On March 30, 2021 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period and full year ended December 31, 2020 (Press release, Spectrum Pharmaceuticals, MAR 30, 2021, View Source [SID1234577350]).

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"The Fast Track designation for poziotinib is a significant achievement towards an expedited review," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "In addition, we are delighted that the FDA has scheduled the pre-approval inspection at the ROLONTIS manufacturing facility for May 2021. The company has made tremendous progress advancing our development programs and conducting our clinical trials, despite the challenges of the global pandemic. I am proud of our employees who demonstrated resiliency and creativity during these unprecedented times."

Pipeline Updates

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Poziotinib received Fast Track designation from the FDA for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 insertion mutations. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions and fill unmet medical needs.
Spectrum is preparing a new drug application (NDA) for poziotinib in the treatment of patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations after a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2020. Submission of the NDA based on the positive results of Cohort 2 from the ZENITH20 clinical trial is planned for later this year.
Preliminary safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial demonstrated improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also demonstrated improved anti-tumor activity with 8mg BID dosing. These results were presented at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 in early March. Spectrum will be presenting further data on BID dosing at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2021.
ROLONTIS (eflapegrastim), a novel long-acting G-CSF

The FDA’s pre-approval inspection of the ROLONTIS manufacturing facility has been scheduled for May 2021. In October 2020, the FDA deferred its action on the Biologics License Application (BLA) for ROLONTIS due to an inability to inspect the drug substance manufacturing facility, citing travel restrictions related to the COVID-19 pandemic.
IGN002, interferon/CD20 monoclonal antibody fusion protein

Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 has two sites open for enrollment in a Phase 1 study for treating relapsed or refractory non-Hodgkin’s lymphoma patients, including diffuse large B-cell lymphoma.
Three-Month Period Ended December 31, 2020 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $49.9 million, or $0.36 per basic and diluted share, in the three-month period ended December 31, 2020, compared to net loss of $40.2 million, or $0.36 per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $47.2 million in the quarter, as compared to $23.3 million in the same period in 2019. Selling, general and administrative expenses were $15.7 million in the quarter, compared to $15.1 million in the same period in 2019.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $28.9 million, or $0.20 per basic and diluted share, in the three-month period ended December 31, 2020, compared to non-GAAP net loss of $33.4 million, or $0.30 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $17.1 million, as compared to $22.4 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $12.3 million, as compared to $11.6 million in the same period in 2019.

Twelve-Month Period Ended December 31, 2020 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $171.3 million, or $1.38 per basic and diluted share, in the twelve-month period ended December 31, 2020, compared to net loss of $135.4 million, or $1.22 per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $109.4 million for the year, as compared to $79.3 million in the same period in 2019. Selling, general and administrative expenses were $60.4 million for the year, compared to $61.4 million in the same period in 2019.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $120.9 million, or $0.97 per basic and diluted share, in the twelve-month period ended December 31, 2020, compared to non-GAAP net loss of $111.9 million, or $1.01 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $75.6 million, as compared to $72.0 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $47.2 million, as compared to $45.5 million in the same period in 2019.

Cash Position and Guidance

Spectrum reported cash, cash equivalents, and marketable securities of approximately $180.0 million as of December 31, 2020, compared to $224 million at December 31, 2019.

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on March 30, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On March 30, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported that it had entered into a clinical collaboration agreement with Bristol-Myers Squibb Company (NYSE: BMY) to evaluate the combination of HUYABIO’s HBI-8000, an epigenetic immunomodifier, and Opdivo (nivolumab), a PD-1 blocking antibody (Press release, HUYA Bioscience, MAR 30, 2021, View Source [SID1234577349]). The Phase 3 trial is designed to evaluate the safety and efficacy of the combination in subjects with unresectable or metastatic melanoma not previously treated with anti-PD-1 therapy.

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"This Phase 3 trial follows our open label Phase 2 study which showed impressive clinical results for the combination of Opdivo and HBI-8000 to treat melanoma," said Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO. "HBI-8000 has been shown to enhance the efficacy of Opdivo through one of its mechanisms of action that controls acetylation and nuclear transportation of PD-L1."

HUYABIO will be the sponsor of the trial. Bristol Myers Squibb will provide Opdivo clinical drug supply for the study. Opdivo is a registered trademark of Bristol Myers Squibb.

