On November 9, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its business update and financial results for the third quarter ended September 30, 2022 (Press release, Curis, NOV 9, 2022, View Source [SID1234623543]).

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The Company plans to release updated data from its TakeAim Leukemia Phase 1/2 trial of emavusertib in relapsed or refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (hrMDS) during the upcoming 64th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in New Orleans on December 10-13, 2022. The release includes data for 11 additional evaluable AML/hrMDS patients treated with monotherapy (total to date 24) in targeted populations (patients with U2AF1, SF3B1 or FLT3 mutations), as well as 5 AML/hrMDS patients treated with the combination of emavusertib and venetoclax.

To further advance the development of emavusertib based on these data, the Company is concentrating its resources to focus on and accelerate emavusertib. Resources will be reallocated to the emavusertib programs and resources dedicated to all other pipeline programs will be reduced. Deprioritization of other programs will enable a reduction of approximately 30% of the Company’s workforce and is expected to extend the Company’s cash runway into 2025.

"We believe emavusertib’s potential to address an area of high unmet need in R/R AML and R/R hrMDS sets it apart. To that end, we are dedicating the resources of the company to prioritize the acceleration of its regulatory path," said James Dentzer, President and Chief Executive Officer of Curis. "While we continue to believe in our entire pipeline, we recognize the unique potential of emavusertib and are fortunate that our existing cash will allow us to extend our runway into 2025 to advance its development," continued Mr. Dentzer.

Third Quarter 2022 and Recent Operational Highlights

Precision Oncology, Emavusertib (IRAK4 Inhibitor)

The Company announced in August that, after review of the comprehensive data packages submitted by the Company, the FDA has allowed enrollment to resume in the TakeAim Lymphoma study and in the monotherapy dose finding phase (Phase 1a) of the TakeAim Leukemia study.

Curis held the first annual IRAK4 in Cancer symposium virtually on October 7, 2022 where leaders from academia and industry gathered to present their cutting edge research on IRAK4, its biology and the role it could play as a target for therapeutic intervention.
Upcoming Milestones

The Company plans to report monotherapy and combination data from the TakeAim Leukemia studies during ASH (Free ASH Whitepaper) 2022.
Third Quarter 2022 Financial Results

For the third quarter of 2022, Curis reported a net loss of $13.3 million or $0.14 per share on both a basic and diluted basis, as compared to a net loss of $11.1 million, or $0.12 per share on both a basic and diluted basis for the same period in 2021. Curis reported a net loss of $45.3 million or $0.49 per share on both a basic and diluted basis, for the nine months ended September 30, 2022 as compared to a net loss of $31.8 million, or $0.35 per share on both a basic and diluted basis for the same period in 2021.

Revenues, net for the third quarter of 2022 and 2021 were $2.8 million and $3.0 million, respectively. Revenues, net for the nine months ended September 30, 2022 were $7.3 million as compared to $7.5 million for the same period in 2021. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the third quarter of 2022 were $15.4 million, as compared to $13.1 million for the same period in 2021. Operating expenses for the nine months ended September 30, 2022 were $50.1 million, as compared to $37.0 million for the same period in 2021, and comprised the following:

Cost of Royalty Revenues. Cost of royalty revenues, which represents amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for the third quarter of 2022 and $0.2 million for the same period in 2021. Cost of royalty revenues for the nine months ended September 30, 2022 were $0.2 million, as compared to $0.4 million for the same period in 2021.

Research and Development Expenses. Research and development expenses were $10.8 million for the third quarter of 2022 as compared to $8.6 million for the same period in 2021. The increase in research and development expenses for the quarter is primarily attributable to increased personnel and consulting costs, partially offset by decreased manufacturing and clinical development costs. Research and development expenses were $34.6 million for the nine months ended September 30, 2022 as compared to $24.1 million for the same period in 2021.

General and Administrative Expenses. General and administrative expenses were $4.6 million for the third quarter of 2022, as compared to $4.3 million for the same period in 2021. The increase in general and administrative expenses was driven primarily by the timing of costs. General and administrative expenses were $15.3 million for the nine months ended September 30, 2022, as compared to $12.5 million for the same period in 2021.

