On September 28, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the U.S. Food and Drug Administration (FDA) has authorized an extension of the in-use period for JELMYTO (mitomycin) for pyelocalyceal solution admixture from 8 hours to 96 hours (four days) following reconstitution of the product (Press release, UroGen Pharma, SEP 28, 2022, View Source [SID1234621513]). This extension is significant and has implications for all stakeholders including physicians, hospitals, pharmacists and the adult patients who use UroGen’s medicine to treat low-grade, upper-tract urothelial cancer (LG UTUC).

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"We strive to improve the care of patients who depend on our cancer therapy and that includes streamlining logistics that can have a significant impact on the delivery, storage and timing of treatment," said Jeff Bova, Chief Commercial Officer, UroGen. "This extension expands access to JELMYTO and gives our customers greater flexibility in choosing when to mix and schedule instillations. It also prepares us for managing future growth based on increased patient volume."

UroGen encourages healthcare providers to consult the new Prescribing Information and speak to their UroGen representative about this extended in-use period to optimize flexibility when treating patients with JELMYTO.

"This label change for JELMYTO gives physicians and patients the option to treat in the morning, whereas, in most cases, the afternoon was the only option before the change," explains Rian Dickstein, M.D., Chairman of Urology, University of Maryland Baltimore Washington Medical Center (UM BWMC). "Previously, centers with mixing partners had to have JELMYTO mixed and sent by courier in the morning, now this extension provides added convenience of opening up additional scheduling options, which is very important as it enables us to more efficiently manage patient care."

About LG UTUC

LG UTUC is a rare disease managed by endoscopic methods and radical nephroureterectomy. Endoscopic resection and laser ablation attempt to preserve the kidney, though there is a high risk of recurrence that may eventually necessitate removal of the kidney. Although kidney removal is the gold standard for treatment of high-grade UTUC, it may be over-treatment in LG UTUC, as kidney removal offers similar five-year survival as kidney-sparing procedures but is associated with significant morbidity. JELMYTO is efficacious as a primary chemoablative therapy in patients with LG UTUC.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG UTUC in adults. It is recommended for primary treatment of biopsy-proven LG UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.

Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.

are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

On September 28, 2022 Prestige Biopharma reported on September 27 through a public disclosure that Octava Fund Limited, the company’s major institutional shareholder, has purchased 57,000 KDR of Prestige Biopharma stock (Press release, Prestige BioPharma, SEP 28, 2022, View Source [SID1234621512]). Tay Lai Wat, Executive Director of Prestige Biopharma, also purchased 5,000 KDR Group to help defend the stock price.

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The company explained that the additional investment from its major institutional shareholder confirmed their steady partnership and trust based on the fundamental and intrinsic value of the company as well as the potential growth of the business.

Recently, Prestige Biopharma withdrew its Marketing Authorisation Application (MAA) for HD201 submitted to the European Medicines Agency (EMA). The company plans to file a new MAA for HD201 to the EMA with supplementation of data and analysis.

Since EMA informed a negative opinion on the Marketing Authorisation Application for the company’s Herceptin Biosimilar in May, major shareholders have been concerned about the sharp drop in stock price and showing support and confidence by purchasing the company’s stock.

In May, Chairman Lisa S. Park and Vice Chairman Michael J. Kim of Prestige Biopharma Group, the largest shareholders of the two companies, bought a total of KRW 7.5 billion worth of stock through Mason Partners, a joint investment company established by Chairman Park and Vice Chairman Kim. In July, Octava Fund had purchased KRW 1.3 billion of Prestige Biopharma stock and KRW 400 million of Prestige Biologics stock, amounting to a total of KRW 1.7 billion.

Tay Lai Wat, Executive Director of Prestige Biopharma, commented: "The recent withdrawal of MAA submitted to the EMA is nothing more than a temporary delay in the company’s plan. The company has no issue with its fundamental value, business competence, and liquidity."

According to the company, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a MAA by the Korea Ministry of Food and Drug Safety. At the same time, the company is on track with the phase 3 clinical trial of its Avastin biosimilar HD204, phase 1 clinical trial of its Humira biosimilar PBP1502 in Europe, and phase 1/2a clinical trial of its first-in-class antibody PBP1510 in Europe and US.

