Docoh
Loading...

OTLK Outlook Therapeutics

Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010/LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg for use in treating a range of retinal diseases in the United States, United Kingdom, Europe, Japan, China and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway, initially for wet AMD.

Company profile

OTLK stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

13 Aug 21
24 Oct 21
30 Sep 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)
Sep 20 Sep 19 Sep 18 Sep 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company 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) 19.69M 19.69M 19.69M 19.69M 19.69M 19.69M
Cash burn (monthly) 5.83M 355.09K 4.07M 4.15M 6.73M 4.78M
Cash used (since last report) 22.27M 1.36M 15.54M 15.85M 25.73M 18.26M
Cash remaining -2.57M 18.33M 4.15M 3.84M -6.03M 1.43M
Runway (months of cash) -0.4 51.6 1.0 0.9 -0.9 0.3

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
5 Oct 21 Hilzinger Kurt J Stock Option Common Stock Grant Acquire A No No 2.12 34,425 72.98K 34,425
5 Oct 21 Sukhtian Faisal Ghiath Stock Option Common Stock Grant Acquire A No No 2.12 44,753 94.88K 44,753
5 Oct 21 Haddadin Yezan Munther Stock Option Common Stock Grant Acquire A No No 2.12 47,335 100.35K 47,335
5 Oct 21 Gangolli Julian S Stock Option Common Stock Grant Acquire A No No 2.12 44,466 94.27K 44,466
5 Oct 21 Auffarth Gerd Stock Option Common Stock Grant Acquire A No No 2.12 25,245 53.52K 25,245

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

52.1% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 65 52 +25.0%
Opened positions 27 52 -48.1%
Closed positions 14 6 +133.3%
Increased positions 11 0 NEW
Reduced positions 15 0 NEW
13F shares
Current Prev Q Change
Total value 147.24M 118.68M +24.1%
Total shares 91.31M 84.54M +8.0%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners
Shares Value Change
BioLexis Pte 50.97M $58.61M 0.0%
Syntone Ventures 19.82M $29.14M 0.0%
BLK Blackrock 5.75M $14.33M +230.2%
Vanguard 4.63M $11.54M +11.3%
LVW Advisors 1.74M $4.34M 0.0%
Geode Capital Management 1.52M $3.78M +104.4%
STT State Street 1.34M $3.34M NEW
Two Sigma Investments 890.67K $2.22M -28.4%
NTRS Northern Trust 880.43K $2.19M +407.5%
Two Sigma Advisers 695.8K $1.73M +15.3%
Largest transactions
Shares Bought/sold Change
BLK Blackrock 5.75M +4.01M +230.2%
STT State Street 1.34M +1.34M NEW
Renaissance Technologies 0 -832.56K EXIT
Geode Capital Management 1.52M +774.41K +104.4%
NTRS Northern Trust 880.43K +706.93K +407.5%
Vanguard 4.63M +469.13K +11.3%
Two Sigma Investments 890.67K -353.37K -28.4%
LNC Lincoln National 253.3K +253.3K NEW
Millennium Management 0 -200.01K EXIT
Nuveen Asset Management 187.65K +187.65K NEW

