An In-Depth Investment Analysis of Olema Pharmaceuticals (NASDAQ: OLMA) - Pioneering a New Endocrine Backbone in Breast Cancer

I. Executive Summary

This report provides an exhaustive investment analysis of Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), a clinical-stage biopharmaceutical company focused on developing novel therapies for women's cancers. The central investment thesis for Olema is a high-risk, high-reward proposition predicated on the clinical and commercial success of its lead product candidate, palazestrant (OP-1250). Palazestrant is a potentially best-in-class, orally-available therapy for estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, the most prevalent subtype of the disease.

Palazestrant's potential is rooted in its differentiated dual mechanism of action as both a Complete Estrogen Receptor Antagonist (CERAN) and a Selective Estrogen Receptor Degrader (SERD). This dual action is designed to provide a more profound and durable blockade of the estrogen receptor signaling pathway, a key driver of tumor growth, thereby overcoming the resistance mechanisms that limit the efficacy of current standard-of-care endocrine therapies. Early-stage clinical data has been promising, demonstrating encouraging anti-tumor activity and a favorable safety profile, both as a monotherapy and in combination with CDK4/6 inhibitors, the current standard of care. This has supported the advancement of palazestrant into two pivotal Phase 3 trials: OPERA-01 in a later-line monotherapy setting and OPERA-02 in a first-line combination setting.

The market opportunity is substantial, with the global SERD therapeutics market projected to grow into a multi-billion dollar segment. Olema has also executed a savvy business development strategy, securing clinical trial collaborations with both Pfizer and Novartis, the two dominant players in the CDK4/6 inhibitor space. These partnerships provide external validation and strategically position palazestrant as a potential "partner of choice" for the entire drug class.

However, the investment is subject to formidable risks. The company's future is almost entirely dependent on the binary outcome of its ongoing clinical trials; a failure in the pivotal OPERA-01 study, with top-line data expected in the second half of 2026, would be catastrophic for the company's valuation. Olema faces intense competition from pharmaceutical giants such as AstraZeneca, Eli Lilly, and Roche, all of whom are developing their own next-generation oral endocrine therapies and possess vastly greater financial and commercial resources. Furthermore, as a pre-revenue company, Olema has a significant cash burn rate. While its financial runway appears sufficient to reach the next major clinical catalyst, any delays will necessitate future dilutive capital raises.

In conclusion, Olema Pharmaceuticals presents a compelling but speculative investment opportunity. The potential for palazestrant to become a new backbone of endocrine therapy in a major oncology market offers substantial upside. This potential is counterbalanced by the inherent and significant risks of clinical development, a highly competitive landscape, and financial dependency on capital markets. This investment is therefore suitable only for investors with a high tolerance for risk, a deep understanding of the biotechnology sector, and a long-term investment horizon aligned with the company's clinical development timelines.

II. Corporate Overview: A Focused Mission in Women's Oncology

Corporate Identity and Mission

Olema Pharmaceuticals, Inc., trading under the NASDAQ ticker OLMA, is a clinical-stage biopharmaceutical company with a dedicated mission to discover, develop, and commercialize targeted therapies for women's cancers, with a primary focus on breast cancer [1]. The company was founded in 2006 as CombiThera, Inc., changing its name to Olema Pharmaceuticals in March 2009, and it became a publicly traded entity following its Initial Public Offering (IPO) on November 19, 2020 [1]. Its stated corporate mission is to "elevate patient care in breast cancer and beyond," driven by a team that has been personally affected by the disease [4]. Olema is headquartered in San Francisco, California, and maintains operations in the key biotechnology hub of Cambridge, Massachusetts [6]. It is important for investors to distinguish this U.S.-based, publicly traded biopharmaceutical company from an unrelated and now-dissolved UK-based entity that shared a similar name but operated in disparate sectors such as agriculture and real estate [8].

