Olema Pharmaceuticals reported a net loss of $73.6 million for the three months ended Sep 30, 2026.
Olema Pharmaceuticals (OLMA) filed a 10-Q with the SEC on Nov 10, 2026, 7:11 am ET. Source: the filing on SEC EDGAR.
Quarterly report, 29 new risk factors
- Form
- 10-Q
- Filed
- Importance
- Notable
- Accession
- 0001193125-26-454421
- Net loss: $73.6 million for the three months ended Sep 30, 2026
- Diluted EPS: -$0.73 for the three months ended Sep 30, 2026
- Cash and equivalents: $47.52 million at Sep 30, 2026
Written from the 10-Q on EDGAR. AI can make mistakes. Check the filing.
Going-concern warning repeated
“As a result, these conditions raise substantial doubt about our ability to continue as a going concern over the long term.”
Also in the prior 10-Q (filed Aug 10, 2026). Prior report Prior on EDGAR
Quoted from the filing.
What changed since last quarter
29 new risk factors · 26 removed
Compared with the 10-Q for the period ended Jun 30, 2026.
| This filing | Previous | Change vs prior 10-Q | |
|---|---|---|---|
| Operating income and margin | −$77.53M | −$67.18M | −15% |
| Net income | −$73.6M | −$63.2M | −17% |
| Operating cash flow | −$47.11M | −$45.9M | −2.6% |
| Cash | $47.52M | $48.6M | −2.2% |
New risk factors (29)
- In connection with any future NDA submission for palazestrant, our third-party manufacturers and clinical trial sites will be subject to inspection for compliance with applicable laws and standards. If clinical data integrity is challenged or our manufacturers are found not to be in compliance, any NDA of ours under…
- A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular products and requiring substitutions of generic products and/or biosimilars. For example…
- If significant adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting patients to the clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our development efforts of that product candidate…
- Following a public consultation conducted in 2022, the United Kingdom enacted the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which came into force on April 28, 2026 following a 12-month implementation period. The amended regulations introduce a more streamlined and risk-proportionate…
- On December 11, 2025, the European Parliament and the Council reached a provisional political agreement on the Pharma Package, which comprises a new directive and regulation intended to replace significant portions of the existing EU pharmaceutical framework. The reform encompasses a broad range of measures…
- and 24 more in the filing
Removed risk factors (26)
- This lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in our failing to obtain regulatory approval to market palazestrant or OP-3136, which would significantly harm our business, financial condition, results of operations, and prospects.
- Following a public consultation that began in 2022, the United Kingdom government has enacted new legislation to overhaul the clinical trials regulatory framework. In April 2025, the UK adopted an amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 intended to support a more streamlined and…
- In addition, on December 11, 2025, the European Commission, the Parliament and the European Council reached a political agreement on a comprehensive overhaul of EU pharmaceutical legislation (the Pharma Package). The reform has been under negotiation since the European Commission submitted its proposal in April 2023…
- Additionally, the California Privacy Rights Act (CPRA) significantly modified the CCPA, including by expanding consumers' rights with respect to certain sensitive personal information. The CPRA also created a new state agency that will be vested with authority to implement and enforce the CCPA and the CPRA. In…
- In addition to the possibility of fines, lawsuits, regulatory investigations, public censure, other claims and penalties, and significant costs for remediation and damage to our reputation, we could be materially and adversely affected if legislation or regulations are expanded to require changes in our data… +1 more paragraph
- and 21 more in the filing