Benzinga | Jun 14, 2021 09:04AM EDT

Avalon GloboCare Announces Execution Of Purchase Agreement For Acquisition Of SenlangBio In All Stock Transaction; Will Sell 15.6% Equity Interest In SenlangBio To Institutional Healthcare Investor For $30M

Avalon GloboCare Corp. (NASDAQ:AVCO) ("Avalon" or "the Company"), a clinical-stage global developer of cell-based technologies and therapeutics, today announced that it has entered into a definitive agreement to acquire Hebei Senlang Biotechnology Co. Ltd. ("SenlangBio"), a PRC limited liability company. SenlangBio is currently the largest cell therapy company in Northern China in terms of bio-manufacturing scale, breadth and depth of clinical development programs, and pre-clinical research. SenlangBio's core technology platforms include chimeric antigen receptor (CAR) T-cells (CAR-T), allogeneic CAR Gamma Delta T-cells (CAR-??T), and armored tumor infiltrating lymphocytes (armTILs). Avalon will acquire SenlangBio's proprietary cellular therapy portfolio consisting of multiple autologous and allogeneic candidates, including both single-target therapies as well as "cocktail" combinations.

In connection with the transaction, Avalon will issue 81 million shares of its common stock (the "Acquisition Shares") to acquire SenlangBio (the "Acquisition"). The terms of the Acquisition will be detailed in Avalon's Current Report on Form 8-K to be filed with respect to the Acquisition on or about the date hereof. Avalon plans to seek approval from its stockholders of the issuance of the Acquisition Shares, as well as the shares potentially issuable in the Equity Financing (described below), in accordance with the rules of the Nasdaq Stock Market ("Nasdaq") at its upcoming 2021 annual stockholder meeting.

Transaction Highlights

* The Acquisition will add SenlangBio's diverse and broad pipeline covering solid tumors and hematologic malignancies, including both autologous and universal ("off-the-shelf") cell therapy programs

* To date, over 300 patients have received one of SenlangBio's 15 cell therapy candidates through investigator-initiated first-in-human clinical trials at 13 partnering hospitals, covering 9 indications with significant unmet medical needs

* Clinical benefit combined with lack of serious adverse events reported in all SenlangBio's clinical trials to date

* Acquisition adds advanced cell/gene engineering and proprietary cell expansion expertise to enable design and development of innovative cell therapy candidates with superior therapeutic efficacy and safety profile

* SenlangBio's intellectual property includes 10 issued patents and 5 patents pending in China, as well as multiple "know-how" IPs

