On November 12, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, reported that it will host an R&D Day on November 15, 2019 (Press release, Agenus, NOV 12, 2019, View Source [SID1234550952]).

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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

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Date: Friday, November 15, 2019

Time: 11:00AM – 2:00PM

Live webcast: View Source

Location: New York, NY (by invitation only)

Agenus has delivered more I-O discoveries to the clinic in the last three years than any large pharma and is on track to file a BLA in 2020 for accelerated approval of its lead candidates Zalifrelimab (anti-CTLA-4) and Balstilimab (anti-PD-1) while also advancing AGEN1181, a potential best-in-class next generation anti-CTLA-4 antibody, and a pipeline of additional antibodies, cell therapies, and vaccines.

The event will be moderated by Dr. Garo Armen, Chairman and Chief Executive Officer, and Dr. Jennifer Buell, Chief Operating Officer, and will include presentations by world experts in I-O, Dr. Steven O’Day, Executive Director of the John Wayne Cancer Institute, and Dr. Manuel Hidalgo, Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center.

The event will be webcast live and may be accessed by visiting the "Events & Presentations" page within the Investors section of the Agenus website www.agenusbio.com or by using the link below. A replay of the webcast will be available on the Agenus website following the event.

On November 12, 2019 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported a proposed public offering of up to 5,000,000 shares of its common stock (Press release, Replimune, NOV 12, 2019, View Source [SID1234550971]). All shares in the offering will be offered by Replimune . In addition, Replimune intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock from Replimune on the same terms and conditions.

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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

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J.P. Morgan Securities LLC, SVB Leerink LLC, and BMO Capital Markets Corp. are acting as book-running managers for the proposed offering. The offering is subject to market and other customary closing conditions, and Replimune cannot assure you as to whether or when the offering may be completed.

This proposed offering will be made only by means of a preliminary prospectus supplement and the accompanying prospectus. A copy of the preliminary prospectus supplement relating to this offering will be filed with the Securities and Exchange Commission (the "SEC") and may be obtained, when available, by visiting EDGAR on the SEC website at www.sec.gov or from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected]; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by e-mail at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

The shares of common stock described above are being offered by Replimune pursuant to its shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Replimune with the SEC on August 8, 2019 and declared effective by the SEC on August 15, 2019. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

On November 12, 2019 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the third quarter of 2019 (Press release, Surface Oncology, NOV 12, 2019, View Source [SID1234550987]).

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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

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"The Surface team’s focus on execution across the pipeline has delivered a next wave of programs on the cusp of entering clinical development and a new development candidate for our first NK cell targeted program, SRF813. We look forward to walking through our phase 1 trial plans for SRF617 and SRF388, as well as our differentiated approach towards targeting the immune checkpoint protein CD112R at our inaugural R&D day," said Jeff Goater, chief executive officer of Surface Oncology.

The R&D day will be introduced by keynote speaker and Surface Oncology scientific advisor E. John Wherry, Ph.D., director of the Penn Institute for Immunology at the University of Pennsylvania, and co-director of the Parker Institute for Cancer Immunotherapy. The event will be broadcast live at investors.surfaceoncology.com. Parties interested in attending should contact [email protected].

Recent & Upcoming Corporate Highlights:

Appointment of Ramy Ibrahim, Ph.D., to the Surface Oncology board of directors. Dr. Ibrahim is a medical oncologist currently serving as chief medical officer and vice president of clinical development at the Parker Institute for Cancer Immunotherapy. He is an acknowledged immunotherapy expert and played an important role in the development of several approved immune checkpoint inhibitor therapies such as durvalumab (Imfinzi), ipilimumab (Yervoy) and nivolumab (Opdivo).
Presentation of three scientific posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference in National Harbor, Maryland, sharing insights from the SRF617, SRF388 and SRF231 programs. These posters will be hosted on the Company’s corporate website.
A new development program, SRF813, to be discussed in detail at the Company’s R&D day. SRF813 is Surface’s first natural killer (NK) cell targeting program, focused on the recently identified immune checkpoint protein CD112R, the blockade of which promotes anti-tumor responses through both innate and adaptive arms of the immune system.
Continued progression of SRF617 (CD39) and SRF388 (IL-27) towards IND filings this year.
Continued enrollment of the ongoing phase 1b study of NZV930 (CD73), licensed to Novartis, which is evaluating combinations of NZV930 with PDR001 (anti PD-1), NIR178 (A2aR inhibitor), as well as a combination of all three therapies. Novartis is responsible for all development costs associated with NZV930. Surface Oncology is currently entitled to cumulative potential milestones in excess of $500 million, as well as tiered royalties on annual net sales by Novartis ranging from high single-digit to mid-teens percentages upon the successful commercialization of NZV930.
Financial Results:

