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The accompanying interim unaudited consolidated financial statements of Opexa Therapeutics, Inc. (“Opexa” or the “Company”), have been prepared in accordance with accounting principles generally accepted in the United States of America and the rules of the Securities and Exchange Commission (“SEC”) and should be read in conjunction with the audited financial statements and notes thereto contained in Opexa’s latest Annual Report filed with the SEC on Form 10-K. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim periods presented have been reflected herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the consolidated financial statements that would substantially duplicate the disclosure contained in the audited consolidated financial statements for the most recent fiscal year as reported in Form 10-K have been omitted.
The accompanying consolidated financial statements include the accounts of Opexa and its wholly owned subsidiaries, Opexa Hong Kong Limited and Opexa Merger Sub, Inc. All intercompany balances and transactions have been eliminated in the consolidation.
Going Concern. The accompanying interim unaudited consolidated financial statements for the six months ended June 30, 2017 have been prepared assuming that the Company will continue as a going concern, meaning the Company will continue in operation for the foreseeable future and will be able to realize assets and discharge liabilities in the ordinary course of operations. As of June 30, 2017, the Company had cash and cash equivalents of $1.8 million as well as accounts payable, short-term notes payable and accrued expenses aggregating $368,547. While the Company has historically recognized revenue related to certain upfront payments received from Ares Trading SA (“Merck Serono”), a wholly owned subsidiary of Merck Serono S.A., in connection with the Option and License Agreement and an amendment thereto between Merck Serono and the Company, the Company has never generated any commercial revenues, nor does it expect to generate any commercial revenues for the foreseeable future or other revenues in the near term that will result in cash receipts. Opexa continues to incur net losses, negative operating cash flows and has an accumulated deficit of approximately $162.9 million as of June 30, 2017. These factors raise substantial doubt as to the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Following the disappointing results from the Phase IIb clinical trial, or Abili-T, announced on October 28, 2016 of its lead product candidate, Tcelna, in patients with secondary progressive MS, or SPMS, during the fourth quarter of 2016 Opexa’s board of directors began evaluating its strategic options to maximize shareholder value, including the possibility of a merger, a sale of the company or all or some of its assets and/or distributing some or all of Opexa’s remaining cash through either a dividend or liquidation of Opexa. During the fourth quarter of 2016 and first quarter of 2017, the Company implemented several reductions in workforce totaling 90% of its then 20 full-time employees. As of June 30, 2017, Opexa had two full-time employees. After further analysis of the data from the Abili-T trial, the Company has determined that it will not move forward with further studies of Tcelna in SPMS at this time and is conducting a review of its preclinical program for OPX-212 in neuromyelitis optica (“NMO”) and the related T-cell platform to assess the viability of continuing to pursue this program. On June 30, 2017, Opexa entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with Acer Therapeutics, Inc. (“Acer”) pursuant to which, among other things, subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, a wholly owned subsidiary of Opexa will merge with and into Acer, with Acer becoming a wholly owned subsidiary of Opexa and the surviving corporation in the Merger. Opexa’s ability to close the proposed Merger with Acer entails numerous significant risks and uncertainties, including the risks and uncertainties set forth in the section entitled “Risk Factors.”
Opexa cannot predict whether or to what extent it might resume drug development activities, or what its future cash needs would be for any such activities. Opexa’s future capital requirements, both near and long-term, will depend on many factors, including, but not limited to the timing and completion of the proposed Merger with Acer and the extent to which Opexa elects to pursue drug development activities in the future.
As Opexa pursues the proposed Merger with Acer, it will continue to explore potential opportunities and alternatives to preserve options should the Merger not be consummated. Additional options may include raising additional capital through either private or public equity or debt financing as well as using its ATM facility and cutting expenses where possible. Opexa believes its ability to issue equity securities or obtain debt financing in the future on favorable terms, or at all, has been substantially impaired, given the disappointing results from the Abili-T trial. There can be no assurance that Opexa will be able to secure additional funds or, if such funds are available, whether the terms or conditions would be acceptable to Opexa.
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Cash and Cash Equivalents.
Opexa considers all highly liquid investments with an original maturity of three months or less, when purchased, to be cash equivalents. Investments with maturities in excess of three months but less than one year are classified as short-term investments and are stated at fair market value.
Opexa primarily maintains cash balances on deposit in accounts at a U.S.-based financial institution. The aggregate cash balance on deposit in these accounts is insured by the Federal Deposit Insurance Corporation up to $250,000. Opexa’s cash balances on deposit in these accounts may, at times, exceed the federally insured limits. Opexa has not experienced any losses in such accounts.
As of June 30, 2017, Opexa had approximately $1.6 million in a savings account. For the six months ended June 30, 2017, the savings account recognized an average market yield of 0.06%. Interest income of $648 was recognized for the six months ended June 30, 2017 in the consolidated statements of operations.
