TuHURA Biosciences Appoints Amanda Garofalo, MSHS, as Senior Vice President of Clinical Operations

Rhea-AI Summary

TuHURA Biosciences (NASDAQ:HURA) appointed Amanda Garofalo, MSHS, as Senior Vice President of Clinical Operations effective April 7, 2026. Garofalo brings over 20 years of Phase I-IV drug and biologic development experience and will oversee day-to-day clinical operations while working with Craig Tendler, M.D.

Her background includes enabling an oversubscribed $305M Series F at Parabilis, managing a portfolio of 200+ oncology trials at EMD Serono, and directing three IND submissions in 12 months at Arcus Biosciences.

Positive

• 20+ years clinical development leadership
• Supported an oversubscribed $305M Series F financing
• Managed a portfolio of 200+ oncology Ph I-IV trials
• Directed submission of 3 INDs in 12 months

Negative

• None.

News Market Reaction – HURA

+1.72%

21 alerts

+1.72% Session close to close

+34.1% Peak Tracked

-6.9% Trough Tracked

$117.61M Market Cap

1.1x Rel. Volume

In the Apr 7 session, HURA gained 1.72%, reflecting a mild positive market reaction. Argus tracked a peak move of +34.1% during that session. Argus tracked a trough of -6.9% from its starting point during tracking. Our momentum scanner triggered 21 alerts that day, indicating elevated trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement underscores TuHURA’s effort to deepen its clinical operations bench as it advances...

Analysis

This announcement underscores TuHURA’s effort to deepen its clinical operations bench as it advances IFx‑2.0 in Phase 3 and TBS‑2025 toward Phase 1b/2. The new SVP brings over 20 years of Phase I–IV development experience, including responsibility for 200+ oncology trials and involvement in a $305M Series F round. Investors may watch how this hire translates into trial execution, enrollment timelines, and alignment with the company’s existing $250,000,000 shelf capacity.

Key Figures

Industry experience: over 20 years Series F funding: $305M IND submissions: 3 new IND submissions +2 more

5 metrics

Industry experience over 20 years Clinical and development experience in Phase I–IV drug and biologic development

Series F funding $305M Oversubscribed, privately funded Series F round at Parabilis Medicines

IND submissions 3 new IND submissions Submitted in 12 months at Arcus Biosciences

Submission timeframe 12 months Period over which 3 INDs were submitted at Arcus Biosciences

Oncology trials portfolio over 200 trials Oncology Phase I–IV trials and related studies at EMD Serono

Historical Context

5 past events · Latest: Apr 01 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 01	Earnings and update	Neutral	-9.5%	Reported 2025 financials and outlined Phase 3 IFx‑2.0 and TBS‑2025 plans.
Mar 23	Clinical leadership hire	Positive	+2.1%	Appointed former JNJ oncology leader to guide VISTA antibody TBS‑2025 program.
Feb 27	Nasdaq compliance	Positive	+3.1%	Regained compliance with Nasdaq $1.00 bid requirement and noted pipeline progress.
Feb 24	Investor conferences	Positive	+20.0%	Announced participation in March investor conferences and webcast presentation.
Feb 17	IND filing	Positive	-15.0%	Filed IND for VISTA antibody TBS‑2025 with planned Phase 2 Simon two‑stage trial.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news reactions have been mixed, with some positive pipeline and conference updates sold off and others seeing strong gains, suggesting inconsistent trading responses to otherwise constructive developments.

Recent Company History

Over the last few months, TuHURA has highlighted progress on its IFx‑2.0 Phase 3 program and the TBS‑2025 VISTA inhibitor, including an IND filing on Feb 17, 2026 and added leadership for its VISTA program on Mar 23, 2026. It regained Nasdaq bid-price compliance on Feb 27, 2026 and reported 2025 financials and a corporate update on Apr 1, 2026. The new SVP of Clinical Operations fits into this pattern of building infrastructure around late-stage and early-stage oncology assets.

Key Terms

phase i-iv, phase 3, phase 1b/2, antibody drug conjugates, +3 more

7 terms

phase i-iv medical

"over 20 years of experience in Phase I-IV drug and biologic development"

Phase I–IV are the sequential stages used to test new drugs and medical treatments, starting with small studies to check safety and dosing (Phase I), moving to early effectiveness (Phase II), larger controlled trials to confirm benefit (Phase III), and ongoing safety or real‑world monitoring after approval (Phase IV). For investors, each phase signals changing levels of risk, time and cost—advancing through phases reduces uncertainty and can sharply increase a product's commercial value, while failures can erase anticipated returns.

phase 3 medical

"from our IFx-2.0 Phase 3 accelerated approval trial, to TBS-2025 advancing"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 1b/2 medical

"TBS-2025 advancing to its Phase 1b/2 trial, and pre-clinical planning"

Phase 1b/2 is a combined early-stage human study that first checks a drug’s safety and side effects in a small group and then expands to test whether it shows signs of working in patients. Think of it as a product test that first confirms it’s safe to use, then looks for early evidence of benefit; positive results can significantly reduce clinical risk and increase a company’s value, while negative results raise the opposite.

antibody drug conjugates medical

"early-stage antibody drug conjugates (ADCs) program. We look forward"

Antibody drug conjugates are targeted medicines that combine an antibody, which seeks out specific markers on diseased cells, with a powerful drug that is released only when the antibody binds its target. Think of it as a guided missile that delivers a toxic payload directly to its target, reducing damage to healthy cells; investors watch them because successful ADCs can offer high-value, niche treatments and drive strong revenue and patent-based protection for developers.

