Pyxis Oncology Announces Initiatives to Prioritize Lead ADC Program; Reports Financial Results for Third-Quarter 2023 and Provides Corporate Update
November 07 2023 - 4:30PM
Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company
focused on developing antibody-drug conjugates (ADCs) and
immune-oncology (IO) therapeutics to target difficult-to-treat
cancers, today announced initiatives to extend its cash runway,
reported financial results for the quarter ended September 30,
2023, and provided a corporate update. The company ended the third
quarter of 2023 with approximately $134.4 million in cash, cash
equivalents, restricted cash and short-term investments.
“We are excited to begin dosing in the fifth
cohort of our Phase 1 trial of our lead asset PYX-201, a
first-in-class and first-in-concept tumor stroma targeting ADC
against EDB-fibronectin in tumor stroma. We believe the progress we
are making through the dose escalation portion of our trial speaks
to the potential safety profile of our ADC drug candidate.
Moreover, based on data from Pfizer’s HER2 ADC previously under
development with the same linker and payload and our preclinical
experiments, we believe that at 3.6 mg/kg and above, we are
approaching biologically active dose levels,” said Lara S.
Sullivan, M.D., President and Chief Executive Officer of Pyxis
Oncology. “In order to maximize PYX-201’s chances of success, as
well as those of PYX-106, we are announcing a number of initiatives
to extend our cash runway into 2026, which we believe is the
responsible thing to do in the current funding environment. We
believe the actions we are taking best position Pyxis Oncology for
future success, with our current cash resources now taking us
beyond important near-term 2024 readouts for our ongoing clinical
trials.”
Pam Connealy, COO and CFO of Pyxis Oncology
added, “In addition to the cost reductions announced today, which
include a 40% decrease in headcount, we are also seeking additional
non-dilutive funding through the potential monetization of our
acquired Apexigen royalty streams. Additionally, we are evaluating
partnerships of several assets that we have chosen not to move into
the clinic and potential antibody and ADC platform technology
collaborations. We believe this increased focus on our lead and
secondary assets, in addition to the changes we are making to the
PYX-106 program, gives us the best chance for success in bringing
our novel ADC and IO candidates to the patients who need them. We
appreciate the contributions from our dedicated team members that
have enabled us to reach this point in our clinical programs.”
Corporate Updates
- PYX-201: Fifth dose cohort open for enrollment in Phase
1 trial. To date, 15 subjects have been dosed with PYX-201
in the PYX-201-101 trial. The fifth dose cohort is expected to
begin enrolling shortly and is planned to evaluate a 3.6 mg/kg dose
administered once every three weeks. Management believes the
efficient progression through dose escalation to date speaks to the
potential safety profile of PYX-201, with preliminary Phase 1 data
expected in 1H 2024.
- PYX-106: Phase 1 trial now focusing on NSCLC and other
tumor types. Following analyses of data from a competing
anti-Siglec-15 clinical trial and a review of internally generated
preclinical results, Pyxis Oncology has decided to focus on
enrolling additional patients with specific tumor types, including
non-small cell lung cancer, in its ongoing Phase 1 trial.
Currently, dosing is ongoing in the second cohort at a dose of 1.0
mg/kg. As a result of this repositioning of the trial, preliminary
data from the PYX-106-101 trial is now anticipated in 2H 2024.
Importantly, the repositioning of the trial has not increased the
cost of the study.
- Cash runway extended to early 2026 due to cost
reductions and portfolio prioritization. Pyxis Oncology
plans to focus its cash resources on and around its two
clinical-stage programs, extending its cash runway past key Phase 1
data readouts for PYX-201 and PYX-106, expected in 2024.
Following a portfolio and business review, the company is
announcing a reduction in overall headcount by approximately 40%
and pausing funding of certain early-stage research
programs. These initiatives are anticipated to extend Pyxis
Oncology’s cash runway into early 2026. In addition, the company
has undertaken monetization efforts for its acquired Apexigen
royalty streams and has also undertaken initiatives for possible
partnerships of several assets that we have chosen not to move into
the clinic, and antibody and ADC platform technologies, which may
bring in additional non-dilutive funding.
- Acquisition of Apexigen completed and further
sotigalimab development. On August 23, 2023, Pyxis
Oncology announced the successful completion of its acquisition of
Apexigen, Inc., in an all-stock transaction valued at approximately
$10.7 million. Opportunity to advance clinical development of
sotigalimab (which Pyxis Oncology has renamed PYX-107) will be
further assessed as part of portfolio evaluation following
preliminary data for our ongoing Phase 1 trial of PYX-201.
Potential Upcoming
Milestones
- PYX-201 (ADC targeting various solid tumors): Report
preliminary Phase 1 data and PK/PD results in 1H 2024.
- PYX-106 (IO targeting various solid tumors): Report preliminary
Phase 1 data and PK/PD results in 2H 2024.
- Updates on additional non-dilutive funding efforts as
appropriate.
