logo
Humacyte Inc (HUMA) Q1 2025 Earnings Call Highlights: A Turnaround with Symvess Launch and ...

Humacyte Inc (HUMA) Q1 2025 Earnings Call Highlights: A Turnaround with Symvess Launch and ...

Yahoo14-05-2025

Revenue: $517,000 for Q1 2025, including $147,000 from the US commercial launch of Symvess.
Cost of Goods Sold: $147,000 for Q1 2025.
Research and Development Expenses: $15.4 million for Q1 2025, down from $21.3 million in Q1 2024.
General and Administrative Expenses: $8.1 million for Q1 2025, up from $5.3 million in Q1 2024.
Other Net Income: $62.3 million for Q1 2025, compared to a net expense of $5.3 million in Q1 2024.
Net Income: $39.1 million for Q1 2025, compared to a net loss of $31.9 million in Q1 2024.
Cash, Cash Equivalents, and Restricted Cash: $113.2 million as of March 31, 2025.
Net Cash Provided: $17.9 million for the first three months of 2025.
Workforce Reduction: Approximately 31 employees, with estimated savings of $13.8 million in 2025 and up to $38 million in 2026.
Warning! GuruFocus has detected 2 Warning Signs with HUMA.
Release Date: May 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Humacyte Inc (NASDAQ:HUMA) successfully launched Symvess, a groundbreaking product for extremity vascular trauma, with initial shipments to three Level 1 trauma centers.
The company has extended its cash runway through recent financing and cost reductions, allowing for aggressive expansion of its commercial launch.
Symvess has been approved by the Value Analysis Committees (VACs) of five hospitals, with 45 hospitals currently evaluating the product.
The publication of a Budget Impact Model in the Journal of Medical Economics demonstrates Symvess's economic value by reducing infections and amputations.
Humacyte Inc (NASDAQ:HUMA) is making progress in the military market, with multiple military treatment facilities expressing interest in purchasing Symvess.
The company faced unfounded negative press regarding Symvess, which created some headwinds in the VAC approval process.
A reduction in workforce by approximately 31 employees was implemented to extend the cash runway, indicating financial constraints.
The volatile economic environment poses challenges to the commercial launch and expansion efforts.
The New York Times article created some pushback from VACs, requiring additional efforts to address concerns.
The process for VAC approvals and sales is expected to be lengthy, with most sales anticipated in the second half of the year.
Q: Can you provide insights into the experience of the three sites that have purchased Symvess and how the VAC process is progressing? A: Dr. Laura Niklason, President and CEO, explained that the first implant was successful, with sales reps present at some sites. The VAC approval process is progressing well, despite some initial setbacks due to negative press. BJ Scheessele, Chief Commercial Officer, added that the sales funnel is strong, with 45 submissions and five approvals, and they expect momentum to build in the second half of the year.
Q: How does the ECAT process work for military and federal hospitals, and are there additional hurdles? A: Dr. Laura Niklason stated that once Symvess is listed on ECAT, military hospitals can order it, but surgeon champions are crucial. BJ Scheessele noted that they are working with a DoD procurement partner to facilitate the process, and military hospitals typically do not have a formal VAC process.
Q: Are current sales force levels sufficient to cover military hospitals and Level 1 trauma centers? A: BJ Scheessele confirmed that the current sales force is adequate to cover existing targets and that they will consider expanding the team as success grows in both civilian and military markets.
Q: Do current revenue estimates for 2025 remain reasonable given recent progress? A: Dale Sander, CFO, confirmed that they are comfortable with the guidance provided earlier, expecting most revenues to come in the second half of the year due to the VAC process.
Q: What learnings from previous Phase III studies are being applied to the V012 trial? A: Dr. Laura Niklason highlighted the importance of managing the conduit in dialysis centers and ensuring adherence to clinical protocols. They are focusing on patient subgroups that struggle with fistulas, anticipating positive trial results.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

The Best Top-Ranked Stocks to Buy in June
The Best Top-Ranked Stocks to Buy in June

