On August 14, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the second quarter ended June 30, 2025, and highlighted recent corporate progress (Press release, Tyra Biosciences, AUG 14, 2025, View Source [SID1234655318]).

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"We see significant opportunity to transform the treatment of bladder cancer and skeletal dysplasia by precisely targeting FGFR3. With BEACH301 open for enrollment and SURF302 advancing in intermediate-risk non-muscle invasive bladder cancer, we’re building a franchise with dabogratinib around the power of FGFR3 selectivity and sensitivity," said Todd Harris, CEO of TYRA. "Backed by a strong balance sheet, we’re well positioned to deliver meaningful Phase 2 readouts in SURF302 and BEACH301.

Second Quarter 2025 and Recent Corporate Highlights

Dabogratinib (TYRA-300)

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Dabogratinib (formerly TYRA-300) is an oral investigational FGFR3-selective inhibitor being developed for the treatment of IR NMIBC and ACH.
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Dosed first patient in Phase 2 NMIBC Study – SURF302. SURF302 is an open-label Phase 2 clinical study evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade, IR NMIBC. Participants will be randomized initially to treatment with dabogratinib at 50 mg once-daily (QD) (Cohort 1) or treatment with dabogratinib at 60 mg QD (Cohort 2). The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, median duration of response, recurrence free survival, progression free survival, safety and tolerability.
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Advanced Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating dabogratinib in children ages 3 to 10 with achondroplasia with open growth plates. The study will enroll children who are treatment-naïve (Cohort 1) and those who have received prior growth-accelerating therapy (Cohort 2) at multiple sites across the globe. Each of these cohorts is expected to enroll up to 10 participants per dose level (0.125, 0.25, 0.375, 0.50 mg/kg) for up to 12 months. The study is now enrolling a safety sentinel cohort of up to 3 participants per dose level in children ages 5 to 10.
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Phase 1/2 mUC Study – SURF301. Dabogratinib continued to be evaluated in Part B of SURF301 (NCT05544552) at potentially therapeutic QD doses in preparation for potential future Phase 2 studies.
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Presented preclinical results at ENDO 2025. The late-breaking poster that was presented summarized the results of dabogratinib across three genetic contexts: wild-type mice, the Fgfr3Y367C/+ mouse model of ACH, and the Fgfr3N534K/+ mouse model of hypochondroplasia. Among other things, dabogratinib significantly improved the size and shape of the skull and foramen magnum in Fgfr3Y367C/+ mice. These studies demonstrate that dabogratinib led to a significant increase in bone growth in two independent FGFR3-driven preclinical models, as well as in wild-type mice, and provide further support to broaden the development of dabogratinib into skeletal dysplasias beyond ACH.

TYRA-430

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Advanced Phase 1 SURF431 Study. TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. Patient dosing is ongoing in SURF431, a Phase 1, multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations. We believe TYRA-430 has the potential to address a significant unmet need in HCC, where there are no approved biomarker-driven, targeted therapies.

TYRA-200

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Advanced Phase 1 SURF201 Study. TYRA-200 is an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The SURF201 study continues to enroll and dose adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations.

SNÅP Platform and Pipeline

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TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.

Second Quarter 2025 Financial Results

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Cash, Cash Equivalents and Short-Term Investments. As of June 30, 2025, TYRA had cash, cash equivalents, and marketable securities of $296.3 million. TYRA’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2027.
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Research and Development (R&D) Expenses. R&D expenses for the three months ended June 30, 2025 were $24.3 million compared to $18.0 million for the same period in 2024. The increase was associated with start-up and enrollment activities for BEACH301, SURF302 and SURF431, as well as increased CMC and personnel-related costs, including non-cash stock-based compensation.
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General and Administrative (G&A) Expenses. G&A expenses for the three months ended June 30, 2025 were $7.1 million compared to $5.5 million for the same period in 2024. The increase was primarily driven by higher personnel-related costs, including non-cash stock-based compensation.
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Net Loss. Second quarter net loss was $28.1 million compared to $18.7 million for the same period in 2024.