Q3 2023 Financial Results
- As of September 30, 2023, Pyxis Oncology had cash and cash
equivalents, including restricted cash, and short-term investments
of $134.4 million (unaudited), which is now expected to fund
operations into early 2026 and reflects continued financial
discipline.
- Research and development expenses were $14.7 million for the
three months ended September 30, 2023, compared to $19.0 million
for the three months ended September 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 $10.7 million for the
three months ended September 30, 2023, compared to $9.4 million for
the three months ended September 30, 2022. The period-over-period
increase was primarily due to higher stock-based compensation
expenses, which were partially offset by lower professional and
consultant fees.
- Net loss was $23.0 million, or $0.56 per common share, for the
three months ended September 30, 2023, compared to $27.7 million,
or $0.85 per common share, for the three months ended September 30,
2022. Net losses for the quarters ended September 30, 2023 and 2022
included $5.2 million and $4.4 million, respectively, related to
non-cash stock-based compensation expense.
- As of September 30, 2023, the outstanding number of shares of
common stock of Pyxis Oncology was 44,294,092.
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 Quarterly
Report on Form 10-Q filed with SEC on August 11,
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.
Investor ContactPam Connealy,
CFO & COOir@pyxisoncology.com
---tables to follow---
Condensed Consolidated Statements of Operations and
Comprehensive Loss(In thousands, except share and
per share amounts)(Unaudited) |
|
|
|
Three Months EndedSeptember 30, |
|
|
Nine Months EndedSeptember 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
14,687 |
|
|
$ |
19,034 |
|
|
$ |
37,979 |
|
|
$ |
56,275 |
|
General and administrative |
|
|
10,667 |
|
|
|
9,359 |
|
|
|
26,450 |
|
|
|
29,233 |
|
Total operating expenses |
|
|
25,354 |
|
|
|
28,393 |
|
|
|
64,429 |
|
|
|
85,508 |
|
Loss from operations |
|
|
(25,354 |
) |
|
|
(28,393 |
) |
|
|
(64,429 |
) |
|
|
(85,508 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income |
|
|
1,707 |
|
|
|
719 |
|
|
|
5,036 |
|
|
|
892 |
|
Sublease income |
|
|
598 |
|
|
|
— |
|
|
|
1,200 |
|
|
|
— |
|
Total other income, net |
|
|
2,305 |
|
|
|
719 |
|
|
|
6,236 |
|
|
|
892 |
|
Net loss |
|
$ |
(23,049 |
) |
|
$ |
(27,674 |
) |
|
$ |
(58,193 |
) |
|
$ |
(84,616 |
) |
Net loss per common share - basic
and diluted |
|
$ |
(0.56 |
) |
|
$ |
(0.85 |
) |
|
$ |
(1.52 |
) |
|
$ |
(2.61 |
) |
Weighted average shares of common
stock outstanding - basic and diluted |
|
|
41,331,806 |
|
|
|
32,561,228 |
|
|
|
38,379,401 |
|
|
|
32,444,072 |
|
Condensed Consolidated Balance Sheets(In
thousands, except share and per share
amounts)(Unaudited) |
|
|
|
September 30,2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,715 |
|
|
$ |
179,293 |
|
Marketable debt securities, short-term |
|
|
118,252 |
|
|
|
— |
|
Restricted cash |
|
|
1,472 |
|
|
|
1,472 |
|
Prepaid expenses and other current assets |
|
|
4,655 |
|
|
|
5,847 |
|
Total current assets |
|
|
139,094 |
|
|
|
186,612 |
|
Property and equipment, net |
|
|
12,175 |
|
|
|
11,165 |
|
Intangible assets, net |
|
|
22,294 |
|
|
|
— |
|
Operating lease right-of-use
assets |
|
|
13,129 |
|
|
|
13,602 |
|
Total
assets |
|
$ |
186,692 |
|
|
$ |
211,379 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,310 |
|
|
$ |
7,097 |
|
Accrued expenses and other current liabilities |
|
|
16,629 |
|
|
|
24,537 |
|
Operating lease liabilities, current portion |
|
|
1,204 |
|
|
|
— |
|
Deferred revenue |
|
|
7,189 |
|
|
|
— |
|
Total current liabilities |
|
|
28,332 |
|
|
|
31,634 |
|
Operating lease liabilities, net
of current portion |
|
|
20,414 |
|
|
|
18,921 |
|
Total liabilities |
|
|
48,746 |
|
|
|
50,555 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, par value $0.001 per share, 10,000,000 shares
authorized; zero shares issued and outstanding |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value per share |
|
|
44 |
|
|
|
34 |
|
Additional paid-in capital |
|
|
408,635 |
|
|
|
373,225 |
|
Accumulated other comprehensive loss |
|
|
(105 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(270,628 |
) |
|
|
(212,435 |
) |
Total stockholders’ equity |
|
|
137,946 |
|
|
|
160,824 |
|
Total liabilities and
stockholders’ equity |
|
$ |
186,692 |
|
|
$ |
211,379 |
|
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