On September 28, 2022 The Board of Directors of Philogen S.p.A. (the "Company" or "Philogen") and, together with its Swiss subsidiary Philochem, (the "Group"), reported that which met today under the chairmanship of Dr. Duccio Neri, approved the condensed consolidated half-yearly financial statements as of June 30, 2022, prepared in accordance with IAS/IFRS (Press release, Philogen, SEP 28, 2022, View Source/documentation/PR/20220928_The_Board_of_Directors_Approves_the_Half-Yearly_Financial_Report_at_30_June_2022_Price_sensitive-Courtesy_English_Translation.pdf" target="_blank" title="View Source/documentation/PR/20220928_The_Board_of_Directors_Approves_the_Half-Yearly_Financial_Report_at_30_June_2022_Price_sensitive-Courtesy_English_Translation.pdf" rel="nofollow">View Source [SID1234621511]).

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Dario Neri, CEO of Philogen, commented on the results for the year and the evolution of the business:
"We are pleased with the Group’s performance in the first half of this year. The Company is going through a very important period as we are approaching the readout of our European Phase III study of Nidlegy in melanoma which we expect to take place in 2023. We are confident that the new GMP facility in Rosia can also be authorized in 2023.

Having completed patient recruitment in the Phase III study of Nidlegy, we have achieved the first target announced at the time of the IPO in March 2021. Patient enrollment in Fibromun’s Phase III sarcoma study is proceeding on schedule. In addition, emerging data from the non-melanoma skin cancer and glioblastoma studies are very encouraging.

Through its subsidiary Philochem, the Group has also consolidated the OncoFAP platform, which opens up new opportunities for both imaging applications and cancer therapy. We have published the first clinical results, derived from the study of more than 60 patients, and more publications will come out soon. I would like to thank the Philogen team for their hard work as we head into a very exciting period."

CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2022
The Group’s Total Revenues as of June 30, 2022 amounted to €20,179 thousand, a sharp increase (+€18,227 thousand) compared to the figure for the period ended June 30, 2021, and consisted of (i) Revenues from contracts with customers amounting to €18,085 thousand and (ii) Other Income amounting to €2,094 thousand. The change is mainly related to revenues generated from existing customer contracts and residually from recurring tax benefits from which the Group benefits such as, by way of example, the research and development tax credit, the technological innovation tax credit and the industry 4.0 tax credit.

Operating costs, amounting to €11,130 thousand, show an increase of approximately 10.7% (25.7% net of 2021 costs related to the IPO process). The change is mainly attributable to the increase in the cost of materials and services related to the Group’s core business activities, as well as to the increase in personnel costs due to the hiring plan aimed at structuring the workforce of the new GMP facility in Rosia (Siena) and to the strengthening of the management and staff functions necessary to meet the new challenges the Group is facing (during the first half of 2022, 15 new employees were hired, bringing the total to 140).

EBITDA showed an increase of €17,156 thousand compared to the previous period, from a negative value (€8,107thousand) as of June 30, 2021 to a positive value (€9,049 thousand) as of June 30, 2022, as a reflection of the above. Depreciation and amortization, amounting to Euro 1,249 thousand, shows an increase of approximately €495 thousand due to the completion and commissioning of the new GMP facility at the Rosia (Siena) site. The investment totaling approximately €12,000 thousand, of which more than €2,000 thousand is currently recovered through the Industry 4.0 tax PRESS RELEASE 2 credit, began in the year 2020 and was completed in the first half of 2022. The new facility will be intended for the production of drugs for the commercial market, and for this it will have to be inspected by the regulatory authority which, in case of a positive outcome, will issue the appropriate authorization. In the meantime, the Company has been active in building a documentary quality system and scheduling testing activities related to the production process. EBIT, calculated as the difference between EBITDA and depreciation and amortization, showed a positive balance of €7,800 thousand as of June 30, 2022 (negative €8,860 thousand as of June 30, 2021). Net financial management as of June 30, 2022 closed with a negative balance of €4,359 thousand (net positive balance of €587 thousand as of June 30, 2021).

