logo
Adaptimmune Therapeutics PLC (ADAP) Q1 2025 Earnings Call Highlights: Strong Tecelra Launch ...

Adaptimmune Therapeutics PLC (ADAP) Q1 2025 Earnings Call Highlights: Strong Tecelra Launch ...

Yahoo14-05-2025
Revenue Guidance: Full-year Tecelra sales projected between $35 million and $45 million.
Net Sales for Q1 2025: $4 million from Tecelra treatments.
Tecelra Treatments Invoiced: 14 treatments in 2025 to date, with 6 in Q1.
Authorized Treatment Centers: 28 centers currently accepting referrals, with a target of approximately 30 by the end of 2025.
Manufacturing Success Rate: 100% success from the US Tecelra manufacturing center.
Average Turnaround Time: 27 days from apheresis to release, beating the target of 30 days.
Peak Sales Projection: $400 million from combined Tecelra and Lete-cel sarcoma franchise.
Warning! GuruFocus has detected 4 Warning Signs with ADAP.
Release Date: May 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Adaptimmune Therapeutics PLC (NASDAQ:ADAP) reported strong momentum with the launch of Tecelra, achieving $4 million in net sales for Q1 2025.
The company has successfully apheresed 21 patients in 2025, with 13 in Q1 and 8 in early Q2, supporting their revenue guidance of $35 million to $45 million for the year.
Adaptimmune has established 28 authorized treatment centers (ATCs) for Tecelra, with plans to reach 30 by the end of 2025, a year ahead of schedule.
The manufacturing success rate for Tecelra has been 100%, with no capacity issues and an average turnaround time of 27 days, beating the target of 30 days.
There have been no patient denials for Tecelra, indicating effective patient access and a positive payer environment.
Adaptimmune Therapeutics PLC (NASDAQ:ADAP) has a going concern warning, indicating less than 12 months of cash runway, which raises concerns about financial sustainability.
The company has not provided detailed cash runway guidance due to various impacting factors, including the success of Tecelra's launch and ongoing cost reduction actions.
The cost of goods sold (COGS) is expected to be higher in the initial quarters, affecting margins, although they are projected to normalize over time.
There is uncertainty regarding the impact of potential regulatory changes on the business, although the company has not seen any negative indications from the FDA.
The company is still exploring strategic options with Cowen, which could imply potential changes or uncertainties in their strategic direction.
Q: Can you clarify if the apheresed patients in Q1 have already been treated and invoiced? A: Cintia Piccina, Chief Commercial Officer, explained that of the 21 apheresed patients year-to-date, at least six have been invoiced, with the majority expected to be invoiced in the coming months.
Q: Should we expect an acceleration in the number of apheresed patients in Q2? A: Adrian Rawcliffe, CEO, stated that while they are comfortable with the sales guidance of $35 million to $45 million for 2025, they are not providing detailed quarterly breakdowns of apheresis numbers.
Q: How has the pace of patient referrals and screening been trending, and do you expect incremental growth? A: Cintia Piccina noted that they expect quarter-over-quarter growth without specific seasonality, driven by increased awareness and the onboarding of more Authorized Treatment Centers (ATCs).
Q: What are the key learnings from the early launch of Tecelra? A: Cintia Piccina highlighted the faster-than-expected onboarding of treatment centers and the 100% manufacturing success rate as positive surprises, with patient onboarding and biomarker testing proceeding smoothly.
Q: How is the company managing its cash position and what are the implications of the recent debt paydown? A: Gavin Wood, CFO, explained that the debt paydown was part of managing the balance sheet and did not impact cash runway. The company has less than 12 months of cash, with ongoing strategic options being explored.
Q: What gives you confidence in providing revenue guidance for the year? A: Adrian Rawcliffe mentioned the visibility into the patient funnel, successful manufacturing, and the increasing number of ATCs as factors supporting the $35 million to $45 million revenue guidance.
Q: What is the drop-off rate for patients from apheresis to infusion? A: Adrian Rawcliffe confirmed that so far, 100% of apheresed patients have received infusions.
Q: Are there any planned manufacturing maintenance activities this year? A: John Lunger, Chief Patient Supply Officer, stated that maintenance is conducted on a rolling basis without impacting capacity, and no significant shutdowns are planned for the year.
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

