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Protagonist Therapeutics to Present at the Stifel 2018 Healthcare Conference Wednesday, Nov. 14

On November 7, 2018 Protagonist Therapeutics, Inc. (NASDAQ:PTGX) reported that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will provide a corporate overview at the Stifel 2018 Healthcare Conference at 8:45 a.m. EST at the Lotte New York Palace Hotel (Press release, Protagonist, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2376046 [SID1234531167]).

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Presentation details:

Event:

Stifel 2018 Healthcare Conference

Date:

Wednesday, Nov. 14

Time:

8:45 a.m. EST

A live and archived audio webcast of the presentation can be accessed by visiting the Investors page of the Protagonist Therapeutics website at View Source

Tocagen to Participate in Investor Conferences in November

On November 7, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that Marty Duvall, chief executive officer, reported that it will present at the following upcoming investor conferences (Press release, Tocagen, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375950 [SID1234531165]):

Wednesday, November 14, 11:00-11:40 a.m. ET in New York City
Stifel Nicolaus Healthcare Conference

Tuesday, November 27, 4:35-4:55 p.m. ET in Boston
Evercore ISI Biopharma Catalyst/Deep Dive Conference

The live audio webcasts from the conferences and subsequent replay may be accessed by visiting the "Events & Presentations" page in the investors section of Tocagen’s website. The webcasts will be available shortly after conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

Protalix BioTherapeutics Reports 2018 Third Quarter Results and Provides Corporate Update

On November 7, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the three months and nine months ended September 30, 2018, and provided a corporate update (Press release, Protalix, NOV 7, 2018, View Source [SID1234531160]).

"In the third quarter we achieved two important milestone events for pegunigalsidase alfa, or PRX-102, our differentiated enzyme replacement therapy in development for the treatment of Fabry disease. First, we expanded our partnership with Chiesi Farmaceutici S.p.A. to include exclusive rights to commercialize and develop PRX-102 in the United States, which significantly strengthened our financial position. Second, we reported positive preliminary results from our BRIDGE study on key kidney function," commented Moshe Manor, Protalix’s President and Chief Executive Officer. "Based on the promising preliminary BRIDGE study results, and taking into account the newly issued guidance from the U.S. Food and Drug Administration (FDA), we plan to engage with the FDA during the first half of 2019 to discuss the most optimal regulatory path forward for PRX-102. While we continue to enroll patients in all of our currently ongoing Fabry disease studies, we believe that with over 110 Fabry patients enrolled across the studies included in our PRX-102 clinical program to date, we have a sufficient number of patients for expedited review, including filing an application for accelerated approval," continued Mr. Manor.

2018 Third Quarter Highlights

·Presented preliminary positive data from the BRIDGE study showing Improvement in kidney function in patients switched from agalsidase alfa (Replagal) to pegunigalsidase alfa and further showing the reversal of a deterioration trend in kidney function to an improvement trend when switched.

·Expanded partnership with Chiesi Farmaceutici S.p.A., or Chiesi, to include U.S. rights for the development and commercialization of PRX-102. Terms of the agreement included an up-front payment of $25 million, up to $20 million in development costs and tiered royalties ranging from 15-40% of net sales.

·Expanded our Board of Directors with the addition of Mr. David Granot as an independent director.

·Continued exploring the potential for partnership opportunities mainly for OPRX-106, and for PRX-110. In parallel, the Company is exploring the option of conducting a controlled phase IIb study of OPRX-106 for the treatment of ulcerative colitis in order to maximize the value of this asset in a manner that will best serve the stockholders’ interest.

Financial Results for the Nine Months ended September 30, 2018

·The Company reported a net loss of $36.2 million, or $0.25 per share, basic and diluted for the nine-month period ended September 30, 2018 compared to a net loss of $32.1 million, or $0.25 per share, basic and diluted for the same period of 2017 excluding remeasurement of a derivative.

The Company recorded total revenues of $7.2 million for the nine-month period ended September 30, 2018, compared to $16.8 million for the same period of 2017. The decrease resulted primarily from decreased shipments of alfataliglicerase to Brazil despite the increase in the number of patients treated with alfataliglicerase, and decreased sales of drug substance to Pfizer.

The $25.0 million in proceeds received from Chiesi during the three-month period ended September 30, 2018 as an upfront payment were not recorded as revenues, and were deferred according to the revenue recognition rules of U.S. generally accepted accounting principles. Such proceeds should be recorded upon the commencement of commercial manufacturing. The same accounting treatment was applied to the $25.0 million upfront payment received by the Company in the fourth quarter of 2017, and the $11.8 million of research and development reimbursement payments the Company has received from Chiesi to date.

·Research and development expenses were $23.8 million for the nine-month period ended September 30, 2018, compared to $19.8 million for the same period of 2017.

