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facility, and has requested a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from vials.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.

On March 30, 2021 Pyxis Oncology ("Pyxis" or the "Company") reported the closing of a $152 million Series B financing, led by Arix Bioscience and co-led by RTW Investments, LP, with participation from additional new investors, including Perceptive Advisors, RA Capital Management, Pfizer Ventures, BVF Partners, L.P., Janus Henderson Investors, Cormorant Asset Management, HBM Healthcare Investments, funds managed by Tekla Capital Management LLC, Acuta Capital Partners, Ridgeback Capital Investments, Surveyor Capital (a Citadel company), Laurion Capital Management, Logos Capital, and LifeSci Venture Partners (Press release, Pyxis Oncology, MAR 30, 2021, View Source [SID1234577345]). This round brings Pyxis’ total funding to $174 million. The Longwood Fund-founded Company’s existing Series A investors including Leaps by Bayer, Longwood Fund, Agent Capital and Ipsen also participated in the offering.

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Pyxis will use the proceeds from the financing to advance its differentiated portfolio of ADCs, a growing class of therapies that deliver highly potent targeted treatments directly to cancer cells, including PYX-201 and PYX-203, both in-licensed from Pfizer, and PYX-202, recently in-licensed from LegoChem Biosciences. The Company will also continue advancing its I/O pipeline to pursue a broad range of therapeutic indications.

In conjunction with the Series B financing, Christian Schetter, Ph.D., Managing Director at Arix Bioscience, Gotham Makker, M.D., Head of Strategic Investments at RTW Investments, LP, and Chris O’Donnell, Partner at Pfizer Ventures, will join the Pyxis Board as Directors.

"We are grateful for the support of these highly sophisticated investors as we strive to improve the lives of patients with difficult-to-treat cancers by progressing a diverse portfolio of potentially groundbreaking ADCs and immunotherapies," said Lara Sullivan, M.D., Chief Executive Officer of Pyxis. "This financing strengthens our ability to build a differentiated portfolio of biologics and allows us to accelerate our efforts to advance multiple promising programs into Phase 1 clinical trials."

Christian Schetter, Ph.D., Managing Director of Arix Bioscience, added, "We are pleased to lead this funding round for Pyxis. Our investment reflects our enthusiasm for the strength of both the management team and the Company’s diverse pipeline of biologics, which have the potential to make a meaningful difference for patients. I/O and ADCs represent two of the most promising strategies for treating cancer and we look forward to supporting this team of industry veterans as they build on their history of advancing groundbreaking therapies for patients suffering from difficult-to-treat cancers."

Gotham Makker, M.D., Head of Strategic Investments at RTW Investments, LP, commented, "We are excited to co-lead this funding round. Under the leadership of its expert management team, the company has developed a robust strategy for growth through its multiple biologics platforms, programs and strategic partnerships. We believe that Pyxis will continue to execute its multi-asset multi-platform corporate strategy and quickly grow into an industry leader in oncology."

About PYX-201
PYX-201 is a first-in-class non-internalizing ADC that targets a tumor-restricted antigen that is overexpressed in several solid tumor types to selectively kill tumor cells while enhancing a robust anti-cancer immune response.

About PYX-202
PYX-202 targets a tumor cell surface antigen that is expressed in a range of solid tumors. PYX-202 is an ADC designed to reduce toxicity by using a highly stable linker and a well-understood cytotoxic agent.

About PYX-203
PYX-203 is an ADC that targets an antigen expressed in certain hematologic malignancies. PYX-203 utilizes a highly potent DNA-damaging agent designed to reduce the potential for development of drug resistance and disease relapse.

On March 30, 2021 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported financial results for the quarter and full year ended December 31, 2020 (Press release, Immatics, MAR 30, 2021, View Source [SID1234577334]).

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Harpreet Singh, Ph.D., CEO of Immatics commented, "The past year was exceptional for Immatics with the advancement of our pipeline programs, expansion of our leadership team and scientific advisory board and the completion of our listing on the Nasdaq. Building on this foundation, we have recently delivered encouraging data from three clinical TCR-T studies demonstrating first anti-tumor activity in heavily pre-treated solid cancer patients. This early data also constitutes a first clinical validation for our differentiated TCR therapeutics platform. We look forward to reporting further data from our Phase 1 ACTengine TCR-T trials as well as the progress in our TCR Bispecifics programs (TCER) in the latter part of this year."

