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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On March 9, 2025, Checkpoint Therapeutics, Inc., a Delaware corporation ("Checkpoint" or the "Company"), reported to have entered into an Agreement and Plan of Merger (the "Original Merger Agreement") with Sun Pharmaceutical Industries, Inc., a Delaware corporation ("Sun Pharma" or "Parent"), and Snoopy Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Parent ("Merger Sub") (Filing, Checkpoint Therapeutics, MAR 9, 2025, View Source [SID1234651933]). The Original Merger Agreement provides that, on the terms and subject to the conditions set forth in the Original Merger Agreement, Parent, Merger Sub and the Company will effect a merger of Merger Sub with and into the Company (the "Merger"), with the Company continuing as the surviving corporation of the Merger and a wholly owned subsidiary of Parent. Capitalized terms used but not otherwise defined herein shall have the meaning ascribed to such terms in the Original Merger Agreement.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On April 14, 2025, the Company, Parent and Merger Sub entered into an Amendment to the Original Merger Agreement (the "Merger Agreement Amendment" and the Original Merger Agreement, as amended by the Merger Agreement Amendment, the "Merger Agreement"). Pursuant to the Merger Agreement Amendment, the definition of "Company Required Vote" is revised to mean "(a) the affirmative vote of a majority of the votes cast at a duly convened meeting of the Company Stockholders by the Unaffiliated Company Stockholders and (b) the affirmative vote of the holders of a majority in voting power of the outstanding Company Common Stock, in the case of each of clause (a) and (b), in favor of the adoption of this Agreement."

Other than as expressly set forth in the Merger Agreement Amendment, the Original Merger Agreement remains unmodified and in full force and effect in accordance with its terms.

A special committee (the "Special Committee") of independent and disinterested members of the Company’s board of directors (the "Company Board") unanimously adopted resolutions recommending that the Company Board approve, adopt and declare advisable the Merger Agreement and submit to the Company’s stockholders, and recommend the adoption by the Unaffiliated Company Stockholders of, the Merger Agreement. Thereafter, the Company Board unanimously authorized and approved the Merger Agreement Amendment and recommended that the stockholders of the Company adopt the Merger Agreement. The Special Committee unanimously determined that the Merger Agreement and the transactions contemplated thereby are advisable, fair to and in the best interests of the Company and the Unaffiliated Company Stockholders. Upon the Special Committee’s recommendation, the Company Board determined that the Merger Agreement and the transactions contemplated thereby are advisable, fair to and in the best interest of the Company and its stockholders.

The foregoing description of the Merger Agreement Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Merger Agreement Amendment, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and the full text of the Original Merger Agreement, a copy of which is attached as Exhibit 2.1 to Checkpoint’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission (the "SEC") on March 10, 2025, each of which is incorporated herein by reference. A copy of the Merger Agreement Amendment has been included to provide Company stockholders and other security holders with information regarding its terms and is not intended to provide any factual information about the Company, Parent, Merger Sub or their respective affiliates. The representations, warranties and covenants contained in the Merger Agreement have been made solely for the purposes of the Merger Agreement and as of specific dates; were made solely for the benefit of the parties to the Merger Agreement; are not intended as statements of fact to be relied upon by Company stockholders or other security holders, but rather as a way of allocating the risk between the parties in the event the statements therein prove to be inaccurate; have been modified or qualified by certain confidential disclosures that were made between the parties in connection with the negotiation of the Merger Agreement, which disclosures are not reflected in the Merger Agreement itself; may no longer be true as of a given date; and may apply standards of materiality in a way that is different from what may be viewed as material by Company stockholders or other security holders. Company stockholders and other security holders are not third-party beneficiaries under the Merger Agreement (except, following the Effective Time, with respect to Company stockholders’ right to receive the Merger Consideration and the right of holders of Company equity awards and Company Warrants to receive the consideration provided for such securities pursuant to the Merger Agreement) and should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company, Parent, Merger Sub or their respective affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Merger Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures. The Company acknowledges that, notwithstanding the inclusion of the foregoing cautionary statements, it is responsible for considering whether additional specific disclosures of material information regarding material contractual provisions are required to make the statements in this Form 8-K not misleading. Notwithstanding the foregoing, information concerning the subject matter of the representations and warranties may change after the date of the Merger Agreement, and unless required by applicable law, Checkpoint undertakes no obligation to update such information.

The Merger Agreement should not be read alone but should instead be read in conjunction with the other information regarding the Merger Agreement, the Merger, the Company, Parent, Merger Sub, their respective affiliates and their respective businesses, that will be contained in, or incorporated by reference into, the proxy statement that the Company will file in connection with the transactions contemplated by the Merger Agreement, as well as in the Forms 10-K, Forms 10-Q, Forms 8-K and other filings that the Company will make with the Securities and Exchange Commission.

