On May 12, 2025 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the first quarter ending March 31, 2025 (Press release, Akoya Biosciences, MAY 12, 2025, View Source [SID1234652860]).

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"Akoya remained focused on operational discipline and innovation in the first quarter of 2025, while successfully increasing our installed base in the face of broader macroeconomic and NIH funding uncertainty. Our technology continues to gain momentum globally, underscored by growing adoption in large-scale population studies as well as an expanding publication footprint across key research areas in high-impact journals," said Brian McKelligon, CEO of Akoya Biosciences. "As we look ahead to combining forces with Quanterix, we are confident in the value-creating opportunities this integration brings—uniting two leaders in proteomics to accelerate the future of precision medicine."

First Quarter 2025 Financial Results

Revenue was $16.6 million in the first quarter of 2025, compared to $18.4 million in the prior year period; a decrease of 9.8%.
Gross margin was 59.3% in the first quarter of 2025, compared to 45.7% in the prior year period.
Operating expenses were $23.3 million for the first quarter of 2025, compared to $30.0 million in the prior year period, an improvement of 22.3%.
Operating loss was $13.4 million for the first quarter of 2025, compared to $21.6 million in the prior year period, an improvement of 37.9%.
Net cash used in operating activities decreased by $13.6 million to $7.2 million in the first quarter of 2025, compared to $20.8 million in the prior year period.
$27.5 million of cash, cash equivalents and marketable securities as of March 31, 2025.

First Quarter 2025 Business Highlights

Akoya and Team SAMBAI announced the selection of PhenoCycler-Fusion as the foundational spatial proteomics platform for a landmark Cancer Grand Challenges-funded study. This large-scale study aims to address cancer inequities through high-plex, high-throughput spatial analysis and will generate data for a first-of-its-kind Biobank and Data Repository.
Akoya and the Singapore Translational Cancer Consortium (STCC) have partnered to deploy the PhenoCode Discovery IO60 panel in the SUPER study, aimed at advancing cancer immunophenotyping in Singapore. The study seeks to identify predictors of PD-1 immunotherapy response in real-world Asian patient populations, bridging cutting-edge spatial proteomics with clinical insights.
At the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (April 25–30, Chicago, IL), Akoya in partnership with Enable Medicine, launched the largest commercially available single-cell spatial proteomics atlas. Akoya also announced the expansion of its Advanced Biopharma Solutions portfolio with a new antibody-drug conjugate (ADC) breast cancer assay and showcased real-world insights from the IO60 panel.
The quarter ended with an instrument installed base of 1,359 (410 PhenoCyclers, 949 PhenoImagers), a year-over-year increase of 12.0% compared to an installed base of 1,213 (354 PhenoCyclers, 859 PhenoImagers) in the prior year period.
The quarter ended with 1,891 total publications citing Akoya’s technology, a year-over-year increase of 44.7% compared to 1,307 total publications in the prior year period.

In light of the pending acquisition by Quanterix Corporation, Akoya will not be hosting an earnings conference call or providing forward-looking guidance at this time.

Important Additional Information

In connection with its proposed acquisition of Akoya (the "Merger"), Quanterix Corporation ("Quanterix") will file with the SEC a post-effective amendment to its previously filed registration statement on Form S-4 (as so amended, the "Registration Statement"), which will contain a preliminary proxy statement of Akoya and a preliminary prospectus of Quanterix (the "Proxy Statement/Prospectus"), and each of Quanterix and Akoya have, and may in the future, file with the SEC other relevant documents regarding the proposed Merger. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT AND THE PROXY STATEMENT/PROSPECTUS CAREFULLY AND IN THEIR ENTIRETY AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC BY QUANTERIX AND AKOYA, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT QUANTERIX, AKOYA AND THE PROPOSED MERGER. A definitive copy of the Proxy Statement/Prospectus will be mailed to Akoya stockholders when that document is final. Investors and security holders will be able to obtain the Registration Statement and the Proxy Statement/Prospectus, as well as other filings containing information about Quanterix and Akoya, free of charge from Quanterix or Akoya or from the SEC’s website when they are filed. The documents filed by Quanterix with the SEC may be obtained free of charge at Quanterix’s website, at www.quanterix.com, or by requesting them by mail at Quanterix Investor Relations, 900 Middlesex Turnpike, Billerica, MA 01821. The documents filed by Akoya with the SEC may be obtained free of charge at Akoya’s website, at www.akoyabio.com, or by requesting them by mail at Akoya Biosciences, Inc., 100 Campus Drive, 6th Floor, Marlborough, MA 01752 ATTN: Chief Legal Officer.