Fourth Quarter 2020 and Subsequent Company Progress

Adoptive Cell Therapy Programs

·ACTengine IMA200 series – Immatics provided a clinical data update from three ongoing ACTengine Phase 1 trials for its engineered Adoptive Cell Therapy approach (also known as TCR-T) in March. The combined data readout during early phases of dose escalation for the ACTengine programs, IMA201, IMA202 and IMA203, indicated first anti-tumor activity with tumor shrinkage observed in 8 out of 10 patients including one unconfirmed partial response as of data cut-off. This was consistent with the observed robust engraftment, persistence and tumor infiltration of infused ACTengine T cells. Overall, all product candidates demonstrated a manageable safety and tolerability profile. An additional Phase 1a read-out for IMA201 and IMA203 and initial Phase 1b data for IMA202 from the dose expansion cohort is planned for H2 2021. Submission of a clinical trial application (CTA) for the fourth IMA200 series program, IMA204, remains anticipated for H2 2021. The company presented the first preclinical data for the program in September 2020, which is directed at a novel target, COL6A3 exon 6 that is expressed in the tumor stroma of a variety of solid cancers.

Immatics Press Release March 30, 2021 1 | 9

TCR Bispecifics Programs

·IMA401 – Immatics presented preclinical proof-of-concept data from its lead TCER program, IMA401, at the European Antibody Congress 2020 in November. IMA401 is an antibody-like, "off-the-shelf" biologic directed against a high-density peptide target derived from MAGEA4/8. Submission of a CTA for IMA401 remains on track by the end of 2021.

·IMA402 – Immatics plans to announce preclinical proof-of-concept data for its second TCER program, IMA402 in Q2 2021. GMP process development activities are targeted to begin at the same time to advance this program towards the Investigational New Drug (IND) stage and clinical development.

Corporate Developments

Scientific Advisory Board Update

·Immatics has established a new Scientific Advisory Board (SAB) comprised of several leaders and scientific pioneers in immuno-oncology, adoptive cell therapies, clinical oncology and cancer biology. The members of the new SAB include Gwendolyn Binder, Dirk Busch, Christoph Huber, Patrick Hwu, Roland Kontermann, Crystal Mackall, Hidde Ploegh, Hans-Georg Rammensee, and Cassian Yee. Patrick Hwu and Crystal Mackall will co-chair the SAB. Additional information about the members can be found on the Immatics website.

Amendment to Resale Registration Statement

·In connection with the filing of the Annual Report on Form 20-F, Immatics will file an amendment to its existing resale registration statement on Form F-1 to update certain information. This registration statement relates solely to the resale of shares by certain stockholders, and the filing of the amendment is not necessarily indicative of any sales by the holders of their shares. No shares will be issued or sold by Immatics pursuant to the registration statement.

Full Year 2020 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €232.0 million ($284.7 million1) as of December 31, 2020 compared to €119.4 million ($146.5 million1) as of December 31, 2019. The increase is mainly the result of the business combination with ARYA Sciences Acquisition Corporation completed in July 2020 (ARYA merger) and the concurrent PIPE Financing.

Immatics Press Release March 30, 2021 2 | 9

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €31.3 million ($38.4 million1) for the year ended December 31, 2020, compared to €18.4 million ($22.6 million1) for the year ended December 31, 2019.

Research and Development Expenses: R&D expenses were €67.1 million ($82.3 million1) for the year ended December 31, 2020, compared to €40.1 million ($49.2 million1) for the year ended December 31, 2019. The increase is mainly due to an increase in preclinical and clinical development expenses and an increase in share-based compensation (€14.5 million; $17.8 million1 for the year ended December 31, 2020 compared to €1.6 million; $1.9 million for the year ended December 31, 2019).

General and Administrative Expenses: G&A expenses were €34.2 million ($42.0 million1) for the year ended December 31, 2020, compared to €11.8 million ($14.5 million1) for the year ended December 31, 2019. The increase is mainly due to an increase in share-based compensation (€10.9 million; $13.4 million1 for the year ended December 31, 2020 compared to €0.5 million; $0.6 million for the year ended December 31, 2019) as well as one-time transaction costs of the NASDAQ listing in connection with the ARYA merger in July.

Net Loss: Net loss was €229.6 million ($281.7 million1) for the year ended December 31, 2020, compared to €32.5 million ($39.9 million1) for the year ended December 31, 2019, of which €152.8 million ($187.5 million1) resulted from a one-time, non-cash expense in connection with the ARYA merger. The main part of this €152.8 million ($187.5 million1) non-cash expense resulted from the share price increase between signing and closing of the ARYA merger.

Full financial statements can be found in the Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2020 (1 EUR = 1.2271 USD).

Upcoming Investor Conferences

·Kempen Life Science – April 28, 2021

·Bank of America Healthcare Conference – May 11-13, 2021

·Jefferies Virtual Healthcare Conference – June 1-3, 2021

To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.