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.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

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.

On November 10, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the third quarter and year-to-date for the period ended September 30, 2021 (Press release, Navidea Biopharmaceuticals, NOV 10, 2021, View Source [SID1234595107]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Alexander L. Cappello, Chair of Navidea’s Board of Directors, said, "During this time of transition in our leadership, we remain focused on our mission of developing precision immunodiagnostic agents and immunotherapeutics to enhance patient care. We are confident that our strong management team, supported by our experienced and active Board of Directors, can execute on our business plan and fulfill the vision we have for Navidea."

Third Quarter 2021 Highlights and Subsequent Events

Submitted draft Clinical Study Report to the U.S. Food and Drug Administration ("FDA") for the Company’s completed NAV3-31 Phase 2b study in Rheumatoid Arthritis ("RA") as part of the briefing package for an End-of-Phase 2 Type B meeting.
Held an End-of-Phase 2 Type B meeting with the FDA to discuss the Company’s ongoing program in RA and advancement to the pivotal Phase 3 trial September 1, 2021 via conference call.
Opened a third site for enrollment in the Company’s NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Enrollment is ongoing and biopsy specimens are in the process of analysis.
Nearly completed enrollment in the Company’s NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept." Arm 1 is 4 subjects from completion and Arm 2 is fully enrolled.
Completed enrollment and imaging data analysis in the investigator-initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Converted the provisional patent application "Synthesis of Uniformly Defined Molecular Weight Mannosylated Dextrans and Derivatives Thereof" to an A1 application on July 9, 2021.
Appointed Alexander L. Cappello and John K. Scott, Jr. to the Board of Directors. Mr. Scott is the Company’s largest shareholder and Mr. Cappello brings over 30 years of banking and public board experience to the Company.
Appointed Thomas F. Farb and Agnieszka Winkler to the Board of Directors. Mr. Farb has over three decades of experience as an investor in and senior executive of numerous life science and information technology companies both in the U.S. and internationally, and Ms. Winkler has extensive professional and board experience with start-up, mid-cap and Fortune 500 companies.
Appointed Michel Mikhail, Ph.D. as Chief Regulatory Officer of Navidea. Dr. Mikhail brings more than 30 years of experience in the pharmaceutical industry and a track record of achievement in research and development ("R&D") and international regulatory affairs at large multinational research-based pharmaceutical companies.
Jed A. Latkin resigned as Chief Executive Officer, Chief Financial Officer and Chief Operating Officer of the Company and as a member of the Company’s Board of Directors. The Company’s Board of Directors has established an Executive Leadership Committee to lead the Company on an interim basis while its next CEO is identified. The Executive Leadership Committee includes Michael Rosol, Ph.D., the Company’s Senior Vice President and Chief Medical Officer; Erika Eves, the Company’s Vice President of Finance and Administration; and Jeffrey Smith, the Company’s Vice President of Operations. The Executive Leadership Committee will work with a newly established Board Oversight Committee, consisting of independent directors Alexander Cappello, Thomas Farb and John K. Scott, Jr.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. We have had a constructive dialogue with the FDA over the results of the completed NAV3-31 Phase 2b trial as well as our proposed plan for the NAV3-33 Phase 3 study, and we continue to prepare for initiation of this trial. We also have active enrollment in the NAV3-32 Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients, and have near full enrollment in the NAV3-35 normative database study. Concurrent with all of this, we continue to make exciting progress in our therapeutics pipeline, and we expect to keep advancing these towards the clinic."