This change is attributable to: (i) net valuation losses of €3,258 thousand related to the change in the fair value of the securities portfolio, (ii) net realized capital losses of €134 thousand, (iii) net foreign exchange valuation losses of €533 thousand and realized losses of €235 thousand, and (iv) interest expense and other charges of €199 thousand. The change in (i) is related to the weakness that characterized the financial market as a whole in the first six months of the year 2022, also due, in particular, to the sharp rise in interest rates that penalized the valuations of fixed-income securities with a short duration. However, the portfolio’s good diversification and the transactions carried out allowed potential losses to be minimized. In this economic environment, management is, even more than before, continuously and constantly monitoring the performance of the invested financial portfolio. Evidence to date shows a trend of reabsorption and contraction of this negative variation.

Finally, it should be noted, as evidence of the exceptional nature of the situation, that Italian regulations have allowed those who prepare financial statements with the OIC standards not to show said latent capital losses in the financial statements, as instead is required by the IFRS standards adopted by the Company. Regarding the change in point (iii), we highlight that the Group operates in Italy and Switzerland with different currencies of account that were affected by the high volatility of exchange rates when converting the subsidiary’s financial statements for consolidation purposes.Taxes, amounting to €1,461thousand, showed an increase of €1,082 thousand mainly related to the higher revenues recorded in the period ended June 30, 2022 compared to the same period of the previous year. The item also includes the reversal of deferred tax effects recognized upon transition to IAS/IFRS. As a result of the above, the Group, for the period ended June 30, 2022, shows a net profit of €1,980 thousand, an increase of €10,633 thousand over the loss for June 30, 2021.

As of June 30, 2022, the net financial position, which was positive, amounted to €82,114 thousand, compared with a net financial position, also positive, of €85,184 thousand as of December 31, 2021. The Group ended the second quarter of 2022 with liquidity of €98,339 thousand compared to €92,593thousand as of March 31, 2022 and €101,678 thousand as of December 31, 2021, showing a decrease of only 3 percent compared to December 31, 2021 due to collections of €16,480 thousand from the progress of ongoing customer contracts.

The following is a table of the Philogen Group’s Net Financial Debt as of June 30, 2022, prepared in accordance with ESMA Guideline 32-382-1138 of March 4, 2021 and Consob’s Attention Reminder No. 5/21: 7.6%, from €76,345 thousand as of March 31, 2022 to €82,114 thousand as of June 30, 2022. In the same period, liquidity increased from €92,593 thousand as of March 31, 2022 to €98,339thousand as of June 30, 2022, showing an increase of approximately 6.2%. The latter change was mainly attributable to (i) collections from contracts with customers in the amount of €16,480thousand, (ii) costs from ordinary operations in the amount of approximately €6,555thousand, (iii) investments for the construction of the new GMP plant in Rosia (Siena) in the amount of approximately €1,752thousand, (iv) the purchase of treasury shares in the amount of €404thousand, and (v) the negative change in the fair value of the securities portfolio in the amount of approximately €2,023thousand. Current and non-current financial debt decreased from €16,248 thousand as of March 31, 2022, to €16,225thousand as of June 30, 2022, showing a decrease of approximately 0.14% resulting from the progress of existing amortization schedules. It should be noted that the financial debt derives, for approximately €12,064 thousand, from the real estate leases for the three company sites, represented according to international accounting standards (IFRS 16). The remaining part, amounting to €4,161 thousand, relates to the outstanding loan stipulated in order to finance the expansion project of the Rosia (Siena) production site. MAJOR EVENTS AFTER THE PERIOD ENDED JUNE 30, 2022 The Group continues the share buyback program, which was approved on November 24, 2021 by the Company’s Board of Directors, with a term of 18 months from the date of approval, and started on December 1, 2021. Since the start of the program and until September 23, 2022, Philogen has purchased 160,132 ordinary shares (equal to 0.3943% of the share capital), with a total value of €2,277,201.35. Notices under Buyback regulations are available on the Company’s website (View Source), "Investors/Buyback" section. FORESEEABLE DEVELOPMENT OF OPERATIONS The Group also reports the following prospective events related to corporate scientific activities: o Nidlegy TM o Following the recruitment of 214 patients in the European Phase III trial in melanoma, clinical activities associated with the trial will continue. Trial read-out is expected upon reaching the 95th event (disease progression or patient death) o With reference to other ongoing clinical trials, recruitment of new patients and opening of new centers is currently ongoing o Monitoring of objective responses observed in the Phase II clinical trial of non-melanoma skin cancers; o Fibromun o With reference to the various ongoing clinical trials, recruitment of new patients and opening of new centers is currently ongoing. o Opening of new centers in Germany, Spain, Italy and Poland for the European Phase III study of first-line soft tissue sarcoma.

