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Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference

On November 10, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference on November 16 and 17, 2021 (Press release, Valneva, NOV 10, 2021, View Source [SID1234595079]).

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Valneva’s Chief Executive Officer Thomas Lingelbach and acting Chief Financial Officer David Lawrence will notably discuss the Company’s late stage vaccine candidates against Lyme disease (VLA15), chikungunya (VLA1553) and COVID-19 (VLA2001).

Valneva recently reported positive Phase 3 results for VLA20011, currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. The Company also announced last week the closing of a $102.0 million Global Offering2.

Valneva’s presentation will take place on November 16, 2021 at 4:20pm GMT and can be accessed via the following link: View Source To request a meeting at the event, please contact your representative at Jefferies.

UroGen Pharma Unveils New Phase 3 Development Plan for UGN-102 at Spotlight Event

On November 10, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, reported at its virtual Spotlight Event being held today that, following recent discussions with the U.S. Food and Drug Administration ("FDA"), it plans to conduct a new, single-arm Phase 3 pivotal study of UGN-102 for the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer ("NMIBC") (Press release, UroGen Pharma, NOV 10, 2021, View Source [SID1234595078]). This new study, which is expected to initiate in early 2022, is expected to enroll approximately 220 patients across 90 sites.

"We have worked diligently with the FDA over the past several years to define the unmet need in low-grade NMIBC, with a particular focus on the intermediate risk population that typically experiences multiple recurrences," said Liz Barrett, President and Chief Executive Officer of UroGen. "We are preparing to initiate a single-arm pivotal study of UGN-102 to form the basis for a New Drug Application for UGN-102 in the treatment of low-grade, intermediate-risk NMIBC. We believe this new study increases the probability of regulatory success for UGN-102 given its streamlined design in addition to the encouraging results observed from our Phase 2 OPTIMA II study."

UroGen is grateful to the investigators and patients who are participating in the ATLAS study and believes the data generated will represent an important component of the planned UGN-102 NDA submission, which remains on track for 2024. In light of the new planned Phase 3 trial, UroGen will stop enrollment in the ATLAS trial. Patients already enrolled in ATLAS will have the option to remain in the study until completion.

In addition to the updated clinical plan for UGN-102, the Spotlight Event features presentations on UroGen’s earlier-stage, locally administered immunotherapy candidates, UGN-301 and UGN-201, as well as two expert panel discussions on future directions in treating NMIBC, other types of bladder cancer and the potential benefits of UroGen’s immunotherapy pipeline products in non-urologic cancers.

Distinguished panelists discussing the current treatment landscape and potential future innovations in NMIBC include:

Dr. Sandip Prasad, a urologist in community practice with Atlantic Medical Group and the Morristown Medical Center;
Dr. Gary Steinberg, Professor of Urology and Director of the Bladder Cancer Program at NYU Langone Medical Center; and
Dr. William Huang, Professor of Urology and Radiology at NYU and Chief of Urology at Tisch Hospital.
The experts reviewing the unmet needs of patients with high-grade NMIBC and the potential for locally applied combination therapy include:

Dr. Karim Chamie, Associate Professor of Urology at UCLA Medical Center; and
Dr. Joshua Meeks, Associate Professor of Urology, Biochemistry and Molecular Genetics at Northwestern University Feinberg School of Medicine.
"Immunotherapy for the treatment of high-grade bladder cancer, with primary attention toward our TLR-7 agonist, UGN-201 and our anti-CTLA4 antibody, UGN-301, is a key area of focus of our earlier-stage pipeline," said Dr. Mark Schoenberg, Chief Medical Officer of UroGen. "We have pursued a series of pre-clinical studies to determine whether our RTGel platform might provide a method for delivering highly potent immunomodulators directly to the bladder surface, avoiding the toxicity associated with systemic administration. Our studies conducted to-date suggest bladder cancer treated with a combination of a TLR-7 agonist and an anti-CTLA4 antibody using our RTGel technology, produces improved survival relative to treatment with other checkpoint inhibitors in RTGel, either alone or in combination with UGN-201."

UroGen is currently conducting non-human primate toxicity studies to facilitate the initiation of a multi-arm Phase 1 study of UGN-301 in early 2022 to be followed by UGN-301 in combination with other agents. This approach leverages UroGen’s unique platform for drug delivery and provides an opportunity to evaluate intravesical delivery of its anti-CTLA4 monoclonal antibody in combination with other immuno-modulators, chemotherapies, gene therapy and innate immune stimulators, including UGN-201.

Ensysce Biosciences Announces Completion of $15 Million Convertible Note Financing

On November 10, 2021 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, reported that it has completed its previously announced private placement under a securities purchase agreement with institutional investors ("Investors") for senior secured convertible notes (the "Notes") and warrants exercisable for Ensysce common stock (the "Warrants") for an aggregate investment of $15 million (Press release, Leisure Acquisition, NOV 10, 2021, View Source [SID1234595075]). The final funding by the Investors of $10 million, prior to fees and offering expenses, occurred on November 5, 2021.

The Notes are convertible into shares of Ensysce common stock at a conversion price of $5.87, a 30% premium to the base price set at the time of the initial closing. The Notes have a maturity date of 21 months from the applicable closing date and will bear interest from date of issuance at 5.0% per annum, with monthly principal payments in cash or common stock beginning approximately 90 days after the initial closing. The Notes were issued with an original discount of six percent (6%). The Warrants have the right to purchase shares of common stock at an exercise price of $7.63, a 30% premium to the conversion price. The Warrants are exercisable for five years following the date of issuance.

