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Adaptimmune Reports Q1 Financial Results and Provides Business Update

On May 13, 2025 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported financial results and provided a business update for the first quarter ended March 31, 2025 (Press release, Adaptimmune, MAY 13, 2025, View Source [SID1234652952]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "The launch of Tecelra continues to rapidly accelerate, as evidenced by all launch metrics. In Q4 2024 we invoiced 2 patients, in Q1 2025 we invoiced 6 patients, and in Q2 to-date we have invoiced 8 patients. The shape of the pipeline of patients being tested and apheresed continues to support a robust acceleration of sales in Q2 and the second half of the year, and we continue to experience 100% manufacturing success rates and no payer denials. As a result, we are now providing guidance for 2025 Tecelra sales in the range of $35-$45 million. I’m confident in the team’s ability to identify eligible patients, manufacture a personalized engineered T cell treatment and ultimately deliver product, demonstrating that we have built a successful business platform for cell therapies in solid tumors, paving the way for an equally successful lete-cel launch in 2026."

Tecelra launch momentum increasing – first commercial product in Adaptimmune’s sarcoma franchise

● 28 Authorized Treatment Centers (ATCs) now accepting referrals
● On track to have the full network of approximately 30 ATCs open by the end of the year
● Invoiced 2 patients in Q4 2024, 6 in Q1 2025, and 8 in Q2 to-date (as of May 9, 2025)
● Apheresed 3 patients in Q4 2024, 13 in Q1 2025, and 8 in Q2 to-date (as of May 9, 2025)
● 100% success rate in manufacturing to date, with no capacity constraints and an average turnaround of 27 days
● Successful patient access to Tecelra with no payer denials to date

Lete-cel – next product in Adaptimmune’s sarcoma franchise

● Pivotal trial met primary endpoint with 42% ORR including 6 complete responses (CTOS 2024)
● On track to initiate rolling BLA submission in late 2025; approval anticipated in 2026
● Lete-cel will more than double the addressable patient population in the sarcoma franchise
● Launch readiness activities are on track

Corporate updates

● Review of strategic options with TD Cowen in progress
● Debt principal paydown of $25 million made in Q1 2025

Upcoming milestones

● Updates on Tecelra launch momentum
● Initiate rolling BLA for lete-cel to treat synovial sarcoma and MRCLS in Q4 2025

Financial Results for the three months ended March 31, 2025

● Cash / liquidity position: As of March 31, 2025, Adaptimmune had cash and cash equivalents of $41.1 million and Total Liquidity1 of $59.6 million, compared to $91.1 million and $151.6 million respectively, as of December 31, 2024.
● Revenue: Revenue for the three months ended March 31, 2025, was $7.3 million, compared to $5.7 million for the same period in 2024. Revenue has increased primarily due to $4.0 million in product sales following the FDA approval of TECELRA on August 1, 2024. This was offset by a $2.4 million decrease in development revenue due to revenue from Galapagos replacing Genentech revenue and Galapagos generating comparatively lower revenue due to the collaboration being at an earlier stage of progress than the Genentech collaboration was in the first quarter of 2024.
● Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2025, were $28.9 million, compared to $35.2 million for the same period in 2024. R&D expenses decreased due to a decrease in the average number of employees engaged in R&D following the restructuring and reprioritization of activities that was announced in November 2024 and a decrease in subcontracted expenditure, offset by a decrease in offsetting reimbursements receivable for R&D tax and expenditure credits.
● Selling, general and administrative (SG&A) expenses: SG&A expenses for the three months ended March 31, 2025, were $23.3 million, compared to $19.7 million for the equivalent period in 2024. SG&A expenses increased due to restructuring charges for the restructuring program initiated in the fourth quarter of 2024 for which there was no equivalent in the first quarter of 2024 and an increase in accounting, legal and professional fees due to fees relating to business development work, offset by a decrease in share-based compensation expense due to forfeitures arising as a result of the restructuring program.
● Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three months ended March 31, 2025, was a loss of $47.6 million ($0.03 per ordinary share), compared to $48.5 million ($0.03 per ordinary share), for the equivalent period in 2024.

Going Concern

Our 2024 Annual Report on Form 10-K, which the Company filed on March 24, 2025, disclosed that there is substantial doubt about our ability to continue as a going concern. We are continuing to implement cost reduction measures and explore the strategic options outlined above.

Today’s Webcast Details

A live webcast and replay can be accessed at View Source . Call in information is as follows: 1-833-821-0158 (US or Canada) or 1-647-846-2266 (International). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

GSK provides update on belrestotug development programme

On May 13, 2025 GSK plc (LSE/NYSE: GSK), with its development partner iTeos Therapeutics, Inc., has reported that it is ending the development programme for belrestotug, an anti-TIGIT monoclonal antibody (Press release, GlaxoSmithKline, MAY 13, 2025, View Source [SID1234652901]). The decision is based on new interim analyses from the phase 2 GALAXIES Lung-201 and GALAXIES H&N-202 studies, which did not meet the established efficacy criteria for continued development. As a result, the collaboration and all belrestotug-containing study cohorts are ending.

GSK in Oncology
Our ambition in oncology is to help increase overall quality of life, maximise survival and change the course of disease, expanding from our current focus on blood and women’s cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor.

