Pyxis Oncology Reports Financial Results for Second-Quarter 2023 and Provides Corporate Update
11 Agosto 2023 - 1:00PM
Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company
focused on developing next-generation therapeutics to target
difficult-to-treat cancers, today reported financial results for
the quarter ended June 30, 2023, and provided a corporate update.
Pyxis Oncology ended the second quarter of 2023
with approximately $144.1 million in cash, cash equivalents,
restricted cash and short-term investments, which is expected to
provide a runway into the first half of 2025, enabling the Company
to evaluate early signs of potential clinical activity for PYX-201
and PYX-106 and potentially allowing the Company to initiate
tumor-specific expansion cohorts following dose selection. “During
the second quarter, we announced our planned acquisition of
Apexigen, Inc., which will bolster Pyxis Oncology’s position at the
forefront of antibody-drug conjugate (ADC) innovation and will
expand our clinical pipeline. We are on track to close the
acquisition later in August. We remain financially disciplined
while executing operationally on each of our two ongoing clinical
trials of PYX-201 and PYX-106 and we are encouraged by the positive
feedback we’ve received from investigators,” said Lara S. Sullivan,
M.D., President and Chief Executive Officer of Pyxis Oncology. “We
continue to anticipate preliminary data, including biomarker
results and early signs of potential clinical activity,
from our Phase 1 trials of PYX-106 in late 2023 and PYX-201 in
early 2024.”
Recent Corporate Updates
- Third
dose level reached in Phase 1 trial of PYX-201: Dosing is
ongoing at the third dose level in the PYX-201-101 trial, and three
clinical sites have begun recruiting in Europe, along with sites in
the U.S.
-
Abstracts accepted for poster presentation at
SITC: Abstracts for trial-in-progress (TIP) posters
describing the PYX-106-101 and PYX-201-101 Phase 1 clinical trials
were accepted for presentation at the Society for the Immunotherapy
of Cancer (SITC) 38th Annual Meeting, to be held November 1-5,
2023, in San Diego.
Upcoming Milestones
- Apexigen, Inc.
transaction expected close, later in August 2023
- Anticipated Yale
presentation of investigator sponsored trial (IST)
results describing an anti-siglec-15 compound’s activity and
safety at the International Association for the Study of Lung
Cancer (IASLC) 2023 World Conference on Lung Cancer, September
2023
- Announce
clinical development plan for sotigalimab, Q4 2023
(assuming closing of the Apexigen transaction)
- Report
pharmacokinetic/pharmacodynamic (PK/PD) data for sotigalimab,
Q4 2023 (assuming closing of the Apexigen transaction)
- Report
preliminary data, including biomarker results and
early signs of potential clinical activity from
PYX-106-101, late 2023
- Report
preliminary data, including biomarker results and
early signs of potential clinical activity from
PYX-201-101, early 2024
Q2 2023 Financial Results
- As of June 30,
2023, Pyxis Oncology had cash and cash equivalents (including
restricted cash) and short-term investments of $144.1 million
(preliminary, unaudited), which is expected to fund operations into
the first half of 2025 and reflects continued financial
discipline.
- Research and
development expenses were $11.4 million for the three months ended
June 30, 2023, compared to $17.2 million for the three months ended
June 30, 2022. The period-over-period decline was primarily due to
lower contract manufacturing and preclinical research costs, which
were partially offset by increased clinical trial-related expenses
for PYX-201 and PYX-106.
- General and
administrative expenses were $6.7 million for the three months
ended June 30, 2023, compared to $8.6 million for the three months
ended June 30, 2022. The period-over-period decrease was primarily
due to a reduction in stock-based compensation expense and lower
professional and consultant fees.
- Net loss was
$15.9 million, or $0.41 per common share, for the three months
ended June 30, 2023, compared to $25.6 million, or $0.79 per common
share, for the three months ended June 30, 2022. Net losses for the
quarters ended June 30, 2023 and 2022 included $3.7 million and
$4.0 million, respectively, related to non-cash stock-based
compensation expense.
- As of June 30,
2023, the outstanding number of shares of common stock of Pyxis
Oncology was 39,376,941.
About Pyxis Oncology, Inc.Pyxis
Oncology, Inc. is a clinical-stage company focused on defeating
difficult-to-treat cancers. The company is efficiently building
next-generation therapeutics that hold the potential for mono and
combination therapies. 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. Pyxis Oncology’s antibody-drug
conjugates (ADCs) and immuno-oncology (IO) programs employ novel
and emerging strategies to target a broad range of solid tumors
resistant to current standards of care. To learn more, visit
www.pyxisoncology.com or follow us on Twitter and LinkedIn.
Forward-Looking StatementsThis
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 Annual
Report on Form 10-K filed with SEC on March 22,
2023, 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.
