when will iterum therapeutics start earning revenue with orlynvah

The deep research logic is organized as follows: 

Okay, let's tackle this question about when Iterum Therapeutics will start earning revenue with ORLYNVAH. The user is interested in penny stocks similar to Newegg, so I need to focus on the revenue potential and timeline for Iterum.

First, I'll check the references provided. The earnings release date is listed as August 5, 2025 . Then, there are multiple press releases about the FDA approval in October 2024 [^2, ^3, ^4, ^5, ^6, ^16, ^17]. The commercial launch was announced on August 20, 2025 [^2, ^5, ^6, ^17]. 

Looking at the financial results from Q2 2025 [^7, ^8, ^9, ^10, ^11, ^13, ^14], the company reported a net loss of $6.51 million for the quarter ending June 30, 2025. They mentioned preparing for the commercial launch in August 2025 and having a cash runway into 2026. The CEO, Corey Fishman, stated they were on track to launch ORLYNVAH that month [^7, ^13, ^14]. 

The user is asking when revenue will start. Since the launch was in August 2025, revenue should start flowing in Q3 2025. However, the Q2 earnings report doesn't mention any revenue yet, which makes sense because the product wasn't launched until the end of Q2. The next earnings report would be Q3 2025, but the user's current time is August 25, 2025, so the Q3 report isn't out yet. 

I should also consider the market context. Iterum is a penny stock with high risk, but the user is interested in such opportunities. The product launch is a significant milestone, but the company is still in a loss-making phase. The commercialization with EVERSANA [^7, ^13, ^14] and the copay savings program [^2, ^5] might help with market penetration. 

Potential risks include the company's cash position. As of June 30, 2025, they had $13 million in cash and raised $2.2 million through an ATM offering [^8, ^11]. They expect this to last into 2026, but if ORLYNVAH doesn't generate enough revenue quickly, they might need more funding. 

The user profile mentions interest in penny stocks like Newegg, which had a successful IPO. Iterum's situation is different since they're a biotech with a niche product. The revenue potential depends on market adoption of ORLYNVAH, which is the first oral penem antibiotic in the U.S. This could be a unique selling point, but the competition and market size need to be considered. 

In conclusion, Iterum started earning revenue with ORLYNVAH in August 2025, but the actual financial impact will be seen in the Q3 2025 earnings report. The company is still in a loss-making phase, and the success of the product launch will be crucial for their future viability.

### 🌟 **Conclusion**
**Iterum Therapeutics (ITRM)** began generating revenue with **ORLYNVAH** starting **August 20, 2025** , following its U.S. commercial launch. However, the company remains in a **loss-making phase** with a **cash runway extending into 2026** . The near-term focus is on **market penetration** and **commercialization** of this first-in-class oral penem antibiotic for uncomplicated urinary tract infections (uUTIs) .

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### 📊 **Analysis**

#### 1. **Revenue Timeline**
- **FDA Approval**: ORLYNVAH received FDA approval on **October 25, 2024** .
- **Commercial Launch**: The product officially launched on **August 20, 2025** , marking the start of revenue generation.
- **Market Penetration**: Iterum partnered with **EVERSANA** for commercialization and introduced a **copay savings program** to enhance patient access .

| Metric | Data |
|--------|-------|
| **Revenue Start Date** | August 20, 2025 |
| **Q2 2025 Net Loss** | $6.51M (pre-launch expenses) |
| **Cash Runway** | $13M (as of June 30, 2025) + $2.2M ATM offering |

#### 2. **Product Potential**
- **Target Market**: uUTIs in adult women with limited treatment options .
- **Market Size**: ~$40M annually .
- **Competitive Edge**: First oral penem antibiotic in the U.S. .

| Metric | Data |
|--------|-------|
| **FDA Designations** | QIDP (Qualified Infectious Disease Product) & Fast Track |
| **Clinical Trials** | Pivotal Phase 3 trials (SURE 1 & REASSURE) |
| **Patient Access** | Copay savings program ($25 max copay) |

#### 3. **Risks & Challenges**
- **Financial Sustainability**: Ongoing net losses and reliance on cash reserves .
- **Market Competition**: Established antibiotics like ciprofloxacin .
- **Regulatory Compliance**: Post-launch monitoring for safety and efficacy .

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### 📊 **Key Takeaways**
- **Revenue Start**: August 20, 2025 .
- **Break-even Risk**: High likelihood of continued losses in 2025-2026 .
- **Growth Catalyst**: Successful market adoption of ORLYNVAH in the underserved uUTI space .

Let me know if you’d like deeper insights into Iterum’s financials or market strategy! 🚀