A Phase 3 Clinical Trial on Disitamab Vedotin as a First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma Reached its Primary Endpoints of PFS and OS

On May 12, 2025 RemeGen Co., Ltd. ("RemeGen", stock symbols: 688331.SH/09995.HK) reported that its phase 3 clinical trial (NCT05302284, study ID: RC48-C016) on disitamab vedotin (DV, brand name: Aidixi), an anti-HER2 antibody-drug conjugate (ADC), in combination with the PD-1 inhibitor toripalimab versus the standard chemotherapy as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC) has reached its primary endpoints of progression-free survival (PFS) and overall survival (OS) (Press release, RemeGen, MAY 12, 2025, View Source;cid=115&id=2596 [SID1234656126]). Statistically significant and clinically meaningful benefits were observed from the strongly positive results of a prespecified interim analysis by Independent Data Monitoring Committee (IDMC). The primary subgroup analysis showed that DV combined with toripalimab significantly improved PFS and OS compared with the standard chemotherapy of la/mUC, irrespective of cisplatin eligibility or HER2 expression level. Furthermore, this regimen exhibited manageable safety profile and tolerable adverse reactions. Detailed data of this study will be presented at major international academic conferences later this year. RemeGen plans to file Biologic License Application (BLA) submission for this indication to the Center of Drug Evaluation of National Medical Products Administration (NMPA) in China.

RC48-C016 is a randomized, active-control, multi-center phase 3 clinical trial evaluating efficacy and safety of DV plus toripalimab versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2-expressing (defined as IHC 1+, 2+ or 3+) la/mUC. The study was initiated in June 2022 and conducted in 74 sites across China with 484 patients enrolled, the contribution of the investigators and patients is greatly appreciated.

"The strongly positive results of DV in combination with toripalimab as a first-line treatment for advanced urothelial carcinoma are encouraging. DV combined with toripalimab significantly improved PFS and OS, irrespective of cisplatin eligibility or HER2 expression level, which proves the success of HER2-ADC plus immunotherapy and represents a major breakthrough in the treatment of urothelial carcinoma worldwide. It is expected that the excellent performance of disitamab vedotin in subsequent studies will provide better decision-making basis for clinicians, bring more benefits to patients, and reshape the global treatment landscape of urothelial carcinoma with the Chinese regimen,"said Dr. Jun Guo, principal investigator of the study and professor at Peking University Cancer Hospital.

About Disitamab Vedotin

DV is the first novel ADC initially developed by a Chinese company and have been granted conditional approval by NMPA for treatment of gastric cancer and la/mUC in China.

RemeGen’s Novel ADC Drug RC278’s Clinical Trial Application Accepted

On May 12, 2025 RemeGen Co., Ltd. (688331.SH/9995.HK) reported that the Clinical Trial Application (CTA) for its novel ADC Drug RC278 has been submitted recently and accepted by National Medical Products Administration (NMPA) Center for Drug Reevaluation (CDE) on May 8th (Press release, RemeGen, MAY 12, 2025, View Source;cid=115&id=2650 [SID1234656125]).

RC278, independently designed and developed by RemeGen, emerges as a potentially First-in-Class/Best-in-Class ADC molecule. RC278 can specifically recognize a new tumor target and contains an innovative linker-cytotoxicity system, showing broad-spectrum antitumor activity, manageable safety and pharmacokinetic characteristics in the pre-clinical study.

As an important drug candidate in RemeGen’s ADC pipeline, RC278 boasts unique target and differentiated molecule design, demonstrating RemeGen’s progress in ADC technology. RC278 will bring new treatment option for the advanced solid tumor patients.

Assertio Reports First Quarter 2025 Financial Results

On May 12, 2025 Assertio Holdings reported financial results for the first quarter ended March 31, 2025 (Press release, Assertio Holdings, MAY 12, 2025, View Source [SID1234654207]).

Said Brendan O’Grady, Chief Executive Officer, "We have achieved substantial progress to date as we implement our business strategy designed to create sustainable near-term growth and increased long-term value as a specialty pharmaceutical company focused on commercial assets. As part of this strategy, Assertio’s 2025 transformation priorities include reducing legal exposure, simplifying our corporate structure and processes, prioritizing investment in growth assets, divesting declining or non-core assets, and using the strength of our balance sheet to close a strategic transaction."

Executing on these priorities through the first quarter, Assertio has:

Settled multiple prior legal matters, including the previously disclosed DOJ False Claims Act qui tam lawsuit, the last remaining Glumetza antitrust action, Spectrum’s legacy Luo securities class action (subject to court approval), and obtained a dismissal of the Company’s Edwards securities class action, reducing future legal costs and further focusing resources on the business.
Begun simplifying its corporate holdings structure by transferring all of its interests in its subsidiary Assertio Therapeutics to an established purchaser of legacy litigation matters resulting in Assertio Therapeutics being owned by the purchaser’s related company, ATIH Industries, LLC. At the closing of this transaction, Assertio Therapeutics held approximately $8.2 million in cash, insurance, a single-digit royalty on Indocin, and certain legal liabilities, including those related to opioid litigation. As a result of this transaction, neither Assertio Holdings nor any of its current subsidiaries are defendants in any opioid-related litigation.
Reallocated corporate resources to focus on growth assets, namely Rolvedon and Sympazan.
Advanced its strategic activities to bring new growth drivers into Assertio’s commercial platform, while also progressing the process to divest non-core assets.
Net Sales and Key Asset Performance

Further, O’Grady said "Looking at the first quarter, net sales came in at $26.0 million, and we are tracking to our full year net product sales and adjusted EBITDA outlook. Rolvedon net sales still finished above our internal expectation, despite Q4 stocking to support customer and volume expansion in Q1, which reflects continued strong demand and commercial execution. As a result, we expect Rolvedon net sales to continue to increase throughout the year. In addition, our revised Sympazan promotional strategy is proving effective, with total Sympazan prescriptions up 6.5% year-over-year in the first quarter. Also, Indocin remained stable in the first quarter, achieving our net sales and contribution expectations."