On May 15, 2023, Emergent BioSolutions Inc. (the "Company") reported to have entered into that certain Fourth Amendment to Amended and Restated Credit Agreement, Waiver and First Amendment to Amended and Restated Collateral Agreement (the "Credit Agreement Amendment"), among the Company, as borrower, certain subsidiaries of the Company, as guarantors, Wells Fargo Bank, National Association, as administrative agent (in such capacity, the "Administrative Agent") and certain lenders party thereto (Filing, 8-K, Emergent BioSolutions, May 15, 2023, View Source [SID1234631842]). The Credit Agreement Amendment amends the Amended and Restated Credit Agreement, dated as of October 15, 2018, among the Company, the lenders party thereto from time to time and the Administrative Agent (as previously amended, modified and supplemented, the "Existing Credit Agreement"), relating to the Company’s senior secured credit facilities consisting of a senior revolving credit facility (the "Revolving Credit Facility") and a senior term loan facility (the "Term Loan Facility" and together with the Revolving Credit Facility, the "Senior Secured Credit Facilities").

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The Credit Agreement Amendment amends the Existing Credit Agreement to, among other things, (a) extend the maturity date of the Senior Secured Credit Facilities from October 13, 2023 to May 15, 2025, (b) reduce the available commitments under the Revolving Credit Facility from $600.0 million to $300.0 million, (c) remove the Company’s ability to incur incremental loans and (d) amend certain mandatory prepayment triggers, affirmative covenants, negative covenants and events of default thereunder. In connection with the Credit Agreement Amendment, the Company used the approximately $270.0 million of proceeds from the previously announced sale of its travel health business to Bavarian Nordic, which closed on May 15, 2023, together with approximately $217.2 million of cash on hand, to repay approximately $144.4 million in outstanding principal amount of loans under the Term Loan Facility and $342.8 million outstanding principal amount of loans under the Revolving Credit Facility.

The Credit Agreement Amendment also (w) amends the consolidated debt service coverage ratio financial covenant to require the minimum level to be 2.25 to 1.00 for the fiscal quarters ending March 31, 2024, June 30, 2024, September 30, 2024 and December 31, 2024, and then 2.50 to 1.00 for each fiscal quarter ending thereafter, (x) amends the consolidated leverage ratio to require the maximum level to be 4.50 to 1.00 for the fiscal quarter ending March 31, 2024 and each fiscal quarter ending thereafter, (y) adds minimum Consolidated EBITDA requirements and maximum capital expenditure requirements for each of the months ending April 30, 2023 through February 29, 2024 and a minimum liquidity requirement as of the end of each calendar month and (z) requires the Company to increase its liquidity by April 30, 2024 by raising at least $75.0 million of equity or unsecured indebtedness.

In addition, the Credit Agreement Amendment replaces the interest rate benchmark such that borrowings under the Revolving Credit Facility and the outstanding principal amount of the Term Loan Facility shall bear interest at a rate per annum equal to (a) a rate based on SOFR, EURIBOR or CDOR plus a margin of 6.00% until March 31, 2024 and thereafter, a margin ranging from 2.75% to 4.00% depending on the Company’s consolidated leverage ratio, or (b) a base rate (which is the highest of the prime rate, the federal funds rate plus 0.50%, and a SOFR rate for an interest period of one month plus 1%) plus a margin of 5.00% until March 31, 2024 and thereafter, a margin ranging from 1.75% to 3.00% depending on the Company’s consolidated leverage ratio. In addition, the commitment fee the Company is required to pay in respect of the annual daily unused commitments under the Revolving Credit Facility shall be 0.15% to 0.40% per annum, depending on the Company’s consolidated leverage ratio.

Under the Credit Agreement Amendment, the Company and the other guarantors have also agreed to provide a lien over certain assets as additional collateral for the benefit of the lenders, including owned real property, equity interests of foreign subsidiaries and certain deposit accounts.

The foregoing description of the Credit Agreement Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Credit Agreement Amendment, a copy of which is filed herewith as Exhibit 10.1 and is incorporated herein by reference. The Credit Agreement Amendment contains representations, warranties and covenants that were made only for purposes of such agreement and as of specific dates, that are solely for the benefit of the parties to such agreement, and that may be subject to limitations agreed upon by the contracting parties. The Credit Agreement Amendment is not intended to provide investors and the public with factual information about the Company’s current state of affairs. Rather, investors and the public should look to other disclosures contained in the Company’s filings with the U.S. Securities and Exchange Commission (the "SEC").

At-the-Market Equity Offering Facility

On May 17, 2023, the Company entered into an Equity Distribution Agreement (the "Distribution Agreement") with Evercore Group L.L.C. and RBC Capital Markets, LLC (together, the "Managers"), as sales agents, under which the Company may offer and sell its common stock, par value $0.001 per share, from time to time having an aggregate offering price of up to $150,000,000 (the "Shares") during the term of the Distribution Agreement through the Managers. The Company will file a prospectus supplement relating to the offer and sale of the Shares pursuant to the Distribution Agreement, which will form a part of the Company’s Registration Statement on Form S-3 (File No. 333-258634), which was initially filed with the SEC and became automatically effective on August 9, 2021.

