On August 13, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) ("Aktis" or the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported financial results and business highlights for the second quarter ended June 30, 2026.

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"This was a quarter of strong execution for Aktis, focused on generating clinical data and building infrastructure to support our clinical pipeline," said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. "Our AKY-2519 clinical imaging and dosimetry data presented at ASCO (Free ASCO Whitepaper) generated significant enthusiasm among clinical investigators, helping to advance enrollment in the ongoing Phase 1b trials of AKY-1189 and AKY-2519, and setting the stage for a data-rich 2027."

Dr. Roden added, "In the second half of 2026, we expect to initiate the Phase 1b trial with AKY-2519 in B7-H3 expressing solid tumors, representing our third Phase 1b trial. We also expect to continue operationalizing our internal GMP facility as part of our comprehensive strategy to enable our own clinical supply for our pipeline. We believe that the breadth of our pipeline, together with our proprietary miniprotein radioconjugate platform and reliable end-to-end supply chain, position us for leadership in targeted radiopharmaceuticals."

Second quarter 2026 and recent business highlights

AKY-1189 highlights

AKY-1189 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver actinium-225 (225Ac) to tumors expressing Nectin-4, a clinically and commercially validated target expressed in several tumor types, including urothelial and breast.

Continued to enroll patients in ongoing Phase 1b, multicenter, open-label NECTINIUM-2 clinical trial of AKY-1189 in patients with locally advanced or mUC, breast cancer, and other Nectin-4 expressing solid tumors.

AKY-2519 highlights

AKY-2519 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver 225Ac to tumors expressing B7-H3, a clinically validated target expressed in prostate, lung, and other solid tumor cancers.

Presented first-in-human clinical imaging and dosimetry data for AKY-2519 across several B7-H3 expressing tumor types, including mCRPC, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May 2026.
Data demonstrated robust tumor uptake and retention of AKY-2519 with limited normal tissue exposure, suggesting the potential for a wide therapeutic window and differentiated profile compared to approved radiopharmaceuticals.
Imaging and dosimetry with AKY-2519 were generally well tolerated, with no reported adverse events or infusion-related reactions. For more information, read the press release here.
Enrolling patients in Phase 1b, multicenter, open-label BActinium-1 clinical trial of AKY-2519 in PLUVICTO-naïve and -experienced patients with mCRPC.
Cleared regulatory review to initiate Phase 1b, multicenter, open-label BActinium-2 clinical trial of AKY-2519 in patients with various other B7-H3 expressing tumors.

Anticipated milestones for the next 12 months

AKY-1189:
Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 clinical trial in the first quarter of 2027.
AKY-2519:
Expect to commence Phase 1b BActinium-2 basket trial in lung and other B7-H3 expressing solid tumor cancers in the second half of 2026.
Expect preliminary data from Phase 1b mCRPC clinical trial in 2027.
Early pipeline:
Two programs tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
Corporate:
In-house Good Manufacturing Practices (GMP) facility expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.

Second quarter 2026 financial results

Cash position: Cash, cash equivalents, and marketable securities were $517.3 million as of June 30, 2026, compared to $226.8 million as of December 31, 2025. The increase in cash, cash equivalents, and marketable securities reflects net proceeds from the Company’s initial public offering in January 2026, primarily offset by cash used in operations. The Company’s cash, cash equivalents, and marketable securities as of June 30, 2026, are expected to fund the Company’s operating plan into 2029.
Collaboration revenue: Collaboration revenue was $3.4 million for the quarter ended June 30, 2026, compared to $1.6 million for the comparable prior-year period. The increase of $1.8 million was attributable to continued advancement of the Company’s research collaboration with Eli Lilly and Company, with revenue recognized over time using the cost incurred input method.
R&D expenses: Research and development expenses were $25.3 million for the quarter ended June 30, 2026, compared to $18.6 million for the comparable prior-year period. The increase of $6.7 million was primarily driven by ongoing operations of the Company’s Phase 1b clinical trial for AKY-1189 and the IND-enabling studies and initiation of clinical trials for AKY-2519.
G&A expenses: General and administrative expenses were $7.0 million for the quarter ended June 30, 2026, compared to $3.9 million for the comparable prior-year period. The increase of $3.1 million was primarily due to higher employee-related costs (including stock-based compensation) associated with increased hiring to support the Company’s growth, as well as increased expenses related to operating as a public company.
Net loss: Net loss was $24.1 million for the quarter ended June 30, 2026, compared to $18.1 million for the comparable prior-year period. The increase in net loss of $6.0 million was primarily driven by higher operating expenses offset by interest income, net of $4.8 million in the quarter.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anticancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end clinical supply chain built for resiliency and scalability, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, AUG 13, 2026, View Source [SID1234670080])

