Sun Pharma to Acquire Checkpoint Therapeutics

On March 9, 2025 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) and Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) ("Checkpoint") reported that they have entered into an agreement by which Sun Pharma will acquire Checkpoint, an immunotherapy and targeted oncology company (Press release, Sun Pharma, MAR 9, 2025, View Source [SID1234651025]).

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Checkpoint is a Nasdaq-listed commercial-stage company focused on developing novel treatments for patients with solid tumor cancers. Checkpoint has received approval from the U.S. Food & Drug Administration (FDA) for UNLOXCYT (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation.

Dilip Shanghvi, Chairman & Managing Director of Sun Pharma, said, "Combining UNLOXCYT, an FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma, with Sun Pharma’s global presence means patients with cSCC may soon have access to an important, new treatment option. The acquisition further bolsters our innovative portfolio in onco-derm therapy."

"I am proud of the dedication and passion of our team at Checkpoint that allowed us to achieve the first and only FDA-approved anti-PD-L1 treatment for patients with advanced cSCC, and we are excited to enter this transaction with Sun Pharma as the next step to bringing UNLOXCYT to cSCC patients in need of a differentiated immunotherapy treatment option," said James Oliviero, President and Chief Executive Officer of Checkpoint. "Sun Pharma is aligned with Checkpoint’s commitment to improving the lives of skin cancer patients, and I believe this transaction will maximize value for our stockholders and provide accelerated access to UNLOXCYT in the United States, Europe and other markets worldwide."

Transaction Summary

Upon completion of the transaction, Sun Pharma will acquire all outstanding shares of Checkpoint and Checkpoint stockholders will receive, for each share of common stock they hold, an upfront cash payment of $4.10, without interest, and a non-transferable contingent value right (CVR) entitling the stockholder to receive up to an additional $0.70 in cash, without interest, if cosibelimab is approved prior to certain deadlines in the European Union pursuant to the centralized approval procedure or in Germany, France, Italy, Spain or the United Kingdom, subject to the terms and conditions in the contingent value rights agreement.

The upfront cash payment of $4.10 per share of common stock represents a premium of approximately 66.0% to Checkpoint’s closing share price on March 7, 2025, the last trading day prior to today’s announcement.

In connection with the transaction, Checkpoint, Sun Pharma and Fortress Biotech, Inc., Checkpoint’s controlling stockholder ("Fortress"; Nasdaq: FBIO), have entered into a royalty agreement, under which following the closing of the transaction Fortress would be entitled to receive royalty payments based on future sales of cosibelimab during a specified term, in lieu of royalty rights that were granted to Fortress in connection with its founding of Checkpoint.

In connection with the evaluation of Checkpoint’s strategic alternatives, the Checkpoint board of directors (the "Board") formed a special committee of independent and disinterested directors (the "Special Committee"), which led the review and negotiations for this transaction. The Special Committee, with the assistance of its independent financial and legal advisors, conducted a comprehensive review of potential strategic alternatives available to Checkpoint and ultimately determined that the compelling and certain cash consideration and meaningful upside presented by the CVRs in this transaction provides superior risk-adjusted value relative to Checkpoint’s standalone prospects and other available alternatives. The Special Committee unanimously approved, and recommended that Checkpoint’s Board approve, the proposed transaction. After considering this recommendation, Checkpoint’s Board unanimously approved the proposed transaction. In arriving at its unanimous recommendation in favor of the transaction, the Special Committee considered several additional factors which will be outlined in public filings to be made by Checkpoint.

The transaction is expected to be completed in the second calendar quarter of 2025. The transaction is subject to customary closing conditions, including required regulatory approvals and approval by the holders of a majority of the voting power of outstanding shares of Checkpoint common stock, and by the holders of a majority of the shares of Checkpoint common stock that are not held by Fortress or by certain other affiliates of Checkpoint.

For the nine-month period ending September 2024, Checkpoint reported $0.04 million in revenue and a net loss of $27.3 million. The R&D expense for the nine-month period was $19.3 million. As of September 30, 2024, Checkpoint had a cash balance of $4.7 million, outstanding accounts payable and accrued expenses of $15.6 million, and outstanding accounts payable and accrued expenses – related party of $2.0 million.