Upcoming Clinical Milestones for Dabogratinib

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BEACH301: dose first child with achondroplasia – 3Q 2025
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SURF302: topline initial three-month complete response data – 1H 2026

About Dabogratinib (formerly TYRA-300)

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia that has demonstrated interim clinical proof-of-concept results in metastatic urothelial cancer (mUC). The current planned clinical development for dabogratinib includes Phase 2 clinical trials for IR NMIBC (SURF302) and pediatric achondroplasia (BEACH301), and potentially mUC.

Please visit the Patients page of our website for more information on our clinical trials.

About TYRA-430

TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 study (SURF431) is a multicenter, open-label, first-in-human study of TYRA-430 and is currently enrolling and dosing adults with advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations (NCT06915753).

About TYRA-200

TYRA-200 is an oral, investigational, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The Phase 1 clinical study of TYRA-200, SURF201 (NCT06160752), is a multi-center, open label study designed to evaluate the maximum tolerated dose and the recommended Phase 2 dose of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling and dosing adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.

On August 14, 2025 TuHURA Biosciences, Inc. (NASDAQ: HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported financial results for the Company’s second quarter ended June 30, 2025, and provided a corporate update (Press release, TuHURA Biosciences, AUG 14, 2025, View Source [SID1234655317]).

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"TuHURA had a strong first-half of the year with the initiation of its Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to pembrolizumab as a first line treatment for patients with advanced or metastatic MCC. Conducted under an SPA Agreement with the FDA, the Phase 3 trial is a single randomized placebo-controlled trial that, if successful, has the potential to both meet and satisfy the requirements for both accelerated and full approval without the need to conduct a post-accelerated approval confirmatory trial. This potentially translates to a meaningful time and cost savings to TuHURA," stated James Bianco, M.D., President and Chief Executive Officer of TuHURA. "In addition to our accelerated approval Phase 3 trial of IFx-2.0, we also initiated a Phase 1b/2a trial employing interventional radiologic administration of IFx-2.0 as an adjunctive therapy to pembrolizumab in first-line treatment of checkpoint-naïve patients with MCC of unknown primary origin (MCCUP). This trial will enroll newly diagnosed patients who present metastatic, deep-seated tumors in the liver, lungs, or retroperitoneum, without accessible cutaneous, subdermal or nodal lesions. Patients with MCCUP represent approximately a thirty percent (30%) of all newly diagnosed advanced or metastatic MCC cases and can meaningfully augment IFx-2.0’s commercial market opportunity."

Dr. Bianco continued, "In addition to our trial initiations in MCC and MCCUP, we recently bolstered our development pipeline with the acquisition of Kineta and their novel VISTA inhibiting antibody, TBS-2025. The acquisition provides for synergies across both TuHURA’s therapeutic focus as well as TuHURA’s antibody peptide or drug candidate (APC, ADC) technologies as we continue to assemble a diversified, late-stage immuno-oncology pipeline. We plan to advance TBS-2025 into a randomized Phase 2 trial in patients with relapsed or refractory NPM1-mutated AML planned for the second half of this year to determine if the addition of TBS-2025 to a menin inhibitor can improve the results seen in patients receiving a menin inhibitor."

Corporate Highlights

Inclusion of TuHURA Biosciences in the Russell 3000 and Russell 2000 Indexes. In June 2025, TuHURA announced its addition to the Russell 3000 Index, with automatic inclusion in the Russell 2000 Index, as a part of the 2025 Russell annual reconstitution. The Company’s addition was effective as of market close on June 27, 2025.
Completion of Kineta, Inc. Acquisition and Kineta’s VISTA Inhibiting mAb. In June 2025, TuHURA announced the closing of its acquisition of Kineta, and Kineta’s novel VISTA inhibiting mAb, now referred to as "TBS-2025." TuHURA plans to initiate a Phase 2 randomized trial of TBS-2025 in combination with a menin inhibitor for the treatment of relapsed or refractory NPM1-mutated AML, compared to a menin inhibitor alone, targeted for the second half of 2025.
Initiation of Phase 3 Accelerated Approval Trial of IFx-2.0 as Adjunctive Therapy to Keytruda in 1L MCC. In June 2025, TuHURA announced that it had initiated its Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in MCC. Conducted under an SPA agreement with the U.S. FDA, TuHURA is investigating the effectiveness of IFx-2.0 as an adjunctive therapy to Keytruda compared to Keytruda plus placebo in first line treatment in advanced or metastatic MCC.
Completed $12.5 Million Equity Financing Transaction and Received an Additional $3.0 Million in Warrant Exercise Proceeds. In June 2025, TuHURA announced that it had entered into a definitive securities purchase agreement for the issuance and sale in a private placement of an aggregate of $12.5 million shares of its common stock. In addition to the offering, the Company secured $3.0 million in additional cash proceeds from the previously disclosed February 2025 cash exercise of approximately 1.0 million warrants to purchase shares of the Company common stock.
Upcoming Targeted Milestones by Program

