Pyxis Oncology, Inc. (Nasdaq: PYXS), a diversified oncology company
focused on developing an arsenal of next-generation therapeutics to
target difficult-to-treat cancers and improve quality of life for
patients, today reported financial results for the second quarter
and six months ended June 30, 2022 and provided a corporate update.
“Our strong balance sheet and cash runway will allow us to fund
the Company through the second half of 2024, solidifying our
position to potentially capitalize on multiple expected near-term
catalysts and advance our programs to clinical development,” said
Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis
Oncology. “We have elected to sharpen our near-term focus on the
clinical execution of our two most advanced programs, anti-EDB
Antibody Drug Conjugate (ADC), PYX-201, and anti-Siglec-15
monoclonal antibody (mAb), PYX-106. We also look forward to
leveraging our team’s extensive industry network in identifying and
facilitating opportunities where we can forge strategic
partnerships to efficiently advance therapies that might change the
treatment paradigm for patients with cancer.”
Corporate Development Highlights
- Focus on advancing lead programs toward the clinic with
near-term catalysts: Pyxis Oncology is on track to file
Investigational New Drug applications (INDs) for PYX-201 and
PYX-106 in 2022. Pyxis Oncology remains confident in the clinical
and commercial opportunity for both programs based on the in vivo
preclinical data to date and looks forward to working with the FDA
to advance both programs into clinical development. PYX-201 is a
novel, non-internalized ADC directed against a first-in-class
target (EDB), which is selectively expressed in a large population
of non-small cell lung cancer (NSCLC), breast cancer, and other
solid tumors. PYX-106 is a potentially best-in-class mAb targeting
Siglec-15, which has demonstrated over six-fold binding affinity
for human Siglec-15 vs. prior attempts against this target.
- Pausing development of anti-CD123 ADC, PYX-203, and
anti-KLRG1 IO program, PYX-102: The Company will pause the
preclinical development of PYX-203 and PYX-102. Pyxis Oncology
remains optimistic about the long-term clinical promise of both
assets and will consider both strategic collaboration and licensing
opportunities and potential future in-house development to maximize
value for both programs.
- Ceasing development of anti-DLK1 ADC, PYX-202:
On March 29, 2022, Pyxis Oncology disclosed it was conducting
additional GLP and non-GLP toxicology studies on PYX-202, the ADC
in-licensed from LegoChem Biosciences, to determine the clinical
viability of the candidate. Upon review and analysis of the data,
the Company has elected to stop the continued development of
PYX-202. Preclinical data suggests DLK1 has the potential to be a
novel therapeutic target in the treatment of small-cell lung cancer
and soft tissue sarcoma. As LegoChem continues to work on the
development of ADCs targeting DLK1 using its proprietary next
generation payloads, Pyxis Oncology looks forward to leveraging its
collaboration with LegoChem to evaluate the potential of these new
candidate ADCs.
Jay Feingold, M.D., Ph.D., Chief Medical Officer of Pyxis
Oncology, commented, “We believe that our therapeutic candidates
have distinct advantages and are ideally suited for targeting
difficult-to-treat tumors. PYX-201 represents a potentially
first-in-class ADC with a novel mechanism of action, and PYX-106
has a differentiated activity profile with the potential to help
patients who don’t respond or have stopped responding to current
PD-1 targeted therapies. We look forward to progressing these two
most advanced programs towards the clinic and filing INDs in the
second half of this year.”
Addition to Board of Directors
Pyxis Oncology has appointed Rachel Humphrey, M.D., to its Board
of Directors. Dr. Humphrey brings over 20 years of experience in
oncology drug development and extensive experience in product
development from pre-IND to commercialization of small molecules,
cytotoxics and biologics in oncology and immuno-oncology. She
currently serves as President and Chief Executive Officer of
Normunity, an innovative immuno-oncology company. She was
previously Chief Medical Officer at Black Diamond Therapeutics, a
precision oncology medicine company, and was a member of the Board
of Directors at Xilio Therapeutics. Prior to that, she served as
Chief Medical Officer and a member of the Board of Directors of
CytomX Therapeutics, a clinical stage oncology company, where she
was responsible for the clinical development of Probody™
Therapeutics for the treatment of cancer. She oversaw the early and
late-stage clinical development of two new oncology molecular
entities, ipilimumab (Yervoy®) while serving as Vice President,
Clinical Development at Bristol-Myers Squibb, and sorafenib
(Nexavar®) at Bayer.
Dr. Sullivan commented, “We are excited to welcome Rachel to our
Board of Directors. Her experience and successful track record in
oncology drug development spanning across large pharmaceutical and
small biotechnology companies will add incredible value to our
already deep bench of industry leaders as we near the clinic with
two promising oncology therapeutic candidates.”
Financial Update for Quarter Ended June 30,
2022
- Pyxis Oncology had cash and cash equivalents of $223 million as
of June 30, 2022, and approximately $207 million (preliminary,
unaudited) as of August 15, 2022, which is expected to fund
operations through the second half of 2024.
- Research and development expenses were $17.2 million for the
three months ended June 30, 2022, compared to $3.2 million for the
three months ended June 30, 2021. The increase was primarily due to
increased expenses associated with contract manufacturing of drug
products and drug substance, preclinical cost related to toxicity
studies and an increase in employee headcount to support research
and development activities.
