On December 15, 2021 Avenue Therapeutics, Inc. (or the "Company") (NASDAQ: ATXI), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, reported the closing of its public offering of 1,910,100 shares of common stock at a public offering price of $1.07 (Press release, Avenue Therapeutics, DEC 15, 2021, View Source [SID1234597229]). The gross proceeds of the offering were approximately $2.0 million before deducting underwriting discounts, commissions and offering expenses. In addition, the Company has granted Aegis Capital Corp. a 45-day option to purchase up to an additional 286,430 shares of common stock to cover over-allotments, if any, at the public offering price, less the underwriting discount.

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 common stock is trading on The Nasdaq Capital Market under the symbol "ATXI".

Aegis Capital Corp. acted as the sole book-running manager for the offering.

A registration statement on Form S-3 relating to common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on December 10, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

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 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 December 15, 2021 PharmaCyte Biotech, Inc. NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the financial results for its second quarter ended October 31, 2021, and provided an overview of recent operational highlights (PharmaCyte’s Fiscal Year begins May 1 and ends April 30) (Press release, PharmaCyte Biotech, DEC 15, 2021, View Source [SID1234597228]).

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!

Cash Position: PharmaCyte had approximately $87 million in cash on hand as of October 31, 2021.

Recent Q2 Highlights—Corporate:

Common stock was listed on Nasdaq Capital Markets as the Company began trading as a Nasdaq-listed company
Closed on a $15-million public offering
Closed on a $70-million registered direct offering
Company had warrant conversions of approximately $10.7 million
PharmaCyte expanded its Product Pipeline beyond its Cancer Program to include a Diabetes Program and a Malignant Ascites Program.
Recent Highlights—Pipeline Products:

The Company’s capital raises allowed PharmaCyte to spend what was needed in Research and Development (R&D) expenses to perform the work required to have the FDA imposed clinical hold lifted. PharmaCyte will issue a 2021 year-end update to detail which tests/studies have been completed, which have commenced, and which remain for PharmaCyte to present to the FDA with updated data in its effort to lift the FDA’s clinical hold.
In August 2021, PharmaCyte announced its clinical trial product, CypCaps remains stable and active at 18 months after completing the 18-month timepoint of ongoing product stability testing required by the U.S. Food and Drug Administration (FDA).
In September 2021, the Company announced the first test results of the biocompatibility studies of its CypCaps clinical trial product candidate. These positive results were from an "In Vitro Complement Activation Study of Empty Cellulose Sulphate Capsules," the same capsules PharmaCyte plans to use in its treatment to treat locally advanced, inoperable pancreatic cancer (LAPC). The first results showed that the capsule material does not activate a major line of the human body’s innate defense – the complement system.
In September 2021, PharmaCyte announced the results of a second FDA-required test of biocompatibility of its CypCaps product for the treatment of LAPC. The results showed that the empty capsule material is "non-hemolytic." The data showed that the capsule material does not cause blood cells to lyse either after direct or indirect contact with blood. Moreover, it confirms prior data that was observed previously in animal models and previous clinical trials.
In September 2021, PharmaCyte announced the results from a third test of biocompatibility of its CypCaps product candidate for pancreatic cancer. The results showed that the empty capsule material is not "mutagenic." A mutagen is a physical or chemical agent that permanently changes genetic material, usually DNA, in an organism and thus increases the frequency of mutations above the natural background level.
Since the close of PharmaCyte’s quarter ended October 31, 2021, the PharmaCyte announced that: (i) the empty capsule material that makes up its CypCaps pancreatic cancer product does not cause skin irritation, (ii) the commencement of a pivotal study to determine if PharmaCyte’s treatment for pancreatic cancer, which PharmaCyte plans to use for the treatment of LAPC—CypCaps combined with the cancer killing chemotherapy prodrug ifosfamide—can also delay the rate of production and accumulation of malignant ascites. This is fluid that accumulates in the abdominal cavity from various cancers, and (iii) the results of an additional, more detailed, analysis of the integration site of the cytochrome P450 2B1 gene from the Company’s genetically modified cell clone that it uses in PharmaCyte’s CypCaps product for the treatment of LAPC.
Recent Highlights—Financial:

During the three months ended October 31, 2021, PharmaCyte’s cash balance and total assets increased by approximately $86 million.

On October 31, 2021, PharmaCyte’s total stockholder equity increased by approximately $86 million from July 31, 2021.

Other PharmaCyte expenses decreased by approximately $25,000 and $23,000 for the three and six months ended October 31, 2021.

Operating expenses increased for the three months ended October 31, 2021, by approximately $55,000 and $197,000 for the six months ended October 31, 2021, due to costs associated with an uplist to Nasdaq Capital Markets, the closing of two public offerings, and putting those funds to use in the start of new tests and studies related to lifting the FDA clinical hold on PharmaCyte’s proposed treatment for LAPC.