Other Expense. For the third quarter of 2022 and 2021, total other expense was $0.7 million and $1.0 million, respectively. Other expense primarily consisted of imputed interest expense related to future royalty payments partially offset by interest income. Other expense was $2.5 million for the nine months ended September 30, 2022, as compared to $2.3 million for the same period in 2021.

As of September 30, 2022, Curis’s cash, cash equivalents and investments totaled $98.7 million, and the Company had approximately 96.4 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2025.

Conference Call Information

Curis management will host a conference call today, November 9, 2022, at 4:30 p.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at in the Investors section.

On November 9, 2022 Selvita S.A. [WSE: SLV], one of the largest contract research organizations (CRO) in Europe, reported its financial results for Q3 2022* (Press release, Selvita, NOV 9, 2022, View Source [SID1234623542]). The Group continues its dynamic growth, exceeding the assumptions of the ambitious development strategy for 2022-2025 presented in March this year .

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In Q3 2022, Selvita Group generated EUR 22.7 million in revenues, indicating a 33% increase y/y. EBITDA profit amounted to EUR 6.2 million and was 31% higher than in the corresponding period in 2021. The net profit reached EUR 3.3 million, i.e., 50% more than in the previous year. This means that the EBITDA profitability will be maintained above 27%, and the net profitability will increase from 12.8% to 14.5% y/y.
In Q1-Q3 2022, the Group generated EUR 65.6 million in revenues, which means an increase of 38% y/y. The EBITDA profit in this period was EUR 18.3 million and was 48% higher than in the previous year. Net profit amounted to EUR 10.3 million (an increase of 68% y/y). Thus, the EBITDA profitability in Q1-Q3 2022 increased from 25.9% to 27.9%, and the net profitability from 12.9% to 15.8% y/y.
The Group’s backlog for 2022 exceeds EUR 83.1 million (as of 06/11/2022) and is 31% higher than the value reported a year earlier (as of 18/11/2021).
– We are happy to say that we are continuing our dynamic growth. The level of revenues generated in the first three quarters of 2022 was almost equal to the revenues generated in the whole of 2021, and what is worth noting is that the second half of last year constitutes a fairly high base for us. We also manage to maintain high profitability at all levels. Backlog for 2022 is approaching currently EUR 85 million, which shows that despite the demanding environment, we are pretty effective in resisting macro-economic factors – says Bogusław Sieczkowski, co-founder and Chief Executive Officer at Selvita.

In the period of Q1-Q3 2022, research and development services provided by Selvita generated EUR 56.3 million (an increase of 35% y/y) and accounted for 86% of the Group’s revenues. In Q3, the activities mentioned earlier generated EUR 19.3 million in revenues, indicating an increase of over 30% y/y. After nine months of 2022, EBITDA generated by research and development services exceeds EUR 17.2 million, which shows a rise of 54% y/y.

– We conduct very intensive business development activities. We have planned to participate in over 40 industry events between September and December this year. I am particularly pleased with the increasing sales of the regulatory research projects, which in the first three quarters of this year generated EUR 8.8 million in revenues, and the current backlog for this type of services amounts to over EUR 10.5 million, i.e., 57% more than a year earlier – comments Milosz Gruca, Vice President of the Management Board of Selvita and Chief Commercial Officer at Selvita.

The bioinformatics segment, i.e., Ardigen, generated EUR 7.4 million in external revenues in Q1-Q3 2022, which indicates a 60% increase y/y (over EUR 2.8 million in revenues in Q3 alone, i.e., 58% higher y/y). The EBITDA profit for this segment amounted to EUR 1.2 million at the end of Q3, and due to the Company’s intensive investments, it was at a level similar to last year’s. The bioinformatics backlog currently amounts to EUR 9.8 million, indicating an increase of 53% compared to the same period in 2021.

– Ardigen invests extensively in research and development, which is associated with increased expenses. However, the Company is fully profitable and finances itself. In the third quarter, Ardigen joined the "JUMP-Cell Painting Consortium" alongside companies such as Amgen, Astra Zeneca, Bayer, Eisai, Merck, Pfizer, and Takeda. Together, we create the world’s most extensive set of imaging data characterizing phenotypic cell changes caused by the activity of small molecule compounds. Joining the consortium will strengthen our credibility and recognition and significantly support our research work, says Janusz Homa, co-founder and Chief Executive Officer at Ardigen.

In the coming months, Selvita plans to complete the construction of its first laboratory building within the planned Selvita Research Center, which will allow adding additional 250 workplaces for scientists.