On August 13, 2026 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial-stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve patients’ lives, reported financial results for the quarter ended June 30, 2026, and provided a corporate update.

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"Over the past several months, we have been focused on strengthening every aspect of the business in advance of our next phase of commercial growth," said Robert Goodman, Chief Executive Officer of Beyond Air. "We strengthened our balance sheet with an up to $30 million financing, and continued to build our commercial infrastructure, customer relationships and sales pipeline. We believe these efforts position us well for the anticipated launch of our second-generation LungFit PH system, pending FDA approval, and support our objective of expanding adoption of LungFit PH over the long term."

Recent Financial and Operating Highlights

Entered into a national group purchasing agreement with a leading U.S. group purchasing organization (GPO), marking the third major U.S. GPO to engage Beyond Air and expanding the Company’s reach by nearly 2,000 U.S. hospitals and health systems.
Regained compliance with Nasdaq’s minimum bid price requirement.
Continued to expand the Company’s global distribution network for LungFit PH, which now covers more than 45 countries positioning the Company for continued international commercial expansion, subject to applicable regulatory approvals.

Pending Regulatory Milestones

Awaiting FDA review of the PMA supplement for the second-generation LungFit PH system, submitted in June 2025.
International submissions for LungFit PH remain on track with local partners.

Financial Results for the Quarter Ended June 30, 2026

Revenues for the quarters ended June 30, 2026 and 2025 were $1.8 million.

Gross margins for the quarter ended June 30, 2026 were 13%, compared to 9% for the same period last year.

Research and development expenses for the quarter ended June 30, 2026 were $2.0 million, compared with $3.1 million for the same period last year.

Selling, general and administrative expenses for the quarter ended June 30, 2026 were $4.9 million, compared with $4.7 million for the same period last year.

Other expense for the quarter ended June 30, 2026 was $1.5 million, compared with $0.5 million for the same period last year.

Net loss attributable to common stockholders of Beyond Air, Inc. for the quarter ended June 30, 2026 was $7.9 million, or a loss of $11.00 per basic and diluted share, compared with a net loss of $7.7 million, or $30.67 per share, for the same period last year.

As of June 30, 2026, the Company reported cash, cash equivalents, restricted cash and marketable securities of $15.2 million. Subsequent to quarter-end, the Company strengthened its balance sheet with an up to $30.1 million financing, consisting of $10.2 million in upfront gross proceeds and up to an additional $20.0 million from the potential exercise of short- and long-term warrants, including $10.0 million tied to FDA approval of the second-generation LungFit PH system. The financing was led by certain institutional healthcare investors, with additional participation from certain of the Company’s directors and executive officers.

Financial Guidance

The Company reaffirms its previously issued revenue guidance of $8 million for calendar year 2026, which does not include any revenue from the second-generation LungFit PH system. The Company also reaffirms its previously issued 2027 revenue guidance of $16-$18 million, representing more than 110% year-over-year growth at the midpoint compared with 2026 guidance and includes anticipated revenue from the second-generation LungFit PH system, pending regulatory approval.

The Company believes it is entering an important new phase of commercial execution and a potential inflection point for revenue growth, supported by expanding market access, growing customer adoption, international expansion and a significantly larger addressable market pending the commercial launch of the second-generation LungFit PH.

Conference Call & Webcast

Thursday, August 13, 2026 @ 8 a.m. ET

Domestic: 1-877-407-0784
International: 1-201-689-8560
Conference ID: 13762077
Webcast: A webcast of the live conference call can be accessed by visiting the Events section of the Company’s website (click here) or directly (click here). An online replay will be available on the Company’s website or via the direct link an hour after the call.

