Enveric Biosciences Announces Closing of $8 Million Registered Direct and Private Placement Offerings, Priced at a Premium to Market Under Nasdaq Rules

On July 26, 2022 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that it has closed its previously announced registered direct offering for the purchase and sale of 375,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof), priced at a premium to market under Nasdaq rules (Press release, Enveric Biosciences, JUL 26, 2022, View Source [SID1234616937]). In addition, the Company has issued to the investors in the registered direct offering unregistered preferred investment options (the "preferred investment options") to purchase up to 375,000 additional shares of the Company’s common stock. The purchase price for one share of common stock (or pre-funded warrant) and one preferred investment option to purchase one share of common stock is $8.00. The preferred investment options have an exercise price of $7.78 per share, are immediately exercisable, and will expire five and one-half years from the date of issuance.

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 Company also closed its previously announced private placement offering for the purchase and sale of 625,000 shares of common stock (or pre-funded warrants in lieu thereof) and preferred investment options to purchase up to 625,000 shares of the Company’s common stock priced at a premium to market under Nasdaq rules. The purchase price for one share of common stock (or pre-funded warrant) and one preferred investment option to purchase one share of common stock is $8.00. The preferred investment options have an exercise price of $7.78 per share, are immediately exercisable, and will expire five and one-half years from the date of issuance.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offerings.

The gross proceeds to the Company from the offerings were approximately $8 million, before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offerings for working capital and general corporate purposes.

The Company also amended certain existing warrants to purchase up to an aggregate of 122,000 shares of common stock of the Company that were previously issued to the investors, with an exercise price of $27.50 per share and expiration date of February 15, 2027, effective upon the closings of the offerings so that the amended warrants have a reduced exercise price of $7.78 per share and expire five and one-half years following the closing of the offerings.

The shares of common stock, pre-funded warrants and shares of common stock underlying the pre-funded warrants (but excluding the shares of common stock and pre-funded warrants issued in the private placement and the preferred investment options and the shares of common stock underlying the preferred investment options) offered by the Company in the registered direct offering were offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-257690) previously filed with the Securities and Exchange Commission (the "SEC") on July 2, 2021, and declared effective by the SEC on July 9, 2021. The offering of the common stock and pre-funded warrants in the registered direct offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered was filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The preferred investment options to purchase common stock, pre-funded warrants and the shares of common stock offered under the private placement, as well as the preferred investment options issued to investors in the registered directed offering, were offered in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, those securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

Under a registration rights agreement with the investors, the Company agreed to file a registration statement with the SEC covering the resale of the shares of the common stock and shares of common stock underlying the pre-funded warrants issued in the private placement and the shares of common stock underlying the preferred investment options issued in both offerings, within 15 days and to use best efforts to have the registration statement declared effective as promptly as practical and in any event within 45 days or within 75 days in the event of a full review by the SEC.

This press release shall not constitute an offer to sell or a 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 prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

TRACON Pharmaceuticals Announces Dosing of 36th Patient in ENVASARC Pivotal Trial Triggering Initial IDMC Efficacy Review Expected in the Fourth Quarter

On July 26, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported the enrollment of the 36th patient in the ENVASARC pivotal trial at the 600 mg dose of envafolimab, which enables the initial independent data monitoring committee (IDMC) interim efficacy analysis to proceed (Press release, Tracon Pharmaceuticals, JUL 26, 2022, View Source [SID1234616954]). The interim analysis is expected to occur in the fourth quarter of this year.

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 initial IDMC interim efficacy analysis proceeds after the 36th patient has been enrolled for at least three months to permit two on study scans to determine the preliminary objective response rate. One objective response is required in each of the trial’s two cohorts to continue accrual in that cohort. The first cohort includes the initial 18 patients who receive single agent envafolimab and the second cohort includes 18 patients who receive envafolimab with ipilimumab. A second IDMC interim efficacy analysis is expected in 2023 following enrollment of the 92nd patient.

