On August 14, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The PYNNACLE clinical trial continues to progress remarkably well, thanks to the dedication and outstanding execution of the clinical investigators, their teams, and ours," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We anticipate submitting an NDA for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027."

PYNNACLE Phase 2 Monotherapy Update:

Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial has been completed. The multicenter, single arm, registrational Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors. PMV Pharma anticipates submitting an NDA for accelerated approval of rezatapopt as a treatment for platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027.

Second Quarter 2026 Financial Results

PMV Pharma ended the second quarter with $79.4 million in cash, cash equivalents, and marketable securities, compared to $112.9 million as of December 31, 2025. Net cash used in operations was $34.3 million for the six months ended June 30, 2026, compared to $36.6 million for the six months ended June 30, 2025.

Net loss for the quarter ended June 30, 2026, was $18.1 million compared to $21.2 million for the quarter ended June 30, 2025. The net loss decrease was primarily due to decreased contract research organization costs and reduced finance support costs.
R&D expenses were $14.7 million for the quarter ended June 30, 2026, compared to $18.4 million for the quarter ended June 30, 2025. The decrease in R&D expenses was primarily due to decreased contract research organization costs for the advancement of the rezatapopt program.
General and administrative (G&A) expenses were $4.2 million for the quarter ended June 30, 2026, compared to $4.5 million for the quarter ended June 30, 2025. The decrease in G&A expenses was primarily due to reduced personnel expenses and a decrease in finance support costs.
About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C advanced solid tumors, conducted across approximately 70 sites.

For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, AUG 14, 2026, View Source [SID1234670147])

On August 14, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported financial results for the three-month and six-month periods ended June 30, 2026, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "The second quarter of 2026 and the period since that time have represented the most consequential stretch in Silexion’s history, as we have transitioned SIL204 from a preclinical and regulatory-preparation asset into an active Phase 2/3 clinical program. With clinical trial authorization from Germany’s BfArM added to the previously received approval from the Israeli Ministry of Health, and the successful initiation of our first clinical site at Tel Aviv Sourasky Medical Center at the end of July, our focus has shifted entirely to clinical execution. In parallel, we continued to expand the scientific profile of SIL204 with new immuno-oncology data supporting a coordinated immune-sensitization signature across four KRAS mutations, reinforcing the rationale for future combination with anti-PD-(L)1 checkpoint inhibitors. We believe this combination of clinical, regulatory, manufacturing, and translational progress positions Silexion at the beginning of what should be a defining stretch for the Company."

Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During the second quarter and subsequent to quarter end, we successfully executed a series of financing transactions. Most recently, we closed a public offering with gross proceeds of approximately $2.5 million. All of those transactions were designed to strengthen our balance sheet and support the transition of SIL204 into its recently initiated Phase 2/3 Clinical Trial, bringing new hope to the patients who need it most, alongside supporting compliance with applicable Nasdaq continued listing requirements."

Recent Milestones & Business Highlights

Phase 2/3 Clinical Program Advanced Across Israel and Germany, and Successfully Initiated at Tel Aviv Sourasky Medical Center: During the second quarter and subsequent to quarter end, Silexion advanced SIL204 into active Phase 2/3 clinical evaluation in locally advanced pancreatic cancer. In April 2026, the Company submitted its Clinical Trial Application to Germany’s Federal Institute for Drugs and Medical Devices (BfArM) through the EU Clinical Trials Information System, with Germany serving as Reference Member State for the European program. In June 2026, the Company received CTA approval from BfArM, accompanied by a positive opinion from the Ethics Committee of the North Rhine Medical Association, adding Germany to the previously received approval from the Israeli Ministry of Health. In May 2026, the Company initiated GMP clinical supply manufacturing of SIL204 with a leading global contract development and manufacturing organization (CDMO), further supporting the operational readiness of the program. On July 29, 2026, subsequent to quarter end, Silexion successfully initiated the Phase 2/3 clinical trial at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov"), one of Israel’s largest and most prominent academic medical centers, clearing the site to commence patient screening, with first patient dosing anticipated to follow. Additional Israeli and German trial sites are progressing through activation and are expected to join the program in the coming months.