Selling, general and administrative expenses were $7.3 million for the nine-month period ended September 30, 2018 compared to $8.2 million for the same period of 2017.

As of September 30, 2018, the Company had $41.9 million of cash and cash equivalents. With the expected decrease in cash consumption resulting primarily from the Company’s U.S. license transaction with Chiesi, the Company expects the cash balance to fund the Company through significant regulatory achievements of PRX-102.

Conference Call and Webcast Information

The Company will host a conference call on Wednesday, November 7, 2018 at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 8567317.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

Calithera Biosciences Reports Third Quarter 2018 Financial Results and Recent Highlights

On November 7, 2018 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the third quarter ended September 30, 2018 (Press release, Calithera Biosciences, NOV 7, 2018, View Source [SID1234531158]). As of September 30, 2018, cash, cash equivalents and investments totaled $141.5 million.

"Calithera continues to advance the development of our novel oncometabolism clinical candidates," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "In this quarter we broadened the development of the novel glutaminase inhibitor CB-839 with two new clinical trial collaborations with Pfizer. We are actively enrolling CANTATA and ENTRATA, two randomized trials of CB-839 for the treatment of patients with renal cell carcinoma, with data from the ENTRATA trial expected in 2019. In addition, we and our partner Incyte expect data on INCB001158 to be presented at a medical meeting in the first half of 2019."

Third Quarter 2018 and Recent Highlights

Announced two new clinical trial collaborations to evaluate Pfizer’s CDK4/6 inhibitor palbociclib, also known as IBRANCE, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib also known as TALZENNA, each in combination with Calithera’s glutaminase inhibitor CB-839. Calithera will initiate Phase 1/2 clinical studies in the first quarter of 2019. Preclinical data suggest that CB-839 synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. CB-839 also synergizes preclinically with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation.

Two Randomized Combination Trials of CB-839 in Combination for the Treatment of Renal Cell Carcinoma. The ENTRATA trial, a randomized double-blind study of late line patients, will enroll approximately 66 patients to receive either CB-839 plus everolimus or everolimus alone. Topline results are expected in 2019. The CANTATA trial is a randomized, global, double-blind trial comparing patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. Topline results are expected in 2020. The trial will enroll patients with clear cell renal cell carcinoma who have previously received one or two prior lines of therapy. The trial, originally designed to enroll 300 patents has been enlarged to approximately 400 patients. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population. Updated Phase 1b data of CB-839 combined with cabozantinib presented in the quarter demonstrated a disease control rate of 100%, and response rate of 50% in 10 evaluable patients with clear cell RCC.

INCB001158 Arginase Inhibitor Immuno-oncology Program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Data from INCB001158 is expected to be presented at a medical meeting in the first half of 2019.

CB-280 Arginase Inhibitor for the Treatment of Cystic Fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. An investigational new drug (IND) application for CB-280 with the FDA is planned for the first half of 2019.

CB-708 Oral Small Molecule CD73 Inhibitor. The immuno-oncology target CD73 is an enzyme that plays a critical role in the process of ATP conversion to adenosine. An IND application for CB-708, an orally administered small molecule inhibitor of CD73, is planned for 2019.

Selected Third Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $141.5 million at September 30, 2018.

Research and development expenses were $16.4 million for the three months ended September 30, 2018, compared with $10.8 million for the same period in the prior year. The increase of $5.6 million was due to an increase in the CB-839 program, including for the CANTATA trial which opened in 2018, an increase in the INCB001158 program, including Incyte’s co-funding of development costs, an increase in the CB-280 program, as well as investment in early stage research.

General and administrative expenses were $3.1 million for both the three months ended September 30, 2018 and 2017 due to consistent headcount and stock-based compensation expense.

Net loss from operations for the three months ended September 30, 2018 was $18.8 million, or $0.52 per share.

Conference Call Information

Calithera will host an update conference call today, November 7, at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 9368596. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

Sarepta Therapeutics Announces Proposed $500,000,000 Public Offering of Common Stock

On November 7, 2018 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a leader in precision genetic medicine for rare diseases, reported that it is offering to sell, subject to market and other conditions, $500,000,000 in shares of its common stock in an underwritten public offering (Press release, Sarepta Therapeutics, NOV 7, 2018, View Source [SID1234531156]). Sarepta also intends to grant the underwriters a 30-day option to purchase an additional $75,000,000 in shares of its common stock offered in the public offering.

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Credit Suisse are acting as joint book-running managers of the proposed offering.

Sarepta intends to use the net proceeds from the offering principally for the continuation and initiation of further clinical trials, commercialization, manufacturing, business development activities including the potential licensing or acquisition of complementary products and technologies and other 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.

The shares are being offered by Sarepta pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to these securities may also be obtained from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of Sarepta, nor shall there be any sale of 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.