On March 22, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the year ended December 31, 2021 and provided a business update (Press release, Phio Pharmaceuticals, MAR 22, 2022, View Source [SID1234610599]).

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"Over the past year, we have made significant progress moving towards the initiation of our first-in-human clinical studies for our lead program, PH-762, in 2022. Currently, we are on track to start enrolling patients in the first of these trials, a Phase 1b study of PH-762 in advanced melanoma, in the coming weeks," said Dr. Gerrit Dispersyn, President and CEO of Phio. "I am proud of the Phio team’s execution of our preclinical program for PH-762, which has generated a steady stream of positive data and supported our regulatory strategy. These studies were conducted during the second year of the ongoing global pandemic, which has proven to be a difficult period of time for the team, yet we incurred only minor delays to our original timelines. I believe the achievement of these milestones within the stated timeframes speak to the strength of our team and the assets in our pipeline, as well as our INTASYL platform. We look forward to continuing to deliver on our current development pipeline in 2022 as our business fulfills its transition into a clinical stage company."

Quarter in Review and Recent Corporate Updates

Granted clinical trial authorization (CTA) by the French National Agency for the Safety of Medicines and Health Products to proceed with a first-in-human clinical trial for PH-762 to treat patients with melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe.
Presented new data in an in vivo hepatocarcinoma model that show PH-762 administered locally cleared untreated distal tumors, which indicates a systemic immune response.
Initiated efficacy animal studies with INTASYL-based antiviral compounds against SARS-CoV-2 infection, the virus that causes COVID-19, following collection of positive results from in vitro studies under this development program.
Upcoming Pipeline Milestones for 2022

Expect to start patient enrollment in a Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma in the first quarter of 2022.
Expect to initiate a first-in-human clinical study on the use of PH-762 in tumor infiltrating lymphocytes (TILs) in adoptive cell therapy (ACT) in patients with advanced melanoma in the second quarter of 2022.
Scheduled to present new study data regarding PH-894, a BRD4-targeting, self-delivering RNAi, at the AACR (Free AACR Whitepaper) Annual Meeting 2022, which is being held in New Orleans, Louisiana, from April 8-13, 2022.
Expect to finalize IND-enabling studies for PH-894 in the second half of 2022.
Additional data publications on the Company’s pipeline programs.
Financial Results

Cash Position

At December 31, 2021, the Company had cash of $24.1 million as compared with $14.2 million at December 31, 2020. The Company expects its current cash will be sufficient to fund currently planned operations to the second quarter of 2023.

Research and Development Expenses

Research and development expenses were approximately $8.9 million for the year ended December 31, 2021, compared to approximately $3.7 million for the year ended December 31, 2020. The increase in research and development expenses was primarily due to manufacturing costs for the Company’s PH-762 and PH-894 INTASYL compounds, fees for the required preclinical studies in support of the Company’s clinical trials for PH-762 and CRO and consulting related costs to support the initiation of the Company’s clinical trials as compared to the same period in the prior year.

General and Administrative Expenses

General and administrative expenses were approximately $4.6 million for the year ended December 31, 2021, compared to approximately $5.1 million for the year ended December 31, 2020. The decrease in general and administrative expenses was primarily due to a decrease in patent and legal fees partially offset by increases in the use of an outside consultant to support business development activities and corporate insurance premiums.

Net Loss

Net loss was $13.3 million, or $1.04 per share, for the year ended December 31, 2021, compared with $8.8 million, or $1.92 per share, for the year ended December 31, 2020. The increase in net loss was primarily attributable to the increase in research and development expenses related to the Company’s manufacturing of its INTASYL compounds and preclinical activities in preparation for the start of its clinical trial with PH-762, as described above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of the Company’s capital raise activities as compared to the prior year period.

On March 22, 2022 Philochem, a subsidiary of the Philogen Group, and Bracco Imaging reported that they have entered into a license and collaboration agreement to develop and commercialize a small organic molecule for imaging applications, with proven ability to selectively detect a variety of metastatic solid tumors in cancer patients, paving the way for a new approach to tumor diagnosis (Press release, Philogen, MAR 22, 2022, View Source(003).pdf [SID1234610598]).

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Philogen and Bracco share an Italian heritage and operate globally in the pharmaceutical and biotech sectors. Bracco and Philochem will pioneer the development of cutting-edge technologies for the discovery and optimization of small molecule ligands that enable unprecedented specificity and sensitivity for the imaging of solid tumors.

Prof. Dr. Dario Neri, Member of the Board of Philochem and CEO of the Philogen Group, commented: "We are extremely pleased to establish a new collaboration with Bracco Imaging, a leading global company in the image diagnostics field. This new collaboration will focus on the development and commercialization of a small molecule for imaging applications, which promises to improve the diagnosis, staging and monitoring of response-to-treatment for cancer patients. Both companies are committed to the development of the product and making it available to patients who may benefit from it."

"We are very excited about this collaboration with Philochem, a leader in the discovery and development of novel pharmaceutical and biopharmaceutical products. It demonstrates Bracco’s commitment to long-term value creation in medical imaging. Over the years, Bracco has built a portfolio of leading products across all imaging modalities and is continuing to invest in innovation to shape the future of precision imaging and improve people’s lives", commented Fulvio Renoldi Bracco, Vice-Chairman & CEO of Bracco Imaging.

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 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 MorphoSys AG (FSE: MOR; NASDAQ: MOR) and Incyte (Nasdaq: INCY) reported that the Swiss agency for therapeutic products (Swissmedic), has granted temporary approval for Minjuvi (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy including an anti-CD20 antibody, who are not eligible for autologous stem cell transplant (ASCT) (Press release, MorphoSys, MAR 22, 2022, View Source [SID1234610594]). Incyte holds exclusive commercialization rights for Minjuvi in Switzerland.

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"The approval of Minjuvi by Swissmedic is excellent news," said Jonathan Dickinson, Executive Vice President and General Manager, Incyte Europe. "There are a substantial number of people living with relapsed or refractory DLBCL in Switzerland and we’re pleased to be able to offer them a new treatment option."

"DLBCL is a fast-growing cancer and can be very hard to treat. Up to 40% of DLBCL patients either relapse after they have been treated or don’t respond to initial treatment at all," said Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys. "Minjuvi addresses this unmet need and its approval in Switzerland is a crucial milestone for these patients."

The approval is based on the results from the L-MIND study evaluating the safety and efficacy of tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed a best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 43.9 months after a minimum follow up of 35 months (secondary endpoint). Tafasitamab together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable.ii

Incyte and MorphoSys share global development rights to tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the U.S. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi (tafasitamab-cxix) in the U.S., and is marketed by Incyte under the brand name Minjuvi in Europe, the UK and Canada.

About Diffuse Large B-Cell Lymphoma
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all casesiii. Each year around 16,000 patients in Europe are diagnosed with relapsed or refractory DLBCLiv,v,vi. The condition is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organsvii. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafterviii,ix,x,xi.

About L-MIND

The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HDC) or autologous stem cell transplant (ASCT). The study’s primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.

For more information about L-MIND, visit View Source

About Minjuvi (tafasitamab)
Tafasitamab is a humanized Fc-modified CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in Europe, the UK and Canada.

XmAb is a registered trademark of Xencor, Inc.