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PhaseBio Pharmaceuticals (PHAS)

PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.

Company profile

Ticker
PHAS
Exchange
Website
CEO
Jonathan Mow
Employees
Incorporated
Location
Fiscal year end
Former names
DT BIOSCIENCES INC, Phase Biosciences Inc
SEC CIK
IRS number
30375697

PHAS stock data

Analyst ratings and price targets

Last 3 months

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

12 Aug 22
1 Oct 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 Dec 19 Dec 18
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) 7.8M 7.8M 7.8M 7.8M 7.8M 7.8M
Cash burn (monthly) 3.63M 4.72M 8.44M 9.88M 3.47M 4.95M
Cash used (since last report) 11.09M 14.44M 25.8M 30.22M 10.61M 15.14M
Cash remaining -3.29M -6.63M -18M -22.41M -2.81M -7.34M
Runway (months of cash) -0.9 -1.4 -2.1 -2.3 -0.8 -1.5

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
23 May 22 Glen Burkhardt Common Stock Sell Dispose S No Yes 0.79 11,248 8.89K 0
20 May 22 Jonathan Birchall Common Stock Grant Acquire A No No 0.6813 20,000 13.63K 20,000
20 May 22 John P Sharp Common Stock Grant Acquire A No No 0.6813 6,026 4.11K 65,767
20 May 22 Glen Burkhardt Common Stock Grant Acquire A No No 0.6813 11,248 7.66K 11,248
20 May 22 Kristopher Hanson Common Stock Grant Acquire A No No 0.6813 4,831 3.29K 8,463
20 May 22 Susan Elizabeth Arnold Common Stock Grant Acquire A No No 0.6813 10,917 7.44K 41,236
60.4% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 57 51 +11.8%
Opened positions 11 10 +10.0%
Closed positions 5 20 -75.0%
Increased positions 13 14 -7.1%
Reduced positions 17 16 +6.3%
13F shares Current Prev Q Change
Total value 40.82M 75.49M -45.9%
Total shares 30.1M 28.85M +4.4%
Total puts 0 35.5K EXIT
Total calls 86K 84.6K +1.7%
Total put/call ratio 0.4
Largest owners Shares Value Change
NEA Management 6.64M $8.77M -0.0%
Avidity Partners Management 4.41M $5.82M 0.0%
Ra Capital Management 2.85M $3.76M 0.0%
Rock Springs Capital Management 2.61M $3.45M +1.3%
Vanguard 1.83M $2.41M -0.5%
Wellington Management 1.67M $2.21M -41.6%
JNJ Johnson & Johnson 1.61M $2.12M 0.0%
MAI Capital Management 1.42M $1.87M NEW
Towercrest Capital Management 1.05M $1.39M NEW
Vericrest Private Wealth 1.05M $1.39M NEW
Largest transactions Shares Bought/sold Change
MAI Capital Management 1.42M +1.42M NEW
Wellington Management 1.67M -1.19M -41.6%
Towercrest Capital Management 1.05M +1.05M NEW
Vericrest Private Wealth 1.05M +1.05M NEW
ExodusPoint Capital Management 0 -394.21K EXIT
Susquehanna International 0 -273.1K EXIT
Spire Wealth Management 8K -245.72K -96.8%
Marshall Wace 221.48K -140.69K -38.8%
MS Morgan Stanley 140.87K -130.41K -48.1%
Endurant Capital Management 243.8K -116.28K -32.3%

