Artios Announces Oversubscribed $115 Million Series D Financing to Accelerate Clinical Programs in Indications of High Unmet Need

On November 17, 2025 Artios Pharma Limited ("Artios"), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response ("DDR") in cancer, reported the successful close of an oversubscribed $115 million Series D financing. The round was co-led by founding investor SV Health Investors and new investor RA Capital Management, with participation from new investor Janus Henderson Investors and broad support from Artios’ existing investors.

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The Series D proceeds will expand the clinical evaluation of Artios’ lead program, alnodesertib, to enroll additional ATM-negative1 patients in each of second-line pancreatic cancer and third-line colorectal cancer, for which the program was recently granted U.S. FDA Fast Track Designation. At the AACR (Free AACR Whitepaper) meeting in April 2025, Artios reported that alnodesertib, in combination with low-dose irinotecan, demonstrated a 50% confirmed overall response rate in patients with ATM-negative solid tumors at the recommended Phase 2 dose in the STELLA Phase 1/2a trial. There are currently no approved therapies specifically for patients whose tumors harbor ATM-deficiency, a population where alnodesertib has demonstrated durable responses across eight different solid tumors.

The proceeds from the financing will also be used to initiate a Phase 2 randomized clinical trial for Artios’ second potential first-in-class candidate, ART6043, in patients with BRCA-mutant HER2-negative breast cancer who are eligible to receive a PARP inhibitor. The DNA polymerase Theta (Polθ) inhibitor, ART6043, demonstrated an attractive tolerability profile, expected PK/PD activity, and promising clinical signals in data from a Phase 1/2a study presented at the ESMO (Free ESMO Whitepaper) Congress in September 2025. The company is also advancing a first-in-class and highly differentiated DDR inhibitor-Antibody Drug Conjugate (DDRi-ADC) program and expects to name a lead candidate in Q1 2026.

"This Series D accelerates our potential path to registration for both alnodesertib and ART6043, broadening development for the next generation of DNA damage response (DDR) therapeutics to indications among the highest of unmet need across pancreatic, colorectal, and breast cancers, where median survival is often measured in months," said Mike Andriole, Chief Executive Officer of Artios. "As we address these indications and prepare for others, I would like to thank our existing investors, led by SV Health, for their ongoing support, and also our new investors, RA Capital Management and Janus Henderson Investors, for joining our mission to bring these potential medicines to patients as quickly as possible."

Nikola Trbovic, Managing Partner, SV Health Investors, added, "We are thrilled to have supported Artios’ evolution, from an early-stage DDR pioneer when we founded the company to the established company it has become, distinguished by a promising and differentiated pipeline. We look forward to continuing to do so as it deploys the Series D proceeds to drive late-stage development of alnodesertib as well as its pipeline. This financing, and the recent appointment of Mike Andriole as CEO, are exciting steps in Artios’ continued growth and its transition toward becoming a commercially oriented organization."

Jake Simson, Partner, RA Capital Management, commented, "We are excited to co-lead this financing round to advance the next generation of DNA damage response therapeutics. Artios’ differentiated clinical programs, alnodesertib and ART6043, together have the potential to meaningfully expand the impact of DDR-targeted therapies. The rate and durability of responses observed to date for alnodesertib across a range of solid tumors and the early clinical results with ART6043 underscore the strength of Artios’ approach and ability to deliver novel, potentially first-in-class treatments for patients while building significant long-term value."

The investors who supported the Series D round include Andera Partners, Avidity Partners, EQT Life Sciences, Invus, IP Group plc, Janus Henderson Investors, M Ventures, Novartis Venture Fund, Omega Funds, Pfizer Ventures, Piper Heartland, RA Capital Management, Sofinnova Partners, Schroders Capital, and SV Health Investors.