Leadership and Expertise

The company's strategic direction is guided by a management team with deep experience in oncology and drug development. At the helm is President and Chief Executive Officer Sean P. Bohen, who holds both a Doctor of Medicine (M.D.) and a Doctor of Philosophy (Ph.D.) [1]. The presence of a chief executive with this dual qualification is a significant qualitative strength for a clinical-stage biotechnology firm. It suggests that pivotal corporate and clinical strategy decisions are grounded in a sophisticated understanding of both the fundamental tumor biology and the practical realities of clinical oncology. This integrated perspective can be instrumental in optimizing clinical trial design, interpreting complex data sets, and navigating the intricate regulatory landscape. The broader leadership team includes seasoned executives with specialized expertise in key functional areas, including operations, finance, clinical development, and legal affairs, which are all critical for advancing a product candidate from the laboratory to the market [1].

III. The Scientific Foundation: Re-engineering the Attack on Estrogen Receptor-Positive Breast Cancer

The Unmet Need and Limitations of Current Therapies

Estrogen receptor-positive (ER+), HER2-negative breast cancer is the most common subtype, accounting for a majority of diagnoses. Endocrine therapy, which targets the estrogen signaling pathway that fuels these tumors, is a cornerstone of treatment. However, the efficacy of current therapies is often limited by the eventual development of resistance, creating a significant unmet medical need for more durable and effective treatments [10].

The existing classes of endocrine therapy have well-documented limitations. Selective Estrogen Receptor Modulators (SERMs) like tamoxifen can exhibit partial agonist activity, meaning they can paradoxically stimulate ER signaling in certain contexts, leaving a vulnerability that cancer cells can exploit for growth [11]. Aromatase Inhibitors (AIs), which block the production of estrogen, are highly effective but place selective pressure on tumors, often leading to the emergence of resistance-conferring mutations in the estrogen receptor gene, known as ESR1 mutations [10]. The first-generation Selective Estrogen Receptor Degrader (SERD), fulvestrant, proved the therapeutic concept of degrading the estrogen receptor but is hampered by poor pharmacokinetic properties and a burdensome intramuscular injection route of administration, which has driven the search for a potent, convenient, and orally-available alternative [13].

Palazestrant (OP-1250): A Differentiated Dual Mechanism of Action

In response to these limitations, Olema has developed palazestrant (OP-1250), an orally-available small molecule engineered with a novel, dual mechanism of action. It functions as both a Complete Estrogen Receptor Antagonist (CERAN) and a Selective Estrogen Receptor Degrader (SERD) [6].

This dual activity is the core scientific differentiator. As a SERD, palazestrant targets the estrogen receptor for destruction. As a CERAN, it is designed to completely block both of the receptor's transcriptional activation function domains, AF1 and AF2 [10]. This is distinct from SERMs, which do not block AF1 activity. This complete antagonism is intended to fully shut down the ER signaling pathway, thereby driving deeper and more durable anti-tumor responses than currently available therapies [11]. Preclinical studies have validated this hypothesis, showing that palazestrant effectively blocks estrogen-induced transcriptional activity, has no partial agonist effects, and demonstrates potent activity against both the normal (wild-type) and mutated forms of the estrogen receptor [10].

The strategic importance of this complete antagonism cannot be overstated. Standard therapies like AIs and SERMs do not fully extinguish the ER signaling pathway. This incomplete blockade creates an evolutionary pressure that allows cancer cells to adapt and develop resistance, frequently through the acquisition of ESR1 mutations. Palazestrant's CERAN activity, by contrast, is designed to block the pathway completely, regardless of the presence of estrogen or common resistance mutations. This implies that, in addition to treating existing resistant tumors, palazestrant could theoretically prevent or significantly delay the emergence of resistance when used in earlier lines of therapy. This potential forms the basis of the long-term investment thesis: that palazestrant could ultimately displace AIs and become the new "backbone" endocrine therapy in the first-line treatment setting, a far larger market opportunity than later-line therapy [20].

IV. Clinical Development and Pipeline Analysis

Palazestrant: The Flagship Asset in Pivotal Trials

Olema's corporate value is overwhelmingly concentrated in its lead asset, palazestrant, which is being advanced through a comprehensive late-stage clinical program.

