UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): December 19, 2017

 

 

 

ELOXX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-31326   84-1368850

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

950 Winter Street, Waltham, MA   02451
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (781) 557-5300

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

  ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 2.01 Completion of Acquisition or Disposition of Assets.

 

On December 19, 2017,  Eloxx Pharmaceuticals Ltd., an Israeli company (“Eloxx”) and Sevion Sub Ltd., an Israeli company (“Acquisition Sub”), and a wholly-owned subsidiary of Sevion Therapeutics, Inc., a Delaware corporation (the “Company”), completed the previously announced merger of Acquisition Sub with and into Eloxx, with Eloxx surviving the merger as a wholly-owned subsidiary of the Company (the “Transaction”). The Transaction was effected pursuant to an Agreement, dated May 31, 2017, by and among the Company, Acquisition Sub and Eloxx as amended on August 1, 2017 and on November 23, 2017 (the “Agreement”).

 

Pursuant to the terms and conditions of the Agreement, at the effective time of the Transaction (the “Effective Time”), each issued and outstanding ordinary and preferred share of Eloxx was converted into the right to receive 5.28 shares of Company common stock, par value 0.01 (the “Common Stock”) after giving effect to the Reverse Stock Split (the “Exchange Ratio”) (as defined in Item 3.03 below), which shall constitute, an aggregate of 68.74% of the issued and outstanding capital stock of the Company as of the Effective Time, calculated on a Fully Diluted As Converted Basis (as defined in the Agreement), but excluding any then outstanding warrants and options to acquire shares of the Company’s Common Stock and any of the warrants and options to acquire ordinary shares of Eloxx that were assumed by the Company in connection with the Transaction.

 

At the Effective Time, the Company also assumed both the outstanding options of Eloxx and the outstanding warrants of Eloxx, each of which was converted into an option or warrant, as applicable, to acquire shares of Company Common Stock. In addition, as part of the Company’s assumption of the outstanding Eloxx options, the Company also assumed Eloxx’s 2013 Share Ownership and Stock Option Plan, including the shares reserved under such plan (as described below in Item 3.02). No fractional shares of common stock were issued in connection with the Transaction. Instead, stockholders of record who were otherwise entitled to receive fractional shares will receive a cash payment.

 

On December 19, 2017, in connection with the Certificate of Amendment described below in Item 5.03 and the consummation of the Transaction, the Company changed its name from “Sevion Therapeutics, Inc.” to “Eloxx Pharmaceuticals, Inc.,” and on December 20, 2017 the stock of the combined company began trading on the OTCQB Marketplace under the name Eloxx Pharmaceuticals, Inc. A copy of the Certificate of Amendment effecting the name change is attached hereto as Exhibit 3.1 and is incorporated herein by reference. This discussion is qualified in its entirety by reference to the full text of the Certificate of Amendment.

 

The foregoing description of the Agreement and the Transaction is not complete and is subject to, and qualified in its entirety by, the full text of the Agreement, which was attached as Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on June 6, 2017, the Amendment to the Agreement, dated as of August 1, 2017, by and among the Company, Acquisition Sub and Eloxx, which was attached as Exhibit 2.3 to the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2017, and the Second Amendment to the Agreement, dated as of November 23, 2017, by and among the Company, Acquisition Sub and Eloxx, which was attached at Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 29, 2017, the terms of which are incorporated herein by reference.

 

Item 3.02 Unregistered Sales of Equity Securities.

 

Pursuant to the Agreement, in connection with the Transaction, the Company issued 20,316,656 shares of common stock to the existing shareholders of Eloxx. Of this amount, approximately 11.9 million shares were issued to existing shareholders of Eloxx pursuant to a certain share purchase agreement previously entered into among Eloxx and certain investors (pursuant to which $21.5 million was invested during the period from May 2017 until August 2017, and an additional $4 million was invested upon consummation of the Transaction).

