DURECT Corporation Announces Proposed Offering of Common Stock

On February 3, 2021 DURECT Corporation (Nasdaq: DRRX) ("DURECT"), a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program, reported that it is commencing an underwritten public offering of its common stock (the "Offering") (Press release, DURECT, FEB 3, 2021, https://www.prnewswire.com/news-releases/durect-corporation-announces-proposed-offering-of-common-stock-301221648.html [SID1234574585]). All of the shares to be sold in the Offering will be sold by DURECT, subject to customary closing conditions. In addition, DURECT intends to grant the underwriter for the Offering a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

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!

Cantor Fitzgerald & Co. is acting as the sole book running manager for the Offering.

The Offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226518) previously filed by DURECT with the Securities and Exchange Commission (the "SEC") on September 28, 2019 and declared effective by the SEC on October 9, 2018. The Offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the Offering will be filed with the SEC. Before you invest, you should read the registration statement, the preliminary prospectus, the documents that DURECT has filed with the SEC that are incorporated by reference into the registration statement, and the other documents DURECT has filed with the SEC for more complete information about DURECT and the offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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 prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

IPA Increases Previously Announced Bought Deal Offering of Common Shares to $21.7 Million

On February 3, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 1,616,293 common shares of the Company (the "Common Shares"), at a price to the public of $13.45 per Common Share, less underwriting discounts and commissions, for gross proceeds to the Company of approximately $21.7 million (Press release, ImmunoPrecise Antibodies, FEB 3, 2021, View Source [SID1234574581]). The closing of the offering is expected to occur on or about February 8, 2021, subject to satisfaction of customary closing conditions.

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!

H.C. Wainwright & Co. is acting as sole book-running manager for the Offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 242,443 Common Shares at the public offering price, less underwriting discounts and commissions. The Company intends to use the net proceeds from the Offering for (i) pursuing the Company’s objective of expanding its operations into Good Laboratory Practice and Good Manufacturing Practice-certified; (ii) the development and commercialization of Talem Therapeutics, LLC’s, a wholly owned subsidiary of the Company, internal and partnered therapeutic discovery programs; (iii) investments in employees, partnerships, cloud computing, data curation and analysis to enable further work toward the development of custom algorithms, cloud computing, large-scale sequence data analysis, and expanded access to next-generation sequencing technologies; (iv) the development of its PolyTopeTM approach to the development of innovative therapeutics and vaccines against the COVID-19; and (v) general corporate and working capital purposes.

In connection with the Offering, the Company filed with the securities regulatory authorities in each of the provinces of Canada (except Quebec), a short form base shelf prospectus dated December 11, 2020. The short form base shelf prospectus was filed on Form F-10 with the U.S. Securities and Exchange Commission (SEC). The Company also filed a preliminary prospectus supplement to the short form base shelf prospectus with the securities regulatory authority in the Province of British Columbia as well as with the SEC as part of a registration statement on Form F-10 under the U.S.-Canada multijurisdictional disclosure system (MJDS). The Common Shares will only be offered and sold in the United States either directly or through duly registered U.S. broker dealers. No Common Shares will be offered or sold to Canadian purchasers.

The Offering is being made in the United States only by means of the registration statement, including the base shelf prospectus and applicable prospectus supplement. Such documents contain important information about the offering. A short form base shelf prospectus and accompanying preliminary prospectus supplement have been filed with the SEC and are available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Copies of the short form base shelf prospectus and accompanying final prospectus supplement will be filed with the SEC and will be available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Electronic copies of the final prospectus supplement and registration statement, when available, may also be obtained from H.C. Wainwright & Co. LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

Prospective investors should read the base shelf prospectus and the prospectus supplement as well as the registration statement before making an investment decision.

No securities regulatory authority has either approved or disapproved the contents of this news release. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

InnoCare Announces First Subject Dosed in Clinical Trial of ICP-192 in the U.S.

