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REPL Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of oncolytic immune-gene therapies for the treatment of cancer. Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. Replimune's Immulytic™ platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment across a broad range of cancers. Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action as well as in standalone indications.

Company profile

Ticker
REPL
Exchange
CEO
Robert Coffin
Employees
Incorporated
Location
Fiscal year end
SEC CIK
Subsidiaries
Replimune, Inc. • Replimune Limited • Replimune Securities Corporation • Replimune (Ireland) Limited ...

REPL stock data

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Calendar

6 Aug 21
27 Oct 21
31 Mar 22
Quarter (USD)
Jun 21 Mar 21 Dec 20 Sep 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Mar 21 Mar 20 Mar 19
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from Replimune earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 194.16M 194.16M 194.16M 194.16M 194.16M 194.16M
Cash burn (monthly) (positive/no burn) (positive/no burn) 9.13M 7.46M 6.1M 5.38M
Cash used (since last report) n/a n/a 35.85M 29.29M 23.98M 21.15M
Cash remaining n/a n/a 158.32M 164.87M 170.19M 173.02M
Runway (months of cash) n/a n/a 17.3 22.1 27.9 32.1

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
18 Oct 21 Love Colin Common Stock Sell Dispose S No Yes 29.58 12,711 375.99K 745,809
15 Oct 21 Love Colin Common Stock Sell Dispose S No Yes 30.31 15,089 457.35K 758,520
15 Oct 21 Love Colin Common Stock Sell Dispose S No Yes 31.16 2,200 68.55K 773,609
23 Sep 21 Omega Fund IV Common Stock Sell Dispose S No Yes 33.58 12,171 408.7K 4,896,074
17 Sep 21 Omega Fund IV Common Stock Sell Dispose S No Yes 33.71 15,465 521.33K 4,908,245
17 Sep 21 Omega Fund IV Common Stock Sell Dispose S No Yes 32.88 78,998 2.6M 4,923,710
16 Sep 21 Omega Fund IV Common Stock Sell Dispose S No Yes 32.55 5,537 180.23K 5,002,708
15 Sep 21 Love Colin Common Stock Sell Dispose S No Yes 31.23 30,000 936.9K 775,809
16 Aug 21 Love Colin Common Stock Sell Dispose S No Yes 29.27 2,700 79.03K 805,809
16 Aug 21 Love Colin Common Stock Sell Dispose S No Yes 30 27,300 819K 808,509

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

80.5% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 107 106 +0.9%
Opened positions 15 13 +15.4%
Closed positions 14 19 -26.3%
Increased positions 38 45 -15.6%
Reduced positions 38 32 +18.8%
13F shares
Current Prev Q Change
Total value 1.39B 1.34B +3.6%
Total shares 37.65M 37.61M +0.1%
Total puts 52.6K 106.9K -50.8%
Total calls 11.4K 0 NEW
Total put/call ratio 4.6 Infinity NaN%
Largest owners
Shares Value Change
TROW T. Rowe Price 5.07M $194.77M +64.7%
Omega Fund Management 5.01M $192.42M 0.0%
Redmile 4.19M $161.04M +1.8%
Atlas Venture Fund X 3.4M $72.55M 0.0%
BLK Blackrock 1.98M $76.14M -10.6%
STT State Street 1.68M $64.69M -10.2%
Ensign Peak Advisors 1.46M $56.23M +4.4%
Vanguard 1.43M $54.78M -7.4%
FMR 1.05M $40.5M -22.7%
Loomis Sayles & Co L P 992.59K $38.14M +27.7%
Largest transactions
Shares Bought/sold Change
TROW T. Rowe Price 5.07M +1.99M +64.7%
Corriente Advisors 449.88K -625.12K -58.2%
BVF 918.93K +457.5K +99.1%
Point72 Asset Management 161.3K -453.98K -73.8%
Wellington Management 366.5K +366.5K NEW
Citadel Advisors 391.48K -342.82K -46.7%
Candriam Luxembourg S.C.A. 485.99K +323.83K +199.7%
FMR 1.05M -310.17K -22.7%
Amundi Pioneer Asset Management 0 -280.01K EXIT
Amundi 273.7K +273.7K NEW