Recent Accounting Pronouncements. The Company has implemented all new accounting pronouncements that are in effect and that may impact its consolidated financial statements. Management has also considered all recent accounting pronouncements issued since the last audit of the Company’s financial statements. The Company’s management believes that these recent pronouncements will not have a material effect on the Company’s financial statements.
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Other current assets consisted of the following at June 30, 2017 and December 31, 2016:
| Description | June 30, 2017 | December 31, 2016 | ||||||
| Deferred offering costs | $ | 49,918 | $ | 111,641 | ||||
| Prepaid expense | 106,052 | 259,921 | ||||||
| Total Other Current Assets | $ | 155,970 | $ | 371,562 | ||||
Deferred offering costs at June 30, 2017 and December 31, 2016 were $49,918 and $111,641 respectively. The June 30, 2017 balance includes costs incurred from third parties in connection with the March 25, 2016 implementation of a new Sales Agreement (“ATM Agreement”) with IFS Securities, Inc. (doing business as Brinson Patrick, a division of IFS Securities, Inc.) as sales agent, pursuant to which Opexa can offer and sell shares of common stock from time to time depending upon market demand, in transactions deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933. These are included in other current assets in the consolidated balance sheets. Upon the sales of shares of common stock under the ATM Agreement, these capitalized costs will be offset against the proceeds of such sales of shares of common stock and recorded in additional paid in capital. As of June 30, 2017, $61,723 of deferred offering costs were recorded in additional paid in capital.
Prepaid expenses at June 30, 2017 and December 31, 2016 were $106,052 and $259,921 respectively. Included in the June 30, 2017 balance is $71,947 of prepaid insurance as well as the remaining balance of Opexa’s NASDAQ Capital Market All-Inclusive Annual Fee of $27,500. The remaining balances are attributable to various service contracts and deposits.
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Notes payable consists of a commercial insurance premium finance agreement - promissory note with AFCO of which $19,604 and $136,038 was outstanding as of June 30, 2017 and December 31, 2016, respectively. The loan has an interest rate of 3.5% per annum and matures July 1, 2017. The second note is also a commercial insurance premium finance agreement – promissory note with AFCO of which $6,928 and $20,604 was outstanding as of June 30, 2017, and December 31, 2016, respectively. The loan has an interest rate of 3.5% per annum and matures September 1, 2017. Payments on the above notes are due and payable monthly until maturity.
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For the six months ended June 30, 2017, equity related transactions were as follows:
During January 2017, Opexa sold an aggregate of 516,278 shares of common stock under its ATM facility with IFS Securities, Inc. (doing business as Brinson Patrick, a division of IFS Securities, Inc.) as sales agent, for gross proceeds of $490,098. Proceeds net of fees and deferred offering costs were $413,662.
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Stock Options
Opexa accounts for stock-based compensation, including options and nonvested shares, according to the provisions of FASB ASC 718, "Share Based Payment.” During the six months ended June 30, 2017, Opexa recognized stock-based compensation expense of $96,554. Unamortized stock-based compensation expense as of June 30, 2017, amounted to $187,063.
Stock Option Activity
A summary of stock option activity for the six months ended June 30, 2017 is presented below:
| Number of Shares | Weighted Avg. Exercise Price |
Weighted Average Remaining Contract Term (# years) |
Intrinsic Value | |||||||||||||
| Outstanding at December 31, 2016 | 481,947 | $ | 12.14 | 7.60 | ||||||||||||
| Exercised | — | — | ||||||||||||||
| Forfeited and canceled | (253,492 | ) | 11.83 | |||||||||||||
| Outstanding at June 30, 2017 | 228,455 | $ | 12.49 | 6.94 | $ | — | ||||||||||
| Exercisable at June 30, 2017 | 185,697 | $ | 14.21 | 6.44 | $ | — | ||||||||||
Employee Options and Non-Employee Options
Option awards are granted with an exercise price equal to the market price of Opexa’s stock at the date of issuance, generally have a ten-year life, and have various vesting dates that range from no vesting or partial vesting upon date of grant to full vesting on a specified date. Opexa estimates the fair value of stock options using the Black-Scholes option-pricing model and records the compensation expense ratably over the service period.
Opexa recognized stock based compensation expense of $96,554 and $342,713 during the six months ended June 30, 2017 and 2016, respectively, for grants made to employees.
In addition, during the six months ended June 30, 2017 there were 253,492 shares underlying options that were forfeited and cancelled.
There were no stock options or restricted stock awards granted during the six months ended June 30, 2017.