On March 7, 2025 Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, reported the appointment of Abbas Kazimi, MS, as Chief Executive Officer and a member of the Board of Directors, effective immediately (Press release, Nimbus Therapeutics, MAR 7, 2025, View Source [SID1234651013]). He succeeds Jeb Keiper, MS, MBA, who has stepped down from the position as part of a planned transition.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to announce the next chapter in leadership at Nimbus. The board is unanimous in its support of Abbas, who has been a critical leader in the last decade of success at Nimbus. With the recent appointment of Peter Tummino, Ph.D., as President of R&D and the strong leadership team in place, we are confident Abbas will continue to deliver on the company’s mission to bring breakthrough medicines to patients," said Bruce Booth, D. Phil., Nimbus’ Chairman of the Board of Directors and co-founder. "We thank Jeb for his passion and leadership in driving the accomplishments Nimbus has achieved to date and have immense respect for what he has done to build the Nimbus we know today."

"After spending over a decade at Nimbus, I couldn’t be more proud of the incredible team we’ve built and our evolution into a world-class small molecule discovery and early development powerhouse," said Mr. Keiper. "In this next phase of growth, I can think of no better leader than Abbas, who has led this team in creating an incredibly valuable biotech company. I look forward to seeing Nimbus continue to advance its promising pipeline under his leadership while I pursue time with my family, biotech boards, and philanthropies that impact our industry."

Mr. Kazimi joined Nimbus in 2014 and has served as Chief Business Officer since 2020. During his tenure, he has helped drive key transactions resulting in over $7 billion in upfront and milestone capital from pharmaceutical partners, including the TYK2 sale to Takeda in 2022. He also has been responsible for expanding Nimbus’ computational drug discovery engine through technology alliances that complement the company’s deep expertise in structure-based drug discovery and medicinal chemistry.

"I am honored to lead Nimbus at this pivotal time in the company’s evolution," said Mr. Kazimi. "Our robust pipeline, anchored by promising programs like our WRN and SIK inhibitors, and our ongoing collaboration with Lilly, continues to validate our approach and strengthen our position in the industry. I’m particularly excited about what Nimbus will continue to discover and advance, as we leverage our computational drug discovery engine to bring innovative medicines for patients."

On March 7, 2025 Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to ITM), reported to unveil its innovative AI-assisted drug discovery engine, Hu-mAtrIxTM (Press release, Nona Biosciences, MAR 7, 2025, View Source [SID1234651014]). This new platform, powered by advanced artificial intelligence, integrates seamlessly with the company’s proprietary Harbour Mice technology platform, aiming to accelerate antibody discovery across multiple key therapeutic areas, including neurodegenerative and metabolic diseases, and more.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Nona’s cutting-edge technology platform enables a fully integrated antibody discovery from protein design and single cell-based antibody screening to next-generation sequencing, antibody modeling and engineering. The Hu-mAtrIxTM platform is designed to significantly shorten discovery timelines, increase efficiency, and improve the overall success rate of antibody drug development by introducing a creative paradigm of antibody discovery empowered by AI and automation technologies.

Hu-mAtrIxTM offers integrated solutions to identify the best antibodies with high efficiency. It allows the exploration of large libraries of human antibody sequences to identify the best sequence with the desired target specificity and binding affinity. Furthermore, it can predict the key antibody properties such as stability, manufacturability and immunogenicity, mitigating development risks in the early stages of discovery.

In addition, Nona Biosciences is developing a new AI model to expand its core technology platform HCAb PlusTM. The new model leverages the unique capabilities of its HCAb Harbour Mice, the industry’s leading fully human heavy-chain-only transgenic mouse platform, and the proprietary HCAb dataset, to push the boundaries of antibody discovery, enabling the identification of rare, highly specific antibodies with greater precision and efficiency.

"We are excited to introduce the Hu-mAtrIxTM platform, an assistant tool to complement and enhance our existing antibody discovery solutions," said Dr. Jingsong Wang, Chairman of Nona Biosciences. "By combining our proprietary Harbour Mice with the power of AI, we are addressing key challenges in drug discovery—reducing time-to-market, increasing the likelihood of successful candidates, and providing our partners with more targeted therapeutic options."

On March 7, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported on highlights and financial results for Q4 and year-end 2024 (Press release, Oncolytics Biotech, MAR 7, 2025, View Source [SID1234651015]). With its lead candidate, pelareorep, demonstrating strong efficacy signals in breast, pancreatic, and anal cancer, the company is strategically advancing toward registrational studies that could redefine treatment landscapes in multiple high-need indications. All dollar amounts are expressed in Canadian currency unless otherwise noted.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics. Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy," said Wayne Pisano, Chair of Oncolytics’ Board of Directors and Interim CEO. "We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission. When adding pancreatic and anal carcinoma to the list of addressable indications where we have generated compelling efficacy signals, pelareorep could have a meaningful impact for a multitude of patients and generate value for our shareholders."

