On October 1, 2020 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that it has entered into a loan facility for up to $75 million with Hercules Capital, Inc. (NYSE: HTGC) and Silicon Valley Bank (SVB) (Press release, Geron, OCT 1, 2020, View Source [SID1234569805]). The loan facility provides the Company with access to non-dilutive financial resources to support the imetelstat development program, as well as working capital and general corporate purposes.

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"This debt financing strengthens our balance sheet and provides additional financial flexibility as our imetelstat program advances with two Phase 3 registration-enabling clinical trials – the ongoing IMerge trial in lower risk myelodysplastic syndromes and the planned trial in refractory myelofibrosis," said Olivia K. Bloom, Chief Financial Officer. "We look forward to working with Hercules and SVB in the future as we include non-dilutive capital in our financing strategy."

The loan facility is available to Geron in three tranches. The Company received $25 million as part of the first tranche at closing, with the remaining $10 million available through June 15, 2021. The second tranche of an additional $15 million is available to Geron in 2021, subject to achievement of certain clinical milestones. The remaining $25 million in the third tranche is available to the Company through year-end 2022, and subject to approval from the lenders.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Geron’s imetelstat development program includes two registration-enabling studies, IMerge, an ongoing Phase 2/3 clinical trial in lower risk myelodysplastic syndromes (MDS), and a planned Phase 3 clinical trial in refractory myelofibrosis (MF) expected to be open for patient screening and enrollment in the first quarter of 2021. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

On October 1, 2020 Replimune Presented the Corporate Presentation (Presentation, Replimune, OCT 1, 2020, View Source [SID1234568709]).

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On October 1, 2020, PDL BioPharma, Inc., ("PDL," "we" or the "Company") reported that completed the previously announced separation of LENSAR, Inc. ("LENSAR") from PDL in the form of a dividend involving the distribution of all outstanding shares of LENSAR common stock owned by PDL to holders of PDL common stock (the "Distribution") (Filing, 8-K, PDL BioPharma, OCT 1, 2020, View Source [SID1234568213]). The Distribution was made to the Company’s stockholders of record as of the close of business on September 22, 2020 (the "Record Date"), and such stockholders received 0.075879 shares of LENSAR common stock for every one PDL common share held as of close of business on the Record Date. Stockholders of PDL who acquired shares of PDL common stock in the "regular way" market since shortly before the record date and through October 1, 2020 acquired such shares with an entitlement to receive shares of LENSAR common stock in connection with the distribution. Stockholders of PDL who acquired their shares of PDL common stock ex-distribution during that time did so without an entitlement to receive shares of LENSAR common stock in connection with the distribution.

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Prior to the Distribution, PDL owned approximately 81.5% of LENSAR common stock. Following the completion of the distribution, PDL does not own any equity interest in LENSAR. As a result of the Distribution, LENSAR became an independent public company whose stock is listed and trading under the symbol "LNSR" on the Nasdaq Stock Market.

Basis of Presentation

The following unaudited pro forma condensed consolidated financial statements were derived from the historical financial statements of PDL as of and for the six months ended June 30, 2020 and for each of the years ended December 31, 2019, 2018 and 2017, which were prepared in accordance with generally accepted accounting principles in the United States of America ("GAAP").

The unaudited pro forma condensed consolidated financial statements for the six months ended June 30, 2020 and the years ended December 31, 2019, 2018 and 2017 assume the Distribution occurred on May 11, 2017 when PDL obtained control of 100% of the voting shares of LENSAR, making it a wholly-owned subsidiary of the Company. The unaudited pro forma condensed consolidated balance sheet assumes the Distribution and the related transactions occurred on June 30, 2020. Beginning in the fourth quarter of 2020, the results of operations of LENSAR will be presented as discontinued operations for historical periods through August 31,2020, the day prior to the Company’s adoption of the liquidation basis of accounting effective September 1, 2020.

The unaudited pro forma condensed consolidated financial statements are provided for illustrative purposes only and do not reflect what PDL’s results of operations or financial position would have been had the Distribution been completed on the dates assumed and are not necessarily indicative of PDL’s future results of operations or financial position.

The following unaudited pro forma condensed consolidated financial statements and the accompanying notes to the unaudited pro forma condensed consolidated financial statements should be read in conjunction with (i) the historical consolidated financial statements of PDL for the years ended December 31, 2019, 2018 and 2017, the accompanying notes to those financial statements and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in exhibit 99.1 of PDL’s Current Report on Form 8-K filed with the Securities and Exchange Commission ("SEC") on June 29, 2020, (ii) the unaudited condensed consolidated financial statements and accompanying notes and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" included in PDL’s Form 10-Q for the six months ended June 30, 2020 filed with the SEC on August 7, 2020 and (iii) the historical consolidated financial statements of LENSAR in LENSAR’s Registration Statement on Form 10 filed with the SEC on August 26, 2020, as amended on September 14, 2020.

On October 1, 2020 The Ohio State University College of Veterinary Medicine (CVM) and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) reported that it have been awarded a five-year, $9.1 million Program Project Grant (PPG) renewal from the National Cancer Institute (NCI) (Press release, The Ohio State University, OCT 1, 2020, View Source [SID1234568064]).