Warrant Activity
A summary of warrant activity for the six months ended June 30, 2017 is presented below:
| Number of Shares | Weighted Avg. Exercise Price |
Weighted Average Remaining Contract Term (# years) |
Intrinsic Value | |||||||||||||
| Outstanding at December 31, 2016 | 3,596,625 | $ | 12.39 | 1.21 | — | |||||||||||
| Forfeited and canceled | (127,894 | ) | 12.72 | — | ||||||||||||
| Outstanding at June 30, 2017 | 3,468,731 | 12.38 | 0.75 | $ | — | |||||||||||
| Exercisable at June 30, 2017 | 3,468,731 | 12.38 | 0.75 | $ | — | |||||||||||
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License Agreement with Baylor College of Medicine
In 2001, Opexa entered into an agreement with Baylor College of Medicine for the exclusive worldwide license to a patient-specific, autologous T-cell immunotherapy for the treatment of MS, which is the initial T-cell technology on which Tcelna is based, including rights to certain patents held by Baylor. In consideration for the right and license to commercially exploit such technology, Opexa agreed to pay the following (per scenario 1 of the license agreement): (i) a 2% royalty on net sales of licensed patented products sold by Opexa or its affiliates where annual gross sales of such products is less than or equal to $500 million; (ii) a 1% royalty on net sales of licensed patented products sold by Opexa or its affiliates where annual gross sales of such products exceed $500 million; (iii) a 1% royalty on net sales of licensed patent pending products sold by Opexa or its affiliates; and (iv) a 1% royalty on net sales of licensed patented products or licensed patent pending products sold by any sublicensees of Opexa. Unless earlier terminated, the Baylor license agreement expires in 2025 upon expiration of the last of the licensed patent rights.
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On February 1, 2017, Opexa entered into an Assignment and Assumption of Lease with KBI Biopharma, Inc. (KBI), pursuant to which Opexa assigned to KBI, and KBI assumed from Opexa, all of Opexa’s remaining rights and obligations under the lease for Opexa’s 10,200 square foot corporate headquarters facility located in The Woodlands, Texas. The facility was originally leased by Opexa from Dirk D. Laukien, as landlord, pursuant to a lease dated August 19, 2005 as amended by that certain First Amendment to Lease Agreement dated May 11, 2015. In light of Opexa’s continuing evaluation of its strategic alternatives following the release of the data from the Abili-T clinical study, management deemed it advisable to reduce the office, R&D and manufacturing space and corresponding rent obligations. The lease had a remaining term through September 2020 and current monthly base rental payments of $16,666.67 with payment escalations to $17,500 over the remaining term. In connection with the lease assignment, Opexa also sold certain furniture, fixtures and equipment (including laboratory and manufacturing equipment) as well as its laboratory supplies located at its corporate headquarters to KBI for cash consideration in the amount of $50,000.
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Opexa considers all highly liquid investments with an original maturity of three months or less, when purchased, to be cash equivalents. Investments with maturities in excess of three months but less than one year are classified as short-term investments and are stated at fair market value.
The Company has implemented all new accounting pronouncements that are in effect and that may impact its consolidated financial statements. Management has also considered all recent accounting pronouncements issued since the last audit of the Company’s financial statements. The Company’s management believes that these recent pronouncements will not have a material effect on the Company’s financial statements.
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| Description | June 30, 2017 | December 31, 2016 | ||||||
| Deferred offering costs | $ | 49,918 | $ | 111,641 | ||||
| Prepaid expense | 106,052 | 259,921 | ||||||
| Total Other Current Assets | $ | 155,970 | $ | 371,562 | ||||
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| Number of Shares | Weighted Avg. Exercise Price |
Weighted Average Remaining Contract Term (# years) |
Intrinsic Value | |||||||||||||
| Outstanding at December 31, 2016 | 481,947 | $ | 12.14 | 7.60 | ||||||||||||
| Exercised | — | — | ||||||||||||||
| Forfeited and canceled | (253,492 | ) | 11.83 | |||||||||||||
| Outstanding at June 30, 2017 | 228,455 | $ | 12.49 | 6.94 | $ | — | ||||||||||
| Exercisable at June 30, 2017 | 185,697 | $ | 14.21 | 6.44 | $ | — | ||||||||||
| Number of Shares | Weighted Avg. Exercise Price |
Weighted Average Remaining Contract Term (# years) |
Intrinsic Value | |||||||||||||
| Outstanding at December 31, 2016 | 3,596,625 | $ | 12.39 | 1.21 | — | |||||||||||
| Forfeited and canceled | (127,894 | ) | 12.72 | — | ||||||||||||
| Outstanding at June 30, 2017 | 3,468,731 | 12.38 | 0.75 | $ | — | |||||||||||
| Exercisable at June 30, 2017 | 3,468,731 | 12.38 | 0.75 | $ | — | |||||||||||
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