(Press release, Beyond Air, AUG 13, 2026, View Source [SID1234670079])

On August 13, 2026 Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, reported financial results and business updates for the second quarter ended June 30, 2026.

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"This quarter marked meaningful progress toward our long-term vision as we continued advancing zolucatetide across multiple Wnt/β-catenin-driven diseases, including toward planned registrational development in desmoid tumors, while also extending the reach of our Helicon platform through our strategic research collaboration with Regeneron focused on developing Antibody-Helicon Conjugates," said Mathai Mammen, M.D., Ph.D., Chairman, President and Chief Executive Officer of Parabilis Medicines.

Dr. Mammen continued, "The body of encouraging clinical evidence for zolucatetide has strengthened our conviction both in its potential to transform the treatment of patients with Wnt/β-catenin-driven diseases and in the broader ability of Helicons to unlock biologically important intracellular targets that have historically been beyond the reach of conventional therapeutic approaches. With a strong balance sheet following our successful initial public offering, we believe we are well positioned to deliver important clinical and regulatory milestones over the coming quarters as we continue advancing medicines designed to target the causal biology and deliver meaningful impact for patients with serious diseases."

Recent Business Highlights & Anticipated Milestones

Continued Advancement of Zolucatetide

Zolucatetide is Parabilis’ lead investigational Helicon and the first and only direct inhibitor of the β-catenin:TCF interaction in clinical development. The investigational therapy is being evaluated as a "pipeline in a product" across multiple Wnt/β-catenin-driven diseases, with promising early clinical data demonstrating its potential in desmoid tumors, with familial adenomatous polyposis (FAP) and adamantinomatous craniopharyngioma (ACP) as potential genetically anchored expansion opportunities.

Desmoid tumors

•
Abstract accepted for oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 (Oct. 23-27, Madrid), with a plan to share clinical data from the February data cut from the ongoing Phase 1/2 study of zolucatetide in desmoid tumor patients
•
Expect to present more mature clinical data from the ongoing Phase 1/2 study in desmoid tumors during the fourth quarter of 2026
•
Expect to engage with the U.S. Food and Drug Administration (FDA) during the fourth quarter of 2026 to discuss and align on the planned registrational Phase 3 trial
•
On track to initiate Phase 3 registrational trial in the first half of 2027

Familial adenomatous polyposis (FAP)

•
Expect to initiate enrollment in a dedicated clinical cohort evaluating zolucatetide in patients with FAP during the second half of 2026
•
Anticipate disclosing additional FAP data in the first quarter of 2027

Adamantinomatous craniopharyngioma (ACP)

•
Expect to share clinical data from additional patients in the first half of 2027 for ACP, a locally aggressive tumor arising near the pituitary gland associated with significant lifelong morbidity and no approved drug therapies, with a conservatively estimated 15-year prevalence of approximately 5,000 to 9,000 patients in the U.S.

Additional Wnt-driven tumors

•
Continue to enroll patients across additional cohorts evaluating zolucatetide across additional indications with high unmet medical need, including hepatocellular carcinoma (HCC), colorectal cancer (CRC) in rational combinations, and other Wnt-driven solid tumors
•
Correspondence published in the New England Journal of Medicine (NEJM) demonstrates durable clinical and radiologic response to zolucatetide in a patient with recurrent ameloblastoma – a locally aggressive tumor of the jaw – driven by Wnt/β-catenin pathway alterations, providing further clinical validation of zolucatetide’s mechanism of action

Expanded the Application of the Helicon Platform

During the second quarter of 2026, Parabilis continued to expand the reach of its proprietary Helicon platform through strategic partnerships and advancement of its wholly-owned discovery pipeline.

•
Announced a strategic collaboration with Regeneron Pharmaceuticals, Inc. focused on developing Antibody-Helicon Conjugates (AHCs), a novel therapeutic modality combining Regeneron’s VelocImmune antibody technologies with Parabilis’ proprietary Helicon platform to selectively target undruggable and challenging intracellular disease-driving proteins; Parabilis received $125 million, including $50 million in upfront consideration and a $75 million equity investment, and the collaboration provides the potential for up to approximately $2.2 billion in development, regulatory and commercial milestone payments, plus up to low double-digit tiered royalties
•
Continued advancing multiple wholly owned Helicon-based preclinical programs targeting historically undruggable intracellular proteins, including ERG and allosteric ARON degraders in prostate cancer and a β-catenin degrader program

Strengthened Leadership and Governance

Parabilis continued to strengthen its leadership team and Board of Directors to support the Company’s next phase of growth as a public company.