As of the date of this Press Release, 41 patients have been treated. In this setting, Fibromun is administered in combination with Doxorubicin. o Safety monitoring of the presence of Objective Responses and Progression Free Survival in patients treated in the dose escalation part of the European Phase I/II study in patients with recurrent glioblastoma. In the first and third patients, a decrease of ~98% e ~85% at 18 and 15 months after the start of tumor treatment, respectively. Long stabilizations of the disease were also observed, exceeding the historical data reported for lomustine alone. As of the date of this Press Release, 12 patients have been treated. o Radio-conjugated OncoFAP o Filing of application to the Italian Drug Agency for a clinical trial with the aim of exploring OncoFAP68Ga (diagnostic agent) in patients with cancer. o Planned new pre-clinical studies with OncoFAP177Lu (diagnostic and therapeutic agent). o New GMP Rosia (Siena) facility: the authorization of AIFA of the new GMP production facility in Rosia for the production and marketing of drugs is expected in 2023. It should be noted that this new facility will complement the PRESS RELEASE 4 existing GMP plant in Montarioso (Siena), which was strengthened in 2021 and is dedicated to the production of investigational drugs. The Group is also engaged in the strengthening of its in-house research and development activities, as well as contractual activities related to discovery and/or manufacturing. It also runs Business Development activities with potential industrial partners in order to seek new scientific collaborations on an opportunistic basis.

OTHER SIGNIFICANT BOARD RESOLUTIONS Approval of the Sustainability Brochure 2021 The Board of Directors approved the Group Sustainability Brochure, referring to the year 2021, which will be published on the Company’s website (View Source) in the "Governance" section. In fact, during the first half of 2022, the Group embarked on a structured and organic path of reporting on sustainability issues, taking sustainability aspects into consideration in a manner consistent with the organizational characteristics of the business. The reporting activity, driven by a desire for transparency to the Group’s stakeholders and the growing momentum of the market and industry regulations, will continue in the coming years with a view to continuous improvement. Reporting, moreover, represents the first milestone in the sustainability journey initiated by the Group, which will lead to a gradual improvement in the governance and management aspects of sustainability areas, as well as an evolution of the Group’s approach to these issues, from an increasingly strategic and integrated perspective with respect to business activities. Pursuant to Article 154-bis, paragraph 2, of Legislative Decree No. 58/1998, the Financial Reporting Officer, Laura Baldi, declares that the accounting information contained in this press release corresponds to the documentary results, books and accounting records.

* * * In line with the recommendations contained in the ESMA/2015/1415 guidelines of October 5, 2015, it should be noted that within the scope of this press release there are some indicators that, although not envisaged by IFRS, are derived from financial quantities envisaged by IFRS. These indicators-which are presented in order to allow a better assessment of the Group’s operating performance-should not be considered as alternatives to those provided for by IFRS and are homogeneous with those reported in the Report and Financial Statements as of December 31, 2020. It should also be noted that the methods for determining these indicators applied therein, since they are not specifically regulated by the relevant accounting standards, may not be homogeneous with those adopted by others and, therefore, these indicators may not be adequately comparable. In compliance with Consob Communication No. 9081707 of September 16, 2009, it should be noted that the alternative performance indicators have not been audited by the Auditing Firm, as have the accompanying financial statements.

On September 28, 2022 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that provided an update on operational progress and its half year financial results for the six-month period ended June 30, 2022 (Press release, Nanobiotix, SEP 28, 2022, View Source [SID1234621509]).

