Autolus Announces Partial Exercise of Underwriters’ Option to Purchase Additional ADSs

On December 21, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that the underwriters of its previously announced public offering of American Depositary Shares, or ADSs, which closed on December 13, 2022, have partially exercised their option to purchase an additional 6,927,102 ADSs, at a price per ADS of $2.00, resulting in additional gross proceeds to Autolus of approximately $13.9 million (Filing, 6-K, Autolus, DEC 21, 2022, View Source [SID1234625502]). After giving effect to the issuance of these additional shares, which closed today, Autolus has sold a total of 81,927,102 ADSs in the offering for aggregate gross proceeds of approximately $163.9 million.

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Jefferies LLC, William Blair & Company L.L.C. and Wells Fargo Securities, LLC acted as joint bookrunners for the offering.

A preliminary prospectus supplement to the prospectus describing the terms of the offering was filed with the Securities and Exchange Commission, or the SEC, on December 8, 2022, and a final prospectus supplement was filed with the SEC on December 12, 2022. The offering of these ADSs is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, which, for the avoidance of doubt, will not constitute a "prospectus" for the purposes of the Regulation (EU) 2017/1129 and has not been reviewed by any competent authority in any member state in the European Economic Area. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained for free from the joint book-running managers for the offering, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York, 10001, at 833-690-2713 or email a request to [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

Protalix BioTherapeutics to Delist its Common Stock from the Tel Aviv Stock Exchange

On December 21, 2022 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell based protein expression system, reported that the Company’s management and Board of Directors have decided that it is in the best interest of the Company to voluntarily delist its common stock from the Tel Aviv Stock Exchange (the "TASE") (Press release, Protalix, DEC 21, 2022, View Source [SID1234625501]).

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The Company believes that delisting its common stock from the TASE will allow management to focus better on the Company’s primary capital market and reduce its cost of operations as the Company will be subject to only one set of listing rules and regulations. Accordingly, the Company has requested that the TASE immediately initiate the delisting process.

"At this stage of the Company’s development, we believe that it is in the best interest of our company and its stockholders that we concentrate our market activity on a single exchange," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We thank all of the investors who traded our common stock on the TASE."

Based upon applicable Israeli law, the Company expects the delisting of its common stock from the TASE to become effective three months from the date of request. During this time, the Company’s common stock will continue to be traded on the TASE.

Trading of the Company’s common stock on the NYSE American will be unaffected by this decision, and the Company will remain subject to the rules and regulations of the U.S. Securities and Exchange Commission and the NYSE American applicable to listed companies. All shares of the Company’s common stock traded on the TASE are expected to transfer to the NYSE American once the delisting from the TASE becomes effective.

The Company is not aware of any technical or substantive impediment to the trading of the Company’s securities on the NYSE American following its delisting from the TASE.

An announcement regarding the delisting procedure and timeline will follow once available. The Company will continue to file public reports and make public disclosures in accordance with the rules and regulations of the U.S. Securities and Exchange Commission and NYSE American after the delisting.

Holders of the Company’s common stock through an Israeli broker, bank or other nominee are encouraged to contact such broker, bank or other nominee with any questions about the transfer of shares to a NYSE American-based account.

Phio Pharmaceuticals Announces New Clinical Program to Study PH-762 for the Treatment of Cutaneous Squamous Cell Carcinoma

On December 21, 2022 Phio Pharmaceuticals Corp., reported that it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL compound, PH-762 (Press release, Phio Pharmaceuticals, DEC 21, 2022, View Source [SID1234625498]). Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi technology is designed to make immune cells more effective in killing tumor cells. PH-762 has been shown to reduce the expression of PD-1, a protein that inhibits T cells’ ability to kill cancer cells. When administered intratumorally in preclinical models PH-762 primes an anti-tumor immune response, and inhibits tumor growth.

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Phio is currently conducting a Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe. Phio expects to commence a US Phase 1b clinical trial early in the 2nd half of 2023. The initial US trial is expected to focus on the treatment of cutaneous squamous cell carcinoma (cSCC) and other selected cutaneous malignancies, following successful regulatory review of the IND.

"Therapeutic interventions for cSCC are limited, and there is increasing unmet medical need. As cSCC tumors comprise approximately 51% of the total incidence of solid tumors in the US, excluding basal cell cancers, we recognize the growing need for alternative therapies for cSCC," said Robert Bitterman, Phio’s Principal Executive Officer and Executive Chairman. Mr. Bitterman has over 25 years of executive leadership experience in the pharmaceutical and biologic life science industry with a proven track record in operations, finance and investor relations.

"While monoclonal antibody therapies (mAbs) are available for the treatment of cSCC, mechanistically they only block the interaction between PD-1 and PD-L1 on the cell surface. PH-762 also has the potential to address PD-1 inside the T cell, essentially further enhancing the activity of the T cell to kill the tumor cells," said Dr. James Cardia, Phio’s Vice President of Scientific Operations. Dr. Cardia led the team that discovered INTASYL.

"PH-762 has the potential to meet a significant medical need in patients who have failed to respond to mAbs, as well as those with resectable and metastatic solid tumors," noted Dr. Mary Spellman, Phio’s Medical and Clinical Development Advisor. "Phio is committed to advancing the study of PH-762 to provide a meaningful therapy for patients with a broad range of solid tumors."

