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.

On January 20, 2021 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported that it has entered into definitive agreements with its two largest institutional investors to purchase approximately $25 million of Oncocyte’s common shares in a registered offering priced at $3.424 per share ("at market"), which was the average of the last five closing prices (Press release, Oncocyte, JAN 20, 2021, View Source [SID1234574168]). The lead investor in the offering, Pura Vida Investments, LLC, a fundamentally driven, healthcare-focused registered investment advisor, increases its ownership of Oncocyte from under 10% to approximately 16%, by agreeing to purchase $20 million of Oncocyte’s common shares, at the close of the transaction. Broadwood Partners, L.P., a long-term investor and Oncocyte’s largest shareholder, was the other participant in the offering.

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This offering was completed directly with Oncocyte’s two top institutional investors and the Company incurred no placement agent fees.

"We are honored to have the continued support and vote of confidence from Pura Vida, a firm whose focus is on innovative and disruptive healthcare companies, and Broadwood Partners, L.P., our largest and long-term shareholder, for our expanding comprehensive portfolio of tests," said Ron Andrews, Chief Executive Office of Oncocyte. "We believe our strengthened balance sheet will help facilitate our planned expansion activities and offerings in lung and other cancers as we prepare to launch DetermaIO and DetermaTX later this year, as well as provide the resourcing necessary to complete development of our anticipated blood-based monitoring offerings. We greatly appreciate their increased investment in, and substantial commitment to, our Company and our mission."

Efrem Kamen, Founder and Managing Member of Pura Vida Investments said, "We believe Oncocyte has the team, technology and expertise to improve patient care across the cancer care continuum. After completing further diligence into the Company’s DetermaIO immune selection data and their blood-based monitoring approach, we believe the Company has done an outstanding job amassing a strong and under-the-radar portfolio of oncology diagnostics. Oncocyte is focused on opportunities in liquid and tissue biopsy that are overlooked and carry significant potential to benefit patient care, healthcare costs, and value for stakeholders. We have confidence in, and look forward to, continuing to work with them on their efforts to improve cancer diagnosis, treatment and patient outcomes."

In connection with the offering, the Company will sell an aggregate of 7,301,402 shares of its common stock at a purchase price of $3.424 per share ("at market"), the average of the last five closing prices. The registered offering is subject to customary closing conditions and is expected to close during the week of January 26, 2021. At the close of this offering, Oncocyte will have 78,661,802 shares outstanding and will have more than $37 million in cash and cash equivalents.

Proceeds from the registered offering provide the strategic capital to accelerate and support the commercial launch of DetermaRx, Oncocyte’s lung cancer treatment stratification test, DetermaIO, a research use only gene expression test to identify patients who will respond to immune therapies, and the continued development of DetermaMx as the company seeks to expand into the estimated $15 billion-plus blood based monitoring market, as well as for general corporate and working capital purposes. Oncocyte may also use proceeds to invest in or acquire businesses or technologies that it believes are complementary, although the Company has no binding agreements with respect to any strategic transactions or acquisitions as of the date of this press release.

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 offer, solicitation, or sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful.

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.

On January 20, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that details of its plans to report fourth quarter 2020 financial results on February 3, 2021 (Press release, Ligand, JAN 20, 2021, View Source [SID1234574134]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

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Fourth Quarter 2020 Earnings Conference Call

What:

Ligand conference call to discuss financial results and provide general business updates

Wednesday, February 3, 2021

Time:

8:30 a.m. Eastern time (5:30 a.m. Pacific time)

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

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."