On May 11, 2021 Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, reported the publication in Frontiers in Immunology of its positive long-term Overall Survival (OS) data from the Phase I trial evaluating the Company’s universal cancer vaccine, UV1, in combination with checkpoint inhibitor ipilimumab in patients with metastatic malignant melanoma (Press release, Ultimovacs, MAY 11, 2021, View Source [SID1234579716]). As published in the journal, in addition to the achievement of the primary endpoints of safety and tolerability, 50% of the patients were still alive at the data cut-off, supporting the combination of the Company’s proprietary UV1 vaccine with ipilimumab, a CTLA-4 checkpoint inhibitor and standard-of-care treatment, in this late-stage patient population.

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"Publishing our clinical trial data in such a prestigious peer-reviewed publication adds validation for UV1 as a promising therapeutic option for cancer patients. As we continue to evaluate UV1 in various combinations and indications, it is valuable to gain increased international recognition from the clinical community for this study," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "Historical data on the use of ipilimumab as monotherapy in malignant melanoma have shown a 5-year survival rate below 20%, therefore the results published today reinforce UV1’s potential in this indication."

The data published in Frontiers in Immunology covers 4.8 years of follow-up on the total of 12 metastatic malignant melanoma patients that were enrolled in the Phase I trial. As reported in the journal, the OS was 50% at 4.8 years, which was confirmed by the results of 5 years of follow-up announced by the Company in December 2020.

Building on these promising Phase I results, Ultimovacs is currently enrolling INITIUM, its Phase II clinical trial evaluating UV1 in combination with ipilimumab and nivolumab in patients with metastatic malignant melanoma. The company expects to announce data on the trial’s primary endpoint in 2H2022. In addition, Ultimovacs has an ongoing and fully-enrolled Phase I trial evaluating UV1 in combination with pembrolizumab, a PD-1 checkpoint inhibitor, as a first line treatment in metastatic malignant melanoma patients.

The publication in Frontiers in Immunology can be found under doi: 10.3389/fimmu.2021.663865.

About UV1

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as an "off-the-shelf" therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

About UV1 Clinical Programs

As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes four randomized, multinational, Phase II combination trials: INITIUM, NIPU, DOVACC and FOCUS, recruiting over 500 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. The DOVACC study is sponsored by the Nordic Society of Gynaecological Oncology. In total, 184 patients with high-grade ovarian cancer will be enrolled to evaluate UV1 in combination with durvalumab and olaparib, both provided by AstraZeneca. FOCUS is an investigator-sponsored, randomized clinical trial enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as standard of care, and will evaluate the impact of adding UV1 to this regimen. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2H2022 and for the DOVACC and FOCUS studies in 2023.

On May 11, 2021 Verastem, Inc. (Nasdaq: VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported financial results for the three months ended March 31, 2021, highlighted recent progress and outlined key corporate objectives (Press release, Verastem, MAY 11, 2021, View Source [SID1234579808]).

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"During the first quarter of 2021, we expanded the selection portion of the Phase 2 RAMP 201 study to include all recurrent low-grade serous ovarian cancer types. This decision was based on the positive updated data from the LGSOC cohort of the Phase 1/2 FRAME which continues to show strong response rates across both KRAS mutant and wild-type recurrent LGSOC, along with robust durability and a favorable tolerability profile," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "We closed the first quarter with just over $127 million in cash, cash equivalent and investments, leaving us well positioned to execute on our two ongoing Phase 2 studies evaluating VS-6766 and defactinib in LGSOC and KRAS G12V non-small cell lung cancer (NSCLC), as well as our other key corporate objectives."

Recent Corporate Highlights

LGSOC

Reported updated data from the LGSOC cohort of the ongoing, investigator-sponsored Phase 1/2 FRAME study evaluating VS-6766 in combination with defactinib in patients with recurrent LGSOC. Combination continues to demonstrate activity, durability and a favorable tolerability profile, including in patients who have progressed following treatment with a MEK inhibitor.

Overall response rate (ORR) across all patients was 52% (11 of 21 patients).

ORR for patients with KRAS mutant LGSOC was 70% (7 of 10 patients).

ORR for patients with wild type LGSOC was 44% (4 of 9 patients).

