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Syndax to Announce Fourth Quarter and Year-end 2020 Financial Results and Host Conference Call and Webcast on March 8, 2021

On March 1, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its fourth quarter and year-end 2020 financial results on Monday, March 8, after the close of the U.S. financial markets (Press release, Syndax, MAR 1, 2021, View Source [SID1234575857]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Monday, March 8, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

MannKind Corporation Announces Proposed Private Placement of Convertible Senior Notes

On March 1, 2021 MannKind Corporation (NASDAQ:MNKD) reported that it intends to offer, subject to market conditions and other factors, $150.0 million aggregate principal amount of Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Mannkind, MAR 1, 2021, View Source [SID1234575856]). MannKind also intends to grant the initial purchasers of the notes an option to purchase, within a 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $22.5 million aggregate principal amount of notes.

The notes will be general unsecured obligations of MannKind and will accrue interest payable semiannually in arrears. Upon conversion, MannKind will pay or deliver, as the case may be, cash, shares of MannKind’s common stock or a combination of cash and shares of MannKind’s common stock, at its election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.

MannKind intends to use the net proceeds from this offering for working capital and other general corporate purposes, including a Phase 3 clinical trial of Afrezza in pediatric subjects and further development of product candidates in MannKind’s pipeline. MannKind may use a portion of the proceeds from this offering to pay down a portion of existing debt or for acquisitions or strategic investments in complementary businesses or technologies, although MannKind does not currently have any plans for any such debt repayment, acquisitions or investments.

The notes and any shares of MannKind’s common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

VBL Therapeutics Announces Patient Dosing Initiated in Randomized, Controlled and Blinded Trial of VB-111 in Patients with Recurrent Glioblastoma Multiforme

On March 1, 2021 VBL Therapeutics (Nasdaq: VBLT) reported that patient dosing has been initiated in a Phase 2 clinical trial investigating ofranergene obadenovec (VB-111) for the treatment of recurrent glioblastoma multiforme (rGBM) (Press release, VBL Therapeutics, MAR 1, 2021, View Source [SID1234575855]). The study is sponsored by Dana-Farber Cancer Institute and is being conducted through a collaboration between VBL and seven leading neuro-oncology medical centers in the U.S.

"This new study builds upon our previous successful Phase 2 trial of VB-111 in recurrent glioblastoma (rGBM) while incorporating lessons learned from the GLOBE study," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "It will use the same VB-111 treatment regimen that induced significant survival benefit in our prior Phase 2 study, this time in patients that go through a second tumor resection. I believe that our perseverance could lead to renewed hope for rGBM patients who are in desperate need of therapies that may change their disease course and prolong life."

The Phase 2 study is enrolling patients with rGBM who are scheduled to undergo a second surgery. VB-111 will be administered either before and after surgery (neo-adjuvant and adjuvant therapy) or after surgery only (adjuvant therapy) and each arm will be compared to a standard of care control arm. In addition to endpoints of progression-free survival (PFS) at 6 months and overall survival (OS), collection of tumor specimens will allow important analysis of the activity of VB-111 within the tumor and will evaluate its effect on the immune system in this immunologically `cold` tumor. Additional information about the new VB-111 study can be found on ClinicalTrials.gov (NCT04406272).

About VB-111 (ofranergene obadenovec)
VB-111 is an investigational, first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the U.S. and Europe, and fast track designation in the U.S. for prolongation of survival in patients with rGBM. VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer (NCT01229865) and recurrent platinum-resistant ovarian cancer (NCT01711970).

Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer

On March 1, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company’s New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer (Press release, Athenex, MAR 1, 2021, View Source [SID1234575854]). The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.

In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm.

The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR). The Agency stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.

The agency recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S. The Agency determined that additional risk mitigation strategies to improve toxicity, which may involve dose optimization and / or exclusion of patients deemed to be at higher risk of toxicity, are required to support potential approval of the NDA.

Athenex plans to request a meeting with the FDA to discuss the Agency’s response, engage in a dialogue on the design and scope of a clinical trial to address the FDA’s requirements and align on the next steps required to obtain approval.

"Our clinical and regulatory teams are disappointed by the complete response letter," said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. "We plan to work with the Agency to resolve the issues raised in the CRL and to obtain approval for oral paclitaxel plus encequidar in metastatic breast cancer."

Dr. Johnson Lau, Chief Executive Officer of Athenex, added, "We remain committed to the breast cancer community and will explore the best path forward to obtain regulatory approval. In the interim, we will identify and undertake the appropriate internal organizational adjustments accordingly."

Webcast and Conference Call

Athenex will host a webcast and conference call today Monday, March 1, 2021, at 8 a.m. ET to discuss this regulatory update for oral paclitaxel, as well as the company’s fourth quarter and full year 2020 financial results. The live call may be access by dialing (877) 407 – 0784 (domestic) or (201) 689-8560 (international) fifteen minutes before the conference call begins and reference the passcode 13715950. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source

Geron to Announce Fourth Quarter and Full Year 2020 Financial Results on March 11, 2021

On March 1, 2021 Geron Corporation (Nasdaq: GERN) reported that it will release its fourth quarter and full year 2020 financial results after the market closes on Thursday, March 11, 2021 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, MAR 1, 2021, View Source [SID1234575852]). Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

A live, listen-only webcast will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the conference call live via telephone by pre-registering online using the following link, View Source Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.