OncoSec Medical Announces Proposed Public Offering of Common Stock

On January 20, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a late-stage biotechnology company focused on designing, developing and commercializing innovative therapies and proprietary medical approaches to stimulate and to guide an anti-tumor immune response for the treatment of cancer reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, OncoSec Medical, JAN 20, 2021, View Source [SID1234574152]). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares to be sold in the offering will be offered by OncoSec.

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BTIG, LLC is acting as sole book-running manager for the offering.

OncoSec intends to use the net proceeds from this offering for (i) clinical, regulatory, manufacturing and, if and when approved, potential commercial activities of its product candidates; (ii) clinical development of our product candidates; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.

OncoSec will file a preliminary prospectus supplement and accompanying base prospectus to its effective shelf registration statement on Form S-3 (File No. 333-233447) with the U.S. Securities and Exchange Commission ("SEC") for the proposed public offering of its common stock. The offering will be made only by means of a prospectus and a prospectus supplement, which will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to these securities may also be obtained, when available, by contacting BTIG, LLC 65 East 55th Street, New York, NY, 10022, or by telephone at (212) 593-7555 or by e-mail at [email protected].

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About TAVO

OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 ("IL-12"), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer ("TNBC"). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.

INOVIO Announces Pricing of Public Offering of Common Stock

On January 20, 2021 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, including COVID-19, cancer and HPV-associated diseases, reported the pricing of an underwritten public offering of 17,700,000 shares of its common stock at a public offering price of $8.50 per share (Press release, Inovio, JAN 20, 2021, View Source [SID1234574151]). In addition, INOVIO has granted the underwriters a 30-day option to purchase up to an additional 2,655,000 shares of common stock at the public offering price, less underwriting discounts and commissions. Gross proceeds to INOVIO from the offering are expected to be approximately $150.5 million, before deducting underwriting discounts and commissions and estimated offering expenses, but excluding any exercise of the underwriters’ option. All of the shares are being sold by INOVIO.

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INOVIO intends to use the net proceeds from this offering for the development of its clinical pipeline, including clinical development expenses relating to INO-4800 and research and development expenses, and for general corporate purposes, including working capital and general and administrative expenses.

BofA Securities, Jefferies and Cantor are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as lead manager for the offering. The Benchmark Company, Maxim Group LLC and National Securities Corporation are acting as co-managers for the offering. The offering is expected to close on or about January 25, 2021, subject to customary closing conditions.

The shares were offered by INOVIO pursuant to a shelf registration statement filed by INOVIO with the Securities and Exchange Commission (SEC) that became automatically effective on January 20, 2021. This offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting: BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities 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.

Turnstone Biologics Acquires Novel Cell Therapy Platform

On January 20, 2021 Turnstone Biologics Corp., a clinical-stage biotechnology company pioneering the development of cancer immunotherapies, reported that it has acquired California-based Myst Therapeutics, a privately held biotechnology company focused on advancing novel T-cell therapies for solid tumors (Press release, Turnstone Biologics, JAN 20, 2021, View Source [SID1234574150]). The acquisition adds a pipeline of innovative TIL programs to Turnstone’s portfolio of oncolytic virus candidates. Financial terms were not disclosed.

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TIL therapy treatment protocols utilize populations of T-cells that are isolated from a patient’s own tumor, expanded and stimulated before being re-administered to the patient. There has been strong clinical evidence demonstrating the benefit of TIL therapy in solid tumors such as melanoma and cervical cancer, however, driving clinical benefit in harder-to-treat cancers has been elusive. The Myst TIL therapy platform has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients.

"Myst has created an industry-best selection strategy for identifying, expanding and stimulating antigen-reactive T-cells in a patient’s tumor," said Mike Burgess, M.D., Ph.D., President of R&D at Turnstone. "It represents the most straight-line solution for broadening the benefit of TILs to other solid tumor indications while maintaining commercial feasibility. We are excited to advance this technology both independently and in combination with our viral immunotherapies."

Myst has focused on applying their innovative T-cell selection strategies to clinically proven TIL treatment protocols. With this acquisition, Turnstone gains full access to this technology, the complete R&D capabilities of Myst along with existing development collaborations, and a pipeline of TIL programs with the lead candidate expected to enter the clinic this year.

"The Myst platform builds on validated and durable responses in the field and represents a next-generation approach to TILs that aligns directly with our commitment to exploiting the full potential of innate and adaptive tumor immunity," said Sammy Farah, Ph.D., CEO at Turnstone. "It further strengthens our internal development expertise and expands our opportunity to deliver transformative medicines to the millions of cancer patients underserved by current treatment options."

