Ponzi scheme – Wikipedia

Ponzi scheme - Wikipedia

With the share price down this year, should you jump in? /PRNewswire/ — Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases,… Home Companies Highlights from the Ratings and Financial Report for KeyCorp (KEY) /PRNewswire/ — Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative… Stock futures surged Monday morning as traders took in promising data on a leading COVID-19 vaccine candidate alongside President-elect Joe Biden’s victory in the U.S. presidential election, ending a days-long nail-biter over which candidate would prevail in winning the White House.

For schemes that promise rewards based on enrolling ever larger numbers of people, see Pyramid scheme.

1920 photo of Charles Ponzi, the namesake of the scheme, while still working as a businessman in his office in Boston

  • High investment returns with little or no risk. Every investment carries some degree of risk, and investments yielding higher returns typically involve more risk. Any “guaranteed” investment opportunity is often considered suspicious.
  • Overly consistent returns. Investment values tend to go up and down over time, especially those offering potentially high returns. An investment that continues to generate regular positive returns regardless of overall market conditions is considered suspicious.
  • Unregistered investments. Ponzi schemes typically involve investments that have not been registered with the SEC or with state regulators. Registration is important because it provides investors with access to key information about the company’s management, products, services, and finances.
  • Unlicensed sellers. Federal and state securities laws require that investment professionals and their firms be licensed or registered. Most Ponzi schemes involve unlicensed individuals or unregistered firms, the few exceptions usually being the aforementioned investment vehicles that started out as legitimate operations but failed to earn the expected returns.
  • Secretive or complex strategies. Investments that cannot be understood or do not give complete information.
  • Issues with paperwork. Excuses are given regarding why clients cannot review information in writing about an investment. Also, account statement errors and inconsistencies are frequently signs that funds are not being invested as promised.
  • Difficulty receiving payments. Clients have failures to receive a payment or have difficulty cashing out their investments. Ponzi scheme promoters routinely encourage participants to “roll over” investments and sometimes promise even higher returns on the amount rolled over.
  • The operator vanishes, taking all the remaining investment money. Promoters who intend to abscond often attempt to do so as returns due to be paid are about to exceed new investments, as this is when the investment capital available will be at its maximum.
  • Since the scheme requires a continual stream of investments to fund higher returns, if the number of new investors slows down, the scheme collapses as the operator can no longer pay the promised returns (the higher the returns, the greater the risk of the Ponzi scheme collapsing). Such liquidity crises often trigger panics, as more people start asking for their money, similar to a bank run.
  • External market forces, such as a sharp decline in the economy, can often hasten the collapse of a Ponzi scheme (for example, the Madoff investment scandal during the market downturn of 2008), since they often cause many investors to attempt to withdraw part or all of their funds sooner than they had intended.
  • In a Ponzi scheme, the schemer acts as a “hub” for the victims, interacting with all of them directly. In a pyramid scheme, those who recruit additional participants benefit directly. Failure to recruit typically means no investment return.
  • A Ponzi scheme claims to rely on some esoteric investment approach, and often attracts well-to-do investors, whereas pyramid schemes explicitly claim that new money will be the source of payout for the initial investments.[3]
  • A pyramid scheme typically collapses much faster because it requires exponential increases in participants to sustain it. By contrast, Ponzi schemes can survive (at least in the short-term) simply by persuading most existing participants to reinvest their money, with a relatively small number of new participants.[14]
  • In most economic bubbles, there is no single person or group misrepresenting the intrinsic value. A common exception is a pump and dump scheme (typically involving buyers and holders of thinly-traded stocks), which has much more in common with a Ponzi scheme compared to other types of bubbles.
  • Ponzi schemes typically result in criminal charges when authorities discover them, but other than pump and dump schemes, economic bubbles do not typically involve unlawful activity, or even bad faith on the part of any participant. Laws are only broken if someone perpetuates the bubble by knowingly and deliberately misrepresenting facts to inflate the value of an item (as with a pump and dump scheme). Even when this occurs, wrongdoing (and especially criminal activity) is often much more difficult to prove in court compared to a Ponzi scheme. Therefore, the collapse of an economic bubble rarely results in criminal charges (which require proof beyond a reasonable doubt to secure a conviction) and, even when charges are pursued, they are often against corporations, which can be easier to pursue in court compared to charges against people but also can only result in fines as opposed to jail time. The more commonly-pursued legal recourse in situations where someone suspects an economic bubble is the result of nefarious activity is to sue for damages in civil court, where the standard of proof is only balance of probabilities and where the plaintiff need not demonstrate mens rea.
  • In some jurisdictions[which?], following the collapse of a Ponzi scheme, even the “innocent” beneficiaries are liable to repay any gains for distribution to the victims. In this context, “innocent” beneficiaries can include anyone who unwittingly profited without being aware of the fraudulent nature of the scheme, and even charities to which perpetrators often give to relatively generously while a scheme is in operation in an effort to enhance their own profile and thereby “profit” from the resulting positive media coverage. This typically does not happen in the case of an economic bubble, especially if nobody can prove the bubble was caused by anyone acting in bad faith, moreover a person whose own participation in an economic bubble is not particularly notable is not likely to enhance participation in the bubble and thus personally profit by donating to charity.
  • Items traded in an economic bubble are much more likely to have an intrinsic value that is worth a substantial proportion of the market price. Therefore, following collapse of an economic bubble (especially one in a commodity such as real estate) the items affected will often retain some value, whereas an investment that is part of a Ponzi scheme will typically be worthless (or very close to worthless). On the other hand, it is much easier to obtain financing for many items that are the frequent subject of bubbles. If an investor trading on margin or borrowing to finance investments becomes the victim of a bubble, he or she can still lose all (or a very substantial portion) of his or her investment capital, or even be liable for losses in excess of the original capital investment.
  • Dunn, Donald (2004). Ponzi: The Incredible True Story of the King of Financial Cons (Library of Larceny) (Paperback). New York: Broadway. ISBN 0-7679-1499-6.
  • Frankel, Tamar (2012). The Ponzi Scheme Puzzle: A History and Analysis of Con Artists and Victims. USA: Oxford University Press. ISBN 0199926611.
  • Schneps, Leila & Colmez, Coralie (2013). Math on trial. How numbers get used and abused in the courtroom. Basic Books. ISBN 978-0-465-03292-1.CS1 maint: uses authors parameter (link) (Eighth chapter: “Math error number 8: underestimation. The case of Charles Ponzi: American dream, American scheme”).
  • Zuckoff, Mitchell (2005). Ponzi’s Scheme: The True Story of a Financial Legend. New York: Random House. ISBN 1-4000-6039-7.
  • Ponzi Schemes FAQ Information and advice from the US Securities and Exchange Commission
  • Fraud Awareness and Prevention Information about spotting fraud from the US Commodities Futures Trading Commission
  • Ponzimonium Free e-book about Ponzi schemes from the US Commodity Futures Trading Commission
  • Source: en.wikipedia.org


