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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 11, 2023

 

 

Pyxis Oncology, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-40881	83-1160910
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
321 Harrison Avenue
Boston, Massachusetts				02118
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 617-221-9059

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		PYXS		The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

 

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Item 2.02 Results of Operations and Financial Condition.

On May 11, 2023, Pyxis Oncology, Inc., or the Company, issued a press release announcing its financial results for the quarter ended March 31, 2023 and provided a corporate update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filings.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits
Exhibit No.		Description
99.1		Press Release dated May 11, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

			Pyxis Oncology, Inc.
Date:	May 11, 2023	By:	/s/ Pam Connealy
			Pam Connealy Chief Financial Officer and Chief Operating Officer

 

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Exhibit 99.1

 

Pyxis Oncology Reports Financial Results for the First Quarter 2023

and Provides Corporate Update

Orphan Drug Designation received for PYX-201 in pancreatic cancer

 

Preliminary data from two Phase 1 trials anticipated late 2023 to early 2024

 

Strong balance sheet with $150.8 million in cash (including restricted cash) and short-term investments and no debt supports operations into 1H 2025

 

BOSTON, Mass., May 11, 2023 – 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 March 31, 2023, and provided a corporate update.

 

Pyxis Oncology ended the first quarter of 2023 with approximately $150.8 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 initiate tumor-specific expansion cohorts following dose selection. Clinical sites are active and patient screening continues in the Phase 1 trial of PYX-106, referred to as PYX-106-101, and dosing is expected to begin during the second quarter of 2023. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for PYX-201 in pancreatic cancer, and subject dosing is underway in the Phase 1 trial of PYX-201, known as PYX-201-101.

“The first quarter of 2023 was marked by the transition of Pyxis Oncology to a clinical-stage company as we initiated two Phase 1 trials for PYX-201 and PYX-106,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “Receipt of ODD for PYX-201 in pancreatic cancer is an important achievement highlighting the need for new treatment options, and we remain focused on execution as our two clinical programs advance. We continue to anticipate preliminary data, including biomarker results and early signs of potential clinical activity, from both trials in the late-2023 to early-2024 timeframe.”

 

Q1 2023 Financial Results

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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.

 

 

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Forward-Looking Statements

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 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.

 

 

Pyxis Oncology Contact

Jennifer Davis Ruff

VP, Investor Relations

jdavisruff@pyxisoncology.com

 

 

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PYXIS ONCOLOGY, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

		Three Months Ended March 31,
		2023				2022
Operating expenses:
Research and development		$	11,901			$	20,071
General and administrative			9,053				11,318
Total operating expenses			20,954				31,389
Loss from operations			(20,954	)			(31,389	)
Other income, net:
Interest and investment income			1,673				9
Sublease income			38				—
Total other income, net			1,711				9
Net loss		$	(19,243	)		$	(31,380	)
Net loss per common share - basic and diluted		$	(0.54	)		$	(0.97	)
Weighted average shares of common stock outstanding - basic and diluted			35,351,671				32,316,689
Other comprehensive income:
Net unrealized gain on marketable debt securities			696				—
Other comprehensive income			696				—
Comprehensive loss		$	(18,547	)		$	(31,380	)

 

 

 

 

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PYXIS ONCOLOGY, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

		March 31, 2023				December 31, 2022
Assets
Current assets:
Cash and cash equivalents		$	53,059			$	179,293
Marketable debt securities, short-term			96,290				—
Restricted cash			1,472				1,472
Prepaid expenses and other current assets			5,361				5,847
Total current assets			156,182				186,612
Property and equipment, net			13,163				11,165
Operating lease right-of-use assets			13,458				13,602
Total assets		$	182,803			$	211,379
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	4,025			$	7,097
Accrued expenses and other current liabilities			6,363				24,537
Operating lease liabilities, current portion			1,213				—
Total current liabilities			11,601				31,634
Operating lease liabilities, net of current portion			19,039				18,921
Total liabilities			30,640				50,555
Commitments and contingencies
Stockholders’ equity:
Preferred stock			—				—
Common stock			37				34
Additional paid-in capital			383,108				373,225
Accumulated other comprehensive income			696				—
Accumulated deficit			(231,678	)			(212,435	)
Total stockholders’ equity			152,163				160,824
Total liabilities and stockholders’ equity		$	182,803			$	211,379

 

 

 

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