On February 9, 2021 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and Edison Oncology Holding Corp., reported that Apollomics has been granted worldwide rights, excluding China, Hong Kong and Taiwan, for the development and commercialization of EO1001 (Press release, Apollomics, FEB 9, 2021, View Source [SID1234574824]). EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent.

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"We are excited to add EO1001 to our clinical development portfolio as its pan-erbB inhibition and well-tolerated preclinical safety profile makes it a potential targeted therapy for the treatment of solid tumor malignancies that overexpress EGFR and/or HER2," said, Sanjeev Redkar, PhD, Co-Founder and President of Apollomics. "In preclinical models, EO1001 is potent against mutations in both the intracellular and extracellular domain of EGFR and has demonstrated activity in tumors with the ability to penetrate the central nervous system. As we advance our clinical development pipeline, we continue to seek assets like EO1001 with clearly defined mechanisms of action and differentiating attributes that we believe can make a difference for cancer patients worldwide. Looking ahead, a Clinical Trial Notification (CTN) Application in Australia will be submitted to initiate a clinical trial in the second quarter of this year."

Under the terms of the agreement, Apollomics has the exclusive rights to develop and commercialize EO1001 globally, except in China, Hong Kong and Taiwan. Edison Oncology will receive an upfront cash payment and will be eligible to receive potential development and sales milestone payments, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for EO1001 in the territories.

"Our extensive and successful preclinical work with EO1001 has led us to this collaboration with Apollomics who will now advance the asset into clinical trials with their experienced development team. Over 90% of solid tumors overexpress erbB pathways, and with the data we have produced to date, we are confident that EO1001 has the potential to improve treatment outcomes for patients suffering from life-threatening cancers," concluded Jeffrey A. Bacha B. Chief Executive Officer of Edison Oncology.

About EO1001

EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, and against mutations in the extracellular domain of EGFR including the EGFR-variant III (EGFRvIII) mutation that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well tolerated and demonstrated activity against treatment-resistant ErbB-driven tumors, including malignancies in the central nervous system, in vivo.

On February 9, 2021 Moberg Pharmas reported that Year-end report 2020 (Press release, Moberg Pharma, FEB 9, 2021, View Source [SID1234574822])

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Financing for both MOB-015 and BUPI

PERIOD (JUL 2019-DEC 2020)

Net revenue SEK 50.5 million (15.6) *
EBITDA SEK 19.8 million (-1.7) *
Operating profit (EBIT) SEK 16.0 million (-3.0) *
Profit after tax SEK 10.2 million (-3.8) *
Total profit SEK 8.6 million (499.4)
Diluted earnings per share SEK 0.54 (-0.21) *
Cash and cash equivalents amounted to SEK 29.3 million (919.1)
Comparative figures for the period refer to January 2019 – June 2019 (Note: 18 months vs. 6 months due to shortened fiscal year)

SIXTH QUARTER (OCT-DEC 2020)

Net revenue SEK 0.0 million (0.0) *
EBITDA SEK -5.3 million (-8.1) *
Operating profit (EBIT) SEK -6.0 million (-8.8) *
Profit after tax SEK -5.7 million (-7.3) *
Total profit SEK -6.7 million (-5.1)
Diluted earnings per share SEK -0.30 (-0.43) *
Cash and cash equivalents amounted to SEK 29.3 million (919.1)
Comparative figures for the sixth quarter refer to April 2019 – June 2019. Note that the rights issue of 150 million SEK was completed in January 2021, after the end of the reporting period

* All comparative figures refer to continuing operations

SIGNIFICANT EVENTS IN THE SIXTH QUARTER (OCT-DEC 2020)

Moberg Pharma announced its intention to submit a registration application for MOB-015 in Europe in 2021. With a normal processing time of about 1.5 years, approval is expected in early 2023 and launch in Europe by the end of 2023.
In November, the company’s Board of Directors resolved to carry out a fully guaranteed rights issue of approximately SEK 150 million for further financing of MOB-015. The rights issue was approved by the Extraordinary General Meeting in December and was fully subscribed without issue guarantees. The issue provided Moberg Pharma with proceeds of approximately SEK 150 million before transaction costs.
The BUPI project was placed in the subsidiary OncoZenge AB, which is now distributed to Moberg Pharma’s shareholders and, as planned, will be separately listed on Nasdaq First North Growth Market in February 2021. OncoZenge has implemented a directed share issue of SEK 10 million and received binding commitments for a fully guaranteed rights issue of approximately SEK 60 million. The investors, including John Fällström, Linc AB and Moberg Pharma’s largest shareholder, Östersjöstiftelsen, subscribed for shares in the directed issue, entered into subscription commitments and guarantee the remainder of the rights issue in OncoZenge.
SIGNIFICANT EVENTS AFTER THE END OF THE SIXTH QUARTER

