On November 25, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the quarter ended September 30, 2022 (Press release, Can-Fite BioPharma, NOV 25, 2022, View Source [SID1234624425]).

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Corporate and Clinical Development Highlights Include:

Complete Clearance of Cancer in a Patient Treated with Namodenoson was Presented at the AASLD Liver Meeting – A poster titled "Complete Response Induced by Namodenoson, an A3 Adenosine Receptor Agonist, in a Patient with Advanced Hepatocellular Carcinoma" was presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in November in Washington, D.C. The findings were published in the October 2022 supplement of HEPATOLOGY, a premier peer-reviewed journal in the field of liver disease. The poster detailed the patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), who participated in Can-Fite’s prior Phase II study. The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for 5 years under an open label extension program until the approval of a compassionate use program in Romania in August.

Namodenoson Approved for Compassionate Use in Romania to Treat Liver Cancer; Phase III Pivotal Global Study Open for Enrolment – Romania became the second country to approve Namodenoson for compassionate use in patients with advanced liver cancer. Can-Fite’s global pivotal Phase III liver cancer study for Namodenoson is open for enrollment of approximately 450 patients diagnosed with HCC and underlying CPB7 who have not responded to other approved therapies.

New Psoriasis Data from Phase III COMFORT Trial Show Superior Safety & Improved Efficacy – The latest findings on Piclidenoson, Can-Fite’s lead drug candidate, from its Phase III COMFORT trial were presented in September at the 31st European Academy of Dermatology and Venerology by Dr. Kim A. Papp, MD, a prominent thought leader in the treatment of psoriasis. In addition to the study meeting its primary endpoint of Piclidenoson’s superiority over placebo, the latest data showed that Piclidenoson had a significantly better tolerability profile than Otezla, the leading oral psoriasis treatment on the market today. GI-related adverse events were 1% for Piclidenoson vs. 6% for Otezla, nervous system disorders were 0.7% for Piclidenoson vs. 9.9% for Otezla and 3.3% for the placebo. The discontinuation rate was significantly higher for Otezla than for Piclidenoson. In achieving psoriasis disability index (PDI) response at week 32, Piclidenoson was comparable to Otezla. Patients treated with Piclidenoson showed an improving progressive response over time, a critically important finding given psoriasis is a chronic disease that may require long-term treatment.

Pivotal Phase III Psoriasis Registration Study is Under Preparation for Submission to FDA & EMA – The pivotal Phase III psoriasis study’s protocol is being developed in conjunction with Dr. Kim Papp, a Key Opinion Leader in dermatology and an investigator in the COMFORT study. Marketing registration plans including chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are being prepared for submission to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Piclidenoson in the treatment of moderate to severe psoriasis.

Safety Study of Piclidenoson for Osteoarthritis in Dogs Successfully Concluded, Efficacy Study to Commence – Following a successful safety study in dogs that explored dose-range safety and pharmacokinetics, Piclidenoson is set to enter efficacy studies in the treatment of canine osteoarthritis through a development and commercialization agreement signed with Vetbiolix, a France based veterinary biotech company. Vetbiolix is financially responsible for the clinical studies. The canine osteoarthritis market is projected to reach $3 billion by 2028 and regulatory approval pathways tend to be shorter than those required for humans.

"The latest Phase III findings for Piclidenoson are highly encouraging and inform the potential for a successful psoriasis registration study which will be conducted under both the FDA and EMA. A favorable outcome could mean marketing approval in two of the largest markets in the world," stated Can-Fite CEO Dr. Pnina Fishman. "While we have distribution agreements in place for Piclidenoson and Namodenoson in the treatment of psoriasis and liver cancer in certain European and Asian markets, we maintain full distribution rights for these late-stage assets in the U.S., the largest market in the world. We are strategically evaluating partnerships in the U.S. as we continue to forge ahead on each of our other indications including Namodenoson in NASH and Piclidenoson for canine osteoarthritis."

Financial Results

Revenues for the nine months ended September 30, 2022 were $0.61 million, a decrease of $0.04 million, or 6.1%, compared to $0.65 million for the nine months ended September 30, 2021. The decrease is considered to be not material.

Research and development expenses for the nine months ended September 30, 2022 were $5.31 million, a decrease of $1.44 million, or 21.3%, compared to $6.75 million for the nine months ended September 30, 2021. Research and development expenses for the nine months ended September 30, 2022 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to the wrap up of the Phase III study of Piclidenoson for the treatment of psoriasis in 2022.

General and administrative expenses for the nine months ended September 30, 2022 were $2.31 million a decrease of $0.40 million, or 14.7%, compared to $2.71 million for the nine months ended September 30, 2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2022.