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also has immunomodulatory impact by increasing the efficacy of checkpoint inhibitors in preclinical animal models. The Company recently reported results from its ongoing Phase 2 study for the nivolumab combination demonstrating an overall objective response rate above 70% with a disease control rate over 90% in a cohort of checkpoint naïve patients with melanoma.

On March 30, 2021 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent business developments (Press release, CorMedix, MAR 30, 2021, View Source [SID1234577348]).

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Recent Corporate Highlights:

CorMedix announced in early March 2021 that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath in its present form. FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility, and has requested a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from vials.
CorMedix continues to work closely with our third-party manufacturing facility and is planning for a meeting with the FDA in mid-April to obtain agreement on the adequacy of our proposed plans for resolution of the deficiencies.
CorMedix transitioned to Nasdaq in early February 2021, which has become the primary trading platform for biopharmaceutical peers and other growth companies.
CorMedix has strengthened its balance sheet via equity financing activity over the past year and early 2021.
CorMedix has been approved by the New Jersey Economic Development Authority (NJEDA) to transfer substantially all of the $1.3 million of its available tax benefits to an unrelated, profitable New Jersey corporation pursuant to the New Jersey Technology Business Tax Certificate Transfer (NOL) program for State Fiscal Year 2020, for approximately $1.3 million in net proceeds. Closing is anticipated in 2Q of 2021.
Khoso Baluch, CorMedix CEO commented, "While we were disappointed that the DefenCath NDA was not approved at its PDUFA date, we remain confident in our efforts to bring DefenCath to hemodialysis patients as an important novel antimicrobial catheter lock solution to reduce catheter related blood stream infections in patients receiving hemodialysis via central venous catheters. We believe we have the right team and resources to accomplish this as we advance DefenCath closer to regulatory approval."

4th Quarter 2020 Financial Highlights

For the fourth quarter of 2020, CorMedix recorded a net loss of $6.1 million, or $0.19 per share, compared with a net loss of $5.3 million, or $0.21 per share, in the fourth quarter of 2019, an increase in net loss of $0.8 million. The increase in net loss in the fourth quarter of 2020 compared with 2019 was primarily driven by increases in employee costs and market research costs. Operating expenses during the fourth quarter of 2020 were $6.1 million, compared with $5.4 million in the fourth quarter of 2019, an increase of approximately $0.7 million.

Full Year 2020 Financial Highlights

For the year ended December 31, 2020, CorMedix recorded a net loss of $22.0 million, or $0.77 per share, compared with a net loss during the year ended December 31, 2019 of $16.4 million before recognition of deemed dividends, or $0.68 per share, an increase in net loss of $5.6 million. The increase in net loss was driven primarily by increases in operating expenses.

Operating expenses during the year ended December 31, 2020 amounted to $27.3 million compared with $20.9 million during the comparable period in 2019, an increase of $6.4 million, or 30%, due to a 21% increase in R&D expense and 41% increase in SG&A expense.

Total cash on hand and short-term investments as of December 31, 2020 amounted to $46.3 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at year end plus the $41.5 million in net proceeds from ATM issuances since the beginning of 2021, it has sufficient resources to fund operations at least into the second half of 2022.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, March 30, 2021, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

On March 30, 2021 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC) (f/k/a Mateon Therapeutics, Inc.) reported that the Financial Industry Regulatory Authority ("FINRA") has confirmed the change in the Company’s name and approved the stock symbol trading on the OTC Markets (Press release, Mateon Therapeutics, MAR 30, 2021, View Source [SID1234577347]). Effective today, March 30, 2021, the ticker symbol is changed from "MATN" to "OTLC".

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On August 14, 2020, the Company filed a Current Report on Form 8-K, in which the Company reported a number of corporate actions approved by the shareholders of the Company on August 10, 2020, including the name change and symbol change. The Company formally changed its name to Oncotelic Therapeutics, Inc. with the State of Delaware in November 2020, as disclosed in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the Securities and Exchange Commission on November 16, 2020. A notice of corporate action was filed with FINRA, requesting confirmation of its name change and approval for the new ticker symbol. On March 29, 2021, the Company received FINRA’s approval on its notice of corporate action confirming the new company name and the change in the Company’s ticker symbol, effective March 30, 2021.

