Pyxis Oncology, Inc. — FY 2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021. This is an annual report, not a standalone fourth-quarter report. Filed March 29, 2022. Pyxis is a preclinical oncology company with no approved products and no product revenue.
Business context and pipeline
The company is developing antibody-drug conjugates (ADCs) and immuno-oncology antibodies for difficult-to-treat cancers, including programs intended to target the tumor microenvironment. All product candidates remained in preclinical development at year-end.
- PYX-201: EDB-targeting ADC; IND submission planned for the second half of 2022.
- PYX-202: DLK1-targeting ADC; additional GLP and non-GLP toxicity studies are needed to assess clinical viability; management expected to provide an update in mid-2022.
- PYX-203: CD123-targeting ADC for AML and other blood cancers; IND submission planned for the second half of 2023.
- PYX-102: internally developed anti-KLRG1 antibody; IND submission anticipated in the second half of 2023.
- PYX-106: anti-Siglec-15 antibody licensed from Biosion after year-end; IND submission planned for the second half of 2022.
Financial performance and liquidity
| Metric | FY 2021 | FY 2020 |
|---|---|---|
| Revenue | No revenue reported | No revenue reported |
| Research and development expense | $51.1 million | $9.0 million |
| General and administrative expense | $18.7 million | $3.8 million |
| Total operating expenses | $69.7 million | $12.9 million |
| Net loss | $76.0 million | $12.8 million |
| Net cash used in operating activities | $35.3 million | $10.1 million |
| Cash and cash equivalents at year-end | $274.7 million | $8.1 million |
| Total liabilities at year-end | $18.7 million | $3.9 million |
Margins are not meaningful given the absence of revenue. The filing reports no borrowings or debt balance. The company had an accumulated deficit of $91.7 million at year-end and stated that its cash was expected to fund operating expenses and capital requirements into the third quarter of 2024, subject to assumptions and potential changes in its operating plan.
Cash from financing activities was $304.0 million in 2021, mainly comprising $152.3 million of net IPO proceeds and $151.6 million of net Series B proceeds. Investing activities used $0.6 million, primarily for property and equipment. The IPO closed in October 2021 at $16.00 per share; 10.5 million shares were sold.
Changes versus the prior year
- Net loss rose by $63.1 million, while operating expenses increased by $56.8 million, reflecting expanded R&D and corporate activity.
- R&D expense increased by $42.0 million. The company cited $25.0 million in Pfizer license fees, $4.4 million in LegoChem license fees, higher cell-line development costs, and increased staffing and laboratory costs.
- G&A expense increased by $14.8 million, including higher personnel, professional, and public-company costs.
- Cash and cash equivalents increased substantially following the Series B financing and IPO.
Outlook, risks and unusual items
- Management expects substantial continued spending and operating losses as it advances preclinical programs, prepares IND filings, and potentially begins clinical trials. Additional capital may be needed; the company does not expect product revenue in the foreseeable future.
- In March 2022, Pyxis licensed PYX-106 from Biosion for $10 million upfront, with up to $217.5 million in contingent milestones for normal approval or $222.5 million for accelerated approval, plus royalties. The license excludes Greater China.
- The company recognized a $6.2 million expense from remeasuring a LegoChem-related derivative liability. The related $9.6 million payment was recorded as payable at year-end and paid in January 2022.
- Pyxis reported a planned approximately 10-year Boston office and laboratory lease, with $33.8 million in undiscounted base rent. The lease was expected to commence in the second quarter of 2022.
- Major risks include clinical and regulatory failure, reliance on third-party manufacturers and research organizations, dependence on licensed intellectual property, competition, need for future financing, and possible COVID-19-related operational or supply disruptions. The company reported no material business disruption from COVID-19 to date.
- The 2021 financial statements received an unqualified audit opinion. Management concluded disclosure controls were effective at year-end; the filing did not include an auditor attestation on internal controls, consistent with the company’s emerging-growth-company exemption.
Most important facts for investors to verify
- Whether PYX-201 and PYX-106 meet their planned IND timelines, and whether PYX-202 toxicity studies support further development.
- Whether preclinical findings translate into acceptable safety and efficacy in human trials.
- Whether the stated cash runway into Q3 2024 remains achievable as development costs, licensing payments, and the Boston lease take effect.
- The terms, timing, and potential dilution or rights impact of any future financing, and the contingent milestone and royalty obligations under licensing agreements.
- Whether management’s market-opportunity and platform claims are borne out by clinical data, regulatory decisions, and competitive developments.