- General and administrative expenses were $8.6 million for the
three months ended June 30, 2022, compared to $2.7 million for the
three months ended June 30, 2021. The increase was primarily due to
higher personnel-related expenses (including stock-based
compensation), increases in legal and professional fees, rent, and
directors and officers insurance expense to support our growth and
operations.
- Net loss was $25.6 million, or $(0.79) per common share, for
the three months ended June 30, 2022, compared to $8.1 million, or
$(5.54) per common share, for the three months ended June 30, 2021.
Net loss for the three months ended June 30, 2022 and 2021 included
$4.0 million and $0.6 million, respectively, related to non-cash
stock-based compensation expense.
- As of August 15, 2022, the outstanding number of shares of
Common Stock of Pyxis Oncology was 32,834,561.
About Pyxis Oncology, Inc. Pyxis Oncology,
Inc. is an oncology company focused on developing an arsenal of
next-generation therapeutics to target difficult-to-treat cancers
and improve quality of life for patients. 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, or ADC, immuno-oncology, or IO,
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 II, Item 1A. of the Company’s Quarterly
Report on Form 10-Q filed with SEC on August 15,
2022 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 hereof 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.
Pyxis Oncology Contact: Courtney Dugan
Vice President, Head of Investor Relations & Corporate
Communications (617) 500-8872 ir@pyxisoncology.com
PYXIS ONCOLOGY, INC.
Condensed Consolidated Statements of
Operations and Comprehensive Loss(In thousands,
except share and per share amounts) (Unaudited)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
17,170 |
|
|
$ |
3,205 |
|
|
$ |
37,241 |
|
|
$ |
35,979 |
|
General and administrative |
|
|
8,556 |
|
|
|
2,736 |
|
|
|
19,874 |
|
|
|
5,691 |
|
Total operating expenses |
|
|
25,726 |
|
|
|
5,941 |
|
|
|
57,115 |
|
|
|
41,670 |
|
Loss from operations |
|
|
(25,726 |
) |
|
|
(5,941 |
) |
|
|
(57,115 |
) |
|
|
(41,670 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
164 |
|
|
|
6 |
|
|
|
173 |
|
|
|
10 |
|
Service fee income from related party |
|
|
— |
|
|
|
181 |
|
|
|
— |
|
|
|
181 |
|
Change in fair value of derivative liability |
|
|
— |
|
|
|
(2,161 |
) |
|
|
— |
|
|
|
(3,261 |
) |
Total other income (expense) |
|
|
164 |
|
|
|
(1,974 |
) |
|
|
173 |
|
|
|
(3,070 |
) |
Loss from equity method
investment in joint venture |
|
|
— |
|
|
|
(231 |
) |
|
|
— |
|
|
|
(231 |
) |
Net loss and
comprehensive loss |
|
$ |
(25,562 |
) |
|
$ |
(8,146 |
) |
|
$ |
(56,942 |
) |
|
$ |
(44,971 |
) |
Net loss per common share - basic
and diluted |
|
$ |
(0.79 |
) |
|
$ |
(5.54 |
) |
|
$ |
(1.76 |
) |
|
$ |
(31.86 |
) |
Weighted average shares of common
stock outstanding - basic and diluted |
|
|
32,451,610 |
|
|
|
1,471,447 |
|
|
|
32,384,522 |
|
|
|
1,411,428 |
|
|
|
PYXIS ONCOLOGY, INC.
Condensed Consolidated Balance
Sheets(In thousands) (Unaudited)
|
|
June 30,2022 |
|
|
December 31,2021 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
223,355 |
|
|
$ |
274,735 |
|
Restricted cash |
|
|
1,472 |
|
|
|
1,472 |
|
Prepaid expenses and other current assets |
|
|
1,768 |
|
|
|
2,466 |
|
Total current assets |
|
|
226,595 |
|
|
|
278,673 |
|
Property and equipment, net |
|
|
965 |
|
|
|
1,007 |
|
Operating lease right-of-use
assets |
|
|
15,003 |
|
|
|
232 |
|
Other assets, noncurrent |
|
|
— |
|
|
|
109 |
|
Total
assets |
|
$ |
242,563 |
|
|
$ |
280,021 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
7,820 |
|
|
$ |
11,951 |
|
Accrued expenses and other current liabilities |
|
|
7,096 |
|
|
|
6,592 |
|
Operating lease liabilities, current portion |
|
|
— |
|
|
|
165 |
|
Total current liabilities |
|
|
14,916 |
|
|
|
18,708 |
|
Operating lease liabilities, net
of current portion |
|
|
15,681 |
|
|
|
— |
|
Total liabilities |
|
|
30,597 |
|
|
|
18,708 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
32 |
|
|
|
32 |
|
Additional paid-in capital |
|
|
360,594 |
|
|
|
352,999 |
|
Accumulated deficit |
|
|
(148,660 |
) |
|
|
(91,718 |
) |
Total stockholders’ equity |
|
|
211,966 |
|
|
|
261,313 |
|
Total liabilities and
stockholders’ equity |
|
$ |
242,563 |
|
|
$ |
280,021 |
|
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