The acquisition of Myst will see an integration of talent across Turnstone’s senior management and R&D teams. Myst CEO, TJ Langer, will join Turnstone’s senior leadership team as Senior Vice President, Cell Therapy Development and External Innovation.

"The Turnstone team has extensive experience in the field of cancer immunotherapy, and I am delighted to join them to further develop this cutting-edge therapeutic modality," said Mr. Langer. "We are confident that our TIL platform has the potential to offer a substantial improvement over current TIL therapies by driving meaningful and robust responses in a wide spectrum of tumors. It is extraordinary to have these leading oncolytic virus and cell therapy programs together under one roof."

Aldeyra Therapeutics, Inc. Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On January 20, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, reported the closing of its underwritten public offering of 7,868,421 shares of its common stock at a public offering price of $9.50 per share, including 1,026,315 additional shares of common stock sold pursuant to the full exercise of the underwriters’ option to purchase additional shares (Press release, Aldeyra Therapeutics, JAN 20, 2021, View Source [SID1234574149]). All of the shares in the offering were sold by Aldeyra. The gross proceeds to Aldeyra following the underwriters’ exercise of their option to purchase additional shares, before deducting underwriting discounts and commissions and offering expenses, were approximately $74.7 million.

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Aldeyra anticipates using the net proceeds from the underwritten offering for the continued development of its lead compound, reproxalap, and its other product candidates, as well as for working capital, and other general corporate purposes.

Jefferies LLC and SVB Leerink LLC acted as joint book-running managers for the offering. BTIG LLC and Oppenheimer & Co. Inc. acted as co-lead managers for the offering.

The shares of common stock described above were offered by Aldeyra pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on July 27, 2018. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on January 14, 2021, and is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to these securities may also be obtained by sending a request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at 877-821-7388 or by email at [email protected], or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities 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 jurisdictions.

AVEO Oncology Announces Commitment for an Incremental $10 Million Loan in Addition to Current Tranched, $35 Million Debt Facility with Hercules Capital

On January 20, 2021 AVEO Oncology (Nasdaq: AVEO) reported that it has received a commitment letter for an incremental $10 million loan from Hercules Capital, Inc. (NYSE: HTGC, "Hercules") and its affiliates, to be added to the current tranched, $35 million debt facility secured with Hercules in August 2020 through an amendment to the amended and restated loan and security agreement (the "Loan Agreement") (Press release, AVEO, JAN 20, 2021, View Source [SID1234574148]). Terms of the facility would remain otherwise unchanged from the Loan Agreement, with the loan bearing a maturity of 36 months, extendable up to 48 months, and an interest-only period of 12 months, extendable up to 30 months upon the achievement of performance milestones related to the approval and commercialization of tivozanib.

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Under the terms of the Loan Agreement, an initial tranche of $15 million was drawn down at signing. Under the terms of the commitment letter, a second tranche of $20 million would be available contingent upon the approval of the tivozanib New Drug Application ("NDA") by the U.S. Food and Drug Administration ("FDA") as a treatment for relapsed or refractory renal cell carcinoma ("RCC"). An additional $10 million will become available if certain sales criteria are met. As previously announced, the FDA has assigned AVEO’s NDA a Prescription Drug User Fee Act target action date of March 31, 2021. The nonbinding commitment letter is subject to AVEO and Hercules entering into a definitive amendment of the Loan Agreement setting forth the terms of the additional borrowing.

"The additional $10 million that would be made available from Hercules Capital with execution of a definitive amendment and the potential approval of tivozanib further supports what we believe will be a robust launch of tivozanib in the U.S.," said Michael Bailey, president and chief executive officer of AVEO. "As we work on expanding our commercial organization in preparation for this potential launch, we also continue to progress our pipeline of clinical programs, including our immunotherapy combination programs for tivozanib, our Phase 2 study of ficlatuzumab and our recently initiated Phase 1 study of AV-380. Throughout 2021, we look forward to a number of milestones designed to enhance our long-term value."

"We are pleased to be expanding our financing partnership with AVEO as they prepare for the potential approval and launch of tivozanib. This amendment and the potential further additional capital from Hercules represents another example of our unique ability to support innovative life sciences companies at all stages of development and through multiple value inflection points," said Bryan Jadot, Senior Managing Director and Life Sciences Group Head for Hercules.