HOOKIPA to Present at the SVB Securities Global Biopharma Conference

On February 7, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the company will participate in the virtual SVB Securities Global Biopharma Conference, February 14 – 16, 2023 (Press release, Hookipa Pharma, FEB 7, 2023, View Source [SID1234626917]).

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Corporate Presentation: Tuesday, February 14, 2023 at 10:00 AM EST

The webcast of the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

Exact Sciences Launches OncoExTra™ Cancer Therapy Selection Test in the U.S.

On February 7, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported the launch of the OncoExTra therapy selection test in the United States (Press release, Exact Sciences, FEB 7, 2023, View Source [SID1234626916]). OncoExTra is a next-generation sequencing (NGS), comprehensive DNA and RNA based genomic test providing doctors and their patients a complete molecular picture of the patient’s cancer. The test provides reliable and actionable results personalized to each patient.

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"The OncoExTra test substantially enhances our ability to characterize and understand solid tumors, giving our patients the best chance at treating their cancer successfully," said Dr. Stephen Gruber, MD, PhD, MPH, vice president of the City of Hope National Medical Center and Director, Center for Precision Medicine at City of Hope. "With this test, I have a much better picture of my patient’s cancer, allowing me to prescribe the most effective treatment for their specific solid tumor."

The majority of eligible cancer patients do not receive comprehensive genomic profiling (CGP) to help understand their disease and guide treatment. Personalized medicine, powered by CGP, helps oncologists understand the unique biology of each patient’s tumor and prescribe treatments determined to offer the best outcomes.

"Exact Sciences continues to build its leadership in cancer diagnostics by offering innovative tests addressing clinical needs at every step of patient cancer care," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are proud to add OncoExTra to our growing portfolio of cancer solutions across the cancer-care continuum, and deliver new levels of tumor-specific information and insights to doctors and patients that guide vital treatment decisions to achieve the best outcomes."

The OncoExTra test uses NGS to assess the tumor’s RNA and DNA, providing actionable information to inform treatment decisions and uncover variants possibly missed by only evaluating DNA. The OncoExTra test works by profiling the entire exome and the transcriptome across approximately 20,000 genes. The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has updated its guidelines to recommend RNA-based fusion testing for patients with no actionable information provided by a standard DNA, multigene panel test. OncoExTra also analyzes all National Comprehensive Cancer Network (NCCN) recommended genes for patients with solid tumors and provides expertly curated, intuitive reports. The OncoExTra test uses matched tumor-normal sequencing, which also limits false positives and allows physicians to make clinical decisions based on somatic variants detected. Medicare covers the OncoExTra test and doctors can order the test for all advanced solid tumors. The sales team that helps educate oncologists on Oncotype tests will also bring OncoExTra to market; most oncologists have ordered Oncotype tests and they can now order both products from a single Exact Sciences portal, streamlining the management and treatment for both early stage and late-stage patients.

The OncoExTra test includes information on targetable mutations and fusions, immuno-oncology signatures and clinical trial options. Healthcare providers can also order immunohistochemical (IHC) panels and individual stains concurrently, allowing them to receive all actionable tumor information from Exact Sciences.

Ensysce Biosciences, Inc. Announces Closing of $3.0 Million Registered Direct Offering Priced at-the-Market Under NASDAQ Rules

On February 7, 2023 Ensysce Biosciences, Inc. (NASDAQ:ENSC) (the "Company"), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, reported that it has closed its previously announced registered direct offering for the purchase and sale of 3,571,431 shares of the Company’s common stock at a purchase price of $0.84 per share of common stock in a registered direct offering priced at-the-market under NASDAQ rules (Press release, Ensysce Biosciences, FEB 7, 2023, View Source [SID1234626915]).

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In addition, in a concurrent private placement, the Company issued warrants to purchase up to 3,571,431 shares of common stock. The warrants have an exercise price of $0.715 per share, are exercisable immediately following issuance and will have a term of five and one-half years from the issuance date.

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

The gross proceeds to the Company from this offering were approximately $3.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include funding capital expenditures and working capital and repaying indebtedness.

The shares of common stock described above (but not the warrants issued in the concurrent private placement or the shares of common stock underlying such warrants) were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-269157) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on January 17, 2023. The offering of the shares of common stock 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 registered direct offering have been 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 or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock 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.

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.