The most common side effects were Grade 1/2 rash, creatine kinase elevation, nausea, hyperbilirubinemia and diarrhea, which were reversible.
Company-sponsored, registration-directed Phase 2 study (RAMP 201) underway investigating VS-6766 alone and in combination with defactinib for the treatment of recurrent LGSOC. Study recently expanded to include both KRAS mutant and KRAS wild-type patients in the selection phase to determine the optimal go-forward regimen for both types of LGSOC.
KRAS G12V Mutant NSCLC

Company-sponsored, registration-directed Phase 2 study (RAMP 202) underway investigating VS-6766 alone and in combination with defactinib for the treatment of patients with KRAS G12V mutant NSCLC.
Upcoming Milestones and Key Priorities for 2021-2022

LGSOC

Updated data from Phase 1/2 FRAME study to be submitted for presentation at a major medical meeting during the second half of 2021.
Complete selection portion of RAMP 201 during first half of 2022; commence expansion portion.
G12V NSCLC

Complete selection portion of RAMP 202 during first half of 2022; commence expansion portion.
First Quarter 2021 Financial Results

Verastem Oncology ended the first quarter 2021 with cash, cash equivalents and investments of $127.1 million.

Total revenue for the three months ended March 31, 2021 (2021 Quarter) was $1.0 million, compared to $5.1 million for the three months ended March 31, 2020 (2020 Quarter).

Total operating expenses for the 2021 Quarter were $15.1 million, compared to $31.4 million for the 2020 Quarter.

Selling, general and administrative expenses for the 2021 Quarter were $6.2 million, compared to $19.6 million for the 2020 Quarter. The decrease of $13.4 million, or 68.4%, primarily resulted from the Company’s shift in strategic direction and COPIKTRA sale to Secura Bio, Inc., which led to lower employee related expenses and consulting and professional fees.

Research and development expense for the 2021 Quarter was $8.9 million, compared to $10.9 million for the 2020 Quarter. The decrease of $2.0 million, or 18.3%, was primarily related to the upfront non-refundable payment of $3.0 million to Chugai Pharmaceutical Co., Ltd for the VS-6766 license in the 2020 Quarter and decreased contract research organization costs, partially offset by increased drug substance and drug product costs and increased investigator sponsored trial expenses.

Net loss for the 2021 Quarter was $15.0 million, or $0.09 per share (basic and diluted), compared to $38.0 million, or $0.35 per share (basic and diluted), for the 2020 Quarter.

For the 2021 Quarter, non-GAAP adjusted net loss was $12.4 million, or $0.07 per share (diluted), compared to non-GAAP adjusted net loss of $21.3 million, or $0.20 per share (diluted), for the 2020 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

Financial Guidance and Outlook

With the proceeds from the sale of COPIKTRA, Verastem Oncology expects that it will have a cash runway until at least 2024 to deliver on the current programs for VS-6766 and defactinib, including clinical and regulatory milestones and development in LGSOC and KRAS mutant NSCLC. Verastem Oncology expects its 2021 annual operating expenses to be approximately $50 million.

Use of Non-GAAP Financial Measures

To supplement Verastem Oncology’s condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), the Company uses the following non-GAAP financial measures in this press release: non-GAAP adjusted net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with the Company’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to the Company’s operating performance and can enhance investors’ ability to identify operating trends in the Company’s business. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company’s operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three months ended March 31, 2021 and 2020 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.

About Defactinib

Defactinib (VS-6063) is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received Orphan Drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions has described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.1,2

About the VS-6766/Defactinib Combination

RAS mutant tumors are present in ~30% of all human cancers, have historically presented a difficult treatment challenge and are often associated with significantly worse prognosis. Challenges associated with identifying new treatment options for these types of cancers include resistance to single agents, identifying tolerable combination regimens with MEK inhibitors and new RAS inhibitors in development addressing only a minority of all RAS mutated cancers.

The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mt tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRAS mt NSCLC and colorectal cancer (CRC). The FRAME study was expanded to include new cohorts in pancreatic cancer, KRASmt endometrioid cancer and KRAS-G12V NSCLC. Verastem Oncology is also supporting an investigator-initiated Phase 2 trial evaluating VS-6766 with defactinib in patients with metastatic uveal melanoma.

Verastem Oncology has initiated Phase 2 registration-directed trials of VS-6766 with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS-G12V NSCLC as part of its RAMP (Raf And Mek Program).

On May 10, 2021 Genmab reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAY 10, 2021, View Source [SID1234579510]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from May 3, 2021 to May 7, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 236,006 shares as treasury shares, corresponding to 0.36% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On May 10, 2021 Codiak BioSciences, Inc. (Nasdaq: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, reported the appointment of Jennifer Wheler, M.D., an industry leader in targeted oncology and immunotherapy drug development, as Chief Medical Officer (Press release, Codiak Biosciences, MAY 10, 2021, View Source [SID1234579550]). Dr. Wheler, who joins the company’s Executive Leadership Team and reports to president and CEO Douglas Williams, Ph.D., will provide leadership and direction for Codiak’s pipeline of clinical development programs through early-stage trials to global regulatory submissions.