– We remain on track to launch the first of our Selvita Research Centre buildings in the first quarter of 2023. In the coming year, we also plan to commence the construction of a second similar building. We have acquired a plot of land that allows for the construction of four such buildings, where a total of over 1 000 workplaces will be created. We are also continuously looking for solutions that would allow us to increase the laboratory space in Poznan and Zagreb – adds Mirosława Zydron, Chief Operating Officer and Member of the Management Board at Selvita.

Implementation of the development strategy 2022-2025

At the end of Q1 2022, Selvita, having achieved the strategic goals set for the end of 2023 one year ahead, announced an updated development strategy for 2022-2025. During this period, the Company plans to triple its sales revenues (up to EUR 200 million) while maintaining high profitability. The Company will implement its strategy through organic growth and acquisitions. The implementation of the planned investments intends to allow Selvita to become the leading global preclinical CRO.

The Selvita Group Development Strategy for 2022-2025 is based on three key pillars:

Comprehensive drug discovery and development offer – supplementing the drug discovery offer and building the drug development segment
Focus on high-value services for the client – specialization in selected therapeutic areas and development of unique competencies
Development of the Group’s operations in the largest markets in the United States and Great Britain – increasing teams and potential new locations for laboratories
In the area of ​​acquisitions, in 2022-2025, Selvita intends to acquire at least two preclinical CROs in Europe or North America, providing services complementary to the Company’s offer or enabling the expansion of the scale of its operations.

– The financial results for 2022 reported to date show that the Company is currently organically growing faster than planned. At the same time, we are in numerous talks with selected potential acquisition targets, and we have every reason to believe that we are also heading in the right direction in this respect – sums up Bogusław Sieczkowski.

*The results do not include the accounting (non-cash) costs of the employee share incentive program.
Backlog as of November 6, 2022.

On November 9, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reoorted the Phase III NAPOLI 3 trial of Onivyde (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) and key secondary efficacy outcome of progression-free survival (PFS) also showed significant improvement over the comparator arm (Press release, Ipsen, NOV 9, 2022, View Source [SID1234623541]). The safety profile of Onivyde in the NAPOLI 3 trial was consistent with those observed in the previous phase I/II mPDAC study.

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Ipsen intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Onivyde in combination with oxaliplatin plus 5- fluorouracil/leucovorin for the treatment of patients with previously untreated mPDAC following the Fast Track Designation granted in 2020. The clinical trial results will be presented at an upcoming medical conference.

"The positive results from the NAPOLI 3 trial demonstrate that compared with the standard-of-care, the investigational Onivyde treatment regimen extended the lives of people living with metastatic pancreatic ductal adenocarcinoma who were previously untreated," said Howard Mayer, Executive Vice President and Head of Research and Development for Ipsen. "The prognosis for people diagnosed with pancreatic cancer is extremely poor and we plan to submit these new findings to the regulatory authority as, if approved, we believe this regimen could offer up an important new treatment option for people living with an aggressive and hard-to-treat cancer. We thank the patients who participated in the study, their families and their healthcare teams."

PDAC is the most common type of cancer that forms in the pancreas with approximately 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally.1,2 Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV).3 Even in later stages, weight loss, abdominal pain and jaundice are the most common symptoms making PDAC difficult to detect.4 Currently, fewer than 20 percent of people diagnosed with PDAC survive longer than one year and overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.1,2

Phase III NAPOLI 3 Study

NAPOLI 3 is a randomized, open-label Phase III trial of Onivyde treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for metastatic pancreatic ductal adenocarcinoma. Onivyde plus oxaliplatin and 5 FU/LV was administered twice in a month (days 1 and 15 of 28 day cycle) compared to an injection of nab-paclitaxel and gemcitabine administered three times a month (days 1, 8, 15 of a 28 day cycle). Approximately 770 patients were enrolled in the trial with the primary outcome measure of overall survival. Secondary outcome measures included progression-free survival, objective response rate, quality of life assessment, incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities. Adverse events and laboratory analyses were also analyzed.

