SEATTLE / Nov 09, 2023 / Business Wire / Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2023, which include:
“Having discontinued our Phase 3 ARTEMIS-IGAN trial, we are closely examining the data to learn what happened and why so that we can apply the findings to the design and conduct of future renal clinical studies across our complement franchise,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Our primary focus is achieving regulatory approval and commercialization for our MASP-2 inhibitor narsoplimab to treat TA-TMA patients and driving our MASP-3 inhibitor OMS906, believed to be the premier alternative pathway target and drug, into multiple Phase 3 programs and completing clinical development as quickly as possible. The upcoming presentations at ASH should help to focus others on the value of these programs – a TA-TMA approval will validate both narsoplimab and our other MASP-2 programs for which there are no predicates given Omeros’ broad patent position, while the multiple indications already validated by other alternative pathway inhibitors deliver a roadmap and are accretive to OMS906 and our MASP-3 platform. We expect that Omeros has the financial runway to capitalize on value-driving milestones for these programs, and we intend to extend that runway further through cost-containment measures and other means. Having secured substantial funding from NIDA for OMS527 and with the potential to lever a relatively small investment into a large value across our immuno-oncology platforms, our pipeline of clinical and earlier-stage assets remains robust with multiple opportunities to grow shareholder value.”
Third Quarter and Recent Clinical Developments
Financial Results
Net loss was $37.8 million in the quarter ended September 30, 2023, or $0.60 per share, compared to a net loss in the prior year quarter of $17.5 million, or $0.28 per share. The increase in the current year quarter net loss was primarily attributable to an incremental $18.9 million gain in discontinued operations in the prior year quarter due to remeasurement of the contract royalty asset. Excluding the incremental gain, net loss for the prior year quarter would have been $36.4 million. Net loss from continuing operations was $51.7 million in the current quarter compared to a net loss of $54.8 million in the prior year quarter. Cash burn for the quarter ending September 30, 2023 was $31.0 million.
For the nine months ended September 30, 2023, our net loss was $108.8 million, or $1.73 per share compared to $81.3 million, or $1.30 per share, in the prior year period. Net loss from continuing operations for the nine months ended September 30, 2023 was $135.6 million compared to a loss of $136.0 million in the prior year period.
For the third quarter of 2023, we earned OMIDRIA royalties of $10.0 million on Rayner Surgical’s U.S. net sales of $33.3 million. This compares to earned royalties of $16.5 million during the third quarter of the prior year on U.S. net sales of $33.0 million. The difference in earned royalties reflects the decrease from 50 percent to 30 percent in the base royalty rate applicable to U.S. net sales of OMIDRIA, which occurred in December 2022 upon achievement of the $200.0 million milestone payment event. The royalty rate applicable to any sales outside the U.S. remains unchanged at 15 percent. Royalties are recorded as a reduction of the OMIDRIA contract royalty asset on our balance sheet.
Total costs and expenses for the third quarter of 2023 were $48.2 million compared to $50.8 million for the third quarter of 2022. The decrease was primarily due to reduction in clinical trial costs. This reduction was partially offset by increases in selling, general and administrative expenses.
Interest expense during the third quarter of 2023 was $7.9 million compared to $4.9 million during the prior year quarter. The increase was due to interest on our OMIDRIA royalty obligation associated with the sale of a portion of our OMIDRIA royalty receivables, an arrangement which we entered into at the end of September 2022.
During the third quarter of 2023, we earned $4.4 million in interest and other income compared to $0.9 million in the prior year quarter. The increase was due to higher average balances available to invest and higher market interest rates in the current year quarter.
Net income from discontinued operations, net of tax, was $13.9 million, or $0.22 per share, in the third quarter of 2023 compared to $37.3 million, or $0.59 per share, in the third quarter of 2022. The decrease in the current year quarter was primarily attributable to an incremental $18.9 million gain in discontinued operations in the prior year quarter due to the remeasurement of the contract royalty asset.
As of September 30, 2023, we had $310.3 million of cash and short-term investments, all of which are held in our name, available for operations and debt service.
On November 15, 2023, the $95.0 million outstanding on the 2023 unsecured convertible senior notes will become due. We anticipate retiring the notes at maturity with available cash and investments.
Conference Call Details
Omeros’ management will host a conference call and webcast 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.
For online access to the live webcast of the conference call, go to Omeros’ website at https://investor.omeros.com/upcoming-events.
To access the live conference call via phone, participants must register at this link to receive a unique PIN. Once registered, you will have two options: (1) Dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the “Call Me” option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN.
