Expands worldwide licensing settlement with Pfizer to acquire extra antibody-drug conjugate (ADC) platform elements
Gains unique rights to Pfizer’s ADC expertise platform and toolkit to sure licensed targets; Initial multi-target sublicense deal executed with stealth ADC firm
Remains on monitor with IND plans for PYX-106 and PYX-201 by the finish of this yr
Strong steadiness sheet with $200 million in money (together with restricted money) as of September 30, 2022 maintains flexibility to pursue business improvement alternatives
CAMBRIDGE, Mass., Nov. 01, 2022 (GLOBE NEWSWIRE) — Pyxis Oncology, Inc. (Nasdaq: PYXS) at present reported monetary outcomes for the third quarter and 9 months ended September 30, 2022 and supplied a company replace.
“The expansion of our exclusive in-licensing agreement with Pfizer continues to strengthen our development and partnership capabilities through exclusive access to Pfizer’s ADC technology platform and toolkit with first right of access to all available Pfizer ADC targets and associated technology,” mentioned Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “As Pfizer’s exclusive sublicensing agent for its ADC technology, our team has already concluded the first multi-target sublicensing agreement with a stealth ADC company demonstrating the durable value of this platform as well as industry interest in the technology. We look forward to further collaborating with other industry partners to fully leverage the potential of this intellectual property.”
Jeff Settleman, Ph.D., Senior Vice President and Chief Scientific Officer for Oncology Research and Development at Pfizer, added, “We are proud to strengthen our agreement with Pyxis Oncology. Pyxis Oncology has assembled a talented team, and we are confident in their ability to fully realize the platform’s clinical potential.”
Corporate Development Highlights
- Pfizer solely out-licensed the entirety of its ADC expertise platform and toolkit to Pyxis Oncology: Under the phrases of the settlement, Pyxis Oncology has unique entry to Pfizer’s ADC expertise platform and toolkit (excluding antibodies) to develop and commercialize ADCs directed to all out there Pfizer ADC targets. The amended settlement gives Pyxis Oncology with the flexibility to sublicense both the full platform or sure elements of the platform to 3rd events. Pyxis Oncology has concluded its first multi-target sublicensing settlement below the new association with a stealth ADC firm. This growth builds on the former settlement, which supplied Pyxis Oncology with a worldwide, royalty-bearing license to develop and commercialize a number of ADC candidates.
- Pyxis Oncology continues to advance lead applications towards the clinic with near-term catalysts: Pyxis Oncology stays on monitor with its IND plans for PYX-106 and PYX-201 by the finish of this yr. The firm stays assured in the scientific and business alternative for each applications primarily based on the in vivo preclinical knowledge up to now and appears ahead to working with the FDA to advance each applications into scientific improvement. PYX-201 is a novel, non-internalized ADC directed in opposition to a first-in-class goal (EDB), which is selectively expressed in a big inhabitants of non-small cell lung most cancers, breast most cancers, and different stable tumors. PYX-106 is a extremely potent immunotherapy that blocks the exercise of Siglec-15, an rising immune suppressor expressed throughout a broad vary of tumors.
“Our team believes in the potential of marrying internal and external development strategies to accelerate promising therapeutics for patients with difficult-to-treat cancers,” continued Dr. Sullivan. “In addition to strengthening our current partnerships, we see a significant opportunity to leverage our strong balance sheet and our team’s extensive industry networks to explore new avenues of scientific and therapeutic advancement.”
Financial Update for Quarter Ended September 30, 2022
- Pyxis Oncology had money and money equivalents (together with restricted money) of $200.0 million as of September 30, 2022, which is predicted to fund operations into the finish of 2024.
- Research and improvement bills had been $19.0 million for the three months ended September 30, 2022, in comparison with $7.8 million for the three months ended September 30, 2021. The enhance was primarily on account of elevated bills related to contract manufacturing of drug merchandise and drug substance, preclinical value associated to toxicity research and a rise in worker headcount to help analysis and improvement actions.
- General and administrative bills had been $9.4 million for the three months ended September 30, 2022, in comparison with $3.8 million for the three months ended September 30, 2021. The enhance was primarily on account of the next personnel-related bills (together with stock-based compensation), and a rise in authorized {and professional} charges, lease and administrators and officers insurance expense to help our progress and operations.
- Net loss was $27.7 million, or $(0.85) per frequent share, for the three months ended September 30, 2022, in comparison with $14.2 million, or $(8.96) per frequent share, for the three months ended September 30, 2021. Net loss for the three months ended September 30, 2022 and 2021 included $4.4 million and $0.3 million, respectively, associated to non-cash stock-based compensation expense.
- As of November 1, 2022, the excellent variety of shares of Common Stock of Pyxis Oncology was 35,097,256.
About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is an oncology firm centered on growing an arsenal of next-generation therapeutics to focus on difficult-to-treat cancers and enhance high quality of life for sufferers. By leveraging our totally built-in analysis, improvement and business capabilities, our skilled staff is effectively constructing a diversified portfolio of next-generation therapeutics. Pyxis Oncology’s therapeutic candidates are designed to straight kill tumor cells, and to deal with the underlying pathologies created by most cancers that allow 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 applications that it’s growing as monotherapies and together with different therapies. To study extra about Pyxis Oncology, go to www.pyxisoncology.com.