As of September 30, 2019, cash, cash equivalents and marketable securities were $111.8 million, compared to $126.3 million on June 30, 2019.

R&D expenses were $12.9 million for the third quarter ended September 30, 2019, compared to $15.8 million for the same period in 2018. The decrease in expenditures was primarily driven by a reduction of manufacturing spend on the SRF231 (CD47) program, which was partially offset by increased spend on SRF617 and SRF388 in preparation for IND filings in the fourth quarter of 2019. R&D expenses included $0.6 million in stock-based compensation expense for the third quarter of 2019.

General and administrative (G&A) expenses were $5.0 million for the third quarter ended September 30, 2019, compared to $4.0 million for the same period in 2018. The increase in G&A expenses is primarily due to increased personnel costs and professional fees. G&A expenses included $1.0 million in stock-based compensation expense for the third quarter of 2019.

For the third quarter ended September 30, 2019, net loss was $16.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.61. Net loss was $17.2 million for the same period in 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.62.

Financial Outlook:

Based upon its current operating plan, which includes anticipated milestones from Novartis, Surface continues to have a projected cash runway through 2021.

On November 12, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported financial results for the third quarter ended September 30, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, NOV 12, 2019, View Source [SID1234551005]).

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"On behalf of the UroGen team, we are very pleased to announce that we have completed the New Drug Application (NDA) submission for UGN-101 to the FDA. This is a very important milestone for UroGen and for patients with low-grade UTUC as UGN-101 has the potential to bring the first primary chemoablation drug to these patients. I am proud of the UroGen team and investigators who have helped to make this key milestone a reality," said Liz Barrett, President and Chief Executive Officer of UroGen. "Beyond UGN-101, we have taken important steps to build a company that can deliver long-term sustainable growth through our focus on high unmet need areas utilizing both local delivery and novel medicines. We’ve demonstrated that relentless commitment with our recently announced positive complete response data for investigational agent UGN-102 in patients with intermediate risk LG NMIBC, and our exclusive collaboration with Agenus to advance therapies for high-grade urinary tract cancers. We look forward to a strong future for UroGen."

