Full Press Release Details
Ocuphire Pharma Announces Financial Results for First Quarter 2024 and Provides Corporate Update
FARMINGTON HILLS, Mich., May 10, 2024 (GLOBE NEWSWIRE) - Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on
developing small molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update.
"Ocuphire has made significant progress in 2024, with important developments for both APX3330 and RYZUMVI ," said George Magrath, M.D., M.B.A., M.S., CEO of Ocuphire.
"We have been engaged in productive dialogue with the U.S. Food and Drug Administration (FDA) with respect to our submitted Special Protocol Assessment (SPA) to formalize the protocol and statistical analysis plan for future Phase 2/3
registrational trials of APX3330 in diabetic retinopathy (DR). If APX3330 is approved, we believe it could be a promising oral treatment option for slowing disease progression in patients with non-proliferative DR who otherwise are monitored and
untreated until they progress to sight-threatening disease. The recent commercial launch of RYZUMVI by our partner Viatris, Inc. (Viatris) (NASDAQ: VTRS) was a major milestone, and an important validation of the clinical development work
conducted by the Ocuphire team over the past several years to advance this product and secure FDA approval. Viatris now has the opportunity to create further value as it pursues additional indications for phentolamine ophthalmic solution,
including the treatment of decreased low contrast visual acuity under low light conditions as well as presbyopia."
Clinical and Regulatory Updates
Phentolamine Ophthalmic Solution
Financial Highlights for the First Quarter Ended March 31, 2024
As of March 31, 2024, Ocuphire had cash and cash equivalents of $47.2 million. Based on current projections, management believes that the cash on hand will be
sufficient to fund operations into mid-2025.
License and collaborations revenue was $1.7 million for first quarter ending March 31, 2024 compared with $1.7 million in the first quarter of 2023. Revenue during both
quarterly periods was derived from the Viatris license agreement largely for the reimbursement of research and development services. During the first quarter of 2024 Ocuphire earned its first royalty payment in the amount of $3,000 stemming from
the sale of RYZUMVI by Viatris in late March 2024.
General and administrative expenses for the first quarter ended March 31, 2024 were $4.7 million, compared to $2.3
million for first quarter of 2023. The increase period over period was primarily attributable to increases in payroll related costs, stock-based compensation, professional services, corporate legal support, legal fees associated with intellectual
property, business development activities and general operating costs. General and administrative expenses included $0.8 million and $0.5 million in stock-based compensation expense during the quarters ended March 31, 2024 and 2023, respectively.
Research and development expenses for the first quarter ended March 31, 2024 were $4.7 million, compared to $5.6
million for the first quarter of 2023. The decrease was primarily attributable to lower clinical costs, lower regulatory costs, and lower manufacturing expenses. These were offset in part by increases in toxicology costs, payroll costs, and general consulting costs. Pursuant to the Viatris license agreement, Ocuphire's budgeted research and development expenses related to the development of PS Products have been fully reimbursed by Viatris to date. Research
and development expenses included $0.2 million and $0.3 million in stock-based compensation expense during the quarters ended March 31, 2024 and 2023, respectively.
Net loss for the quarter ended March 31, 2024 was $7.1 million (or $0.29 per basic and diluted share) as compared to a net loss of $5.8 million (or $0.28 per basic and
diluted share) for the first quarter of 2023.
For further details on Ocuphire's financial results, refer to the Company's Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission.
About Ocuphire Pharma
Ocuphire is a clinical-stage ophthalmic biopharmaceutical company focused on developing novel therapies for the treatment of retinal and refractive eye disorders.
Ocuphire's lead retinal product candidate, APX3330, is an oral small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein) for the treatment of
non-proliferative diabetic retinopathy (NPDR). Ref-1 is a regulator of the transcription factors HIF-1 and NF- B. Inhibiting REF-1 reduces
levels of vascular endothelial growth factor (VEGF) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet to be administered twice per day for the treatment of diabetic
retinopathy (DR). A Phase 2 study in subjects with DR and an End-of-Phase 2 meeting have been completed, and a SPA was submitted to the U.S. Food and Drug Administration (FDA) in February 2024 and active discussions continue with the agency.