(Press release, Artios Pharma, NOV 17, 2025, View Source [SID1234660013])

PRV111, in Development as the First Non-Surgical Therapy for Early-Stage Non-Invasive Oral Cancer and High-Grade Dysplasias, Meets Its Primary Efficacy Endpoint in Ongoing Phase 2/3 Trial

On November 17, 2025 Privo Technologies reported results from the CLN-004 Phase 2/3 (Cohort 1) trial evaluating PRV111, a nanoengineered, cisplatin-releasing patch for the treatment of non-invasive oral cancer and high-grade dysplasia (HGD). These conditions are common, recur frequently, and typically require repeated surgical excision, which can impair speech, swallowing, and appearance.

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In this trial, PRV111 delivered a 92% pathologic CR rate, eliminated the need for surgery in all patients, and demonstrated durable local control. Manijeh Goldberg, PhD, MBA, Founder and CEO of Privo Technologies, commented:
"The complete response rate achieved with PRV111 is among the highest reported for localized therapies in this setting. Patients typically face repeated surgical resections, which can lead to fibrosis, scar formation, and anatomic distortion that can permanently affect speech and other functionality. This non-surgical patch not only cleared the tumors but preserved native tissue function. These results reinforce PRV111’s potential to redefine the standard of care for oral precancer and early carcinoma in situs. We are one step closer to providing patients with an office-based, non-surgical alternative to repeated operative procedures."

The CLN-004 study builds upon Privo’s earlier clinical experience with PRV111 (CLN-001), which showed promising local tumor responses with no systemic toxicity in a first-in-human setting. The results of that earlier trial were published in Nature Communications and highlighted by Forbes for their innovative approach to localized cancer drug delivery.

Detailed Results:
Twelve patients with biopsy-confirmed non-invasive oral cancers or high-grade dysplasia received a single cycle of PRV111. Eleven patients achieved centrally confirmed pathologic CRs; the twelfth patient was down staged to low-grade dysplasia, eliminating the need for surgery. All treated lesions resolved, and mucosal surfaces regenerated without scarring or distortion. At a median follow-up of ~6 months, no recurrences were observed; several patients have maintained responses beyond six months, and the longest ongoing response now ~12 months. There were no systemic toxicities, dose-limiting toxicities, or treatment-related serious adverse events. Treatment-related events were primarily mild, transient oral symptoms.

Transforming the Treatment Paradigm:
Current management of non-invasive oral cancer and HGD relies on surgical excision, which is associated with high recurrence and morbidity. PRV111 is designed to deliver high concentrations of cisplatin directly into dysplastic tissue through a brief, office-based procedure, avoiding systemic side effects associated with traditional chemotherapy. This topical approach represents the first non-surgical alternative in development focused on treating this class of disease.

Next Steps:
Privo Technologies is initiating a registrational study of PRV111 in non-invasive oral cancers and high-grade dysplasias. The company will also explore PRV111 in other early malignant and premalignant lesions where non-surgical alternatives could provide significant benefits.

About PRV111:
PRV111 is a nanoengineered, polymeric topical patch designed to deliver high-dose cisplatin directly into oral lesions and adjacent mucosa while minimizing systemic exposure. The patch adheres to the lesion, achieves rapid drug permeation into dysplastic tissue and regional lymphatics, and is removed after treatment.

(Press release, Privo Technologies, NOV 17, 2025, View Source [SID1234660006])

Further endorsement of amsulostat’s potential with positive opinion for Orphan Drug Designation in the EU for myelofibrosis

On November 17, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that it has received a positive opinion on the submission of Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for its advanced clinical asset amsulostat (SNT-5505) for the treatment of myelofibrosis (MF).

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An ODD grant will provide numerous incentives for Syntara in the European Union (EU) as it develops amsulostat, including ten years market exclusivity upon approval, clinical trial protocol assistance, access to the centralised authorisation procedure in Europe, and certain fee reductions.

Amsulostat already has ODD in the US from the Food & Drug Administration (FDA) for the treatment of MF.