About INTASYL

INTASYL compounds are chemically modified siRNAs that are designed to provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity targeting a broad range of cell types and tissues. INTASYL drugs precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy (ACT) applications. In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial convenience to the prescriber and patient. Phio believes that INTASYL is the only self-delivering RNA interference (RNAi) technology focused on immuno-oncology therapeutics.

ORIC Pharmaceuticals Announces Clinical Development Collaboration with Pfizer for ORIC-533 in Multiple Myeloma and Concurrent $25 Million Equity Investment by Pfizer

On December 21, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that it has entered into a clinical development collaboration for a potential Phase 2 study of ORIC-533 in multiple myeloma with Pfizer and agreed to sell 5,376,344 of its common shares at a price of $4.65 per share to Pfizer for proceeds of approximately $25.0 million (Press release, ORIC Pharmaceuticals, DEC 21, 2022, View Source [SID1234625496]). The common shares were sold to Pfizer in a registered direct offering conducted without an underwriter or placement agent. The offering is expected to close on or about December 23, 2022, subject to customary closing conditions.

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ORIC and Pfizer have entered into the clinical development collaboration to leverage Pfizer’s global development capabilities and expertise to enhance the clinical development program for ORIC-533, an oral small molecule inhibitor of CD73. Through the agreement, the parties plan to potentially advance ORIC-533 into a Phase 2 combination study with elranatamab, Pfizer’s investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody in development for the treatment of multiple myeloma. ORIC will maintain full economic ownership and control of ORIC-533. In conjunction with the investment, Jeff Settleman, Ph.D., Chief Scientific Officer, Oncology Research & Development, Pfizer, will join ORIC’s Scientific Advisory Board.

"We continue to be encouraged by the potential of ORIC-533 as a first-in-class treatment for patients with multiple myeloma, and a natural next step is to explore ORIC-533 in combination with approved and emerging therapies, including BCMA directed therapies," said Jacob M. Chacko, M.D., chief executive officer. "Given Pfizer’s strong commitment, extensive capabilities and deep expertise in developing treatments for oncology, including elranatamab in multiple myeloma, we are proud to partner with them to develop a potential novel treatment regimen for patients with multiple myeloma. We look forward to realizing the full potential of ORIC-533 and continuing to advance our promising pipeline."

"We are excited to support the clinical development of ORIC-533, which represents a novel mechanism in multiple myeloma and a promising product candidate to combine with elranatamab," said Dr. Settleman. "Given the high unmet need for patients with multiple myeloma and potential for relapse, we believe new treatments and combinations with novel mechanisms of action that counter mechanisms leading to resistance are essential to improving outcomes. We are encouraged by the potential of ORIC-533 and, through our relationship with ORIC, look forward to continuing to work toward improving the lives of people with cancer."

ORIC intends to use the proceeds from the offering to fund ongoing and planned clinical trials, including studies of ORIC-533; ORIC-114, its brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations; and ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer; and for working capital and general corporate purposes.

Including Pfizer’s equity investment, ORIC expects its cash runway to be extended into the first half of 2025.

The securities described above were offered by means of a prospectus supplement dated December 21, 2022, and accompanying prospectus dated April 27, 2022, forming a part of the Company’s effective shelf registration statement (File No. 333-255833). The prospectus supplement and accompanying prospectus relating to this offering will be filed with the U.S. Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website at www.sec.gov.

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

Oncocyte Announces Initiatives to Focus Corporate Strategy

On December 16, 2022 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, reported a reduction in force involving over 40% of Oncocyte’s workforce to realign its team towards key products that address larger markets (Press release, Oncocyte, DEC 21, 2022, View Source [SID1234625495]).

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Additionally, Oncocyte has entered into a Stock Purchase Agreement pursuant to which Oncocyte will transfer 70% of its ownership of Razor Genomics, Inc. to buyers who are leaders in the development of early stage lung cancer diagnostics and the provision of gene-expression-based prognostic tests. Oncocyte will retain a 30% stake in Razor. The transaction involves the transfer of all of the assets and liabilities related to DetermaRx. The closing of the transaction will occur at a later date, subject to the satisfaction of the closing conditions set forth in the agreement.

Additionally, the C-suite has been restructured and the positions occupied by Gisela Paulsen, President and Chief Operating Officer, and Douglas Ross, Chief Scientific Officer, will be eliminated. Oncocyte expects that Ms. Paulsen and Dr. Ross will serve as advisors during a transition phase over the next quarter.

"We expect the transfer of the Razor entity will allow us to eliminate development and commercialization costs with respect to DetermaRx while retaining 30% of any potential upside from the test, which is used to assess the risk of recurrence for patients with early-stage lung cancer," said Joshua Riggs, Oncocyte’s Interim CEO. "We believe this transaction, along with the reduction in force, will prepare us for a more focused strategy and further elongate our cash runaway as we prepare for key commercial and developmental milestones in 2023. We plan to keep shareholders updated with our enhanced focus and strategy in Q1 2023."