PharmaCyte’s R&D expenses increased from the start of its fiscal year to about $360,000 to date. The two capital raises PharmaCyte conducted in August 2021 allowed for these necessary expenses to be possible.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On December 15, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its lead program, investigating ST101 for the treatment of advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy (Press release, Sapience Therapeutics, DEC 15, 2021, View Source [SID1234597227]). This is the second FTD designation received for the ST101 program, following FTD for recurrent glioblastoma (GBM), announced in early December 2021. ST101 is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors, which includes expansion cohorts in patients with cutaneous melanoma and refractory GBM.

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!

Dr. Barry Kappel, Sapience’s CEO and President, commented, "Melanoma is the fifth most diagnosed cancer in the U.S., with more than 100,000 new cases per year, and no well-established standard of care treatment regimen. We believe we have a significant opportunity to deliver a novel therapeutic option with ST101, which has a durable clinical efficacy and an excellent safety profile, for melanoma patients whose disease has progressed following treatment with anti-PD-1 therapy."

Dr. Gina Capiaux, PhD, Sapience’s Head of Regulatory Affairs added, "This is the second Fast Track designation received for ST101, underscoring the advancement of our ST101 program and its potential therapeutic benefit for both melanoma and GBM patients. We are grateful for the opportunity to quickly advance the development of ST101 for patients in need."

Fast Track designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Sapience also previously received Orphan Drug Designation from the U.S. FDA and European Commission for ST101 for the treatment of glioma.

About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted Fast Track Designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation by the European Commission for the treatment of glioma.

On December 15, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) ("Corcept"), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported an update to its offer to purchase up to 10,000,000 shares of its common stock at a price not greater than $23.75 nor less than $20.75 per share closing at one minute after 11:59 P.M., New York City time, on December 15, 2021 (the "Tender Offer") (Press release, Corcept Therapeutics, DEC 15, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-waiver-condition-its-tender-offer [SID1234597226]).

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!

Corcept’s Board of Directors has determined that it is advisable to proceed with the Tender Offer despite the recent fluctuations in the price of Corcept’s stock and has therefore declined to exercise Corcept’s option, as set forth in the offer to purchase, to terminate the Tender Offer due to changes in the company’s stock price.
The Tender Offer is subject to other terms and conditions, which are described in detail in the offer to purchase. Except for the waiver of the share price condition set forth above, the terms and conditions of the Tender Offer remain the same.

None of Corcept, the members of its Board of Directors, the dealer manager, the financial advisor, the information agent or the depositary for the Tender Offer makes any recommendation as to whether or not any stockholder should participate in the Tender Offer or as to the purchase price or purchase prices at which stockholders may choose to tender their shares.

The sole dealer manager for the Tender Offer is Truist Securities, Inc. D.F. King is serving as the information agent for the Tender Offer and Continental Stock Transfer & Trust Company is serving as the depositary. Canaccord Genuity LLC is serving as a financial advisor. For all questions relating to the Tender Offer, please contact the information agent, D.F. King & Co., Inc. at [email protected] or call toll-free at 1 (800) 431-9646, or call the dealer manager, Truist Securities, Inc. at 1 (404) 926-5832.

On December 15, 2021 Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that AstraZeneca (LSE/STO/Nasdaq: AZN) has exercised its first license option for an Invir.IO oncolytic virus (OV) developed from their on-going OV collaboration (Press release, Transgene, DEC 15, 2021, View Source [SID1234597225]). The exercise of this option for an OV, integrating an undisclosed transgene, will result in Transgene receiving an $8 million payment from AstraZeneca. Transgene is also eligible to receive development, regulatory and sales-based milestones payments as well as a royalty based on future commercial sales.

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!

Hedi Ben Brahim, Chairman and CEO of Transgene, commenting on today’s news said, "We are delighted that AstraZeneca has decided to exercise its first license option for an oncolytic virus generated from our on-going Invir.IO collaboration. We have developed a very productive working relationship with the AstraZeneca team and based on long standing expertise developing Vaccinia based viruses capable of carrying payloads that enhance the OV’s antitumoral properties. We are looking forward to seeing this exciting OV candidate progress into clinical development."

Transgene’s Invir.IO collaboration agreement with AstraZeneca started in 2019. Under the terms of the agreement Transgene is contributing its OV expertise, including viral design, and engineering, to the collaboration. It is also providing access to its novel and improved Vaccinia Virus double-deleted (TK- RR-) backbone, which forms the basis for its Invir.IO platform, and is responsible for in vitro preclinical development of the OV candidates generated from the collaboration. AstraZeneca has selected several transgenes to be integrated within candidates generated with the Invir.IO viral backbone and is responsible for further in vivo preclinical development. Under the terms of the agreement, up to five novel oncolytic immunotherapies can be co-developed.

Transgene has an in-house pilot manufacturing capability that allows it to produce GMP batches of Invir.IO drug candidates for clinical development.

Recent clinical data, presented by Transgene in September 2021 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) virtual meeting confirmed that OVs based on Transgene’s proprietary double deleted VVcopTK-RR- virus backbone can be administered intravenously (see press release here). Transgene believes that Invir.IO OVs delivered via the intravenous route could greatly expand the number of solid tumors that could be treated with this therapy, significantly increasing the commercial potential of Transgene’s OV candidates.