Myelofibrosis is a disorder in which normal bone marrow tissue is gradually replaced with a fibrous scar-like material. Over time, this leads to progressive bone marrow failure. It can occur at any age but is usually diagnosed later in life, between the ages of 60 and 70 years, with its cause remaining largely unknown.

Syntara recently announced positive top-line Phase 2a data for amsulostat in MF, with patients sub optimally controlled on ruxolitinib with 73% achieving at least a 50% reduction in total symptom score, and nearly half showing meaningful spleen volume reduction after a year of treatment. This sustained improvement in clinical measures of efficacy is backed up by excellent tolerability and no treatment-related adverse events.

Syntara has received feedback from the FDA on a recommended pathway for further development, and is progressing a design for the next trial of amsulostat.

Syntara CEO Gary Phillips commented: "Receipt of this positive opinion for Orphan Drug Desgination in the EU comes after detailed review of the amsulostat pre-clinical and clinical dossier by the EMA, providing further validation of the potential that the drug has to benefit myelofibrosis patients. We continue to engage with our advisors and regulatory authorities to design a clinical trial that leverages the product’s strong differentiating features as a well-tolerated and effective therapy. Our goal is to ensure the study design is compelling for investors and strategic partners by clearly demonstrating how amsulostat can positively impact the current standard of care."

(Press release, Syntara, NOV 17, 2025, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/42cc5d05-d389-5ba0-606c-034c87587de6/03023812.pdf [SID1234660003])

CASI Pharmaceuticals Announces Third Quarter 2025 Business and Financial Results

On November 14, 2025 CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on the development of CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, reported business and financial results for the quarter ended September 30, 2025 (the "third quarter").

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"We are focused on capitalizing and advancing our CID-103 clinical program in renal allograft antibody mediated rejection (AMR), first in the U.S. under an already approved IND, followed by China where a regulatory package has been accepted and is under review," said David Cory, CEO of CASI. "In addition, we look forward to presenting results of our ongoing Phase 1 dose-escalation study of CID-103 in chronic immune thrombocytopenia (ITP) at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 meeting on December 7."

Business Highlights

Program Updates and Upcoming Milestones

CID-103 for Antibody-Mediated Rejection (AMR) for Renal Allografts

FDA clearance of IND application

Phase 1 study in U.S. preparation ongoing

Proposed Phase 1/2 study in China — Regulatory submission under review

CID-103 for Immune Thrombocytopenia (ITP)

Phase 1 dose-escalation study enrolling and dosing at highest dose of 900 mg

Poster presentation of results at ASH (Free ASH Whitepaper) 2025 on December 7, 2025 in Orlando, FL

CID-103 Subcutaneous Formulation

Assessing multiple technologies toward a SQ delivery formulation for registration trials

Corporate

Appointed James Huang as Independent Director to Board of Directors

Appointed Barbara Krebs-Pohl as Independent Director to Board of Directors

Appointed David Cory as CEO and Director to Board of Directors

Targeting completion of divestiture of China business in Q2 2026

Third Quarter 2025 Financial Highlights

CASI raised ~ $5.7M (after commissions) from at-the-market (ATM) facility during 3Q 2025.

As of September 30, 2025, CASI total shares outstanding was 20,548,273.

Revenues for the third quarter of 2025 were $3.1 million, a 60% decrease compared to $7.8 million in the same period last year. The decrease was mainly attributable to the Company’s estimation of goods return for EVOMELA. In June 2025, the Company and China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. ("CRPCGIT"), the Company’s sole distributor for EVOMELA, entered into a modified distribution agreement, in which the Company allows CRPCGIT to return goods that are close to expiration dates and cannot be sold. The Company estimated the quantity of goods return in the future for the goods sold in this quarter, and the revenue with respect to the estimated quantity has not been recognized.

Cost of revenue for the third quarter of 2025 was $2.4 million, a 35% decrease compared to $3.7 million in the same period last year. The decrease was mainly attributable to decrease of royalty costs for EVOMELA which is in line with the decrease of revenues.

