July 1, 2020 VIA E-MAIL Joseph G. Sansone, Chief, Market Abuse Unit, U.S. Securities and Exchange Commission 100 F Street, NE Washington, DC 20549-2977 sansonej@sec.gov Re: Violations of Securities Laws by Moderna, Inc., Its Officers, and Former Board Member Dear Mr. Sansone: I am President and founder of Accountable.US, a non-profit organization that monitors public corruption on a non-partisan basis. I write to alert the U.S. Securities and Exchange Commission (“SEC”) regarding potential violations of the U.S. securities laws committed by officers and a board member of Moderna, Inc., and also possibly by the company itself. This misconduct was particularly egregious because it involved not only financial fraud and manipulation of the financial markets, but also because it exploited widespread fears surrounding the ongoing COVID-19 pandemic. I strongly urge the SEC to investigate these matters. BACKGROUND COVID-19 has now claimed over 300,000 deaths worldwide, with almost a third of those deaths in the United States. The pandemic, caused by a highly contagious strain of the coronavirus, has brought the world’s largest economies to a halt as they impose quarantines, enact travel restrictions, and implement emergency economic measures. We are now living in the largest economic recession since the Great Depression. The best medical and scientific minds are now working around the clock to develop treatments for the virus; every company with involvement in relevant technology is racing to develop a vaccine that will save lives and rescue the world’s economy. The financial benefit to the company that develops this vaccine is obvious. A. The stock price of Moderna Inc. rose dramatically in response to encouraging news about an experimental vaccine for coronavirus. Given the public’s desperation, it came as good news when on May 12, 2020, Moderna, Inc., a publicly-traded biotech company based in Cambridge, Massachusetts, announced significant steps toward achieving this holy grail. On May 12, Moderna issued a key press release regarding the progress of its vaccine research.1 The release included two announcements.2 First, it stated that the company had received Fast Track designation from the U.S. Food and Drug Administration (FDA) to test its experimental coronavirus vaccine.3 The designation was important because it provided for “early and frequent communication with the FDA, in addition to a rolling submission” of a marketing application for the anticipated vaccine.4 Second, and potentially more importantly, the press release stated that the FDA had completed its review of Moderna’s Investigational New Drug application, approval of which determined whether the company’s research could proceed into a Phase 2 study, an important predicate to ultimate approval of the vaccine.5 The press release included optimistic quotes regarding the vaccine by Moderna’s Chief Medical Officer, Tal Zaks, M.D., Ph.D.6 Days later, on May 18, the company issued another key press release, this time relating to promising results of Moderna’s Phase 1 testing, another important milestone to ultimate approval of the vaccine.7 The second press release touted the findings of a safety trial showing that the vaccine caused eight participants to develop antibodies that could protect against the disease. The second press release also quoted Dr. Zaks.8 As would be expected, the financial markets responded enthusiastically to these widelycirculated public announcements. On the same day that Moderna announced the hopeful findings of its safety trial, the company’s stock price reached an all-time high of $87 a share, up 344% from its January 2 opening price of $19.57.9 That was a culmination of a steady rise in stock 1 Press Release, Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus, May 12, 2020, available