Financial Results

Total net revenues for the third quarter of 2021 were $96,000, compared to $268,000 for the same period in 2020. Total net revenues for the first nine months of 2021 were $481,000, compared to $695,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, offset by receipt of reimbursement from Cardinal Health 414, LLC of certain R&D costs and the partial recovery of debts previously written off in 2015.
R&D expenses for the third quarter of 2021 were $1.0 million, compared to $1.4 million in the same period in 2020. R&D expenses for the first nine months of 2021 were $3.8 million, compared to $3.7 million in the same period in 2020. The net increase during the year to date was primarily due to net increases in drug project expenses, including increased Manocept therapeutic and Tc99m tilmanocept development costs, offset by decreased Manocept diagnostic development costs. The net increase in research and development expenses also included increased regulatory consulting and general office expenses offset by decreased employee compensation including incentive-based awards.
Selling, general and administrative ("SG&A") expenses for the third quarter of 2021 were $1.5 million, compared to $1.8 million in the same period in 2020. SG&A expenses for the first nine months of 2021 were $5.1 million, compared to $4.9 million in the same period in 2020. The net increase during the year to date was primarily due to increased consulting services related to preparation for European distribution of Tc99m tilmanocept, increased employee compensation including incentive-based awards, increased insurance cost, increased director fees related to additional board members, increased travel costs, increased European license fees, increased general office expenses, and a loss on the third quarter 2021 abandonment of certain intellectual property, offset by decreased legal and professional services, decreased investor relations costs, decreased facilities costs and decreased franchise taxes.
Navidea’s net loss attributable to common stockholders for the third quarter of 2021 was $2.4 million, or $0.08 per share, compared to $3.3 million, or $0.13 per share, for the same period in 2020. Navidea’s net loss attributable to common stockholders for the first nine months of 2021 was $8.1 million, or $0.28 per share, compared to $8.4 million, or $0.37 per share, for the same period in 2020.
Navidea ended the third quarter of 2021 with $7.2 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. As noted in the Company’s press release dated November 3, 2021, questions will not be taken during the conference call. Previously-submitted questions will be read aloud and answered during the Q&A portion of the conference call, and we may also respond to questions on an individual basis or by posting answers on our website after the call.

A live audio webcast of the conference call will be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On November 10, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company that utilizes the latest biotechnology to discover and deliver novel medicines, reported that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation (ODD) to zandelisib for the treatment of follicular lymphoma (Press release, MEI Pharma, NOV 10, 2021, View Source [SID1234595140]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Orphan-drug designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the U.S. ODD granted therapies entitle companies to development incentives including tax credits for qualified clinical trials, exemptions from certain FDA application fees, and the potential of seven years of marketing exclusivity in the event of regulatory approval. ODD does not shorten the duration of the regulatory review or approval process. For more information on ODD, please visit the FDA website at View Source

About Zandelisib

Zandelisib, a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. In March 2020 the U.S. FDA granted zandelisib Fast Track designation for treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies.

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S. and will pay MEI escalating tiered royalties on ex-U.S. sales.

Ongoing zandelisib studies include the TIDAL study (NCT03768505), a global Phase 2 trial evaluating zandelisib as a single agent across two cohorts: the first cohort for the treatment of adults with r/r FL and the second cohort for r/r marginal zone lymphoma (MZL), in both cases after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Enrollment in the FL cohort is complete; enrollment in the MZL cohort is ongoing. Subject to the results and discussions with FDA, data from each study cohort are intended to be submitted to FDA to support separate accelerated approval marketing applications under 21 CFR Part 314.500, Subpart H.

Also ongoing is the Phase 3 COASTAL study (NCT04745832) comparing zandelisib plus rituximab to standard of care chemotherapy plus rituximab, in patients with r/r follicular or marginal zone lymphomas who received ≥ 1 prior line of therapy, which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide. COASTAL is intended to support marketing applications in the U.S. and globally. COASTAL is also intended to act as the required confirmatory study for potential U.S. accelerated approvals of zandelisib based on the TIDAL study.

Other ongoing studies include a Phase 2 pivotal study in Japan (NCT04533581) in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) conducted by Kyowa Kirin.

About Follicular Lymphoma

Follicular lymphoma (FL) is the most common indolent lymphoma, comprising about 20-30% of all non-Hodgkin lymphomas (NHL). The disease also forms on B cells, is chronic in most cases and tends to progress slowly. Most people diagnosed with FL are over 65 years of age. Sometimes follicular lymphomas can change into diffuse large B-cell lymphoma, a fast-growing (aggressive) type of NHL.

