Opus Genetics Announces Financial Results for Third Quarter 2024 and Provides Corporate Update
Opus Genetics reported Q3 2024 financial results following its October acquisition by Ocuphire Pharma. The combined company, now trading as IRD, has a pro forma cash balance of $37 million, expected to extend runway into 2026. Q3 revenue was $3.9 million, down from $11.9 million in Q3 2023. Net loss was $7.5 million ($0.29 per share) compared to net income of $5.6 million in Q3 2023. The company expects four clinical data readouts in 2025, including Phase 3 studies for Phentolamine Ophthalmic Solution and gene therapy trials.
Opus Genetics ha riportato i risultati finanziari del terzo trimestre 2024 dopo l'acquisizione avvenuta in ottobre da parte di Ocuphire Pharma. La nuova azienda, che ora opera come IRD, ha un saldo di cassa pro forma di 37 milioni di dollari, previsto per estendere la liquidità fino al 2026. I ricavi del terzo trimestre sono stati di 3,9 milioni di dollari, in calo rispetto agli 11,9 milioni del terzo trimestre 2023. La perdita netta è stata di 7,5 milioni di dollari (0,29 dollari per azione), rispetto a un utile netto di 5,6 milioni nel terzo trimestre 2023. L'azienda prevede quattro letture di dati clinici nel 2025, comprese le sperimentazioni di fase 3 per la Soluzione Oftalmica di Fentolamina e studi di terapia genica.
Opus Genetics informó los resultados financieros del tercer trimestre de 2024 tras su adquisición en octubre por Ocuphire Pharma. La empresa combinada, que ahora opera como IRD, tiene un saldo de caja pro forma de 37 millones de dólares, lo que se espera que extienda su liquidez hasta 2026. Los ingresos del tercer trimestre fueron de 3,9 millones de dólares, una disminución con respecto a los 11,9 millones del tercer trimestre de 2023. La pérdida neta fue de 7,5 millones de dólares (0,29 dólares por acción) en comparación con una ganancia neta de 5,6 millones de dólares en el tercer trimestre de 2023. La compañía espera cuatro lecturas de datos clínicos en 2025, incluyendo estudios de fase 3 para la Solución Oftálmica de Fentolamina y ensayos de terapia génica.
Opus Genetics는 Ocuphire Pharma에 의한 10월 인수 이후 2024년 3분기 재무 결과를 발표했습니다. 이제 IRD라는 이름으로 거래되는 통합 회사는 3,700만 달러의 준비 자금을 보유하고 있으며, 이는 2026년까지의 운영 자금을 연장할 것으로 예상됩니다. 3분기 수익은 390만 달러로, 2023년 3분기의 1,190만 달러에서 감소했습니다. 순손실은 750만 달러(주당 0.29 달러)로, 2023년 3분기 560만 달러의 순이익과 비교됩니다. 회사는 2025년에 Fentolamine 안약 및 유전자 치료 시험을 포함한 네 가지 임상 데이터 읽기를 기대하고 있습니다.
Opus Genetics a publié les résultats financiers du troisième trimestre 2024 suite à son acquisition par Ocuphire Pharma en octobre. La société fusionnée, qui opère désormais sous le nom de IRD, dispose d'un solde de trésorerie pro forma de 37 millions de dollars, prévu pour prolonger sa capacité financière jusqu'en 2026. Le chiffre d'affaires du troisième trimestre a atteint 3,9 millions de dollars, en baisse par rapport aux 11,9 millions de dollars du troisième trimestre 2023. La perte nette s'est élevée à 7,5 millions de dollars (0,29 dollar par action), contre un bénéfice net de 5,6 millions de dollars au troisième trimestre 2023. L'entreprise prévoit quatre publications de données cliniques en 2025, y compris des études de phase 3 pour la Solution Ophtalmique de Phentolamine et des essais de thérapie génique.