    Is BJ's Restaurants Stock a Buy?

    Is BJ’s Restaurants Stock a Buy?

    BJ’s Restaurants (NASDAQ:BJRI), a casual dining and beer establishment, has had a rough year. The stock price, which is down 18% in 2020, reflects this reality.

    Certainly, it is far from the only industry participant that has felt the pinch from these trying days. That raises the question: Does it represent a good value? Alternatively, is the price down because it didn’t pivot quickly enough? Should you follow the numbers or have faith in a recovery?

    An empty bar and restaurant.

    Image source: Getty Images.

    The restaurant industry is known for its competitive nature. This is certainly true of the casual dining space. There are numerous options for restaurant-goers, such as The Cheesecake Factory and Texas Roadhouse, to name just a couple.

    BJ’s tries to stand out by offering its own craft beers and providing a broad number of items on the menu (such as 20 different kinds of pizza).

    However, this has failed to drive same-store sales (comps) increases recently. Although BJ’s 2019 comps rose by 1.1%, this was driven by increased spending. Traffic to its restaurants fell by 1.9%. BJ’s can’t keep relying on people to spend more money, though. Management claims most of its restaurants are mature and operating near full capacity, but that wouldn’t explain the drop in patronage. Ultimately, BJ’s needs to get people to visit its restaurants.

    These results were before COVID-19 reared its ugly head and forced BJ’s to close its doors to the public. Although all but one of its 210 restaurants have reopened, the majority have limited indoor seating capacity, while some only have outdoor dining. Under these circumstances, it is not too surprising that BJ’s third-quarter comps dropped by more than 30%.

    Unfortunately, COVID-19 cases are surging in the U.S., and the situation doesn’t look likely to dissipate anytime soon. Obviously, this makes things tougher for the company, which has restaurants in 29 states. Governments may reimpose tougher restrictions on eating out, or people may decide to take safety precautions by cooking at home.

    A key component of management’s growth plan is to open new restaurants. However, after opening seven in 2019, the company has only opened one new location this year. Ultimately, BJ’s expects to double the number of restaurants, but with the pullback in openings — which is understandable — it is unclear how long it will take.

    In the near term, BJ’s has to contend with COVID-19 hurting results and putting its expansion plans on hold. You could overlook these factors if you felt the company was operating from a position of strength. BJ’s lukewarm sales trend heading into the year raises questions about its long-term success, though.

    In this ultra-competitive sector, there are likely better options from which to choose. This one doesn’t look too appetizing.

    Source: www.fool.com

    Author: Lawrence Rothman, CFA


    Cogent Biosciences Reports Third Quarter 2020 Financial Results and Provides Corporate Updates

    Cogent Biosciences Reports Third Quarter 2020 Financial Results and Provides Corporate Updates

    CAMBRIDGE, Mass., Nov. 9, 2020 /PRNewswire/ — Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced financial results for the third quarter ended September 30, 2020 and provided several corporate updates.

    “Over the past quarter, Cogent Biosciences has made tremendous progress establishing a clear strategy and focus that positions us as an emerging leader in the field of precision medicines for patients with genetically driven diseases,” said Andrew Robbins, President and CEO of Cogent Biosciences. “We are excited by the potential of our lead program, PLX9486, and look forward to presenting final clinical data from its Phase 1/2 study in GIST patients at CTOS 2020. We look forward to initiating new clinical trials of PLX9486 in patients with systemic mastocytosis and GIST in 2021, beginning in 1H 2021 with a trial of PLX9486 in advanced systemic mastocytosis (ASM) patients.”