On November 10, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the third quarter and nine months ended September 30, 2021, and provided a corporate update (Press release, Lipocine, NOV 10, 2021, View Source [SID1234595156]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Third Quarter and Recent Corporate Highlights

Entered into a license agreement with Antares Pharma to commercialize TLANDO in the US
Lipocine to receive up to $21.0 million in licensing fees, including $11.0 million payable immediately and $10.0 million to be paid in the future subject to certain conditions
Lipocine is entitled to commercial sales milestone payments of up to $160.0 million and tiered royalties on net sales of TLANDO from mid-teens up to 20%
Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S.
Antares Pharma was also granted an option to license TLANDO XR for development and commercialization in the U.S. for additional licensing fees ($4.0 million), clinical and regulatory milestone payments ($35.0 million), sales milestone payments and royalties (mid-teens up to 20%)
The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH")
The FDA has affirmed that the resubmission of the New Drug Application ("NDA") for TLANDO will be a Class 1 resubmission, with a two-month FDA review goal period
The FDA previously granted tentative approval to TLANDO in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
The product is not eligible for final approval and marketing in the U.S. until the expiration of the FDA’s Orange Book listed exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo, which expires on March 27, 2022
Announced positive topline 36-week results from its Phase 2 proof-of-concept Liver Fat intervention with oral Testosterone ("LiFT") clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed NASH
Study met its primary endpoint. At 12 weeks, treatment with LPCN 1144 resulted in statistically significant liver fat reduction, assessed by MRI-PDFF
Both LPCN 1144 treatment arms showed significant improvement in NASH without worsening of fibrosis
Efficacy and safety results from the LiFT study have been accepted for late-breaking presentations at the American Association for the Study of Liver Diseases ("AASLD") The Liver Meeting on November 12-15, 2021
Company intends to meet with the FDA regarding the path forward for an accelerated approval and to discuss Phase 3 study requirements
Third Quarter Ended September 30, 2021 Financial Results

Lipocine reported a net loss of $3.1 million, or ($0.03) per diluted share, for the third quarter ended September 30, 2021, compared with a net loss of $4.3 million, or ($0.07) per diluted share, for the third quarter ended September 30, 2020.

Research and development expenses were $2.4 million for the third quarter ended September 30, 2021, compared with $2.5 million for the third quarter ended September 30, 2020. The decrease for the third quarter of 2021 was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study as well as decrease costs related to TLANDO. These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs.

General and administrative expenses were $1.2 million for the third quarter ended September 30, 2021, compared with $1.9 million for the third quarter ended September 30, 2020. The decrease in general and administrative was primarily related to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense.

As of September 30, 2021, the Company had $38.7 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

Subsequent to the end of the third quarter, the Company received an $11.0 million upfront license fee as part of the licensing agreement with Antares Pharma to commercialize TLANDO.

Nine Months Ended September 30, 2021 Financial Results

Lipocine reported a net loss of $13.3 million, or ($0.15) per diluted share, for the nine months ended September 30, 2021, compared with a net loss of $16.5 million, or ($0.32) per diluted share, for the nine months ended September 30, 2020.

Research and development expenses were $5.4 million for the nine months ended September 30, 2021, compared with $7.3 million for the nine months ended September 30, 2020. The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study, a decrease in costs related to TLANDO and a decrease in personnel costs primarily related to reduced stock compensation expense. These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs.

General and administrative expenses were $4.3 million for the nine months ended September 30, 2021, compared with $5.9 million for the nine months ended September 30, 2020. The decrease in general and administrative expenses was primarily due to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense. These decreases were offset by an increase in corporate insurance expense.

On November 10, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Søren Bregenholt, Chief Executive Officer, will participate and host one-on-one investor meetings at the following upcoming investor conferences (Press release, Alligator Bioscience, NOV 10, 2021, View Source [SID1234595045]):

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Redeye Life Science Day 2021
Location: Hybrid Event
Date: Thursday, November 11, 2021
Type: Live Presentation

Time: 16:30 – 16:50 CET

Live presentations can be viewed via the following link: View Source

H.C. Wainwright 7th Annual Israel Conference
Location: Virtual

Date: Monday, November 15, 2021
Type: Live Presentation & 1×1’s

Time: 14:00 – 14:30 CET

Inv€$tival Showcase 2021
Location: London and Virtual

Dates: November 8 – 15, 2021
Type: In Person 1×1’s, Nov 15, 2021

Jefferies HealthCare Conference
Location: London and Virtual
Date: November 16, 2021

Type: In Person 1×1’s

ØU Life Science Life Science Investor Konference Summit
Location: Copenhagen
Date: Wednesday, November 24, 2021
Type: Live Presentation & 1×1’s

Time: 15:50 – 16:20 CET

Presentation can be viewed via the following link: View Source

All presentations will be available via a digital library, which is accessible to event participants only. Please contact the organizers to if you wish to attend or Julie Silber if you wish to schedule a meeting with Alligator.