at: https://investors.modernatx.com/node/8931/pdf. 2 Id. 3 Id. 4 Id. 5 Press Release, Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus, May 12, 2020, available at: https://investors.modernatx.com/node/8931/pdf. 6 Id. 7 Press Release, Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus, May 18, 2020, available at: https://investors.modernatx.com/node/8986/pdf 8 9 Id. Matthew Fox, Moderna Falls 20% Amid Reports That Insiders Have Sold $89 Million in Shares This Year as The Stock Has Spiked, Business Insider (May. 27, 2020), available at: https://markets.businessinsider.com/news/stocks/moderna-stock-price-amid-millions-insider-sales-sharescoronavirus-vaccine-2020-5-1029238487 prices since the May 12 announcement.10 Both these public announcements were significant for one clearly-evident reason: People are desperate for a vaccine. Observers anticipated Moderna’s press release dated May 18 after President Trump appointed Dr. Moncef Slaoui to lead a national effort to develop, manufacture, and distribute COVID-19 vaccines. Notably, Dr. Slaoui sat on Moderna’s Board of Directors until he stepped down on May 15, 2020, to accept the appointment. That same day, he stood alongside the President of the United States in a Rose Garden ceremony and announced to the nation: “I have very recently seen early data from a clinical trial with a coronavirus vaccine. And this data made me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020.”11 Given the board position that Dr. Slaoui had just left, he did not need to mention Moderna by name to make clear where he had seen the promising “early data.” Indeed, when he made the statement, at least one national periodical, The New York Times, associated his comments with Moderna.12 B. Moderna’s stock price plummeted as medical experts cast doubt on the studies’ findings. The boost to Moderna’s financial value was short-lived. Over the next few days, investors’ confidence plummeted as medical experts began to cast doubt on the study’s findings. One physician pointed out that the results involved only a small number of patients and left many unresolved questions about its efficacy in different populations, potential adverse effects, and the scalability of the treatment.13 Moreover, although Moderna’s press releases had touted favorable results for eight patients out of forty-five, the announcements were silent as to the remaining thirty-seven participants.14 These revelations have caused dramatic declines in the Moderna’s share price, causing the stock to lose a third of its value since the meteoric rise following the company’s press releases on May 12 and May 18, and Dr. Slaoui’s statement on May 15.15 10 Historical Data, Moderna, Inc., Yahoo! Finance, https://finance.yahoo.com/quote/MRNA/history?p=MRNA 11 The White House. Remarks by President Trump on Vaccine Development (May 15, 2020), available at: https://www.whitehouse.gov/briefings-statements/remarks-president-trump-vaccine-development/ 12 David E. Sanger, et al., Trump Vows Vaccine by End of Year, and Mobilizes Military to Help, N.Y. TIMES, May 18, 2020, https://www.nytimes.com/2020/05/15/us/politics/coronavirus-vaccine-timeline.html 13 Alaric Dearment, Experts Cautiously Optimistic On Moderna’s Early Covid-19 Vaccine Data As Market Exuberance Fades, MEDCITY NEWS (May 20, 2020), https://medcitynews.com/2020/05/experts-cautiouslyoptimistic-on-modernas-early-covid-19-vaccine-data-as-market-exuberance-fades/. 14 Helen Branswell, Vaccine Experts Say Moderna Didn’t Produce Data Critical to Assessing Covid-19 Vaccine, STAT (May 19, 2020), https://www.statnews.com/2020/05/19/vaccine-experts-say-moderna-didntproduce-data-critical-to-assessing-covid-19-vaccine/. 