In connection with the transaction, Fortress, which holds a majority of Checkpoint’s outstanding voting power, has agreed to vote in favor of the transaction.

Advisors

Barack Ferrazzano Kirschbaum & Nagelberg LLP and Allen Overy Shearman Sterling US LLP are serving as legal advisors to Sun Pharma.

Locust Walk is serving as the exclusive financial advisor to Checkpoint and lead financial advisor to Checkpoint on the transaction.

Cooley LLP and Morris, Nichols, Arsht & Tunnell LLP are serving as legal advisors to the Special Committee. Kroll, LLC is serving as financial advisor to the Special Committee.

Alston & Bird LLP is serving as legal advisor to Checkpoint.

About Cutaneous Squamous Cell Carcinoma

cSCC is the second-most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, each year approximately 40,000 cases become advanced and an estimated 15,000 people in the United States die from this disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region, and that invade blood vessels, nerves and vital organs, such as the eye or ear.

STADA’s growth journey continues in 2024 – Significant increase in sales and profits – Growing ahead of the market

On March 7, 2025 STADA, a leading healthcare and pharmaceutical company in Consumer Healthcare, Generics and Specialty pharmaceuticals, reported the company continued its profitable growth journey in 2024 (Press release, Stada, MAR 7, 2025, View Source [SID1234654338]). STADA again outperformed market sales growth in all three business segments – supported by its strong commercial network in Europe, and complemented by a growing presence in the MENA, Eurasia and Asia-Pacific regions. Group sales grew by 9% to € 4.059 billion versus the 2023 financial year. At the same time, earnings before interest, taxes, depreciation and amortization, adjusted for special items and currency effects, (adj. cc EBITDA) rose by 11% to € 886 million, while the adj. cc EBITDA margin increased further to 21.8%.

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"We have again in 2024 demonstrated our ability to continue growing faster than the market in all business segments. This is based on our entrepreneurial culture, our broad range of brands, our reliable production network, and the high level of trust we enjoy among our partners and customers," commented CEO Peter Goldschmidt.

STADA’s corporate culture has changed fundamentally in recent years. "At STADA, our culture drives performance. Our purpose of Caring for People’s Health as a Trusted Partner, underpinned by our values and vision, gives us a clear direction and a drive constantly to deliver ahead of the market," explained Goldschmidt. This is reflected in the outstanding results in the group’s employee survey, which in November 2024 found that 84% of employees are proud to work for STADA. As part of the evaluation by the independent Top Employers Institute, STADA was recognized as a "Top Employer 2025 Europe" for the fourth time in a row.

Akeso Announces The Publication of Its Phase III Clinical Trial Results for Ivonescimab in Head-to-Head Comparison with Pembrolizumab in The Lancet

On March 7, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the groundbreaking results of the Phase III clinical study (HARMONi-2/AK112-303) of its first-in-class PD-1/VEGF bispecific antibody, ivonescimab, as a monotherapy compared to pembrolizumab monotherapy in the first-line treatment of PD-L1 positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC) have been published in The Lancet (Press release, Akeso Biopharma, MAR 7, 2025, View Source [SID1234651020]).

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The Lancet is a prestigious international medical journal, and the publication of the HARMONi-2 study results in The Lancet is a strong recognition by the academic community to the breakthrough clinical potential of ivonescimab. Previously, clinical research on using ivonescimab for the treatment of various malignant tumors has been published in renowned international medical journals such as JAMA, Journal of Thoracic Oncology, eClinical Medicine (a sub-journal of The Lancet), and Drugs.

At the 2024 World Conference on Lung Cancer (WCLC), the results of the HARMONi-2 study were presented as an oral report by the principal investigator of the study, Professor Zhou Caicun, a renowned oncology expert who is the President-Elect of IASLC, and the director of the Department of Oncology at the Shanghai East Hospital, Tongji University.