 

Pursuant to the subscription agreements previously entered into among the Company and certain investors, as previously disclosed in the Company’s Current Report on Form 8-K dated July 28, 2017, the Company issued approximately 4,499,997 shares upon consummation of the Transaction.  An additional 500,000 shares were previously issued in July 2017 pursuant to such subscription agreements.   

 

In addition, at the Effective Time, the Company assumed the obligations under outstanding warrants previously issued by Eloxx and, in connection therewith, issued warrants to purchase 346,307 shares of the Company’s common stock to certain warrant holders of Eloxx.

 

Further, at the Effective Time, the Company assumed all of the outstanding obligations under the Eloxx 2013 Share Ownership and Option Plan (the “2013 Plan”) and, accordingly, the Company has reserved 2,307,738 shares of the Company’s common stock for issuance upon the exercise of such options. As part of the Company’s assumption of the outstanding options under the 2013 Plan, the Company also assumed the 2013 Plan and accordingly reserved 189,751 shares of the Company’s common stock for future grants. (such number excludes the grants to Mr. Gregory Weaver and Dr. Neal Sharpe, approved by the Company’s Board on December 20, 2017).

 

 

 

 

The number of securities issued, the nature of the Transaction, and the nature and amount of consideration received by the Company are described in Item 2.01 of this Form 8-K, which is incorporated by reference into this Item 3.02. Such sales were exempt from registration under Section 4(a)(2) and Regulation D under the Securities Act of 1933, as amended (the “Securities Act”), and the rules promulgated thereunder.

 

Item 3.03 Material Modification to Rights of Security Holders.

 

As previously announced in the Company’s Current Report on Form 8-K dated December 7, 2017, at a special meeting of the stockholders of the Company held on December 7, 2017, the Company’s stockholders approved the Company’s Amended and Restated Certificate of Incorporation, as amended, to effect a reverse split of the Company’s Common Stock and authorized the Company’s Board of Directors (the “Board”) to, in its sole discretion, select a ratio between 1-for-2 and 1-for-100, inclusive.

 

Subsequently, the Board determined to set the reverse stock split ratio at 1-for-20 (the “Reverse Stock Split”). The Reverse Stock Split became effective as of 4:00 p.m., Eastern Time on December 19, 2017, pursuant to a Certificate of Amendment (the “Certificate of Amendment”) to the Company’s Amended and Restated Certificate of Incorporation, as amended, filed with the Secretary of State of the State of Delaware on December 18, 2017.

 

A copy of the Certificate of Amendment is attached hereto as Exhibit 3.2 and is incorporated herein by reference. This discussion is qualified in its entirety by reference to the full text of the Certificate of Amendment.

 

In connection with the Reverse Stock Split, the CUSIP number of the Common Stock was changed to 29014R 103. The Common Stock began trading on the OTCQB Marketplace on a split-adjusted basis on December 20, 2017.

 

As a result of the Reverse Stock Split, every twenty (20) shares of the Company’s issued and outstanding Common Stock will be converted into one (1) share of Common Stock, reducing the number of issued and outstanding shares of the Company’s Common Stock from approximately 53,957,518 to approximately 2,697,876 million, including and accounting for the issuance of shares in connection with the Transaction. There was no change in the par value of the Common Stock.

 

No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who otherwise would be entitled to receive fractional shares because they hold a number of pre-reverse stock split shares of the Company’s common stock not evenly divisible by twenty (20), instead received a cash amount equal to the resulting fractional interest in one share of the Company’s Common Stock to which the stockholder would have otherwise be entitled at the closing trading price of the Company’s Common Stock on December 18, 2017, the trading day immediately preceding the effective date of the reverse stock split, multiplied by twenty.

 

The Reverse Stock Split will not change the authorized number of shares of Common Stock or preferred stock of the Company. Pursuant to the terms of the Company’s outstanding convertible securities, its options and warrants, the number of shares into which such convertible securities may be converted will be proportionately adjusted to reflect the Reverse Stock Split, and, pursuant to their terms, a proportionate adjustment will be made to the per share exercise price and number of shares issuable under of all of the Company’s outstanding stock options and warrants to Common Stock, and the number of shares reserved for issuance pursuant to the Company’s equity compensation plans will be reduced proportionately.

