On March 22, 2022 Nuvectis Pharma, Inc (NASDAQ: NVCT), ("Nuvectis" or the "Company") is a biopharmaceutical company focused on the development of precision medicines for serious conditions of unmet medical need in oncology reported its financial results for the fiscal year 2021 and provided an update on recent business progress (Press release, Nuvectis Pharma, MAR 22, 2022, View Source [SID1234610596]).

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"We founded Nuvectis with the goal of becoming a leading biopharmaceutical company focused on the development of innovative treatments for people suffering from serious conditions in oncology for which the prognosis is poor and there are very limited treatment options, and we believe that we are on our way to achieving that," said Ron Bentsur, Chairman and Chief Executive Officer. Mr. Bentsur continued, "2021 was a very exciting year for Nuvectis," "In 2021, we completed two exclusive world-wide licensing deals to develop and commercialize our first two drug candidates, and with our recently completed initial public offering, we are now poised to continue to advance our pipeline.

Mr. Bentsur added, "We are particularly pleased with the recent commencement of the Phase 1 study for NXP800, our potentially first-in-class Heat Shock Factor 1 ("HSF1") pathway inhibitor, and with the progress of NXP900, our selective Proto-oncogene c-Src ("SRC") SRC/YES1 kinase inhibitor. 2022 is expected to be another exciting year for Nuvectis as we look forward to reporting additional data during the year. Importantly, we remain cash prudent, effectively managing our cash position with an emphasis towards value creation activities."

2021 and Recent Highlights

NXP800

We commenced a Phase 1 study for NXP800, an HSF1 pathway inhibitor, which will have two parts: a dose-escalation Phase 1a, initiated in December 2021, which will be followed by an expansion Phase 1b. In the Phase 1a, the safety and tolerability of NXP800 will be evaluated in patients with advanced solid tumors to identify a dose and dosing schedule for the Phase 1b. In the Phase 1b, the safety and preliminary anti-tumor activity of NXP800 will be evaluated in biomarker-selected patients, initially in ovarian clear cell carcinoma and ovarian endometrioid carcinoma, two unmet medical needs.

NXP900

We began Investigational New Drug ("IND")-enabling studies for NXP900, a novel selective SRC/YES1 inhibitor, in the fourth quarter of 2021. To date, several in-vivo preclinical studies have been conducted with NXP900 in triple negative breast cancer with promising results. Nuvectis is currently conducting in vivo studies with NXP900 in various other tumor types to potentially identify additional cancers of focus for future clinical trials. Nuvectis intends to complete the IND-enabling studies for NXP900 in 2022.

Initial Public Offering on Nasdaq Capital Market

We completed our initial public offering ("IPO") in February 2022, raising $16M in gross proceeds.

Full Year 2021 Financial Results

Cash, cash equivalents and short-term investments were $5.7 million as of December 31, 2021, compared to zero as of December 31, 2020. This does not include the $16.0 million in gross proceeds from the Company’s IPO, completed in February 2022.

Research and development expenses were $9.6 million for the year ended December 31, 2021, including $0.9 million of non-cash equity-based compensation expense and $7.0 million of one-time upfront payments made in connection with our world-wide license agreements for NXP800 and NXP900.

General and administrative expenses were $3.3 million for the year ended December 31, 2021, including $1.0 million of non-cash equity-based compensation expense.

The Company’s net loss was $12.9 million for the year ended December 31, 2021, which included $1.9 million of non-cash equity-based compensation expense and the $7.0 million of one-time upfront payments made in connection with our world-wide license agreements for NXP800 and NXP900.

Management Changes

We are pleased to announce that Michael Carson, who recently joined Nuvectis as Vice President of Finance, is replacing Uri Ben-Or who served as our Interim Chief Financial Officer. Mr. Carson comes to Nuvectis with comprehensive experience in finance, accounting and audit at companies including Abbott Laboratories, Neuronetics, Smiths Medical, and most recently as the Vice President of Finance at Xylocor Therapeutics. Prior to entering private industry, Mr. Carson worked for public accounting firms Deloitte and Crowe in their assurance practices. He is a licensed Certified Public Accountant and holds degrees in Mechanical Engineering and Accounting from Lafayette College. "I believe Michael’s expertise in the life sciences industry, including recent small-company experiences, makes him an ideal fit to help us deliver long-term value to our shareholders", said Mr. Bentsur. "Additionally, I want to thank Uri for his service to the company over the last several months, which included the IPO process.