Yahoo

time15 minutes ago

  • Yahoo

The Best Top-Ranked Stocks to Buy in June

The S&P 500 jumped 6% last month for its best May since 1990 and its strongest monthly performance since November 2023. Meanwhile, the Nasdaq surged nearly 10% as Wall Street dove headfirst back into beaten-down technology stocks. The bulls pressed their advantage to start June, pushing the Nasdaq up 0.7% higher on Monday and 1% through midday trading Tuesday, boosted by strong showings from Nvidia and other tech giants. The bulls are in charge, fueled by tech earnings growth and trade war progress. Now they are attempting to break above a key trading range before they send the market to new all-time highs. It's time to explore how investors can use a Zacks screen to help find some of the best Zacks Rank #1 (Strong Buy) stocks to buy in June and throughout the summer of 2025. Zacks Rank #1 (Strong Buy) stocks outperform the market in good and bad times. However, there are over 200 stocks that earn a Zacks Rank #1 at any given time. Therefore, it's helpful to understand how to apply filters to the Zacks Rank in order to narrow the list down to a more manageable and tradable set of stocks. Clearly, there are only three items on this screen. But together, these three filters can result in some impressive returns. • Zacks Rank equal to 1 Starting with a Zacks Rank #1 is often a strong jumping off point because it boasts an average annual return of roughly 24.4% per year since 1988. • % Change (Q1) Est. over 4 Weeks greater than 0 Positive current quarter estimate revisions over the last four weeks. • % Broker Rating Change over 4 Week equal to Top # 5 Top 5 stocks with the best average broker rating changes over the last four weeks. This strategy comes loaded with the Research Wizard and is called bt_sow_filtered zacks rank5. It can be found in the SoW (Screen of the Week) folder. Here is one of the five stocks that qualified for the Filtered Zacks Rank 5 strategy today… OppFi's (OPFI) works with banks to provide financial products and services for 'everyday Americans' via its tech-enabled digital finance platform. OppFi partners with community banks to offer installment loans to middle-income Americans who are underserved by traditional financial institutions because of low credit scores and more. Image Source: Zacks Investment Research The company's digital OppLoans platform uses AI-driven underwriting to offer transparent, responsible lending with same-day funding. OppFi also supports financial education through partnerships to help customers improve their financial health. OppFi is projected to grow its earnings by 30% this year and 9% next year on 10% and 4%, respective revenue expansion. The financial services firm has crushed our bottom-line estimates by an average of 60% in the trailing four quarters, including a big beat-and-raise Q1 in early May. OppFi's recent upward earnings revisions are part of a much larger uptrend during the past year. Image Source: Zacks Investment Research OPFI stock has soared 300% in the past 12 months to crush its Business Services sector's 13%. Its recent outperformance is part of a 550% two-year run that's taken it above its summer 2021 levels after it went public via a SPAC. Despite the surge, investors can buy OppFi stock 22% below its February peaks while holding its ground above its 2021 IPO levels and its 21-day moving average recently. OppFi also trades at a 60% discount to its sector and 45% below its highs at 9.4X forward 12-month earnings. Get the rest of the stocks on this list and start looking for the newest companies that fit these criteria. It's easy to do. And it could help you find your next big winner. Start screening for these companies today with a free trial to the Research Wizard. You can do it. Click here to sign up for a free trial to the Research Wizard today. Want more articles from this author? Scroll up to the top of this article and click the FOLLOW AUTHOR button to get an email each time a new article is published. Disclosure: Officers, directors and/or employees of Zacks Investment Research may own or have sold short securities and/or hold long and/or short positions in options that are mentioned in this material. An affiliated investment advisory firm may own or have sold short securities and/or hold long and/or short positions in options that are mentioned in this material. Disclosure: Performance information for Zacks' portfolios and strategies are available at: Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report OppFi Inc. (OPFI) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Personalis' NeXT Personal® Predicts Cervical Cancer Recurrence Risk in New CALLA Phase 3 Study Analysis Presented at ASCO
Personalis' NeXT Personal® Predicts Cervical Cancer Recurrence Risk in New CALLA Phase 3 Study Analysis Presented at ASCO

Yahoo

timean hour ago

  • Yahoo

Personalis' NeXT Personal® Predicts Cervical Cancer Recurrence Risk in New CALLA Phase 3 Study Analysis Presented at ASCO

