Sotigalimab

Pyxis Oncology, which went public in fall 2021, is hoping tough decisions will help prioritize programs with the highest likelihood of success. Pyxis Oncology needs to pave a longer cash runway. To do so, the Pfizer-partnered antibody-drug conjugate (ADC) biotech is cutting 40% of staff, slimming its programs and looking to monetize royalty opportunities from a recently acquired company—among other cost-cutting measures. It’s a stark change from the recent headlines around ADC-focused companies, which have been snagging deals with Big Pharmas left and right. Pyxis, which went public in fall 2021, is hoping the tough decisions will help prioritize programs with the highest likelihood of success. The pipeline will continue to focus on lead tumor stroma-targeting ADC PYX-201 and secondary program PYX-106 in non-small cell lung cancer (NSCLC), with early-stage research programs paused. “In order to maximize PYX-201’s chances of success, as well as those of PYX-106, we are announcing a number of initiatives to extend our cash runway into 2026, which we believe is the responsible thing to do in the current funding environment,” CEO Lara Sullivan, M.D., said in a postmarket release Tuesday. “We believe the actions we are taking best position Pyxis Oncology for future success, with our current cash resources now taking us beyond important near-term 2024 readouts for our ongoing clinical trials.” PYX-201, which was in-licensed from Pfizer, is being tested in a phase 1 trial of patients with solid tumors at the moment. The fifth dose cohort recently opened for enrollment, and 15 people have been dosed in other groups so far. The company believes that the swift escalation in dosing “speaks to the potential safety profile” of the therapy. Preliminary phase 1 data are expected in the first half of 2024. “Based on data from Pfizer’s HER2 ADC previously under development with the same linker and payload and our preclinical experiments, we believe that at 3.6 mg/kg and above, we are approaching biologically active dose levels,” Sullivan said. PYX-106 was originally being targeted at a wider array of tumors, but Pyxis has decided to only include patients with NSCLC. Dosing had already gotten underway in a phase 1 test, so, with the “repositioning,” initial results are now anticipated in the second half of 2024. Pyxis said the update does not increase costs of the trial. Another med in the pipeline is sotigalimab, which came under Pyxis’ purview with the May acquisition of Apexigen and has been renamed PYX-107. The new owner has not yet decided the future for the CD40 agonist, which is being tested in phase 2 for melanoma and liposarcoma. But one thing is for sure, PYX-107 will have to wait until the phase 1 data for PYX-201 are available, Pyxis said. Then, the legacy Apexigen med “will be further assessed as part of portfolio evaluation.” As cash resources shift to the two main programs, Pyxis will say goodbye to 40% of its staff. The company's current workforce is estimated to be around 75 people, according to LinkedIn and Crunchbase. With $134 million in cash as of Sept. 30, the company expects the runway to last through the upcoming major milestones for the two main programs into early 2026, as long as it executes “continued financial discipline.” According to a third-quarter earnings report, the runway had previously been expected to last about a year without the changes. As for Apexigen, which was acquired in an all-stock transaction valued at around $10.7 million, Pyxis “has undertaken monetization efforts” for the company’s royalty streams. Sullivan and her team are also looking for partnerships for some of Apexigen’s programs that will not be advancing into the clinic under the Pyxis name, plus antibody and ADC platform technologies it has no use for that may bring in non-dilutive funding. In announcing the acquisition, Pyxis said Apexigen’s antibody-generation platform would be complementary to its existing linkers, payloads and conjugation chemistries. The buyer also seemed excited about Apexigen’s sotigalimab, calling it “a potential best-in-class phase 2 CD40 agonist.” But just over three months after the deal officially closed in August, it seems Pyxis is already offloading the very assets that made the Apexigen acquisition so attractive. This is not the first time Pyxis has had to take a hard reality check and slim down its pipeline from five main candidates. Pyxis paused two programs, an anti-CD123 therapy called PYX-203 and the anti-KLRG1 med PYX-102, in August 2022. Now, the company plans to evaluate partnering opportunities for the two programs. Another asset was scrapped completely last summer as well. Those moves left Pyxis with a runway extending into the second half of 2024. Pyxis emerged onto the public markets in October 2021 at around $13 per share. The company's shares closed Tuesday at $1.66 apiece.

