Enlivex Therapeutics Announces up to $15 Million Registered Direct Offering

On May 28, 2024 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale in a registered direct offering of an aggregate of 3,571,429 ordinary shares (or ordinary share equivalents in lieu thereof) and clinical milestone-linked warrants, composed of Series A warrants to purchase up to 3,571,429 ordinary shares and Series B warrants to purchase up to 3,571,429 ordinary shares, at a purchase price of $1.40 per ordinary share (or ordinary share equivalents in lieu thereof) and associated warrants (Press release, Enlivex Therapeutics, MAY 28, 2024, View Source [SID1234643732]).

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The warrants will have an exercise price of $1.40 per share and will be exercisable immediately upon issuance. The Series A warrants will expire upon the earlier of 18 months following the issuance date and 60 days following the Company’s public announcement of positive topline results from the ENX-CL-05-001 trial of AllocetraTM for the treatment of moderate-to-severe knee osteoarthritis. The Series B warrants will expire upon the earlier of five and one-half years following the issuance date and 60 days following the Company’s public announcement of its filing with the FDA for approval for Allocetra’sTM osteoarthritis related indication.

The offering is expected to close on or about May 29, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential gross proceeds from the warrants, if fully exercised on a cash basis, will be approximately $10.0 million. No assurance can be given that any of the warrants will be exercised. The Company intends to use the net proceeds for working capital and general corporate purposes.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The securities described above are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form F-3 (File No. 333-264561), including a base prospectus, that was originally filed with the Securities and Exchange Commission (the "SEC") on April 29, 2022, and declared effective by the SEC on May 5, 2022. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of such effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein or any other securities, nor shall there be any sale of the securities described herein or any other securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

West to Participate in Upcoming Investor Conference

On May 28, 2024 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will present at the William Blair 44th Annual Growth Stock Conference in Chicago, IL on Tuesday, June 4, 2024 at 8:00 AM CT (Press release, West Pharmaceutical Services, MAY 28, 2024, https://www.westpharma.com/investors/press-releases?utm_source=SitecoreSend&utm_medium=Email&utm_campaign=Investors_Email&campaignid=null&utm_content=28_May_2024&utm_term=null&creative=null&device=null&matchtype=null#2024-may-28-west-to-participate-in-upcoming-investor-conference [SID1234643749]).

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A live audio webcast of the event will be available in the "Investors" section of the Company’s website at www.westpharma.com. Replay of the webcasts will be available for approximately 90 days after the event.

Exact Sciences to Participate in June Investor Conferences

On May 28, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, MAY 28, 2024, View Source [SID1234643733]).

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William Blair 44th Annual Growth Stock Conference, Chicago
Presentation on Tuesday, June 4, 2024 at 1:40 p.m. ET
Jefferies Healthcare Conference, New York
Fireside chat on Wednesday, June 5, 2024 at 11:00 a.m. ET
Goldman Sachs 45th Annual Global Healthcare Conference, Miami
Fireside chat on Tuesday, June 11, 2024 at 3:20 p.m. ET

The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

Bio-Thera and STADA Reach Exclusive Agreement for BAT2506, a Proposed Golimumab Biosimilar, in the EU and UK

On May 28, 2024 Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG reported to have have reached an exclusive commercialization and license agreement for BAT2506, a biosimilar candidate to Simponi (golimumab) (Press release, BioThera Solutions, MAY 28, 2024, View Source [SID1234643750]).

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Under the agreement, Bio-Thera Solutions ("Bio-Thera") will maintain responsibility for development, manufacturing, and supply of BAT2506. STADA Arzneimittel AG ("STADA") will have exclusive rights to commercialize the product in the European Union (EU), the UK, Switzerland and selected other countries.

Bio-Thera will receive an upfront payment of US$10 million, as well as further development and commercial milestones of up to US$147.5 million, subject to the fulfillment of certain conditions.

"STADA is one of the premier biosimilar companies in Europe, and we are pleased to establish a partnership with STADA for BAT2506", said Dr. Shengfeng Li, CEO of Bio-Thera. "We look forward to working with STADA to bring BAT2506 to immunology patients in Europe."

"With global sales in 2023 of US$2.2 billion, including more than US$1 billion outside of the US, golimumab represents a compelling opportunity to broaden patient access to biological treatments and build scale in immunology alongside our approved adalimumab and ustekinumab biosimilars. Bio-Thera’s broad expertise in biologic medicines, including with two biosimilars already approved by the US Food and Drug Administration, makes it an attractive partner for STADA," commented STADA’s head of Global Specialty, Bryan Kim.

Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers.

Cellectis Reports Financial Results for First Quarter 2024

On May 28, 2024 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported business updates and reported financial results for the three-month period ending March 31, 2024 (Press release, Cellectis, MAY 28, 2024, View Source [SID1234644826]).

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"We are thrilled to have announced the closing of the additional equity investment of $140 million by AstraZeneca. This followed AstraZeneca’s initial payment of $105 million, composed of a $80 million equity investment and a $25 million upfront payment under our research collaboration.

Following AstraZeneca’s additional investment, we expect our cash runway to fund operations into 2026. We will continue to focus our efforts and expenses on advancing its core clinical trials BALLI-01, NATHALI-01 and AMELI-01, which remain wholly owned assets, while building, within our owned preclinical pipeline and in collaboration with AstraZeneca, the next generation of medicines to address areas of high unmet patient needs.

We strongly believe that gene edited cell and gene therapy products are revolutionizing medicine across a number of therapeutic areas and will become a large part of molecular medicine of the future." said André Choulika, Ph.D., Chief Executive Officer at Cellectis.

Pipeline Highlights

UCART Clinical Programs

Cellectis continues to focus on the enrollment of patients in the BALLI-01 study (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), in the NATHALI-01 study (evaluating UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL), and in the AMELI-01 study (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML).
We expect to provide updates in the advancements of BALLI-01 and NATHALI-01 by year-end 2024.

Partnerships

Licensed Allogeneic CAR T-cell Development Programs

Anti-CD19 program

Allogene’s investigational oncology products utilize Cellectis technologies. Servier, which has an exclusive license to the anti-CD19 investigational products from Cellectis, has granted Allogene an exclusive sublicense to these products in the U.S., European Union and the United Kingdom.

Allogene announced the execution with Servier of an amendment to the sublicense to expand the licensed territory to the European Union and the United Kingdom.
Allogene announced that it continues to focus on the development of its investigational product cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A), as part of the first line (1L) treatment plan for LBCL patients who are at risk of relapse following 1L chemoimmunotherapy. Allogene announced that start-up activities for the ALPHA3 trial are ongoing with a planned study initiation in mid-2024.
Allogene further announced that enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel.

Anti-CD70 program

The anti-CD70 program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this program.

Allogene announced that a Phase 1 data update of the ongoing TRAVERSE trial with ALLO-316 in RCC from approximately 20 patients with CD70 positive RCC is planned by YE 2024.

Corporate Updates

Collaboration and Investment Agreements with AstraZeneca

On May 6, 2024, Cellectis announced the completion of the subsequent investment of $140M in Cellectis by AstraZeneca (LSE/STO/Nasdaq: AZN).
AstraZeneca subscribed for 10,000,000 "class A" convertible preferred shares and 18,000,000 "class B" convertible preferred shares, in each case at a price of $5.00 per convertible preferred share, issued by the board of directors of Cellectis.
AstraZeneca owns approximately 44% of the share capital and 30% of the voting rights of the Company (based on the number of voting rights currently outstanding).