Financial expenses, net for the nine months ended September 30, 2022 were $0.14 million compared to finance income, net of $0.31 million for the nine months ended September 30, 2021. The decrease in financial income, net was mainly due to revaluation of the Company’s short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.

Net loss for the nine months ended September 30, 2022 was $7.15 million compared with a net loss of $8.50 million for the nine months ended September 30, 2021. The decrease in net loss for the nine months ended September 30, 2022 was primarily attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.

As of September 30, 2022, Can-Fite had cash and cash equivalents and short term deposits of $10.79 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the nine months ended September 30, 2022 is due to the ongoing operations of the Company.

The Company’s consolidated financial results for the nine months ended September 30, 2022 are presented in accordance with US GAAP Reporting Standards.

On November 25, 2022, Biomea Fusion, Inc. (the "Company") reported that entered into an equity distribution agreement (the "Agreement") with Piper Sandler & Co., as sales agent (the "Sales Agent"), with respect to an "at the market offering" program. Pursuant to the prospectus supplement relating to the Offering (as defined below), dated as of November 25, 2022 (the "Prospectus Supplement"), the Company may offer and sell, from time to time in its sole discretion, shares of its common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $100 million (the "Shares") through the Sales Agent (the "Offering") (Filing, 8-K, Biomea Fusion, NOV 25, 2022, View Source [SID1234624424]).

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Any Shares offered and sold in the Offering will be issued pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-267884), filed with the Securities and Exchange Commission (the "Commission") on October 14, 2022 (the "Registration Statement"), including the base prospectus contained therein, the Prospectus Supplement, and any applicable additional prospectus supplements related to the Offering that form a part of the Registration Statement.

The Sales Agent may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, including sales made directly through The Nasdaq Global Select Market ("Nasdaq") or on any other existing trading market for the Common Stock. The Sales Agent will use commercially reasonable efforts to sell the Shares from time to time consistent with their normal sales practices and applicable federal rules, regulations and Nasdaq rules, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay the Sales Agent a commission up to 3.0% of the gross sales proceeds of any Shares sold through the Sales Agent under the Agreement, and also has provided the Agent with customary indemnification and contribution rights.

The Sales Agent is not required to sell any specific number or dollar amount of securities, but will use commercially reasonable efforts to sell, on behalf of the Company, all of the shares of Common Stock requested to be sold by the Company, consistent with their normal trading and sales practices, on mutually agreed terms between the Sales Agent and the Company. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the opinion of Goodwin Procter LLP relating to the legality of the issuance and sale of the shares in the Offering is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On November 25, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) ("Spectrum" or the "Company"), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Spectrum’s New Drug Application (NDA) for poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer ("NSCLC") harboring HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, NOV 25, 2022, View Source [SID1234624420]). The FDA issued a CRL indicating the poziotinib application cannot be approved in its present form. Based on the CRL, the Company would have to generate additional data including a randomized controlled study prior to approval.

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"While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed."

Mr. Riga continued, "We are committed to exploring potential strategic alternatives for poziotinib, including partnerships and business development opportunities, and will determine the best path forward in support of patients. We are grateful to the patients, families, and clinicians who participated in the poziotinib program and to the team members who have dedicated their time and efforts."

The Company will de-prioritize poziotinib program activities, effective immediately, and is in the process of reducing its R&D workforce by approximately 75%. Based on the anticipated cost savings from the restructuring, Spectrum believes it will be able to generate the working capital required to support its strategic refocusing through 2024.

The Company will focus efforts on driving growth for its recently launched commercial drug, ROLVEDON. ROLVEDON was approved by the FDA in September 2022. It is for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Spectrum launched ROLVEDON, which has an estimated market opportunity of approximately $2 billion, shortly following the FDA’s approval.

On November 25, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported that analysis of the AGENT study’s final data confirmed topline results presented on August 3, 2022 (Press release, Isofol Medical, NOV 25, 2022, View Source [SID1234624419]). Moreover, no predictive gene expressions for clinical response could be identified. Isofol is continuing its efforts to terminate the AGENT study in line with applicable ethical and regulatory requirements, complete the final study report for submission to regulatory agencies and prepare a manuscript for a scientific publication. Isofol is in parallel continuing to investigate possible future paths forward for the company.

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The information in the press release is intended for investors.

On August 3, 2022, Isofol presented topline results showing that the AGENT study met neither its primary endpoint nor key secondary endpoint. Based on analysis of additional study data that Isofol obtained since then, the company can today confirm that the AGENT study’s final data confirms the conclusions that were communicated in conjunction with topline results and study updates from August 31 and September 7, namely that:

Neither the primary endpoint of objective response rate (ORR) nor the key secondary endpoint of progression-free survival (PFS) were met.
With regards to safety data, there were no differences between the study arms with the exception of a non-statistically significant detriment in overall survival (OS) in the arfolitixorin arm.
There were no significant differences in any major subgroups.
There were preliminary indications that the risk of death was 11 percent greater in the experimental arm compared with the control arm.
Data surrounding gene expression was also analyzed during the fourth quarter. Conclusions from this analysis did not identify any predictive biomarkers.