On March 30, 2021 Omega Therapeutics, Inc. ("Omega"), a development-stage biotechnology company leveraging its proprietary epigenomic programming platform to biologically engineer a new class of programmable epigenetic medicines, reported the closing of an upsized Series C financing of $126 million (Press release, Omega Therapeutics, MAR 30, 2021, View Source [SID1234577346]). Joining Flagship Pioneering, Omega’s institutional founder and principal backer, are leading life science investors including Invus, Fidelity Management & Research Company, funds and accounts managed by BlackRock, Cowen, Point72, Logos Capital, Mirae Asset Capital and other undisclosed new and returning institutional investors. With this financing, Omega has raised over $210 million since its founding in 2017.

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Proceeds from the financing will be used to support the advancement of Omega’s lead epigenomic controller candidate, OTX-2002, and to advance the next wave of novel pipeline therapeutics that it expects to be generated by the company’s proprietary Omega Epigenomic ProgrammingTM platform, with an initial focus in oncology, regenerative medicine, inflammation, autoimmune, metabolic and rare genetic diseases. The proceeds will also be used to continue developing the Omega Epigenomic Programming platform and build a manufacturing footprint.

"We are grateful to our new and existing investors for the commitment to our bold vision of creating the industry’s first fully programmable epigenetic medicines," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "This financing enables us to advance OTX-2002 through the required IND-enabling studies with the goal of filing an IND and entering the clinic thereafter. It also allows us to continue unlocking the potential of our Omega Epigenomic Programming platform where we expect to be unveiling several additional drug candidates addressing a wide range of high unmet need diseases during 2021."

"Omega is at a pivotal stage of its development, as it prepares to debut several new pipeline assets and advance each toward clinical trials. We look forward to partnering with our new and existing investors to build out a robust pipeline, bring exciting new medicines to patients in need, and significantly grow value for all of our stakeholders," commented Roger Sawhney, Chief Financial Officer of Omega Therapeutics.

"In a short three years since its founding, Omega has made significant progress by leveraging its deep expertise of nature’s universal operating system for gene control to power its Omega Epigenomic Programming platform," said Noubar Afeyan, Ph.D., Co-founder and Chairman of the Board for Omega Therapeutics and Chief Executive Officer of Flagship Pioneering. "We welcome this exceptional group of new investors as Omega continues to pioneer and works to establish a new class of transformative programmable medicines."

In January 2021, Omega unveiled OTX-2002, its first epigenomic controller development candidate and the industry’s first programmable epigenetic medicine. OTX-2002 is engineered to specifically control c-myc (MYC) oncogene expression. In preclinical models of hepatocellular carcinoma (HCC), OTX-2002 potently downregulated MYC expression, a result that has historically eluded many prior attempts and therapeutic approaches. The Company is currently advancing OTX-2002 into Investigational New Drug (IND)-enabling studies. Omega plans to nominate additional development candidates in 2021, with an initial focus on regenerative medicine, inflammatory diseases, acute respiratory distress syndrome (ARDS) associated with COVID-19, alopecia, neutrophilic dermatoses, non-small cell lung cancer (NSCLC) and an additional oncogene target.

About Omega Epigenomic Programming Platform and Omega Epigenomic Controllers

Omega Therapeutics leverages its pioneering Epigenomic Programming platform to identify novel targets, develop first-in-class programmable epigenetic medicines, and enable rational drug development and manufacturing. Omega examines Insulated Genomic Domains (IGDs), the three-dimensional architecture of the human genome and its accompanying regulators, and has identified and classified thousands of genomic "zip codes" across the ~15,000 IGDs as new drug targets. Omega’s new class of medicine, called Omega Epigenomic Controllers, modulate IGDs using therapeutics that can be programmed to precisely up or down regulate single or multi-gene expression with controlled durability. These epigenomic controllers intervene at the pre-transcriptional level and they function without altering the native human genetic code or nucleic acid sequences. Using a rational and robust target identification and validation process, enhanced by a strong computational and data driven foundation, Omega is able to efficiently design and optimize potential epigenomic controllers from its platform. This entirely new and breakthrough approach allows the Company’s product candidates to also drug previously ‘undruggable’ targets across a broad range of diseases.