Opus Genetics hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht, nach der Übernahme durch Ocuphire Pharma im Oktober. Das fusionierte Unternehmen, das jetzt als IRD handelt, verfügt über einen pro forma Bargeldbestand von 37 Millionen Dollar, der voraussichtlich bis 2026 ausreicht. Die Einnahmen im dritten Quartal betrugen 3,9 Millionen Dollar, ein Rückgang von 11,9 Millionen Dollar im dritten Quartal 2023. Der Nettoverlust betrug 7,5 Millionen Dollar (0,29 Dollar pro Aktie), verglichen mit einem Nettoertrag von 5,6 Millionen Dollar im dritten Quartal 2023. Das Unternehmen erwartet vier klinische Datenveröffentlichungen im Jahr 2025, einschließlich Phase-3-Studien für die Phentolamin-Augentropfen und Gene-Therapie-Studien.
- Pro forma cash balance of $37 million extending runway into 2026
- Pipeline expansion with seven new gene therapy assets
- Positive six-month proof-of-concept data for OPGx-LCA5 gene therapy
- Four clinical data readouts expected in 2025
- Revenue decreased from $11.9M in Q3 2023 to $3.9M in Q3 2024
- Net loss of $7.5M in Q3 2024 vs net income of $5.6M in Q3 2023
- R&D expenses increased to $9.0M from $3.5M year-over-year
- G&A expenses increased to $2.9M from $2.1M year-over-year
Insights
The merger between Ocuphire and Opus Genetics marks a significant strategic shift, creating a specialized gene therapy company with
- Existing revenue from RYZUMVI royalties
- Four clinical readouts expected in 2025
- Potential future cashflow from Phentolamine Ophthalmic Solution
The clinical pipeline shows strong potential, particularly with OPGx-LCA5's early proof-of-concept data showing visual improvement in all three adult patients with late-stage disease. The upcoming pediatric trial expansion and OPGx-BEST1's development represent significant opportunities in the inherited retinal diseases space. The parallel development of Phentolamine Ophthalmic Solution 0.75% in two Phase 3 trials (LYNX-2 and VEGA-3) provides near-term catalysts. The partner-funded development model for Phentolamine reduces financial risk while maintaining upside potential through royalties and milestones.
In October, Ocuphire Pharma acquired Opus Genetics, creating a leading, clinical-stage company focused on the development of gene therapy treatments for rare inherited retinal diseases (IRDs)
The pro forma cash balance of the combined company was approximately
Four clinical data readouts expected in 2025
FARMINGTON HILLS, Mich., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmologic disorders, today announced financial results for the third quarter ended September 30, 2024 and provided a corporate update.
“In October 2024, we acquired Opus Genetics with the goal of creating a leading gene therapy franchise to treat inherited retinal diseases,” said George Magrath, M.D., now CEO of Opus Genetics. “The transaction expanded our pipeline substantially, adding compelling gene therapy assets. The most advanced of these new candidates, LCA5, has generated positive six-month proof-of-concept data in patients with advanced disease. A second candidate, OPGx-BEST1 targets one of the largest IRD populations, and we’re excited to begin dosing patients next year. We continue to develop Phentolamine Ophthalmic Solution
Corporate Updates
Acquisition of Opus Genetics
- On October 22, Ocuphire acquired Opus Genetics, Inc., a clinical-stage gene therapy company for inherited retinal diseases (IRDs), in an all-stock transaction. The merger creates a transformative biotech company committed to being a leader in the development of gene therapies for the treatment of IRDs. In connection with the merger, the combined company was renamed Opus Genetics, Inc., and began trading on Nasdaq under the ticker symbol “IRD,” effective as of October 24, 2024. As consideration for the Opus Acquisition, the Company issued 5,237,063 shares of its common stock and 14,145.374 shares of Series A Preferred Stock, each of which is convertible into 1,000 shares of common stock. As of November 7, 2024 there were 31,568,457 shares of the Company’s common stock outstanding. If the shares of Series A Preferred Stock were converted as of that date, there would be a total of 45,713,831 shares of common stock outstanding.
