Loading...
Docoh

Olema Pharmaceuticals (OLMA)

Olema Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Its lead product candidate, OP-1250, is an oral therapy with combined activity as both a complete estrogen receptor (ER) antagonist, and a selective ER degrader (SERD). OP-1250, both as a monotherapy and in combination with inhibitors of cyclin-dependent kinase4 (CDK4)/6 demonstrated robust tumour shrinkage in several xenograft models, including a breast cancer brain metastasis model.

Company profile

OLMA stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

8 Aug 22
15 Aug 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 24.53M 24.53M 24.53M 24.53M 24.53M 24.53M
Cash burn (monthly) (no burn) 2.16M 11.1M 8.01M 8.82M 6.26M
Cash used (since last report) n/a 3.29M 16.91M 12.2M 13.44M 9.53M
Cash remaining n/a 21.24M 7.61M 12.32M 11.08M 14.99M
Runway (months of cash) n/a 9.8 0.7 1.5 1.3 2.4

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
17 Jun 22 Andrew Rappaport Stock Option Common Stock Grant Acquire A No No 3.61 21,520 77.69K 21,520
17 Jun 22 Gorjan Hrustanovic Stock Option Common Stock Grant Acquire A No No 3.61 21,520 77.69K 21,520
17 Jun 22 Graham G. Walmsley Stock Option Common Stock Grant Acquire A No No 3.61 21,520 77.69K 21,520
17 Jun 22 Butitta Cynthia M Stock Option Common Stock Grant Acquire A No No 3.61 21,520 77.69K 21,520
17 Jun 22 Ian T Clark Stock Option Common Stock Grant Acquire A No No 3.61 21,520 77.69K 21,520
13F holders Current Prev Q Change
Total holders 90 97 -7.2%
Opened positions 15 39 -61.5%
Closed positions 22 21 +4.8%
Increased positions 24 34 -29.4%
Reduced positions 33 13 +153.8%
13F shares Current Prev Q Change
Total value 219.14M 424.06M -48.3%
Total shares 42.8M 45.81M -6.6%
Total puts 82.5K 24.5K +236.7%
Total calls 42K 124.3K -66.2%
Total put/call ratio 2.0 0.2 +896.6%
Largest owners Shares Value Change
Biotechnology Value Fund L P 7.41M $64.85M 0.0%
BVF 7.41M $31.57M 0.0%
Logos Global Management 3.74M $15.95M 0.0%
JHG Janus Henderson 3.56M $15.15M +18.8%
BLK Blackrock 2.55M $10.87M +11.1%
Fairmount Funds Management 2.11M $12.39M NEW
Cormorant Asset Management 2.08M $8.87M -4.0%
Vivo Capital 1.69M $7.2M 0.0%
Vanguard 1.39M $5.91M -35.5%
Citadel Advisors 1.26M $5.37M -11.6%
Largest transactions Shares Bought/sold Change
Fairmount Funds Management 2.11M +2.11M NEW
Ra Capital Management 504.51K -1.65M -76.5%
Wellington Management 988.04K -1.03M -51.1%
VR Adviser 0 -816.65K EXIT
Vanguard 1.39M -761.86K -35.5%
JHG Janus Henderson 3.56M +561.99K +18.8%
FMR 108.65K -454.21K -80.7%
Norges Bank 0 -402.9K EXIT
Candriam Luxembourg S.C.A. 0 -332.57K EXIT
ArrowMark Colorado 200.3K -298.22K -59.8%