Expanded Immuno-Oncology Profile for SIL204 – Coordinated Immune-Sensitization Signature Across Three Pathways and Four KRAS Mutations: During and subsequent to the second quarter, Silexion reported preclinical findings that extended SIL204’s therapeutic profile beyond direct anti-tumor activity into immune sensitization. In May 2026, the Company reported statistically significant upregulation of MHC-I following SIL204 treatment in human KRAS-mutant pancreatic and non-small cell lung cancer cells, supporting potential future evaluation alongside anti-PD-1 therapies including pembrolizumab (Keytruda). In August 2026, the Company reported additional statistically significant upregulation of FAS (CD95), the immune "death receptor," and downregulation of HLA-G, an established immune checkpoint, across three distinct KRAS mutations in pancreatic and non-small cell lung cancer cell lines. Taken together, these findings support a coordinated immune-sensitization signature across three key immune pathways — increased antigen presentation, restored susceptibility to immune-mediated apoptosis, and reduced immune checkpoint activity — observed across four KRAS mutations (G12D, G12V, G12C, and G12R), reinforcing the scientific rationale for combining SIL204 with anti-PD-(L)1 checkpoint inhibitor therapies.

Capital-Structure Actions to Support Clinical Execution and Continued Nasdaq Listing: During the second quarter and subsequent to quarter end, Silexion executed a series of financing transactions in support of the Phase 2/3 clinical program and support compliance with applicable Nasdaq continued listing requirements, including a May 2026 warrant exercise inducement transaction, ongoing sales of ordinary shares under the Company’s at-the-market facility, further partial conversions of principal under its related party promissory note, shareholder-approved successive increases in authorized share capital, and a 1-for-10 reverse share split effected on May 28, 2026. Most recently, on August 13, 2026, the Company closed a registered public offering with aggregate gross proceeds of approximately $2.5 million and net proceeds of approximately $2.1 million.

Financial Results for the Three Months Ended June 30, 2026

Research and development ("R&D") expenses for the three months ended June 30, 2026, were approximately $2.2 million, compared to approximately $1.0 million for the three months ended June 30, 2025, an increase of 120.0%. The increase resulted mainly from an increase in subcontractors’ and consultants’ expenses related to the operational ramp-up and preparations, required to support the initiation of our Phase 2/3 human clinical trial, which was initiated in July 2026.

General and administrative ("G&A") expenses for the three months ended June 30, 2026, were approximately $1.5 million, compared to approximately $1.3 million for the three months ended June 30, 2025, an increase of 15.4%. The increase resulted mainly from an increase in professional services costs, primarily related to consultants and other expenses associated with the costs of operating as a public company.

Financial expenses (income), net for the three months ended June 30, 2026, were approximately $(0.1) million of financial income, net, compared to approximately $0.2 million of financial expenses, net, for the three months ended June 30, 2025. The change was mainly due to the revaluation of the related party promissory note.

Net loss for the three months ended June 30, 2026, was approximately $3.6 million, compared to approximately $2.5 million for the three months ended June 30, 2025, an increase of 44.0%. The increase was mainly due to higher research and development expenses related to preparations for the human clinical trial initiated in July 2026, and higher general and administrative expenses, partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.

Financial Results for the Six Months Ended June 30, 2026

R&D expenses for the six months ended June 30, 2026, were approximately $3.6 million, compared to approximately $1.6 million for the six months ended June 30, 2025, an increase of 125.0%. The increase was primarily attributable to higher subcontractors’ and consultants’ expenses related to the operational ramp-up and preparations, required to support the initiation of the Company’s Phase 2/3 human clinical trial, which was initiated in July 2026.

G&A expenses for the six months ended June 30, 2026, were approximately $2.8 million, compared to approximately $2.3 million for the six months ended June 30, 2025, an increase of 21.7%. The increase resulted mainly from an increase in professional services costs, primarily related to legal, consultants, and other expenses associated with the costs of operating as a public company.

Financial expenses (income), net for the six months ended June 30, 2026, were approximately $(0.1) million of financial income, compared to approximately $0.3 million of financial expenses for the six months ended June 30, 2025. The decrease was mainly due to the revaluation of the related party promissory note.

Net loss for the six months ended June 30, 2026, was approximately $6.3 million, compared to approximately $4.2 million for the six months ended June 30, 2025, an increase of 50.0%. The increase was mainly due to higher research and development expenses (mainly related to preparations for the human clinical trial, initiated in July 2026) and higher general and administrative expenses, partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.

