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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): November 12, 2024

 

 

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 November 12, 2024, Pyxis Oncology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2024 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 November 12, 2024
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:	November 12, 2024	By:	/s/ Pamela Connealy
			Pamela Connealy Chief Financial Officer and Chief Operating Officer

 

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Pyxis Oncology Provides Corporate Update and Reports Financial Results for Third Quarter 2024

- Preliminary data from the first-in-patient Phase 1 dose escalation trial of PYX-201 to be announced at upcoming virtual and in-person event in New York City on Wednesday, November 20, 2024, at 4:30 p.m. ET

- Preliminary data from the Phase 1 trial of PYX-106 is expected to be reported by year-end 2024

- Expected cash runway into 2H 2026

BOSTON, Mass., November 12, 2024– 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 third quarter ended September 30, 2024, and provided a corporate update. The Company ended the third quarter of 2024 with $146.3 million in cash, cash equivalents, restricted cash, and short-term investments, which is expected to provide a cash runway into the second half of 2026 and enable the Company to fund the next phase of PYX-201 clinical development.

“At Pyxis Oncology, our team has been working diligently to deliver preliminary data from our first-in-patient clinical trial of PYX-201. Investigator enthusiasm around our novel mechanism of action, along with our clinical development team’s operational execution, has kept us on track to provide the preliminary clinical findings from our ongoing dose escalation study,” said Lara S. Sullivan, M.D., President and CEO of Pyxis Oncology.

Dr. Sullivan continued, “We have now enrolled 80 patients in the PYX-201 trial across multiple tumor types, and I am thrilled to present the Phase 1 dose escalation data next Wednesday in New York City at our first-ever Pyxis Oncology Investor Event.”

Recent Clinical Program Updates

PYX-201

PYX-201 is an antibody-drug conjugate (ADC) that is designed to uniquely target Extradomain-B Fibronectin (EDB+FN), which is believed to be a key structural component of the tumor extracellular matrix. PYX-201 is the Company’s lead clinical program being evaluated in an ongoing Phase 1 trial in multiple types of solid tumors.

 

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PYX-106

PYX-106, a fully human Siglec-15-targeting antibody designed to block suppression of T-cell proliferation and function, is being evaluated in an ongoing Phase 1 clinical study in multiple types of solid tumors.

Third Quarter 2024 Financial Results

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. PYX-201, an antibody-drug conjugate (ADC) that uniquely targets EDB+FN, a non-cellular structural component of the tumor extracellular matrix, and PYX-106, a fully human Siglec-15-targeting antibody designed to block suppression of T-cell proliferation and function, are being evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors. 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

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proliferation and immune evasion. Pyxis Oncology’s ADC 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 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 Quarterly Report on Form 10-Q filed with SEC on November 12, 2024, and our other filings, each of which is on file with the Securities and Exchange Commission. 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

Pamela Connealy

CFO and COO

ir@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 September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Revenues
Royalty revenues		$	—			$	—			$	8,146			$	—
Sale of royalty rights			—				—				8,000				—
Total revenues			—				—				16,146				—
Costs and operating expenses:
Cost of revenues			—				—				475				—
Research and development			17,741				14,687				44,723				37,979
General and administrative			6,013				10,667				20,339				26,450
Total costs and operating expenses			23,754				25,354				65,537				64,429
Loss from operations			(23,754	)			(25,354	)			(49,391	)			(64,429	)
Other income, net:
Interest and investment income			1,846				1,707				5,419				5,036
Sublease income			705				598				2,212				1,200
Total other income, net			2,551				2,305				7,631				6,236
Net loss		$	(21,203	)		$	(23,049	)		$	(41,760	)		$	(58,193	)
Net loss per common share - basic and diluted		$	(0.35	)		$	(0.56	)		$	(0.73	)		$	(1.52	)
Weighted average shares of common stock outstanding - basic and diluted			60,715,041				41,331,806				57,511,997				38,379,401

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PYXIS ONCOLOGY, INC.

Condensed Consolidated Balance Sheets

(In thousands, except per share amounts)

(Unaudited)

		September 30, 2024				December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	12,056			$	9,664
Marketable debt securities, short-term			132,762				109,634
Restricted cash			1,472				1,472
Prepaid expenses and other current assets			2,578				3,834
Total current assets			148,868				124,604
Property and equipment, net			10,396				11,872
Intangible assets, net			23,619				24,308
Right-of-use asset			12,428				12,942
Total assets		$	195,311			$	173,726
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	4,870			$	3,896
Accrued expenses and other current liabilities			14,057				12,971
Operating lease liabilities, current portion			1,393				1,232
Deferred revenues			—				7,660
Total current liabilities			20,320				25,759
Operating lease liabilities, net of current portion			19,030				20,099
Financing lease liabilities, net of current portion			117				—
Deferred tax liability, net			2,164				2,164
Total liabilities			41,631				48,022
Commitments and contingencies
Stockholders’ equity:
Preferred stock, par value $0.001 per share			—				—
Common stock, par value $0.001 per share			59				45
Additional paid-in capital			481,255				411,821
Accumulated other comprehensive income			351				63
Accumulated deficit			(327,985	)			(286,225	)
Total stockholders’ equity			153,680				125,704
Total liabilities and stockholders’ equity		$	195,311			$	173,726

 

 

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