anti-tigit medical

"resulting in the successful commencement of the anti-TIGIT, CD-73 inhibitor"

Anti-TIGIT is a type of cancer immunotherapy drug that blocks TIGIT, a protein on immune cells that can put the brakes on the body’s attack on tumors. Think of TIGIT as a “mute” button on immune cells and anti-TIGIT as the button that unmutes them, potentially allowing a stronger anti-cancer response. Investors watch anti-TIGIT programs because clinical trial results and regulatory decisions determine whether they can become widely used, commercially successful treatments or fail in development.

cd-73 inhibitor medical

"the successful commencement of the anti-TIGIT, CD-73 inhibitor, and A2a/A2b"

A CD-73 inhibitor is a drug that blocks the CD73 enzyme, which helps tumors hide from the immune system by producing a chemical that calms immune cells. For investors, these drugs are important because they represent a strategy to make cancer treatments more effective and can drive value through clinical trial results, regulatory milestones, or partnership deals; success is high-reward but typically high-risk given development and approval uncertainty.

adenosine receptor antagonist medical

"and A2a/A2b adenosine receptor antagonist programs at Arcus Biosciences"

An adenosine receptor antagonist is a drug or compound that blocks the action of adenosine, a natural molecule that tells cells to slow down or relax various functions such as heart rhythm, blood flow and certain brain signals. For investors, these blockers matter because they can form the basis of medicines or diagnostic agents; clinical trial results, safety, and market potential for such drugs can materially affect a biotech or pharmaceutical company's value, much like a key that prevents a door from closing and thus changes how a system behaves.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Mrs. Garofalo brings over 20 years of experience in Phase I-IV drug and biologic development

TAMPA, Fla., April 7, 2026 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced Amanda Garofalo, MSHS, as Senior Vice President (SVP) of Clinical Operations.

Mrs. Garofalo, who brings over 20 years of clinical and development experience, will work closely with Craig Tendler, M.D., and oversee day-to-day clinical operations.

"We warmly welcome Amanda to the TuHURA team," said James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. "Her extensive experience across all stages of biotech drug development will greatly enhance our efforts as we continue to advance our clinical programs from our IFx-2.0 Phase 3 accelerated approval trial, to TBS-2025 advancing to its Phase 1b/2 trial, and pre-clinical planning for our early-stage antibody drug conjugates (ADCs) program. We look forward to working with her as we advance towards our clinical milestones this year."

Mrs. Garofalo, a distinguished twenty-year industry veteran with global leadership experience in Phase I-IV drug and biologic development, joins TuHURA from Parabilis Medicines (formerly FOG Pharmaceuticals), where she enabled enrollment, data availability and due diligence activities necessary to execute an oversubscribed, privately funded $305M Series F funding round. Prior, Mrs. Garofalo was the Head of Oncology Delivery, Clinical Delivery & Patient Centricity at EMD Serono where she was responsible for a portfolio of over 200+ Oncology Ph I-IV sponsored and non-sponsored clinical trials, managed access programs, post-marketing surveillance and real-world evidence (RWE) studies. Before that, Mrs. Garofolo directed the submission of 3 new IND submissions in just 12 months, resulting in the successful commencement of the anti-TIGIT, CD-73 inhibitor, and A2a/A2b adenosine receptor antagonist programs at Arcus Biosciences. Mrs. Garofalo has also served as the Global Clinical Program Lead at Indivior; Senior Clinical Project Manager at Medimmune; and various positions at GlaxoSmithKline Pharmaceuticals including Clinical Investigation Lead and Operations and Science Leader. Mrs. Garofalo received a Master of Science in Health Science with a focus in Clinical Research Administration from George Washington University and a Bachelor of Science in Biology from the College of William and Mary. She also completed an Advanced Management Program at The Wharton School of Business.

About TuHURA Biosciences, Inc. 
TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.

TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is conducting a single randomized placebo-controlled Phase 3 accelerated approval registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda^® (pembrolizumab) compared to Keytruda^® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma (MCC).

In addition to its innate immune agonist product candidate, TuHURA acquired TBS-2025 in its acquisition by merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb advancing to Phase 1b/2 development in mutNPM1 r/r AML. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional ADCs targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.

For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-Looking Statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely," or the negative or plural of these words or similar expressions. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on TuHURA's website and at www.sec.gov.

The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

Investor Contact: 
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-appoints-amanda-garofalo-mshs-as-senior-vice-president-of-clinical-operations-302735470.html

SOURCE TuHURA Biosciences, Inc.

FAQ

Who is Amanda Garofalo and what role did TuHURA (HURA) announce on April 7, 2026?

Amanda Garofalo was named Senior Vice President of Clinical Operations at TuHURA (HURA) on April 7, 2026. According to the company, she brings over 20 years of clinical development experience to oversee daily clinical operations.

How will Amanda Garofalo's experience impact TuHURA's IFx-2.0 Phase 3 and TBS-2025 trials?

Her appointment is expected to strengthen trial execution and oversight for IFx-2.0 Phase 3 and TBS-2025 Phase 1b/2. According to the company, she will work with clinical leadership to advance these specific programs toward near-term milestones.

What prior achievements does Amanda Garofalo bring that are relevant to TuHURA investors?

Garofalo enabled enrollment and due diligence for an oversubscribed $305M Series F and managed 200+ oncology trials. According to the company, these results demonstrate experience with financing support and large clinical portfolios.

Will Amanda Garofalo directly oversee TuHURA's early-stage ADC and preclinical planning?

Yes; the company said she will oversee day-to-day clinical operations, including support for early-stage ADC preclinical planning. According to the company, her remit spans Phase 3 through early-stage development activities.