Financial report summary

?
Risks
  • We have never generated revenue from product sales and may never be profitable.
  • We are substantially dependent on the success of our only product candidate, OP-1250, which is currently in the early stages of clinical development. If we are unable to complete development of, obtain regulatory approval for and commercialize OP-1250 in one or more indications and in a timely manner, our business, financial condition, results of operations and prospects will be significantly harmed.
  • The regulatory approval processes of the FDA, EMA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for OP-1250 or any future product candidates we may develop, our business, financial condition, results of operations and prospects will be significantly harmed.
  • Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and jeopardize or delay our ability to obtain regulatory approval and commence product sales.
  • Because we are pursuing a variety of target indications for OP-1250, we may expend our limited resources to pursue a particular indication and fail to capitalize on indications or additional product candidates that may be more profitable or for which there is a greater likelihood of success.
  • Even if approved, OP-1250 may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
  • If we experience delays or difficulties in the enrollment and/or maintenance of patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • We intend to develop OP-1250, and may develop future product candidates, in combination with other therapies, which exposes us to additional risks.
  • The incidence and prevalence for target patient populations of OP-1250 are based on estimates and third-party sources. If the market opportunities for OP-1250, or any future product candidate we may develop, if and when approved, are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability might be materially and adversely affected.
  • Interim, initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than OP-1250, or product candidates we may develop in the future, our commercial opportunities will be negatively impacted.
  • Changes in methods of OP-1250 manufacturing or formulation may result in additional costs or delay.
  • Any product candidate we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
  • Guidelines and recommendations published by various organizations can reduce the use of OP-1250 or any future product candidates we may develop.
  • We may be unable to obtain U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize OP-1250 or any future product candidate we may develop.
  • The withdrawal of the United Kingdom from the European Union may adversely impact our ability to obtain regulatory approvals of our product candidates in the United Kingdom, result in restrictions in the importation of our product candidates between the United Kingdom and the European Union, and may require us to incur additional expenses to commercialize our product candidates in the United Kingdom and the European Union.
  • Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage, such inability could significantly harm our business, financial condition, results of operations and prospects.
  • OP-1250 and any future product candidates we develop may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could inhibit regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
  • The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • Obtaining and maintaining regulatory approval of OP-1250, or any product candidate we develop in the future, in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of OP-1250, or any product candidate we develop in the future, in other jurisdictions.
  • Even if OP-1250, or any product candidate we develop in the future, receives regulatory approval, it will be subject to significant post-marketing regulatory requirements and oversight.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • We may face difficulties from changes to current regulations and future legislation.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could significantly harm our business, financial condition, results of operations or prospects.
  • Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing.
  • Our business activities may be subject to the U.S. Foreign Corrupt Practices Act, or the FCPA, and similar anti- bribery and anti-corruption laws of other countries in which we operate, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • The COVID-19 pandemic could adversely impact our business, including our nonclinical studies and clinical trials.
  • Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
  • If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market OP-1250 or any product candidate we may develop in the future, we may not be able to successfully sell or market OP-1250 or any future product candidate we may develop that obtain regulatory approval.
  • We have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators.
  • In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Our internal computer systems, or those of any of our CROs, manufacturers, other contractors, consultants, collaborators, potential future collaborators, or other third parties (including service providers in our supply chain) may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
  • EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our product in the European member states.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • New or future changes to tax laws could materially adversely affect our company.
  • A variety of risks associated with marketing OP-1250 or any future product candidate we may develop internationally could significantly harm our business, financial condition, results of operations and prospects.
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Our commercial success depends significantly on our ability to operate without infringing, misappropriating or otherwise violating the patents and other proprietary rights of third parties. Claims by third parties that we infringe, misappropriate or otherwise violate their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • We may not be successful in obtaining or maintaining necessary rights from third parties for that we identify as necessary for OP-1250 through acquisitions and in-licenses.
  • We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
  • Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
  • Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications or those of our licensors and the enforcement or defense of our issued patents or those of our licensors.
  • Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect OP-1250 or any future product candidates we may develop.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on OP-1250 or any future product candidates we may develop for an adequate amount of time.
  • If we do not obtain patent term extension for OP-1250 or any future product candidates we may develop, our business, financial condition, results of operations and prospects may be significantly harmed.
  • We will not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment, and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business, financial condition, results of operations and prospects could be significantly harmed.
  • If we are unable to protect the confidentiality of our trade secrets, our business, financial condition, results of operations, prospects and competitive position would be significantly harmed.
  • We may be subject to claims that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets.
  • Our rights to develop and commercialize our technology and product candidate may be subject, in part, to the terms and conditions of licenses granted to us by others.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • We contract with third parties for the manufacture of OP-1250 for nonclinical studies and our ongoing clinical trials, and expect to continue to do so for additional clinical trials and ultimately for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of OP-1250 or other drugs necessary for the development or commercialization of OP-1250 or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • The manufacture of drugs is complex and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide adequate supply of OP-1250 for clinical trials or our product for patients, if approved, could be delayed or prevented.
  • We have engaged in and may in the future engage in additional acquisitions, strategic partnerships or in-licensing opportunities, that may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • We have entered into collaborations with third parties for the development and commercialization of OP-1250. If those collaborations are not successful, we may not be able to capitalize on the market potential of OP-1250.
  • If we decide to establish collaborations in the future, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • An active trading market for our common stock may not be sustained.
  • The price of our stock has been and may continue to be volatile, and you could lose all or part of your investment.
  • If securities or industry analysts do not publish research or reports, or if they publish adverse or misleading research or reports, regarding us, our business or our market, our stock price and trading volume could decline.
  • Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to OP-1250 or future product candidates we may develop on unfavorable terms to us.
  • Effective December 31, 2021, we are no longer an “emerging growth company,” and the reduced reporting requirements applicable to “emerging growth companies” no longer apply, which increases our costs as a result of being a public company and places additional demands on management.
  • The requirements of being a public company may strain our resources, result in more litigation and divert management’s attention.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • We may be subject to securities litigation, which is expensive and could divert management attention.
  • We do not currently intend to pay dividends on our common stock and, consequently, your ability to achieve a return on your investment will depend on appreciation of the value of our common stock.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Provisions in our amended and restated certificate of incorporation and amended and restated bylaws and Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
Management Discussion
  • Research and development expenses for the three months ended June 30, 2022 were $27.1 million, compared to $11.9 million for the three months ended June 30, 2021. The increase of $15.1 million was primarily due to increased spending in (i) advancing the clinical study for our lead product candidate OP-1250 and the associated contract manufacturing costs, (ii) other nonclinical research and discovery program costs, including the $8.0 million upfront payment in connection with the Aurigene Agreement, and (iii) personnel-related costs due to increased headcount, including non-cash stock-based compensation expenses increase of $0.9 million.
  • General and administrative expenses for the three months ended June 30, 2022 were $6.2 million compared to $4.6 million for the three months ended June 30, 2021. The increase of $1.6 million was primarily due to increased spending in (i) personnel-related expenses, which was partially offset by a non-cash stock-based compensation expenses decrease of $0.1 million, and (ii) public entity related costs, including legal compliance and other corporate costs.
  • Other income for the three months ended June 30, 2022 was $0.4 million, which primarily consisted of interest income from our marketable securities.

Content analysis

?
Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. senior Avg
New words: Aurigene, billing, Cambridge, CNS, Connecticut, dollar, Euro, frame, half, incorrectly, low, mg, molecule, preclinical, remeasured, Remeasurement, spot, sthe, thereunder, UCPA, undisclosed, upfront, Utah, VCDPA, VDCPA
Removed: CMO, commenced, epidemic, Refer, reluctance