On March 22, 2022 Paige, the global leader in AI-based diagnostic software in pathology, reported that launched its latest product, Paige Breast Lymph Node, an AI medical device software that helps pathologists detect if breast cancer has metastasized to lymph nodes, concurrent with pathologists’ own interpretive review* (Press release, Paige AI, MAR 22, 2022, View Source [SID1234610613]). The product was unveiled at the United States and Canadian Academy of Pathology (USCAP) Annual Meeting taking place March 19-24, 2022.

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Determining whether cancer in the breast has spread to the lymphatic system is critical to a patient’s diagnosis and planned treatment. Due to the size of the tissue area and size of the small micro-metastases, a pathologist’s accurate assessment of a lymph node slide can be tedious and time-consuming.

Designed to increase the accuracy and efficiency in the detection of breast cancer metastases that are most at-risk for being missed, Paige Breast Lymph Node leverages AI to empower pathologists to identify tumor metastases of any size, including small micrometastases, more efficiently and reliably. It is designed to enhance diagnostic accuracy for the most subtle metastatic foci and has over 98% slide level sensitivity to detect metastases of any size. A positive indication of metastatic breast cancer will be displayed at the individual lymph node level with Paige’s proprietary TissueMap, which highlights all regions on a slide that are suspicious for cancer. In addition, both slides and cases with suspected positive lymph nodes are highlighted, facilitating their prioritization and efficient review by the pathologist.

"Accurate detection of breast cancer metastases is paramount for physicians and their patients, but it can be a laborious, manual task for pathologists," said David Klimstra, M.D., Founder and Chief Medical Officer at Paige. "Paige Breast Lymph Node offers pathologists a quicker and more efficient way to analyze large quantities of lymph node tissue, as well as peace of mind for them and their patients."

Paige Breast Lymph Node will be available immediately as part of the Paige Breast Suite. This software uses the same underlying AI technology as Paige Prostate, which can work with a broad range of data, staining techniques, and scanning artifacts, resulting in a generalizable AI that can be quickly deployed in a variety of laboratory and hospital settings.

"Paige Breast Lymph Node bolsters the value of the Paige Breast Suite to clinical pathologists," said Andy Moye, Ph.D., Chief Executive Officer at Paige. "This product launch is an important step in our overall commercialization strategy as we bring the power of our AI platform to new disease areas. Alongside our FDA-approved Paige Prostate, the generalizability of the AI further validates the broader use of Paige’s software in assisting pathologist to diagnose cancer."

Paige will host a webinar on March 30 to demonstrate how Paige Breast Lymph Node can be used in clinical practice. For more information about Paige Breast Lymph Node, visit View Source or contact [email protected].

*Paige Breast Lymph Node is available for research use only in United States and in other regions where research use is permitted. Research use only products should not be used in diagnostic procedures.

On March 22, 2022 BioCanRx reported that it has funded important research into immunotherapy, helping to make a promising new avenue for cancer treatment a reality for Canadians whose cancer has not responded to other treatments (Press release, BioCanRx, MAR 22, 2022, View Source;utm_medium=rss&utm_campaign=another-made-canada-car-t-trial-based-canadian-manufacturing-capability [SID1234610572]). An equally important part of its work, however, has been developing the infrastructure needed to provide manufacturing and testing capacity here in Canada, through its support of core facilities across the country.

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Today, thanks to BioCanRx’s investment, we have the capacity to manufacture CAR-T (chimeric antigen receptor) cells, one of the most promising avenues for immunotherapy, here in Canada. CAR-T therapy involves enriching a cancer patient’s own T cells with a CAR gene that contains receptors that bind to specific proteins, or antigens, found on the surface of cancer cells. This helps the patient’s own immune system better fight the cancer.

Now BioCanRx is funding the clinical trials and enabling studies for clinical trials that have been made possible by this manufacturing capability.

First, there was CLIC-01, led by the Ottawa Hospital Research Institute’s Dr. Natasha Kekre and focussing on the CD19 antigen. Now, Dr. Kevin Hay of the BC Cancer Research Institute (with additional support from the BC Cancer Foundation) is leading the development of a second clinical trial (CLIC-02) focussing on the CD22 antigen, which will be the first deliverable in the antigen-to-clinic pipeline BioCanRx has been developing.

