Pyxis Oncology Provides Corporate and Financial Update
March 29 2022 - 6:35AM
Pyxis Oncology, Inc. (Nasdaq: PYXS), a multi-asset multi-modality
company focused on developing next-generation therapeutics for
difficult to treat cancers, today provided a corporate and
financial update and reported financial results for the full year
ended December 31, 2021.
“We have had a highly productive start to 2022, advancing our
lead programs toward first-in-human clinical trials while executing
our strategy of identifying the most promising scientific
breakthroughs and therapeutics in the treatment of cancers,” said
Lara Sullivan, M.D., Chief Executive Officer of Pyxis Oncology.
“The in-licensing of Biosion’s anti-Siglec-15 (PYX-106) and the
introduction of our first internally developed candidate anti-KLRG1
(PYX-102) further validate our approach to portfolio and pipeline
expansion by identifying and progressing some of the most promising
scientific and clinical advances from either our internal discovery
engines or external sources.”
“We are excited to partner with Pyxis Oncology and its
experienced management team for the development of this promising
asset,” said Hugh M. Davis, Ph.D., Chief Operating Officer,
Biosion, Inc. and President, Biosion USA, Inc. “While
immunotherapies have improved the lives of many patients, only a
fraction respond to treatment, suggesting that our understanding of
how cancer is able to evade the immune system is incomplete. We
believe that anti-Siglec-15 may represent a breakthrough and that
targeting siglec-15 could extend the benefits of immunotherapies to
broader patient populations, including those who have failed
PD-(L)1 targeting therapies.”
Corporate Development Highlights
- License agreement with
Biosion adds anti-Siglec-15 to Pyxis Oncology’s IO
pipeline: Pyxis Oncology announced today it has
in-licensed anti-Siglec-15, now referred to as PYX-106, a
potentially best-in-class monoclonal antibody which is a novel
immune checkpoint. In pre-clinical studies, PYX-106 is broadly
expressed across a range of solid tumors among difficult-to-treat
cancers. The American Academy for Cancer Research (AACR) has
accepted an abstract submitted by Biosion for PYX-106. The poster
will be made available at the start of the AACR Annual Meeting on
April 8, 2022. Pyxis Oncology expects to file an IND for PYX-106 in
the second half of 2022.
- Pipeline expansion with the
addition of Company’s first internally developed
candidate: Pyxis Oncology announced today the declaration
of its first internally developed candidate, an anti-KLRG1
monoclonal antibody program now referred to as PYX-102. PYX-102
originated as part of the Company’s proprietary IO target catalog
and work out of Pyxis Oncology founder Tom Gajewski’s lab at the
University of Chicago. The Company expects to provide further
updates closer to the planned IND submission for PYX-102 in the
second half of 2023.
- Additional GLP study
underway for PYX-202: Pyxis
Oncology’s anti-DLK1 ADC, PYX-202, was
licensed in from LegoChem Biosciences, Inc. in December 2020.
In preparation for an IND filing and based on observation of the
Company’s GLP studies to date, management has decided to conduct
additional GLP and non-GLP toxicity studies to determine whether
PYX-202 is a viable clinical candidate. The Company will continue
to monitor the progress of its PYX-202 program and expects to
provide an update about PYX-202 in mid-2022.
- Advancing programs toward
the clinic with near-term catalysts: Pyxis Oncology
expects to file INDs for anti-EDB, PYX-201, and anti-CD123,
PYX-203, in the second half of 2022 and in the second half of 2023,
respectively.
Financial Update
- As of March 29, 2022, Pyxis Oncology
had cash and cash equivalents of approximately $253 million
(preliminary, unaudited), which is expected to fund operations into
the third quarter of 2024.
“With a solid balance sheet and cash runway sufficient to
deliver multiple catalysts through the third quarter of 2024, we
remain focused on building and advancing our pipeline through a
multi-asset multi-modality approach that we believe will unlock
benefits for patients,” said Pam Connealy, Chief Financial
Officer.
- Research and development expenses
for the full year ended December 31, 2021 were $51.1 million,
compared to $9.1 million for the full year ended December 31, 2020.
The increase in research and development expenses was primarily
attributed to increased expenses associated with the addition of
three antibody-drug conjugates to the Company’s portfolio and an
increase in employee headcount to support research and development
activities.
- General and administrative expenses
for the full year ended December 31, 2021 were $18.6 million,
compared to $3.8 million for the year ended December 31, 2020. The
increase was primarily attributed to higher personnel-related
expenses (including stock-based compensation), and costs incurred
to support the growth and expansion of the business, overhead and
facilities.
- Net loss for the full year ended
December 31, 2021 was $76.0 million ($8.95 per common share),
compared to $12.8 million ($12.45 per common share) for the year
ended December 31, 2020. The increase in net loss is primarily
attributed to the addition of three antibody-drug conjugates to the
Company’s portfolio and the Company’s preparations to initiate
human clinical trials for PYX-201.
- As of March 25, 2022, the
outstanding number of shares of Common Stock of Pyxis Oncology was
32,841,747.
Conference Call and Webcast Details
Pyxis Oncology management will host a conference call and live
webcast on Tuesday, March 29, 2022, at 8:00 a.m. ET to discuss
recent corporate updates. The live call can be accessed by dialing
(833) 945-2461 (domestic) or (520) 809-9726 (international) using
the conference ID 5458057. A live webcast can be accessed at
https://edge.media-server.com/mmc/p/c8uwd9dr or on the Investors
section of the Pyxis Oncology website at ir.pyxisoncology.com. A
replay of the webcast will be available approximately two hours
after completion of the call and will be archived on the Company’s
website for up to 45 days.