OncoZenge was granted a new European patent for BUPI. The patent provides broad protection for sustained-release lozenges containing bupivacaine, for treatment or alleviation of pain in the oral cavity and is based on a previously granted patent that specifically protects the use of lozenges for treatment of pain due to oral mucositis in cancer patients.
February 5th was the record date for the Lex Asea distribution of OncoZenge shares. For every ten ordinary shares in Moberg Pharma on the record date of the distribution, shareholders are entitled to one share in OncoZenge
STATEMENTS FROM THE CEO

In December, a rights issue was fully subscribed which meant that no issue guarantees had to be used. The proceeds of SEK 150 million secure the financing for registration activities as well as clinical work for MOB-015. The path forward is clear, with submission of a registration application in Europe in the second half of 2021 as the next step. Concurrently, we are spinning off and separately listing the BUPI project through the subsidiary OncoZenge AB, with secured financing of SEK 70 million and a first day of trading on Nasdaq First North Growth Market on February 12.

Moberg Pharma’s primary asset is MOB-015, where preparations are underway for registration in Europe, based on two large Phase 3 studies totaling more than 800 patients. Since the primary endpoint was met in both the North American and European studies, both studies are expected to be used as a basis for product registration in Europe. Our plan is to submit a registration application in Europe in the second half of 2021, after which we expect the application to be approved within 18 months, indicating that MOB-015 could be launched in Europe by the end of 2023. For the U.S., we intend to discuss the next step in an advice meeting with the FDA after pre-submission meetings have been completed with regulatory authorities in the EU, with the assumption that an additional study may be needed for registration in the U.S.

For the commercialization of MOB-015, Moberg Pharma plans to drive the promotion of MOB-015 in the U.S. – the largest and most important market – to be able to share best practices with our partners. We know this market well after having taken Kerasal Nail from launch to a leading position with 30% market share in the U.S. We made Kerasal Nail available in more than 30,000 U.S. stores and achieved broad reach, thanks to effective consumer marketing and excellent partners in logistics and sales. With a prescription product we will focus on the largest segment, podiatrists, who fill approximately 40% of the prescriptions, and will collaborate with partners and distributors to reach dermatologists and general practitioners. Our experience of DTC marketing to U.S. consumers in the nail fungus category is a significant advantage.

Prior to year-end, the BUPI project was placed in the subsidiary OncoZenge AB with a separate listing on Nasdaq First North Growth Market planned in February. The spin-off into a separate company ensures focus and offers an opportunity to develop the product’s full potential and create significant value for our shareholders. OncoZenge completed a directed issue in December which secured the working capital requirement for 2021 and bolstered the shareholder base with respected shareholders, such as John Fällström and Linc AB. In addition, a new patent was recently granted which substantially broadens intellectual property rights for BUPI in Europe, where it protects the use of BUPI within all relevant indications for oral pain relief. The next step in the spin-off of OncoZenge is ongoing. Moberg Pharma’s shares in OncoZenge are distributed to Moberg Pharma’s shareholders according to Lex ASEA rules, where shareholders who owned shares on February 5 receive one share in OncoZenge for every ten ordinary shares they own in Moberg Pharma.

All in all, I am very satisfied that the financing has been secured for both companies and that spin-off of OncoZenge soon will be completed. Both teams are now well-positioned to fully focus on achieving our business goals.

On February 9, 2021 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported that the CanStem303C study evaluating the efficacy and safety of investigational agent napabucasin when given in combination with FOLFIRI with or without bevacizumab in patients with previously treated metastatic colorectal cancer failed to reach the primary endpoints of overall survival (OS) (Press release, Sumitomo Dainippon Pharma, FEB 9, 2021, View Source [SID1234574821]). Napabucasin in combination with FOLFIRI failed to show significant OS improvement in the general study population and in patients whose tumor was positive for the phosphorylated signal transducer and activator of transcription 3 (pSTAT3) biomarker.