Balance Sheet

As of June 30, 2026, the Company had cash and cash equivalents of approximately $2.2 million, compared to approximately $6.0 million as of December 31, 2025.
During the second quarter and subsequent to quarter end, the Company strengthened its capital position through a series of financing transactions, most recently the closing on August 13, 2026, of a public offering yielding aggregate gross proceeds of approximately $2.5 million. As a result of these transactions and those detailed in the Company’s Quarterly Report on Form 10-Q, the Company estimates that its shareholders’ equity, as of June 30, 2026 (as adjusted to reflect the foregoing transactions to date), is currently approximately $3.2 million, which exceeds the Nasdaq Capital Market’s $2.5 million minimum shareholders’ equity requirement for continued listing. Accordingly, the Company believes that it has restored compliance with the applicable shareholders’ equity requirement.

(Press release, Silexion Therapeutics, AUG 14, 2026, View Source [SID1234670146])

On August 14, 2026 LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, reported financial results for the quarter ended June 30, 2026, and provided recent pipeline and business updates.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We enter the second half of 2026 with a clear focus on executing our Phase 3 ELAINE-3 trial and advancing lasofoxifene toward what we believe could be a transformative treatment option for patients with ESR1-mutated metastatic breast cancer," said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. "We have enrolled 495 patients and remain on track to complete enrollment of ELAINE-3 in the fourth quarter of 2026 with topline data expected in the second half of 2027. As the treatment landscape for metastatic breast cancer continues to evolve, we believe the differentiated profile of lasofoxifene positions it to address a significant unmet need as a potential endocrine therapy partner and create opportunities beyond ELAINE-3, including additional combination strategies and future label expansions. The body of clinical and scientific evidence behind lasofoxifene supports our confidence in its potential to greatly benefit patients battling this difficult-to-treat form of breast cancer."

"As we approach the completion of enrollment in this Phase 3 registrational trial, we are investing today in critical CMC, regulatory, and commercial readiness activities to ensure we are well-positioned to bring this therapy to patients as quickly as possible, if approved. With our talented team and the potential to add up to an additional $146 million upon exercise of cash-exercisable warrants issued in our December 2025 financing, we believe LeonaBio is well-positioned to deliver on multiple value-creating milestones in the years ahead," added Dr. Litton.

Clinical Development & Pipeline Programs

Lasofoxifene – A third generation novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer.

In December 2025, LeonaBio acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene.

Lasofoxifene is being advanced in ELAINE-3, a Phase 3 clinical trial (NCT05696626), in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, following progression on aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is a statistically significant improvement in progression free survival (PFS), as determined by blinded, independent central review (BICR). ELAINE-3 aims to establish a new standard of care for this genetically defined patient group with limited treatment options.
The Company expects to complete enrollment of ~600 participants in the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027.
Lasofoxifene was previously evaluated in two Phase 2 studies in patients with ER+, HER2-negative locally advanced or metastatic breast cancer expressing an ESR1 mutation, ELAINE-1 and ELAINE-2.
ELAINE-1, an open-label, randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene as a potential monotherapy. Although the trial was not powered, results included longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%) and a durable complete response lasting more than 2.5 years. The treatment was well-tolerated with patients reporting quality-of-life benefits.
ELAINE-2, an open-label study evaluating lasofoxifene in combination with abemaciclib, demonstrated clinical benefits in heavily pretreated patients, with a median progression-free survival of approximately 13 months, an objective response rate of 56% and a clinical benefit rate of 65.5%. The combination was generally well-tolerated with most adverse events being low grade.
In April 2026, LeonaBio hosted a virtual Key Opinion Leader event with two leading physicians in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of care for patients with treatment-resistant ER+, HER2-negative, ESR1-mutated metastatic breast cancer.
The event titled, "Modulation and Combination: the Potential for Lasofoxifene to Transform the Standard-of-Care in Metastatic Breast Cancer," featured a discussion with David Portman, M.D., Chief Executive Officer of Sermonix Pharmaceuticals and an oncology consultant to LeonaBio, along with two physician experts in the breast cancer field. A replay of the event is available on the LeonaBio website under "Events & Presentations" in the "Investor Relations" section here.