    Recent Program and Corporate Highlights

  • Andrew Robbins appointed President, CEO and Director
  • Mr. Robbins is an accomplished executive with extensive commercial, development, and strategic leadership experience during a 20-year career in the pharmaceutical industry, with a specific focus on oncology and hematology products. Most recently, as COO of Array Biopharma, he led the successful launch of MEKTOVI® (binimetinib) and BRAFTOVI® (encorafenib) for BRAF-mutant metastatic melanoma patients.
  • PLX9486 + sunitinib GIST Phase 1/2 trial selected for CTOS 2020 oral presentation
  • Title: The Potent and Selective Kit Inhibitor PLX9486 Dosed in Combination with Sunitinib Demonstrates Promising Progression Free Survival (PFS) in Patients with Advanced Gastrointestinal Stromal Tumor (GIST): Final Results of a Phase 1/2 Study
  • Date: Friday, November 20, 2020 from 11:30 a.m. – 12:30 p.m. ET
    Presenter: Jonathan Trent, M.D., Ph.D., University of Miami Health System, Sylvester Comprehensive Cancer Center
  • Cogent Biosciences positioned as an emerging leader in the field of precision medicine for patients with genetically driven diseases
  • Completed Kiq LLC acquisition: On July 6, 2020, Cogent Biosciences (previously Unum Therapeutics) announced the sign and close of the Kiq LLC (“Kiq”) acquisition including global rights to PLX9486, a selective and potent KIT inhibitor.
  • Completed $104.4M Series A preferred stock private placement: Concurrent with the acquisition of Kiq, Cogent Biosciences completed the sale of Series A non-voting convertible Preferred Stock (“Series A Preferred Stock”) in exchange for gross proceeds of $104.4 million.
  • Announced new company as Cogent Biosciences: The new name reflects our mission to design rational precision therapies that treat the underlying cause of disease in order to improve patients’ lives.
  • Out licensed BOXR programs to SOTIO: On August 31, Cogent Biosciences announced the sale of its cell based BOXR programs to SOTIO, a clinical stage immuno-oncology company owned by PPF Group. Under the terms of the agreement, SOTIO made an upfront payment of $8.1 million, and certain Cogent Biosciences stockholders of record (as of July 6, 2020) were granted a non-tradeable contingent value right (CVR). Holders of the CVR will be entitled to receive certain stock and/or cash payments from net proceeds received by Cogent Biosciences.
  • Reverse Stock Split Enabling Preferred Share Conversion

    At a special shareholder meeting held on November 6, 2020, Cogent Biosciences’ stockholders approved a reverse stock split. With this authority, Cogent Biosciences’ board of directors approved the reverse stock split at a ratio of 1-for-4, effective November 6, 2020. This ensured that sufficient common shares were authorized and issuable to allow for full conversion of the Series A Preferred Stock. Cogent Biosciences’ common stock will begin trading on a split-adjusted basis upon market open on November 9, 2020. Immediately following the Reverse Stock Split and assuming full conversion of the Series A preferred stock, Cogent Biosciences would have approximately 52.2 million shares of Common Stock outstanding.

    The reverse stock split impacts all holders of Cogent Biosciences stock proportionally and will not impact any stockholder’s percentage ownership of common stock.

    Third Quarter 2020 Financial Results

  • Collaboration Revenue: Collaboration revenue recognized during the third quarter ended September 30, 2020 of $0.3 million compared to $1.0 million in the same period of 2019.
  • R&D Expenses: Research and development expenses of $5.0 million for the third quarter ended September 30, 2020 compared to $10.3 million for the same period of 2019. This decrease is primarily related to the reduction in clinical activity of legacy cell-therapy clinical trials.
  • G&A Expenses: General and administrative expenses for the third quarter ended September 30, 2020 were $5.6 million, compared to $2.7 million for the same period of 2019. The increase is primarily related to higher professional fees and stock compensation.
  • Acquired In-Process R&D Expense: Acquired in-process R&D expense of $46.9 million during the current quarter was a result of the accounting treatment related to the asset acquisition of Kiq LLC, including PLX9486, on July 6, 2020.
  • Other Income (expense): Other income (expense) for the third quarter ended September 30, 2020 was $7.2 million, compared to $0.1 million for the same period of 2019. The increase is primarily related to the gain on the sale of the BOXR platform to SOTIO.
  • Net Loss: Net loss attributable to common stockholders was $50.0 million, or $5.07 per share, for the third quarter ended September 30, 2020 compared with a net loss attributable to common stockholders of $11.9 million, or $1.56 per share, for the same period of 2019.
  • Cash and Cash Equivalents: As of September 30, 2020, Cogent Biosciences had cash and cash equivalents of $129.4 million.
  • About Cogent Biosciences, Inc.
    Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, PLX9486, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Cogent Biosciences is headquartered in Cambridge, MA. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: Twitter and LinkedIn.