•
Expanded the Company’s executive leadership team through the appointments of Helen Ho, Ph.D., as Chief Business & Strategy Officer, and Tom Kotarakos as Chief Financial Officer
•
Appointed Alan M. Sebulsky to the Board of Directors, bringing more than three decades of biopharmaceutical finance and operational leadership experience

Completed Initial Public Offering

During the quarter, Parabilis successfully completed its upsized initial public offering, raising a total of $770.5 million (before offering expenses), strengthening the Company’s balance sheet to support the continued advancement of its clinical pipeline and proprietary Helicon platform.

•
Closed upsized initial public offering of common stock, including the full exercise of the underwriters’ option to purchase additional shares, at an initial public offering price of $20.00 per share
•
Completed a concurrent private placement with Regeneron resulting in gross proceeds of approximately $75 million
•
Began trading on the Nasdaq Global Select Market under the ticker symbol "PBLS" on June 10, 2026

Second Quarter Financial Results

Cash position: Cash, cash equivalents and marketable securities were $1.1 billion as of June 30, 2026, compared to $27.7 million as of December 31, 2025. The Company’s cash, cash equivalents and marketable securities as of June 30, 2026 are expected to fund its operations into 2030.

R&D expenses: Research and development expenses were $39.4 million for the quarter ended June 30, 2026, compared to $30.1 million for the comparable prior year period. The increase of $9.3 million was primarily driven by ongoing investment in the clinical development of zolucatetide across a number of indications, increased employee-related costs (including stock-based compensation) associated with increased hiring to support the advancing clinical pipeline, and progression of the Company’s preclinical β-catenin, ERG, and ARON degrader programs.

G&A expenses: General and administrative expenses were $11.7 million for the quarter ended June 30, 2026, compared to $6.4 million for the comparable prior year period. The increase of $5.3 million was primarily due to higher employee-related costs (including stock-based compensation) related to increased hiring to support the Company’s growth as it advances its clinical programs, and expenses associated with operating as a public company.

Net loss: Net loss was $52.5 million for the quarter ended June 30, 2026, compared to $34.8 million for the comparable prior year period. The increase in net loss of $17.7 million was primarily driven by increased operating expenses.

(Press release, Parabilis Medicines, AUG 13, 2026, View Source [SID1234670075])

On August 13, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported VEPPANUTM (vepdegestrant) is now available by prescription in the United States for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer (mBC), as detected by a U.S. Food and Drug Administration (FDA)-authorized test, with disease progression following at least one line of endocrine therapy.

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"The commercial launch of VEPPANU marks an important milestone for Rigel and, more importantly, for patients living with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. In a pivotal trial, VEPPANU was generally well tolerated and demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus fulvestrant in this patient population. As the first and only FDA-approved PROTAC, VEPPANU introduces a novel mechanism of action and represents an important new treatment option for healthcare providers to consider with their patients," said Raul Rodriguez, Rigel’s president and CEO. "Supported by our established oncology infrastructure, experienced commercial and medical affairs teams and comprehensive patient support programs, we are well positioned to execute a successful commercial launch of VEPPANU, allowing Rigel to deliver for patients while advancing our long-term growth strategy."

VEPPANU is the first and only FDA-approved PROteolysis TArgeting Chimera (PROTAC). PROTACs are a new class of heterobifunctional protein degraders designed to harness the body’s natural machinery to selectively degrade, rather than inhibit, disease-causing proteins. The recommended dosage of VEPPANU is 200 mg taken orally once daily. VEPPANU is immediately available through Rigel’s network of specialty distributors and specialty pharmacies in the United States and Puerto Rico at $29,400 per 30-day supply.