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Benny Sorensen, M.D., Ph.D., who has led the preclinical to clinical translational work and clinical strategy for Codiak for the past five years, advancing exoSTINGTM and exoIL-12TM through IND/CTA and into the current Phase 1 trials will become Senior Vice President, Strategic Projects. Dr. Sorensen will report to president and CEO Douglas Williams and continue as a member of Codiak’s Executive Leadership Team. He will help direct business development and other strategic external partnering projects and continue to provide support for the ongoing clinical trials.

"In the past year, our clinical team, led by Benny, has initiated two clinical programs and we expect to file an IND for a third program later this year, all of which are evaluating the potential for engineered exosomes to engage the immune system in novel ways to attack intractable cancers. With the anticipated advancement and intensified focus in oncology, we believe it is an ideal time for us to expand our team for the next phase of growth," said Dr. Williams. "As a clinical oncologist with many years of patient treatment and drug development experience, Jennifer knows this space incredibly well and will bring valuable leadership and deep domain expertise to the outstanding team that we already have in place."

Dr. Wheler brings more than 20 years of experience in industry and academic clinical research to Codiak, including a strong track record of successful early-stage oncology drug development. A board-certified oncologist, she served most recently as chief medical officer of Bicara Therapeutics, where she designed and led the first-in-human Phase I/II trial for the company’s bi-functional antibody candidate, including building the clinical trial infrastructure, clinical operations team and KOL network. Previously, Dr. Wheler led first-in-human studies for novel immuno-oncology assets at Novartis Institutes for BioMedical Research. From 2006 to 2015, she worked in the Department of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center where she served as Principal Investigator on more than 30 Phase 1 trials, including one of the first published trials of randomized data demonstrating benefit for treating patients with therapy matched to their tumor’s molecular profile. She is co-author on more than 145 peer-reviewed publications. Dr. Wheler completed fellowships in breast cancer medicine at Memorial Sloan Kettering Cancer Center and in oncology at Yale Cancer Center and her internal medicine residency at Columbia University Irving Medical Center and New York-Presbyterian Hospital. She received her A.B. from Princeton University and her M.D. from Weill Cornell Medical College in New York. With a background in the arts, Dr. Wheler also founded Collage, a nonprofit organization that brings personalized and innovative art programs to patients living with cancer.

"Codiak has a rich pipeline of first-in-class molecules that leverages a deep understanding of exosome biology and engineering. These exquisitely constructed molecules combine targeted and immunomodulatory approaches that have previously been elusive—the potential to impact the lives of patients with cancer and other diseases is immense," said Dr. Wheler. "As an oncologist who has spent much of my career investigating new drugs designed to improve outcomes for patients, I see this as an tremendous opportunity: the science is compelling, the early clinical data support the desired product profile and the team is superb. I am excited to lend my experience to help lead the current clinical programs and work to guide the next programs into the clinic."

"I’m excited to welcome Jennifer to Codiak," said Dr. Sorensen. "With two oncology-focused programs now in the clinic and a third on track for IND this year, her background and experience will be incredibly valuable as we continue to advance these candidates. I look forward to collaborating with her as Codiak remains focused on moving the exoSTING and exoIL-12 clinical trials toward expected data read-outs later this year and prepares for the planned exoASO-STAT6 IND submission."

On May 10, 2021 Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2021, which include (Press release, Omeros, MAY 10, 2021, View Source [SID1234579577]):