Financial report summary

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Risks
  • We have no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • If we receive regulatory approval for bentracimab, or alternatively if the SFJ Agreement were to be terminated, we will be required to make substantial payments to SFJ pursuant to the SFJ Agreement. If we do not have sufficient funding or cash flow from our business to meet our payment obligations under the SFJ Agreement, SFJ could exercise its remedies as a holder of a first-priority security interest in our assets and our business could be materially harmed.
  • If Alfasigma does not satisfy its obligations under our agreement with them, or if they terminate our partnership with them, we may not be able to commercialize our partnered product candidate as planned and our expected revenue from this agreement could be materially affected.
  • Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises such as the COVID-19 pandemic, political crises, geopolitical events, such as the crisis in Ukraine, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance.
  • We currently have only one clinical-stage product candidate, bentracimab, a ticagrelor reversal agent. If we are unable to successfully develop, receive regulatory approval for and commercialize bentracimab, or successfully develop any other product candidates, or experience significant delays in doing so, our business will be harmed.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. If we are not able to obtain required regulatory approval for our product candidates, our business will be substantially harmed.
  • Based on feedback from the FDA, we intend to seek regulatory approval of bentracimab in the United States through an accelerated approval process. If we are not successful with this process, the development and commercialization of bentracimab could be delayed, abandoned or significantly more costly.
  • Clinical product development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs and experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials.
  • Interim “top-line” and preliminary results 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.
  • Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent or delay regulatory approval and commercialization, increase our costs or necessitate the abandonment or limitation of the development of some of our product candidates.
  • As an organization, we have never completed pivotal clinical trials, and we may be unable to do so for any product candidates we may develop.
  • If we experience delays or difficulties in the enrollment and/or maintenance of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Our clinical development of bentracimab depends on the continued use of ticagrelor as an antiplatelet therapy.
  • ELP is a novel technology, which makes it difficult to predict the time, risks and cost of development and of subsequently obtaining regulatory approval of our ELP product candidates.
  • Breakthrough Therapy designation by the FDA and PRIME designation by the EMA for bentracimab, or any other product candidate, may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that the product candidate will receive marketing approval.
  • We may not be successful in our efforts to increase our pipeline of product candidates, including by pursuing additional indications for our current product candidates or in-licensing or acquiring additional product candidates for other diseases.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • The United Kingdom’s withdrawal from the European Union may adversely impact our ability to obtain regulatory approvals of our product candidates in the United Kingdom, result in restrictions or imposition of taxes and duties for importing our product candidates into the United Kingdom, and may require us to incur additional expenses in order to develop, manufacture and commercialize our product candidates in the United Kingdom.
  • Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • If we are unable to establish sales, marketing and distribution capabilities for bentracimab, PB6440 or any other product candidate that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.
  • We face substantial competition, which may result in a smaller than expected commercial opportunity and/or others discovering, developing or commercializing products before or more successfully than we do.
  • The success of bentracimab as a ticagrelor reversal agent, PB6440 for treatment-resistant hypertension or any future product candidate will depend significantly on coverage and adequate reimbursement or the willingness of patients to pay for these procedures.
  • The market for bentracimab, PB6440 or any other product candidates may be smaller than we expect.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • We rely on third parties to conduct a significant portion of our existing clinical trials and potential future clinical trials for product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
  • We currently rely, and expect to continue to rely, on third parties for the cGMP manufacture of bentracimab, PB6440 and any other product candidates that we may pursue, for clinical development as well as for commercial manufacturing, if we receive marketing approval. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • We are collaborating with SFJ for the development of bentracimab and with Alfasigma for the commercialization of bentracimab in Europe and certain other geographic areas, and we may seek additional collaborations with third parties for the development or commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • We may seek to establish additional collaborations, and if we are unable to do so, we may have to alter our development and commercialization plans.
  • If we are unable to obtain or protect intellectual property rights related to any of our product candidates, we may not be able to compete effectively in our market.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time, and if we do not obtain protection under the Hatch-Waxman Amendments and similar non-United States legislation for extending the term of patents covering each of our product candidates, our business may be materially harmed.
  • If we fail to comply with our obligations in our current and future intellectual property licenses with third parties, including the SFJ Agreement and the Alfasigma Sublicense, we could lose rights that are important to our business.
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our future patents.
  • We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful.
  • We may be unsuccessful in licensing or acquiring intellectual property from third parties that may be required to develop and commercialize our product candidates.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain.
  • We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • We may be subject to claims challenging the inventorship or ownership of our future patents and other intellectual property.
  • Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • We may enjoy only limited geographical protection with respect to certain patents, and we may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Any trademarks we have obtained or may obtain may be infringed or otherwise violated, or successfully challenged, resulting in harm to our business.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Our relationships with customers, healthcare providers, physicians and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • We are, and may further become, subject to stringent and changing obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of collaborators, partners, customers or sales; and other adverse business consequences.
  • Even if we obtain regulatory approval for bentracimab, PB6440 or any future product candidates, they will remain subject to ongoing regulatory oversight.
  • Healthcare legislative or regulatory reform measures may have a negative impact on our business and results of operations.
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We expect to expand our clinical development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • The trading price of the shares of our common stock has and may be volatile, and purchasers of our common stock could incur substantial losses.
  • A significant portion of our total outstanding shares are available for immediate resale. This could cause the market price of our common stock to drop significantly, even if our business is doing well.
  • The issuance of additional stock in connection with financings, acquisitions, investments, our equity incentive plan or otherwise will dilute all other stockholders.
  • Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
  • Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.
  • We are an “emerging growth company” and a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to emerging growth companies and smaller reporting companies, our common stock may be less attractive to investors.
  • We have broad discretion in the use of our cash and cash equivalents.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.
  • 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 of America 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.
  • Our business activities will be subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery and anti-corruption laws.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
  • New or future changes to tax laws could materially adversely affect our company.
  • We might not be able to utilize a significant portion of our net operating loss carryforwards.
  • Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
  • We incur significant costs and demands upon management as a result of being a public company.
  • Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our cybersecurity.
Management Discussion
  • Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations.
  • The information in this discussion contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning our strategy, future operations, future financial position, future revenues, projected costs, prospects and plans and objectives of management. The words “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as required by law.
  • We are a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular diseases. Our lead product candidate, bentracimab (also known as PB2452), is a novel reversal agent for the antiplatelet drug ticagrelor. Bentracimab has been generally well tolerated in our completed trials, with no drug-related serious adverse events, or SAEs. In our completed Phase 2a and Phase 2b clinical trials of bentracimab, we observed immediate and complete reversal of ticagrelor’s antiplatelet activity within five minutes following initiation of infusion and sustained reversal for over 20 hours. We are currently conducting our pivotal Phase 3 REVERSE-IT trial of bentracimab in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure. In a prespecified interim analysis of 150 enrolled patients (142 of whom enrolled required urgent surgery or an invasive procedure and eight of whom enrolled with uncontrolled major or life-threatening bleeding), bentracimab achieved the primary endpoint of the trial by immediately and sustainably reversing the antiplatelet effects of ticagrelor. We are developing bentracimab pursuant to a co-development agreement, or the SFJ Agreement, with SFJ Pharmaceuticals X, Ltd., an SFJ Pharmaceuticals Group company, or SFJ. We are also developing our preclinical product candidate, PB6440, for treatment-resistant hypertension. Except for the rights that we granted to Alfasigma S.p.A., or Alfasigma, for bentracimab, we retain worldwide commercial rights to all of our product candidates.

Content analysis

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New words: bid, chain, Connecticut, coupled, delisted, deteriorate, energy, labor, macroeconomic, military, notifying, phishing, ransomware, regained, slowdown, stability, startup, unemployment, VCDPA, widespread
Removed: cure