More information on how to order VEPPANU can be found at www.RIGELONECARE.com. For those who qualify, Rigel offers patient assistance programs for patients prescribed VEPPANU by their doctor. RIGEL ONECARE, the company’s comprehensive patient support center, can help patients and physicians as they navigate insurance coverage requirements and provide financial assistance when needed and if eligible, along with other support programs. To learn more, visit www.RIGELONECARE.com or contact RIGEL ONECARE at 833-RIGELOC (833-744-3562).

In May 2026, Rigel announced it entered into an exclusive, global license agreement with Arvinas, Inc. and Pfizer Inc. to develop, manufacture and commercialize VEPPANU.

About ER+/HER2-, ESR1-mutated Metastatic Breast Cancer
Breast cancer is the most common cancer in women in the United States, except for skin cancers.1 The estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) patient population represents the majority (70%) of breast cancer, where treatment with endocrine therapies (aromatase inhibitors) is the standard of care. While endocrine therapy remains a cornerstone of metastatic ER+/HER2- breast cancer treatment, up to 50% of patients treated with endocrine therapy and a CDK4/6 inhibitor acquire estrogen receptor 1 gene (ESR1) mutations, resulting in endocrine resistance and poor prognosis. Treatment options in second-line and later ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer setting include chemotherapy, selective estrogen receptor degraders (SERDs), and as of May 2026, vepdegestrant, the first and only FDA-approved oral PROteolysis TArgeting Chimera (PROTAC).

About VEPPANUTM (vepdegestrant)

INDICATION
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor–1 (ESR1)–mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
QTc Interval Prolongation
VEPPANU can cause QT (QTc) interval prolongation. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and during treatment with VEPPANU. Perform an ECG prior to initiation of treatment with VEPPANU and do not initiate VEPPANU in patients with QTc >470 msec. Repeat ECG approximately 4 weeks after initiating treatment and as clinically indicated. Avoid concomitant use of VEPPANU with strong CYP3A inhibitors or drugs known to prolong the QTc interval.

Embryo-Fetal Toxicity
Based on findings from animal studies and its mechanism of action, VEPPANU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose.

ADVERSE REACTIONS
Serious adverse reactions occurred in 9% of patients who received VEPPANU. The serious adverse reactions included any fracture (1.3%), fall, hypercalcemia, hepatic injury, pneumonia, musculoskeletal pain (0.6% each), and QTc prolonged (0.3%). Fatal adverse reactions occurred in 1.0% of patients who received VEPPANU, including dyspnea, cerebral ischemia, and unknown cause (one patient each).

Permanent discontinuation of VEPPANU due to an adverse reaction occurred in 2.9% of patients, dosage interruptions of VEPPANU due to an adverse reaction occurred in 14% of patients, and dosage reductions of VEPPANU due to an adverse reaction occurred in 1.9% of patients.

The most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation.

Clinically relevant adverse reactions in <10% of patients who received VEPPANU included headache, hot flush, diarrhea, vomiting, bradycardia, and urinary tract infection.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid concomitant use of VEPPANU with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce VEPPANU dosage.
Strong CYP3A Inducers: Avoid concomitant use with strong CYP3A inducers in patients receiving VEPPANU. If concomitant use cannot be avoided, increase VEPPANU dosage.
Certain P-gp Substrates: Avoid concomitant use with certain P-gp substrates where minimal increases in concentration may lead to serious adverse reactions.
Certain UGT1A9 Substrates: Refer to the Prescribing Information for UGT1A9 substrates where minimal increases in the concentration may lead to serious adverse reactions.
Avoid concomitant use of VEPPANU with other drugs with a known potential to prolong the QTc interval.

LACTATION
Advise lactating women not to breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.

Click here for Important Safety Information and Full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

VEPPANU is a trademark and RIGEL ONECARE is a registered trademark of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, AUG 13, 2026, View Source [SID1234670071])

On August 13, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended June 30, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development programs.

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"The second quarter was marked by continued execution across the MICVO program and a financing that strengthened our balance sheet and extended our cash runway into the second quarter of 2027," said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. "The additional capital gives us greater flexibility to incorporate longer patient follow-up and planned analyses into our next clinical updates. We expect to report updated monotherapy data in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) this fall, followed by updated first-line combination data with pembrolizumab in the fourth quarter. We remain focused on generating the clinical evidence needed to evaluate MICVO’s potential to address the significant unmet need in head and neck cancer, regardless of HPV status or prior therapy."