On February 3, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported the first subject dosed in clinical trial of pan-FGFR inhibitor ICP-192 in the United States (Press release, InnoCare Pharma, FEB 3, 2021, View Source [SID1234574580]).

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!

ICP-192 is a highly selective small-molecule pan-FGFR inhibitor for the treatment of various solid tumors with FGFR aberrations. Currently it is in Phase I/II clinical studies in China and the United States.

The Phase II trial in China is a multi-center, open-label clinical trial designed to evaluate the safety and efficacy of ICP-192 in patients with advanced cholangiocarcinoma and urothelial cancer that have FGFR aberrations. The phase II clinical trials have enrolled nearly 20 patients, and cases of partial response and complete response have been observed in patients of FGFR gene alterations.

"We will continue to advance ICP-192 in clinical studies for the treatment of advanced solid tumors with FGFR aberrations in China and global," said Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare. "ICP-192 is an excellent drug candidate for the treatment of solid tumors with FGFR aberrations. We will work together with top clinical experts to rapidly advance the trials to explore the potential usage of ICP-192 in a variety of solid tumors. We hope to provide patients with better treatment options."

ICP-192 is the second innovative drug candidate discovered by InnoCare, which was approved for the initiation of clinical trials in the U.S.

Quanterix Announces Proposed Public Offering of $200.0 Million of its Common Stock

On February 3, 2021 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported that it has commenced an underwritten public offering of $200.0 million of its common stock (Press release, Quanterix, FEB 3, 2021, View Source [SID1234574579]). In connection with the offering, Quanterix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price less the underwriting discounts and commissions. All of the shares in the offering will be sold by Quanterix. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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!

Goldman Sachs & Co. LLC, SVB Leerink LLC and Cowen and Company, LLC are acting as joint bookrunning managers for the offering. Canaccord Genuity LLC is acting as lead manager for the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3ASR (File No. 333-249925) previously filed with the Securities and Exchange Commission ("SEC") on November 6, 2020, which automatically became effective upon filing. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Goldman Sachs & Co. LLC, 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526 or by e-mail at [email protected], from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6105 or by e-mail at [email protected], or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Indapta Therapeutics Announces Key Management Team Appointments to Advance into Clinical Trials in 2021

On February 3, 2021 Indapta Therapeutics Inc. ("Indapta"), a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic FcRγ-deficient natural killer (G-NK) cell therapy to treat multiple cancers, reported the appointments of Lori Kunkel, M.D., as its Senior Clinical Advisor, Robert Sikorski, M.D., Ph.D., as its Founding Chief Medical Officer, and Jim Weiss as a member of its Board of Directors (Press release, Indapta Therapeutics, FEB 3, 2021, View Source [SID1234574578]).

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!

"I’m delighted to welcome these industry veterans to our team at this exciting time in Indapta’s evolution into the clinic," said Guy DiPierro, Chief Executive Officer and Founder of Indapta. "Lori and Bob bring vast and relevant clinical experience and strategic expertise to help shepherd Indapta through our clinical trials in multiple indications and phases of development. Dr. Kunkel’s knowledge of oncology drug development and commercialization, along with Dr. Sikorski’s extensive cell therapy experience, will help accelerate our clinical programs in multiple cancer types. And Jim Weiss will bring data-driven digitally-based commercial strategy, marketing and communications savvy as product development and launches become increasingly virtual in the post pandemic landscape."

Dr. Kunkel has more than two decades of experience in oncology and immunology drug development and commercialization. Previously, she was the acting Chief Medical Officer at Loxo Oncology, which was acquired by Eli Lilly, and subsequently served on the Board of Directors. Earlier, she served as Chief Medical Officer at Pharmacyclics, which was acquired by AbbVie, and at Proteolix, Inc., which was acquired by Onyx Pharmaceuticals, which in turn was acquired by Amgen, where she contributed to the global approvals of cancer therapeutics IMBRUVICA and Kyprolis. Dr. Kunkel spent 10 years in academic medicine and served as a faculty member at the Bone Marrow Transplant Unit in the Division of Hematology/Oncology at the University of California, Los Angeles. She currently serves on the Boards of Directors of Curis, Inc., Nurix Therapeutics, OricPharma and Maverick Therapeutics.