    Forward Looking Statements
    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: projected cash runways; future product development plans; upcoming results from clinical trials including from its lead program, PLX9486; and any future payouts under the CVR. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Cogent’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

    COGENT BIOSCIENCES, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (in thousands, except share and per share amounts)
    (unaudited)

    Three Months Ended September 30,

    Nine Months Ended September 30,

    2020

    2019

    2020

    2019

    Collaboration revenue

    $

    312

    $

    1,020

    $

    7,871

    $

    7,211

    Operating expenses:

    Research and development

    5,003

    10,335

    19,630

    33,355

    General and administrative

    5,598

    2,721

    12,074

    8,274

    Acquired in-process research and development

    46,910

    46,910

    Total operating expenses

    57,511

    13,056

    78,614

    41,629

    Loss from operations

    (57,199)

    (12,036)

    (70,743)

    (34,418)

    Other income (expense):

    Interest income

    23

    31

    73

    206

    Gain on disposal of long-lived assets

    7,463

    82

    7,470

    82

    Other income

    239

    239

    Change in fair value of CVR liability

    (509)

    (509)

    Total other income (expense), net

    7,216

    113

    7,273

    288

    Net loss

    $

    (49,983)

    $

    (11,923)

    $

    (63,470)

    $

    (34,130)

    Net loss per common share, basic and diluted

    $

    (5.07)

    $

    (1.56)

    $

    (7.56)

    $

    (4.49)

    Weighted average common shares outstanding, basic and diluted

    9,850,530

    7,665,281

    8,392,741

    7,604,688

    Comprehensive loss:

    Net loss

    $

    (49,983)

    $

    (11,923)

    $

    (63,470)

    $

    (34,130)

    COGENT BIOSCIENCES, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (in thousands, except share and per share amounts)
    (unaudited)

    September 30, 2020

    December 31, 2019

    Cash, cash equivalents and marketable securities

    $

    129,420

    $

    37,424

    Working capital

    $

    113,295

    $

    27,343

    Total assets

    $

    139,870

    $

    49,423

    Total liabilities

    $

    23,812

    $

    17,661

    Total stockholders’ equity (deficit)

    $

    (22,174)

    $

    31,762

    SOURCE Cogent Biosciences, Inc.

    Source: www.prnewswire.com

    Author: Cogent Biosciences, Inc.


    Highlights from the Ratings and Financial Report for KeyCorp (KEY)

    Highlights from the Ratings and Financial Report for KeyCorp (KEY)

    KeyCorp (NYSE:KEY) went down by -2.58% from its latest closing price compared to the recent 1-year high of $20.52. The company’s stock price has collected -1.23% of loss in the last five trading sessions. Press Release reported on 10/29/20 that KeyCorp To Present At The BancAnalysts Of Boston Virtual Conference

    KeyCorp (NYSE:KEY) scored a price-to-earnings ratio above its average ratio, recording 11.27 x from its present earnings ratio. Plus, the 36-month beta value for KEY is at 1.56. Opinions of the stock are interesting as 6 analysts out of 22 who provided ratings for KeyCorp declared the stock was a “buy,” while 1 rated the stock as “overweight,” 11 rated it as “hold,” and 3 as “sell.”

    The average price from analysts is $13.89, which is $1.03 above the current price. KEY currently public float of 970.48M and currently shorts hold a 2.08% ratio of that float. Today, the average trading volume of KEY was 8.04M shares.

    KEY stocks went down by -1.23% for the week, with a monthly drop of -3.68% and a quarterly performance of 0.87%, while its annual performance rate touched -33.58%. The volatility ratio for the week stands at 4.98% while the volatility levels for the past 30 days are set at 3.80% for KeyCorp. The simple moving average for the period of the last 20 days is -1.11% for KEY stocks with a simple moving average of -0.81% for the last 200 days.

    Many brokerage firms have already submitted their reports for KEY stocks, with Wedbush repeating the rating for KEY by listing it as a “Neutral.” The predicted price for KEY in the upcoming period, according to Wedbush is $14 based on the research report published on October 26th of the current year 2020.

    After a stumble in the market that brought KEY to its low price for the period of the last 52 weeks, the company was unable to rebound, for now settling with -37.54% of loss for the given period.

    Volatility was left at 3.80%, however, over the last 30 days, the volatility rate increased by 4.98%, as shares sank -2.29% for the moving average over the last 20 days. Over the last 50 days, in opposition, the stock is trading +1.18% upper at present.

    During the last 5 trading sessions, KEY fell by -1.23%, which changed the moving average for the period of 200-days by -33.54% in comparison to the 20-day moving average, which settled at $12.95. In addition, KeyCorp saw -36.66% in overturn over a single year, with a tendency to cut further losses.

    Reports are indicating that there were more than several insider trading activities at KEY starting from Mago Angela G, who sale 3,646 shares at the price of $12.46 back on Jul 24. After this action, Mago Angela G now owns 168,183 shares of KeyCorp, valued at $45,429 using the latest closing price.

    Highsmith Carlton L, the Director of KeyCorp, purchase 2,000 shares at $11.89 during a trade that took place back on May 26, which means that Highsmith Carlton L is holding 66,874 shares at $23,780 based on the most recent closing price.

    Current profitability levels for the company are sitting at:

  • +26.81 for the present operating margin
  • The net margin for KeyCorp stands at +22.25. The total capital return value is set at 6.53, while invested capital returns managed to touch 5.92. Equity return is now at value 8.80, with 0.90 for asset returns.