Participants in the Solicitation

Quanterix and Akoya and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Akoya in respect of the proposed Merger. Information about Akoya’s directors and executive officers is available in the Proxy Statement/Prospectus and in Amendment No. 1 to Akoya’s Annual Report on Form 10-K for fiscal year ended December 31, 2024, filed with the SEC on April 28, 2025, and other documents filed by Akoya with the SEC. Other information regarding the persons who may, under the rules of the SEC, be deemed participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the Proxy Statement/Prospectus and other relevant materials to be filed with the SEC regarding the proposed Merger when they become available. Investors should read the definitive Proxy Statement/Prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from Quanterix or Akoya as indicated above.

No Offer or Solicitation

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the Merger, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act.

On May 12, 2025 Agenus Inc. ("Agenus" or the "Company") (NASDAQ: AGEN), a leader in immuno-oncology, reported financial and operational results for the first quarter of 2025, and shared key clinical and strategic milestones supporting the advancement of its botensilimab (BOT) and balstilimab (BAL) program (Press release, Agenus, MAY 12, 2025, View Source [SID1234652859]).

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"The growing strength of our BOT/BAL data across multiple hard-to-treat cancers reinforces our conviction in its transformative potential and fuels our unwavering commitment to delivering this combination to patients." said, Garo Armen, Ph.D., Chairman and CEO of Agenus. "With expanded datasets, key leadership appointments, and the FDA’s renewed focus on accelerating cures and meaningful treatments, Agenus is entering a pivotal phase—advancing toward regulatory engagement with financial discipline and a sharp focus on bringing innovative immunotherapies to individuals living with cancer."

Key Highlights from Q1 2025

New Data:

•
BOT/BAL continues to demonstrate robust and durable responses across microsatellite stable (MSS) "cold tumors" where current immuno-oncology treatments have historically failed. At American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, Illinois, new data highlighted the activity and safety profile in both multiple mismatch repair–proficient (pMMR/MSS) and mismatch repair–deficient (dMMR/MSI-H) solid tumors in neoadjuvant and later line treatment settings.
o
Notably, new data from the investigator-sponsored pan-cancer NEOASIS study–a now the third clinical study evaluating BOT/BAL in the neoadjuvant setting–were presented. These initial results from the safety run-in portion indicate that BOT/BAL can induce pathological responses in patients with solid tumors beyond CRC, including TNBC and sarcomas. No dose-limiting toxicities were observed, and all patients proceeded to their scheduled surgery.

o
100 percent of dMMR CRC patients given a higher dose of BOT/BAL achieved pCR.
o
New data from the HCC cohort of the ongoing Phase 1 study were also presented. The HCC cohort comprised of patients with difficult-to-treat disease who had progressed following standard treatments, including approved immunotherapies. The durable responses and disease control in heavily pretreated HCC patients highlight the strength and differentiation of the BOT/BAL combination.
o
data on late stage pan tumor activity to be presented at an upcoming kay cancer conference.
New Leadership:

•
Dr. Richard Goldberg, an internationally recognized leader in GI cancer treatment and research, stepped out of early retirement to join Agenus as Chief Development Officer to support the advancement of BOT/BAL for patients. Dr. Goldberg will lead the company’s efforts as it prepares to re-engage global regulatory authorities with expanded data and longer-term follow-up in metastatic CRC.
New Efficiencies:

•
Agenus is on track to reduce its annualized operating cash burn below $50 million starting in the second half of 2025, supported by recent cost optimization measures enabling the company to direct resources toward ensuring the potential of BOT/BAL is realized. The company is in final stages of an important collaboration which will result in substantial cash infusion.
Q1 2025 Financial Highlights

Agenus ended the first quarter 2025 with a consolidated cash balance of $18.5 million compared to $40.4 million on December 31, 2024. Cash used in operations for the first quarter ended March 31, 2025 was $25.6 million, reduced from $38.2 million for same period in 2024.

For the first quarter ended March 31, 2025, Agenus recognized revenue of $24.1 million and incurred a net loss of $26.4 million, or $1.03 per share. For the first quarter ended March 31, 2024, Agenus recognized revenue of $28.0 million and incurred a net loss of $63.5 million or $3.04 per share. Revenue primarily includes non-cash royalty revenue.