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"I am encouraged by the progress of NANORAY-312 as we, in partnership with LianBio, have been able to activate more than 50 sites globally and recruit our first patients in Europe and Asia," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. "We view the evaluation of radiotherapy-activated NBTXR3 as a single agent for the treatment of elderly patients with locally advanced head and neck cancer as the foundation of a potentially industry-leading head and neck cancer treatment franchise, and look forward to advancing toward our second planned registrational program for patients with recurrent and/or metastatic head and neck cancer in the coming months."

Recent Operational Highlights, Pipeline Status and Upcoming Milestones

Priority Registration Pathway in Locally Advanced Head & Neck Cancer, Local Control as Single Agent Activated by Radiotherapy (RT):

Randomized first patient in Europe in pivotal Phase 3 study NANORAY-312, evaluating RT-activated NBTXR3 with or without cetuximab in elderly patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
Strategic partner LianBio enrolled the first patient in Asia in Q3 2022, and continues to ramp up site activations in the region to support planned enrollment of ~100 patients in NANORAY-312.
Initiated clinical site activation for NANORAY-312 in the United States (US) in Q3 2022, and expect patient enrollment to begin in Q4 22.
Completed enrollment in Study 102 and provided data as of February 2022 showing on-going median overall survival of 17.9 months in the all-treated population (n=56) and 23.0 months in the evaluable patients (n=44). Data with minimum follow-up of one year for full study population are expected in mid-2023.
Priority Pathway in Immunotherapy for Recurrent/Metastatic Head & Neck Cancer, Priming Immune Response in Combination with Anti-PD-1 Treatment:

Received preliminary feedback from FDA regarding a potential Phase 3 registrational program for patients with unresectable locoregional recurrent (LRR) or relapsed or metastatic head and neck squamous cell carcinoma (R/M HNSCC) that developed primary or secondary resistance to previous anti-PD-1/PD-L1 therapy, suggesting a single, randomized, controlled trial including a pre-specified comparative analysis of overall response rate (ORR) may be suitable to support an accelerated approval, subject to confirmation of clinical benefit based on overall survival (OS) results from the same trial
Completed enrollment and determined recommended phase 2 dose (RP2D) at 33% of tumor volume in all three cohorts of Study 1100, a US Phase 1 dose escalation and dose expansion study evaluating RT-activated NBTXR3 in combination with immune checkpoint inhibitors for patients with advanced cancers. The recommended dose is now being evaluated in the dose expansion part of Study 1100 and will serve as the proposed dose for planned registration pathway in patients with inoperable R/M HNSCC that is resistant to prior immunotherapy
Amended protocol for the Study 1100 to include one cohort focused on patients with R/M HNSCC that is resistant to anti-PD-1; a second cohort focused on patients with R/M HNSCC that is naive to anti-PD-1; and a third cohort focused on patients with lung, liver, or soft tissue metastases from primary non-small cell lung cancer, malignant melanoma, hepatocellular carcinoma, renal cell carcinoma, urothelial cancer, cervical cancer, or triple-negative breast cancer.
Expect to provide updated data including approximately ~28 patients at medical conference during the fourth quarter of 2022
Plan to submit protocol for potential registration pathway for NBTXR3 immunotherapy combination to US FDA by Q1 23
Expanding NBTXR3 Opportunity, Collaborating with World-Class Partners to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profile:

