Pyxis Oncology Reports Financial Results for the Second Quarter Ended June 30, 2022 and Provides Pipeline Update
• Prioritized pipeline to focus on most advanced programs while maintaining financial flexibility to pursue business development opportunities
• Cash balance of
“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
Corporate Development Highlights
- Focus on advancing lead programs toward the clinic with near-term catalysts:
Pyxis Oncologyis on track to file Investigational New Drug applications (INDs) for PYX-201 and PYX-106 in 2022. Pyxis Oncologyremains 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 Oncologyremains 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 Oncologydisclosed 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 Oncologylooks forward to leveraging its collaboration with LegoChem to evaluate the potential of these new candidate ADCs.
Addition to Board of Directors
Financial Update for Quarter Ended
Pyxis Oncologyhad cash and cash equivalents of $223 millionas 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 millionfor the three months ended June 30, 2022, compared to $3.2 millionfor 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 millionfor the three months ended June 30, 2022, compared to $2.7 millionfor 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, 2022and 2021 included $4.0 millionand $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 Oncologywas 32,834,561.
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:
Vice President, Head of Investor Relations & Corporate Communications
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts) (Unaudited)
|Three Months Ended
||Six Months Ended
|Research and development||$||17,170||$||3,205||$||37,241||$||35,979|
|General and administrative||8,556||2,736||19,874||5,691|
|Total operating expenses||25,726||5,941||57,115||41,670|
|Loss from operations||(25,726||)||(5,941||)||(57,115||)||(41,670||)|
|Other income (expense):|
|Service fee income from related party||—||181||—||181|
|Change in fair value of derivative liability||—||(2,161||)||—||(3,261||)|
|Total other income (expense)||164||(1,974||)||173||(3,070||)|
|Loss from equity method investment in joint venture||—||(231||)||—||(231||)|
|Net loss and comprehensive loss||$||(25,562||)||$||(8,146||)||$||(56,942||)||$||(44,971||)|
|Net loss per common share - basic and diluted||$||(0.79||)||$||(5.54||)||$||(1.76||)||$||(31.86||)|
|Weighted average shares of common stock outstanding - basic and diluted||32,451,610||1,471,447||32,384,522||1,411,428|
Condensed Consolidated Balance Sheets
(In thousands) (Unaudited)
|Cash and cash equivalents||$||223,355||$||274,735|
|Prepaid expenses and other current assets||1,768||2,466|
|Total current assets||226,595||278,673|
|Property and equipment, net||965||1,007|
|Operating lease right-of-use assets||15,003||232|
|Other assets, noncurrent||—||109|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and other current liabilities||7,096||6,592|
|Operating lease liabilities, current portion||—||165|
|Total current liabilities||14,916||18,708|
|Operating lease liabilities, net of current portion||15,681||—|
|Commitments and contingencies|
|Additional paid-in capital||360,594||352,999|
|Total stockholders’ equity||211,966||261,313|
|Total liabilities and stockholders’ equity||$||242,563||$||280,021|
Source: Pyxis Oncology