Under the Distribution Agreement, the Company will set the parameters for the sale of the Shares, including the number of shares to be issued, the time period during which sales are requested to be made and any minimum price below which sales may not be made. Subject to the terms and conditions of the Distribution Agreement, the Managers will use commercially reasonable efforts to sell

the Shares by methods deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made directly on the New York Stock Exchange or any other trading market for the Company’s stock. The Company will pay the Managers a commission of up to 3.0% of the aggregate gross proceeds of any Shares sold by the Managers, if any.

The Company is not obligated to sell any Shares pursuant to the Distribution Agreement. The Distribution Agreement contains customary representations, warrantees and agreements between the Company and the Managers, including customary indemnification rights, including for liabilities under the Securities Act. The offering of Shares pursuant to the Distribution Agreement will terminate upon the termination of the Distribution Agreement in accordance with its terms. The Company and the Managers may terminate the Distribution Agreement at any time by providing each other with written notice.

The foregoing summary of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Distribution Agreement, a copy of which is filed as Exhibit 10.1 hereto and is incorporated herein by reference. The Distribution Agreement contains representations, warranties and covenants that were made only for purposes of such agreement and as of specific dates, that are solely for the benefit of the parties to such agreement, and that may be subject to limitations agreed upon by the contracting parties. The Distribution Agreement is not intended to provide investors and the public with factual information about the Company’s current state of affairs. Rather, investors and the public should look to other disclosures contained in the Company’s filings with the SEC.

The legal opinion of Covington & Burling LLP relating to the Shares is filed herewith as Exhibit 5.1.

On May 15, 2023 Therapeutic Solutions International (TSOI) spin-off Res Nova Bio announced today a collaboration with Cure Stat Rx, a premiere compounding Pharmacy in the manufacture of initiate doses of FloraStilbene for a planned 12 patient Phase I/II trial aimed at assessing immunomodulatory activity of the drug candidate in advanced breast cancer patients (Press release, Therapeutics Solutions International, MAY 15, 2023, View Source [SID1234631761]).

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The Company previously announced Institutional Review Board clearance to initiate the clinical trial. As part of the collaboration, Ramesh Chigurupati, President of Cure Stat Rx has joined the Advisory Board of Res Nova.

"I am honored to partner with Chigurupati and the team at Cure Stat Rx who have second-to-none expertise in compounding and drug formulation across a range of therapeutic indications," said Famela Ramos, President, and CEO of Res Nova Bio. "Based on our preclinical and pilot clinical data, we are confident that our proposed Phase I/II trial will support the use of FloraStilbene as an immune enhancer in general and specifically a stimulator of natural killer cell activity in advanced cancer patients."

"I have worked with Chigurupati for many years in delivering personalized medicine to patients," said Dr. James Veltmeyer, Chief Medical Officer of Res Nova. "Having seen first-hand the potent therapeutic effects of the Res Nova immunotherapy product ValloVax, I look forward to working with Cure Stat Rx to translate FloraStilbene into the clinical domain."

Cure Stat Rx is an accredited compounding pharmacy specializing in cancer treatments. Cure Stat Rx clinical and compounding staff is knowledgeable and well trained in immuno-oncology.

"Despite significant advances in cancer immunotherapy, many approaches do not induce responses because patients have low immune responses to begin with. By leveraging the significant body of work developed by TSOI in the area of pterostilbene and immuno-oncology, it is exciting to watch how rapidly Famela Ramos and her team are moving towards treating patients with this first in class approach," said Timothy Dixon, President, and CEO of Therapeutic Solutions International and Chairman of Res Nova Bio.

On May 15, 2023 Investigators from Baylor College of Medicine (BCM) in collaboration with Immunai reported to have published results from a clinical study in which Immunai’s technology helped identify BTG1 as a novel molecular target that can be used to enhance the potency of natural killer T (NKT)- and T cell-based cancer immunotherapy (Press release, Immunai, MAY 15, 2023, View Source [SID1234631760]). The study was published today in Nature Medicine.

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As part of this collaboration, Immunai leveraged its advanced multi-omics platform to analyze clinical samples from an ongoing trial conducted at BCM. These studies led to the identification of BTG1 as a novel driver of NKT cell hyporesponsiveness that can be targeted to enhance CAR-NKT cell anti-tumor function. This discovery has the potential to improve the ability of NKT and T cell therapy products to target and eliminate malignant cells.