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OMIDRIA revenues for the first quarter of 2021 were $21.1 million compared to $10.6 million in the fourth quarter of 2020. The increase over the prior quarter reflects limited fourth-quarter sales due to delayed confirmation (issued in December) by the Centers for Medicare and Medicaid Services (CMS) that OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% receives separate payment when used in the ambulatory surgery center (ASC) setting.
Net loss in the first quarter of 2021 was $35.1 million, or $0.57 per share, including non-cash expenses of $4.1 million, or $0.07 per share. This compares to a net loss of $37.3 million, or $0.60 per share, which included non-cash expenses of $3.5 million, or $0.07 per share, for the previous quarter.
At March 31, 2021, Omeros had cash, cash equivalents and short-term investments available for operations of $100.5 million.
Dosing of patients with narsoplimab in the I-SPY COVID-19 platform trial began in March 2021. The platform trial, sponsored by Quantum Leap Healthcare Collaborative and partly funded by BARDA, is enrolling patients nationwide to evaluate potential therapies for the treatment of critically ill COVID-19 patients.
Omeros’ Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangipathy (HSCT-TMA or TA-TMA) is under priority review by the U.S. FDA with an action date of July 17, 2021 under the Prescription Drug User Fee Act (PDUFA).
In late April, the Centers for Disease Control and Prevention (CDC) and CMS approved a new ICD-10 diagnosis code for TA-TMA, creating a disease-specific code by which facilities will bill for services, and two new ICD-10 procedural codes that allow physicians to bill for the administration of narsoplimab.
"2021 is off to a strong start as we make great progress toward the anticipated launch of narsoplimab for TA-TMA while building momentum with our ophthalmic drug OMIDRIA following CMS’ confirmation of separate payment for OMIDRIA in the ASC setting," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "Narsoplimab dosing is well underway in the I-SPY COVID-19 platform trial, and the need for a therapeutic to treat critically ill COVID-19 patients is receiving increased focus from both U.S. and international agencies. Looking further across our franchise of complement inhibitors, two other narsoplimab Phase 3 programs are running in IgA nephropathy and aHUS, we expect initial data readout next month from the Phase 1 trial of our MASP-3 inhibitor OMS906, and our subcutaneously delivered long-acting MASP-2 inhibitor OMS1029 is slated to enter the clinic in the first half of next year. Our preclinical programs are also progressing, led by our efforts to deliver a GPR174 inhibitor to the clinic as quickly as possible. With the PDUFA date for narsoplimab in TA-TMA rapidly approaching, we remain committed to bringing a long line of important, first-in-class drugs to market."

First Quarter and Recent Developments

Recent developments regarding OMIDRIA include the following:
Omeros continued to add new ASC customers in the first quarter of 2021, including seven large ASC chains and private equity groups. The total number of purchasing ASCs increased by 43% in the first quarter over the previous quarter.
A manuscript on pain control and reduction of opioid use intraoperatively with the use of OMIDRIA during cataract surgery has been submitted for publication. Another manuscript on the perioperative use of opioids in cataract surgery pain management and the role of non-opioid alternatives like OMIDRIA has also been submitted for publication.
The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act has been re-introduced in the Senate. The NOPAIN Act would extend separate payment for non-opioid alternatives like OMIDRIA in both ASCs and hospital outpatient departments on a renewable five-year basis. Currently, OMIDRIA is separately paid in the ASC setting.
Recent developments regarding narsoplimab, Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in advanced clinical programs for the treatment of TA-TMA, immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS) and critically ill COVID-19 patients, include the following:
Data from the pivotal trial of narsoplimab in TA-TMA was featured in a podium presentation at the annual European Society for Blood and Marrow Transplantation (EBMT) meeting in March.
An abstract on narsoplimab treatment in adults with high-risk TA-TMA has also been accepted for oral presentation at the 2021 Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June.
Discussions with the U.S. and foreign governments regarding funding and manufacturing support for narsoplimab are ongoing.
Updates regarding Omeros’ other development programs and platforms include the following:
Omeros has completed all of the intravenous cohorts and the first subcutaneous dosing cohort in the single-ascending-dose study in its Phase 1 clinical trial evaluating OMS906, the company’s inhibitor of MASP-3, the key activator of the alternative pathway of complement. Initial data from the placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose trial are expected later this quarter.
A paper detailing the mechanism of action of PDE7 inhibition in nicotine addiction will soon be published in the peer-reviewed Journal of Neuroscience. Omeros has completed a successful Phase 1 trial with OMS527, its PDE7 inhibitor.
Financial Results

For the first quarter of 2021, OMIDRIA revenues were $21.1 million compared to $10.6 million for the fourth quarter of 2020. The uncertainty around OMIDRIA’s reimbursement status affected revenues in the fourth quarter and extending into early February 2021.

Total costs and expenses for the first quarter of 2021 were $51.7 million compared to $47.2 million for the first quarter of 2020. The increase was primarily due to research and development expenses related to narsoplimab manufacturing. Until approval for narsoplimab in TA-TMA is certain, manufacturing costs for narsoplimab are expensed as incurred instead of included as inventory.

For the three months ended March 31, 2021, Omeros reported a net loss of $35.1 million, or $0.57 per share, which included non-cash expenses of $4.1 million, or $0.07 per share. This compares to a net loss in the previous quarter of $37.3 million, or $0.60 per share, which included non-cash expenses of $3.5 million, or $0.07 per share.

As of March 31, 2021, the company had $100.5 million of cash, cash equivalents and short-term investments. The company also has a line of credit, which permits borrowing up to the lesser of 85 percent of eligible accounts receivable less certain reserves and $50.0 million.

On March 1, 2021, the company entered into an "at the market" sales agreement which allows the company to sell, from time to time, up to $150.0 million of its common stock.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 6999269. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 6999269.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at View Source