• OPERA-01 (Phase 3 Monotherapy): This is the company's first pivotal trial, evaluating palazestrant as a single agent for patients with 2/3L ER+/HER2- metastatic breast cancer. This patient population represents a significant unmet need, as these individuals have already progressed on prior endocrine therapy and a CDK4/6 inhibitor [6]. Following a dose-finding portion of the study, the company, in alignment with the U.S. Food and Drug Administration (FDA), selected a 90 mg once-daily dose to move forward [6]. Patient enrollment in this global trial is ongoing. The release of top-line data from OPERA-01 represents the single most significant, value-defining catalyst for the company and is anticipated in the second half of 2026 [6].
• OPERA-02 (Phase 3 Combination): This planned second pivotal trial will assess palazestrant in the frontline metastatic setting, in combination with Novartis's CDK4/6 inhibitor, ribociclib (Kisqali) [6]. This trial targets the largest commercial opportunity and is critical to establishing palazestrant as a potential new standard-of-care backbone therapy. The trial is on track to be initiated in the third quarter of 2025 [6].
• Regulatory Status: Underscoring the unmet need in the target population, the FDA has granted Fast Track designation to palazestrant for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy [6]. This designation is intended to facilitate development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

Analysis of Supporting Clinical Data (Phase 1b/2)

The decision to advance palazestrant into costly Phase 3 trials is supported by encouraging data from earlier-stage studies, particularly from the trial combining it with ribociclib.

• In updated results with a median follow-up of 12 months, the combination demonstrated promising clinical activity, with the median progression-free survival (PFS) — a key measure of efficacy — not yet having been reached [28].
• The 6-month PFS rate was 73% across all patients, a strong early signal of durable disease control [28].
• Crucially, the drug showed robust activity across key patient subgroups, which is vital for broad market adoption. The 6-month PFS rate was 81% in patients whose tumors harbored ESR1 mutations and 70% in patients with ESR1 wild-type tumors, suggesting efficacy both in tumors with and without this common resistance mechanism [28].
• The clinical benefit rate (CBR), a measure of patients achieving a response or stable disease for at least six months, was a high 76% [28].
• From a safety and tolerability perspective, the combination was well-tolerated. The safety profile was consistent with the known profiles of ribociclib and endocrine therapy, with no new or unexpected safety signals emerging [30]. Importantly, pharmacokinetic analysis showed no clinically meaningful drug-drug interaction between palazestrant and the CDK4/6 inhibitors ribociclib or palbociclib, which simplifies its potential use in combination regimens [25].

Beyond Palazestrant: The Emerging KAT6 Program (OP-3136)

While palazestrant is the primary value driver, Olema is also advancing a second, earlier-stage asset, OP-3136. This is a novel, orally-available small molecule inhibitor of lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast cancer and other solid tumors [1]. The Investigational New Drug (IND) application for OP-3136 was cleared by the FDA in December 2024, and the drug is currently enrolling patients in a Phase 1 clinical study [24]. Preclinical data has shown that OP-3136 has anti-proliferative activity and is synergistic with endocrine therapies, including palazestrant, and CDK4/6 inhibitors [27].

The development of OP-3136, while still in its nascent stages, is strategically significant. Currently, Olema's valuation is almost entirely dependent on the success of palazestrant, creating a high-stakes, binary risk profile centered on the OPERA-01 data readout. The advancement of OP-3136 represents the company's first step toward diversifying this risk. Its novel mechanism of action, targeting the epigenetic regulator KAT6, is completely distinct from ER antagonism, providing a separate and complementary approach to cancer therapy. The preclinical evidence of synergy with palazestrant hints at a potential long-term strategy of developing proprietary, wholly-owned combination therapies. Such combinations could create a more durable and defensible commercial franchise, potentially extending patent protection and creating layers of value beyond palazestrant as a monotherapy. While not a near-term value driver, the progress of OP-3136 is a critical indicator of the company's internal discovery capabilities and its potential to build a sustainable oncology pipeline for long-term investors.