Adaptimmune Therapeutics Stock (ADAP) Rockets 50% on CCO Severance Agreement
Adaptimmune Therapeutics Stock (ADAP) Rockets 50% on CCO Severance Agreement

Business Insider

timea day ago

  • Business Insider

Adaptimmune Therapeutics Stock (ADAP) Rockets 50% on CCO Severance Agreement

Adaptimmune Therapeutics (ADAP) stock rocketed higher on Monday after the clinical-stage biopharmaceutical company reached a severance agreement with former Chief Commercial Officer Cintia Piccina. Under the terms of this agreement, Piccina will receive 12 months of pay, $473,800, in a lump-sum payment. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Piccina will also continue to be able to benefit from the Employee 2016 Share Option Scheme. This will allow her to exercise vested options until January 30, 2032. The former CCO was also permitted a 'period of 12 months from the Separation Date to exercise any other Market Value Options that have vested by the Separation Date.' Piccina was terminated as the CCO of Adaptimmune Therapeutics on August 8, 2025. The reason for this was redundancy. Piccina's severance agreement with the company will go into effect on August 23, 2025. Adaptimmune Therapeutics Stock Movement Today Adaptimmune Therapeutics stock was up 47.23% in pre-market trading on Monday, following an 18.38% fall on Friday. The shares have also decreased 88.98% year-to-date and 94.69% over the past 12 months. Today's news saw heavy trading of ADAP stock, with some 270 million shares traded, compared to a three-month daily average of about 38 million units. Is Adaptimmune Therapeutics Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Adaptimmune Therapeutics is Moderate Sell, based on four Hold and two Sell ratings over the past three months. With that comes an average ADAP stock price target of 35 cents, representing a potential 488.24% upside for the shares.

CEL-SCI Reports Fiscal Third Quarter 2025 Financial Results
CEL-SCI Reports Fiscal Third Quarter 2025 Financial Results

Business Wire

time6 days ago

  • Business Wire

CEL-SCI Reports Fiscal Third Quarter 2025 Financial Results

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the three months ended June 30, 2025, as well as key recent clinical and corporate developments. 'Commercial and regulatory momentum for Multikine is accelerating due to three driving factors—our partnership negotiations in Saudi Arabia, the increasing interest in CEL-SCI from investors in the Middle East, and continued recognition in the global scientific and regulatory community that PD-L1 is a valuable predictive marker for head and neck cancer,' stated CEL-SCI CEO, Geert Kersten. 'We are particularly encouraged about the potential for Multikine to become commercially available in Saudi Arabia in 2025. Should this happen, we believe it could support our regulatory and commercial efforts worldwide.' Corporate and Clinical Developments include: CEL-SCI's CEO and a Director of the Company each purchased a combined total of 32,116 shares of restricted common CEL-SCI stock in July 2025. Gross proceeds of approximately $5.7 million were raised by CEL-SCI in July 2025 through the sale of 1,500,000 shares of common stock at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. In May of 2025, the Company raised gross proceeds of $5 million through the sale of 2,000,000 shares of common stock priced at $2.50 per share. CEL-SCI is set to sign a commercialization and regulatory partnership agreement with a leading Saudi Arabian pharmaceutical company for Multikine* (Leukocyte Interleukin, Injection) in the treatment of head and neck cancer in the Kingdom of Saudi Arabia. A Breakthrough Medicine Designation application for Multikine was filed by the pharma partner with the Saudi Food and Drug Authority (SFDA). According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of the Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia. Several leading Saudi funds have expressed interest in investing in CEL-SCI, Multikine and/or a potential joint venture to serve the wider Middle East and North Africa (MENA) market. CEL-SCI's offering with Multikine is in line with Saudi Arabia's Vision 2030 initiative which seeks to make the Kingdom a global biotech hub. Given the SFDA's 60-day timeline to make Multikine potentially available, in-country investors have expressed interest in bringing a much-needed cancer treatment to market while also supporting their nation's health-tech goals. A new study supports CEL-SCI's strategy to seek early approval in the U.S. CEL-SCI is in final preparations before starting enrollment of its 212-patient Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. The U.S. Food and Drug Administration (FDA) has given CEL-SCI the go-ahead for the study. CEL-SCI plans to seek early approval based on early tumor responses. A third-party study recently published in Cancer Cell titled 'Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies' provides support for CEL-SCI's approach. The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The third-party study published in Cancer Cell gives further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer. More data on PD-L1 as a predictive biomarker signals a clear regulatory pathway for Multikine in PLD-L1 negative patients. There is a growing body of data on PD-L1 as a predictive biomarker and diagnostic for cancer. In June, the FDA approved Merck's KEYTRUDA® (pembrolizumab), an anti-PD-L1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. Of note, the FDA granted Merck priority review in February 2025 and approval in June 2025 based on interim results. This sets a positive precedent for Multikine in PD-L1 low and negative patients. Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by only 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival. Financial Results During the three months ended June 30, 2025, net loss available to common shareholders was $5.7 million compared to $7.5 million in the prior year period. Basic and diluted net loss per common share was $1.36 for the three months ended June 30, 2025, compared to $4.18 for the three months ended June 30, 2024. In demonstration of his deep commitment to the Company and Multikine's potential to significantly improve patient outcomes, CEO Geert Kersten has been and is currently working without taking a salary. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor before surgery, radiation and chemotherapy because that is the time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced not yet treated resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

