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 News Release - December 29, 2020

AIVITA Biomedical Closes $25 Million Financing Round

IRVINE, Calif., Dec. 29, 2020 -- (Healthcare Sales & Marketing Network) -- AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and prevention of COVID-19, has closed its Series B-2 financing round for up to $25 million. Financing was provided by several life sciences investment firms.

Proceeds will support clinical development of AIVITA's personalized immunotherapy programs, including Phase 2 studies in glioblastoma and ovarian cancer, as well as AIVITA's application for commercial approval of its melanoma immunotherapy via Japan's expedited regenerative medicine regulatory pathway. Proceeds will also support AIVITA's ongoing development of a personalized vaccine for COVID-19 prevention, which is currently in a Phase 2/3 study.

"The completion of this financing round reflects strong asset development, an outstanding team and a focused strategy," said Hans S. Keirstead, Ph.D., chairman and chief executive officer of AIVITA. "AIVITA has clearly proven that personalized pan-antigenic vaccines are highly efficacious, safe and inexpensive to produce."

AIVITA's cancer immunotherapy programs are designed to target the seed of all cancers – tumor initiating cells – with a pan-antigenic approach that targets all neoantigens on those cells. Previous studies of these cancer immunotherapies have demonstrated promising safety and efficacy in multiple cancer types. AIVITA's COVID-19 vaccine program uses the same autologous cell therapy platform, with patients' own dendritic cells loaded with SARS-CoV-2 spike proteins and re-administered to potentially provide enhanced protection against viral mutations. The company has also leveraged its core technologies to create a skincare line launching in the US market in January 2021, known as Root of Skin™ MD, which dedicates net proceeds toward the treatment of cancer.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA's ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating, cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%) and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA's AVOVA-1 trial patients can visit: https://www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA's glioblastoma Phase 2 single-arm study is active and completed treating 57 patients with the tumor-initiating cell-targeting immunotherapy, AV-GBM-1.

In a final analysis of progression-free survival, patients treated with AV-GBM-1 had a 38% increase in progression-free survival as compared to Stupp's standard of care.

For additional information about AIVITA's AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA's melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA's tumor-initiating, cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA's AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

About AIVITA Biomedical

AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of people with cancer.

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date as of which it is made and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on a number of assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.


Source: AIVITA Biomedical

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