 

Item 4.01 Changes in Registrant’s Certifying Accountant.

 

Effective on December 19, 2017, the Company dismissed RSM US LLP (“RSM”) as its independent registered public accounting firm. Effective December 20, 2017, the Board engaged Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global (“EY”), as the independent registered public accounting firm to audit the Company’s financial statements for the fiscal year ending December 31, 2017.

 

RSM audit reports on the Company’s financial statements for the fiscal years ended June 30, 2016 and June 30, 2017 did not contain an adverse opinion or a disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles, except that the reports contained an explanatory paragraph noting that there was substantial doubt as to the Company’s ability to continue as a going concern. In addition, Sevion management concluded that there was a reportable event pursuant to Item 304(a)(1)(v)(A) of Regulation S-K, due to Sevion management’s determination that material weaknesses existed in Sevion’s internal control over financial reporting as of June 30, 2016 and June 30, 2017 and, as a result, its disclosure controls and procedures were not effective.

 

 

 

 

During the years ended June 30, 2016 and June 30, 2017 and the subsequent interim period through the date of RSM dismissal, there were no disagreements with RSM on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of RSM would have caused it to make reference to the subject matter thereof in connection with its report.

 

During the years ended June 30, 2016 and June 30, 2017 and the subsequent interim period through the date of RSM’s dismissal, neither the Company nor anyone acting on its behalf consulted EY regarding the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on the Company’s financial statements.

 

The Company provided RSM with a copy of this report prior to the filing hereof and have requested that RSM furnish to us a letter addressed to the SEC stating whether it agrees with the statements made by us in this report. RSM has furnished such letter, which letter is filed as an exhibit hereto, as required by Item 304(a)(3) of Regulation S-K under the Securities Act. 

 

Item 5.01 Changes in Control of Registrant.

 

The information set forth in Item 2.01 regarding the Transaction and the information set forth in Item 5.02 regarding the Company’s Board is incorporated by reference into this Item 5.01.

 

Item 5.02 Departure of Directors of Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

 

Director Departures

 

On December 14, 2017, and effective at the Effective Time, David Rector, John Braca, and Dr. Phillip Frost resigned from their positions as directors of the Company. On December 18, 2017, and effective at the Effective Time, Dr. Vaughn Smider resigned from his position as director of the Company. Their resignations were in connection with the Transaction and not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Mr. Steven Rubin continues to serve as a director of the Company.

 

Appointment of Directors

 

Effective on December 19, 2017, Dr. Robert Heft, Tomer Kariv, Ran Nussbaum, Dr. Silvia Noiman, Gadi Veinrib, Dr. Zafrira Avnur and Martijn Kleijwegt, each of whom served on the board of directors of Eloxx prior to the Transaction, were appointed to the Board.

 

Except for the provisions of the Agreement pursuant to which Eloxx and certain significant shareholders have rights to designate members of the Board, there is no arrangement or understanding between Dr. Heft, Mr. Kariv, Mr. Nussbaum, Dr. Noiman, Mr. Veinrib, Dr. Avnur and Mr. Kleijwegt, respectively, and any other person pursuant to which any of Dr. Heft, Mr. Kariv, Mr. Nussbaum, Dr. Noiman, Mr. Veinrib, Dr. Avnur and Mr. Kleijwegt was appointed as a director. 