The HARMONi-2 study demonstrated that in the intent-to-treat population, ivonescimab monotherapy significantly extended progression-free survival (PFS) compared to pembrolizumab monotherapy, reducing the risk of disease progression by 49% (PFS HR 0.51, P<0.0001). Subgroup analyses revealed that regardless of patients’ age, gender, ECOG performance status, PD-L1 expression, histological type, or the presence of liver or brain metastases, the ivonescimab group showed significant improvement in efficacy compared to the pembrolizumab group. The ivonescimab HARMONi-2 study is the world’s first randomized, double-blind, controlled Phase III clinical trial to achieve significantly positive results compared to pembrolizumab.

Based on these promising results, the sNDA for ivonescimab monotherapy as a first-line treatment for PD-L1 positive NSCLC is under review with priority status in China. Ivonescimab in combination with chemotherapy for EGFR-TKI-resistant non-squamous NSCLC, has already been approved and included in the 2024 China National Reimbursement Drug List. The growing body of clinical evidence from multiple Phase II and Phase III studies continues to validate ivonescimab’s efficacy benefit and safety profile. These results are often published in major international conferences and in top-tier journals, providing oncologists strong scientific basis for treatment decisions.

Akeso has strategically positioned ivonescimab within a comprehensive development plan, aiming to reshape the landscape of cancer immunotherapy and establish a new global standard of care. Ivonescimab, in combination with chemotherapy, has been approved in China for the treatment of EGFR-TKI-resistant, non-squamous NSCLC. The New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC (in comparison to pembrolizumab) is currently under review and has been granted priority status in China.

Three international multicenter Phase III clinical trials, led by our partner Summit Therapeutics, are progressing efficiently or are being initiated:

The HARMONi study, an international multicenter Phase III clinical trial evaluating ivonescimab in combination with chemotherapy for non-squamous NSCLC with progression after third-generation EGFR-TKI treatment, has had patient enrollment completed and has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA),
The HARMONi-3 study, an international multicenter Phase III clinical trial comparing ivonescimab combined with chemotherapy as first-line treatment for both squamous and non-squamous NSCLC (versus pembrolizumab combined with chemotherapy),
The HARMONi-7 study, an international multicenter Phase III clinical trial evaluating ivonescimab monotherapy as first-line treatment for PD-L1 high-expressing NSCLC (versus pembrolizumab).
Several Phase III clinical trials are progressing efficiently or are being initiated in China, including:

Ivonescimab combined with chemotherapy as first-line treatment for squamous NSCLC (vs. tislelizumab combined with chemotherapy, HARMONi-6/AK112-306),
Ivonescimab combined with chemotherapy as first-line treatment for biliary tract cancer (vs. durvalumab combined with chemotherapy, HARMONi-GI1/AK112-309),
Ivonescimab combined with AK117 (CD47) as first-line treatment for PD-L1 positive head and neck squamous cell carcinoma (vs. pembrolizumab, SOLO-10/AK117-302),
First-line treatment for triple-negative breast cancer (HARMONi-BC1/AK112-308).

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On March 7, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the grants of inducement restricted stock units ("RSUs") to 7 new employees in connection with their employment with UroGen (Press release, UroGen Pharma, MAR 7, 2025, View Source [SID1234651018]). These new team members will support the ongoing commercialization of Jelmyto (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

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Up to 18,500 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs. The RSUs will vest equally over three years, with one-third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU grant notice and agreement thereunder. The RSUs were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq Listing Rule 5635(c)(4).

RAPT Therapeutics to Participate in Upcoming Investor Conferences

On March 7, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported that members of the RAPT management team will participate in the following investor conferences in March (Press release, RAPT Therapeutics, MAR 7, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-participate-upcoming-investor-conferences-0 [SID1234651017]):

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Leerink Global Healthcare Conference – Fireside chat on Tuesday, March 11, 2025 at 3:40 p.m. ET
Barclays 27th Annual Global Healthcare Conference – Fireside chat on Wednesday, March 12, 2025 at 10:30 a.m. ET

To access the live webcasts or subsequent archived recordings of the discussions, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.