PYX-201 (a novel first-in-concept and first-in-class tumor stroma targeting antibody-drug conjugate [ADC] product candidate) Phase 1 trial progressing with fifth dose cohort at 3.6 mg/kg; data expected 1H 2024. PYX-106 (a fully human immunotherapy antibody candidate): Phase 1 trial now focusing on NSCLC and other tumor types; data expected 2H 2024. Cash runway extended to early 2026 due to cost reductions and portfolio prioritization, allows for preliminary data readouts from PYX-201 and PYX-106 programs. Balance sheet includes $134.4 million in cash, restricted cash, and short-term investments. BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing antibody-drug conjugates (ADCs) and immune-oncology (IO) therapeutics to target difficult-to-treat cancers, today announced initiatives to extend its cash runway, reported financial results for the quarter ended September 30, 2023, and provided a corporate update. The company ended the third quarter of 2023 with approximately $134.4 million in cash, cash equivalents, restricted cash and short-term investments. “We are excited to begin dosing in the fifth cohort of our Phase 1 trial of our lead asset PYX-201, a first-in-class and first-in-concept tumor stroma targeting ADC against EDB-fibronectin in tumor stroma. We believe the progress we are making through the dose escalation portion of our trial speaks to the potential safety profile of our ADC drug candidate. Moreover, based on data from Pfizer’s HER2 ADC previously under development with the same linker and payload and our preclinical experiments, we believe that at 3.6 mg/kg and above, we are approaching biologically active dose levels,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “In order to maximize PYX-201’s chances of success, as well as those of PYX-106, we are announcing a number of initiatives to extend our cash runway into 2026, which we believe is the responsible thing to do in the current funding environment. We believe the actions we are taking best position Pyxis Oncology for future success, with our current cash resources now taking us beyond important near-term 2024 readouts for our ongoing clinical trials.” Pam Connealy, COO and CFO of Pyxis Oncology added, “In addition to the cost reductions announced today, which include a 40% decrease in headcount, we are also seeking additional non-dilutive funding through the potential monetization of our acquired Apexigen royalty streams. Additionally, we are evaluating partnerships of several assets that we have chosen not to move into the clinic and potential antibody and ADC platform technology collaborations. We believe this increased focus on our lead and secondary assets, in addition to the changes we are making to the PYX-106 program, gives us the best chance for success in bringing our novel ADC and IO candidates to the patients who need them. We appreciate the contributions from our dedicated team members that have enabled us to reach this point in our clinical programs.” Corporate Updates PYX-201: Fifth dose cohort open for enrollment in Phase 1 trial. To date, 15 subjects have been dosed with PYX-201 in the PYX-201-101 trial. The fifth dose cohort is expected to begin enrolling shortly and is planned to evaluate a 3.6 mg/kg dose administered once every three weeks. Management believes the efficient progression through dose escalation to date speaks to the potential safety profile of PYX-201, with preliminary Phase 1 data expected in 1H 2024.PYX-106: Phase 1 trial now focusing on NSCLC and other tumor types. Following analyses of data from a competing anti-Siglec-15 clinical trial and a review of internally generated preclinical results, Pyxis Oncology has decided to focus on enrolling additional patients with specific tumor types, including non-small cell lung cancer, in its ongoing Phase 1 trial. Currently, dosing is ongoing in the second cohort at a dose of 1.0 mg/kg. As a result of this repositioning of the trial, preliminary data from the PYX-106-101 trial is now anticipated in 2H 2024. Importantly, the repositioning of the trial has not increased the cost of the study.Cash runway extended to early 2026 due to cost reductions and portfolio prioritization. Pyxis Oncology plans to focus its cash resources on and around its two clinical-stage programs, extending its cash runway past key Phase 1 data readouts for PYX-201 and PYX-106, expected in 2024. Following a portfolio and business review, the company is announcing a reduction in overall headcount by approximately 40% and pausing funding of certain early-stage research programs. These initiatives are anticipated to extend Pyxis Oncology’s cash runway into early 2026. In addition, the company has undertaken monetization efforts for its acquired Apexigen royalty streams and