On November 21, 2022 SIWA Therapeutics reported the aging-related and cancer cell-derived oxidatively-stressed tumor microenvironment and other cell damages drive cell senescence and other oxidative cellular responses (Press release, SIWA Therapeutics, NOV 22, 2022, View Source [SID1234624385]). Tumor fibrosis reduces the effectiveness of anti-cancer immune responses and senescent cells (SCs), in turn, promote immune suppression, tumor progression, and metastasis. Hence, according to a study conducted by Translational Genomics Research Institute on behalf of SIWA Therapeutics, Inc. as presented by Dr. Gabriela Rossi, Chief Research Officer of SIWA Therapeutics, Inc. ("SIWA") at the AACR (Free AACR Whitepaper) Special Conference: Aging and Cancer November 17 -20, 2022, targeting damaged cells, including SCs and cancer cells, with SIWA318H, presents an attractive approach for cancer therapy.

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SIWA318H is a monoclonal antibody that selectively targets an advanced glycation end product oxidative stress biomarker on the surface of dysfunctional cells exhibiting both (a) aerobic glycolysis and b) oxidative stress. The SIWA318H biomarker is associated with cancer cells, SCs, oxidatively-damaged cells, and infected cells. SIWA318H has been shown to exhibit strong binding to pancreatic cancer patient derived xenograph tumors as demonstrated by immunochemistry bind to an ADCC inducing human IgG FcγR3 receptor to enable ADCC as a mechanism of action for SIWA318H.

In an in vivo study using a humanized mouse xenograft model for pancreatic cancer, it was shown thattreatment with SIWA318H (both high and low dose groups) statistically significantly reduced tumor growth compared to the isotype antibody control group (P < 0.0001). In addition, there was a significantly higher number of mice that had complete remission in the SIWA318H-treated groups compared to the isotype control group: 37.5% in high dose group (P = 0.0325) and 43.8% in low dose group (P = 0.0143). Moreover, mice treated with SIWA318H had a median overall survival of > 45 days compared to 26 days for the isotype control mice. There was no difference in animal body weight between the SIWA318H-treated mice and the isotype control mice indicating that the treatment with SIWA318H was well tolerated.

Immunohistochemical analysis of tumor tissues taken from the in vivo study showed that SIWA318H treatment significantly reduced (a) tumor fibrosis as measured by the area of αSMA+ staining and (b) the number of senescent cells in the tumor stroma as measured by the number of p16INK4a positive cells in αSMA+ areas.

In summary, the SIWA results demonstrate that SIWA318H is a novel antibody that exhibits potent preclinical antitumor activity against pancreatic cancer. SWA318H is currently under development for a first-in-human clinical trial.

On November 18, 2022 Cassava Sciences, Inc. (Nasdaq: SAVA) (the "Company" or "Cassava Sciences"), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported that it has entered into a definitive agreement with several healthcare-focused and other institutional investors for the purchase of 1,666,667 shares of its common stock, at a purchase price of $30 per share, for gross proceeds of approximately $50 million, in a registered direct offering (Press release, Pain Therapeutics, NOV 22, 2022, View Source [SID1234624384]). The closing of the offering is expected to occur on or about November 22, 2022, subject to the satisfaction of customary closing conditions.

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

Cassava Sciences intends to use the net proceeds from this offering for working capital and general corporate purposes, including development of simufilam, the Company’s lead drug candidate for the treatment of Alzheimer’s disease.

The shares of common stock are being offered by Cassava Sciences pursuant to an automatic "shelf" registration statement on Form S-3, which was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 10, 2021 and became effective immediately upon filing, and the prospectus contained therein. The offering will be made only by means of a prospectus supplement that forms a part of the registration statement.

A prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, 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) 856-5711 or e-mail 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 22, 2022 Oncosec presented its corporate presentation (Presentation, OncoSec Medical, NOV 22, 2022, View Source [SID1234624383]).

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On November 22, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, reported that the Company will participate in a fireside chat at the 5th Annual Evercore ISI HealthCONx Conference on Wednesday, November 30, 2022, at 12:35 p.m. ET/9:35 a.m. PT (Press release, Alpine Immune Sciences, NOV 22, 2022, View Source [SID1234624379]).

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A live webcast of the fireside chat will be available in the investor relations section of the Company’s website at View Source and a replay will be available on the Company’s website for 90 days following the live event.

On November 22, 2022 Alpha Tau Medical Ltd. (Nasdaq: DRTS and DRTSW), ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported third quarter 2022 financial results and provided a corporate update (Press release, Alpha Tau Medical, NOV 22, 2022, View Source [SID1234624373]).

