Molecular Templates, Inc. Announces Proposed Public Offering of Common Stock

On February 17, 2021 Molecular Templates, Inc. (Nasdaq: MTEM) (the "Company" or "Molecular"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer and other serious diseases, reported that it has commenced an underwritten public offering of its common stock (Press release, Molecular Templates, FEB 17, 2021, View Source [SID1234575187]). Molecular also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by Molecular.

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Molecular intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund: its Phase II clinical studies for MT-3724 and/or development of other CD20-targeted molecules; its ongoing Phase I clinical study of MT-5111; its share of development expenses in its CD38 collaboration with Takeda; its PD-L1 program (including its anticipated upcoming Phase I clinical study for MT-6402); further preclinical development and drug discovery activities in its other programs; and for working capital and general corporate purposes. The offering is subject to market and other conditions, 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.

BofA Securities, Cowen, Evercore ISI and Barclays are acting as joint book-running managers for the offering.

The securities are being offered by Molecular pursuant to a shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC. A preliminary prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained from BofA Securities, Inc., c/o BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or via e-mail at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or via telephone at (833) 297-2926; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, via telephone at (888) 474-0200, or via e-mail at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at (888) 603-5847, or via e-mail at [email protected][email protected]. You may also obtain these documents free of charge by visiting the SEC’s website at www.sec.gov.

This press release does 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Nkarta Announces February and March 2021 Investor Conference Schedule

On February 17, 2021 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported its participation at these upcoming investor conferences (Press release, Nkarta, FEB 17, 2021, View Source [SID1234575186]):

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SVB Leerink 10TH Annual Global Healthcare Conference
February 26, 2021
Fireside chat presentation: 1:40 p.m. ET

Cowen 41ST Annual Health Care Conference
March 3-4, 2021
No presentation

Barclays Global Healthcare Conference
March 11, 2021
Fireside chat presentation: 10:20 a.m. ET

Live audio webcasts of the presentations will be available on the Investors section of Nkarta’s website, www.nkartatx.com. Replays of the webcasts will be archived on the website for approximately four weeks.

Ultragenyx to Present at Upcoming Investor Conferences

On February 17, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the following upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, FEB 17, 2021, View Source [SID1234575185]):

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SVB Leerink 10th Annual Global Healthcare Conference on Wednesday, February 24, 2021 at 2:20 PM ET.

Cowen 41st Annual Health Care Conference on Monday, March 1, 2021 at 2:00 PM ET.
The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

Salarius Completes Dose-Escalation Stage of Phase 1/2 Clinical Trial in Relapsed and Refractory Ewing Sarcoma Patients, Initiates Expansion Stage in Ewing and Ewing-related Sarcoma Patients

On February 17, 2021 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, reported that it has completed the dose-escalation stage and established the recommended Phase 2 dose (RP2D) for its ongoing Phase 1/2 clinical trial in relapsed/refractory (R/R) Ewing sarcoma (Press release, Salarius Pharmaceuticals, FEB 17, 2021, View Source [SID1234575184]).

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The Phase 1/2 clinical trial of seclidemstat in patients with Ewing sarcoma was designed as an open-label, multi-center, dose-finding study. The primary objectives of the study were to determine the safety and tolerability of seclidemstat. Secondary objectives were to assess the maximum-tolerated dose (MTD), the RP2D, preliminary anti-tumor activity, pharmacokinetics (PK), and pharmacodynamics.

Data from patients treated in the dose-escalation portion of the trial demonstrated seclidemstat had a manageable safety profile. The RP2D for the expansion stage has been established and, importantly, PK data from the dose-escalation portion of the trial indicated that treatment at the RP2D achieved plasma concentrations above levels where seclidemstat demonstrated activity in preclinical studies. Salarius is preparing to submit the full findings from the dose-escalation trial, including details on safety, dosing, and initial efficacy signals, for presentation at an upcoming medical conference. Conference embargo rules prevent additional disclosures at this time.

"The completion of dose escalation in Ewing sarcoma patients and establishment of the RP2D represent important milestones in our clinical development of seclidemstat," stated David Arthur, President and CEO of Salarius Pharmaceuticals. "We are encouraged by data from the dose-escalation phase and look forward to continuing development of seclidemstat for difficult to treat cancers."

Salarius is evaluating its lead drug candidate, seclidemstat, in patients with R/R Ewing sarcoma, a rare and deadly pediatric bone and soft tissue cancer and in a Phase 1/2 trial enrolling patients with Advanced Solid Tumors (AST). Seclidemstat is a novel, oral reversible inhibitor of the lysine-specific histone demethylase 1 enzyme (LSD1), an enzyme that has been shown to play a key role in the development and progression of certain cancers.

As previously reported, a refractory Ewing sarcoma patient treated with single-agent seclidemstat for six cycles (a cycle is 28 days), demonstrated a reduction in prospectively defined target lesions starting at end of cycle 2 with further target lesion tumor shrinkage through end of cycle 4 and cycle 6 (over 75% tumor shrinkage). The appearance of new non-target lesion at the end of cycle 2 resulted in classification of progressive disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Salarius believes this data demonstrates preliminary drug activity in a patient with refractory Ewing sarcoma. Additional data from the dose-escalation portion of the Ewing sarcoma trial has demonstrated further evidence of drug activity, which Salarius hopes to expand upon during the upcoming dose-expansion portion of the trial by treating R/R Ewing sarcoma patients with seclidemstat.

In addition to treating R/R Ewing sarcoma patients, the expansion portion of the Phase 1/2 trial will enroll patients with additional select sarcomas that share a similar biology to Ewing sarcoma. Fusions of similar oncogenes to those that are translocated in Ewing sarcoma occur in tumors, such as myxoid liposarcoma, desmoplastic small round cell tumors, and others known as Ewing-related sarcomas or FET-translocated sarcomas. The decision to include Ewing-related sarcoma patients was supported by preclinical data and encouraging clinical data in Salarius’ AST trial. Of the small subset of Ewing-related sarcoma patients with progressive disease that enrolled in the AST trial, all patients demonstrated preliminary evidence of seclidemstat drug activity at levels below the RP2D. Encouragingly, in this subset of seclidemstat treated patients, the median time to progression was above the benchmarks established for single-agent activity in the advanced, relapsed soft tissue sarcoma setting. Ewing-related sarcoma patients will continue to be treated with single-agent seclidemstat to generate more safety and early efficacy activity in this patient population. Safety and efficacy results from the AST trial are planned for presentation at an upcoming medical conference. Conference embargo rules prevent further disclosure at this time.

This study will continue to evaluate safety and antitumor activity with data readouts expected towards the end of this year and early next year.

Mr. Arthur concluded, "We are encouraged by the preliminary results from the Ewing sarcoma trial and the Advanced Solid Tumor trial that have demonstrated antitumor activity in patient populations with advanced disease. Based on the totality of the data accumulated thus far, we are optimistic about the potential of seclidemstat in multiple cancers."

Dr. Reddy’s Laboratories announces the launch of Capecitabine Tablets, USP in the U.S. Market

On February 17, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Capecitabine Tablets, USP a therapeutic equivalent generic version of Xeloda (capecitabine) Tablets approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, FEB 17, 2021, View Source [SID1234575183]).

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The Xeloda brand and generic had U.S. sales of approximately $90 million MAT for the most recent twelve months ending in October 2020 according to IQVIA Health*.

Dr. Reddy’s Capecitabine Tablets, USP are available in 150 mg and 500 mg strengths in bottle count sizes of 60 and 120, respectively.