Additional Information and Where to Find It
This press release is not a proxy statement or
solicitation of a proxy, consent or authorization with respect to
any securities or in respect of the proposed business combination
and shall not constitute an offer to sell or a solicitation of an
offer to buy any securities nor shall there be any sale of
securities in any state or jurisdiction in which such offer,
solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction. No offer of securities shall be made except by means
of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933. The Company has filed with the Securities
and Exchange Commission (the “SEC”) a Registration Statement on
Form S-4 in connection with the transaction and Apexigen has filed
with the SEC and mailed to its stockholders a proxy
statement/prospectus in connection with the transaction. INVESTORS
AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT,
PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT
MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS
TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN
THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and
security holders are able to obtain free copies of the registration
statement and the proxy statement/prospectus and other documents
filed with the SEC by the Company and Apexigen through the website
maintained by the SEC at www.sec.gov. In addition, investors and
security holders are able to obtain free copies of the registration
statement and the proxy statement/prospectus from the Company by
contacting ir@pyxisoncology.com or from Apexigen by contacting
ir@apexigen.com.
Participants in the Solicitation
The Company and Apexigen, and their respective
directors and executive officers, may be deemed to be participants
in the solicitation of proxies in respect of the proposed
transaction. Information regarding the Company’s directors and
executive officers is contained in the Company’s proxy statement,
filed with the SEC on April 28, 2023. Information regarding
Apexigen’s directors and executive officers is contained in
Apexigen’s Annual Report on Form 10-K, filed with the SEC on
February 22, 2023. Additional information regarding the persons who
may be deemed participants in the proxy solicitation and a
description of their direct and indirect interests in the proposed
business combination are available in the registration statement
and the proxy statement/prospectus.
Pyxis Oncology ContactJennifer
Davis RuffVP, Investor Relationsjdavisruff@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, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,391 |
|
|
$ |
17,170 |
|
|
$ |
23,292 |
|
|
$ |
37,241 |
|
General and administrative |
|
|
6,730 |
|
|
|
8,556 |
|
|
|
15,783 |
|
|
|
19,874 |
|
Total operating expenses |
|
|
18,121 |
|
|
|
25,726 |
|
|
|
39,075 |
|
|
|
57,115 |
|
Loss from operations |
|
|
(18,121 |
) |
|
|
(25,726 |
) |
|
|
(39,075 |
) |
|
|
(57,115 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income |
|
|
1,656 |
|
|
|
164 |
|
|
|
3,329 |
|
|
|
173 |
|
Sublease income |
|
|
564 |
|
|
|
— |
|
|
|
602 |
|
|
|
— |
|
Total other income, net |
|
|
2,220 |
|
|
|
164 |
|
|
|
3,931 |
|
|
|
173 |
|
Net loss |
|
$ |
(15,901 |
) |
|
$ |
(25,562 |
) |
|
$ |
(35,144 |
) |
|
$ |
(56,942 |
) |
Net loss per common share - basic
and diluted |
|
$ |
(0.41 |
) |
|
$ |
(0.79 |
) |
|
$ |
(0.95 |
) |
|
$ |
(1.76 |
) |
Weighted average shares of common
stock outstanding - basic and diluted |
|
|
38,389,123 |
|
|
|
32,451,610 |
|
|
|
36,878,787 |
|
|
|
32,384,522 |
|
|
|
PYXIS ONCOLOGY,
INC.Condensed Consolidated Balance
Sheets(In thousands, except share and per share
amounts)(Unaudited)
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
25,898 |
|
|
$ |
179,293 |
|
Marketable debt securities, short-term |
|
|
116,765 |
|
|
|
— |
|
Restricted cash |
|
|
1,472 |
|
|
|
1,472 |
|
Prepaid expenses and other current assets |
|
|
5,169 |
|
|
|
5,847 |
|
Total current assets |
|
|
149,304 |
|
|
|
186,612 |
|
Property and equipment, net |
|
|
12,643 |
|
|
|
11,165 |
|
Operating lease right-of-use
assets |
|
|
13,283 |
|
|
|
13,602 |
|
Total
assets |
|
$ |
175,230 |
|
|
$ |
211,379 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,305 |
|
|
$ |
7,097 |
|
Accrued expenses and other current liabilities |
|
|
7,393 |
|
|
|
24,537 |
|
Operating lease liabilities, current portion |
|
|
527 |
|
|
|
— |
|
Total current liabilities |
|
|
9,225 |
|
|
|
31,634 |
|
Operating lease liabilities, net
of current portion |
|
|
20,730 |
|
|
|
18,921 |
|
Total liabilities |
|
|
29,955 |
|
|
|
50,555 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
39 |
|
|
|
34 |
|
Additional paid-in capital |
|
|
392,900 |
|
|
|
373,225 |
|
Accumulated other comprehensive loss |
|
|
(85 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(247,579 |
) |
|
|
(212,435 |
) |
Total stockholders’ equity |
|
|
145,275 |
|
|
|
160,824 |
|
Total liabilities and
stockholders’ equity |
|
$ |
175,230 |
|
|
$ |
211,379 |
|
Grafico Azioni Pyxis Oncology (NASDAQ:PYXS)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Pyxis Oncology (NASDAQ:PYXS)
Storico
Da Giu 2023 a Giu 2024