The total gross proceeds from the issuance of the Notes pursuant to the securities purchase agreement, totaling $15 million before fees and expenses, will be used for general working capital purposes. The first closing on September 24, 2021 provided $5 million of funding and the second closing on November 5, 2021 provided $10 million of funding. At the second closing, the Company issued to the institutional investors referenced above, (i) Notes in the aggregate principal amount of $10.6 million for an aggregate purchase price of $10 million and (ii) Warrants to purchase 722,317 shares of the Company’s common stock at an exercise price of $7.63.

"The completion of our financing provides us with additional and necessary proceeds to continue our advancement of our lead clinical trial programs, including completion of our PF614-102 bioequivalence study and our nasal and oral human abuse liability studies, as a well as to continue the clinical development of our overdose protection platform with our lead product PF614-MPAR," said Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences. "We remain focused on our commitment to stem the prescription drug abuse epidemic by bringing our unique pipeline of products to the industry, which will ultimately provide safer options for both prescribers and patients."

A registered broker-dealer is acting as the sole placement agent in connection with the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful. This news release is being issued pursuant to and in accordance with Rule 135c under the Securities Act of 1933, as amended.

Enterome to present significant progress with its OncoMimics™ pipeline at Jefferies London Healthcare Conference

On November 10, 2021 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its unique ability to decode the gut microbiome’s interaction with the immune system, reported that its CEO, Pierre Belichard, will present (in person) and participate at the Jefferies London Healthcare Conference in London, UK, which will take place November 16-19, 2021 (Press release, Enterome, NOV 10, 2021, View Source [SID1234595073]).

Presentation details

Enterome Presentation (in person) – Wednesday November 17, 2021 at 2:25 pm GMT

Webcast: View Source

The presentation will be webcast live and archived for 30 days thereafter.

Enterome’s CEO, Pierre Belichard, will provide an overview of the Company and the progress it has made with its advanced OncoMimics pipeline of transformational medicines for cancer as well as its other fully owned EndoMimics pipeline for immune diseases.

Enterome’s most advanced OncoMimics drug candidates are:

EO2401, a therapeutic cancer vaccine candidate currently in clinical development for recurrent glioblastoma and adrenal tumors. EO2401 has already shown strong immunogenicity data in brain and adrenal cancer patients with clinical proof of concept data expected in H1 2022, and
EO2463, a second OncoMimic cancer vaccine, in clinical development for the treatment of indolent non-Hodgkin lymphoma with clinical proof of concept data planned for H1 2023
In addition, the Company’s most advanced EndoMimics candidate is:

EB1010, a new orally delivered bioactive and a potent local inducer of IL-10, which has been selected to provide improved therapeutic outcomes for patients with inflammatory bowel disease (IBD). EB1010 is expected to enter clinical trial in 2023

Cassava Sciences Reports Third Quarter 2021 Financial Results

On November 10, 2021 AUSTIN, Texas, Nov. 10, 2021 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the third quarter ended September 30, 2021 (Press release, Pain Therapeutics, NOV 10, 2021, View Source [SID1234595069]). Net loss for the third quarter ended September 30, 2021, was $9.6 million, or $0.24 per share, compared to a net loss of $1.4 million, or $0.06 per share, for the same period in 2020. Net cash used in operations was $22.2 million during the first nine months of 2021. Net cash use for operations for full-year 2021 is expected to be approximately $25 to $30 million, up from previous guidance of $20 to $25 million due to a significant prepayment made to a contract research organization for our Phase 3 clinical program with simufilam. An additional $22.0 million was used during the third quarter of 2021 for an all-cash purchase of an office complex in Austin, Texas, which will serve as the Company’s future corporate headquarters. Cash and cash equivalents were $241.5 million as of September 30, 2021, with no debt.

Financial Highlights for Third Quarter 2021

At September 30, 2021, cash and cash equivalents were $241.5 million, compared to $93.5 million at December 31, 2020, with no debt.

Net cash used in operations during the nine months ended September 30, 2021 was $22.2 million, net of reimbursements received from the National Institutes of Health (NIH) grant awards. An additional $22.0 million was used during the third quarter of 2021 for the purchase of an office complex in Austin, Texas, which will serve as the Company’s future corporate headquarters.

Net cash use for operations for full year 2021 is expected to be approximately $25 to $30 million, up from previous guidance of $20 to $25 million due to a prepayment made to a contract research organization for Phase 3 clinical program with simufilam. Net cash use in 2021 is expected to be driven by prepayments made for clinical trial management services for Phase 3 studies, higher headcount and personnel expenses, manufacturing costs around large-scale drug supply, and professional services expenses related to clinical programs.

R&D expenses were $8.0 million compared to $0.4 million for the same period in 2020. This increase was due primarily to costs related to manufacture of clinical trial supplies for and the initiation of a Phase 3 clinical program with simufilam, costs of an on-going open-label study in simufilam, as well as increased personnel expenses. These increases were partially offset by an increase in grant funding received from NIH and recorded as a reduction in research and development expenses.

Research grant funding reimbursements of $2.0 million were received from NIH and recorded as a reduction in research and development (R&D) expenses. This compared to $1.0 million of NIH grant receipts received for the same quarter in 2020.

General and administrative (G&A) expenses were $1.7 million compared to $1.0 million for the same period in 2020. This increase was due primarily to higher legal fees and insurance costs as well as depreciation and amortization for an office complex in Austin, Texas, purchased in third quarter 2021 as compared to the prior year.