Earnings summaries and quarterly performance for TuHURA Biosciences, Inc./NV.
Research analysts covering TuHURA Biosciences, Inc./NV.
Recent press releases and 8-K filings for HURA.
TuHURA Biosciences Receives FDA Orphan Drug Designation for IFx-2.0
HURA
Product Launch
New Projects/Investments
- TuHURA Biosciences, Inc. (NASDAQ:HURA) announced on February 2, 2026, that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to IFx-2.0.
- The ODD is for the treatment of stage IIB to stage IV cutaneous melanoma.
- This designation provides significant benefits, including seven years of market exclusivity, increased FDA engagement, tax credits for certain research, research grants, and a waiver of the New Drug Application user fee.
- The ODD was based on data from a previously completed Phase 1 study of IFx-2.0, which demonstrated its safety and clinical benefit in patients refractory to checkpoint inhibitor therapy.
5 days ago
TuHURA Biosciences Announces Kintara's REM-001 Trial Success and CVR Share Release
HURA
M&A
- TuHURA Biosciences, Inc. announced that Kintara's REM-001 clinical trial for ten metastatic cutaneous breast cancer patients met its primary endpoint, demonstrating safety with signs of clinical efficacy following eight weeks of follow-up.
- This achievement triggers the release of an aggregate of 1,539,958 shares of TuHURA common stock to legacy Kintara Therapeutics stockholders.
- The shares are expected to be distributed to Contingent Value Right (CVR) holders within the next ten business days, as per the CVR Agreement dated October 18, 2024.
Dec 15, 2025, 12:50 PM
TuHURA Biosciences Announces Recent Financing and Clinical Program Updates
HURA
New Projects/Investments
Guidance Update
- TuHURA Biosciences recently completed an equity financing transaction, securing $15.6 million in gross proceeds, which is expected to provide a cash runway to achieve multiple key milestones across its three development programs.
- The company's lead Phase 3 program for IFx-2.0 as an adjunctive therapy with Keytruda® in advanced and metastatic Merkel cell carcinoma (MCC) is targeting completion of enrollment by Q4 2026.
- TuHURA anticipates receiving FDA clearance in 2026 to initiate a randomized Phase 2 trial for TBS-2025, a VISTA inhibiting antibody, in NPM1 mutated relapsed/refractory AML.
- The company also expects to present preliminary data from its IFx-2.0 basket trial, data on inhibiting DOR in Q2 2026, and proof-of-concept data for its lead ADC in Q4 2026.
Dec 11, 2025, 12:30 PM
TuHURA Biosciences Announces Registered Direct Offering
HURA
Debt Issuance
New Projects/Investments
- TuHURA Biosciences, Inc. announced a registered direct offering to raise approximately $15.6 million in gross proceeds.
- The offering includes the sale of 9,462,423 shares of common stock at a purchase price of $1.65 per share, along with Series A and Series B warrants to purchase an equal number of shares.
- The warrants will have an exercise price of $1.95 per share and become exercisable six months after issuance.
- The offering is structured in three tranches: the first closing is expected on or about December 10, 2025, for approximately $8.6 million; the second closing by January 30, 2026, for approximately $5 million; and the third closing by February 27, 2026, for approximately $2 million. The latter two tranches involve K&V Investment One LLC.
- The net proceeds from the offering are intended for working capital, satisfaction of the Company's $3.4 million bridge note obligation to the Matthew Nachtrab Revocable Trust, and general corporate purposes.
Dec 10, 2025, 9:30 PM
TuHURA Biosciences Announces Registered Direct Offering
HURA
Debt Issuance
New Projects/Investments
- TuHURA Biosciences, Inc. (NASDAQ:HURA) entered into a definitive agreement for a registered direct offering of 9,462,423 shares of its common stock, along with Series A and Series B warrants to purchase an equal number of shares, at a purchase price of $1.65 per share and accompanying warrants.
- The offering is structured in three tranches, with the first closing expected on or about December 10, 2025, generating approximately $8.6 million in gross proceeds.
- Subsequent closings are anticipated by January 30, 2026, and February 27, 2026, bringing the total expected gross proceeds from the offering to approximately $15.6 million.
- The company intends to use the net proceeds for working capital, to satisfy a $3.4 million bridge note obligation to the Matthew Nachtrab Revocable Trust, and for general corporate purposes.
Dec 9, 2025, 2:49 PM
TuHURA Biosciences, Inc. Announces Merger Completions and Private Placement
HURA
M&A
New Projects/Investments
- TuHURA Biosciences, Inc. completed a reverse recapitalization with Kintara Therapeutics, Inc. on October 18, 2024, with Legacy TuHURA as the accounting acquirer and its securityholders owning approximately 95.6% of the combined company.
