Pyxis Oncology Provides Corporate and Financial Update
Announces Expansion of Novel Immuno-Oncology Therapeutic Portfolio with Addition of Anti-Siglec-15 In-licensed from Biosion (PYX-106)
Introduces First Internally Developed IO Candidate Anti-KLRG1 (PYX-102)
Cash Runway Sufficient for Multiple Milestones Through Third Quarter 2024
Company to Host Conference Call and Webcast Today at
“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
“We are excited to partner with
Corporate Development Highlights
- License agreement with Biosion adds anti-Siglec-15 to Pyxis Oncology’s IO pipeline:
Pyxis Oncologyannounced 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 Oncologyexpects 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 Oncologyannounced 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 Oncologyfounder 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 Oncologyexpects 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.
- As of
March 29, 2022, Pyxis Oncologyhad 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
- Research and development expenses for the full year ended
December 31, 2021were $51.1 million, compared to $9.1 millionfor 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, 2021were $18.6 million, compared to $3.8 millionfor 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, 2021was $76.0 million( $8.95per common share), compared to $12.8 million( $12.45per common share) for the year ended December 31, 2020. The increase in net loss is primarily attributed to the addition of three antibody-drug conjugates to the Company’s portfolio and the Company’s preparations to initiate human clinical trials for PYX-201.
- As of
March 25, 2022, the outstanding number of shares of Common Stock of Pyxis Oncologywas 32,841,747.
Conference Call and Webcast Details
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Part I, Item 1A. of the Company's most recent Annual Report on Form 10-K and in our other filings with the
Investor and Media Contact
VP, Head of Investor Relations and Corporate Communications
---tables to follow---
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Research and development||$||51,054||$||9,048|
|General and administrative||18,663||3,846|
|Total operating expenses||69,717||12,894|
|Loss from operations||(69,717||)||(12,894||)|
|Other (expense) income:|
|Service fee income from related party||181||—|
|Change in fair value of derivative liability||(6,231||)||—|
|Total other (expense) income||(6,027||)||66|
|Loss from equity method investment in joint venture||(231||)||—|
|Net loss and comprehensive loss||$||(75,975||)||$||(12,828||)|
|Net loss per common share - basic and diluted||$||(8.95||)||$||(12.45||)|
|Weighted average shares of common stock outstanding - basic and diluted||8,493,273||1,030,556|
Consolidated Balance Sheets
|Cash and cash equivalents||$||274,735||$||8,080|
|Prepaid expenses and other current assets||2,466||23|
|Total current assets||278,673||8,103|
|Property and equipment, net||1,007||1,103|
|Operating lease right-of-use assets||232||836|
|Other assets, noncurrent||109||109|
|Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)|
|Accrued expenses and other current liabilities||6,592||1,997|
|Operating lease liabilities, current portion||165||615|
|Total current liabilities||18,708||3,689|
|Operating lease liabilities, net of current portion||—||165|
|Commitments and contingencies|
|Series A Convertible Preferred Stock||—||21,942|
|Series B Convertible Preferred Stock||—||—|
|Stockholders’ equity (deficit):|
|Additional paid-in capital||352,999||97|
|Total stockholders’ equity (deficit)||261,313||(15,645||)|
|Total liabilities, convertible preferred stock and stockholders’ equity (deficit)||$||280,021||$||10,151|
Source: Pyxis Oncology