IFx-2.0

Year-End 2025: TuHURA anticipates providing an update on enrollment progress in its Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line MCC
Q1 2026: Anticipated topline results from Phase 1b/2a clinical trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line treatment for MCC of unknown primary origin (MCCUP)
2H 2026: Anticipated topline results from Phase 3 accelerated approval trial
TBS-2025

2H 2025: Planned initiation of Phase 2 trial of VISTA inhibiting mAb in combination with a menin inhibitor for the treatment of relapsed or refractory NPM1-mutated AML
APC and ADC Development Candidates

TuHURA continues to advance its bi-specific, bi-functional immune modulating ADCs and APCs that target the Delta Opioid Receptor (DOR) on MDSCs, inhibiting their immune suppressing effects in the tumor microenvironment while localizing a checkpoint inhibitor like TBS-2025
In 2025, TuHURA anticipates presenting non-clinical data at relevant medical meetings
Financial Results for the Three Months and Six Months Ended June 30, 2025

Research and development expenses were $4.9 million and $2.8 million for the three months ended June 30, 2025, and 2024, respectively.

Net cash outflows from operating activities were ($10.9) million and ($8.9) million for the six months ended June 30, 2025, and 2024, respectively.

As of June 30, 2025, TuHURA’s total shares outstanding was approximately 49.9 million.

On August 14, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended June 30, 2025 (Press release, Soligenix, AUG 14, 2025, View Source [SID1234655316]).

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"As we quickly approach the latter part of 2025 into 2026, the Company remains confident about its late-stage rare disease pipeline and upcoming key development milestones," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "These include top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) before yearend, as well as continued clinical update for the ongoing investigator-initiated study (IIS) evaluating extended HyBryte (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL). Further, we anticipate top-line results in 2026 from our actively enrolling confirmatory Phase 3 study of HyBryte (synthetic hypericin) for early-stage CTCL, where we plan to provide an enrollemt update later this year. Recently, we were also pleased to announce the successful completion of our Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet’s Disease having achieved the study objective of demonstrating biological efficacy in this difficult to treat chronic disease."

Dr. Schaber continued, "With approximately $5.1 million in cash at June 30, 2025, exclusive of approximately $1.4 million of net cash received via our At-The-Market ("ATM") facility on July 1, 2025, we’re focused on carefully allocating resources to hit our strategic goals and upcoming milestones. While this cash balance provides sufficient operating runway through the first quarter of 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On July 31, 2025, the Company announced that it had completed its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet’s Disease and achieved the study objective of demonstrating biological efficacy. To view this press release, please click here.
On July 8, 2025, the Company issued a shareholder update letter, detailing the important and potentially transformational development milestones. To view this letter, please click here.
On July 1, 2025, the Company announced it had successfully completed the transfer of the manufacturing process for its synthetic hypericin active ingredient from Europe to the United States under its partnership agreement with Sterling Pharma Solutions. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2025

Soligenix reported no revenue for the quarter ended June 30, 2025, consistent with comparable de minimis revenue during the same period of 2024.

Soligenix’s net loss was $2.7 million, or ($0.82) per share, for the quarter ended June 30, 2025, compared to $1.6 million, or ($1.31) per share, for the quarter ended June 30, 2024. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in other income attributable to the change in the fair value of debt during the three months ended June 30, 2024 with no corresponding change in fair value during the three months ended June 30, 2025.

Research and development expenses were $1.7 million for the quarter ended June 30, 2025 as compared to $0.5 million for the same period in 2024. The increase was primarily due to costs associated with the Phase 2a study in Behçet’s Disease and the second confirmatory Phase 3 CTCL trial as well as increases in third party manufacturing.

General and administrative expenses were $1.1 million for the quarter ended June 30, 2025 as compared to $1.2 million for the same period in 2024. The decrease was primarily attributable to decreases in professional expenses.