- As a combined company, we have an expanded pipeline that includes seven assets from our adeno-associated virus (AAV)-based gene therapy portfolio, each of them being developed for a specific IRD, as well as Phentolamine Ophthalmic Solution
0.75% , which is currently being evaluated in presbyopia and dim (mesopic) light vision disturbances (sometimes referred to as DLD) after keratorefractive surgery. - Our most advanced gene therapy candidate, OPGx-LCA5, is being developed to treat LCA5, an early-onset, severe hereditary retinal diseases. An open-label, dose-escalation Phase 1/2 clinical trial is ongoing. The trial has shown early clinical proof-of-concept, with new six-month data demonstrating visual improvement in three out of three adult patients participating in the trial, each of whom has late-stage disease. Enrollment of the first pediatric patients is expected in the first quarter of 2025, with the first data anticipated in the third quarter of 2025.
- OPGx-BEST1 is in development for Bestrophin1-associated retinal disease. IND-enabling studies with OPGx-BEST1 have generated compelling proof-of-concept efficacy data and exhibited favorable safety. We anticipate filing a Clinical Trial Authorization (CTA) application in Germany in 2025 for commencement of a Phase 1/2 clinical trial.
Phentolamine Ophthalmic Solution
- Enrollment is ongoing in the LYNX-2 Phase 3 registration study evaluating Phentolamine Ophthalmic Solution
0.75% for the treatment of dim light disturbances under mesopic (low) light conditions following keratorefractive surgery. Top-line data are expected in the first quarter of 2025. The LYNX-2 trial is being conducted under conditions of a Special Protocol Assessment (SPA) with the FDA. - The VEGA-3 Phase 3 trial evaluating Phentolamine Ophthalmic Solution
0.75% for the treatment of presbyopia is also enrolling patients. Top-line results are expected in the first half of 2025. - The Phentolamine Ophthalmic Solution
0.75% development portfolio is being funded by Ocuphire’s partner in both indications (presbyopia and dim light vision disturbances).
APX3330
- The Company intends to seek a strategic partner to advance further late-stage development of APX330, its novel, oral REF-1 inhibitor for diabetic retinopathy (DR), given the development timelines and capital requirements. In the meantime, discussions remain ongoing with the FDA regarding the SPA for a Phase 3 program in DR.
Financial Highlights for the Third Quarter Ended September 30, 2024
As of September 30, 2024, Ocuphire had cash and cash equivalents of
License and collaborations revenue was
Revenue for the three months ended September 30, 2024 also included an earned royalty payment in the amount of
General and administrative expenses for the three months ended September 30, 2024 were
Research and development expenses for the three months ended September 30, 2024 were
Net loss for the quarter ended September 30, 2024, was
For further details on our financial results, including results for the nine-month period ended September 30, 2024, please refer to our Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission.
About Opus Genetics
Opus Genetics is a clinical-stage ophthalmic biotechnology company developing gene therapies to treat patients with inherited retinal diseases (IRDs) and therapies to treat patients with other ophthalmologic disorders. The pipeline includes adeno-associated virus (AAV)-based gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa. The company’s most advanced gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial, with encouraging early data. BEST1 gene therapy is designed to address mutations in the BEST1 gene, which is associated with retinal degeneration; A Phase 1/2 study will be initiated in 2025. The pipeline also includes Phentolamine Ophthalmic Solution
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 expectations regarding our cash runway, data from and future enrollment for our clinical trials, our pipeline of additional indications, expectations of potential growth, and our expectations regarding integration following the acquisition of Opus Genetics, including with respect to the combination of their portfolio of clinical assets into our existing portfolio and our combined focus on gene therapy treatment.
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 Ocuphire’s Annual Report on Form 10-K. 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,” “aim,” “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 our 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 success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts;
- Regulatory requirements or developments;
- Changes to or unanticipated events in connection with clinical trial designs and regulatory pathways;
- Delays or difficulties in the enrollment of patients in clinical trials;
- Substantial competition and rapid technological change;
- Our development of sales and marketing infrastructure;
- Future revenue losses and profitability;
- Our relatively short operating history;
- Changes in capital resource requirements;
- Risks related to our inability to obtain sufficient additional capital to continue to advance our product candidates and our preclinical programs;
- Domestic and worldwide legislative, regulatory, political and economic developments;
- Employee misconduct;
- Reliance on third parties;
- Future, potential product liability and securities litigation;
- System failures, unplanned events, or cyber incidents;
- The substantial number of shares subject to potential issuance associated with our equity line of credit arrangement;
- Risks that our partnership or other licensing arrangements, may not facilitate the commercialization or market acceptance of our product candidates;
- Future fluctuations in the market price of our common stock;
- Our ability to realize the expected benefits of the acquisition of Opus Genetics;
- Our ability to execute clinical programs for gene therapies successfully and changes in expected commercial value we predict from the development of gene therapies;
- The success and timing of commercialization of any of our product candidates; and
- Obtaining and maintaining our intellectual property rights.