"All in all, the final study results did not show any clinical or business value for Isofol either. We remain greatly disappointed. The company’s management and board of directors will continue to diligently work together to investigate possible options for Isofol’s future," said Ulf Jungnelius, CEO of Isofol.

Isofol’s work to terminate the AGENT study, which currently involves detailed quality control and regulatory documentation from the study sites involved, is continuing, and is estimated to be completed by the turn of the year.

Isofol intends to publish key data from the study in a scientific publication to enable the medical community to fully leverage the lessons learned from the study. The preparation of a manuscript for scientific publication is ongoing and the intention is to submit it to a peer-reviewed journal in oncology during the first quarter of 2023.

About the AGENT study
The Phase III AGENT Study is the first to evaluate a meaningful alternative to the standard of care for most patients with metastatic colorectal cancer (mCRC) in 20 years and involves approximately 90 clinics in the U.S., Canada, Europe, Australia, and Japan. The Phase III randomized, controlled, multi-center study of 490 patients assessed the efficacy and safety of arfolitixorin, [6R]-5,10 methylene-THF (MTHF), compared to leucovorin, both used in combination with 5-U, oxaliplatin, and bevacizumab, in first line mCRC patients.

The study was designed to show that arfolitixorin was better than leucovorin and that the results would be statistically significant. Patients were randomized in a 1:1 ratio with the primary endpoint being an overall response rate (ORR) >10 percent improvement vs. the control arm. The key secondary endpoint is a clinically meaningful positive trend in progression free survival (PFS). Other secondary endpoints include duration of response (DOR), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells.

In the AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not achieve a statistically significant overall response rate of ≥ 10% as compared to patients treated with the standard of care (leucovorin + 5-FU, oxaliplatin and bevacizumab).

On November 24, 2022 Kyowa Kirin Co., Ltd., (TSE:4151, President and CEO: Masashi Miyamoto, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, and Grünenthal GmbH (CEO: Gabriel Baertschi), a global, science-based, privately-owned pharmaceutical company, reported that they have signed a Joint Venture Collaboration for Kyowa Kirin International’s established medicines portfolio (Press release, Kyowa Hakko Kirin, NOV 24, 2022, View Source [SID1234624414]). The Joint Venture Collaboration comprises 13 brands across 6 therapeutic areas primarily focused on pain management, including Abstral and PecFent for breakthrough cancer pain, Moventig for opioid-induced constipation, and Adcal-D3 for osteoporosis. The Joint Venture Collaboration is subject to obtaining customary approvals and clearances, including anti-trust and works councils as legally required. Completion of the deal is anticipated for Q2 2023.

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The total revenues of the portfolio in 2021 were approximately €200 million. The products are marketed through affiliates in seven major European countries and through a network of partners in various additional territories worldwide. Grünenthal has agreed to pay approximately €80 million upfront plus royalties over the term of the collaboration. Grünenthal will make an additional payment upon purchase of the remaining share and the intellectual property (IP) of the portfolio.

"As a leader in pain management, and with our proven track record in growing established brands, we believe we can help even more patients benefit from this unique group of medicines", said Gabriel Baertschi, Chief Executive Officer, Grünenthal. "This portfolio of established brands matches very well with Grünenthal’s geographical footprint and therapeutic areas."

Abdul Mullick, President of Kyowa Kirin International said, "Our search for a partner included three key priorities: a team who shares our commitment to patients and to our employees, a partner who is looking to support our growth agenda, and a company with which we can establish a close, collaborative partnership that promises benefits for all our stakeholders while operating at the highest ethical standards. This collaboration will bring a renewed focus, the resources and the commercial infrastructure required to grow the established medicines portfolio to deliver life-changing value to more patients."

Subject to approval, Grünenthal will own a 51 percent majority share in the new company. Kyowa Kirin will own a 49 percent share and will initially retain the IP related to the portfolio.

Grünenthal intends to purchase the remaining 49 percent share and the IP at the beginning of 2026.

About the portfolio

The portfolio includes medicines that deliver life-changing value for hundreds of thousands of patients. The portfolio is available in seven major European markets through affiliates and in various additional territories worldwide through a network of partners. Key products in the portfolio include Abstral and PecFent (Fentanyl) for breakthrough cancer pain, Moventig (Naloxegol) for opioid-induced constipation and Adcal-D3 (calcium and vitamin D3) for osteoporosis.