Financial Highlights

(in thousands, except per share data)

(unaudited)

Cash and cash equivalents

March 31, 2025

$ 18,488

December 31, 2024

$ 40,437

Key Financial Metrics

Q1 2025

Q1 2024

Cash used in operations

$ 25,618

$ 38,191

Revenue, including non-cash royalties

24,066

28,005

Net loss

26,370

63,454

Non-cash expenses included in net loss

19,388

38,255

Exhibit 99.1

Net loss per share attributable to Agenus Inc. common stockholders

1.03

3.04

Conference Call

Date: Monday, May 12th, at 8:30 a.m. ET
To access dial-in numbers, please register here.
Conference ID: 73242

Webcast

A live webcast and replay of the conference call will be accessible on the company’s website at View Source

About Botensilimab (BOT)

Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

About Balstilimab (BAL)

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.

On May 11, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that its B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL) (Press release, InnoCare Pharma, MAY 11, 2025, View Source [SID1234652836]). This marks the first BCL2 inhibitor to receive BTD recognition in China!

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Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin’s lymphomas (NHLs), and as well as acute myeloid leukemia (AML). BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "We are delighted that mesutoclax has been granted Breakthrough Therapy Designation, which will help expedite multi-center, multi-indication clinical trials for mesutoclax in China and globally to benefit patients as early as possible."

Clinical trials of mesutoclax are ongoing both in China and globally, including a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of CLL/SLL patients, as well as a clinical trial of mesutoclax for the treatment of AML.

The Breakthrough Therapy Designation (BTD) by the CDE aims to accelerate the clinical development of new drugs that demonstrate significant clinical advantages. New drugs granted BTD are typically intended for diseases that are life-threatening or severely impair quality of life, and have demonstrated clear advantages in efficacy or safety during clinical trials.

On May 11, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported preliminary clinical data for CT0596, an allogeneic BCMA-targeted CAR-T developed using the THANK-u Plus platform (Press release, Carsgen Therapeutics, MAY 11, 2025, View Source [SID1234652835]). CT0596 is currently being evaluated in an early exploratory clinical study for relapsed/refractory multiple myeloma (R/R MM) or relapsed/refractory plasma cell leukemia (R/R PCL) to assess its safety, and preliminary efficacy.

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As of May 6, 2025, 8 patients with R/R MM who had received at least three prior lines of therapy were enrolled and infused with CT0596 following lymphodepletion with the FC regimen (fludarabine 22.5-30 mg/m² and cyclophosphamide 350-500 mg/m²). Key findings from up to four months of follow-up include:

No dose-limiting toxicities (DLTs), ≥Grade 3 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GVHD) were reported. The product demonstrated a favorable safety profile, with no patients discontinuing treatment due to adverse events.
1) Among 5 patients who completed the first efficacy assessment at Week 4, 3 patients (60%) achieved stringent complete response/complete response (sCR/CR), and 4 patients (80%) achieved minimal residual disease (MRD)-negativity in the bone marrow. 2) Early efficacy data from 2 patients at Day 14 showed reductions in measurable lesions by ≥92% and ≥65%, respectively. 3) 1 patient had not yet reached the protocol-specified efficacy assessment timepoint.
All sCR/CR patients remained in ongoing responses, including the first patient who completed the four-month follow-up.
Based on the preliminary safety and efficacy data, CT0596 demonstrated favorable tolerability and encouraging efficacy signals in R/R MM patients across all predefined dose levels, with CAR-T expansion observed. These findings warrant further exploration not only in R/R MM, but also in other plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells. CARsgen plans to present detailed clinical data at upcoming scientific conferences. The company anticipates submitting an Investigational New Drug (IND) application for this product candidate in the second half of 2025.

About THANK-u Plus

CARsgen has developed the THANK-u Plus platform as an enhanced version of its proprietary THANK-uCAR allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. THANK-u Plus demonstrates sustained expansion regardless of varying NKG2A expression levels on NK cells and exhibits significantly improved expansion compared to THANK-uCAR. Preclinical studies show that THANK-u Plus delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR. Allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibit robust antitumor activity in the presence of NK cells, indicating that THANK-u Plus has broad potential for developing diverse allogeneic CAR-T therapies. CARsgen is developing allogeneic CAR-T products using THANK-u Plus platform to increase CAR T cell expansion, persistence and efficacy.

On May 9, 2025 Oncolys BioPharma reported its Non-consolidated Financial Results for the Three Months Ended March 31, 2025 (Press release, Oncolys BioPharma, MAY 9, 2025, View Source [SID1234654151]).

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