15 Joe Tenebruso, Why Moderna Stock Dropped Today, NASDAQ (May 27, 2020), https://www.nasdaq.com/articles/why-moderna-stock-dropped-today-2020-05-27. C. Senior executives at Moderna sold millions in stocks and profited heavily from their trades. Evidence suggests that Moderna and at least two of its officers, possibly among others, may have improperly exploited coronavirus fears to boost the company’s value, as well as their own bank accounts, through the short-term financial boost from public announcements regarding the company’s vaccine testing. As the stock price rose following the announcements, at least two top executives earned millions in profits from exercising stock options and selling Moderna shares. According to SEC disclosures, Chief Financial Officer Lorence Kim, M.D. sold 502,000 shares of Moderna stock between May 12 and May 18 while the stock was near its peak value.16 Those shares had a total value of approximately $36,643,134.17. Id. This was a dramatic departure from Dr. Kim’s previous trading activity: Between January 1, 2020 and May 11, 2020, Dr. Kim had only sold 140,000 shares of Moderna stock, at a total value of $3.7 million.17 According to Moderna, these trades were scheduled in advance under an automated 10b5-1 plan, before he was aware of material non-public information relating to test results and the company’s imminent press announcements on May 15 and May 18. Following the public disclosure of these trades, Kim has announced without explanation that he will be leaving Moderna in August 2020.18 Likewise, SEC disclosures show that Dr. Zak sold a high number of Moderna shares in the period roughly corresponding to Moderna’s press announcements on May 12 and May 18. Starting on May 12 and ending on May 19, Dr. Zaks sold 250,088 shares of Moderna Stock, for a total value of approximately $17,829,420.30.19 These sales also represented much larger quantities than Dr. Zaks had historically sold. In the first five months of 2020 combined, Dr. Zaks had only sold 104,770 shares of Moderna stock.20 Moderna has also claimed that Dr. Zak’s trades were pre-scheduled through an automated 10b5-1 plan, supposedly before he was in possession of material non-public information, such as the May 12 and May 18 public announcements.21 16 See Appendix A, Trading Activity of CFO Lorence Kim, May 12, 2020 – May 18, 2020. 17 See Appendix B, Trading Activity of CFO Lorence Kim, January 1, 2020 – May 11, 2020. 18 Moderna Reports First Quarter 2020 Financial Results and Provides Business Updates, BUSINESS WIRE (May 7, 2020), https://www.businesswire.com/news/home/20200507005478/en/Moderna-Reports-Quarter-2020Financial-Results-Business. 19 See Appendix C, Trading Activity of CMO Zaks Tal Zvi, May 12, 2020 – May 18, 2020. 20 See Appendix D, Trading Activity of CMO Zaks Tal Zvi, January 1, 2020 – May 11, 2020. 21 Michael Hiltzik, Column: Moderna Execs Sold $29 Million In Stock After Its Early Vaccine Announcement, L.A. TIMES (May 26, 2020), https://www.latimes.com/business/story/2020-05-26/moderna-execs-stock-sales. POSSIBLE SECURITIES VIOLATIONS The above facts potentially give rise to two distinct violations of the federal securities laws that merit investigation by the SEC, as well other law-enforcement authorities. The suspicious coincidence of the timing of the trades by Drs. Kim and Zaks in conjunction with Moderna’s public announcements, which were ultimately undermined by experts, raises serious questions—specifically, whether Drs. Kim and Zaks traded on the basis of material nonpublic information in violation of Section 10(b) of the Securities Exchange Act of 1934 (Exchange Act) and its implementing regulation, Rule 10b-5. See 15 U.S.C. § 78j(b); 17 C.F.R. § 240.10b5-1. If the executives knew about the results of Moderna’s test trials and public announcements relating to the trials, and set trades exploiting their foreknowledge under 105-1 plans, they profited by violating