Financial report summary

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Risks
  • Risks related to product development
  • Our product candidates are in the early stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable. We have never generated any revenue from product sales and may never be profitable.
  • An underlying problem with our Immulytic platform would adversely affect our business and may require us to discontinue development of product candidates based on the same or similar therapeutic approaches.
  • We will not be able to commercialize our product candidates if our preclinical studies do not produce successful results and/or our clinical trials do not demonstrate the safety and efficacy of our product candidates.
  • We anticipate that our product candidates will be used in combination with third-party drugs, some of which are still in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs.
  • If we fail to develop additional product candidates, our commercial opportunity could be limited.
  • Risks related to regulatory approval
  • Even if our development efforts are successful, we may not obtain regulatory approval for any of our product candidates in the United States or other jurisdictions, which would prevent us from commercializing our product candidates. Even if we obtain regulatory approval for our product candidates, any such approval may be subject to limitations, including with respect to the approved indications or patient populations, which could impair our ability to successfully commercialize our product candidates.
  • The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates as expected, and our ability to generate revenue may be materially impaired.
  • The FDA or a comparable foreign regulatory authority may determine that our product candidates have undesirable side effects that could delay or prevent their regulatory approval or commercialization.
  • Changes in product candidate manufacturing or formulation may result in additional costs or delay.
  • Regulatory approval by the FDA or comparable foreign regulatory authorities is limited to those specific indications and conditions for which approval has been granted, and we may be subject to substantial fines, criminal penalties, injunctions, or other enforcement actions if we are determined to be promoting the use of our products for unapproved or “off label” uses, resulting in damage to our reputation and business.
  • Even if our product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense and limit how we manufacture and market our products.
  • Obtaining and maintaining marketing approval for our product candidates in one jurisdiction would not mean that we will be successful in obtaining marketing approval of that product candidate in other jurisdictions, which could prevent us from marketing our products internationally.
  • Risks related to commercialization
  • If we are unable to successfully commercialize any product candidate for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed.
  • We face significant competition from other biopharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. If their product candidates are shown to be safer or more effective than ours, our commercial opportunity may be reduced or eliminated.
  • If we are unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market and sell our product candidates, if they are approved, the revenues that we generate may be limited and we may never become profitable.
  • Our product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development.
  • If our product candidates do not achieve broad market acceptance, the revenues that we generate from their sales may be limited, and we may never become profitable.
  • The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates.
  • Negative developments in the field of immuno-oncology could damage public perception of our product candidates and negatively affect our business.
  • Risks related to our financial position and need for additional capital
  • We are a clinical stage biopharmaceutical company with a very limited operating history. We have incurred net losses since our inception and anticipate that we will continue to incur substantial and increasing net losses in the foreseeable future. We may never achieve or sustain profitability.
  • We have never generated any revenue from product sales, and our ability to generate revenue from product sales and become profitable will depend significantly on our success in achieving a number of goals.
  • We will require additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
  • Risks related to intellectual property
  • If we are unable to obtain, maintain and protect our intellectual property rights for our technology and product candidates, or if our intellectual property rights are inadequate, our competitive position could be harmed.
  • Third parties may in the future initiate legal proceedings alleging that we are infringing their intellectual property rights, and we may become involved in lawsuits or other administrative procedures to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful and have a material adverse effect on the success of our business.
  • Risks related to manufacturing and our reliance on third parties
  • We have agreements with BMS and Regeneron, and in the future may have agreements with other companies, to obtain the supply of anti-PD-1 therapies for the development of our product candidates. If our relationships with BMS, Regeneron, or
  • any future collaborator or supplier are not successful, we may be delayed in completing the development of our product candidates.
  • Our collaboration agreements with any future partners may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
  • We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials. If those third parties do not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with regulatory requirements, we may be unable to obtain regulatory approval for our product candidates or any other product candidates that we may develop in the future.
  • If the manufacturers upon which we rely fail to produce our product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to biopharmaceutical manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates and may lose potential revenues.
  • The transition of our manufacturing operations to our new facility may result in further delays or expenses, and we may not experience the anticipated operating efficiencies.
  • Risks related to legal and compliance matters
  • We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and have to limit the commercialization of any approved products and/or our product candidates.
  • We are subject to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and other anticorruption laws, as well as import and export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, financial condition, results of operations, stock price and prospects.
  • If we fail to comply with federal and state healthcare laws, including fraud and abuse and health and other information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, stock price and prospects will be materially harmed.
  • We are subject to new legislation, regulatory proposals and healthcare payor initiatives that may increase our costs of compliance, and adversely affect our ability to market our products, obtain collaborators, and raise capital.
  • Our employees, independent contractors, consultants, commercial partners, principal investigators, CMOs, or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
  • Violations of or liabilities under environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material adverse effect on the success of our business.
  • Our internal computer systems, or those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our development programs.
  • Risks related to our operations
  • Our financial condition and results of operations could be adversely affected by the coronavirus disease-2019, or COVID-19, outbreak.
  • We will need to expand the size of our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
  • We are highly dependent on our key personnel, including Philip Astley-Sparke, our Chief Executive Officer; Robert Coffin, Ph.D., our President and Chief Research & Development Officer; and Colin Love, Ph.D., our Chief Operating Officer. If we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • If we fail to establish and maintain proper and effective internal control over financial reporting our ability to produce accurate and timely financial statements could be impaired.
  • Risks related to our common stock and general risks
  • An active trading market for our common stock may not be sustained.
  • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
  • We have broad discretion in how we use our cash, cash equivalents and investments, and may not use these resources effectively, which could affect our results of operations and cause our stock price to decline.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • Our executive officers, directors, and stockholders and their affiliates who beneficially own more than 5% of our common stock exercise significant influence over our company, which limits your ability to influence corporate matters and could delay or prevent a change in corporate control.
  • Conflicts of interest may arise because some members of our board of directors are representatives of our principal stockholders.
  • 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 stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • Unfavorable market and economic conditions may have serious adverse consequences on our business, financial condition, results of operations, stock price and prospects.
  • Exchange rate fluctuations may materially affect our results of operations and financial conditions.
Management Discussion
  • Research and development expenses for the three months ended June 30, 2021 were $18.6 million, compared to $12.2 million for the three months ended June 30, 2020. The increase of $6.4 million was due primarily to an increase of approximately $5.4 million in unallocated research and development costs, as well as a net increase of approximately $1.0 million in direct research costs related to our ongoing clinical trials for RP1, RP2 and RP3. The increase in unallocated research and development costs is mainly attributable to a $4.2 million in personnel-related costs, including a $2.7 million increase in payroll and fringe benefits and a stock-based compensation increase of $1.5 million. The increase in personnel-related costs largely reflected the hiring of additional personnel in our research and development functions as we expand the development plan in multiple indications. Personnel related costs for the three months ended June 30, 2021 and 2020 included stock-based compensation expense of $2.5 million and $1.0 million, respectively.
Content analysis
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H.S. senior Avg
New words: body, breast, chart, closest, conducing, confirmatory, CR, depth, diverge, driven, endpoint, estate, facilitate, factored, fringe, gastrointestinal, IGNYTE, NMSC, nonqualified, oderparepvec, online, ORR, Oxley, proximity, purpose, real, reliable, ROU, roughly, RSU, secondary, signal, SITC, situation, strongly, summary, therewith, traditionally, unmet, vusolimogene, workforce
Removed: Abingdon, ancillary, assist, Clarifying, commenced, consistently, construction, context, converted, customer, deemphasize, distinct, documentation, England, epidemic, execute, expedient, extension, fairly, feet, firm, formal, Franchi, function, improve, Interaction, Jean, lacked, landlord, led, microsatellite, occupancy, occupied, onetime, optional, paper, precluded, presenting, pursuit, reclassified, regime, remeasured, remediate, remediation, removed, rendered, renewing, restatement, Retail, retrospective, retrospectively, serve, shared, spending, supervisory, tenant, twelve, vested, Woburn, written