CEL-SCI's Multikine Head and Neck Cancer Immunotherapy Breakthrough Medicine Designation Filed in Saudi Arabia: Allows for Patient Access and Reimbursement/Sale Upon Granting of the Designation Which Takes Approximately 60 Days Based on SFDA Timeline
CEL-SCI's Multikine Head and Neck Cancer Immunotherapy Breakthrough Medicine Designation Filed in Saudi Arabia: Allows for Patient Access and Reimbursement/Sale Upon Granting of the Designation Which Takes Approximately 60 Days Based on SFDA Timeline

Business Wire

time13-08-2025

  • Business Wire

CEL-SCI's Multikine Head and Neck Cancer Immunotherapy Breakthrough Medicine Designation Filed in Saudi Arabia: Allows for Patient Access and Reimbursement/Sale Upon Granting of the Designation Which Takes Approximately 60 Days Based on SFDA Timeline

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced that a Breakthrough Medicine Designation application has been filed with the Saudi Food and Drug Authority (SFDA) for Multikine* (Leukocyte Interleukin, Injection) in the Kingdom of Saudi Arabia by one of the Kingdom's premier pharmaceutical and healthcare companies. CEL-SCI has signed a Memorandum of Understanding (MOU) with this Saudi pharma company for the commercialization of Multikine in Saudi Arabia. A final partnership agreement is expected during the 3 rd quarter of 2025. Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is to activate a person's immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world's largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%. According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia. The Saudi pharma company is well positioned to procure reimbursement and to accelerate Multikine's sale and commercial launch. Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and a potential joint venture to serve the wider Middle East and North Africa (MENA) market. CEL-SCI is working closely with First Berlin of Germany and its Saudi representatives to advance its commercialization program for Multikine. Martin Bailey, Managing Director and Founder of First Berlin, the lead advisor, commented, 'CEL-SCI's prospective new partner is a prominent and innovative leader that has rendered many valuable healthcare services to the Kingdom. The Saudi pharma company's keen interest in Multikine to make patients' first cancer treatment more curative is very much in line with their forward-thinking approach and fits well with Saudi Arabia's Vision 2030 and the National Biotechnology Strategy. We look forward to facilitating the signing of a final partnership agreement and making Multikine available to patients as quickly as possible.' 'This MOU and the filing for Breakthrough Medicine Designation mark a significant advancement for Multikine's global regulatory, patient access/sale and commercial roll out,' stated CEL-SCI CEO, Geert Kersten. 'We've had a highly productive working relationship with this prestigious Saudi pharma company, First Berlin, and the SFDA and hope to see Multikine improve longevity and well-being for head and neck cancer patients in Saudi Arabia.' About the SFDA's Breakthrough Medicine Program The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia's Vision 2030 initiative. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines' benefits justify their risks. Eligibility includes having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation: Target serious debilitating or life-threatening conditions with unmet medical need. The medicinal product is likely to offer major advantages over methods currently used. The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance. The product is not registered at any regulatory authority at the time of submission of the designation request. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to finalize a partnering agreement and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store