the federal securities laws. Indeed, the SEC prosecuted similar misconduct in the cases of Drs. Franklin M. Chu and Daniel J. Lama in the Central District of California.22 In those cases, the Commission alleged that the defendants, two medical investigators who led clinical trials for an experimental drug to treat prostate cancer, learned that the FDA was halting the trials because of negative side effects. The Commission brought charges against Dr. Chu for insider trading, charges that resulted in disgorgement and civil penalties for Chu and Lama.23 Moderna has explained the massive uptick in trading activity by Drs. Kim and Zaks by explaining that the transactions were through Rule 10b5–1 trading plans, such that the sales were planned before the executives learned of the trial results or the press announcements.24 But questions still remain about (1) when the trades were scheduled; (2) when Drs. Zaks and Kim learned of the test results and press announcements that naturally would be expected to—and, in fact, did—boost the company’s share price; (3) and why Moderna chose to release the statements when it did. Moreover, the Commission should also investigate whether Moderna and corporate principals illegally manipulated the financial markets, particularly Dr. Slaoui, whose statement in the Rose Garden regarding knowledge of successful vaccine trials surely boosted Moderna’s reputation. As you are aware, a defendant commits market violation in violation of the Commodity Exchange Act when the defendant possesses an ability to influence market prices and intentionally causes artificial price inflation. See In re Amaranth Nat. Gas Commodities 22 See SEC v. Franklin M. Chu, Civil Action No. 5:14-cv-00995 (C.D. Cal.); SEC v. Daniel J. Lama, Civil Action No. 5:14-cv-00996 (C.D. Cal.). 23 Litigation Release, SEC Charges Two Clinical Drug Trial Doctors with Insider Trading, May 19, 2014, available at: https://www.sec.gov/litigation/litreleases/2014/lr22996.htm 24 Michael Hiltzik, Column: Moderna Execs Sold $29 Million In Stock After Its Early Vaccine Announcement, L.A. TIMES (May 26, 2020), https://www.latimes.com/business/story/2020-05-26/moderna-execs-stock-sales. Litig., 730 F.3d 170, 173 (2d Cir. 2013). Given Dr. Slaoui’s former position on Moderna’s Board of Directors and high-profile political appointment, his highly-publicized reference to personal knowledge of a vaccine breakthrough could only be understood by the public as a preview to imminent \promising news regarding Moderna’s vaccine trials. His influence, magnified by the platform provided by the Rose Garden, gave Dr. Slaoui ample opportunity to inflate Moderna’s stock price artificially. Thus, the Commission should also investigate his conduct, and whether it was coordinated with others at Moderna. CONCLUSION In sum, the activities described above suggest that securities laws, as well as federal criminal laws, may have been violated by Moderna, and Drs. Kim, Zaks, and Slaoui. I recommend a full investigation by federal law-enforcement authorities to either lay these suspicions to rest, or to rectify this misconduct through legal process. Very truly yours, Kyle Herrig President, Accountable.US Enclosures cc: Carl W. Hecker, Inspector General, Office of the Office of Inspector General, SEC Andrew Lelling United States Attorney Office of the U.S. Attorney for the District of Massachusetts Robert Zink Chief, Fraud Section, Criminal Division, U.S. Department of Justice APPENDIX A Trading Activity of CFO Lorence Kim (May 12, 2020 – May 18, 2020) Date 5/12/2020 5/12/2020 5/12/2020 5/12/2020 5/12/2020 5/12/2020 5/12/2020 5/12/2020 5/15/2020 5/15/2020 5/15/2020 5/15/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 5/18/2020 Amount of Shares 11,643 229,357 35,182 31,948 104,544 61,412 5,677 2,237 2,600 5,442 