As of June 30, 2025, the Company’s cash position was approximately $5.1 million, exclusive of approximately $1.4 million of net cash received via its ATM facility on July 1, 2025.

On August 14, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported its financial results and business update to shareholders for the second quarter ended June 30, 2025 (Press release, Renovorx, AUG 14, 2025, View Source [SID1234655315]).

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"We are pleased to report second quarter 2025 revenue of over $400,000. This growth highlights the strong clinical need and market demand for our patented RenovoCath device as a standalone targeted drug-delivery product among both new and existing customers. We are proud of the initial organic revenue growth over the first two full quarters since launching RenovoCath commercial sales, especially since this was achieved without a dedicated sales and marketing team. With the recent hiring of Phil Stocton as our Senior Director of Sales and Market Development, our goal is to stay lean, while also continuing to build commercialization momentum. We will continue to gather important data about our market (such as such as sales cycles, activation times, individual customer preferences and other commercial matters), as we seek to grow our customer base, fulfill repeat RenovoCath orders, and position ourselves for commercial growth over the long term," said Shaun Bagai, CEO of RenovoRx.

"At the same time, we are very excited to report that the independent Data Monitoring Committee (DMC) for our ongoing Phase III TIGeR-PaC trial recently completed their review of our second pre-planned interim analysis and has recommended that we continue the study. This is great news, as we believe the DMC’s recommendation is an expression of confidence in the potential for a positive outcome in the trial overall," continued Mr. Bagai.

"With a view towards preserving the integrity of the TIGeR-PaC trial for FDA purposes, and following our review of general FDA guidance, discussions with the DMC, and consultation with regulatory advisors, we are deferring publishing our second interim data. Outside of our Chief Medical Officer, Dr. Ramtin Agah, who has been speaking directly with the DMC, our entire team will remain blinded to the interim data. We will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal Phase III trials. As of August 12, 2025, 95 patients have been randomized and 61 events have occurred, putting us on target to complete enrollment this year or early next year," concluded Mr. Bagai.

RenovoCath Commercialization Update

RenovoRx continued its RenovoCath commercialization progress, with thirteen cancer center customers approved to purchase the device, including several high-volume, National Cancer Institute (NCI)-designated academic and community centers, an increase from five centers in the first quarter of 2025. Four of these thirteen cancer centers have used the device in patients, and all have made repeat purchase orders subsequently. RenovoRx believes that many of the 18 cancer centers that have used RenovoCath as part of its ongoing, pivotal Phase III TIGeR-PaC trial could also be potential customers for RenovoCath after the completion of TIGeR-PaC enrollment, which is expected later this year or early next year. All of this is being accomplished in-house by RenovoRx without a dedicated sales and marketing team. RenovoRx plans to strategically add a small number of sales personnel in the second half of 2025 as it looks to widen market penetration in 2026.

RenovoRx believes that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an estimated initial $400 million peak annual U.S. sales opportunity. Beyond historical RenovoCath usage, RenovoRx commercial efforts are already indicating the adoption of RenovoCath technology for the treatment of other solid tumors. This serves as the basis for our belief in the potential for a several-billion-dollar TAM as we expand into additional applications.

Ongoing Pivotal Phase III TIGeR-PaC Trial Update

In the TIGeR-PaC trial, RenovoRx is evaluating its first investigational drug-device combination oncology product candidate which uses the proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform enabled by RenovoCath for the treatment of locally advanced pancreatic cancer (LAPC). RenovoRx’s combination product candidate utilizes RenovoCath for the intra-arterial administration of the chemotherapy gemcitabine (or IAG).

The current protocol and statistical analysis plan for the Phase III TIGeR-PaC trial requires 114 randomized patients, with 86 events, or deaths, necessary to complete the final analysis.

In the second quarter of 2025, the 52nd death triggered the second pre-planned interim analysis to be reviewed by the independent Data Monitoring Committee. The DMC has concluded its review and has recommended that the Company continue with the trial. To avoid compromising the integrity of the trial with the FDA, and after discussions with the DMC and consultation with its regulatory advisors, RenovoRx elected to defer publishing the interim data. RenovoRx will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal Phase III trials.