Recent Highlights and Upcoming Milestones

UGN-101 (mitomycin gel) for instillation for patients with low-grade upper tract urothelial cancer (LG UTUC):
The Company completed its NDA submission to the FDA, and the FDA has a 60-day filing review period to determine whether the NDA submission is complete. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of LG UTUC. UGN-101 is eligible for Priority Review and the Company is planning for anticipated approval and launch in 1H 2020. UGN-101 plans for launch readiness are on track for January 2020.
The NDA submission is supported by positive data from the pivotal Phase 3 OLYMPUS clinical trial.
UroGen also initiated a retreatment protocol as an extension to OLYMPUS to evaluate the efficacy and safety of retreatment with UGN-101 in patients from the trial who initially achieved a CR and were subsequently found to have a documented recurrence of LG UTUC during follow-up.
UGN-102 (mitomycin gel) in development for intravesical instillation for patients with intermediate risk low-grade non-muscle invasive bladder cancer (LG NMIBC):
UroGen recently presented interim results from the single-arm, open-label Phase 2b OPTIMA II trial of investigational UGN-102 for patients with intermediate risk LG NMIBC. LG NMIBC is defined as those with one or two of the following criteria: multifocal disease, large tumors and rapid rates of recurrence.
In an interim analysis, 63% (20/32) of patients from the Phase 2b OPTIMA II trial achieved a CR. Patients will continue to be followed with 12-month durability to be reported at a later date.
The most common treatment emergent adverse events (TEAEs) included dysuria, pollakiuria, fatigue, hematuria and urinary tract infection. The majority were characterized as mild or moderate in severity and transient.
The trial completed enrollment of 63 patients ahead of schedule at clinical sites across the U.S. and Israel. The Company intends to initiate a pivotal Phase 3 trial in 2020 following a planned discussion with the FDA in 1Q 2020.
This is a patient population whereby the current standard of care, transurethral resection of bladder tumor, or TURBT, is used repeatedly to address chronic recurrence of disease. These patients experience what can be viewed as a form of surgical failure and many undergo multiple surgical procedures during life to "manage" bladder cancer recurrences.
There are no drugs currently approved by the FDA as first-line treatment for intermediate risk LG NMIBC. UGN-102 has the potential to provide a non-surgical alternative for the treatment of chronic relapse for approximately 80,000 patients characterized as intermediate risk.
Pipeline Advancement:
UGN-201 (TLR 7/8 agonist) for patients with high-grade NMIBC:
UroGen is exploring the utility of UGN-201 in the context of novel combinatorial immunotherapy for NMIBC. Nonclinical data suggests an efficacy signal when UGN-201 is administered locally with anti-CTLA4 antibody in a murine model of high-grade bladder cancer. The Company plans to optimize combinations and advance into human studies.
Exclusive Worldwide License Agreement with Agenus Inc. to Advance Treatment of High-Grade Urinary Cancers
UroGen entered into an exclusive worldwide license agreement with Agenus to develop and commercialize zalifrelimab (AGEN1884, anti-CTLA-4 antibody) in combination with UGN-201 for the treatment of urinary tract cancers via intravesical delivery. Zalifrelimab (AGEN1884, anti-CTLA-4 antibody) is currently being evaluated by Agenus as a monotherapy in PD-1 refractory patients.
The initial indication for development will be high-grade NMIBC.
UroGen will be responsible for all development and commercialization activities.
Third Quarter 2019 Financial Results; 2019 Guidance

As of September 30, 2019, cash, cash equivalents and marketable securities totaled $221.7 million.
Research and development expenses for the three months ended September 30, 2019 were $9.5 million, including non-cash share-based compensation expense of $2.1 million. Research and development expenses for the nine months ended September 30, 2019 were $29.2 million, including non-cash share-based compensation expense of $6.4 million.
General and administrative expenses for the three months ended September 30, 2019 were $14.0 million, including non-cash share-based compensation expense of $5.2 million. General and administrative expenses for the nine months ended September 30, 2019 were $40.5 million, including non-cash share-based compensation expense of $15.5 million.
The Company reported a net loss of $22.3 million, or basic and diluted net loss per ordinary share of $1.06, for the three months ended September 30, 2019. The Company reported a net loss of $66.2 million, or basic and diluted net loss per ordinary share of $3.25, for the nine months ended September 30, 2019.
Including the recently announced Agenus deal, the Company is still on track to end the year with a net loss for the year in the range of $100 to $110 million, which is expected to include non-cash stock-based compensation expense in the range of $28 to $30 million, subject to market conditions.
Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 am Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 49159339. An archive of the webcast will be available for two weeks on the Company’s website.

On November 12, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that it is offering to sell $55 million of its common stock in an underwritten public offering (Press release, BioCryst Pharmaceuticals, NOV 12, 2019, https://biocryst.gcs-web.com/news-releases/news-release-details/biocryst-commences-public-offering-common-stock-0 [SID1234550961]). As part of this offering, BioCryst intends to grant the underwriters a 30-day option to purchase up to an additional $8.25 million of its common stock. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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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

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J.P. Morgan is acting as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. are acting as lead managers for the offering.

All of the shares to be sold in the offering are being sold by BioCryst, with the proceeds to be used for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic BCX7353 program, primarily focusing on the U.S., EU and Japan; development of the BCX9930 program; development of the BCX9250 program; post-approval commitments for RAPIVABTM/ALPIVABTM; funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering is being made by means of a prospectus supplement and related prospectus. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204.