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"Alpha Tau remained active in the third quarter, as we continued preparations for our upcoming U.S. pivotal study in recurrent cutaneous squamous cell carcinoma and laid the groundwork for exploration of our Alpha DaRT oncology treatment platform across a broad set of applications," said Alpha Tau CEO Uzi Sofer. "At the same time, we have remained highly visible through a series of scientific publications and presentations to discuss our Alpha DaRT treatment. In anticipation of pivotal study data and a potential U.S. launch, we are actively preparing for our global commercialization efforts, having brought the highly experienced Peter Melnyk into the role of Chief Commercial Officer, while we continue to ramp up manufacturing capacity across the world. Peter will focus on prelaunch activities across the U.S. and international markets to help prepare for future reimbursement and commercialization efforts. In parallel, we continue to initiate a number of feasibility trials in internal organs and develop new delivery technologies for Alpha DaRT to expand its use in patients underserved by current treatments. With all of this activity, we remain well capitalized and focused on efficient operations as we continue to execute on our strategic plans."

Recent Corporate Highlights:

· Peter Melnyk, a former member of Alpha Tau’s Board of Directors, assumed the full-time position of Alpha Tau’s Chief Commercial Officer.
· Two landmark pre-clinical studies demonstrating significant potential synergies between the Alpha DaRT treatment and standard-of-care immunotherapy, chemotherapy and anti-angiogenic therapy were published in major peer-reviewed journals.
o Study on combination with anti-PD1 therapy published by International Journal of Radiation Oncology, Biology, Physics, known in the field as the Red Journal, the official journal of the American Society for Radiation Oncology (ASTRO).
o Study on combinations with chemotherapy and anti-angiogenic therapy in human glioblastoma multiforme xenografts published by Frontiers in Oncology, in its Radiation Oncology section.
· Medicines and Healthcare products Regulatory Agency of the United Kingdom approved clinical trial in squamous cell carcinoma of the vulva at Addenbrookes Hospital in Cambridge.
· Health Canada approved the addition of Jewish General Hospital in Montreal as a second site in the Company’s clinical trial in advanced pancreatic cancer.
· Dr. Christopher Barker of Memorial Sloan Kettering Cancer Center presented at the ASTRO 2022 Annual Meeting on results of the Company’s U.S. pilot feasibility study completed earlier in 2022.
· Investigators at The University of Texas MD Anderson Cancer Center presented a poster at the Radiation Research Society’s 2022 Annual Meeting on tumor growth delay and immune stimulation using the Alpha DaRT in treating 4T1 murine triple-negative breast cancer tumors.

Upcoming Anticipated Milestones

· Expecting first patient treated in U.S. multi-center pivotal trial in recurrent cutaneous SCC around year-end 2022.
· Targeting recruitment in the Canadian feasibility trial in pancreatic tumors to begin around year-end 2022.
· Planning to begin an Israeli feasibility trial in pancreatic tumors in the first quarter of 2023.
· Planned submission of Alpha DaRT pivotal trial results in head and neck SCC to Japan’s regulatory authority, PMDA, around year-end 2022, for marketing approval.
· Targeting Health Canada approval for initiation of liver cancer feasibility trial by the first quarter of 2023.

Financial results for the third quarter ended September 30, 2022

R&D expenses for the quarter ended September 30, 2022 were $4.8 million, compared to $3.0 million for the same period in 2021, primarily due to increased R&D headcount, costs associated with our U.S. multi-center pivotal study and other clinical studies, and increased share-based compensation costs and accrual of other compensation expenses.

Marketing expenses for the quarter ended September 30, 2022 were $0.2 million, compared to $0.1 million for the same period in 2021.

G&A expenses for the quarter ended September 30, 2022 were $2.3 million, compared to $0.5 million for the same period in 2021, primarily due to increased professional fees (including D&O insurance), share-based compensation, advisors and other expenses associated with being a public company, and accrual of other compensation expenses.

Financial income, net, for the quarter ended September 30, 2022 was $4.7 million, compared to financial expense, net of $1.2 million for the same period in 2021, primarily due to the remeasurement of warrants and interest income on cash balances.

For the quarter ended September 30, 2022, the Company had a net loss of $2.6 million, or ($0.04) per share, compared to a loss of $4.8 million, or ($0.12) per share, in the same period in 2021.

Balance Sheet Highlights

As of September 30, 2022, the Company had cash and cash equivalents, restricted cash and short-term deposits in the amount of $108.5 million, compared to $31.9 million on December 31, 2021. The Company expects that this cash balance will be sufficient to fund operations for at least two years.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.