Second Quarter 2025 and Subsequent Key Highlights

During the second quarter of 2025, RenovoRx increased production of the RenovoCath device to meet increased demand for the targeted delivery of diagnostic and/or therapeutic agents from oncologists and interventional radiologists. The principal manufacturer of RenovoCath devices is Medical Murray Inc., based in the U.S. in North Barrington, IL.

RenovoRx highlighted strong progress in its commercialization efforts. Since launching its commercial efforts in December 2024, RenovoRx has established commercial momentum for RenovoCath, with thirteen cancer center customers approved to purchase the device, including several high-volume, National Cancer Institute (NCI)-designated academic and community centers, an increase from five centers in the first quarter of 2025. Four of these thirteen cancer centers have used the device in patients, and all have made repeat purchase orders subsequently.

This momentum highlights the growing clinical demand across the United States for novel, localized solid tumor drug-delivery options beyond methods like systemic intravenous delivery of chemotherapy. RenovoRx believes that many of the 18 cancer centers that have used RenovoCath as part of its ongoing, pivotal Phase III TIGeR-PaC trial could also be potential customers for RenovoCath after the completion of TIGeR-PaC enrollment, which is expected later this year or early next year.

To coordinate, execute, and expand its commercial efforts for RenovoCath, subsequent to the quarter, RenovoRx hired Philip Stocton as Senior Director of Sales and Market Development. Mr. Stocton brings over 25 years of experience in MedTech sales, marketing, and leadership from various commercial positions at Terumo, Johnson & Johnson, Varian (acquired by Siemens), and, most recently, Sirtex Medical. Over the past 10 years, he has specialized in interventional oncology in both domestic and international roles. Prior to his hiring, Mr. Stocton had been consulting for RenovoRx in connection with its RenovoCath commercial launch planning efforts.

During the quarter, RenovoRx initiated patient enrollment with Johns Hopkins Medicine for the Phase III TIGeR-PaC clinical trial, becoming the newest addition to a distinguished network of clinical cancer sites across the United States participating in the trial.

RenovoRx also received an Issue Notification from the U.S. Patent and Trademark Office (USPTO) indicating that U.S. patent No. 12,290,564 became effective on May 6. This patent, titled "Methods for Treating Tumors," expands protection of methods for drug delivery with RenovoRx’s TAMP therapy platform, enabled by RenovoCath. The patent covers new methods for treating a tumor by delivering drugs locally to a region of an artery or blood vessel that is near the tumor after treating this region to reduce the microvasculature. The new patent provides protection through November of 2037.

Subsequent to the quarter, RenovoRx launched a multi-center post-marketing registry study to follow patients undergoing cancer treatment delivered by its RenovoCath device to solid tumors. The PanTheR study is an important initiative aimed at evaluating the safety and effectiveness of RenovoCath in real-world clinical settings. This multi-center, post-marketing observational registry study is designed to assess long-term safety and survival outcomes in patients with solid tumors who receive targeted drug delivery via RenovoCath. By collecting real-world data on the use of RenovoCath across a broader range of tumor types, PanTheR aims to provide valuable insights into patient outcomes and support the generation of additional safety data.

Financial Highlights for the Second Quarter Ended June 30, 2025

Revenue: RenovoRx reported second quarter revenues of approximately $422,000 from commercial sales of the RenovoCath device, driven by new customer purchase orders and early repeat orders from our initial sites. June 30, 2025 marked our second full quarter of revenue generation from RenovoCath sales.

Cash Position: As of June 30, 2025, the Company had $12.3 million in cash and cash equivalents. The Company’s plan is for revenues from RenovoCath sales to reduce its burn rate over time. The Company believes that cash as of June 30, 2025 will fully fund both ongoing RenovoCath scale-up efforts and additional progress towards the completion in the Phase III TIGeR-PaC trial.

R&D Expenses: Research and development expenses were $1.4 million, for the quarter ended June 30, 2025, compared to $1.5 million for the quarter ended June 30, 2024. The $0.1 million decrease was primarily driven by a decrease in other clinical and regulatory expenses including an allocation of selling, general and administrative expenses to research and development of $0.2 million. This decrease was offset by an increase in non-recurring engineering costs to scale manufacturing and the development of our next generation RenovoCath delivery system by $0.1 million to support and expand our commercial program.

SG&A Expenses: Selling, general, and administrative expenses were approximately $1.5 million, for the quarter ended June 30, 2025, remaining relatively unchanged from the same period in the prior year.