Published data from a preclinical study conducted in collaboration between The University of Texas MD Anderson Cancer Center (MD Anderson) in the International Journal of Nanobiotechnology showing that adding NBTXR3 to a combination of radiotherapy, anti-PD-1, and anti-CTLA-4 produced significant antitumor effects against both primary and secondary tumors, improved the mouse survival rate from 0 to 50%, and induced long term antitumor memory. These data further the hypothesis that the potential immune priming effects of NBTXR3 could extend beyond anti-PD-1.
Researchers from MD Anderson published a peer-reviewed clinical case study reporting preliminary data on the first-in-human administration of NBTXR3 for the treatment of pancreatic cancer not eligible for surgery, demonstrating feasibility with no treatment-related toxicity. Determination of the recommended Phase 2 dose (RP2D) for NBTXR3 in pancreatic cancer is expected by the end of 2022.
Data from a Phase 1b/2 head and neck cancer study in Asia evaluating NBTXR3 combined with concurrent weekly low-dose cisplatin-containing chemoradiation showed that, in 12 evaluable patients with stage 4 disease, the combination therapy was feasible, had a favorable safety profile for patients with LA-HNSCC, produced a 100% disease control rate, and an overall response rate of 58.3%.
Data from a Phase 1b/2 rectal cancer study in Asia evaluating NBTXR3 combined concurrent chemoradiation showed that, in 31 evaluable patients with unresectable disease, the combination in the preoperative setting was feasible, had a favorable safety profile, and enabled 96% of evaluable patients to undergo R0 surgery. The combination therapy produced a 100% disease-control rate, a 35.5% overall response rate, and a 20% pathological complete response rate in 25 patients who underwent surgery.
"Building on initiatives begun in 2021, Nanobiotix committed in the first half of 2022 to further reduce operating costs and better align financial resources with strategic priorities" said Bart Van Rhijn, chief financial officer of Nanobiotix. "Midway through the year, we can see that the focused execution in our clinical development programs was matched by a similar focus on strengthening our financial position, and the success is equally apparent."

Financial Results for the First Half of 2022

Revenue and Other Income: Revenue and other income remained stable for the six months ended June 30, 2022 at €1.3 million, compared to approximately the same figure for the six months ended June 30, 2021. The Company has mainly benefited from the research tax credit, granted by the French government to encourage companies to conduct technical and scientific research.

Research and Development ("R&D") Expenses: R&D expenses consist primarily of preclinical, clinical and manufacturing expenses related to the development of NBTXR3. These expenses for the six months ended June 30, 2022, were €16.6 million, compared to €15.5 million for the six months ended June 30, 2021. Purchases, sub-contracting and other expenses increased by €1.2 million for the six month period ended June 30, 2022 as compared to the same period in 2021. This increase reflects the Company’s focus on advancing its clinical trial development priorities, specifically the global Phase 3 registrational trial, NANORAY-312.

Selling, General and Administrative ("SG&A") Expenses: SG&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. Total SG&A expenses for the six months ended June 30, 2022, were €9.6 million, compared to €10.2 million for the prior-year six-month period.

Purchases, fees and other expenses decreased by €0.9 million for the six month period ended June 30, 2022 as compared to the same period in 2021, illustrating the Company’s focus on enhancing operational efficiencies and optimizing capital allocation for continued investment in priority development pathways.

Net loss: Net loss attributable to common shareholders for the six months ended June 30, 2022 was €26.4 million, or €0.76 per share. This compares to a net loss attributable to common shareholders of €30.4 million, or €0.88 per share, for the same period in 2021.

Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2022, were €63.0 million, compared to €83.9 million as of December 31, 2021.

Financial Guidance: In September 2022, the Company reached an agreement in principle to restructure its existing debt obligations with the European Investment Bank (EIB). Once finalized and executed with the EIB, the amendment to the debt restructuring is expected to extend the Company’s operating runway through the end of 2023. Combined with committed capital available through its previously announced, untapped equity line of credit, Nanobiotix expects to be able to fund its current R&D and clinical programs into the first quarter of 2024.

These results are represented in the condensed consolidated financial statements as of June 30, 2022 and have been subjected to a limited review by the Company’s statutory auditors.

Availability of the half-year financial report

The 2022 half-year financial report has been filed with the French Financial markets authority (Autorité des marchés financiers). It is available to the public on the company’s website, www.nanobiotix.com.

Financial Agenda

November 9th, 2022: Third Quarter Corporate and Financial Update

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across solid tumors that can be treated with radiotherapy and across different therapeutic combinations.

On September 28, 2022 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported that Chandler Robinson, MD, Monopar’s Chief Executive Officer, will present at the Roth Inaugural Healthcare Opportunities Conference (Press release, Monopar Therapeutics, SEP 28, 2022, View Source [SID1234621508]).

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