Onviyde (irinotecan liposome injection)

Onivyde is a long-circulating, liposomal topoisomerase inhibitor designed to interrupt DNA replication in cancer cells. Onivyde enters cancer cells using a naturally occurring process (enhanced permeability and retention or EPR effect) and as macrophages unpack the liposomes, Onivyde is activated facilitating the release of the cytotoxic payload into the tumor, including irinotecan and its conversion into SN-38, its active metabolite. Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company with a strong international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan.

Onivyde is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: SEVERE NEUTROPENIA and SEVERE DIARRHEA

Fatal neutropenic sepsis occurred in 0.8% of patients receiving Onivyde. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving Onivyde in combination with 5-FU and LV. Withhold Onivyde for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.

Severe diarrhea occurred in 13% of patients receiving Onivyde in combination with 5-FU/LV. Do not administer Onivyde to patients with bowel obstruction. Withhold Onivyde for diarrhea of Grade 2–4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.

CONTRAINDICATION

Onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to Onivyde or irinotecan hydrochloride.

Warnings and precautions

Severe neutropenia: see boxed WARNING. In patients receiving Onivyde/5-FU/LV, the incidence of Grade 3/4 neutropenia was higher among Asian (18/33 [55%]) vs White patients (13/73 [18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of Asian vs 1% of White patients

Severe diarrhea: see boxed WARNING. Severe and life-threatening late-onset (onset >24 hours after chemotherapy [9%]) and early-onset diarrhea (onset ≤24 hours after chemotherapy [3%], sometimes with other symptoms of cholinergic reaction) were observed

Interstitial lung disease (ILD): Irinotecan HCl can cause severe and fatal ILD. Withhold Onivyde patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue Onivyde in patients with a confirmed diagnosis of ILD

Severe hypersensitivity reactions: Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue Onivyde in patients who experience a severe hypersensitivity reaction

Embryo-fetal toxicity: Onivyde can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during and for 1 month after Onivyde treatment

Adverse reactions

The most common adverse reactions (≥20%) were diarrhea (59%), fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased appetite (44%), stomatitis (32%), and pyrexia (23%)
The most common Grade 3/4 adverse reactions (≥10%) were diarrhea (13%), fatigue/asthenia (21%), and vomiting (11%)
Adverse reactions led to permanent discontinuation of Onivyde in 11% of patients receiving Onivyde/5- FU/LV; The most frequent adverse reactions resulting in discontinuation of Onivyde were diarrhea, vomiting, and sepsis
Dose reductions of Onivyde for adverse reactions occurred in 33% of patients receiving Onivyde/5 FU/LV; the most frequent adverse reactions requiring dose reductions were neutropenia, diarrhea, nausea, and anemia
Onivyde was withheld or delayed for adverse reactions in 62% of patients receiving Onivyde/5-FU/LV; the most frequent adverse reactions requiring interruption or delays were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia
The most common laboratory abnormalities (≥20%) were anemia (97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%), hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia (35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia (29%), and hyponatremia (27%)

Drug Interactions

Avoid the use of strong CYP3A4 inducers, if possible, and substitute non-enzyme inducing therapies ≥2 weeks prior to initiation of Onivyde
Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to starting therapy

Special Populations

Pregnancy and Reproductive Potential: See WARNINGS & PRECAUTIONS. Advise males with female partners of reproductive potential to use condoms during and for 4 months after Onivyde treatment
Lactation: Advise nursing women not to breastfeed during and for 1 month after Onivyde treatment

On November 9, 2022 Philogen S.p.A. (the "Company" or "Philogen" and, together with its Swiss subsidiary Philochem, the "Group"), reported that approved the Group’s net financial position as of September 30, 2022 and noted the progress of the main trials with Nidlegy and Fibromun (Press release, Philogen, NOV 9, 2022, View Source [SID1234623540]).

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Dario Neri, CEO and Chief Scientific Officer of Philogen S.p.A., commented: "The clinical programs of our two most advanced products are progressing in line with our expected timelines. After having reached the 214 patients foreseen in the protocol, we expect the read-out of our European Phase III study of Nidlegy in melanoma to occur in 2023. Enrollment of patients in the Fibromun Phase III sarcoma study is proceeding on schedule, and we expect to complete enrolment of 118 patients by the end of 2023.

Moreover, the emerging data from the non-melanoma skin cancer and glioblastoma studies are very encouraging. We expect the Phase I/II combination study of Fibromun and lomustine in glioblastoma at first progression to move to the randomized Phase II part in the first half of 2023.

