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.

On May 22, 2023 Hanx Biopharmaceuticals, Inc. (HanxBio) reported that it has received Investigational New Drug (IND) approval to begin a Phase IB/II clinical trial of its potential first-in-class recombinant anti-CD47/PD-1 bispecific antibody (BsAb), HX009, in patients with relapsed/refractory lymphoma (Press release, HanX Biopharmaceuticals, MAY 22, 2023, View Source [SID1234655954]). This Phase IB/II study, being conducted in the United States, will evaluate HX009 in patients with lymphoma who have failed standard therapy.

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This marks another important milestone in the development of HX009 and the company’s drug development program. HX009 has been studied in solid tumors and lymphoma indications in Australia and China. The FDA’s approval of clinical trials in the United States strengthens HX009’s global development and enhances the company’s position in bispecific antibody research.

Dr. Lei Zhang, CMO of HanxBio, said: "We are pleased that our HX009 program has received approval from the U.S. FDA for investigational clinical trials. While immune checkpoint inhibitors (ICIs) have shown great promise in a wide range of oncology indications, many challenges remain, including in lymphoma. Therefore, there is significant value in developing next-generation ICIs, including BsAbs, such as dual CD47 and PD-1 BsAbs like HX009. We look forward to rapidly advancing HX009’s clinical development and bringing new treatment options to patients to address unmet medical needs."

On May 22, 2023 PharmEnable, a drug discovery company focused on chemical novelty, diversity and complexity, reported it has closed a Pre-Series A investment round of $7.5M to develop the next generation of small molecule drugs against disease areas of high clinical need (Press release, PharmEnable, MAY 22, 2023, View Source [SID1234641052]).

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The funding round was led by MP Healthcare Venture Management (MPH), the venture arm of Mitsubishi Tanabe Pharma Group, with additional participation from existing investors including Cambridge Enterprise, the commercialisation arm of the University of Cambridge, University of Cambridge Enterprise Fund VIII, managed by Parkwalk Advisors, Heyford Trust, o2h Ventures, Martlet Capital, Arrowfield Capital, Wren Capital and life science experienced angel investors including Jonathan Milner.

The funds will be used to advance and expand PharmEnable’s portfolio of wholly owned and co-discovery projects across oncology and neurology targets, as well as supporting further platform R&D.

PharmEnable uses its proprietary platform to discover targeted therapies with the aim of replicating the specificity of biologics, but with improved efficacy, absorption and distribution properties enabled by custom-designed oral small molecules, which are also easier to scale and manufacture. The Company’s approach combines advanced medicinal chemistry with state-of-the-art AI technology, allowing it to unlock challenging biological targets by mapping unexplored chemical space. This approach delivers novel proprietary candidate drug molecules with the required 3-dimensional structure elements that lead to improved selectivity and ultimately reduce attrition rates. The aim is to develop therapies that are highly effective with fewer side effects to treat diseases with a high clinical need.

PharmEnable has a pipeline of wholly owned oncology programmes, as well as ongoing co-discovery projects with several pharma and biotech companies, including a partnership with Sosei Heptares to unlock novel drug candidates for neurological disease. The wholly owned programmes focus on addressing some of the key challenges in oncology such as tumour penetration and overcoming resistance mechanisms, through designing novel, complex small molecules with improved selectivity and carefully balanced properties.

Alongside the investment, PharmEnable’s Board has been expanded with Dr Jeffrey Moore joining as a Board Director, representing MP Healthcare. Dr Keith Blundy has replaced Dr Christine Martin as an Investor Director on behalf of Cambridge Enterprise. Both bring significant pharma and biotech experience.

Dr Jeffrey Moore is President of MP Healthcare, and has been working in the biotech sector for 25 years, both as an investor and in operating roles at Millennium Pharmaceuticals and Scriptgen. Until recently Dr Keith Blundy was the CEO of STORM Therapeutics and prior to that Chief Executive of Cancer Research Technology Ltd (CRT), the commercial arm of Cancer Research UK. He was formerly a director of KuDOS Pharmaceuticals Ltd, Mission Therapeutics, Cancer Therapeutics Pty and Inivata Ltd.

CEO of PharmEnable Dr Hannah Sore said:

"At PharmEnable, we believe that everyone deserves safe and effective treatments, and we are committed to applying the principles chemical novelty, diversity and 3-dimensionality to design powerful new small molecule drugs. I am delighted that MP Healthcare has led our Pre-Series A to enable our mission to deliver life-changing medicines to patients who need them.

"I am pleased to welcome the highly experienced Dr Jeffrey Moore and Dr Keith Blundy to our Board and look forward to working our team, our Board and our investors to deliver novel therapeutics for the most challenging disease areas, ultimately making a difference to patients’ lives."

Dr Jeffrey Moore, Board Director of PharmEnable on behalf of new investor MP Healthcare, said:

"MPH is dedicated to supporting next generation products and technologies to increase the options available to patients with significant unmet medical needs. We continue to explore novel modalities of treatment, including biotherapeutics, nucleic acid medicines and cell therapies. However, we continue to recognize the clear benefits that small molecules can offer. After an extensive review of available companies and technologies, we concluded that PharmEnable’s robust technology platform was best positioned to effectively explore novel chemical space and deliver the next generation of small molecule therapeutics."

On May 22, 2023 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) ("TransCode" or the "Company"), the RNA Oncology Company committed to more effectively treating cancer using RNA therapeutics, reported that its Board of Directors approved a 1-for-20 reverse stock split, to be effective 4:05 p.m. Eastern Time today, May 22, 2023 (Press release, TransCode Therapeutics, MAY 22, 2023, View Source [SID1234631922]). TransCode common stock is expected to begin trading on a split-adjusted basis on the Nasdaq Capital Market on Tuesday, May 23, 2023, under the current trading symbol, "RNAZ." The reverse stock split was approved by TransCode’s stockholders on May 10, 2023, and is intended to increase the per share trading price of the Company’s common stock to enable the Company to satisfy the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

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The 1-for-20 reverse stock split will automatically convert 20 current shares of TransCode’s common stock into one new share of common stock. No fractional shares will be issued in connection with the reverse stock split. Stockholders of record who would otherwise hold a fractional share of TransCode’s common stock will receive a cash payment in lieu thereof at a price equal to that fraction of a share to which the stockholder would otherwise be entitled multiplied by the closing price of TransCode’s common stock on the Nasdaq Capital Market on May 22, 2023. The reverse split will reduce the number of shares of outstanding common stock from approximately 16,998,534 shares to approximately 849,926 shares. Proportional adjustments also will be made to the exercise prices of TransCode’s outstanding stock options and warrants, and to the number of shares issued and issuable under TransCode’s stock incentive plans.

Vstock Transfer LLC will act as the exchange agent for the reverse stock split. Stockholders of record are not required to take any action to receive post-split shares in book-entry. Stockholders owning shares through a bank, broker, custodian or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to the holding entity’s particular processes; such stockholders will not be required to take any action in connection with the reverse stock split. However, these banks, brokers, custodians or other nominees may have different procedures than registered stockholders for processing the reverse stock split and making payment for fractional shares. If a stockholder holds shares of common stock with a bank, broker, custodian or other nominee and has any questions in this regard, stockholders are encouraged to contact their bank, broker, custodian or other nominee for more information.

In connection with the reverse stock split, the Company’s CUSIP number will change to 89357L 204 as of 4:05 pm on Monday, May 22, 2023.