In addition, Ocuphire has a partnership with Viatris to develop and commercialize PS, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil
size. PS was approved by the FDA for the treatment for pharmacologically-induced mydriasis under the brand name RYZUMVI in September 2023. PS is also in Phase 3 clinical development for the treatment of presbyopia and for the treatment of
decreased visual acuity under low light (mesopic) conditions after keratorefractive surgery.
Ocuphire is also developing APX2009 and APX2014, second-generation analogs of APX3330. These programs are being evaluated for treating other retinal diseases such as
age-related macular degeneration and geographic atrophy. For more information, please visit www.ocuphire.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning the research takeaways from the ZETA-1 trial, the efficacy of APX3330 in slowing the progression of diabetic retinopathy, the
safety and tolerability of APX3330, applications of PS in ophthalmology, the registration program for PS, the LYNX-2 Phase 3 registration study, the benefits, uses, and side effects of PS treatment, ongoing
discussions with the FDA regarding various of our drug products, continued drug development under our agreement with Viatris, and the sufficiency of cash on hand to meet future funding needs.
These forward-looking statements relate to us, our business prospects and our results of operations and are subject to certain risks and
uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such
differences include, but are not limited to, those described under the heading "Risk Factors" included in our Annual Report on Form 10-K and in subsequent filing with the U.S. Securities and Exchange Commission (SEC). Readers are cautioned not to
place undue reliance on these forward-looking statements, which speak only as of the date of this report. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake
no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise.
These forward-looking statements are based upon Ocuphire's current expectations and involve assumptions that may never materialize or may prove to be incorrect.
Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation:
The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. Readers
are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the SEC that advise interested parties of the risks and factors that may affect our business. All forward-looking
statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were
| Corporate | Investor Relations |
| Nirav Jhaveri, M.B.A. CFO ir@ocuphire.com | Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com |
Ocuphire Pharma, Inc.
Condensed Balance Sheets
(in thousands, except share amounts and par value)
| As of | ||||||||
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 47,161 | $ | 50,501 | ||||
| Accounts receivable | 1,924 | 926 | ||||||
| Contract assets and unbilled receivables | 1,194 | 1,407 | ||||||
| Prepaids and other assets | 1,560 | 1,099 | ||||||
| Short-term investments | 5 | 15 | ||||||
| Total current assets | 51,844 | 53,948 | ||||||
| Property and equipment, net | - | - | ||||||
| Total assets | $ | 51,844 | $ | 53,948 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,064 | $ | 2,153 | ||||
| Accrued expenses | 3,649 | 1,815 | ||||||
| Derivative liability | 74 | 74 | ||||||
| Total current liabilities | 5,787 | 4,042 | ||||||
| Total liabilities | 5,787 | 4,042 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, par value $0.0001; 10,000,000 shares authorized as of March 31, 2024 and December 31, 2023; no shares issued and outstanding at March 31, 2024 and December 31, 2023. | - | - | ||||||
| Common stock, par value $0.0001; 75,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 25,085,592 and 23,977,491 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively. | 3 | 2 | ||||||
| Additional paid-in capital | 134,626 | 131,370 | ||||||
| Accumulated deficit | (88,572 | ) | (81,466 | ) | ||||
| Total stockholders' equity | 46,057 | 49,906 | ||||||
| Total liabilities and stockholders' equity | $ | 51,844 | $ | 53,948 |
Ocuphire Pharma, Inc.
Condensed Statements of Comprehensive Loss
(in thousands, except share and per share amounts)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| License and collaborations revenue | $ | 1,711 | $ | 1,749 | ||||
| Operating expenses: | ||||||||
| General and administrative | 4,670 | 2,285 | ||||||
| Research and development | 4,749 | 5,595 | ||||||
| Total operating expenses | 9,419 | 7,880 | ||||||
| Loss from operations | (7,708 | ) | (6,131 | ) | ||||
| Fair value change in derivative liabilities | - | - | ||||||
| Other income, net | 602 | 340 | ||||||
| Loss before income taxes | (7,106 | ) | (5,791 | ) | ||||
| Benefit (provision) for income taxes | - | - | ||||||
| Net loss | (7,106 | ) | (5,791 | ) | ||||
| Other comprehensive loss, net of tax | - | - | ||||||
| Comprehensive loss | $ | (7,106 | ) | $ | (5,791 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.29 | ) | $ | (0.28 | ) | ||
| Number of shares used in per share calculations: | ||||||||
| Basic and diluted | 24,520,475 | 20,939,607 |