On January 19, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reported that the U.S. Food and Drug Administration ("FDA") has granted fast track designation for the Company’s personalized cancer therapy, EVX-01, in combination with KEYTRUDA (Press release, Evaxion Biotech, JAN 19, 2023, View Source [SID1234626381]).

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In December 2023, Evaxion received FDA approval to proceed with its Phase 2b clinical trial, where EVX-01 is given in combination with KEYTRUDA to patients with metastatic melanoma. On January 17, 2023, Evaxion furthermore received fast track designation for the vaccine candidate. The fast track is designed to expedite the FDA’s review of innovative, new drugs that demonstrate the potential to address an unmet medical need.

"We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine. This is first and foremost to the benefit of the patients. And it is a great validation of our AI platform, PIONEER, and our drug development candidate," says Per Norlén, CEO at Evaxion.

EVX-01 is a peptide-based cancer immunotherapy and is Evaxion’s most advanced clinical asset. Under the program, a unique drug is generated for each patient based on gene analysis of their tumors and on matching with their immune system. This process is made possible by the Company’s proprietary AI platform, PIONEER.

The ongoing Phase 2b study is conducted at clinical sites across the United States, Europe, and Australia. It is carried out in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA. The trial was initiated in Australia with the enrollment of the first patient in September 2022.
Read about EVX-01 Ph2b on clinicaltrials.gov: NCT05309421

On January 19, 2023 Eli Lilly and Company (NYSE: LLY) will reported its fourth-quarter 2022 financial results on Thursday, Feb. 2, 2023 (Press release, Eli Lilly, JAN 19, 2023, View Source [SID1234626380]). Lilly will also conduct a conference call that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 10 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On January 19, 2023 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 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) ("Concert") reported that they have executed a definitive agreement under which Sun Pharma will acquire all outstanding shares of Concert through a tender offer for an upfront payment of $8.00 per share of common stock in cash, or $576 million in equity value (Press release, Concert Pharmaceuticals, JAN 19, 2023, View Source [SID1234626379]). Concert stockholders will also receive a non-tradeable contingent value right (CVR) entitling holders to receive up to an additional $3.50 per share of common stock in cash, payable upon deuruxolitinib achieving certain net sales milestones within specified periods, subject to the terms and conditions contained in a contingent value rights agreement detailing the terms of the CVRs. The transaction was approved by the Boards of Directors of both companies.

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The upfront payment of $8.00 per share of common stock in cash represents a premium of approximately 33% to Concert’s 30-day volume weighted average price as of January 18, 2023, the last trading day prior to today’s announcement.

Concert is a late-stage biotechnology company pioneering the use of deuterium in medicinal chemistry. Concert has an extensive patent portfolio, including its lead product candidate deuruxolitinib – an oral inhibitor of Janus kinases JAK1 and JAK2 for the treatment of Alopecia Areata, an autoimmune dermatological disease – which is in late-stage development. Concert has completed the evaluation of the efficacy and safety of deuruxolitinib in adult patients with moderate to severe Alopecia Areata in its THRIVE-AA Phase 3 clinical program and two open label, long-term extension studies are ongoing in North America and Europe. Sun Pharma’s immediate focus would be to follow Concert’s plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2023.

Alopecia Areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia Areata may affect up to 2.5% of the United States and global population during their lifetime1,2,3. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia Areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited treatment options available for Alopecia Areata.

"Sun Pharma is building a global Dermatology and Ophthalmology franchise and aims to be a preferred development and commercial partner in these therapies worldwide. The acquisition of Concert adds a late-stage, potential best-in-class treatment for Alopecia Areata in deuruxolitinib," said Abhay Gandhi, CEO North America, Sun Pharma. "There is a significant unmet need in the Alopecia Areata space and we aim to build on Concert’s commitment to supporting the Alopecia Areata patient community. We are well-positioned to successfully bring this product to market globally. I look forward to welcoming the exceptionally talented Concert team who have worked tirelessly to develop the product to bring it to market."