V. Market Opportunity and Competitive Landscape

Market Sizing and Dynamics

The commercial opportunity for a successful oral SERD is substantial. The global market for SERD therapeutics was valued at approximately $1.5 billion in 2022 and is projected to experience robust growth. Forecasts vary, but market size estimates for the early 2030s range from $2.1 billion to $6.4 billion, implying compound annual growth rates (CAGRs) of between 4.8% and 17.5% [31]. This growth is fueled by the high and growing incidence of breast cancer worldwide and the pressing clinical need for more effective therapies to combat endocrine resistance. Specific forecasts for palazestrant project potential peak annual sales of $686 million by 2036, highlighting the significant revenue potential for a single successful agent in this class [35].

Competitive Intelligence: A Crowded Field of Titans

Palazestrant is not being developed in a vacuum. It is entering an intensely competitive therapeutic area populated by some of the world's largest and most well-resourced pharmaceutical companies. A clear understanding of this competitive landscape is essential for any investment decision. The first oral SERD, elacestrant (Orserdu) from Stemline Therapeutics, has already received FDA approval, setting a commercial and clinical benchmark. Several other companies have next-generation oral endocrine therapies in late-stage development.

Table 1: Competitive Landscape of Next-Generation Oral Endocrine Therapies

Strategic Collaborations: Validation and De-Risking

To navigate this challenging landscape, Olema has forged critical clinical trial collaborations with Pfizer and Novartis, the undisputed leaders in the CDK4/6 inhibitor market [22].

• The most recent agreement, announced on September 2, 2025, is with Pfizer to conduct a Phase 1b/2 study combining palazestrant with Pfizer's investigational selective CDK4 inhibitor, atirmociclib [6]. This is Olema's second collaboration with Pfizer; the first was established in November 2020 to evaluate palazestrant with palbociclib (Ibrance), the first-to-market CDK4/6 inhibitor [20].
• The collaboration with Novartis is foundational to the planned pivotal OPERA-02 trial, which will combine palazestrant with ribociclib (Kisqali), a drug that has shown an overall survival benefit in the first-line setting [24].

These collaborations are more than just clinical supply agreements; they represent a sophisticated business development strategy. By partnering with the makers of both Ibrance and Kisqali, Olema is strategically positioning palazestrant as a potential "partner of choice" for the entire CDK4/6 inhibitor class. This makes palazestrant agnostic to which CDK4/6 inhibitor a physician prefers, potentially broadening its market adoption upon approval. Furthermore, these partnerships provide significant external validation of palazestrant's scientific and clinical promise from two of the most respected companies in oncology. This de-risks the development path and could create a competitive dynamic between Pfizer and Novartis, both of whom now have a vested interest in the success of palazestrant, potentially sparking a future bidding war for the asset or an acquisition of Olema itself [44].

VI. Financial Health and Capital Structure

Balance Sheet and Cash Position

A rigorous assessment of a clinical-stage biotech's financial health is paramount. As of the end of the second quarter of 2025 (June 30, 2025), Olema Pharmaceuticals reported a strong balance sheet, with cash, cash equivalents, and marketable securities totaling $361.9 million [29]. The company's financial position was significantly bolstered by a successful $250 million equity private placement completed in late 2024, which attracted both new and existing institutional investors [24]. Olema carries minimal leverage, with total debt reported at only $4.76 million [44]. This strong cash position is reflected in its robust liquidity ratios, with a Quick Ratio of 11.00 and a Current Ratio of 11.09, indicating a substantial ability to meet short-term obligations [44].

Income Statement and Cash Burn

As is typical for a company at this stage of development, Olema does not generate any product revenue and operates at a net loss [9]. These losses are expected to continue and likely increase as its pivotal Phase 3 clinical trials progress.

• For the full fiscal year ended December 31, 2024, the company reported a net loss of $129.5 million, an increase from the $96.7 million net loss reported for 2023 [9].
• The primary driver of these expenses is research and development (R&D). GAAP R&D expenses rose to $124.5 million in 2024, compared to $86.1 million in 2023, reflecting the escalating costs of late-stage clinical trials for palazestrant and the advancement of the OP-3136 program [9].
• For the first quarter of 2025, the company reported a net loss of $30.4 million, which annualizes to approximately $121.6 million [47].