Research and development expenses for the third quarter of 2025 were $1.4 million, which is stable compared to $1.5 million in the same period last year.

General and administrative expenses for the third quarter of 2025 were $4.9 million, a 14% decrease compared to $5.7 million in the same period last year. In June 2025, CASI Pharmaceuticals (Wuxi) Co., Ltd., a Company’s wholly owned subsidiary, started its production and certain costs in the amount of $0.9 million in relation to the GMP facilities were recorded into inventory instead of general and administrative expenses since then.

Selling and marketing expenses for the third quarter of 2025 were $4.6 million, a 6% decrease compared to $4.9 million in the same period last year.

Net loss for the third quarter of 2025 was $10.9 million, compared to $8.4 million in the same period last year. The increase in net loss was mainly attributable to the decrease in revenues.

As of September 30, 2025, cash and cash equivalents of the Company was $4.7 million, compared to $13.5 million as of December 31, 2024.

Further information regarding the Company, including its Quarterly Report for the third quarter, can be found at www.casipharmaceuticals.com.

Nasdaq Non-Compliance

On May 5, 2025, Nasdaq notified the Company that its market value of listed securities (MVLS) had fallen below the minimum requirement of $35 million for 30 consecutive trading days, and as a result, did not comply with Listing Rule 5550(b)(2). The Company was provided 180 calendar days, or until November 3, 2025, to regain compliance with this rule. On November 5, 2025, the Company received a delisting determination from Nasdaq, which was made as the Company did not regain compliance for the extended compliance standard period set by Nasdaq during such 180-calendar-day grace period that ended on November 3, 2025.

The Company has already appealed this determination and requested a hearing on the matter to present a detailed plan to Nasdaq to regain compliance, seeking a further extension of grace period to comply with the Nasdaq MVLS requirement. This appeal will stay the suspension of the Company’s ordinary shares.

The Company remains committed to ensuring compliance and maintaining its Nasdaq listing.

(Press release, CASI Pharmaceuticals, NOV 14, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=6727513873403786&symbol=CASI [SID1234661703])

Entry into a Material Definitive Agreement

On November 14, 2025 Repare Therapeutics Inc. (the "Company") reported to have entered into an Arrangement Agreement (the "Agreement") with XenoTherapeutics, Inc., a Massachusetts non-profit corporation ("Xeno"), Xeno Acquisition Corp., a Delaware corporation and wholly-owned subsidiary of Xeno ("Purchaser"), and solely for purposes of Section 9.15 thereof, XOMA Royalty Corporation, a Nevada corporation ("XRC"), pursuant to which Purchaser will acquire all of the issued and outstanding common shares (the "Common Shares," and the holders of such Common Shares, the "Shareholders") of the Company (the "Transaction"). Under the terms of the Agreement, the Shareholders will receive a cash payment per Common Share (the "Cash Amount") that will be determined based upon the Company’s cash balance immediately prior to the closing of the Transaction ("Closing") after deducting certain transaction costs, the aggregate amount of outstanding liabilities, and a transaction fee to Xeno. In addition, each Shareholder will also receive one non-transferable contingent value right (each, a "CVR") for each Common Share that will entitle the holder to receive a pro rata portion of potential payments, in cash, described in, and subject to and in accordance with the terms and conditions of, the CVR Agreement (as defined and further described below). The cash payable at Closing is currently estimated to be approximately $1.82 per Common Share, exclusive of payments received pursuant to the CVR.

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The Company’s transaction committee comprised entirely of independent directors of the board of directors of the Company (the "Board," and such transaction committee, the "Transaction Committee") following receipt and review of the opinion of the Transaction Committee’s financial advisors, determined that the Arrangement (defined below) is fair to the Shareholders, and that the Arrangement is in the best interests of the Company.