Patents

APP
Utility
Treatment Using Oncolytic Virus
19 Aug 21
An oncolytic virus for use in a method of treating or preventing cutaneous squamous cell carcinoma (CSCC), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), small cell lung cancer (SCLC), advanced recurrent head and neck cancer, squamous cell carcinoma of the head and neck (SCCHN), nasopharyngeal carcinoma (NPC), hepatocellular carcinoma (HCC), anal cancer, colorectal cancer (CRC), basal cell carcinoma (BCC), Merkel cell carcinoma, appendiceal carcinoma, sarcoma of the skin, recurrent melanoma after surgery, advanced or metastatic urothelialcarcinoma, liver metastases, microsatellite instability high cancer (MSI-H), mixed advanced solid tumors, virally caused cancer, locoregionally advanced cancer, pediatric cancer, cancer in patients with no or minimal pre-existing anti-cancer immunity, cancer as first line therapy, cancer in previously treated patients, cancer in patients who have not received checkpoint blockade therapy, and/or cancer in patients who have received checkpoint blockade therapy, wherein the oncolytic virus: is, or is derived from, a clinical isolate which has been selected by comparing the abilities of a panel of three or more clinical isolates of the same viral species to kill tumor cells of two or more tumor cell lines in vitro and selecting a clinical isolate which is capable of killing cells of two or more tumor cell lines more rapidly and/or at a lower dose in vitro than one or more of the other clinical isolates in the panel; comprises (i) a fusogenic protein-encoding gene; and (ii) an immune stimulatory molecule or an immune stimulatory molecule-encoding gene; comprises (i) a GM-CSF-encoding gene; and (ii) an immune co-stimulatory pathway activating molecule or an immune co-stimulatory pathway activating molecule-encoding gene; and/or comprises a gene encoding a CTLA-4 inhibitor.
APP
Utility
Engineered Virus
19 Aug 21
The present invention relates to oncolytic virus comprising: (i) a GM-CSF-encoding gene; and (ii) an immune co-stimulatory pathway activating molecule or an immune co-stimulatory pathway activating molecule-encoding gene.
GRANT
Utility
Engineered virus
16 Mar 21
The present invention relates to oncolytic virus comprising: (i) a GM-CSF-encoding gene; and (ii) an immune co-stimulatory pathway activating molecule or an immune co-stimulatory pathway activating molecule-encoding gene.
APP
Utility
Oncolytic Virus Strain
1 Jul 20
The present invention relates to an oncolytic virus which is, or is derived from, a clinical isolate which has been selected by comparing the abilities of a panel of three or more clinical isolates of the same viral species to kill tumor cells of two or more tumor cell lines in vitro and selecting a clinical isolate which is capable of killing cells of two or more tumor cell lines more rapidly and/or at a lower dose in vitro than one or more of the other clinical isolates in the panel.
APP
Utility
Modified Oncolytic Virus
24 Jun 20
The present invention relates to an oncolytic virus comprising: (i) a fusogenic protein-encoding gene; and (ii) an immune stimulatory molecule-encoding gene.