    Based on KeyCorp (KEY), the company’s capital structure generated 83.86 points at debt to equity in total, while total debt to capital is 45.61. Total debt to assets is 9.85, with long-term debt to equity ratio resting at 70.69. Finally, the long-term debt to capital ratio is 38.45.

    When we switch over and look at the enterrpise to sales, we see a ratio of 4.41, with the company’s debt to enterprise value settled at 0.42. The liquidity ratio also appears to be rather interesting for investors as it stands at 0.03.

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    Source: newsheater.com

    Author: Denise Gardner


    Kodiak Sciences Announces Third Quarter 2020 Financial Results and Recent Business Highlights

    Kodiak Sciences Announces Third Quarter 2020 Financial Results and Recent Business Highlights

    PALO ALTO, Calif., Nov. 9, 2020 /PRNewswire/ — Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, today reported business highlights and financial results for the third quarter ended September 30, 2020.

    “We continue our strong execution in this second half of 2020,” said Victor Perlroth, MD, Chief Executive Officer of Kodiak. “Our DAZZLE study of KSI-301 in wet age-related macular degeneration has only a handful of patients left to enroll, and we are now enrolling GLEAM and GLIMMER in Diabetic Macular Edema and BEACON in Retinal Vein Occlusion. With over 300 retina specialists, clinical coordinators and staff having participated in our most recent Virtual Investigator Meeting, we are humbled and inspired by the receptivity and enthusiasm of the retina community for KSI-301 and its emerging clinical profile. These accomplishments, powered by our growing Kodiak team, bring us one step closer to a series of top-line data readouts beginning in early 2022. This 2022 Vision will, if successful, enable a single multi-indication BLA filing in 2022.”

    Recent Business Highlights

  • Upgraded Pivotal Study Program: We finalized the design of our KSI-301 pivotal study programs in RVO and DME and have launched all three studies. We are currently conducting two Phase 3 studies in DME (GLEAM and GLIMMER) to provide the mutually-confirmatory studies required by FDA for initial demonstration of safety and efficacy, one study in wet AMD (our ongoing DAZZLE study), and one study in RVO (BEACON). Each study protocol design has been optimized based on Phase 1b data and experience and will include the same treatment-naïve patient populations as in the Phase 1b, as well as tighter dosing interval ranging, tighter disease control, and decreased subjectivity for retreatments, and each has high statistical power for non-inferiority (>90%). We also intend to initiate in early 2021 a Phase 3 study of KSI-301 in non-proliferative diabetic retinopathy (GLOW).
  • DAZZLE Study Progress: We saw robust patient enrollment through the third quarter of 2020 and have completed U.S. patient recruitment into our DAZZLE pivotal study in wet AMD – a potential reflection of the enthusiasm for KSI-301 on the part of clinical investigators and patients. EU patient enrollment commenced in June 2020 and we continue to see robust recruitment. We expect to complete overall DAZZLE study enrollment by year end 2020. With a one-year primary endpoint, we remain on track for a DAZZLE study top-line data readout in early 2022. As of November 4, 2020, over 545 of the planned 550 patients have been enrolled in DAZZLE.
  • GLEAM / GLIMMER and BEACON Study Initiations: We initiated two Phase 3 studies in DME (GLEAM and GLIMMER) and one Phase 3 study in RVO (BEACON) in the third quarter of 2020. The randomization of treatment-naïve patients into these three studies is a critical step to build the clinical evidence for KSI-301 as a safe, effective and highly durable therapy for patients with retinal diseases. The initiation of the additional Phase 3 studies and the robust patient recruitment into DAZZLE represent strong operational progress towards our 2022 Vision of a single BLA filed for KSI-301 in wet AMD, DME, and RVO in 2022.
  • Continued maturation of Phase 1b Data: Updated safety and efficacy results from our ongoing Phase 1b trial of KSI-301 in patients with treatment naïve wet AMD, DME, or RVO were presented at the American Society of Retina Specialists 2020 Virtual Annual Meeting in July 2020. We believe the data continue to support the “anti-VEGF Generation 2.0” profile of KSI-301. We intend to continue presenting data updates from the Phase 1b as the study progresses over its full three-year duration.
  • Commercial Manufacturing Progress: We successfully negotiated a long-term agreement with Lonza for the manufacture of KSI-301. This agreement will provide Kodiak with a custom-built bioconjugation facility with a capacity to supply millions of doses per year. With construction targeted for completion in 2021, the Lonza-Kodiak Ibex facility will provide Kodiak with the facility needed for commercial-scale manufacturing of KSI-301. The timing of this expanded partnership is designed to support Kodiak’s BLA submission timeline in 2022, and the scale is designed to support KSI-301’s potential to achieve significant market share as a new first-line agent designed to improve outcomes for patients with common and serious retinal vascular diseases.
  • Completed Lease Agreement for Kodiak’s New U.S. Headquarters: We have leased approximately 82,662 square feet located at 1200 Page Mill Road, Palo Alto, California and approximately 72,812 square feet located at 1250 Page Mill Road, Palo Alto, California. These newly leased buildings will serve as Kodiak’s U.S. headquarters for office and laboratory space. We also leased approximately 10,750 square feet in Visp, Switzerland, for manufacturing support and supervision.
  • Expected Upcoming Events/Milestones