The Board, after consultation with the Company’s management and legal advisors and, following the receipt and review of the unanimous recommendation from the Transaction Committee and the opinion of the Transaction Committee’s financial advisors, has unanimously approved the Transaction and determined that the Transaction is in the best interests of the Company and is fair to the Shareholders. The Board has unanimously resolved to recommend that the Shareholders vote in favor of the Transaction, subject to the terms and conditions contained in the Agreement.

The Transaction will be implemented by way of a court-approved plan of arrangement under the Business Corporations Act (Québec) (the "QBCA," and such transaction, the "Arrangement") and will require approval of at least: (i) 662⁄3% of the votes cast by the Shareholders, and (ii) a majority of the votes cast by the Shareholders excluding votes held by certain "interested parties" required to be excluded by Multilateral Instrument 61-101, at a special meeting to be held to consider the Transaction. In addition to approval by the Shareholders, the Transaction is also subject to customary closing conditions, including: (i) obtaining the necessary interim and final orders of the Superior Court of Québec; (ii) Shareholders of not more than five percent (5%) of the outstanding Common Shares of the Company having exercised rights of dissent under the QBCA in respect of the Arrangement; (iii) the accuracy of the representations and warranties made by the parties in the Agreement, subject to specified qualifications; and (iv) compliance by each of the Company and Purchaser with certain covenants under the Agreement subject to specified qualifications.

The Agreement contains representations and warranties from both the Company, on the one hand, and Xeno and Purchaser, on the other hand, customary for a transaction of this nature. The Agreement also contains customary covenants and agreements, including with respect to the operations of the business of the Company between the date of the Agreement and Closing. Pursuant to the Agreement, XRC has unconditionally and irrevocably guaranteed the full and timely performance and satisfaction of certain of Xeno and Purchaser’s obligations under the Agreement.

Subject to certain limited exceptions, during the period from the date of the Agreement through the Effective Time (as defined in the Agreement), the Company has agreed not to, directly or indirectly, solicit, initiate, propose, encourage or facilitate any inquiry, discussion, offer or request that constitutes, or would reasonably be expected to lead to an Acquisition Proposal (as defined in the Agreement), or take certain other restricted actions in connection therewith. Notwithstanding this limitation, the Company may, under certain specified circumstances, furnish information to, and participate in discussions or negotiations with, third parties with respect to an Acquisition Proposal if the Board determines in good faith, after consultation with its outside legal counsel and financial advisors, that such acquisition proposal either (i) constitutes a Superior Proposal (as defined in the Agreement) or (ii) is reasonably likely to lead to or result in a Superior Proposal.

The Agreement contains customary termination rights for Purchaser, on the one hand, and the Company, on the other hand, including, among others, for failure to consummate the Transaction on or before the Outside Date (as defined in the Agreement). If the Agreement is terminated under certain circumstances specified in the Agreement, including in connection with the Company’s entry into an agreement with respect to a Superior Proposal (as described above), the Company will be required to pay Purchaser a termination fee of $2,000,000.

Each holder of Company restricted share units and in-the-money stock options shall receive the cash amount that such holder is entitled to receive, as well as one CVR, pursuant to the terms of the Agreement.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement, a copy of which is filed as Exhibit 2.1 hereto and is incorporated herein by reference.

The Agreement has been included with this filing only to provide shareholders with information regarding its terms. It is not intended to provide any other factual information about the Company, Xeno, Purchaser, XRC or their respective subsidiaries and affiliates. The Agreement contains representations and warranties by the Company, on the one hand, and Xeno and Purchaser, on the other hand, made solely for the benefit of the other. The assertions embodied in those representations and warranties are subject to qualifications and limitations agreed to by the respective parties in negotiating the terms of the Agreement, including information in confidential disclosure schedules delivered in connection with the signing of the Agreement. Moreover, certain representations and warranties in the Agreement were made as of a specified date, may be subject to a contractual standard of materiality different from what might be viewed as material to shareholders, or may have been used for the purpose of allocating risk between the Company, on the one hand, and Xeno and Purchaser, on the other hand, rather than establishing matters as facts. Shareholders are not third-party beneficiaries under the Agreement, and should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of the parties thereto or any of their respective subsidiaries or affiliates. In addition, information concerning the subject matter of the representations and warranties may change after the date of the Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures.