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"Patients with metastatic colorectal cancer have a high unmet medical need, and our hope was to develop a new treatment option for this population. We are disappointed with the results of this Phase 3 trial and would like to express gratitude to the trial participants, investigators and staff for their efforts and contributions to the study," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "SDP Oncology is committed to continuing our pursuit of advancing our pipeline to bring forward innovative treatments for patients with cancer."

The multicenter, open-label, randomized Phase 3 CanStem303C study evaluated the efficacy and safety of napabucasin in approximately 1,250 patients with previously treated metastatic colorectal cancer. Patients were randomized 1:1 in the study. The study had two primary endpoints – overall survival in all randomized patients and overall survival in a subpopulation of patients whose tumor was positive for the pSTAT3 biomarker. Napabucasin at a dose of 240 mg was administered orally, twice daily in combination with FOLFIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab.

The most common adverse events, occurring in patients in the napabucasin combination arm, were consistent with previously published data and included diarrhea, nausea, vomiting and abdominal pain.

Final data and analyses of this study will be published for the oncology community.

About Napabucasin

Napabucasin is an investigational, orally administered reactive oxygen species (ROS) generator that is bioactivated by the intracellular antioxidant NAD(P)H:quinone oxidoreductase 1 (NQO1).1 Napabucasin exerts its antitumor activity by increasing levels of ROS beyond a cytotoxic threshold, causing cancer cell death.1,2

About Colorectal Cancer

Colorectal cancer is the third leading cause of cancer-related deaths in men and in women in the U.S. It is estimated that there will be 149,500 new cases of colorectal cancer and 52,980 deaths from colorectal cancer in the U.S. this year.3 Metastatic colorectal cancer occurs when cancer cells break way from a tumor in the colon or the rectum to other parts of the body through the bloodstream or lymphatic system.4 Approximately 22% of colorectal cancer cases are metastatic at initial diagnosis, and about 70% of patients will eventually develop metastatic relapse. Patients with metastatic colorectal cancer face poor prognosis in general, with a relative 5-year survival rate of 14%, compared to 71% and 90% in those with regional and localized colorectal cancer in the U.S.5

On February 9, 2021 Enveric Biosciences Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 3,007,026 shares of Enveric’s common stock, at a purchase price of $4.27 per share, in a registered direct offering (Press release, Enveric Biosciences, FEB 9, 2021, View Source [SID1234574820]). Enveric has also agreed to issue to the investors unregistered warrants to acquire 1,503,513 shares of Common Stock at $4.90 per share, exercisable immediately and terminating five years after the date of issuance. The closing of the offering is expected to occur on or about February 11, 2021, subject to the satisfaction of customary closing conditions. Following completion of the offering, the Enveric is expected to have 18,336,367 shares of common stock issued and outstanding.

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The gross proceeds to Enveric from this offering are expected to be approximately $12,840,000, before deducting advisory and other offering expenses. Enveric intends to use the net proceeds from this offering for working capital and general corporate purposes.

Palladium Capital Group, LLC acted as a financial advisor to the issuer.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Enveric pursuant to a "shelf" registration statement on Form S-3 (File No. 333-233260) previously filed with the Securities and Exchange Commission (the "SEC") on August 14, 2019, and declared effective by the SEC on November 19, 2019, and an additional registration statement on Form S-3 filed pursuant to Rule 462(b) relating to these securities became automatically effective upon filing. The offering of the securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source

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 shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock 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. Enveric has agreed to register the shares of common stock issuable upon exercise of the warrants for resale pursuant to a customary registration rights agreement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 9, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported that Revitope Oncology is extending its collaboration to develop a systems pharmacology model for Revitope’s dual antigen targeting TwoGATE platform for solid tumor indications (Press release, Applied BioMath, FEB 9, 2021, View Source [SID1234574819]). "Our previous collaborations with Applied BioMath proved extremely valuable as we leveraged their models to identify optimal therapeutic parameters in our development process," said Werner Meier, CSO of Revitope Oncology. "We look forward to extending our prior collaboration with this project to help accelerate our lead pipeline candidate towards the clinic." In this collaboration, Applied BioMath will develop a semi-mechanistic systems pharmacology model to aid in the prediction of a human efficacious dose.

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Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "We are very excited to assist Revitope as they advance their therapeutic," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "Systems pharmacology models are increasingly necessary given the complexity of modern therapeutics. We look forward to extending our collaboration with the Revitope Oncology team."