"We are pleased to enter into this exciting transaction with Sun Pharma, which delivers substantial value to our shareholders and is the outcome of a thorough review process overseen by the Concert Board," stated Roger Tung, Ph.D., President and CEO of Concert. "Our mission at Concert has always been to translate innovative science to clinical solutions in order to meaningfully improve patients’ lives. We are proud to see our team’s accomplishment – creating a valuable new drug candidate for a major, underserved disease – appropriately recognized and valued by Sun Pharma as a means to expand their ongoing, international commitment to dermatology. I am confident that this transaction will maximize value for our shareholders and enhance access to deuruxolitinib for patients with Alopecia Areata."

Transaction Terms and Timeline to Closing

Under the terms of the merger agreement, Sun Pharma will promptly commence a tender offer to acquire all outstanding shares of Concert common stock. Concert stockholders will be offered an upfront payment of $8.00 per share of common stock in cash. Concert’s Board of Directors unanimously recommends that Concert stockholders tender their shares in the tender offer.

Concert stockholders will also receive a non-tradeable CVR, which entitles Concert stockholders to receive up to an additional $3.50 per share of common stock in cash, payable upon deuruxolitinib achieving certain net sales milestones within specified periods, subject to the terms and conditions contained in the contingent value rights agreement detailing the terms of the CVRs. These milestones, subject to terms and conditions as specified in the contingent value rights agreement, include: (i) $1.00 per share of common stock, payable the first time that in any fiscal year between the time of the first commercial sale of deuruxolitinib in the U.S. and March 31, 2027, net sales of deuruxolitinib is equal to or exceeds $100 million, and (ii) an additional $2.50 per share of common stock, payable the first time that in any period of four consecutive fiscal quarters between the time of the first commercial sale of deuruxolitinib in the U.S. and December 31, 2029, net sales of deuruxolitinib is equal to or exceeds $500 million. There can be no assurance that any payments will be made with respect to the CVRs.

The transaction is expected to be completed in the first quarter of 2023. The transaction is subject to the tender of a majority of the outstanding shares of Concert’s common stock, as well as the receipt of applicable regulatory approvals and other customary closing conditions. Following the successful closing of the tender offer, Sun Pharma will acquire all remaining shares of Concert that are not tendered into the tender offer and all shares of Concert’s preferred stock through a second-step merger at the same price of $8.00 per share of common stock, plus one non-tradeable CVR. The merger will be effected as soon as practicable after the closing of the tender offer.

For the nine-month period ending September 2022, Concert reported total revenue of $29 thousand and a net loss of $90.6 million. The R&D expense for that nine-month period was $75.7 million. As of September 30, 2022, Concert had approximately $148.9 million in cash, cash equivalents and investments.

Sun Pharma had net cash of $1.6 billion as of September 30, 2022.

Advisors

Moelis & Company LLC is serving as financial advisor to Sun Pharma, and Davis Polk & Wardwell LLP is serving as legal advisor. MTS Health Partners, L.P. and Chestnut Partners, Inc. are serving as financial advisors to Concert, and Goodwin Procter LLP is serving as legal advisor. In addition, MTS Securities, LLC (an affiliate of MTS Health Partners, L.P.) provided an opinion to the Board of Directors of Concert regarding the fairness of the offer consideration to be received by the holders of Concert common stock in the transaction, subject to the qualifications and limitations set forth therein.

On January 19, 2023-Brenus Pharma, a biotech company specialized in the development of new generations of allogeneic cell-based immunotherapies, and InSphero AG, a pioneer in 3D cell-based assays and organ-on-a-chip technology, reported that they have received a €1.5 million grant for the collaborative project "STC-1010 : A First-in-Class Allogeneic Cell Vaccine Against Cancer", which aims to use 3D cell culture to develop a novel cell immunotherapy for colorectal cancer (Press release, Brenus Pharma, JAN 19, 2023, View Source [SID1234626378]).

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Funding is provided by the Eurostars fund, a support mechanism for small and medium-sized enterprises under the European Commission’s "Horizon 2020" research and innovation support program, as well as by Bpifrance and InnoSuisse.