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The PPG has been continually funded since 2003 and will allow investigators from the CVM, OSUCCC – James and collaborators at the Washington University – St. Louis to continue studying retrovirus models of cancer.

The grant renewal extends through 2025 and is led by principal investigator Patrick Green, PhD, associate director for basic research at the OSUCCC – James and director of the Center for Retrovirus Research in the CVM.

The goal of this PPG is to use a human T-cell leukemia virus type 1 (HTLV-1) T-cell immortalization model to gain an understanding of the microenvironmental, cellular and viral factors that lead to adult T-cell (ATL) leukemia.

"This is a powerful area of basic research we expect to result in new targets for the treatment of HTLV-1 infection, ATL and related leukemias and lymphomas," says Green, who also serves as professor and associate dean for research and graduate studies in the CVM and holds the Robert H. Rainier Chair in Industrial Veterinary Medicine and Research.

"This grant has allowed our multidisciplinary team to advance understanding of how retrovirus proteins contribute to cell immortalization, how retroviruses cause cellular changes that position infected cells to progress to metastatic cancer, and how ATL cells contribute to paraneoplastic disease syndromes and can be targeted for anticancer therapy," Green adds. "These are important discoveries, and this renewed funding with allow us to continue momentum in this area of cancer research."

The collaborative research grant is organized around three research projects and three research cores.

Projects include:

Role of HTLV-1 HBZ in Transformation and Disease

(Leader: Patrick Green, PhD; Co-I: Amanda Panfil, PhD)

This project will characterize the mechanism of HBZ gene products relating to HTLV-1 infection, viral latency and emergence of ATL. The major focus is on identifying and characterizing cellular binding partners that interact with HBZ messenger RNA (mRNA) and HBZ protein, and to determine the impact of those interactions on viral pathogenesis.

Effect of HTLV-1 Viral Oncogenes on the Bone Marrow Microenvironment in ATL

(Leader: Katherine Weilbaecher, MD; Co-I: Deborah Veis, MD, PhD)

This project will define the molecular mechanisms that HTLV-1-transformed cells use to interact with cells in the bone microenvironment, which include osteoblasts, bone marrow stromal cells, macrophage lineage cells and osteoclasts. Researchers will also focus on the relationship between HTLV-1 HBZ gene expression and both the Wnt non-canonical pathway (involving Wnt5a) and the HPSE gene. This work will utilize mouse transgenic and humanized animal models to evaluate the relevance of these pathways on HTLV-1 bone pathology.

Role of CTCF in HTLV-1 Replication and Transformation

(Leader: Lee Ratner, MD, PhD)

Researchers will determine if and how the CTCF gene modulates the behavior of HTLV-1-infected T cells as it relates to virus expression, HBZ gene regulation, methylation of provirus elements, site of virus integration and effect on surrounding host genes.

The PPG also supports administrative/biostatistics, virus vector and animal research cores relating to this ongoing retrovirus research.

Co-investigators in the PPG include: Amanda Panfil, PhD, Stefan Niewiesk, DVM, PhD, and Krista La Perle, DVM, PhD, from the CVM; Kristine Yoder, PhD, Soledad Fernandez, and Lianbo Yu, PhD, from Ohio State’s College of Medicine; Amanda MacFarlane, PhD, from the OSUCCC – James; and Lee Ratner, MD, PhD, Katherine Weilbaecher, MD, and Deborah Veis, MD, PhD, from Washington University. Panfil, Niewiesk and La Perle are in the Leukemia Research Program at the OSUCCC – James, where Yoder is in the Molecular Carcinogenesis and Chemoprevention Program, and Fernandez is in the Cancer Biology Program.

On October 1, 2020 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a biopharmaceutical company pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins through degradation, reported the pricing of its upsized initial public offering of 9.6 million shares of common stock at a public offering price of $19 per share, before underwriting discounts and commissions, for gross proceeds of $182.4 million (Press release, C4 Therapeutics, OCT 1, 2020, View Source [SID1234567980]). All shares of common stock are being offered by C4T. The shares are expected to begin trading on the Nasdaq Global Market on October 2, 2020, under the symbol "CCCC." The offering is expected to close on October 6, 2020, subject to the satisfaction of customary closing conditions. Additionally, C4T has granted the underwriters a 30-day option to purchase up to an additional 1.44 million shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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Jefferies, Evercore ISI, BMO Capital Markets and UBS Investment Bank are acting as joint book-running managers for the offering.

A registration statement relating to these securities became effective on October 1, 2020. The offering will be made only by means of a prospectus, copies of which may be obtained from 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 email at [email protected]; or from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474 0200, or by email at [email protected]; or from BMO Capital Markets Corp. at 3 Times Square, 25th Floor, New York, NY 10036, Attention: Equity Syndicate Department, or by telephone at (800) 414-3627, or by email to [email protected]; or from UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, New York 10019, or by telephone at (888) 827-7275, or by e-mail at [email protected].

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.