If the filing person has previously filed a statement on Schedule 13G to report the acquisition which is the subject of this Schedule 13D, and is filing this schedule because of Rule 13d-1(e), Rule 13d-1(f) or Rule 13d-1(g), check the following box  ¨.

Note: Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See Rule 13d-7(b) for other parties to whom copies are to be sent.

The information required on the remainder of this cover page shall not be deemed to be “filed” for purpose of Section 18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).

(1)    Calculated based on (i) 771,959,579 shares outstanding as of July 28, 2022, as reported by the Issuer in its Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 4, 2022.

(1)    Includes (i) 27,599,870 shares of Common Stock held individually by Dr. Hsiao; (ii) 5,127,404 shares of Common Stock held by Hsu Gamma Investment, L.P. (“Hsu Gamma”), which is controlled by Dr. Hsiao as general partner; (iii) options to acquire 2,250,000 shares of Common Stock, which are exercisable within 60 days; and (v) approximately 1,000,000 shares of Common Stock underlying $5,000,000 of the Issuer’s 5% Convertible Promissory Notes (the “Notes”), which Notes were issued on February 27, 2018 and mature on February 27, 2023 and may be redeemed at any time prior to maturity upon 30 days’ notice at a conversion price of $5.00, subject to adjustment. If the holder elects to convert the Notes, the note holder would receive 200 shares of the Issuer’s Common Stock per $1,000 of principal amount of Notes.

(2)    Calculated based on (i) 771,959,579 shares outstanding as of July 28, 2022, as reported by the Issuer in its Form 10-Q filed with the SEC on August 4, 2022; (ii) options to acquire 2,250,000 shares of Common Stock, which are exercisable within 60 days; and (iii) 1,000,000 shares of Common Stock underlying the Notes.

(a)-(b) Dr. Hsiao may be deemed to beneficially own 35,977,274 shares of Common Stock, which consist of (i) 5,127,404 shares of Common Stock held by Hsu Gamma, and (ii) 29,887,360 shares of Common Stock held individually. The 29,887,360 shares of Common Stock individually held by Dr. Hsiao include (i) 27,599,870 shares of Common Stock held individually; and (iii) options to purchase 2,250,000 shares of Common Stock, exercisable within 60 days of the date hereof. The 35,977,274 shares of Common Stock beneficially owned by Dr. Hsiao constitute approximately 4.6% of the Issuer’s outstanding shares of Common Stock, based upon 771,959,579 shares of Common Stock outstanding as of July 28, 2022 as reported by the Issuer in its Form 10-Q filed with the SEC on August 4, 2022, and calculated in accordance with Rule 13d-3. Dr. Hsiao has sole voting and dispositive power over 35,977,274 shares of Common Stock.

Hsu Gamma beneficially owns 5,127,404 shares of Common Stock, which constitutes approximately 0.7% of the Issuer’s outstanding shares of Common Stock, based upon 771,959,579 shares of Common Stock outstanding as of July 28, 2022 as reported by the Issuer in its Form 10-Q filed with the SEC on August 4, 2022, and calculated in accordance with Rule 13d-3. Dr. Hsiao is the general partner of Hsu Gamma and holds sole voting and dispositive power with respect to the 5,127,404 shares of Common Stock held by Hsu Gamma.