On May 23, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the details of its investor webcast being held Monday, June 5, 2023 at 8:00 a.m. ET (7:00 a.m. CT) to discuss lead-in data from its ongoing Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) (Press release, Cogent Biosciences, MAY 23, 2023, View Source [SID1234631955]). The data are being presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3, 2023 at 2:15 p.m. ET (1:15 p.m. CT).

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The webcast event will be led by Andrew Robbins, Cogent’s President and Chief Executive Office and will include a presentation by Andrew J. Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School.

The live webcast can be accessed on the Investors and Media page of Cogent’s website at investors.cogentbio.com/events. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

On May 23, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that it has entered into a definitive agreement for the issuance and sale of an aggregate of 3,256,269 shares of its common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to 3,256,269 shares of common stock and Series B warrants to purchase up to 3,256,269 shares of common stock, at a purchase price of $3.071 per share of common stock (or pre-funded warrant in lieu thereof) and associated warrants, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Checkpoint Therapeutics, MAY 23, 2023, View Source [SID1234631953]).

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The Series A warrants will be exercisable immediately upon issuance and will expire five years following the issuance date and have an exercise price of $2.821 per share and the Series B warrants will be exercisable immediately upon issuance and will expire eighteen months following the issuance date and have an exercise price of $2.821 per share.

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

The closing of the offering is expected to occur on or about May 25, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $10 million. Checkpoint intends to use the net proceeds of this offering for working capital and general corporate purposes, including the manufacturing of cosibelimab and certain pre-commercial activities in anticipation of potential approval and commercial launch.

The securities described above are being offered by Checkpoint pursuant to a shelf registration statement on Form S-3 (File No. 333-270843) that was previously filed with the Securities and Exchange Commission ("SEC") on March 24, 2023, and subsequently declared effective on May 5, 2023. The securities offered in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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.

On May 23, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported first-quarter 2023 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, MAY 23, 2023, View Source [SID1234631952]).

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"Our immediate priority is to complete enrollment in our ongoing Phase 3 registration-enabling RINGSIDE study in which we are currently evaluating AL102 in desmoid tumors," said Ken Berlin, President and Chief Executive Officer of the Company. "We also look forward to providing a detailed update from the patients who were enrolled in Phase 2 (Part A) of RINGSIDE at the forthcoming ASCO (Free ASCO Whitepaper) annual meeting. For AL101, we expect to gain clarity this year on the development path in recurrent/metastatic adenoid cystic carcinoma (R/M ACC)."

First Quarter 2023 and Recent Business Highlights

Completed merger between Ayala Pharmaceuticals Inc. and Advaxis, Inc. The merger closed on January 19, 2023.
Continued progress in Phase 3 RINGSIDE trial: Enrollment continues in Phase 3 of the RINGSIDE trial, a double-blind placebo-controlled study enrolling up to 156 patients globally with progressive desmoid disease, randomized to either AL102 or placebo. The primary endpoint is progression free survival with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures.
Upcoming Milestones

ASCO poster presentation on RINGSIDE: A poster featuring updated results from the Phase 2 portion of RINGSIDE, evaluating AL102 in desmoid tumors, will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, June 3.
Data from Phase 1 trial of ADXS-504: ADXS-504 is being evaluated in a Phase 1 investigator-sponsored study at Columbia University in patients with biochemically recurrent (early) prostate cancer. Readout of initial clinical and PSA data are expected in 2023.
Gain clarity on path for future development plan for AL101 in recurrent/metastatic adenoid cystic carcinoma (R/M ACC), expected in 2023.
Consolidated Financial Results for the Quarter Ended March 31, 2023

Cash position On March 31, 2023, the consolidated cash and cash equivalents position was $16.8 million.

Revenue Collaboration revenue was $4 thousand in the three months ended March 31, 2023, compared with $0.5 million in the comparable period of 2022, mainly as a result of the Novartis Agreement.

R&D Expenses Research and development expenses were $7.3 million for the three months ended March 31, 2023 compared to $7.5 million for the three months ended March 31, 2022, a decrease of $0.2 million.

G&A Expenses General and administrative expenses were $4.6 million for the three months ended March 31, 2023 compared to $2.4 million for the three months ended March 31, 2022, an increase of $2.2 million.

Net Loss The net loss for the three months ended March 31, 2023 was approximately $7.4 million or ($1.67) per share based on approximately 4.4 million weighted average shares outstanding. This compares with a net loss for the three months ended March 31, 2022 of approximately $10.0 million or ($3.47) per share based on approximately 2.9 million weighted average shares outstanding.

For further details on the Company’s financial results, refer to our quarterly report on Form 10-Q for the three months ended March 31, 2023, filed with the Securities and Exchange Commission.

ON May 23, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported first quarter 2023 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAY 23, 2023, View Source [SID1234631950]).

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"This year we are focused on advancing our ReSTART U.S. multicenter pivotal trial in recurrent cutaneous squamous cell carcinoma, which is expected to produce data in 2024, and on initiating a series of feasibility trials in difficult-to-treat internal organ tumors with high unmet need, such as pancreatic and liver cancers," stated Alpha Tau CEO Uzi Sofer. "Read-outs from the pivotal trial and these smaller feasibility programs should represent meaningful inflection points for our growth story and could pave the way for larger studies that may support potential U.S. marketing authorizations in other indications. In parallel, we are preparing for potential future product launches by advancing our commercial planning activities and solidifying our supply chain. Alpha Tau remains adequately capitalized to support all of these programs over the coming years," he concluded.