9,715 2,243 29,022 211,978 3,768 7,640 18,675 35,569 16,736 56,379 59,175 33,792 5,868 2,600 798 Acquired (A) or Disposed (D) A A D D D D D D D D D D A A D D D D D D D D D D D Share Price Value Cite $12.21 $10.90 $62.56 $63.57 $64.67 $65.47 $66.43 $67.32 $63.80 $64.96 $66.05 $66.68 $14.22 $12.21 $76.45 $77.48 $79.40 $80.24 $81.43 $82.28 $83.33 $84.27 $85.16 $86.54 $86.96 $142,161.03 $2,499,991.30 $2,200,985.92 $2,030,934.36 $6,760,860.48 $4,020,643.64 $377,123.11 $150,594.84 $165,880.00 $353,512.32 $641,675.75 $149,563.24 $412,692.84 $2,588,251.38 $288,063.60 $591,947.20 $1,482,795.00 $2,854,056.56 $1,362,812.48 $4,638,864.12 $4,931,052.75 $2,847,651.84 $499,718.88 $225,004.00 $69,394.08 SEC Form 4, 5/14/2020 SEC Form 4, 5/14/2020 SEC Form 4, 5/14/2020 SEC Form 4, 5/14/2020 SEC Form 4, 5/14/2020 SEC Form 4, 5/14/2020 SEC Form 4, 5/14/2020 SEC Form 4, 5/14/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 SEC Form 4, 5/19/2020 APPENDIX B Trading Activity of CFO Lorence Kim (January 1, 2020 – May 11, 2020) 1/22/2020 1/27/2020 1/28/2020 2/7/2020 2/25/2020 2/25/2020 Amount of Shares 2,000 23,805 900 33,295 100 1,248 Acquired (A) or Disposed (D) D D D D D D 2/26/2020 12,819 2/26/2020 2/26/2020 3/4/2020 3/16/2020 3/16/2020 3/16/2020 3/16/2020 4/15/2020 Date Share Price Value Cite $23.04 $23.01 $23.37 $23.06 $26.14 $25.59 $46,080.00 $547,753.05 $21,033.00 $767,782.70 $2,614.00 $31,936.32 SEC Form 4, 1/23/2020 SEC Form 4, 1/29/2020 SEC Form 4, 1/29/2020 SEC Form 4, 2/11/2020 SEC Form 4, 2/27/2020 SEC Form 4, 2/27/2020 D $28.79 $369,059.01 SEC Form 4, 2/27/2020 745 5,088 20,000 2,792 6,704 9,370 1,134 6,177 D D D D D D D D $29.46 $27.96 $27.71 $24.68 $25.85 $26.74 $27.39 $34.24 $21,947.70 $142,260.48 $554,200.00 $68,906.56 $173,298.40 $250,553.80 $31,060.26 $211,500.48 SEC Form 4, 2/27/2020 SEC Form 4, 2/27/2020 SEC Form 4, 3/5/2020 SEC Form 4, 3/18/2020 SEC Form 4, 3/18/2020 SEC Form 4, 3/18/2020 SEC Form 4, 3/18/2020 SEC Form D, 4/16/2020 4/15/2020 1,517 D $35.81 $54,323.77 SEC Form D, 4/16/2020 4/15/2020 4/15/2020 4/15/2020 4,566 7,340 400 D D D $36.57 $37.62 $38.24 $166,978.62 $276,130.80 $15,296.00 SEC Form D, 4/16/2020 SEC Form D, 4/16/2020 SEC Form D, 4/16/2020 APPENDIX C Trading Activity of CMO Zaks Tal Zvi (May 12, 2020 – May 19, 2020) Date Amount of Shares Acquired (A) or Disposed (D) Share Price Value Cite 5/12/2020 1,365 D $66.43 $90,676.95 SEC Form 4, 5/14/2020 5/12/2020 19,817 D $63.59 $1,260,163.03 SEC Form 4, 5/14/2020 5/12/2020 125,044 A $12.21 $1,526,787.24 SEC Form 4, 5/14/2020 5/12/2020 25,905 D $65.46 $1,695,741.30 SEC Form 4, 5/14/2020 5/12/2020 17,744 D $62.65 $1,111,661.60 SEC Form 4, 5/14/2020 5/12/2020 300 D $67.23 $20,169.00 SEC Form 4, 5/14/2020 5/12/2020 59,913 D $64.72 $3,877,569.36 SEC Form 4, 5/14/2020 5/19/2020 125,044 D $78.16 $9,773,439.04 SEC Form 4, 5/20/2020 5/19/2020 12,563 A $12.21 $153,394.23 SEC Form 4, 5/20/2020 5/19/2020 112,481 A $12.21 $1,373,393.01 SEC Form 4, 5/20/2020 APPENDIX D Trading Activity of CMO Zaks Tal Zvi (January 1, 2020 – May 11, 2020) Date Amount of Shares Acquired (A) or Disposed (D) Share Price Value Cite 2/21/2020 10,000 D $18.47 $184,700.00 SEC Form 4, 2/24/2020 2/28/2020 16,1120 A $25.93 $4,177,841.60 SEC Form 4, 3/3/2020 2/28/2020 10,000 D $23.38 $233,800.00 SEC Form 4, 3/3/2020 3/6/2020 10,000 D $27.98 $279,800.00 SEC Form 4, 3/9/2020 3/13/2020 10,000 D $23.00 $230,000.00 SEC Form 4, 3/16/2020 3/20/2020 10,000 D $29.13 $291,300.00 SEC Form 4, 3/23/2020 3/27/2020 10,000 D $28.37 $283,700.00 SEC Form 4, 3/30/2020 4/3/2020 10,000 D $32.81 $328,100.00 SEC Form 4, 4/6/2020 4/13/2020 10,000 D $32.00 $320,000.00 SEC Form 4, 4/14/2020 4/17/2020 10,000 D $48.81 $488,100.00 SEC Form 4, 4/20/2020 4/24/2020 10,000 D $47.15 $471,500.00 SEC Form 4, 4/27/2020 5/5/2020 4,770 D $50.48 $240,789.60 SEC Form 4, 5/6/2020