BCM conducted extensive in vitro and in vivo studies to validate the superior anti-tumor activity of CAR-NKT cells modified to target BTG1, demonstrating the potential of this approach for use as a cutting-edge therapy. Importantly, CAR-NKT cells genetically modified to target BTG1 were able to overcome exhaustion, a major obstacle for developing effective cell therapy products.

This breakthrough is significant as it opens the door to more effective and targeted immunotherapies to treat a range of malignancies and other diseases. By combining Immunai’s expertise in multi-omics platforms with BCM’s research capabilities, the collaboration has paved the way for innovative treatment options that could improve patient outcomes worldwide.

"This project highlights Immunai’s platform capabilities in discovering and improving therapeutics, applicable to diverse types of cell therapies and other immune modulating therapies within oncology and inflammatory diseases," said Noam Solomon, CEO of Immunai. "Immunai has been committed from the beginning to developing its cutting-edge platform to deliver actionable therapeutic insights that have the potential to transform patients’ lives, and our work with BCM is also a great reflection of our commitment to improving clinical outcomes with our partners."

"Effectively harnessing knowledge from precious patient samples poses a paramount challenge in clinical research. The state-of-the-art single-cell RNA sequencing technology developed by Immunai allowed us to accurately measure gene expression changes in thousands of individual CAR-NKT cells before and after infusion into patients. The discoveries made during BCM and Immunai’s productive collaboration have already resulted in two Nature Medicine publications in less than three years and informed the development of more effective cancer immunotherapy," said Dr. Leonid Metelitsa, Director, Center for Advanced Innate Cell Therapy at Texas Children’s Hospital and Baylor College of Medicine.

The study was made possible through a long-standing collaboration between the two organizations structured around joint IP ownership, highlighting the power of combining industry-leading technology with top-tier academic research.

On May 15, 2023 BiOneCure Therapeutics, Inc. reported a strategic collaboration with Nanjing Leads Biolabs to develop a range of innovative anti-drug conjugates (ADCs) for treating solid tumors (Press release, BiOneCure Therapeutics, MAY 15, 2023, View Source [SID1234631759]). BiOneCure is a clinical-stage biopharmaceutical company dedicated to developing next-generation ADCs, while Leads Biolabs is a clinical-stage biotech focused on the research, development, and commercialization of next-generation tumor immunotherapy antibody drugs.

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"We are excited to collaborate with Leads Biolabs to develop ADC drugs," said Dr. Haifeng Bao, CEO of BiOneCure. "Through this collaboration, we aim to accelerate innovation and development in the ADC field and provide better treatment options for patients."

BiOneCure has developed several proprietary ADC payload-linker platforms, and its first product, BIO-106, an anti-Trop-2 ADC, is currently in a Phase I clinical study. Meanwhile, Leads Biolabs has established a rich portfolio of more than 20 novel mono- or bispecific antibody drug projects to fulfill unmet medical needs. The two companies’ technologies are highly complementary, making this a promising win-win collaboration that will significantly promote the R&D and product development capabilities of both parties.

"We believe that BiOneCure has leading ADC technology platforms, and their ADC molecule is in the clinical stage," said Dr. Xiaoqiang Kang, founder and chairman of Leads Biolabs. "Leads Biolabs is a clinical-stage antibody new drug company, with multiple antibody technology platforms. We are convinced that this collaboration will greatly expand the innovative R&D capabilities of both parties."

On May 15, 2023 Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing transformative biologic medicines for hard-to-treat diseases, reported that it has entered into a clinical trial collaboration and supply agreement with Merck to evaluate HMBD-001 in combination with cetuximab in squamous non-small cell lung carcinoma (sqNSCLC) (Press release, Hummingbird Bioscience, MAY 15, 2023, View Source [SID1234631758]).

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Under this collaboration, Hummingbird Bioscience will evaluate the safety, tolerability, and anti-tumor activity of its potentially best-in-class HER3-targeting antibody, HMBD-001, in combination with standard of care chemotherapy with or without Merck’s cetuximab, anti-EGFR mAb, in patients with sqNSCLC in a Phase 1b clinical trial, to be initiated in the second half of 2023. Merck will supply cetuximab for the Hummingbird Bioscience-sponsored study and both parties will retain all commercial rights to their respective compounds.

"We are excited to collaborate with Merck to study a promising, new treatment regimen for sqNSCLC patients with significant unmet need. This is the first squamous disease setting of several for which HER3 plays a critical role in etiology and where HER targeted therapies could potentially deliver clinical benefit," said Jerome Boyd-Kirkup, Ph.D., Chief Scientific Officer, Hummingbird Bioscience. "In addition to standard of care chemotherapy, the inhibition of HER3 or the concurrent inhibition of HER3 and EGFR has significant potential to improve outcomes in sqNSCLC patients refractory to front-line immunotherapies."

Hummingbird Bioscience recently presented strong scientific rationale and preclinical data for HMBD-001 used as monotherapy and in combination with cetuximab in various squamous cell carcinomas at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Meeting in April.