Recent Corporate Highlights:

● In March, the Company initiated and treated the first patients in its U.S. multicenter pivotal ReSTART trial in recurrent squamous cell carcinoma which remains on track. For more information, please refer to NCT05323253.

● In April, the first patient with advanced inoperable pancreatic cancer was treated in a feasibility and safety study of Alpha DaRT at the Jewish General Hospital in Montreal, Canada, which is an affiliated teaching hospital of McGill University, Faculty of Medicine. For more information, please refer to NCT04002479.

● In March, the Company received Health Canada approval to open a liver cancer feasibility trial. For more information, please refer to NCT05829291.

● In May, the results of the Company’s U.S. multicenter pilot trial in skin cancer were published in JAMA Network Open, showing a 100% Complete Response rate at 12 weeks post treatment and no device-related serious adverse events or systemic toxicity reported. For more information, please see the publication here.

● In May, the first patient with squamous cell carcinoma of the vulva was treated in an investigator-initiated feasibility and safety study at Addenbrookes Hospital of the Cambridge University Hospitals NHS Foundation Trust.

● In March, the Company received an amended radioactive license approval from the Israeli Ministry of Environmental Protection that could expand production to up to 300,000 Alpha DaRT sources per year in the Company’s main manufacturing facility in Jerusalem. The Company also received approvals from the Israeli Ministry of Environmental Protection and the Animal Testing Council at the Israeli Ministry of Health to conduct pre-clinical experiments using mice and rats, to enable the continued exploration of potential combinations between the Alpha DaRT and systemic therapies.

Upcoming 2023 Milestones

● Planning to begin recruitment in Israeli feasibility trials in lung and pancreatic tumors in the middle of 2023, having already received all necessary trial approvals.

● Targeting recruitment in the Canadian liver cancer feasibility trial to begin in the middle of 2023.

● Planned submission of Alpha DaRT pivotal trial results in head and neck cancer to Japan’s regulatory authority, PMDA in the second half of 2023, for potential marketing authorization.

● Currently compiling longer-term data from patients treated with the Alpha DaRT for skin, superficial or head and neck tumors, to be released and potentially submitted for publication in a scientific journal by the end of 2023.

Financial results for quarter ended March 31, 2023

R&D expenses for the quarter ended March 31, 2023 were $6.3 million, compared to $5.2 million for the same period in 2022, due to increased employee compensation and benefits, increased operating costs, and increased pre-clinical study and clinical trial expenses particularly as related to its U.S. multi-center pivotal trial.

Marketing expenses for the quarter ended March 31, 2023 were $0.4 million, compared to $0.2 million for the same period in 2022 due to increased employee compensation and benefits, including share-based compensation and the hiring of its chief commercial officer.

G&A expenses for the quarter ended March 31, 2023 were $1.9 million, compared to $3.3 million for the same period in 2022, due to a reduction in one-off costs, including employee compensation and benefits, associated with its financing transaction in the first quarter of 2022.

Financial income, net, for the quarter ended March 31, 2023 was $0.5 million, compared to $17.0 million of financial expense, net, for the same period in 2022, due to lower expense from remeasurement of warrants and an increase in interest from bank deposits.

For the quarter ended March 31, 2023, the Company had a net loss of $8.2 million, or $0.12 per share, compared to a net loss of $25.7 million, or $0.54 per share, in the first quarter of 2022.

Balance Sheet Highlights

As of March 31, 2023, the Company had cash and cash equivalents, restricted cash and deposits in the amount of $100.5 million, compared to $105.4 million at December 31, 2022. The Company expects that this cash balance will be sufficient to fund anticipated 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.

On May 22, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company’s board of directors (the "Board") has approved a reverse stock split of its common stock at a ratio of 1 post-split share for every 1,000 pre-split shares (Press release, Propanc, MAY 23, 2023, View Source [SID1234631920]). The reverse stock split was approved by the Board and the Company’s majority stockholder, representing the majority vote of the stockholders of the Company, on May 1, 2023.

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On May 1, 2023, the Company filed a certificate of amendment to the Company’s certificate of incorporation, as amended, with the Secretary of State of the State of Delaware to effectuate the reverse stock split. The Company expects that the common stock will begin trading on a split-adjusted basis at the open of trading on Tuesday, May 23, 2023, under the new CUSIP number 74346N602. The reverse stock split does not affect the total number of shares of capital stock, including the common stock, that the Company is authorized to issue, or the par value of the common stock, which shall remain as set forth pursuant to the Company’s certificate of incorporation.

"The primary purpose of the reverse split is to create long term shareholder value by positioning the Company for further investment to achieve our strategic objectives," said James Nathanielsz, Propanc’s Chief Executive Officer. "The reverse split will place us in a better position to receive further funding from one of our institutional investors to advance our lead product candidate, PRP, towards a First-In-Human study, as well as supporting our joint research projects with the Universities of Jaén and Granada, which includes expanding our intellectual property portfolio by identifying new patentable discoveries, and developing a synthetic recombinant proenzyme formulation as a backup clinical compound to PRP."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers.