On November 3, 2021 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) ("ANI" or the "Company") reported the pricing of an underwritten public offering of 1,500,000 shares of its common stock at a public offering price of $50.00 per share (Press release, ANI Pharmaceuticals, NOV 3, 2021, View Source [SID1234594277]). The gross proceeds of the offering to the Company are expected to be $75 million, before deducting the underwriting discounts and commissions and other offering expenses. In addition, ANI granted the underwriters a 30-day option to purchase up to an additional 225,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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 closing of the offering is expected to occur on or about November 8, 2021, subject to the satisfaction of customary closing conditions.

Guggenheim Securities is acting as lead book-running manager for the offering. Raymond James is also acting as book-running manager for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

The securities described above are being offered by ANI pursuant to a shelf registration statement on Form S-3 (File No. 333-239771) which was initially filed by the Company with the Securities and Exchange Commission (the "SEC") on July 9, 2020 and was declared effective by the SEC on July 17, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on November 3, 2021 and is available on the SEC’s website at View Source The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about the Company and the offering. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected], and from Raymond James & Associates, Inc. Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by email at [email protected].

This press release shall 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 3, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and The Royal Marsden NHS Foundation Trust, one of the United Kingdom’s (UK) leading cancer research organizations, reported that they have agreed to enter into a partnership to establish an in-house liquid biopsy testing service using Guardant Health’s industry-leading proprietary digital sequencing platform (Press release, Guardant Health, NOV 3, 2021, View Source [SID1234594275]).

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 service is expected to become operational at the end of 2022 and will be available for clinical research and clinical care. This will be the first UK hospital for Guardant Health to house a dedicated liquid biopsy testing facility for cancer diagnostics.

"We are delighted to announce this partnership with Guardant Health, establishing a state-of-the-art liquid biopsy testing facility. In a clinical diagnostic setting, it will provide many of our patients with more rapid access to bespoke diagnostic testing, leading to earlier, faster, and more accurate diagnosis, along with targeted treatment selection and monitoring," said Professor Michael Hubank, Director of Clinical Genomics (Research) at The Royal Marsden NHS Foundation Trust. "The opening of this service will also allow us to significantly increase our capacity for research using liquid biopsies. Bringing expanded capacity for genomic testing, the facility will help us identify more people with cancer for clinical trials based on targeted treatments, improving outcomes for patients across the UK and beyond."

It is estimated that there were around 375,000 new cancer cases in the UK from 2016-20181, with approximately 166,000 cancer deaths in the UK from 2016-2018.1 Guardant Health’s tests are used by oncologists around the world to guide treatment decisions across solid tumor cancers, and by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development. Guardant Health has achieved CE Mark and U.S. Food and Drug Administration approval for its Guardant360 CDx assay for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid cancerous tumor.

"We are pleased to announce this partnership with The Royal Marsden NHS Foundation Trust, which will enable clinicians to quickly and accurately detect relevant tumor alterations with a blood test to guide personalized treatment plans and provide researchers with diagnostic tools to support clinical research and innovation," said Helmy Eltoukhy, Guardant Health Co-CEO. "This partnership further advances our goal of ensuring all patients with cancer have access to the latest innovations to inform their treatment management to enable the best possible outcomes."

On November 3, 2021 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) ("ANI") reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, ANI Pharmaceuticals, NOV 3, 2021, View Source [SID1234594274]). All of the shares to be sold in the offering will be offered by ANI. The offering is subject to market 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. In addition, ANI intends to grant the underwriters a 30-day option to purchase up to an additional 15% 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!

Guggenheim Securities is acting as book-running manager.

ANI anticipates using the net proceeds from the offering to fund its Cortrophin commercialization efforts, including, but not limited to, sales and marketing and consulting expenses related thereto, and for general corporate purposes. We may also use a portion of the net proceeds to in-license, acquire or invest in additional businesses, technologies, products or assets.

The securities described above are being offered by ANI pursuant to a shelf registration statement on Form S-3 (File No. 333-239771) which was initially filed by the Company with the Securities and Exchange Commission (the "SEC") on July 9, 2020, and was declared effective by the SEC on July 17, 2020.

The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying 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 at View Source Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 3, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported updated clinical data from a Phase 1 study of tidutamab, an SSTR2 x CD3 bispecific antibody, in patients with neuroendocrine tumors (NETs) (Press release, Xencor, NOV 3, 2021, View Source [SID1234594273]). The data will be presented during the North American Neuroendocrine Tumor Society’s 2021 Multidisciplinary NET Medical Virtual Symposium (NANETS).

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 Phase 1 study of tidutamab in patients with neuroendocrine tumors informed our view that an XmAb CD3 bispecific antibody is generally well tolerated in solid tumors, with a low incidence and severity of CRS, and can induce meaningful biological activity in a challenging disease setting," said Allen Yang, M.D., Ph.D., senior vice president and chief medical officer at Xencor. "Importantly, we identified a recommended dose for continued study, and a Phase 1b/2 study has been opened to evaluate tidutamab as a potential treatment option for patients with Merkel cell carcinoma and small cell lung cancer, SSTR2-expressing tumor types known to be responsive to immunotherapy."