Contingent Value Rights Agreement

At or prior to the time at which the Arrangement becomes effective, Xeno and Purchaser will authorize and duly adopt, execute and deliver, and will ensure that a rights agent mutually agreeable to Xeno and the Company executes and delivers, a Contingent Value Rights Agreement (the "CVR Agreement"). Each CVR will represent a contractual right to receive contingent cash payments equal to:

i.
100% of certain additional receivables that may be received by the Company within ninety (90) days following Closing (net of certain permitted deductions incurred in connection therewith);

ii.
a percentage of the net proceeds received from the Company’s existing partnerships with Bristol-Myers Squibb, Debiopharm and DCx Biotherapeutics, as follows: (i) 90% received from the Closing date until the 2nd anniversary thereof, (ii) 85% received from the 2nd anniversary of the Closing date until the 4th anniversary of the Closing date, (iii) 80% received from the 4th anniversary of the Closing date until the 6th anniversary of the Closing date, and (iv) 75% received from the 6th anniversary of the Closing date until the 10th anniversary of the Closing date;

iii.
100% of the net proceeds received by the 10th anniversary of the Closing date for any license or disposition of the Company’s product candidates and/or intellectual property related to its RP-1664 program, RP-3500 (Camonsertib) program, or any other license or disposition of the Company’s product candidates or research programs if such license or disposition is entered into prior to the Closing date; and

iv.
100% of the net proceeds received by the 10th anniversary of the Closing date for any license or disposition of the Company’s Polq program, RP-3467, to any person with whom negotiations were initiated prior to the Closing date; and

v.
50% of the net proceeds received by the 10th anniversary of the Closing date for any license or disposition of the Company’s product candidates and/or intellectual property that occurs within 10 years following the Closing date if such license or disposition is entered into following the Closing Date.

The right to the contingent payments contemplated by the CVR Agreement is a contractual right only and will not be transferable, except in the limited circumstances specified in the CVR Agreement. The CVRs will not be evidenced by a certificate or any other instrument and will not be registered with the United States Securities and Exchange Commission (the "SEC"). The CVRs will not have any voting or dividend rights and will not represent any equity or ownership interest in Xeno, any constituent corporation party to the Transaction or any of their respective affiliates. No interest will accrue on any amounts payable on the CVRs to any holders.

The form of the CVR Agreement is included as Schedule F to Exhibit 2.1 attached hereto and is incorporated herein by reference. The foregoing description of the CVR Agreement does not purport to be complete and is qualified in its entirety by reference to the full text thereof.

Voting and Support Agreements

In connection with the execution of the Agreement, Purchaser entered into voting and support agreements (the "Voting Agreements") with the Company’s officers and directors. The Voting Agreements provide that, among other things, those parties irrevocably agree (i) to vote all voting securities of the Company beneficially owned by them in favor of the approval and adoption of the Arrangement and the transactions contemplated therein and (ii) to support actions necessary to consummate the Arrangement, on the terms and subject to the conditions of such Voting Agreements. The Voting Agreements shall automatically terminate upon the earlier of (i) the Effective Time or (ii) the termination of the Agreement in accordance with their terms. The Common Shares subject to the Support Agreements comprise approximately 0.25% of the outstanding Common Shares.

The foregoing description of the Voting Agreements does not purport to be complete and is qualified in its entirety by reference to the Voting Agreements, a form of which is filed as Exhibit 10.1 hereto and is incorporated herein by reference.

(Filing, Repare Therapeutics, NOV 14, 2025, View Source [SID1234660027])