  • Complete enrollment in DAZZLE pivotal Phase 2b/3 randomized head-to-head study of KSI-301 against aflibercept in treatment naïve wet macular degeneration patients by year-end 2020
  • Presentation on KSI-301 and Kodiak’s ABC Platform at Late Breaking Developments Part II of American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting in November 2020
  • Presentation of KSI-301 one-year data from Phase 1b study in wet AMD, DME and RVO cohorts at Angiogenesis, Exudation, and Degeneration 2021 – Virtual Edition meeting in February 2021
  • Initiate pivotal Phase 3 randomized study of KSI-301 in non-proliferative diabetic retinopathy patients (the GLOW study) in early 2021
  • Third Quarter 2020 Financial Results

    Cash Position

    Kodiak ended the third quarter of 2020 with $380.5 million of cash, cash equivalents and marketable securities. Based on the company’s current cash position, Kodiak estimates having sufficient funds to execute on current operating plans into 2022.

    Net Loss

    The net loss for the third quarter of 2020 was $36.1 million, or $0.80 per share on both a basic and diluted basis, as compared to a net loss of $12.4 million, or $0.33 per share on both a basic and diluted basis, for the third quarter of 2019.

    R&D Expenses

    Research and development (R&D) expenses were $29.3 million for the third quarter of 2020, as compared to $10.1 million for the third quarter of 2019.

    G&A Expenses

    General and administrative (G&A) expenses were $7.4 million for the third quarter of 2020, as compared to $2.6 million for the third quarter of 2019.

    About KSI-301

    KSI-301 is an investigational anti-VEGF therapy built on the Kodiak’s Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing agents. Kodiak’s objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. The Company’s Phase 2b/3 DAZZLE pivotal study in patients with treatment-naïve wet AMD was initiated in October 2019, and Kodiak initiated the Phase 3 GLEAM, GLIMMER, and BEACON pivotal studies of KSI-301 in diabetic macular edema and retinal vein occlusion in September 2020. These studies are anticipated to form the basis of the Company’s initial BLA to support potential approval and commercialization. An additional pivotal study in patients with non-proliferative diabetic retinopathy is planned. Kodiak Sciences Inc. is developing KSI-301 and owns global rights to KSI-301.

    About the GLEAM and GLIMMER Studies in DME

    The Phase 3 GLEAM and GLIMMER studies are global, multi-center, randomized studies designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve diabetic macular edema (DME). In each study, patients are randomized to receive either intravitreal KSI-301 on an individualized dosing regimen every eight to 24 weeks after only three loading doses or intravitreal aflibercept every eight weeks after five loading doses per its label. Each study is expected to enroll approximately 450 patients worldwide. The primary endpoint for both studies is the change from baseline in best-corrected vision at one year, and patients will be treated and followed for two years. Additional information about the GLEAM study (also called Study KS301P104) and the GLIMMER study (also called Study KS301P105) can be found on www.clinicaltrials.gov under Trial Identifiers NCT04611152 and NCT04603937, respectively (https://clinicaltrials.gov/ct2/show/NCT04611152 and https://clinicaltrials.gov/ct2/show/NCT04603937).

    About the BEACON Study in RVO

    The Phase 3 BEACON study is a global, multi-center, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve macular edema due to retinal vein occlusion (RVO), including both branch and central subtypes. Patients are randomized to receive either intravitreal KSI-301 every eight weeks after only two loading doses or monthly intravitreal aflibercept per its label, for the first six months. In the second six months, patients in both groups will receive treatment on an individualized basis per protocol-specified criteria. The study is expected to enroll approximately 550 patients worldwide. The primary endpoint is the change from baseline in best-corrected vision at six months, and patients will be treated and followed for one year. Additional information about the BEACON study (also called Study KS301P103) can be found on www.clinicaltrials.gov under Trial Identifier NCT04592419 (https://clinicaltrials.gov/show/NCT04592419). 

    About the DAZZLE Study in Wet AMD

    The Phase 2b/3 DAZZLE study is a global, multi-center, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve wet AMD. Patients are randomized to receive either KSI-301 on an individualized dosing regimen as infrequently as every five months and no more often than every three months or to receive aflibercept on its labeled every eight-week dosing regimen, each after three monthly initiating doses. The study is expected to enroll approximately 550 patients worldwide. The primary endpoint is at one year and each patient will be treated and followed for two years. Additional information about DAZZLE (also called Study KSI-CL-102) can be found on www.clinicaltrials.gov under Trial Identifier NCT04049266 (https://clinicaltrials.gov/show/NCT04049266). 

    About the KSI-301 Clinical Program

    The KSI-301 Clinical Program is designed to assess KSI-301’s safety, efficacy and durability in wet AMD, DME, RVO and non-proliferative DR (without DME) through clinical studies run in parallel. We are conducting two Phase 3 studies in DME (the GLEAM and GLIMMER studies) to provide the mutually confirmatory studies required by FDA for initial demonstration of safety and efficacy. We also are conducting one study in wet AMD (our ongoing DAZZLE study) and one study in RVO (the BEACON study) to support approval in these indications. We intend to file this package together in a single BLA in 2022. We also plan to run an additional study in patients with non-proliferative DR without DME (the GLOW study). We expect that the global KSI-301 clinical program will be conducted at 150+ study sites in more than 10 countries.