A poster with data from the study is available in the NANETS Virtual Poster Hall, and it will be made available under Archived Scientific Presentations on the Events & Presentations page in the Investors section of www.xencor.com. In addition to the poster, these results will be presented during the Clinical Abstracts session, which begins at 1:25 p.m. ET on Saturday, November 6, 2021.

Key Highlights

The primary objectives of the Phase 1 study were to determine the safety and tolerability profile of tidutamab in patients with advanced, well-differentiated NETs of pancreatic, gastrointestinal, lung and undetermined origin, and to identify the maximum tolerated dose and/or recommended dosing regimen for continued study, which was determined to be a 0.3 mcg/kg priming dose followed by 1.0 mcg/kg on subsequent dosing days.

At data cut-off in August 2021, 41 patients with neuroendocrine tumors, with the initial lesion location in the pancreas (46%), intestine (22%), lung (20%), and other GEP-NET or unknown (12%), received doses of tidutamab ranging from 0.1 to 2.0 mcg/kg. Dosing in the study included a lower priming dose, followed by a higher repeated dose on subsequent dosing days. The 20 patients in the expansion cohort received the recommended dosing regimen. Patients had a median age of 64 years and a median of four prior lines of systemic therapies. Fifty percent of patients received prior peptide receptor radionuclide therapy.

Tidutamab was generally well tolerated at the 0.3/1.0 mcg/kg dose identified for the expansion portion of the study. All 41 patients treated were included in the safety analysis. The most common treatment-related Grade 3 or Grade 4 adverse events across all doses were lymphopenia (29%), gamma-glutamyl transferase increases (20%), transaminase increases (20%) and vomiting (17%). In addition, Grade 3 esophageal dysmotility was observed in 7% of patients. CRS of any grade was observed in 41% of patients. The majority of CRS was limited to Grade 1 and Grade 2 and to the first two doses. Grade 3 CRS was observed in two patients (5%) upon the first dose. All patients experiencing CRS fully recovered.

Analysis of peripheral blood biomarkers indicated that tidutamab induced acute and sustained T-cell activation at the recommended dose for expansion. CD8-positive effector T cells showed a dose-dependent increase in proliferation (Ki67) and activation (PD-1) markers that began within 48 hours of the first dose and persisted at least seven weeks, as measured at cycle 2, day 22.

The best overall response was stable disease, with a disease control rate of 27%. Higher tumor PD-L1 expression was associated with a shorter time on study, and the patients with prolonged stable disease were most likely to have low or absent PD-L1 expression, suggesting a potential beneficial effect from the combination of tidutamab with PD-L1 inhibitors.

About Tidutamab

Tidutamab is a tumor-targeted bispecific antibody that contains both an SSTR2 binding domain and a T-cell binding domain (CD3). An XmAb bispecific Fc domain serves as the scaffold for the two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on tidutamab. SSTR2 (somatostatin receptor 2) is an antigen highly expressed on some solid tumors, and engagement of CD3 by tidutamab activates T cells for highly potent and targeted killing of SSTR2-expressing tumor cells. Tidutamab is being evaluated in an ongoing Phase 1b/2 study, which is enrolling patients with Merkel cell carcinoma and small cell lung cancer, SSTR2-expressing tumor types known to be responsive to immunotherapy.

On November 3, 2021 PAVmed Inc. (Nasdaq: PAVM, PAVMZ), a highly differentiated, multi-product, commercial-stage medical device company, and its major subsidiary Lucid Diagnostics Inc. (Nasdaq: LUCD), a cancer prevention medical diagnostics company reported that the companies will host a joint business update conference call on Tuesday, November 16, 2021, at 4:30 PM EDT (Press release, PAVmed, NOV 3, 2021, View Source [SID1234594272]). During the call, Lishan Aklog, M.D., Chairman and Chief Executive Officer of the companies, will provide a business update including an overview of the Company’s near-term milestones and growth strategy. In addition, Dennis McGrath, the companies’ Chief Financial Officer, will discuss the companies’ third quarter 2021 financial results.

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 conference call, U.S.-based listeners should dial 877-407-3982 and international listeners should dial 201-493-6780. All listeners should provide the operator with the conference call name "PAVmed, Inc. Business Update Conference Call" to join. Individuals interested in listening to the live conference call via webcast may do so by visiting the investor relations section of the Company’s website at www.pavmed.com.

Following the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing 844-512-2921 from within the U.S. or 412-317-6671 from outside the U.S. To access the replay, all listeners should provide the following pin number: 1374402. The webcast will be available for replay on the investor relations section of the Company’s website at www.pavmed.com.