Corcept Therapeutics Settles Patent Litigation with Sun Pharmaceutical

On June 15, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it has entered into an agreement with Sun Pharmaceutical Industries Limited and related entities ("Sun") resolving patent litigation related to Korlym, Corcept’s medication for the treatment of patients with Cushing’s syndrome(Press release, Corcept Therapeutics, JUN 15, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-settles-patent-litigation-sun [SID1234584024]). The litigation has been pending in the United States District Court for the District of New Jersey since 2019, shortly after Sun notified Corcept that it had submitted an Abbreviated New Drug Application (ANDA) to the United States Food and Drug Administration (FDA) seeking approval to market a generic version of Korlym.

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In connection with the settlement, Corcept has granted Sun the right to sell a generic version of Korlym in the United States beginning October 1, 2034 or earlier under circumstances customary for settlement agreements of this type.

"It is gratifying to put this lawsuit behind us," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Litigation is a costly, time-consuming diversion from our efforts to grow our Korlym business and continue the development of our increasingly mature pipeline of selective cortisol modulators – including relacorilant, our planned successor to Korlym for the treatment of patients with Cushing’s syndrome."

The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation. As required by law, Corcept and Sun will submit the agreement to the United States Federal Trade Commission (FTC) and the United States Department of Justice (DOJ) for review. Similar patent litigation brought by Corcept against two other companies that have filed ANDAs seeking approval to market generic Korlym remains pending.

About Korlym

Korlym modulates the effect of cortisol at the glucocorticoid receptor, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness.

eFFECTOR Therapeutics to Present at JMP Securities 2021 Life Sciences Conference

On June 15, 2021 eFFECTOR Therapeutics, Inc. ("eFFECTOR"), a biopharmaceutical company focused on pioneering the development of selective translation regulation inhibitors ("STRIs") for the treatment of cancer, reported that Steve Worland, Ph.D., president and chief executive officer of eFFECTOR, and Chris Ehrlich, chief executive officer and director of Locust Walk Acquisition Corp. (NASDAQ: LWAC), a special purpose acquisition company, will present a company overview at the JMP Securities 2021 Life Sciences Conference on Thursday, June 17 at 2:00 p.m. ET (Press release, eFFECTOR Therapeutics, JUN 15, 2021, View Source [SID1234583983]).

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A live webcast will be accessible from the "Events and Presentation" page of the "News" section of the eFFECTOR’s website (www.effector.com).

As previously announced on May 27, 2021, eFFECTOR entered into a definitive Agreement and Plan of Merger (the "Merger Agreement") with LWAC and Locust Walk Merger Sub, Inc., a wholly owned subsidiary of LWAC ("Merger Sub"). Upon the closing of the transaction, anticipated to occur in the third quarter of 2021, subject to approval of LWAC stockholders and the satisfaction or waiver of certain other customary closing conditions, the combined company will be named eFFECTOR Therapeutics, Inc. and is expected to be listed on the Nasdaq Capital Market under the ticker symbol "EFTR".

PDS Biotech Prices Public Offering of Common Stock

On June 15, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune(R) T-cell activating technology, reported the pricing of its previously announced underwritten public offering of 5,294,118 shares of its common stock at a public offering price of $8.50 per share(Press release, PDS Biotechnology, JUN 15, 2021, View Source [SID1234584097]). The gross proceeds to PDS Biotech, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $45.0 million. All of the shares of common stock to be sold in the offering are being offered by PDS Biotech. PDS Biotech has granted the underwriters a 30-day option to purchase up to an additional 794,117 shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about June 17, 2021, subject to customary closing conditions.

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

PDS Biotech intends to use a portion of the net proceeds from this offering for the development of our clinical pipeline and for general corporate purposes including working capital.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and became effective on July 31, 2020. A preliminary prospectus supplement relating to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, NY 10022, Attn: Capital Markets Department, or by email at [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.

Inhibikase Therapeutics Prices Follow-On Public Offering of Common Stock

On June 15, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders inside and outside of the brain, reported the pricing of an underwritten public offering of 15 million shares of its common stock at a public offering price of $3.00 per share for total gross proceeds of approximately $45 million (the "Offering) before deducting underwriting discounts and commissions and offering expenses payable by Inhibikase. In addition, Inhibikase has granted the underwriters a 45-day option to purchase up to 2.25 million additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on June 18, 2021, subject to customary closing conditions.

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Inhibikase intends to use the net proceeds from the public offering, together with existing funds, to fund the costs of a Phase 1b extension study for IkT-148009 in Parkinson’s patients and to validate target engagement markers in the central and peripheral nervous system; to fund production of IkT-148009 for Phase 1b and Phase 2 clinical studies and to fund a Phase 2 efficacy trial of IkT-148009 in Parkinson’s patients. This funding will further support the clinical dose calibration study(ies) of IkT-001Pro in healthy subjects to support approval under the Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act and to fund drug product production for IkT-001Pro. The balance will support general research and development activities, medicinal chemistry for additional molecules and IND-enabling studies, team building, and other general corporate activities

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering. JonesTrading Institutional Services LLC is acting as the co-manager for the offering.

The offering is being made pursuant to a registration statement on Form S-1 (File No. 333-257032) that was declared effective by the Securities and Exchange Commission (the "SEC") on June 15, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email 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.

INmune Bio, Inc. Announces $15 Million Credit Facility to Purchase Xencor Option to Reduce Future Dilution

On June 14, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the, "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that the Company has entered into a new $15 million credit facility with Silicon Valley Bank (SVB) and an affiliate of SVB Financial Group(Press release, INmune Bio, JUN 15, 2021, View Source [SID1234584028]). INmune intends to use the proceeds from the facility to partially fund the buyout of an option held by Xencor, Inc., resulting from INmune’s in-licensing of XPro1595 (now known by its generic name, pegipanermin) in October 2017. Total consideration to be paid to Xencor by INmune is $18.3 million, comprised of $15 million of cash and $3.3 million of INMB shares at a price of $17.14 resulting in the issuance of 192,533 shares.

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Pursuant to the original 2017 in-licensing agreement, INmune granted Xencor an option to purchase an additional number of shares of common stock equal to 10% of INmune’s fully diluted company shares for a period of seven years. The retirement of the Xencor option eliminates an estimated 2.1 million shares of potential future common stock dilution upon exercise of the option.

Concurrent with this transaction, David Szymkowski, Ph.D., Vice President of Preclinical Operations at Xencor, stepped down from INmune’s Board of Directors.

"INmune Bio has made significant progress to date on the development of XPro1595, including the announcement of encouraging data in Alzheimer’s disease earlier this year," stated David Szymkowski, PhD, Vice President of Preclinical Operations at Xencor. "XPro1595 is a novel approach to addressing the neuroinflammation implicated in a number of serious neurological indications, where more effective treatment options are desperately needed. We look forward to INmune’s continued progress as XPro1595 advances in multiple clinical studies."

"We are grateful to the team at Xencor for reaching this agreement and allowing us to simplify our capital structure," stated RJ Tesi, MD, Chief Executive Officer of INmune Bio. "We remain acutely focused on the timely initiation of Phase 2 trials of XPro1595 in Alzheimer’s and treatment resistant depression later this year."

About XPro1595 (Pegipanermin)

XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that uses a dominant-negativeTNF technology that is very different from approved TNF inhibitors that block the effects of both soluble and trans-membrane TNF. Pegipanermin neutralizes soluble TNF, without affecting trans-membrane TNF or TNF receptors. XPro1595 could have substantial beneficial effects in patients with Alzheimer’s and other neurodegenerative diseases by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.