    About Kodiak Sciences Inc.

    Kodiak (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases. Founded in 2009, we are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC Platform™ uses molecular engineering to merge the fields of antibody-based and chemistry-based therapies and is at the core of Kodiak’s discovery engine. Kodiak’s lead product candidate, KSI-301, is a novel anti-VEGF antibody biopolymer conjugate being developed for the treatment of retinal vascular diseases including age-related macular degeneration, the leading cause of blindness in elderly patients in the developed world, and diabetic eye diseases, the leading cause of blindness in working-age patients in the developed world. Kodiak has leveraged its ABC Platform to build a pipeline of product candidates in various stages of development including KSI-501, our bispecific anti-IL-6/VEGF biopolymer conjugate for the treatment of neovascular retinal diseases with an inflammatory component, and we are expanding our early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases such as dry AMD and glaucoma. Kodiak is based in Palo Alto, CA. For more information, please visit www.kodiak.com.

    Forward-Looking Statements

    This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding the potential licensure of KSI-301 and a single BLA submission in wet AMD, DME, RVO and diabetic retinopathy in 2022; the sufficiency of our cash, cash equivalents and marketable securities to fund our operations into 2022; our platform technology and potential therapies; future development plans, including our ability to initiate the GLOW study in early 2021 and present top-line data readout in DAZZLE in early 2022; the ability of the Lonza-Kodiak Ibex facility to provide commercial-scale manufacturing of KSI-301; clinical and regulatory objectives and the timing thereof, anticipated design of planned clinical trials, expectations regarding the potential efficacy and commercial potential of our product candidates; and the anticipated presentation of data; the results of our research and development efforts and our ability to advance our product candidates into later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” and other similar expressions among others. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the preliminary safety, efficacy and durability data for our KSI-301 product candidate will not continue or persist; cessation or delay of any of the ongoing clinical studies and/or our development of KSI-301 may occur, including as a result of the ongoing COVID-19 pandemic; future potential regulatory milestones of KSI-301, including those related to current and planned clinical studies may be insufficient to support regulatory submissions or approval; anticipated presentation of data at upcoming conferences may not occur; our research and development efforts and our ability to advance our product candidates into later stages of development may fail; any one or more of our product candidates may not be successfully developed, approved or commercialized; adverse conditions in the general domestic and global economic markets, including the COVID-19 pandemic, which may significantly impact our business and operations, including out of our headquarters in the San Francisco Bay Area and our clinical trial sites, as well as the business or operations of our manufacturers, contract research organizations or other third parties with whom we conduct business; as well as the other risks identified in our filings with the Securities and Exchange Commission. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.

    Kodiak Sciences Inc.
    Condensed Consolidated Statements of Operations
    (Unaudited)
    (in thousands, except share and per share amounts)

    Three Months Ended

    September 30,

    Nine Months Ended
    September 30,

    2020

    2019

    2020

    2019

    Operating expenses

    Research and development

    $

    29,306

    $

    10,115

    $

    70,033

    $

    24,676

    General and administrative

    7,357

    2,617

    19,132

    8,330

    Total operating expenses

    36,663

    12,732

    89,165

    33,006

    Loss from operations

    (36,663)

    (12,732)

    (89,165)

    (33,006)

    Interest income

    645

    277

    2,551

    1,070

    Interest expense

    (6)

    (2)

    (19)

    (8)

    Other income (expense), net

    (98)

    77

    120

    195

    Net loss

    $

    (36,122)

    $

    (12,380)

    $

    (86,513)

    $

    (31,749)

    Net loss per common share, basic and diluted

    $

    (0.80)

    $

    (0.33)

    $

    (1.92)

    $

    (0.85)

    Weighted-average common shares outstanding used in computing net loss per common share, basic and diluted

    45,119,885

    37,330,066

    44,972,085

    37,291,328

    Kodiak Sciences Inc.
    Condensed Consolidated Balance Sheet Data
    (Unaudited)
    (in thousands)

    September 30,

    2020

    December 31,

    2019

    Cash, cash equivalents and marketable securities

    $

    380,450

    $

    348,177

    Working capital

    $

    359,240

    $

    327,519

    Total assets

    $

    480,736

    $

    358,866

    Accumulated deficit

    $

    (244,644)

    $

    (158,131)

    Total stockholders’ equity

    $

    281,780

    $

    345,359

    SOURCE Kodiak Sciences Inc.

    http://www.kodiak.com

    Source: www.prnewswire.com

    Author: Kodiak Sciences Inc.


    Stock market news live updates: Markets soar, Dow futures add more than 1,400 points after upbeat vaccine data, Biden victory

    Stock market news live updates: Markets soar, Dow futures add more than 1,400 points after upbeat vaccine data, Biden victory

    Stock futures surged Monday morning as traders took in promising data on a leading COVID-19 vaccine candidate as well as President-elect Joe Biden’s victory in the U.S. presidential election, ending a days-long nail-biter over which candidate would prevail in winning the White House.

    Contracts on the Dow jumped more than 1,400 points, or about 5%, setting the index up to extend its sharp gains from last week. Contracts on the S&P 500 jumped more than 3%, while those on the Nasdaq lagged as traders turned away from the software stocks and other tech names that had comprised the “stay-at-home” trade.”

