1stOncology™: Cancer Intelligence Service – Page 9991 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Janux Therapeutics Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On June 15, 2021 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing novel T cell engager immunotherapies, reported the closing of its previously announced initial public offering of 13,110,000 shares of its common stock, which includes 1,710,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $17.00 per share. Including the option exercise, the aggregate gross proceeds to Janux from the offering were approximately $222.9 million, before deducting the underwriting discounts and commissions and offering expenses(Press release, Janux Therapeutics, JUN 15, 2021, View Source [SID1234584029]). The shares began trading on the Nasdaq Global Market on June 11, 2021, under the ticker symbol "JANX."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

BofA Securities, Cowen and Evercore ISI acted as joint book-running managers for the offering. H.C. Wainwright & Co. acted as lead manager for the offering.

Registration statements relating to the offering of these securities have been filed with the Securities and Exchange Commission (SEC) and became effective on June 10, 2021. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering was made only by means of a written prospectus. Copies of the final prospectus relating to the initial public offering may be obtained from: BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001 or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926 or by email at [email protected]; or 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].

This press release shall not constitute an offer to sell or a 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.

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.

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.

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.

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.

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.

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.

CRISPR Therapeutics and Capsida Biotherapeutics Announce Strategic Collaboration to Develop Gene-Edited Therapies for Amyotrophic Lateral Sclerosis and Friedreich’s Ataxia

On June 15, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, and Capsida Biotherapeutics Inc., a biotechnology company dedicated to developing breakthrough gene therapies using fully integrated adeno-associated virus (AAV) engineering, cargo development and manufacturing, reported a strategic partnership to research, develop, manufacture and commercialize in vivo gene editing therapies delivered with engineered AAV vectors for the treatment of familial amyotrophic lateral sclerosis (ALS) and Friedreich’s ataxia (Press release, CRISPR Therapeutics, JUN 15, 2021, View Source [SID1234584021]).

Under the agreement, CRISPR Therapeutics will lead research and development of the Friedreich’s ataxia program and perform gene-editing activities for both programs, and Capsida will lead research and development of the ALS program and conduct capsid engineering for both programs. Capsida’s high-throughput AAV engineering platform generates capsids optimized to target specific tissue types and limits transduction of tissues and cell types that are not relevant to the target disease, potentially allowing for improved efficacy and safety. CRISPR Therapeutics and Capsida will each have the option to co-develop and co-commercialize the program that the other company leads. Following such option, the companies would equally share all research, development and commercialization costs and profits worldwide related to the collaboration product. As part of the collaboration, Capsida will also be responsible for process development and clinical manufacture of both programs and have the option to manufacture commercial products generated under the agreement.

"We are excited to enter this collaboration with Capsida. The combination of Capsida’s AAV engineering platform and CRISPR Therapeutics’ gene-editing platform has the potential to enable transformative gene-edited therapies for patients with neurological diseases," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "This new partnership is one more step in our overall strategy of bringing together innovative and complementary technologies to unlock the full potential of our core platform."

"Bringing together Capsida’s fully integrated, tissue targeting gene therapy platform with CRISPR Therapeutics’ leading gene-editing capabilities gives us the potential to develop first-in-class gene therapies for patients with severe neurological disorders and expand the reach of Capsida’s broadly enabling capabilities," said Robert Cuddihy, M.D., Chief Executive Officer of Capsida Biotherapeutics.