Zentalis Leads a Trio of Biotechs Charting a Course for Wall Street

On March 9, 2020 Zentalis Pharmaceuticals reported set a preliminary $100 million target for its IPO, according to documents filed with the Securities and Exchange Commission (Press release, Zentalis Pharmaceuticals, MAR 9, 2020, View Source [SID1234555312]). The New York-based company has applied for a Nasdaq listing under the stock symbol "ZNTL." That company is joined by Ayala Pharmaceuticals and Lyra Therapeutics, both of which also filed IPO paperwork last Friday.

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Zentalis is developing small molecules to address biological pathways of cancers. The company says in its prospectus its small molecules are different than currently marketed therapies, and that they also have the potential to address large populations of cancer patients.

The Zentalis pipeline consists of four compounds, three of which are in early-stage clinical testing. Lead drug candidate, ZN-c5, is designed to target estrogen receptors (ER), proteins to which the hormone estrogen binds. Tumors that are ER positive and human epidermal growth factor receptor (HER2) negative rely on these proteins for their growth and survival. Zentalis’s ZN-c5 is an oral drug that’s a selective estrogen receptor degrader (SERD). The compound is in Phase 1/2 testing.

The Zentalis drug is intended to challenge fulvestrant (Faslodex), an AstraZeneca (NYSE: AZN) SERD. In 2018, the last year prior to the launch of generic competition, fulvestrant accounted for more than $1 billion in revenue for AstraZeneca. This drug is administered via two 5 mL intramuscular injections given once a month. In addition to being painful, injections of the drug into the muscle restricts how much ER degradation can be achieved, limiting its efficacy, Zentalis says.

As a once-daily pill, Zentalis believes its drug would offer patients more convenience. The drug might also be more effective. According to early data from a Phase 1/2 study, the drug was rapidly absorbed and achieved high exposure levels in the body. The Zentalis drug was well tolerated by patients and no dose-limiting toxicities were reported. Additional preliminary data from the dose escalation portion of the study are expected in the second half of this year.

The Zentalis drug is also being tested in combination with palbociclib (Ibrance), a Pfizer (NYSE: PFE) cancer drug that is FDA approved as a treatment for HR positive, HER2 negative breast cancer. Under an agreement with Pfizer, the pharmaceutical giant is supplying its drug for the study at no cost to Zentalis, according to the filing. Zentalis is responsible for conducting the study and paying for it. The agreement does not give Pfizer the right to participate in future Zentalis clinical trials, and each company keeps rights to their respective drugs.

The Zentalis pipeline also includes ZN-c3 and ZN-e4, drugs in early-stage development for solid tumors and non-small cell lung cancer respectively. Preliminary data for those tests are expected in 2021. Another Zentalis compound, ZN-d5, is an experimental treatment for B-cell lymphoma. In the first half of this year, the company plans to seek FDA clearance to begin clinical testing of that drug. Zentalis says in the prospectus that it will use the IPO proceeds to continue development of its three clinical-stage compounds and to advance its B-cell lymphoma drug to human testing.

Since its 2014 founding, Zentalis has raised $162.1 million, according to the filing. The most recent financing was an $85 million Series C round that closed in December. As of the end of last year, the company had $67.2 million in cash. Its largest shareholders include Recurium Equity, Matrix Capital Management Master Fund, and Viking Global Investors. The percentage of Zentalis held by those shareholders is more than 5 percent, but the exact amount was not disclosed.

Lilly to Participate in Barclays Global Healthcare Conference

On March 9, 2020 Eli Lilly and Company (NYSE:LLY) reported that it will participate in the Barclays Global Healthcare Conference on Tuesday, March 10, 2020 (Press release, Eli Lilly, MAR 9, 2020, View Source [SID1234555311]. Ilya Yuffa, vice president, U.S. Diabetes, and Jeffrey Emmick, M.D., Ph.D., vice president, diabetes product development, will participate in a virtual fireside chat at 10:45 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

ImmunoPrecise Announces Debt Settlement of Previously Issued Debentures

On March 9, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC QB: IPATF) reported that it wishes to settle up to $796,875 of previously issued debentures including interest by issuing up to 1,328,125 Shares at a price of $0.60 per Share (the "Debt Settlement") (Press release, ImmunoPrecise Antibodies, MAR 9, 2020, View Source [SID1234555310]). The purpose of the Debt Settlement is to reduce the ongoing debt obligations of the debentures and is subject to the approval of the TSX Venture Exchange.