The project "STC-1010: A First-in-Class Allogeneic Cell Vaccine Against Cancer", coordinated by Brenus in collaboration with InSphero, was officially launched on November 1 st 2022 for a duration of 36 months. This collaboration aims to leverage the innovation of the 3D model in the development of the STC-1010 drug candidate, based on Brenus’ technology platform, and soon to enter the clinical phase, targeting metastatic colorectal cancer.

This tool, using 3D cell culture, should make it possible to get closer to the clinical conditions of patients to select new drug candidates and thus accelerate and secure their development.

Paul Bravetti, CEO of Brenus Pharma, declares: « Despite advances in therapy, a significant number of cancers remain resistant to treatment because the cancer cells can adapt and become invisible to the immune system, causing the patient to relapse. These cold tumors, which escape the immune cells and become for the most part insensitive to immunotherapies (only 5% of colorectal cancers are sensitive, for example), represent one of the greatest challenges for oncology research today. Our STC platform enables the production of new generation immunotherapies that will give the patient’s immune system a step ahead by educating it to anticipate and fight against the resistance and escape mechanisms put in place by cancer cells. The ambition of this technology is to offer a solution to a large population of patients who are currently at an impasse with current treatments. We are delighted with the collaboration with InSphero, which is fully in line with our strategy to develop new drugs for cancer patients.

Jan Lichtenberg, co-founder and CEO of InSphero adds : « We are delighted to partner with Brenus Pharma on the Allogenix project. 3D cellular approaches will play an important role in the future of innovative therapies such as those delivered by the STC platform, ensuring accelerated and quality data assessment. InSphero’s revolutionary cryopreservation technology will also support complementary developments for the Brenus STC platform. The resulting new medicines will provide solutions for patients suffering from tumors around the world. We look forward to this successful partnership, which would not have been possible without the trust and support of EUROSTARS."

About Eurostars Eurostars is part of the Horizon Europe program which supports innovative SMEs and project partners (universities, research organizations and other types of organizations) by funding international collaborative R&D and innovation projects. Eurostars is managed by EUREKA, an intergovernmental network of 37 countries.

On January 19, 2023 bluebird bio, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC, as representatives of the several underwriters listed on Schedule I attached thereto (the "Underwriters"), in connection with the public offering, issuance and sale by the Company of 20,000,000 shares of the Company’s common stock, $0.01 par value per share (the "Common Stock"), at a public offering price of $6.00 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333-236489) and a related prospectus supplement filed with the Securities and Exchange Commission (the "Offering") (Filing, 8-K, bluebird bio, JAN 19, 2023, View Source [SID1234626377]). Under the terms of the Underwriting Agreement, the Company also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 3,000,000 shares of Common Stock at the public offering price, less underwriting discounts and commissions. The closing of the Offering is expected to occur on or about January 23, 2023, subject to the satisfaction of customary closing conditions.

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The Company expects to receive net proceeds from the Offering of approximately $113.55 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds of the Offering to support commercialization and manufacturing for its two approved gene therapies, ZYNTEGLO and SKYSONA, to accelerate future commercialization activities for its gene therapy candidate, lovotibeglogene autotemcel, for sickle cell disease, if approved, and to fund working capital and other general corporate purposes. The Company believes that its cash, cash equivalents, restricted cash and marketable securities, together with the net proceeds from this offering, will fund its operations into the fourth quarter of 2024.

The Underwriting Agreement contains customary representations, warranties and covenants by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made solely for the benefit of the parties thereto and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Underwriting Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Underwriting Agreement and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Securities and Exchange Commission.

The foregoing description of the Underwriting Agreement is not complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this report and is incorporated by reference herein.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated January 19, 2023, regarding the validity of the shares of common stock to be issued and sold in the offering. A copy of the opinion is filed as Exhibit 5.1 to this Current Report on Form 8-K.

Forward-Looking Statements

This Current Report on Form 8-K (the "Current Report") contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the consummation of the offering, the terms of the offering, the satisfaction of customary closing conditions with respect to the offering, the anticipated amount of net proceeds from the offering, the intended use of such net proceeds and projected cash runway. Statements using words such as "expect", "anticipate", "believe", "may", "will" and similar terms are also forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this Current Report or to update them to reflect events or circumstances occurring after the date of this Current Report, whether as a result of new information, future developments or otherwise.