Net Loss: Net loss was $2.9 million for the quarter ended June 30, 2025, compared to a net loss of $2.4 million for the quarter ended June 30, 2024. The $0.5 million increase was primarily due to the change in the fair value of the warrant liability of $0.9 million offset by a decrease in loss from operations of $0.4 million.

Shares Outstanding: As of August 11, 2025, shares of common stock outstanding totaled 36,645,884.

Conference Call Details

Event: RenovoRx Second Quarter 2025 Financial Results Conference Call
Date: Thursday, August 14, 2025
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until September 14, 2025, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number: 13754672.

On August 14, 2025 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing antibody-drug conjugate (ADC) therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended June 30, 2025, and provided a business update (Press release, Pyxis Oncology, AUG 14, 2025, View Source [SID1234655314]).

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"We are invigorated by the progress we’re making, particularly in our ongoing clinical trials, where we’re seeing that MICVO’s unique mechanism as an extracellular targeted ADC has the potential to transform the treatment of advanced solid tumors," said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "The encouraging clinical and preclinical data observed to date suggest that MICVO may offer a differentiated treatment approach as both a monotherapy and in combination with pembrolizumab for HNSCC and other advanced solid tumors. We look forward to evaluating the emerging clinical data as we continue to advance this novel ADC."

Pipeline Updates

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Pyxis Oncology anticipates having preliminary data from the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial evaluating MICVO in 2L and 3L R/M HNSCC patients who have received prior platinum and PD-1 inhibitor therapy in the second half of 2025. Preliminary data from the trial in 2L and 3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy are anticipated in the first half of 2026. R/M HNSCC continues to be an area of high medical need despite potential improvements in treatment options.

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Pyxis Oncology anticipates having preliminary data from the Phase 1/2 combination study of MICVO in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in R/M HNSCC and other advanced solid tumors in the second half of 2025.

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In July 2025, Pyxis Oncology received a $2.8 million ($3 million milestone payment, less $0.2 million of tax in China) milestone payment from Simcere Pharmaceutical Group Limited ("Simcere") for the approval of suvemcitug (BD0801) in China by the National Medical Products Administration. The Company is eligible to receive mid to high single-digit percentage royalties on net sales of suvemcitug in China, under the terms of the Company’s license and collaboration agreement. In addition to suvemcitug, Pyxis Oncology retains rights to two other antibodies in development by Apexigen’s licensees, discovered through the APXiMAB platform.

Second Quarter 2025 Financial Results

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As of June 30, 2025, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $90.4 million. The Company believes that its current cash, cash equivalents, restricted cash and short-term investments will be sufficient to fund its operations into the second half of 2026.

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Revenues for the quarter ended June 30, 2025 were $2.8 million, compared to $0 for the quarter ended June 30, 2024. During the quarter, we recognized $2.8 million of milestone revenue ($3 million of milestone less $0.2 million of tax in China) related to regulatory approval of suvemcitug in China. The regulatory milestone was pursuant to an out-licensing and collaboration agreement between our subsidiary company, Apexigen, and Simcere, for the development and commercialization of suvemcitug for oncology in China.

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Research and development expenses were $17.1 million for the quarter ended June 30, 2025, compared to $14.0 million for the quarter ended June 30, 2024. The increase in expenses of $3.1 million was due to increased manufacturing of drug product and drug substance and clinical trial-related expenses for monotherapy and combination therapy of MICVO aggregating to $3.8 million, partially offset by reduction in expenses related to PYX-106 by $1.1 million as the clinical development of PYX-106-101 was paused in December 2024.

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General and administrative expenses were $5.4 million for the quarter ended June 30, 2025, compared to $6.1 million for the quarter ended June 30, 2024. The decrease was primarily due to lower corporate insurance costs, lower facilities costs and decrease in legal, professional, and consulting fees.

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Net loss was $18.4 million, or ($0.30) per common share, for the quarter ended June 30, 2025, compared to $17.3 million, or ($0.29) per common share, for the quarter ended June 30, 2024. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended June 30, 2025 was $15.3 million, compared to net loss of $14.4 million for the quarter ended June 30, 2024.

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As of August 13, 2025, the outstanding number of shares of Common Stock of Pyxis Oncology was 62,018,135.