Brelgometon (ATH-1105) – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. Brelgometon is currently in clinical development for the potential treatment of ALS.

LeonaBio’s first-in-human Phase 1 double-blind, placebo-controlled clinical trial (NCT06432647) enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of brelgometon, demonstrating a favorable safety and tolerability profile as well as dose-proportional pharmacokinetics and CNS penetration and supporting its advancement into a Phase 2 proof-of-concept trial.
The Company expects to provide an update on the timing of a proposed Phase 2 proof-of-concept clinical trial following completion of enrollment of the Phase 3 ELAINE-3 clinical trial as it continues to focus on its lasofoxifene program.

Corporate Updates

LeonaBio announced the appointment of Fred Callori, J.D., Natalie Holles and Peter B. Silverman, J.D. to its Board of Directors, effective as of May 5, 2026. The company also announced that John Fluke, Jr., who served on the Board since 2014, retired effective May 4, 2026.

Fred Callori, J.D., has served as a Partner and Managing Director at Perceptive Advisors LLC, an investment firm that specializes in investing in biotechnology stocks, since January 2018.
Natalie Holles has served as the Chief Executive Officer and member of the Board of Directors of Aura Biosciences, a clinical-stage biotechnology company, since April 2026. Ms. Holles served as the Chief Executive Officer of Third Harmonic Bio, a biopharmaceutical company, from August 2021 to December 2025.
Peter B. Silverman, J.D., served as Chief Operating Officer of Merus N.V. (formerly, Nasdaq: MRUS), a biotechnology company, from January 2023 until its acquisition by Genmab A/S in December 2025, and prior to that, Mr. Silverman held several leadership roles at Merus. Mr. Silverman has served as a member of the board of directors of Kinaset Therapeutics, a biopharmaceutical company, since January 2026.

Financial Results

Cash Position. Cash, cash equivalents and investments were $51.1 million as of June 30, 2026, compared to $88.3 million as of December 31, 2025. Net cash used in operations was $37.9 million for the quarter ended June 30, 2026, compared to $21.7 million for the quarter ended June 30, 2025. In conjunction with the December 2025 Sermonix license agreement, LeonaBio announced a $90 million private placement financing of common stock and warrants, with the Series A warrants providing, if exercised in full, up to an additional $146 million to support development through key clinical and regulatory milestones.
Research and Development (R&D) Expenses. R&D expenses were $12.9 million for the quarter ended June 30, 2026, compared to $3.7 million for the quarter ended June 30, 2025. The increase was driven primarily by clinical trial spend related to the ELAINE-3 trial for lasofoxifene.
General and Administrative (G&A) Expenses. G&A expenses were $6.6 million for the quarter ended June 30, 2026, compared to $3.6 million for the quarter ended June 30, 2025. The increase was driven primarily by personnel-related expenses, including stock-based compensation and professional service fees.
Net Loss. Net loss was $19.0 million, or $0.80 per share, for the quarter ended June 30, 2026, compared to a net loss of $7.0 million, or $1.78 per share, for the quarter ended June 30, 2025.

(Press release, LeonaBio, AUG 14, 2026, View Source [SID1234670145])

On August 14, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported financial results for the Company’s second quarter ended June 30, 2026, and provided a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have made significant progress in advancing all our programs forward and are positioned to continue driving towards several anticipated milestones targeted for the second half of the year," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "In the second half, we anticipate receiving safe-to-proceed feedback from FDA and to initiating our Phase 1b/2 trial of VISTA in mutNPM1 r/r AML, initiating our in vivo POC studies for MDSC Inhibitors (Bi-specific antibody drug conjugates (ADCs)), potentially receiving orphan drug designation in Merkel cell carcinoma (MCC) for IFx-2.0, and potentially receiving orphan drug designation in AML for TBS-2025. The recent $50 million term credit facility made available to us by our largest shareholder provides us a non-convertible source of operating capital with adequate runway for us to achieve our strategic objectives and execute on our goals."