A replay of the call will be made accessible online at https://investor.omeros.com/archived-events.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros’ long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1 multi-ascending-dose clinical trial. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing in clinical programs for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder and, in addition, is being developed as a therapeutic for other addictions as well as for a major complication of treatment for movement disorders. Omeros also is advancing a broad portfolio of novel immuno-oncology programs comprised of two cellular and three molecular platforms. For more information about Omeros and its programs, visit www.omeros.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including statements regarding the anticipated next steps in relation to the biologics license application for narsoplimab, the timing of regulatory events, the availability of clinical trial data, the prospects for obtaining FDA approval of narsoplimab in any indication, expectations regarding the initiation or continuation of clinical trials evaluating Omeros’ drug candidates and the anticipated availability of data therefrom, and expectations regarding the sufficiency of the Company’s capital resources to fund operations, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unanticipated or unexpected outcomes of regulatory processes in relevant jurisdictions, unproven preclinical and clinical development activities, the Company’s financial condition and results of operations, regulatory processes and oversight, challenges associated with manufacture or supply of our investigational or clinical products, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2023. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
OMEROS CORPORATION | ||||||||||||||||
|
| Three Months Ended |
| Nine Months Ended | ||||||||||||
|
| September 30, |
| September 30, | ||||||||||||
|
| 2023 |
| 2022 |
| 2023 |
| 2022 | ||||||||
|
| |
|
| |
|
| |
|
| |
| ||||
Costs and expenses: |
| |
|
|
|
|
|
| |
|
|
|
|
| ||
Research and development |
| $ | 31,731 |
|
| $ | 38,568 |
|
| $ | 85,980 |
|
| $ | 86,172 |
|
Selling, general and administrative |
|
| 16,422 |
|
|
| 12,198 |
|
|
| 38,785 |
|
|
| 37,079 |
|
Total costs and expenses |
|
| 48,153 |
|
|
| 50,766 |
|
|
| 124,765 |
|
|
| 123,251 |
|
Loss from operations |
|
| (48,153 | ) |
|
| (50,766 | ) |
|
| (124,765 | ) |
|
| (123,251 | ) |
Interest expense |
|
| (7,916 | ) |
|
| (4,932 | ) |
|
| (23,781 | ) |
|
| (14,799 | ) |
Interest and other income |
|
| 4,413 |
|
|
| 906 |
|
|
| 12,913 |
|
|
| 2,069 |
|
Net loss from continuing operations |
|
| (51,656 | ) |
|
| (54,792 | ) |
|
| (135,633 | ) |
|
| (135,981 | ) |
Net income from discontinued operations, net of tax |
|
| 13,906 |
|
|
| 37,336 |
|
|
| 26,888 |
|
|
| 54,665 |
|
Net loss |
| $ | (37,750 | ) |
| $ | (17,456 | ) |
| $ | (108,745 | ) |
| $ | (81,316 | ) |
|
| |
|
| |
|
| |
|
| |
| ||||
Basic and diluted net income (loss) per share: |
| |
|
| |
|
| |
|
| |
| ||||
Net loss from continuing operations |
| $ | (0.82 | ) |
| $ | (0.87 | ) |
| $ | (2.16 | ) |
| $ | (2.17 | ) |
Net income from discontinued operations |
|
| 0.22 |
|
|
| 0.59 |
|
|
| 0.43 |
|
|
| 0.87 |
|
Net loss |
| $ | (0.60 | ) |
| $ | (0.28 | ) |
| $ | (1.73 | ) |
| $ | (1.30 | ) |
|
| |
|
| |
|
| |
|
| |
| ||||
Weighted-average shares used to compute basic and diluted net income (loss) per share |
|
| 62,856,721 |
|
|
| 62,730,015 |
|
|
| 62,840,990 |
|
|
| 62,728,276 |
|
OMEROS CORPORATION | ||||||||
|
| September 30, |
| December 31, | ||||
|
| 2023 |
| 2022 | ||||
Assets |
| |
|
| |
| ||
Current assets: |
| |
|
| |
| ||
Cash and cash equivalents |
| $ | 30,640 |
|
| $ | 11,009 |
|
Short-term investments |
|
| 279,670 |
|
|
| 183,909 |
|
OMIDRIA contract royalty asset, short-term |
|
| 29,228 |
|
|
| 28,797 |
|
Receivables |
|
| 6,878 |
|
|
| 213,221 |
|
Prepaid expense and other assets |
|
| 4,922 |
|
|
| 6,300 |
|
Total current assets |
|
| 351,338 |
|
|
| 443,236 |
|
OMIDRIA contract royalty asset |
|
| 119,502 |
|
|
| 123,425 |
|
Right of use assets |
|
| 19,460 |
|
|
| 21,762 |
|
Property and equipment, net |
|
| 1,717 |
|
|
| 1,492 |
|
Restricted investments |
|
| 1,054 |
|
|
| 1,054 |
|
Total assets |
| $ | 493,071 |
|
| $ | 590,969 |
|
|
| |
|
| |
| ||
Liabilities and shareholders’ equity (deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
| $ | 5,866 |
|
| $ | 5,989 |
|
Accrued expenses |
|
| 34,859 |
|
|
| 30,551 |
|
Current portion of unsecured convertible senior notes, net |
|
| 94,909 |
|
|
| 94,381 |
|
Current portion of OMIDRIA royalty obligation |
|
| 6,654 |
|
|
| 1,152 |
|
Current portion of lease liabilities |
|
| 4,888 |
|
|
| 4,310 |
|
Total current liabilities |
|
| 147,176 |
|
|
| 136,383 |
|
Unsecured convertible senior notes, net |
|
| 221,828 |
|
|
| 220,906 |
|
OMIDRIA royalty obligation |
|
| 118,770 |
|
|
| 125,126 |
|
Lease liabilities, non-current |
|
| 19,249 |
|
|
| 22,426 |
|
Other accrued liabilities, non-current |
|
| — |
|
|
| 444 |
|
Shareholders’ equity (deficit): |
|
|
|
|
|
|
|
|
Common stock and additional paid-in capital |
|
| 730,510 |
|
|
| 721,401 |
|
Accumulated deficit |
|
| (744,462 | ) |
|
| (635,717 | ) |
Total shareholders’ equity (deficit) |
|
| (13,952 | ) |
|
| 85,684 |
|
Total liabilities and shareholders’ equity (deficit) |
| $ | 493,071 |
|
| $ | 590,969 |
|
Last Trade: | US$10.31 |
Daily Change: | 0.07 0.68 |
Daily Volume: | 2,418,216 |
Market Cap: | US$597.460M |
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