About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is a multi-asset multi-modality company
focused on defeating difficult to treat cancers and improving
patient lives. By leveraging our fully integrated research,
development and commercial capabilities, our expert team is
efficiently building a diversified portfolio of next-generation
therapeutics. Pyxis Oncology’s therapeutic candidates are designed
to directly kill tumor cells, and to address the underlying
pathologies created by cancer that enable its uncontrollable
proliferation and immune evasion. Since its launch in 2019, Pyxis
Oncology has developed a broad portfolio of novel antibody-drug
conjugate product candidates, and monoclonal antibody, or mAb,
preclinical discovery programs that it is developing as
monotherapies and in combination with other therapies. To learn
more about Pyxis Oncology, visit www.pyxisoncology.com.
Forward-Looking Statements
This press release contains forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws.
These statements are often identified by the use of words such as
“anticipate,” “believe,” “can,” “continue,” “could,” “estimate,”
“expect,” “intend,” “likely,” “may,” “might,” “objective,”
“ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to
be,” “will,” “would,” or the negative or plural of these words, or
similar expressions or variations, although not all forward-looking
statements contain these words. We cannot assure you that the
events and circumstances reflected in the forward-looking
statements will be achieved or occur and actual results could
differ materially from those expressed or implied by these
forward-looking statements. Factors that could cause or contribute
to such differences include, but are not limited to, those
identified herein, and those discussed in the section titled “Risk
Factors” set forth in Part I, Item 1A. of the Company's most recent
Annual Report on Form 10-K and in our other filings with the SEC.
These risks are not exhaustive. New risk factors emerge from time
to time, and it is not possible for our management to predict all
risk factors, nor can we assess the impact of all factors on our
business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those
contained in any forward-looking statements. In addition,
statements that “we believe” and similar statements reflect our
beliefs and opinions on the relevant subject. These statements are
based upon information available to us as of the date of this
Annual Report on Form 10-K, and while we believe such information
forms a reasonable basis for such statements, such information may
be limited or incomplete, and our statements should not be read to
indicate that we have conducted an exhaustive inquiry into, or
review of, all potentially available relevant information. These
statements are inherently uncertain, and investors are cautioned
not to unduly rely upon these statements. Except as required by
law, we undertake no obligation to update any forward-looking
statements to reflect events or circumstances after the date of
such statements.
Investor and Media ContactCourtney DuganVP,
Head of Investor Relations and Corporate Communications
ir@pyxisoncology.com
---tables to follow---
PYXIS ONCOLOGY, INC.
Consolidated Statements of Operations and
Comprehensive Loss
(In thousands, except share and per share
data)
|
|
Years Ended December 31, |
|
|
|
2021 |
|
|
2020 |
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
51,054 |
|
|
$ |
9,048 |
|
General and administrative |
|
|
18,663 |
|
|
|
3,846 |
|
Total operating expenses |
|
|
69,717 |
|
|
|
12,894 |
|
Loss from operations |
|
|
(69,717 |
) |
|
|
(12,894 |
) |
Other (expense) income: |
|
|
|
|
|
|
Interest income |
|
|
23 |
|
|
|
66 |
|
Service fee income from related party |
|
|
181 |
|
|
|
— |
|
Change in fair value of derivative liability |
|
|
(6,231 |
) |
|
|
— |
|
Total other (expense) income |
|
|
(6,027 |
) |
|
|
66 |
|
Loss from equity method
investment in joint venture |
|
|
(231 |
) |
|
|
— |
|
Net loss and
comprehensive loss |
|
$ |
(75,975 |
) |
|
$ |
(12,828 |
) |
Net loss per common share - basic
and diluted |
|
$ |
(8.95 |
) |
|
$ |
(12.45 |
) |
Weighted average shares of common
stock outstanding - basic and diluted |
|
|
8,493,273 |
|
|
|
1,030,556 |
|
PYXIS ONCOLOGY, INC.
Consolidated Balance Sheets
(In thousands)
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
274,735 |
|
|
$ |
8,080 |
|
Restricted cash |
|
|
1,472 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
2,466 |
|
|
|
23 |
|
Total current assets |
|
|
278,673 |
|
|
|
8,103 |
|
Property and equipment, net |
|
|
1,007 |
|
|
|
1,103 |
|
Operating lease right-of-use
assets |
|
|
232 |
|
|
|
836 |
|
Other assets, noncurrent |
|
|
109 |
|
|
|
109 |
|
Total
assets |
|
$ |
280,021 |
|
|
$ |
10,151 |
|
Liabilities, Convertible
Preferred Stock and Stockholders’ Equity (Deficit) |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
11,951 |
|
|
$ |
1,077 |
|
Accrued expenses and other current liabilities |
|
|
6,592 |
|
|
|
1,997 |
|
Operating lease liabilities, current portion |
|
|
165 |
|
|
|
615 |
|
Total current liabilities |
|
|
18,708 |
|
|
|
3,689 |
|
Operating lease liabilities, net
of current portion |
|
|
— |
|
|
|
165 |
|
Total liabilities |
|
|
18,708 |
|
|
|
3,854 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Series A Convertible Preferred
Stock |
|
|
— |
|
|
|
21,942 |
|
Series B Convertible Preferred
Stock |
|
|
— |
|
|
|
— |
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
32 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
352,999 |
|
|
|
97 |
|
Accumulated deficit |
|
|
(91,718 |
) |
|
|
(15,743 |
) |
Total stockholders’ equity (deficit) |
|
|
261,313 |
|
|
|
(15,645 |
) |
Total liabilities,
convertible preferred stock and stockholders’ equity
(deficit) |
|
$ |
280,021 |
|
|
$ |
10,151 |
|
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