Financial Runway Analysis

Based on the June 30, 2025 cash position of $361.9 million and an anticipated annualized cash burn rate that will likely trend towards $140-$160 million as the two large Phase 3 trials run concurrently, Olema appears to have a cash runway sufficient to fund its operations into 2026. This timeline is critical, as it should allow the company to reach the pivotal top-line data readout from the OPERA-01 trial in the second half of 2026 without needing to raise additional capital under duress. However, this runway leaves little margin for significant delays or unforeseen expenses. This situation creates a "financing overhang" on the stock, as the market will anticipate an eventual need for a future, potentially dilutive, capital raise to fund commercial launch preparations or to bridge any gap should trial timelines be extended. Consequently, the company's ability to meticulously manage its burn rate and execute its clinical development plan on schedule is of paramount importance to shareholders.

VII. Valuation and Market Perspective

Current Market Valuation

As of early September 2025, Olema Pharmaceuticals' market capitalization has been volatile, fluctuating in a range of approximately $435 million to $570 million, reflecting the market's dynamic assessment of its clinical progress and the broader sentiment in the biotechnology sector [44].

Valuation Metrics

Standard valuation metrics that rely on earnings or sales are not applicable to Olema, as the company is pre-revenue and unprofitable [45]. Therefore, valuation must be assessed through other means, such as peer comparison on available metrics and analyst-derived price targets based on future discounted cash flow models.

• The Price-to-Book (P/B) ratio is one of the few relevant tangible metrics. Olema's P/B ratio stands at approximately 1.3x [45]. This is a key data point when compared to the broader biotechnology industry.

Table 2: Valuation Peer Comparison

The fact that Olema's P/B ratio is substantially lower than the biotechnology industry average is telling. It suggests that the market is assigning a relatively low value to the company's intangible assets—namely, its intellectual property portfolio and the future commercial potential of its clinical pipeline—compared to its peers. From one perspective, this could represent a significant value opportunity, where a successful clinical outcome for palazestrant could lead to a dramatic re-rating of the stock. From another, it reflects the market's heavy discounting of the substantial clinical, competitive, and financial risks that the company faces.

Analyst Consensus and Price Targets

In stark contrast to the market's cautious valuation, the Wall Street analyst community is overwhelmingly bullish on Olema's prospects.

• The consensus rating among covering analysts is a "Strong Buy", with multiple sources indicating that 100% of analysts have a "Buy" or "Strong Buy" recommendation [55].
• The average 12-month analyst price target is consistently cited in the range of $22 to $25, with the full range of targets spanning from a low of $18 to a high of over $30 [46].
• This consensus price target implies a potential upside of more than 300% from the stock's trading levels in late August and early September 2025 [56]. This significant divergence between the current market price and analyst targets is characteristic of high-risk, catalyst-driven biotechnology stocks, where the valuation is heavily skewed by the binary outcome of future clinical data.

VIII. Investment Thesis and Comprehensive Risk Assessment

The Bull Case (Arguments for Investment)

1. Differentiated Science: Palazestrant's unique dual CERAN/SERD mechanism provides a strong scientific rationale for its potential to overcome the key resistance pathways that limit current endocrine therapies, positioning it as a potential best-in-class agent.
2. Promising Early Data: The Phase 1b/2 clinical results, particularly in combination with ribociclib, have shown strong preliminary signals of efficacy (high clinical benefit rates and 6-month progression-free survival rates) and a clean safety and combinability profile, de-risking the move into pivotal trials.
3. Large Market Opportunity: The ER+/HER2- breast cancer market is a multi-billion dollar therapeutic area with a clear and persistent unmet need for better, more convenient, and more durable oral therapies.
4. External Validation from Industry Leaders: The clinical collaborations with both Pfizer and Novartis, the two undisputed leaders in the CDK4/6 inhibitor space, lend significant credibility to the palazestrant program and Olema's development strategy.
5. Favorable Valuation: The company's stock trades at a significant discount to its biotechnology peers on a price-to-book basis, suggesting that a positive clinical outcome could lead to substantial multiple expansion and share price appreciation.
6. Unanimous Analyst Support: The strong consensus "Buy" rating from all covering Wall Street analysts indicates a high degree of confidence within the expert financial community regarding the company's science, strategy, and long-term potential.

