On November 7, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that its Chief Executive Officer Thomas Lingelbach and Chief Financial Officer Peter Bühler will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take place November 15-17, 2022 in London, England (Press release, Valneva, NOV 7, 2022, View Source [SID1234623387]).

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Additionally, Mr. Lingelbach and Mr. Bühler will participate in a fireside chat on Tuesday, November 15, 2022, at 11:30am GMT, to discuss the Company’s late-stage vaccine candidates against chikungunya (VLA1553) and Lyme disease (VLA15), as well as its commercial products. The webcast will be accessible live via the following link, View Source A replay of the webcast will be available following the live events in the "Investor" section of the Valneva website at www.valneva.com.

To request a meeting at the event, please contact your representative at Jefferies.

On November 7, 2022 Ocuphire Pharma, Inc. (Nasdaq: OCUP) reported it has concluded an exclusive license agreement with FamyGen Life Sciences, Inc. (Famy) for the development and commercialization of Nyxol across three indications in US, Europe, Japan, India, China and other global markets (Press release, Ocuphire Pharma, NOV 7, 2022, View Source [SID1234623364]). In connection with its separately announced transaction with Famy, Viatris Inc. (Nasdaq: VTRS), a leading global healthcare company, has agreed to commercialize Nyxol following each regulatory approval.

"Famy and Ocuphire have been engaging for several months, in a collaborative spirit, to conclude this agreement. This partnership provides a clear pathway to completing development and regulatory activities and executing a successful US and global commercial launch of Nyxol through Viatris," said Mina Sooch, MBA, founder and CEO of Ocuphire. With its strategic commitment to ophthalmics and its global commercial infrastructure, we believe Viatris provides a great opportunity for all of the Nyxol indications to realize their full commercial potential in their respective markets. In addition, the upfront payment and development funding provided by this transaction markedly improve our cash position into 2025, allowing us to expedite the registration trials for presbyopia and night vision disturbances and to execute our late-stage development strategy for the APX3330 retina program."

Under the terms of the license agreement, Ocuphire will receive an upfront cash payment of $35 million. Famy will fund Nyxol development through FDA approvals, that will be managed by Ocuphire, including clinical, manufacturing, and regulatory activities required for FDA approval of all three Nyxol indications, including Nyxol+Low-Dose Pilocarpine. With the upcoming NDA submission for the reversal of mydriasis indication this quarter, Ocuphire has the potential to receive a $10 million milestone payment upon FDA approval later in 2023 and thereafter to receive additional regulatory milestones for presbyopia and night vision disturbances indications. In addition to funding Ocuphire’s development of Nxyol in the US, Famy will undertake development in the non-US markets.

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Upon commercialization, Ocuphire will receive tiered double-digit royalties on worldwide net sales through 2040 and is eligible to receive sales milestone payments upon achievement of certain annual sales thresholds.

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On November 7, 2022 Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported the commencement of a proposed underwritten public offering of $150,000,000 of common shares (Press release, Roivant Sciences, NOV 7, 2022, View Source [SID1234623340]). Roivant expects to grant the underwriter a 30-day option to purchase up to $22.5 million of additional common shares. The offering is subject to market conditions and other factors, 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.

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Cantor Fitzgerald & Co. is acting as sole bookrunner for the offering.

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on October 3, 2022. The offering will be made only by means of a prospectus supplement and accompanying prospectuses. A preliminary prospectus supplement related to the offering has been filed with the SEC and is available free of charge by visiting EDGAR on the SEC’s website at www.sec.gov.

Copies of the preliminary prospectus supplement and the accompanying prospectuses relating to the offering may be obtained free of charge from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

On November 7, 2022 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported that John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer, is scheduled to participate in a fireside chat in person at the Stifel 2022 Healthcare Conference in New York City on Tuesday, November 15, 2022 at 10:55 a.m. ET (Press release, Geron, NOV 7, 2022, View Source [SID1234623339]).

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A webcast of the presentation will be available through the Investor Relations section of Geron’s website under Events. Following the presentation, the webcast will be archived and available for replay for a period of 30 days.

On November 7, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended September 30, 2022 (Press release, ORIC Pharmaceuticals, NOV 7, 2022, View Source [SID1234623338]).

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"We are pleased with the steady enrollment progress across our three ongoing Phase 1b studies and are looking forward to sharing initial clinical data for ORIC-533, ORIC-114 and ORIC-944 in the first half of 2023. Building on the strong enrollment in South Korea for ORIC-114, our brain penetrant EGFR/HER2 exon 20 program, we accelerated plans for the US IND filing and received clearance from the FDA during the third quarter," said Jacob M. Chacko, MD, chief executive officer. "We continue to be encouraged by data demonstrating ORIC-533, our oral small molecule inhibitor of CD73, has therapeutic potential in multiple myeloma and look forward to the presentation of ORIC-533 preclinical data at the 2022 ASH (Free ASH Whitepaper) Annual Meeting next month."

Third Quarter 2022 and Other Recent Highlights

ORIC-114 US IND Filing and FDA Clearance: ORIC continued to expand the clinical development of ORIC-114 by submitting and receiving clearance from the FDA of its US IND application in the third quarter of 2022. A Phase 1b trial with ORIC-114 as a single agent is already underway in South Korea and has been enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows patients with CNS metastases that are either treated or untreated but asymptomatic.

ORIC-533 Preclinical Data to be Presented at the 2022 ASH (Free ASH Whitepaper) Annual Meeting: ORIC announced a preclinical poster presentation on its CD73 inhibitor in multiple myeloma will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 10-13, 2022, in New Orleans, LA.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

ORIC-533 (oral CD73 inhibitor): Initial Phase 1b data in 1H 2023

ORIC-114 (brain penetrant EGFR/HER2 exon 20 inhibitor): Initial Phase 1b data in 1H2023

ORIC-944 (allosteric PRC2 inhibitor): Initial Phase 1b data in 1H 2023

Third Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $218.0 million as of September 30, 2022, which the company expects will fund its current operating plan into the second half of 2024.

R&D Expenses: Research and development (R&D) expenses were $14.7 million for the three months ended September 30, 2022, compared to $12.9 million for the same period in 2021. The increase was primarily driven by a net increase in external expenses related to the advancement of product candidates as well as higher personnel costs. For the nine months ended September 30, 2022, R&D expenses were $45.4 million, compared to $40.1 million for the same period of 2021. The increase was primarily driven by a net increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and other product candidates as well as higher personnel costs, including non-cash stock-based compensation of $0.8 million.

G&A Expenses: General and administrative (G&A) expenses were $6.0 million for the three months ended September 30, 2022, compared to $5.6 million for the same period in 2021. The increase was primarily due to higher personnel costs. For the nine months ended September 30, 2022, G&A expenses were $19.3 million compared to $16.0 million for the same period of 2021. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.1 million.

IPR&D Expenses: In-process research and development (IPR&D) expense of $5.0 million for the three and nine months ended September 30, 2022, was due to a development milestone payment made to Voronoi related to ORIC-114. There were no similar costs in 2021.