in
this press release speak only as of the date of this press release,
even if subsequently made available by Pardes on its website or
otherwise. Pardes disclaims any intention or obligation to update
publicly any forward-looking statements, whether in response to new
information, future events, or otherwise, except as required by
applicable law.
Investor Contacts: Patrick O'Brien
pobrien@pardesbio.com
Select Financial Information:
Pardes Biosciences, Inc. |
Condensed Statements of Operations |
(Unaudited) |
(in thousands, except share and per share amounts) |
|
|
Three Months Ended |
|
|
|
|
|
|
December 31, |
|
|
Year Ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
19,432 |
|
|
$ |
10,360 |
|
|
$ |
70,350 |
|
|
$ |
28,152 |
|
General and administrative |
|
|
6,731 |
|
|
|
3,947 |
|
|
|
29,467 |
|
|
|
10,336 |
|
Total operating expenses |
|
|
26,163 |
|
|
|
14,307 |
|
|
|
99,817 |
|
|
|
38,488 |
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income, net |
|
|
1,941 |
|
|
|
(20 |
) |
|
|
3,183 |
|
|
|
(30 |
) |
Net loss |
|
$ |
(24,222 |
) |
|
$ |
(14,327 |
) |
|
$ |
(96,634 |
) |
|
$ |
(38,518 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.41 |
) |
|
$ |
(1.60 |
) |
|
$ |
(1.66 |
) |
|
$ |
(10.13 |
) |
Weighted-average number of
common shares - basic and diluted |
|
|
59,334,504 |
|
|
|
8,965,699 |
|
|
|
58,127,385 |
|
|
|
3,800,506 |
|
Pardes Biosciences, Inc. |
Condensed Balance Sheets |
(Unaudited) |
(in thousands) |
|
|
December 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
59,284 |
|
|
$ |
268,678 |
|
Short-term investments |
|
|
138,056 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
3,062 |
|
|
|
6,581 |
|
Total current assets |
|
|
200,402 |
|
|
|
275,259 |
|
Other assets |
|
|
219 |
|
|
|
— |
|
Total assets |
|
$ |
200,621 |
|
|
$ |
275,259 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,929 |
|
|
$ |
2,385 |
|
Accrued expenses |
|
|
15,496 |
|
|
|
6,580 |
|
Total current liabilities |
|
|
20,425 |
|
|
|
8,965 |
|
Total liabilities |
|
|
20,425 |
|
|
|
8,965 |
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
6 |
|
|
|
6 |
|
Additional paid-in capital |
|
|
328,372 |
|
|
|
317,812 |
|
Accumulated other comprehensive loss |
|
|
(24 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(148,158 |
) |
|
|
(51,524 |
) |
Total stockholders' equity |
|
|
180,196 |
|
|
|
266,294 |
|
Total liabilities and stockholders' equity |
|
$ |
200,621 |
|
|
$ |
275,259 |
|
Grafico Azioni Pardes Biosciences (NASDAQ:PRDS)
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