Daré Bioscience Announces $7.0 Million Registered Direct Offering Priced At-The-Market under Nasdaq Rules

On August 30, 2023 Daré Bioscience, a leader in women’s health innovation, reported that it has entered into a definitive agreement with an institutional investor and an investor affiliated with the licensor of one of the company’s early stage product candidates for the purchase and sale of 10,000,000 shares of the company’s common stock and warrants to purchase up to 10,000,000 shares of the company’s common stock in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Daré Bioscience, AUG 30, 2023, View Source [SID1234634783]). Each warrant is exercisable for one share of the company’s common stock. The offering price was $0.70 per share of common stock and accompanying warrant. The warrants will be exercisable beginning six months after issuance, have a term of five and one-half years from the date of issuance and have an exercise price of $0.77 per share. The closing of the offering is expected to occur on or about September 1, 2023, subject to the satisfaction of customary closing conditions.

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The aggregate gross proceeds to Daré from the offering at the closing are expected to be $7.0 million before deducting estimated offering expenses payable by Daré. Daré intends to use the proceeds from the offering for general corporate purposes, which may include clinical trials, research and development activities, general and administrative costs, and to meet working capital needs.

The securities described above are being offered and sold by Daré pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254862), including a base prospectus, previously filed with the Securities and Exchange Commission, or the SEC, on March 30, 2021, and declared effective by the SEC on April 7, 2021. Such securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and an accompanying base prospectus relating to the securities will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained, when available, by visiting the SEC’s website at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall 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 registration or qualification under the securities laws of any such state or other jurisdiction.

XBiotech Announces Enrollment Completion of Phase II, Placebo Controlled, Multicenter Study for Natrunix in Pancreatic Cancer

On August 30, 2023 XBiotech Inc. reported completion of enrollment of the Phase II portion of its 1-BETTER study—a Phase I/II randomized, double-blind, placebo-controlled clinical study for Natrunix in combination with chemotherapy for treating pancreatic cancer (Press release, XBiotech, AUG 30, 2023, https://investors.xbiotech.com/news-releases/news-release-details/xbiotech-announces-enrollment-completion-phase-ii-placebo [SID1234634782]).

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Natrunix is indistinguishable from a naturally occurring antibody present in a healthy human. Natrunix binds and neutralizes a potent substance, a so called cytokine known as interleukin-1a (IL-1a), that causes connective tissue breakdown, growth of new blood vessels, and recruitment of white blood cells. Malignant tumors, like pancreatic cancer, stimulate the body’s production of IL-1a that induce tumor neovascularization, growth and spread. Additionally, IL-1a acts as an alarm signal when there is body injury (such as when tumors grow), enhancing pain perception, metabolism, appetite, fatigue, and anxiety. The insult from chemotherapy also induces IL-1a production. Adding Natrunix to your chemotherapy regimen may therefore provide numerous benefits, including anti-tumor activity, reduction in chemotherapy side effects, improvement in chemotherapy activity—including increasing the number of cycles of therapy that can be tolerated while improving quality of life.

Twenty-two leading cancer centers across the United States have been involved in the Phase I/II study. Pancreatic cancer is the 4th leading cause of cancer death in the United States and the incidence has been increasing steadily since 2000. In 2022, an estimated 50,000 people died from pancreatic cancer in the United States. The Natrunix antibody therapy represents a groundbreaking approach to therapy.

The Phase II portion enrolled 65 subjects using the maximum dose studied from the Phase I study that were randomized on a 1:1 basis to receive either Natrunix in combination with ONIVYDE+LV+5-FU (Arm 1), or placebo plus the chemotherapy combination. Key endpoints in the Phase II portion are safety and tolerability, progression-free survival, overall survival and time-to-treatment-failure.

About Natrunix
Natrunix is a True Human antibody that was discovered, developed and manufactured by XBiotech. True Human antibodies are derived—without modification—from individuals who possess natural immunity to certain diseases. In many individuals, the body naturally produces antibodies to block pathological inflammation associated with interleukin-1, one of the most extensively studied inflammatory pathways in medicine. Other marketed biological drugs attempt to treat diseases by blocking interleukin-1, however none specifically and exclusively target interleukin-1 alpha (IL-1a). There is also no other marketed monoclonal antibody therapy derived unaltered from a natural human immune response.

Theratechnologies Announces All U.S. Oncology Clinical Sites Now Enrolling for Phase 1 Trial of Sudocetaxel Zendusortide

On August 30, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that all five of the U.S.-based clinical sites participating in the conduct of the Phase 1 clinical trial of the Company’s lead investigational peptide drug conjugate, sudocetaxel zendusortide, are now activated to screen, enroll and dose advanced ovarian cancer patients (Press release, Theratechnologies, AUG 30, 2023, View Source [SID1234634781]). A sixth site based in Canada is finalizing its start-up activity.

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Full details about the study design, participation criteria and contact information for the sites can be found at : View Source

About Sudocetaxel Zendusortide and SORT1+ Technology

Sudocetaxel zendusortide is currently Theratechnologies’ lead investigational peptide drug conjugate candidate for the treatment of cancer derived from its SORT1+ Technology. It is the Company’s proprietary peptide linked to docetaxel – a commonly used cytotoxic agent used to treat many cancers. The FDA granted fast track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a phase 1 clinical trial.

Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ Technology for cancer drug development targeting SORT1 receptors. The SORT1 receptor plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.

Sutro Biopharma to Participate in Upcoming Investor Conferences

On August 30, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that Bill Newell, Chief Executive Officer, will participate in two upcoming investor conferences (Press release, Sutro Biopharma, AUG 30, 2023, View Source [SID1234634780]).

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Presentation Details:

Citi 18th Annual BioPharma Conference
Format: Fireside Chat
Date: Wednesday, September 6, 2023
Time: 8:00 a.m. ET / 5:00 a.m. PT
Location: Boston

2023 Wells Fargo Healthcare Conference
Format: Fireside Chat
Date: Thursday, September 7, 2023
Time: 10:15 a.m. ET / 7:15 a.m. PT
Location: Boston

Webcasts of the fireside chats will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the event.

Sensei Biotherapeutics to Participate in Upcoming Investor Conferences

On August 30, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that Company management will participate in the following investor conferences in September 2023 (Press release, Sensei Biotherapeutics, AUG 30, 2023, View Source [SID1234634779]):

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Citi’s 18th Annual Biopharma Conference
September 5th-7th
Boston, MA

Wells Fargo’s 2023 Healthcare Conference
September 5th-8th
Boston, MA

Portfolio managers and analysts who would like to request a meeting with management should contact their representative at the respective hosting firms.