Financial report summary

?
Competition
Allergan
Risks
  • We have incurred significant losses and negative cash flows from operations since our inception and expect to continue to incur significant losses and negative cash flows from operations for at least the next 12 months.
  • Our independent registered public accounting firm has indicated that our recurring losses, negative cash flows from operations and accumulated deficit raise substantial doubt about our ability to continue as a going concern.
  • We may not be entitled to forgiveness of our Paycheck Protection Program, or PPP, loan, and our application for the PPP loan could in the future be determined to have been impermissible or could result in damage to our reputation.
  • We have never generated any revenue from product sales and may never be profitable.
  • We will need to raise substantial additional funding to complete the development of our product candidate pipeline. This additional funding may not be available on acceptable terms or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
  • Raising additional capital may cause dilution to our securityholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • We are highly dependent on the success of ONS-5010, our only product candidate in active development, and if ONS-5010 does not successfully complete clinical development or receive regulatory approval, or is not successfully commercialized, our business may be harmed.
  • Due to our limited resources and access to capital, we have, and will continue to need to, prioritize development of certain product candidates; and these decisions may prove to have been wrong and may harm our business.
  • Clinical drug development is a lengthy and expensive process and we may encounter substantial delays in our clinical trials or may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
  • The results of previous clinical trials may not be predictive of future results, and the results of our current and planned clinical trials may not satisfy the requirements of the FDA, EMA or other foreign regulatory agencies.
  • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if granted.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates, and our existing insurance coverage may not be sufficient to satisfy any liability that may arise.
  • Failure to obtain regulatory approval in any targeted jurisdiction would prevent us from marketing our products to a larger patient population and reduce our commercial opportunities.
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
  • The development and commercialization of pharmaceutical products is subject to extensive regulation, and we may not obtain regulatory approvals for ONS-5010 in any of the indications for which we plan to develop it, or any future product candidates, on a timely basis or at all.
  • Any delays in the commencement or completion, or termination or suspension, of our planned or future clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
  • If we experience delays or difficulties in enrolling patients in our planned clinical trials, our receipt of necessary regulatory approval could be delayed or prevented.
  • Adverse side effects or other safety risks associated with ONS-5010 or any future product candidate could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon further development, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced or more effective than ours. Other products may be approved and successfully commercialized before ours, which may adversely affect our financial condition and our ability to successfully commercialize our product candidates.
  • The commercial success of any current or future product candidate will depend upon the degree of market acceptance by physicians, patients, third-party payors and others in the medical community.
  • Even if ONS-5010 is approved, off-label repackaging of Avastin at compounding pharmacies may continue, which could have a material adverse effect on our business and financial condition.
  • We currently have no marketing and sales organization. If we are unable to establish sales and marketing capabilities in jurisdictions for which we choose to retain commercialization rights, we may be unable to generate any revenue.
  • We may need to enter into alliances with other companies that can provide capabilities and funds for the development and commercialization of product candidates. If we are unsuccessful in forming or maintaining these alliances on favorable terms, our business could be harmed.
  • The third-party coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
  • We rely on third parties to conduct our preclinical and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be harmed.
  • Previously, we manufactured bulk drug substance for preclinical and clinical supplies of our product candidates in our in-house facility. Our business could be harmed if our new contract manufacturer is unable to manufacture our product candidates at the necessary quantity or quality levels.
  • Any adverse developments affecting the manufacture of ONS-5010 could substantially increase our costs and limit supply for such product candidate.
  • We may depend on third parties for the commercialization of ONS-5010, and failure to commercialize in those markets could harm our business and operating results.
  • Our 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 are required to co-fund the development of, and proportionately share in the revenue from, the commercialization of ONS-3010 in the United States, Canada, E.U., Japan, Australia and New Zealand under a joint participation agreement with Huahai. We may also be required to form a joint venture to further co-develop and commercialize ONS-3010 with Huahai in the agreed countries, if so requested by Huahai.
  • We currently engage single source suppliers for clinical trial services and multiple source suppliers for future drug substance manufacturing, fill-finish manufacturing and product testing of ONS-5010. The loss of any of these suppliers, or any future single source suppliers, could harm our business.
  • If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed. Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • So called “submarine” patents may be granted to our competitors that may significantly alter our launch timing expectations, reduce our projected market size, cause us to modify our product or process or block us from the market altogether.
  • We may not identify relevant patents or may incorrectly interpret the relevance, scope or expiration of a patent, which might adversely affect our ability to develop and market our products.
  • We may become involved in lawsuits to protect or enforce any future patents, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • If we are unable to obtain and maintain effective patent rights for our product candidates or any future product candidates, we may not be able to prevent competitors from using technologies we consider important in our successful development and commercialization of our product candidates, resulting in loss of any potential competitive advantage our patents may have otherwise afforded us.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submissions, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • If we are unable to maintain effective proprietary rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets.
  • We may be subject to claims challenging the inventorship of our patent filings and other intellectual property.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property and other 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.
  • We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
  • Our business could be adversely affected by the effects of health pandemics or epidemics, including the ongoing COVID-19 global pandemic, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations, or materially affect our operations, including at our headquarters in New Jersey, and at our clinical trial sites, as well as the business or operations of our manufacturers, CROs or other third parties with whom we conduct business.
  • We may not be successful in our efforts to identify, develop or commercialize additional product candidates.
  • We are highly dependent on the services of our key executives and personnel, and if we are not able to retain these members of our management or recruit additional management, clinical and scientific personnel, our business will suffer.
  • Healthcare legislative reform measures may harm our business and results of operations.
  • We are subject, directly and indirectly, to federal and state healthcare laws and regulations, including fraud and abuse, false claims, physician payment transparency and health information privacy and security laws. If we are unable to comply or have not fully complied with such laws, we could face substantial penalties.
  • The international aspects of our business expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
  • 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 harm our business.
  • The trading price of our securities is likely to be volatile, and purchasers of our securities could incur substantial losses.
  • BioLexis has beneficial ownership of a significant percentage of our common stock, has the right, together with an affiliate, to designate members to our board of directors proporationate to its ownership, and is able to exert significant control over matters subject to stockholder approval, which could prevent new investors from influencing significant corporate decisions.
  • 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.
  • If securities or industry analysts do not publish research, or publish unfavorable research, about our business, the market price of our securities and trading volume could decline.
  • We are an “emerging growth company” and a “smaller reporting company” and, because we have opted to use the reduced reporting requirements available to us, certain investors may find investing in our securities less attractive.
  • We have and will continue to incur significant costs and demands upon management as a result of complying with the laws and regulations affecting public companies in the United States, which may harm our operating results.
  • Due to the speculative nature of warrants, there is no guarantee that it will ever be profitable for holders of the Series A warrants to exercise such warrants.
  • Future sales and issuances of our common stock or rights to purchase securities, including pursuant to our equity incentive plans or exercise of warrants, could result in additional dilution of the percentage ownership of our stockholders and could cause the market price of our securities to fall.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • We do not intend to pay dividends on our capital stock, and as such any returns will be limited to the value of our securities.
  • Provisions in our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our securityholders or remove our current management.
  • Our amended and restated certificate of incorporation and our amended and restated bylaws, each as amended, provide that the Court of Chancery of the State of Delaware will be the exclusive forum 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, 2021 remained consistent compared to the three months ended June 30, 2020. A $0.6 million increase in ONS-5010 development costs related to our ongoing activities to support our planned BLA filing for wet AMD were offset by a $0.7 million decrease in stock-based compensation due to the vesting of restricted stock awards in June 2020.
  • General and administrative expenses for the three months ended June 30, 2021 decreased by $0.4 million compared to the three months ended June 30, 2020. The decrease was primarily due to a $0.7 million loss on lease termination in 2020,
  • decrease in professional fees of $0.1 million and decrease in compensation related costs of $0.1 million, partially offset by a $0.5 million increase in stock-based compensation due to stock options granted in fiscal 2021 to employees and directors.
Content analysis
?
Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. sophomore Avg
New words: ATM, baseline, Beijing, dataset, employment, exert, Hedging, influence, investee, ITT, marked, maximum, NaN, newly, PP, pro, proportionate, rata, reclassified, relevant, representation, score, secondary, short, showed, statistically, Wainwright
Removed: advancing, confer, delayed, disposal, enrolled, high, missed, twenty, unusually