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 Securities and Exchange Commission 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. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contacts
| Corporate | Investor Relations |
| Nirav Jhaveri, MBA CFO ir@opusgtx.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 | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 36,632 | $ | 50,501 | ||||
| Accounts receivable | 1,857 | 926 | ||||||
| Contract assets and unbilled receivables | 1,468 | 1,407 | ||||||
| Prepaids and other assets | 429 | 1,099 | ||||||
| Short-term investments | 3 | 15 | ||||||
| Total current assets | 40,389 | 53,948 | ||||||
| Property and equipment, net | — | — | ||||||
| Total assets | $ | 40,389 | $ | 53,948 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 844 | $ | 2,153 | ||||
| Accrued expenses | 5,171 | 1,815 | ||||||
| Derivative liability | 74 | 74 | ||||||
| Total current liabilities | 6,089 | 4,042 | ||||||
| Total liabilities | 6,089 | 4,042 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value | — | — | ||||||
| Common stock, par value | 3 | 2 | ||||||
| Additional paid-in capital | 138,160 | 131,370 | ||||||
| Accumulated deficit | (103,863 | ) | (81,466 | ) | ||||
| Total stockholders’ equity | 34,300 | 49,906 | ||||||
| Total liabilities and stockholders’ equity | $ | 40,389 | $ | 53,948 | ||||
| Ocuphire Pharma, Inc. | ||||||||||||||||
| Condensed Statements of Comprehensive Loss | ||||||||||||||||
| (in thousands, except share and per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| License and collaborations revenue | $ | 3,867 | $ | 11,935 | $ | 6,690 | $ | 17,358 | ||||||||
| Operating expenses: | ||||||||||||||||
| General and administrative | 2,894 | 2,055 | 10,918 | 8,680 | ||||||||||||
| Research and development | 8,982 | 3,494 | 19,817 | 13,812 | ||||||||||||
| Total operating expenses | 11,876 | 5,549 | 30,735 | 22,492 | ||||||||||||
| (Loss) income from operations | (8,009 | ) | 6,386 | (24,045 | ) | (5,134 | ) | |||||||||
| Financing costs | — | (1,328 | ) | — | (1,328 | ) | ||||||||||
| Fair value change in derivative liability | — | 61 | — | 61 | ||||||||||||
| Other income, net | 483 | 456 | 1,648 | 1,224 | ||||||||||||
| (Loss) income before income taxes | (7,526 | ) | 5,575 | (22,397 | ) | (5,177 | ) | |||||||||
| Provision for income taxes | — | (14 | ) | — | (14 | ) | ||||||||||
| Net (loss) income | (7,526 | ) | 5,561 | (22,397 | ) | (5,191 | ) | |||||||||
| Other comprehensive (loss) income, net of tax | — | — | — | — | ||||||||||||
| Comprehensive (loss) income | $ | (7,526 | ) | $ | 5,561 | $ | (22,397 | ) | $ | (5,191 | ) | |||||
| Net (loss) income per share: | ||||||||||||||||
| Basic | $ | (0.29 | ) | $ | 0.26 | $ | (0.88 | ) | $ | (0.25 | ) | |||||
| Diluted | $ | (0.29 | ) | $ | 0.25 | $ | (0.88 | ) | $ | (0.25 | ) | |||||
| Number of shares used in per share calculations: | ||||||||||||||||
| Basic | 26,145,080 | 21,446,648 | 25,501,117 | 21,117,211 | ||||||||||||
| Diluted | 26,145,080 | 22,405,995 | 25,501,117 | 21,117,211 | ||||||||||||
FAQ
What was Opus Genetics (IRD) revenue in Q3 2024?
How much cash does Opus Genetics (IRD) have after the merger?
When will Opus Genetics (IRD) report its next clinical data?