"Indapta’s promising preclinical data combined with its proprietary manufacturing process and its innovative management team is what drew me to the company," said Dr. Kunkel. "I’m looking forward to working with Guy, the management team and Board members and applying my experience to position Indapta’s products in the current therapy regimen, design the clinical trials, work with the FDA, and help rapidly advance Indapta’s G-NK cell therapy through the clinic and too approval."

Dr. Sikorski has extensive drug development experience, having most recently served as Chief Medical Officer at FivePrime Therapeutics, a public biotechnology company, where he led the development of a biologics pipeline that spanned preclinical discovery through proof of concept to pivotal trials. Previously, he led an early-stage clinical development group at Medimmune/AstraZeneca that advanced six novel molecules into clinical trials. He played a leading role in building Medimmune/AstraZeneca’s oncology portfolio through corporate partnering and acquisition efforts. Earlier in his career, he led late-stage clinical development and post marketing efforts for several commercial drugs and drug candidates at Amgen. He began his career as a Howard Hughes Research Fellow and Visiting Scientist at the National Cancer Institute and the National Human Genome Research Institute in the laboratory of Nobel Laureate Harold Varmus. Dr. Sikorski has served as an editor for Science and the Journal of the American Medical Association.

"The team at Indapta has developed a novel and powerful allogeneic NK cell product and manufacturing process that could serve as a platform for multiple next-generation anti-cancer therapies," said Dr. Sikorski. "I’m excited by the opportunity to bring this cutting-edge science to the treatment of cancer patients."

Mr. Weiss has 30 years of experience in strategic media and marketing communications in the healthcare and technology sectors and has been involved in nearly every aspect of corporate, product and organizational communications. He is the Founder and Chief Executive Officer of W2O, the leading independent provider of analytics-driven, digital-first marketing and communications to the healthcare sector. During his career, Mr. Weiss has been recognized as one of the most influential people in health communications, receiving many accolades, including Top 50 Health Influencer and Top 25 Innovator in Communications. He began his career at Genentech during its formative commercial years. Mr. Weiss currently serves on the Board of Trustees of the Cancer Research Institute and The Commons Project and is an Advisory Board member of both the Newhouse School and the Healthcare Businesswomen’s Association.

"Jim has advised me at numerous companies, from private to public, and from preclinical to commercial, driving value through key inflection points," said Dov Goldstein, M.D., Chief Financial and Business Officer of Indapta. "A founder and owner of a company that has grown to include more than 1,500 employees, Jim understands how to scale and evolve a company through various stages of success. We know our efforts at Indapta will benefit from his insights while serving on our Board."

Indapta’s G-NK Cell Therapy

Indapta Therapeutics is developing a universal, allogeneic G-NK cell therapy designed to substantially improve the cytotoxicity of monoclonal antibody therapy in multiple cancers. G-NK cells are a specific and potent subset of NK (natural killer) cells with specialized anti-tumor activity resulting from an epigenetic change, rather than engineering. Indapta has further enhanced G-NK cells via specific G-NK cell subset selection and its proprietary manufacturing process which, when combined, produce a G-NK cell therapy that demonstrates higher efficacy, persistence and enhanced cryopreservation than multiple monoclonal antibody therapies alone or monoclonal antibody therapies combined with conventional NK cells.

When a monoclonal antibody binds to the tumor target and to Indapta’s G-NK cell therapy product, it initiates the release of dramatically more cancer killing compounds than conventional NK cells, allowing for increased efficacy and potentially less frequent dosing. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell banked product with low variability. In vivo studies have demonstrated the safety of Indapta’s G-NK cell therapy.