Forward-Looking Statements
This press launch incorporates forward-looking statements for the functions of the secure harbor provisions below The Private Securities Litigation Reform Act of 1995 and different federal securities legal guidelines. These statements are sometimes recognized by the use of phrases akin to “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the unfavourable or plural of those phrases, or related expressions or variations, though not all forward-looking statements include these phrases. We can not guarantee you that the occasions and circumstances mirrored in the forward-looking statements might be achieved or happen and precise outcomes may differ materially from these expressed or implied by these forward-looking statements. Factors that would trigger or contribute to such variations embody, however usually are not restricted to, these recognized herein, and people mentioned in the part titled “Risk Factors” set forth in Part II, Item 1A. of the Company’s Quarterly Report on Form 10-Q filed with SEC on November 1, 2022 and in our different filings with the SEC. These dangers usually are not exhaustive. New danger elements emerge on occasion, and it isn’t attainable for our administration to foretell all danger elements, nor can we assess the impression of all elements on our business or the extent to which any issue, or mixture of things, could trigger precise outcomes to vary materially from these contained in any forward-looking statements. In addition, statements that “we believe” and related statements replicate our beliefs and opinions on the related topic. These statements are primarily based upon data out there to us as of the date hereof and whereas we consider such data types an inexpensive foundation for such statements, such data could also be restricted or incomplete, and our statements shouldn’t be learn to point that we’ve got carried out an exhaustive inquiry into, or overview of, all doubtlessly out there related data. These statements are inherently unsure, and buyers are cautioned to not unduly depend upon these statements. Except as required by legislation, we undertake no obligation to replace any forward-looking statements to replicate occasions or circumstances after the date of such statements.
Pyxis Oncology Contact
Pamela Connealy
Chief Financial Officer
(617) 453-3596
[email protected]
Investor Contact
Ashley Robinson
LifeSci Advisors, LLC
[email protected]
—tables to follow—
PYXIS ONCOLOGY, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In 1000’s, besides share and per share quantities) (Unaudited)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating bills: | ||||||||||||||||
Research and improvement | $ | 19,034 | $ | 7,849 | $ | 56,275 | $ | 43,828 | ||||||||
General and administrative | 9,359 | 3,772 | 29,233 | 9,463 | ||||||||||||
Total working bills | 28,393 | 11,621 | 85,508 | 53,291 | ||||||||||||
Loss from operations | (28,393 | ) | (11,621 | ) | (85,508 | ) | (53,291 | ) | ||||||||
Other revenue (expense): | ||||||||||||||||
Interest revenue | 719 | 6 | 892 | 16 | ||||||||||||
Service charge revenue from associated get together | — | — | — | 181 | ||||||||||||
Change in honest worth of by-product legal responsibility | — | (2,560 | ) | — | (5,821 | ) | ||||||||||
Total different revenue (expense) | 719 | (2,554 | ) | 892 | (5,624 | ) | ||||||||||
Loss from fairness technique funding in three way partnership | — | — | — | (231 | ) | |||||||||||
Net loss and complete loss | $ | (27,674 | ) | $ | (14,175 | ) | $ | (84,616 | ) | $ | (59,146 | ) | ||||
Net loss per frequent share – fundamental and diluted | $ | (0.85 | ) | $ | (8.96 | ) | $ | (2.61 | ) | $ | (40.27 | ) | ||||
Weighted common shares of frequent inventory excellent – fundamental and diluted | 32,561,228 | 1,581,610 | 32,444,072 | 1,468,777 |
PYXIS ONCOLOGY, INC.
Condensed Consolidated Balance Sheets
(In 1000’s) (Unaudited)
September 30, 2022 | December 31, 2021 | |||||||
Assets | ||||||||
Current belongings: | ||||||||
Cash and money equivalents | $ | 198,538 | $ | 274,735 | ||||
Restricted money | 1,472 | 1,472 | ||||||
Prepaid bills and different present belongings | 2,798 | 2,466 | ||||||
Total present belongings | 202,808 | 278,673 | ||||||
Property and tools, internet | 6,391 | 1,007 | ||||||
Operating lease right-of-use belongings | 14,696 | 232 | ||||||
Other belongings, noncurrent | — | 109 | ||||||
Total belongings | $ | 223,895 | $ | 280,021 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 5,509 | $ | 11,951 | ||||
Accrued bills and different present liabilities | 13,586 | 6,592 | ||||||
Operating lease liabilities, present portion | — | 165 | ||||||
Total present liabilities | 19,095 | 18,708 | ||||||
Operating lease liabilities, internet of present portion | 16,053 | — | ||||||
Total liabilities | 35,148 | 18,708 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ fairness: | ||||||||
Preferred inventory | — | — | ||||||
Common inventory | 32 | 32 | ||||||
Additional paid-in capital | 365,049 | 352,999 | ||||||
Accumulated deficit | (176,334 | ) | (91,718 | ) | ||||
Total stockholders’ fairness | 188,747 | 261,313 | ||||||
Total liabilities and stockholders’ fairness | $ | 223,895 | $ | 280,021 |