    Shares of Pfizer (PFE) jumped more than 12% in pre-market trading after the company announced that their clinical trial showed that their vaccine candidate was more than 90% effective in preventing COVID-19 in participants with no evidence of a previous coronavirus infection. Shares of BioNTech (BNTX), which is working on the vaccine alongside Pfizer, jumped more than 14% higher during the early session.

    Biden, alongside Vice President-elect Kamala Harris, is set to usher in a push for bigger fiscal stimulus, a public option in health care, investment in sustainability, and a more measured approach to foreign policy and trade, among other key issues. And in his victory speech Saturday, Biden promised to work toward these goals with an eye toward uniting a deeply divided nation, calling for an end of “this grim era of demonization in America” and underscoring that “if we can decide not to cooperate, then we can decide to cooperate.”

    So far, traders have cast bets that some of the suspected “market negative” potential of a Biden presidency, such as a move to raise corporate taxes, would be tempered by a Senate that remained under Republican control. Two Senate races remain outstanding in Georgia and will not be decided until January, though prediction markets have so far given Democrats relatively slim odds of winning both seats needed for the party to claim a majority in the chamber.

    “A divided government would constrain the Biden administration’s ability to implement plans for large-scale fiscal stimulus and public investment, tax, healthcare and climate related legislation,” analysts from BlackRock Investment Institute said in a note Saturday. “We see an increased focus on sustainability under a divided government, but through regulatory actions, rather than via tax policy or spending on green infrastructure. It also would likely signify a return to more predictable trade and foreign policy – even as U.S.-China rivalry is set to stay elevated due to bipartisan support for a more competitive stance.”

    The analysts added that “some fiscal stimulus looks possible” during the lame-duck session in Congress, though the size and scope of any forthcoming package is likely to be much smaller than what a united Democratic government might have advanced.

    “We’re monitoring the fiscal response closely, as a premature retrenchment could set back an economic restart that has so far surprised to the upside,” they said.

    Other economists also expressed optimism that a stimulus package might get passed ahead of Inauguration Day, even after the months’ worth of discussions between Trump administration officials and congressional lawmakers fizzled out without an agreement.

    “We are becoming increasingly hopeful that pressure from business leaders and vulnerable Republican Senators in 2022 will mean that something can pass before the end of the year, and very preferably before the end of the month,” Ian Shepherdson, chief economist for Pantheon Macroeconomics, said in a note Sunday.

    Meanwhile, for the high-flying tech stocks that have driven the market higher for much of this year, a Biden presidential victory with a likely Republican Senate poses the “goldilocks Election outcome,” according to WedBush analyst Dan Ives.

    “Investors should expect a ratcheting down of US/China tensions and the ‘decoupling path’ of the Cold Tech war, which is a bullish sign for Apple (AAPL) and semi [semiconductor] stocks looking ahead,” Ives said in a note Saturday. Concerns of a tougher antitrust environment for Big Tech companies have also likely eased, he added.

    Biden is also set to strike a more serious tone on combatting the coronavirus pandemic, with the outbreak having already taken the lives of more than 230,000 Americans, sickened more than 9.8 million and dragged U.S. economic activity to a historic nadir. And while vote counts were under way last week, coronavirus cases hit a grim milestone in the United States: A record more than 120,000 new cases reported on Friday alone. Biden is set to announce a new 12-person coronavirus task force on Monday, as one of his first major acts during his presidential transition, according to reports from Axios and CNN.

    Here were the main moves in equity markets, as of 7:16 a.m. ET:

    • S&P 500 futures (ES=F): 3,629.40, up 119.5 points or 3.4%

    • Dow futures (YM=F): 29,737.00, up 1,456 points or 5.15%

    • Nasdaq 100 futures (NQ=F): 12,144.25, up 98.25 points or 0.8%

    Shares of Pfizer and German drug-maker BioNTech each soared Monday morning after the companies announced that their Phase 3 clinical trials showed their COVID-19 vaccine candidate was more than 90% effective in preventing the coronavirus in participants with no evidence of a previous infection.

    The trial’s analysis assessed 94 confirmed COVID-19 infections among nearly 44,000 participants.

    “The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose,” the companies said in a statement. “This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.”

    The companies added that they planned to submit a request for Emergency Use Authorization of their vaccine candidate to the U.S. Food and Drug Administration after they have a total of two months’ worth of data to achieve the agency’s safety requirements. This is expected to take place in the third week of November.

    Here were the main moves in markets, as of 6:01 p.m. ET Sunday evening:

    • S&P 500 futures (ES=F): 3,517.00, up 16.25 points or 0.46%

    • Dow futures (YM=F): 28,334.00, up 130 points or 0.46%

    • Nasdaq futures (NQ=F): 12,141.5, up 66.5 points or 0.55%

    Wilmington, PennsylvaniaNov. 7, 2020President-elect Joe Biden addresses supporters at Chase Center in Wilmington, DE, on Nov, 7, 2020 after being named the winners. (Carolyn Cole / Los Angeles Times via Getty Images)

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    Source: finance.yahoo.com

    Author: Emily McCormick·ReporterNovember 9, 2020, 4:36 PM·6 min read


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