* Acquisition includes the SenlangBio Clinical Laboratory, a wholly owned subsidiary of SenlangBio that provides third-party clinical testing services including: 1) general biochemical, genomic and proteomic testing; 2) cell therapy related testing such as hematology, immunology, cancer biomarkers, immuno-phenotyping, and others In-house, large-scale bio-manufacturing capabilities and capacities: Lead Clinical Assets Senl_1904B: Senl_NS7CAR: CAR-??T cell-therapy candidates: Avalon and SenlangBio have also entered into agreements with an institutional healthcare investor which has committed to invest approximately USD $30 million in exchange for approximately 15.6% of the equity ownership of SenlangBio in a private placement financing (the "Equity Financing"), which is expected to close in three equal installments of approximately USD $10 million, at a fixed price, the first to be upon the closing of the Acquisition, the second to be within three months after the closing and the third to be within six months after the closing. The SenlangBio shares purchased in the Equity Financing will be exchangeable from time to time between the six-month and five year-anniversaries of the respective installments, at the option of the investor, into shares of Avalon Common Stock at a fixed price of $1.21 per Avalon common share, which is the at-the-market price under the rules of the Nasdaq Stock Market. No warrants or other equity-linked or debt instruments will be issued in connection with the transaction. The transaction is aligned with Avalon's mission of developing next generation cell and gene therapies to address unmet medical needs, including for some of the world's most challenging diseases. Avalon believes the Acquisition positions the Company as a vertically integrated leader in cellular medicine, seamlessly integrating SenlangBio's innovative research, broad repertoire of pipeline candidates, and state-of-the-art bio-manufacturing/bio-processing infrastructure to accelerate the clinical translation of cellular-based technologies. "Today's transaction is an affirmation of our commitment to bringing life-saving cell and gene therapies to market," said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare. "Harnessing advanced cell and gene engineering strategies, SenlangBio has developed unique core technology platforms for highly effective immune effector cell cancer therapies. Their autologous CAR-T candidates have already demonstrated significant positive responses in early clinical studies against relapsed and refractory B-cell and T-cell leukemias and lymphomas, with promising positive response rates and were well tolerated by patients." "SenlangBio also brings a group of unique next-generation universal/allogeneic ("off-the-shelf") CAR-??T candidates for the treatment of relapsed/refractory AML and MDS, as well as multiple solid tumor malignancies. They have established a ??T cell-based universal CAR (GDUCARx) technology platform, which can expand ??T cells greater than 5,000-fold as compared to conventional cell culture protocols and have demonstrated strong cell killing of myeloid and solid tumor cells. We are very excited about this technology platform as an off-the-shelf CAR-??T cell therapy modality that may significantly drive down costs and rapidly deliver life-saving cellular therapeutics to patients," noted Dr. Jin. "Notably, SenlangBio brings added capabilities to Avalon with their 16,000 square-foot GMP facility, which supports in-house bio-manufacturing, bio-processing, and QA/QC processes. This acquisition will expand our portfolio of cellular therapeutic candidates, intellectual properties as well as potentially increase opportunities for high-impact scientific and clinical publications, out-licensing partnership and co-development with large biopharmaceutical companies. SenlangBio's geographic advantage will allow us to further penetrate the northern China market and increase market expansion across China, as well as provide opportunities for international multi-center clinical trials. Through our combined technology platforms, we believe we can effectively drive innovation and transformative R&D, as well as accelerate research-to-clinical translation enabling widespread patient accessibility and broader commercial adoption of cell and gene therapies," added Dr. Jin. 16,000 square-foot Good Manufacturing Practice (GMP) facility for bio-manufacturing, bioprocessing, and Quality Assurance/Quality Control (QA/QC) processes 5 production lines dedicated to autologous CAR-T with an estimated annual capacity to produce 5,000-unit doses of CAR-T cell therapy products 2 universal ("off-the-shelf") production lines with an estimated annual output of 10,000-unit doses of CAR-??T cell therapy products In-house research and production capabilities for lentiviral vectors, plasmids, T-cell cultures, validation bio-assays, as well as QA/QC processes Description: Autologous anti-CD19 CAR-T for relapsed or refractory (R/R) B-cell lymphoblastic leukemia (B-ALL) Clinical stage and data: Successfully completed principal investigator (PI)-initiated first-in-human clinical trial which demonstrated 97.2% (35/36) complete remission rate and only 5.6% (2/36) Grade 3 Cytokine Release Syndrome (CRS) among R/R B-ALL patients Recently received approval of Investigational New Drug (IND) application by China's National Medical Products Administration (NMPA) to initiate Phase I clinical trial in R/R B-ALL during the third quarter of 2021 Description: Potentially breakthrough treatment for T-cell blood cancers comprised of autologous anti-CD7 CAR-T for T-cell ALL and T-cell lymphoblastic lymphoma (T-LBL) Clinical stage and data: Successfully completed PI-initiated first-in-human clinical trial; 8 out of 8 T-ALL and T-LBL patients achieved complete remission, and none developed greater than Grade 2 CRS; plan to file an IND application with the NMPA around the third quarter of 2021 and start an official Phase I clinical trial upon approval of the IND application Description: Universal/allogeneic ("off-the-shelf") cell therapy modality; potentially breakthrough treatment for relapsed and refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS); targeting multiple solid tumor malignancies, including pancreatic, gastric, ovarian, sarcomas, and others Clinical stage and data: Successfully completed pre-clinical, IND-enabling stage and currently in preparation to initiate 3-4 PI-initiated first-in-human clinical trials targeting AML, MDS and solid tumors around the fourth quarter of 2021