Finally, as previously communicated, we are confident that the new GMP plant in Rosia can also be authorized in 2023."

NET FINANCIAL POSITION AS OF SEPTEMBER 30, 2022

The following is a table of the Philogen Group’s Net Financial Debt as of September 30, 2022, prepared in accordance with ESMA Guideline 32-382-1138 of March 4, 2021 and Consob’s Attention Reminder No. 5/21The Group ended the third quarter of 2022 with liquidity of 92,332 thousand euros compared to 101,677 thousand euros as of December 31, 2021, and a positive net financial position as of September 30, 2022 of 76,229 thousand euros compared to a net financial position, also positive, of 85,184 thousand euros as of December 31, 2021 (showing a percentage decrease of approximately 10% compared to December 31, 2021).

Between the second and third quarters of 2022, the positive net financial position shows a percentage decrease of about 7% from 82,114 thousand euros as of June 30, 2022 to 76,229 thousand euros as of September 30, 2022. In the same period, liquidity decreased from 98,339 thousand euros as of June 30, 2022 to 92,332 thousand euros as of September 30, 2022, showing a decrease of approximately 6%. The latter change was mainly attributable to (i) collections from contracts with customers in the amount of 1,672 thousand euros, (ii) costs from ordinary operations in the amount of approximately 6,042 thousand euros, (iii) capital expenditures for the equipment of the new GMP plant in Rosia (Siena) inthe amount of approximately 1,180 thousand euros, (iv) the purchase of treasury shares in the amount of 164 thousand euros, and (v) the net negative change in the fair value of the securities portfolio in the amount of approximately 292 thousand euros.

Current and noncurrent financial debt decreased from 16,225 thousand euros as of June 30, 2022 to 16,103 thousand euros as of September 30, 2022, showing a decrease of approximately 122 thousand euros resulting from the progress of existing amortization schedules. It should be noted that the financial indebtedness derives, for approximately 12,066 thousand euros, from the real estate leases for the three company sites, represented in accordance with international accounting standards (IFRS 16). The remaining part, amounting to 4,037 thousand euros, relates to two outstanding loans stipulated to partially finance the expansion project of the Rosia (Siena) production site.

PROGRESS STATUS OF THE MAIN TRIALS WITH Nidlegy and Fibromun

The most advanced programs are on schedule. Specifically, as of September 30, 2022:

(i) Nidlegy, Philogen’s most advance product, is progressing according to the expected timeline in the European Phase III study in Stage IIIB,C melanoma. Specifically:
▪ 214 patients foreseen by the protocol have been treated, as stated in the prospectus published in March 2021. As of the date of this release, the 95 events, which according to the protocol will allow the final data read-out (an event consists of disease progression or death of a patient), have not yet accrued. The read-out of the study is expected in 2023;
▪ Clinical trials in melanoma in the United States are also continuing, as well as a study in nonmelanoma skin cancers in Europe;

(ii) Fibromun, the second most advanced product after Nidlegy, is proceeding according to the expected timeline for ongoing clinical trials in the following areas: o Soft tissue sarcoma:
▪ 45 patients have been treated in the European Phase III study to date, with the goal of enrolling 118 patients. Fifteen centers have been opened, with the goal of expanding to approximately 25 by the first half of 2023. Philogen is confident of completing enrollment by the end of 2023. o Glioblastoma (the most lethal brain tumor):
▪ In the Phase I/II trial to treat patients with glioblastoma at first progression, the first two cohorts of Phase I have been completed. The third and final cohort is expected to begin later this year. The study will then transition to the randomized Phase II. Patients in this study are receiving Fibromun in combination with lomustine. To date, durable antitumor responses have been observed in the first two cohorts, which is typically never observed with lomustine alone.

The manager responsible for preparing the Company’s financial reports, Laura Baldi, declares pursuant to paragraph 2 Article 154 bis of the Consolidated Law on Finance that the accounting information contained in this press release corresponds to the documentary results, books and accounting records.

On November 9, 2022 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its first quarter fiscal year 2023 operating results on Monday, November 14, 2022, before the open of the U.S. financial markets (Press release, Palatin Technologies, NOV 9, 2022, View Source [SID1234623539]).

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Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on November 14, 2022, at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

Schedule for the Operating Results Press Release, Conference Call / Audio Webcast

View Source

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source.