FREMONT, Calif., June 03, 2025--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced the presentation of new results from the CALLA phase 3 study showing for the first time its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test detected cervical cancer progression, up to 16 months ahead of imaging. The results demonstrate the potential of NeXT Personal to enable earlier detection in a cancer with high recurrence rates. The results were presented yesterday by Jyoti Mayadev, MD, from the University of California San Diego, at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago in an oral presentation titled "Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses." The results from this study were also simultaneously published in the journal Annals of Oncology. Samples were analyzed from patients with cervical cancer who had enrolled in the original CALLA clinical trial. In this new study analysis, NeXT Personal was used to look for small traces of ctDNA in blood samples from a cohort of 186 patients with locally advanced cervical cancer. Dr. Mayadev's team found that overall ctDNA levels after chemoradiotherapy (CRT) treatment were strongly predictive of risk of cervical cancer progression. "Despite standard chemoradiotherapy, up to half of patients with locally advanced cervical cancer relapse, underscoring the urgent need for better prognostic tools. In the CALLA phase 3 study, ultrasensitive, tumor-informed ctDNA analysis emerged as a powerful predictor of progression and survival—detecting relapse up to ~16 months before imaging. These findings highlight ctDNA's potential to guide treatment decisions and personalize care in high-risk cervical cancer," said Dr. Mayadev. Key findings presented: Detection of ctDNA following CRT was independently prognostic of patient outcomes. Risk of progression and death were at least 95% lower for patients where ctDNA was not detected ~3 months after completing CRT. Detection of ctDNA after CRT was associated with high subsequent risk of disease progression, and was detected a median of ~5 months and up to ~16 months earlier than by imaging scans. High ctDNA levels (≥ median) at baseline was associated with higher risk of progression and death. "We are excited to see the results presented for NeXT Personal in this large phase 3 study in cervical cancer," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "Cervical cancer is the fourth most common cancer for women globally, resulting in hundreds of thousands of deaths each year. The new results show the strong potential for an ultrasensitive MRD test like NeXT Personal to inform treatment for cervical cancer patients." About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit and connect with us on LinkedIn and X (Twitter). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to the attributes, advantages, sensitivity, clinical relevance or importance of the NeXT Personal test. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the ability of NeXT Personal to detect small traces of ctDNA, detect residual or recurrent cancer early (including detection earlier than standard of care imaging), monitor or predict a patient's response to therapy or risk of cancer recurrence, accurately predict clinical outcomes for cancer patients, or impact cancer care or management (including for escalation or de-escalation of treatment), or to the clinical adoption or use of, or the ability of Personalis to obtain Medicare coverage or reimbursement for, the NeXT Personal test, or to the sufficiency of the publication and study results described in this press release to support such adoption, use, coverage or reimbursement. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Personalis' Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on February 27, 2025, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 6, 2025. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law. Not affiliated with or endorsed by ASCO. View source version on Contacts Investors: Caroline Cornerinvestors@ 415-202-5678 Media Contact pr@

Why Guardant Health Stock Surged Nearly 9% Higher Today
Why Guardant Health Stock Surged Nearly 9% Higher Today

Yahoo

timean hour ago

  • Yahoo

Why Guardant Health Stock Surged Nearly 9% Higher Today

The company's Shield multi-cancer detection test won an important designation from a top regulator. This should help bring it to market quicker. 10 stocks we like better than Guardant Health › Precision oncology specialist Guardant Health (NASDAQ: GH) was something of a stock market star on Tuesday. On the back of very positive news in the regulatory sphere, the company's shares jumped almost 9% higher today. This made it quite the outperformer on the exchange, as the bellwether S&P 500 index's gain was a relatively modest 0.6%. This morning before market open, Guardant announced that the U.S. Food and Drug Administration (FDA) had granted the healthcare company's Shield multi-cancer detection (MCD) test its Breakthrough Device designation. This instantly confers a high status on Shield, as the FDA's designation is given only to a small clutch of medical devices that can either diagnose or treat a disease more effectively than other products. In Shield's case, it is quite a versatile diagnostic device that can screen for a wide range of cancers, including colorectal, lung, and ovarian. It is designed to evaluate people 45 years of age or older who are at a typical average risk for cancer. According to Guardant, Shield has 98.6% specificity and 75% sensitivity in detecting certain cancers. In its news release touting the FDA's move, Guardant quoted its co-CEO AmirAli Talasaz as saying that it "shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw." "We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly," he added. Another big plus of the Breakthrough Device designation is that it's part of an FDA initiative aimed at getting useful medical products to market faster. Talasaz and his team at Guardant might just get their wish with Shield before long. Before you buy stock in Guardant Health, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Guardant Health wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $657,385!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $842,015!* Now, it's worth noting Stock Advisor's total average return is 987% — a market-crushing outperformance compared to 171% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of June 2, 2025 Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Guardant Health. The Motley Fool has a disclosure policy. Why Guardant Health Stock Surged Nearly 9% Higher Today was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store