"We are pleased at the pace of enrollment in ENVASARC and have accrued more than 36 patients in fewer than six months since the FDA approved the amended protocol. As a result, we are currently ahead of the enrollment projection that would allow for full accrual of the 160 planned patients dosed with 600 mg of envafolimab before the end of 2023," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to reporting the IDMC recommendations following the two interim safety analyses and interim efficacy analysis expected this year."

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

Sanofi partners with Howard University in an unprecedented pharmacy fellowship program

On July 26, 2022 As part of its ongoing efforts to address disparities in underrepresented communities, Sanofi reported a collaboration with Howard University College of Pharmacy for a two-year post-professional Doctorate in Pharmacy fellowship program (Press release, Sanofi, JUL 26, 2022, View Source [SID1234616971]). Sanofi’s goal is to hire fellows into permanent full-time positions at the company, marking the first time a Howard University College of Pharmacy industry partner has committed to post-fellowship employment.

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!

Set to begin in the second half of 2022, the program will award ten PharmD graduate students an opportunity to participate in practical learning experiences across multiple research and development fields, including oncology, rare diseases, neurology, immunology, regulatory, pharmacovigilance, clinical and operations, as well as US medical, public policy and patient advocacy.

John Reed, MD., Ph.D.
Global Head of Research and Development at Sanofi
"At Sanofi, we recognize that work-force diversity correlates strongly with creativity, successful problem solving, and visionary innovation. This collaboration with Howard University will allow us the opportunity to foster the next generation of scientists from historically underrepresented communities. We look forward to working with the fellows as they begin their training and become Sanofi team members who will undoubtedly help contribute to frontier innovations as we bring the next generation of life-saving medicines to patients worldwide."

Sanofi employees represent the variety of Sanofi’s patients, customers and partners, which builds a better understanding of needs and forges stronger connections. An inclusive culture unleashes our potential, increases innovation, improves our products and makes us better all around. For example, by facilitating the increased participation of diverse populations in clinical trials, Sanofi is striving to aid in the improvement of social equity and human health. With these beliefs and ambitions, the company is honored is to begin this collaboration with Howard University College of Pharmacy. The fellows’ contributions will help to bolster Sanofi’s mission and our diverse top-tier talent pipeline, and empower scholars to pursue STEM research in the future.

Anthony K. Wutoh, Ph.D., R.Ph.,
Howard University Provost and Chief Academic Officer
"We look forward to the partnership with Sanofi, a global leader in healthcare innovation, and the launch of this unique fellowship program. Howard University is among the nation’s largest producers of African-American students who complete doctorates in science, technology, engineering, and physical sciences. The Sanofi fellowship will allow promising graduates to gain real-world experience while contributing to a field that has historically overlooked and undervalued people of color."

The fellowship program with Howard University College of Pharmacy is part of Diversity, Equity & Inclusion (DE&I) strategy, which set new objectives in June 2021 to be achieved by 2025. The strategy is built around three key pillars: building representative leadership, creating a work environment where employees can bring their whole selves and engaging with the company’s diverse communities. Earlier this year, Sanofi took additional steps forward in its DE&I strategy by introducing a DE&I Board, joining the Novartis Beacon of Hope program, and fostering the creation of Global Employee Resource Groups framework.

2022 2Q Earnings

On July 26, 2022 Hanmi reported 2022 second quarter earnings (Presentation, Hanmi, JUL 26, 2022, View Source [SID1234618931]).

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!


Exelixis to Release Second Quarter 2022 Financial Results on Tuesday, August 9, 2022

On July 26, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that its second quarter 2022 financial results will be released on Tuesday, August 9, 2022 after the markets close (Press release, Exelixis, JUL 26, 2022, View Source [SID1234616938]). At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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!

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 888-338-9509 (domestic) or 412-902-4281 (international) and ask to be joined into the Exelixis conference call to participate by phone.

A telephone replay will be available until 8:00 p.m. ET on August 11, 2022. Access numbers for the telephone replay are: 877-344-7529 (domestic) and 412-317-0088 (international); the passcode is 8698613. A webcast replay will also be archived on www.exelixis.com for one year.