The Bear Case (Comprehensive Risk Factors)

An investment in Olema is accompanied by substantial risks that must be carefully considered. These risks are extensively detailed in the company's regulatory filings and are inherent to the nature of clinical-stage biotechnology investing [62].

1. Clinical and Regulatory Risk: This is the most significant and immediate risk. The company's future hinges on the binary outcome of its Phase 3 trials, particularly OPERA-01. A failure to meet the primary endpoint of progression-free survival would likely result in a catastrophic decline in the stock price. There is also the risk that unforeseen safety issues or adverse events could emerge in a larger patient population, jeopardizing regulatory approval [55].
2. Competitive Risk: Olema is a small-cap company competing directly against global pharmaceutical giants like AstraZeneca, Eli Lilly, and Roche. These competitors are also developing next-generation oral SERDs and possess vastly greater resources for R&D, manufacturing, marketing, and sales. A competitor could produce superior clinical data, reach the market faster, or use its commercial might to limit palazestrant's market share [41].
3. Financial Risk: Olema is not profitable and has a high and increasing cash burn rate to fund its expensive late-stage trials. While the current financial runway is projected to last until the next major data catalyst, any operational delays or unexpected costs could force the company to seek additional financing from a position of weakness. Such capital raises are almost certain to be dilutive to existing shareholders [55].
4. Commercialization Risk: Obtaining FDA approval is only one hurdle. Even if palazestrant is approved, Olema will face the immense challenge of commercialization. This includes establishing a manufacturing supply chain, building a sales and marketing infrastructure, and, most importantly, securing favorable pricing and reimbursement from third-party payors in a cost-conscious healthcare environment [62].
5. Single-Asset Dependency: The company's valuation is almost entirely tethered to the success of palazestrant. While the OP-3136 program offers a glimpse of pipeline diversification, its failure would not materially impact the company's near-term prospects. Conversely, the failure of palazestrant would have a disproportionately devastating impact on the company's viability [26].
6. Intellectual Property Risk: The company's success depends on its ability to obtain and defend its patent portfolio. These patents can be challenged in court or circumvented by competitors with novel chemical entities, and the process of enforcing intellectual property rights globally is complex and costly [62].

IX. Concluding Remarks and Outlook

An investment in Olema Pharmaceuticals is a high-conviction wager on a compelling scientific hypothesis: that the complete blockade of the estrogen receptor pathway via a dual-action CERAN/SERD will translate into superior clinical outcomes for patients with ER+/HER2- breast cancer. The potential reward for this wager is substantial, as reflected in the significant upside implied by consensus analyst price targets. A successful palazestrant could transform the treatment paradigm and generate hundreds of millions, if not billions, in revenue.

This potential, however, is inextricably linked to immense and unavoidable risks. The investment outcome is overwhelmingly dependent on the success of late-stage clinical trials, in a field where the historical probability of success is low. The competitive pressures are formidable, and the financial resources, while currently adequate, are finite.

Therefore, Olema Pharmaceuticals is a stock suitable only for investors with a high tolerance for risk, a long-term investment horizon, and a thorough understanding of the volatile nature of the biotechnology sector. The investment narrative will be defined by a series of key clinical and regulatory milestones.

Key Catalysts to Monitor:

• Near-Term (2025): The successful initiation of the pivotal Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in the frontline setting will be a key operational milestone [6]. The presentation of mature data from the ongoing Phase 1b/2 combination study with ribociclib will also be important for reinforcing confidence in the drug's profile [27].
• Long-Term (2026): The top-line data readout from the pivotal Phase 3 OPERA-01 monotherapy trial is the single most important, company-defining catalyst. This event, anticipated in the second half of 2026, will be the ultimate arbiter of palazestrant's efficacy in a registrational setting and will be the primary determinant of the company's future trajectory [6].

Ultimately, the investment case for Olema is a binary one, balanced on the knife's edge of clinical trial data. A positive outcome could unlock tremendous value, while a negative one would lead to significant capital loss.

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