Second Quarter and Recent Corporate Highlights:

Filed Investigational New Drug (IND) Application for Evaluation of the TBS-2025 VISTA Inhibiting Antibody in Molecularly Defined Subsets of AML and other Blood Related Cancers. The IND is aligned with guidance previously provided by the U.S. Food and Drug Administration (FDA) on the development pathway for both monotherapy and combination with menin inhibitors for Acute Myeloid Leukemia (AML). The FDA noted that the previously planned IND meeting would not be necessary and instead the FDA provided written responses to questions and information related to the Company’s proposed Phase 1b/2 development plan for TBS-2025 in AML.
In April 2026, the Company announced a $50 million credit facility and royalty transaction extending its anticipated cash runway into 2028. Under the terms of the loan agreement for the credit facility, TuHURA will have the ability to draw down on the facility on an as-needed basis to fund monthly expenses for ongoing clinical development and operations. The facility bears a 12% annual interest rate on outstanding funds drawn, with interest paid monthly and principal repayment due at a 5-year maturity date for April 21, 2031. The facility was provided by TuHURA’s largest shareholder.
Currently Anticipated Milestones by Program
IFx-2.0 (Innate Immune Agonist)

2H 2026: Expect to receive orphan drug designation in MCC
1H2027: Expect preliminary results from IR study IFX-2.0 with Keytruda for deep seated MCC
2H 2027: Expect to complete enrollment in the Phase 3 study of IFx-2.0
TBS-2025 (VISTA inhibiting mAb)

2H 2026: Expect to initiate Phase 1b/2 trial of VISTA in mutNPM1 r/r AML
2H 2026: Expect to receive orphan drug designation in AML
1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML
MDSC Inhibitors (Bi-specific ADCs)

2H 2026: Presentations at key scientific meetings
2H 2026: Initiation of ADC in vivo POC studies
Summary of Financial Results for the Second Quarter 2026
Cash and cash equivalents of $1.0 million at June 30, 2026. In April 2026 and July 2026, the Company received $0.3 million and $0.1 million, respectively, in gross proceeds under the ATM Program. Additionally, the Company has received $5.7 million in gross proceeds to date on the Parkview credit facility, which includes $2.15 million subsequent to June 30, 2026. TuHURA’s total common shares outstanding were approximately 63.7 million at June 30, 2026.

Research and development expenses were $6.6 million and $4.9 million for the 3 months ended June 30, 2026, and 2025, respectively. The increase of $1.7 million was related to an increase in clinical development activity the Company’s ongoing and planned clinical trials.

General and administrative (G&A) expenses were $2.1 million and $1.9 million for the 3 months ended June 30, 2026, and 2025, respectively. The increase of $0.3 million was primarily due to increases in non-cash stock compensation expense and costs associated with being a public company.

Net cash outflows from operating activities were ($13.0) million and ($10.9) million for the 6 months ended June 30, 2026, and 2025, respectively.

Net cash flows from financing activities were $10.6 million and $8.1 million for the 6 months ended June 30, 2026, and 2025, respectively.

(Press release, TuHURA Biosciences, AUG 14, 2026, View Source [SID1234670144])

On August 14, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology, reported that the U.S. Federal and Drug Administration (FDA) has granted Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma. Spevatamig was also granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024, and orphan drug designation for metastatic pancreatic cancer in 2022. Recently, Phanes has expanded its clinical trial collaboration with Merck to study spevatamig in combination with pembrolizumab for the frontline (1L) treatment of BTC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Spevatamig has the potential to be a transformational treatment option for patients with BTC," said Ming Wang, PhD, MBA, CEO of Phanes. "Following the successful completion of enrollment in our Phase 2 clinical trial of spevatamig in combination with chemotherapy for the frontline treatment of metastatic pancreatic ductal adenocarcinoma, we are making significant progress in the Phase 2 study of the molecule in BTC."

Spevatamig is an I2E, an emerging class of IO agents. I2Es are expected to activate macrophages and dendritic cells to recognize and destroy cancer cells, providing a mechanism complementary to immune checkpoint inhibitors (ICIs) to leverage the immune system to attack tumors, especially "cold tumors" that are less likely to respond to ICIs.

ABOUT SPEVATAMIG

Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple cancer indications, including a Phase 2 study evaluating the safety, tolerability and efficacy of spevatamig in combination with chemotherapy in patients with PDAC in the first-line setting. Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. It has the potential to become the first I2E for a solid tumor indication and is combinable with various anti-cancer therapies.

(Press release, Phanes Therapeutics, AUG 14, 2026, View Source [SID1234670143])