has also undertaken initiatives for possible partnerships of several assets that we have chosen not to move into the clinic, and antibody and ADC platform technologies, which may bring in additional non-dilutive funding.Acquisition of Apexigen completed and further sotigalimab development. On August 23, 2023, Pyxis Oncology announced the successful completion of its acquisition of Apexigen, Inc., in an all-stock transaction valued at approximately $10.7 million. Opportunity to advance clinical development of sotigalimab (which Pyxis Oncology has renamed PYX-107) will be further assessed as part of portfolio evaluation following preliminary data for our ongoing Phase 1 trial of PYX-201. Potential Upcoming Milestones PYX-201 (ADC targeting various solid tumors): Report preliminary Phase 1 data and PK/PD results in 1H 2024.PYX-106 (IO targeting various solid tumors): Report preliminary Phase 1 data and PK/PD results in 2H 2024.Updates on additional non-dilutive funding efforts as appropriate. Q3 2023 Financial Results As of September 30, 2023, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments of $134.4 million (unaudited), which is now expected to fund operations into early 2026 and reflects continued financial discipline. Research and development expenses were $14.7 million for the three months ended September 30, 2023, compared to $19.0 million for the three months ended September 30, 2022. The period-over-period decline was primarily due to lower contract manufacturing and preclinical research costs, which were partially offset by increased clinical trial-related expenses for PYX-201 and PYX-106.General and administrative expenses were $10.7 million for the three months ended September 30, 2023, compared to $9.4 million for the three months ended September 30, 2022. The period-over-period increase was primarily due to higher stock-based compensation expenses, which were partially offset by lower professional and consultant fees.Net loss was $23.0 million, or $0.56 per common share, for the three months ended September 30, 2023, compared to $27.7 million, or $0.85 per common share, for the three months ended September 30, 2022. Net losses for the quarters ended September 30, 2023 and 2022 included $5.2 million and $4.4 million, respectively, related to non-cash stock-based compensation expense.As of September 30, 2023, the outstanding number of shares of common stock of Pyxis Oncology was 44,294,092. 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. Forward-Looking StatementsThis 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 11, 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. Investor ContactPam Connealy, CFO & COOir@pyxisoncology.com ---tables to follow--- Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share amounts)(Unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2023 2022 2023 2022 Operating expenses: Research and development $14,687 $19,034 $37,979 $56,275 General and administrative 10,667 9,359 26,450 29,233 Total operating expenses 25,354 28,393 64,429 85,508 Loss from operations (25,354) (28,393) (64,429) (85,508)Other income, net: Interest and investment income 1,707 719 5,036 892 Sublease income 598 — 1,200 — Total other income, net 2,305 719 6,236 892 Net loss $(23,049) $(27,674) $(58,193) $(84,616)Net loss per common share - basic and diluted $(0.56) $(0.85) $(1.52) $(2.61)Weighted average shares of common stock outstanding - basic and diluted 41,331,806 32,561,228 38,379,401 32,444,072 Condensed Consolidated Balance Sheets(In thousands, except share and per share amounts)(Unaudited) September 30,2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $14,715 $179,293 Marketable debt securities, short-term 118,252 — Restricted cash 1,472 1,472 Prepaid expenses and other current assets 4,655 5,847 Total current assets 139,094 186,612 Property and equipment, net 12,175 11,165 Intangible assets, net 22,294 — Operating lease right-of-use assets 13,129 13,602 Total assets $186,692 $211,379 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $3,310 $7,097 Accrued expenses and other current liabilities 16,629 24,537 Operating lease liabilities, current portion 1,204 — Deferred revenue 7,189 — Total current liabilities 28,332 31,634 Operating lease liabilities, net of current portion 20,414 18,921 Total liabilities 48,746 50,555 Commitments and contingencies Stockholders’ equity: Preferred stock, par value $0.001 per share, 10,000,000 shares authorized; zero shares issued and outstanding — — Common stock, $0.001 par value per share 44 34 Additional paid-in capital 408,635 373,225 Accumulated other comprehensive loss (105) — Accumulated deficit (270,628) (212,435)Total stockholders’ equity 137,946 160,824 Total liabilities and stockholders’ equity $186,692 $211,379