Pipeline & Corporate Updates

•
Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study for 2L+ R/M HNSCC in Fall 2026. The update is expected to include patients treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, together with detailed analyses of the dose cap impact on safety, tolerability, efficacy and initial durability.
•
The Company completed target enrollment in the Phase 1 Part 2 monotherapy dose expansion study in the first quarter of 2026.
•
The ongoing MICVO Phase 1 monotherapy study is a multi-part study. Part 1 was a dose escalation study across multiple doses and tumor types, with initial results shared in November 2024. Part 2, a dose expansion study in 2L+ R/M HNSCC, is currently ongoing. Preliminary Phase 1 study results in 2L+ R/M HNSCC were shared in December 2025, supporting MICVO’s broad potential to address a significant unmet need for patients regardless of HPV status or prior therapy.
•
The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post-platinum and anti-PD-(L)1-experienced patients (Arm 1) and post-EGFRi and anti-PD-(L)1-experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20.
•
In December 2025, a dose cap was implemented for higher body weight patients. Based on internal PK simulation modeling indicating that MICVO exposures with dose capping and adjusted ideal bodyweight (AIBW) dosing are expected to be comparable, dose capping was prioritized due to its operational simplicity and speed of implementation. The Fall 2026 monotherapy disclosure will remain focused on patients treated at or below the dose cap.
•
Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) for 1L R/M HNSCC patients in the fourth quarter of 2026.

•
The ongoing MICVO Phase 1/2 study evaluating MICVO in combination with KEYTRUDA (pembrolizumab) is currently in dose escalation across multiple doses for the treatment of 1L R/M HNSCC. Preliminary positive results for the treatment of 1L/2L+ R/M HNSCC were shared in December 2025.
•
In June 2026, Pyxis Oncology announced up to $114 million of private placement financing with new and existing healthcare-focused investors to advance MICVO through key clinical milestones.
•
On July 2, 2026, the Company completed the private placement which resulted in upfront gross proceeds of approximately $50 million, before deducting placement agent fees and offering expenses, and anticipates up to an additional approximately $64 million of gross proceeds, before placement agent fees, if the accompanying warrants are exercised in full for cash.
•
The upfront proceeds from the private placement, together with existing cash, extended the Company’s cash runway into the second quarter of 2027. The additional capital from the private placement provides flexibility to continue patient follow-up and allow the data to mature following completion of enrollment of the 2L+ R/M HNSCC study.

Second Quarter 2026 Financial Results

•
As of June 30, 2026, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $34.5 million. Additionally, on July 2, 2026, the Company completed the private placement which resulted in upfront gross proceeds of approximately $50 million (of which $10.0 million was received on June 30, 2026), before deducting placement agent fees and offering expenses. The Company believes that its cash and cash equivalents, including restricted cash, and short-term investments as of June 30, 2026, along with the upfront proceeds from the private placement, will be sufficient to fund its operations into the second quarter of 2027.
•
Research and development expenses were $16.1 million for the quarter ended June 30, 2026, compared to $17.1 million for the quarter ended June 30, 2025. The decrease was primarily due to a $3.5 million increase in clinical trial related expenses related to monotherapy and combination therapy of MICVO, $1.1 million increase in preclinical studies, offset by a reduction of $4.7 million in manufacturing costs.
•
General and administrative expenses were $9.9 million for the quarter ended June 30, 2026, compared to $5.4 million for the quarter ended June 30, 2025. The increase was primarily due to an increase in severance costs and higher stock-based compensation.
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Net loss was $25.3 million, or ($0.40) per common share, for the quarter ended June 30, 2026, compared to $18.4 million, or ($0.30) per common share, for the quarter ended June 30, 2025. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended June 30, 2026 was $19.8 million, compared to a net loss of $15.3 million for the quarter ended June 30, 2025.
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As of August 12, 2026, the outstanding number of shares of Common Stock of Pyxis Oncology was 83,408,050.

(Press release, Pyxis Oncology, AUG 13, 2026, View Source [SID1234670070])