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Immune Therapeutics, Inc. Provides Updates and Guidance on Reverse Stock Split and Name Change

On March 9, 2020 Immune Therapeutics, Inc. (OTC Pink: IMUN) ("Immune" "IMUN" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of therapies for the treatment of autoimmune diseases, inflammatory diseases and cancer reported an update on the pending 1000-to-1 reverse stock split and name change of Immune Therapeutics (Press release, Immune Therapeutics, MAR 9, 2020, View Source [SID1234555308]).

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Immune Therapeutics originally submitted the reverse and name change request for a corporate action to FINRA and paid the applicable fees on November 27, 2019. Since then, the company has responded in a timely fashion to all of FINRA’s requests for further information, and we continue in our efforts to work diligently and cooperatively with FINRA to process the reverse and name change. FINRA requested a copy of the File-stamped articles of amendment from the state of incorporation approving the name change and reverse split which can be found by clicking on the following link.

The Company approved the amended Articles of Incorporation and filed them with the State of Florida Division of Corporation, on February 20, 2020; the State of Florida accepted and approved the 1000-to-1 reverse split leaving 458,019 shares issued and outstanding. Please note that the Company has no control of the FINRA approval process and as such the timing of any decisions our not in the Company’s control.

Michael K. Handley, CEO of Immune, said, "We had hoped the process of implementing the reverse and name change would have occurred sooner, but we are confident and fully committed to seeing the reverse and name change through. Furthermore, I would personally like to thank all of our shareholders for their patience in this process. We realize this delay may have eroded shareholder confidence, however, based on the extensive review by FINRA, we are optimistic that their approval may be given soon, at which time we will inform shareholders immediately. I would like to thank our shareholders on behalf of Immune and myself for standing behind us as we continue to work in your interests with a commitment to improving shareholder value and bringing lifesaving drugs to the market."

In regard to Immune’s drug programs, the Company has made great progress to the restructuring and advancement of its Lodonal and MENK programs, and will release detailed updates shortly on both these and its business development activities. In the interim, Immune would like to announce it has assisted Cytocom in with the advancement of their Crohn’s therapy program with Lodonal by requesting a Type C meeting with the FDA. Immune and Cytocom expect to have the Type C meeting in the next several months and plan to receive guidance on the final steps to approving the drug for Crohn’s disease.

AbbVie Announces Extension of Expiration Date for Exchange Offers for Allergan Notes

On March 9, 2020 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported the extension of the expiration date of the offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") any and all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc. ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (the "Allergan Notes") for new notes to be issued by AbbVie (the "AbbVie Notes") and the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt certain amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes (Press release, AbbVie, MAR 9, 2020, View Source [SID1234555302]). AbbVie hereby extends such expiration date from 5:00 p.m., New York City time, on March 13, 2020 to 5:00 p.m., New York City time, on March 27, 2020 (as the same may be further extended, the "Expiration Date").

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On the early participation date of November 7, 2019, requisite consents were received and supplemental indentures were executed eliminating substantially all of the covenants, restrictive provisions, events of default and any guarantees of the related Allergan Notes in each Allergan Indenture. Such supplemental indentures will become operative only upon settlement of the Exchange Offers.

The Exchange Offers and Consent Solicitations were commenced in connection with AbbVie’s previously announced proposed acquisition of Allergan plc (the "Acquisition") and are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal, each as amended by the press releases dated November 18, 2019, December 20, 2019, January 27, 2020 and February 24, 2020 and as amended hereby (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and the Expiration Date of each of the Exchange Offers is expected to be extended to occur on or about the closing date of the Acquisition. As a result, the Expiration Date may be further extended one or more times. AbbVie currently anticipates providing notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on March 6, 2020, the principal amounts of Allergan Notes set forth in the table below were validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Allergan Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" as defined in Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), or not a "U.S. person" and outside the United States within the meaning of Regulation S under the Securities Act. Except as amended by the press releases dated November 18, 2019, December 20, 2019, January 27, 2020 and February 24, 2020 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the Offering Documents, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-3900 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source