Both these trials are targeting B-cell blood cancers and, says Dr. Hay, "are inter-related in terms of developing CAR-T therapies for patients." They also share personnel, ensuring that each project learns from the others, and also help each other out in practical ways. This new trial also ties into another BioCanRx enabling study led by the National Research Council’s Dr. Scott McComb, who is developing CARs targeting multiple B-cell cancer antigens at the same time, one of which is the CD22 CAR that Dr. Hay is using in his research as the basis for the CLIC-02 trial.

The CLIC-01 trial is based on CD19-targeting receptors, for which there are other, commercial products available. The novelty of that first project, says Dr. Hay, was the use of a Canadian biomanufacturing facility to manufacture the CD19 CAR-T cells. His project, focussing on the CD22 target, is, he says, "coming in closer to the ground level," as there are currently no approved CD22-based therapies commercially available, in Canada or elsewhere in the world.

"We are getting CAR-T clinical trials to Canadian patients earlier and earlier," he says.

The work will fill an important gap in options for treating B-cell blood cancers, as not all patients respond to CD19 CAR-T therapy.

Currently, Dr. Hay is assembling the research and knowledge needed to support a clinical trial application (CTA) to Health Canada, which he expects to happen by the end of this year. With Health Canada approval, he then plans to have two phase 1 trials running simultaneously, one for leukemia and one for lymphoma. The trials will focus on determining the optimal dose for the CAR-T therapy by starting at a low level and gradually increasing it if there prove to be no toxic side effects at the lower level. He has already secured funding from the Canadian Institutes of Health Research (CIHR) for the lymphoma trial and is waiting to hear results from other funding applications for the leukemia trial, so that, with Health Canada approval in hand, he and his team will be able to get both CLIC-02 trials underway as quickly as possible.

The project, and its potential results, underscore the importance of BioCanRx’s integrated approach to advancing cancer treatment, one that brings together researchers, their research and the infrastructure they need to improve outcomes for and, ultimately, save the lives of people with cancer.

On March 22, 2022 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported the upsizing and closing of its previously announced offering to institutional and accredited investors consisting of 3,878,789 common shares at a purchase price of $1.65 per share, sold pursuant to a registered direct offering for gross proceeds of approximately $6.4 million before deducting placement agent fees and expenses (Press release, Nymox, MAR 22, 2022, View Source [SID1234610597]). The Company has also issued to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 3,878,789 common shares. The warrants are exercisable immediately at an exercise price of $2.00 per share and will expire five (5) years from the date of an effective registration statement covering the shares underlying the warrants.

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Nymox intends to use the proceeds for general corporate purposes, including working capital.

A.G.P./Alliance Global Partners acted as sole placement agent for the offering.

This offering of the common shares (but not the warrants or the common shares underlying the warrants) was made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-261571) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering was filed with the SEC and is available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Nymox has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Nymox and such offering.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the common shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying common shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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 March 22, 2022 Stilla Technologies, the multiplex digital PCR company, reported it has entered into agreements with 12 distributors throughout EMEA: LABGENE Scientific (Switzerland), CARLO ERBA Reagents (Italy), Bonsai Lab (Portugal and Spain), SEM (Turkey), Explorea (Czech Republic, Slovakia, Hungary), Biodynamics (Greece), AH diagnostics (Sweden, Norway, Finland, Denmark, Baltic countries), Alliance Global (Gulf, Levant, African Continent including South Africa, Central Asia, Pakistan), Danyel Biotech (Israel), Zahrawi Group (Bahrain), TK Biotech (Poland), and RIDACOM (Bulgaria) (Press release, Stilla Technologies, MAR 22, 2022, View Source [SID1234610614]). The agreements grant distribution rights to Stilla’s full product portfolio including the six-color naica system – Stilla’s next generation multiplexing digital PCR platform – as well as microfluidic chips and reagents optimized for a wide variety of applications including cancer and liquid biopsy studies, cell and gene therapies, and infectious disease detection.

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"With the expanded global availability of our powerful digital PCR solution, Stilla is answering scientists’ demand for faster turnaround time, higher precision and sensitivity," said Matthew Grow, PhD, Vice President Global Marketing and Commercial Operations, Stilla Technologies. "We are excited to partner with leading distributors who bring deep relationships and a proven history of delivering the most innovative solutions to biomedical researchers and clinicians in their respective territories."

With U.S. headquarters in Boston, MA, and European headquarters in Paris, France, Stilla’s expanded global distribution comes on the heels of the global launch of its six-color naica system.