Fourth Quarter and Subsequent Highlights

GOBLET gastrointestinal cancer data continue to demonstrate pelareorep’s potential across multiple indications. Oncolytics presented two posters at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in San Francisco in January (link to the PR).
•Promising Data in Anal Cancer with 33% Response Rate, Including a Durable 15+ Month Complete Response: In the ongoing GOBLET study, Oncolytics’ pelareorep combination therapy achieved a 33% objective response rate (ORR), including a complete response lasting over 15 months, in twelve evaluable patients with second-line or later unresectable squamous cell carcinoma of the anal canal treated with pelareorep and atezolizumab (link to the poster). This encouraging signal in a very tough-to-treat disease further supports pelareorep’s potential in solid tumors. The success criteria in Stage 1 of this Simon two-stage design were previously met; enrollment into Stage 2 of this cohort has begun and will add 18 additional evaluable patients. Data from Stage 2 is expected to determine if there is an efficacy signal sufficient to proceed to a registration-enabling study.
•Encouraging Progress in Pancreatic Cancer Cohort with Safety Milestone Cleared: GOBLET Cohort 5, with funding from the Pancreatic Cancer Action Network (PanCAN), is treating newly diagnosed metastatic pancreatic ductal adenocarcinoma patients with pelareorep + modified FOLFIRINOX with and without atezolizumab. The protocol-specified safety run-in phase has been completed, and the results were presented at the ASCO (Free ASCO Whitepaper) GI meeting in January of this year (link to the poster). Following a review of the safety run-in data, an independent Data Safety Monitoring Board recommended that the study continue, and the Paul Ehrlich Institute (PEI), Germany’s medical regulatory body, approved this recommendation. Accordingly, enrollment into Stage 1 of this Simon two-stage study, consisting of 30 evaluable patients, has resumed and is ongoing.

Ongoing plans to initiate a registration-enabling study in HR+/HER2- metastatic breast cancer. Oncolytics continues to engage with regulators, key opinion leaders, and other relevant stakeholders to finalize the clinical plan for and initiate a large phase 2 study that has the potential to be registration-enabling. We expect a progression-free survival (PFS) readout approximately two years after enrollment begins. The final BRACELET-1 data showed robust improvements for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy in terms of PFS, overall survival (OS), 24-month OS rate, and confirmed objective response rate (link to the PR). These data substantiate the results from IND-213, in which median overall survival was nearly doubled in HR+/HER2- metastatic breast cancer patients who received pelareorep combined with paclitaxel compared to paclitaxel alone. If a PFS benefit comparable to the results seen in BRACELET-1 is observed in the registration-enabling study, the company expects to file for accelerated approval with the FDA.

Financial Highlights

•As of December 31, 2024, the Company reported $15.9 million in cash and cash equivalents. The Company has a projected cash runway through key milestones and into the third quarter of 2025.

•The net loss for the fourth quarter of 2024 was $8.0 million, compared to a net loss of $3.9 million for the fourth quarter of 2023. The basic and diluted loss per share was $0.10 in the fourth quarter of 2024, compared to a basic and diluted loss per share of $0.05 in the fourth quarter of 2023.

•Research and development expenses for the fourth quarter of 2024 were $4.6 million, compared to $4.7 million for the fourth quarter of 2023. The decrease was primarily attributable to lower personnel-related expenses related to lower cash annual short-term incentive awards. This decrease was partially offset by increased expenditures related to our clinical trials and share-based compensation expense.

•General and administrative expenses for the fourth quarter of 2024 were $3.9 million, compared with $4.2 million for the fourth quarter of 2023. The decrease was primarily due to lower personnel-related expenses and lower cash annual short-term incentive awards. The decrease was partly offset by higher share-based compensation expense.

•Net cash used in operating activities for the twelve months ended December 31, 2024, was $27.0 million, compared to $28.4 million for the twelve months ended December 31, 2023. The decrease reflected non-cash working capital changes, partly offset by higher net operating activities in 2024.

Anticipated Milestones

•H1 2025: Finalize protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA
•H2 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in advanced or metastatic HR+/HER2- breast cancer
•H2 2025: Initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer

Webcast and Conference Call

Management will host a conference call for analysts and investors at 8:30 a.m. ET today, March 7, 2025. To access the call, please dial (888) 510-2154 (North America) or (437) 900-0527 (International), and if needed, provide Conference ID: 48422. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 48422#.