Lilly to Participate in SVB Securities Global Biopharma Conference

On February 7, 2023 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the SVB Securities Global Biopharma Conference on Thursday, Feb. 16, 2023. Ilya Yuffa, executive vice president and president, Lilly International, will participate in a virtual fireside chat at 12 p.m., Eastern time (Press release, Eli Lilly, FEB 7, 2023, View Source [SID1234626914]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Entry into a Material Definitive Agreement

On February 3, 2023, DURECT Corporation ("DURECT"), reported that it has entered into a securities purchase agreement (the "Purchase Agreement"), with two institutional healthcare investors (the "Purchasers"), relating to the purchase and sale of an aggregate of (i) 1,700,000 shares (the "Shares") of its common stock, par value $0.0001 per share ("Common Stock"), (ii) pre-funded warrants to purchase 300,000 shares of Common Stock, and (iii) accompanying common warrants, to purchase an aggregate of 2,000,000 shares of Common Stock in a registered direct offering (the "Offering") (Filing, 8-K, DURECT, FEB 7, 2023, View Source [SID1234626913]). The aggregate gross proceeds to DURECT from the Offering were $10.0 million before deducting placement agent fees and other estimated offering expenses payable by DURECT and excluding the proceeds, if any, from the exercise of the pre-funded warrants and common warrants issued in the Offering.

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The pre-funded warrants are exercisable immediately following the closing date of the Offering and have an unlimited term and an initial exercise price of $0.00001 per share. The common warrants will be immediately exercisable and have a five year term and an initial exercise price of $5.00 per share. The combined offering price is $5.00 per Share and accompanying common warrant, or in the case of pre-funded warrants, $4.99999 per pre-funded warrant and accompanying common warrant. A holder (together with its affiliates) may not exercise any portion of a pre-funded warrant or common warrant to the extent that the holder would own more than 4.99% (or, at the election of the holder 9.99%) of DURECT’s outstanding Common Stock immediately after exercise.

The common warrants include full ratchet anti-dilutive adjustment rights in the event DURECT issues shares of Common Stock or Common Stock equivalents in the future with a value less than the then effective exercise price of such common warrants subject to certain customary exceptions. The common warrants also include certain rights upon "fundamental transactions" as described in the common warrants, including the right of the holders thereof to receive from DURECT or a successor entity the same type or form of consideration (and in the same proportion) that is being offered and paid to the holders of Common Stock in such fundamental transaction in the amount of the Black Scholes value (as described in such common warrants) of the unexercised portion of the applicable common warrants on the date of the consummation of such fundamental transaction. In addition, a holder of a common warrant may also effect an "alternative cashless exercise" on or prior to the six (6) month anniversary of the original issuance date. In such event, the aggregate number of shares of our Common Stock issuable in such alternative cashless exercise shall equal the product of (x) the aggregate number of shares of our Common Stock that would be issuable upon exercise of the common warrant in accordance with the terms of such common warrant if such exercise were by means of a cash exercise rather than a cashless exercise and (y) 0.66.

The Purchase Agreement contains customary representations, warranties and agreements by DURECT, customary conditions to closing, and indemnification obligations of DURECT and the Purchasers. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of the Purchase Agreement and as of a specific date, were solely for the benefit of the parties to the Purchase Agreement, and may be subject to limitations agreed upon by the contracting parties.

DURECT engaged Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. to act as lead placement agents in the Offering. DURECT has agreed to pay the placement agents a cash fee equal to 6.0% of the aggregate gross proceeds generated from the Offering and to reimburse certain expenses of the placement agents in connection with the Offering in an amount not to exceed $150,000.

DURECT intends to use the proceeds from the Offering primarily for general corporate purposes, which may include clinical trials, research and development activities, capital expenditures, and selling, general and administrative costs, facilities expansion, and to meet working capital needs. The closing of the Offering is expected to occur on February 8, 2023, subject to customary closing conditions.

The Offering is being made pursuant to DURECT’s registration statement on Form S-3 (File No. 333-258333), previously filed with the U.S. Securities and Exchange Commission ("SEC") on July 30, 2021, and declared effective by the SEC on August 16, 2021, and a prospectus supplement thereunder.

A copy of the form of common warrant is filed as Exhibit 4.1 hereto, a copy of the form of pre-funded warrant is filed as Exhibit 4.2 hereto and the Purchase Agreement is filed as Exhibit 10.1 hereto. The foregoing descriptions of the terms of the Purchase Agreement and the pre-funded and common warrants are qualified in their entirety by reference to such exhibits. A copy of the opinion of Orrick, Herrington & Sutcliffe LLP relating to the legality of the issuance and sale of the Common Stock and pre-funded and common warrants in the Offering is attached to this Current Report on Form 8-K as Exhibit 5.1.