- The company successfully completed a business combination with Kineta on June 30, 2025, where TuHURA was the accounting acquirer, and its existing securityholders retained approximately 92.4% ownership of the combined entity.
- In connection with the Kineta Mergers, TuHURA entered into a June 2025 Private Placement to issue 4,759,309 shares of common stock and warrants for an aggregate offering amount of $12,612,169, with $8,912,151 received to date and $3,700,018 committed to be purchased by December 31, 2025.
- TuHURA acquired the rights to Kineta's novel KVA12123 antibody, now renamed TBS-2025, and committed to fund up to an additional $900,000 for its clinical trial expenses.
Nov 18, 2025, 10:03 PM
TuHURA Biosciences Reports Q3 2025 Financial Results and Provides Corporate Update
HURA
Earnings
Guidance Update
New Projects/Investments
- TuHURA Biosciences, Inc. reported research and development expenses of $4.9 million for the three months ended September 30, 2025, and net cash outflows from operating activities of ($22.1) million for the nine months ended September 30, 2025.
- The company's Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy with Keytruda® for advanced and metastatic Merkel cell carcinoma is currently underway.
- TuHURA is on track to submit its proposed Phase 2 plan for TBS-2025 to the FDA in Q4 2025 and initiate the Phase 2 randomized study in Q1 2026.
- In November 2025, TuHURA filed for a $50 Million At-The-Market (ATM) facility to potentially sell shares once the S-3 registration statement becomes effective.
Nov 14, 2025, 12:10 PM
TuHURA Biosciences Reports Q3 2025 Financial Results and Provides Corporate Update
HURA
Earnings
New Projects/Investments
Hiring
- TuHURA Biosciences reported research and development expenses of $4.9 million for the third quarter ended September 30, 2025, and net cash outflows from operating activities of ($22.1) million for the nine months ended September 30, 2025.
- The company's Phase 3 accelerated approval trial for IFx-2.0 in Merkel cell carcinoma is underway, and it plans to submit the Phase 2 protocol for TBS-2025 to the FDA in Q4 2025, with trial initiation in Q1 2026.
- In November 2025, TuHURA filed for a $50 million At-The-Market (ATM) facility and appointed Dr. Michael Turner as Vice President of Immunology.
Nov 14, 2025, 12:00 PM
TuHURA Biosciences, Inc. Provides Business and Risk Factor Updates, Details Clinical Progress and Financial Challenges
HURA
M&A
New Projects/Investments
Profit Warning
- TuHURA Biosciences, Inc. is a clinical stage immuno-oncology company with its lead product candidate, IFx2.0, having initiated a Phase 3 registration trial in June 2025 for advanced or metastatic Merkel cell carcinoma.
- The company completed the acquisition of Kineta, Inc. on June 30, 2025, which brought the TBS-2025 (VISTA-inhibiting monoclonal antibody) program, currently being planned for a randomized Phase 2 trial in mutated NPM1 AML.
- TuHURA Biosciences, Inc. has incurred significant losses since inception and its recurring losses from operations and financial condition raise substantial doubt about its ability to continue as a going concern.
- For the year ended December 31, 2024, the company reported a pro forma net loss attributable to common stockholders of $(58,827,514) and a pro forma basic and fully diluted loss per share of $(1.12).
Nov 3, 2025, 9:10 PM
TuHURA Biosciences, Inc. Secures $3 Million Bridge Loan
HURA
Debt Issuance
- TuHURA Biosciences, Inc. entered into a Secured Promissory Note and Loan Agreement on October 27, 2025, to secure a bridge loan of up to $3,000,000 from Matthew Joseph Natchtrab Revocable Trust.
- An initial advance of $1,500,000 was made on October 27, 2025, with the remaining amount available over a 30-day period. The loan carries an interest rate of 3% per month.
- The loan is secured by a first priority perfected security interest in the company's U.S. patents related to its ImmuneFxTM technology platform.
- The outstanding principal and accrued interest are due on the earlier of December 31, 2025, or 30 days following the successful closing of an equity financing exceeding $12,000,000. A $180,000 loan fee is also payable at maturity.
- In connection with the initial advance, the company issued a warrant to purchase up to 65,217 shares of common stock, exercisable for two years from the issuance date.
Oct 31, 2025, 9:00 PM
Quarterly earnings call transcripts for TuHURA Biosciences, Inc./NV.
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