 

The Board appointed the following directors to serve on the following committees of the Board:

 

Committee   Directors
Audit Committee   Steven Rubin, Martijn Kleijwegt and Gadi Veinrib
Compensation Committee   Dr. Robert Heft, Gadi Veinrib and Dr. Zafrira Avnur
Corporate Governance and Nominating Committee   Dr. Robert Heft, Gadi Veinrib and Dr. Zafrira Avnur

 

 

 

 

 

 

 

Named Executive Officers Departures

 

As of the Effective Time, on December 19, 2017, each of David Rector (Chief Executive Officer), Dr. Vaughn Smider (Chief Scientific Officer ), Dr. Miguel A. de los Rios (Vice President of Research and Development), Dr. James Graziano (Chief Technology Officer) and James Schmidt (Chief Financial Officer) voluntarily resigned from their respective positions as officers of the Company.

 

Pursuant to Sevion’s retention policy, Dr. Smider, Dr. de los Rios and Dr. Graziano will receive cash payments of $40,000, $87,500 and $122,500, respectively, as severance. Dr. de los Rios and Dr. Graziano will also received $33,000 each to cover certain employee benefits costs.

 

Appointment of Officers

 

Following the consummation of the Transaction, on December 20, 2017, Dr. Silvia Noiman was appointed Chief Executive Officer of the Company. In this role Dr. Noiman will serve as the Company’s Principal Executive Officer. In addition, also effective on December 20, 2017, Gregory Weaver and Dr. Pedro Huertas were appointed as the Chief Financial Officer of the Company and Chief Medical Officer of the Company, respectively. In his role as Chief Financial Officer, Mr. Weaver will serve as the Company’s Principal Accounting Officer.

 

Employment Arrangement with Dr. Silvia Noiman

 

The terms of Dr. Noiman’s compensation for service as an officer of the Company have not yet been determined.  The Company is currently compensating Dr. Noiman in accordance with the terms of her consulting agreement with Eloxx, dated as of December 1, 2014, which is attached as Exhibit 10.1 hereto.

 

Pursuant to her consulting agreement, Dr. Noiman is entitled to a monthly consulting fee of Israeli New Shekel (NIS) 60,000, plus the applicable value added tax. In addition, upon the completion of certain performance milestones, the Compensation Committee of the Board may consider, at its sole discretion, granting Dr. Noiman a bonus, in an amount up to three (3) months of the consulting fee, subject to the approval of the Board. The consulting agreement with Dr. Noiman is terminable by either of the parties by a four (4) months prior written notice to the other party, unless otherwise earlier terminated for cause, in which case a fourteen (14) day prior written notice to Dr. Noiman of any breach is required instead. On April 2014, Dr. Noiman was granted with an option to purchase 349,400 Ordinary Shares of the Company, which were subject to a 3-year vesting, at an exercise price equal to their par value. This option includes an acceleration in the event that Eloxx terminates the engagement with Dr. Noiman, as well as extended exercise period to three (3) years following termination. In addition, Dr. Noiman was granted (i) on November 2014, an option to purchase 74,871 Ordinary Shares of the Company, in the aggregate, valued at $60,000 (which includes an extended exercise period), (ii) on January 2016, an option to purchase 69,880 Ordinary Shares of the Company, in the aggregate, valued at $70,000 (iii) on July 2017, an option to purchase 45,557 Ordinary Shares of the Company, in the aggregate, valued at $43,536 (the foregoing figures have been adjusted to reflect both the Exchange Ratio and the Reverse Stock Split) . These options were assumed by the Company in connection with the Transaction as described in Items 2.01 and 3.02 above.

 

Employment Arrangement with Gregory Weaver

 

The terms of Mr. Weaver’s compensation for service as an officer of the Company, have not yet been determined.  The Company is currently compensating Mr. Weaver in accordance with the terms of his offer letter from Eloxx, dated as of September 11, 2017, which is attached as Exhibit 10.2 hereto.

 

Pursuant to the terms of his offer letter, Mr. Weaver is entitled to an annual salary of $345,000, and to additional employee benefits, such as paid annual vacation days, severance pay, annual recreation allowance, manager’s insurance, sick leave, health and dental insurance, enrollment in the 401k plan and expense reimbursement. In addition, Mr. Weaver is entitled to an annual target bonus of up to 40% of his base salary bonus, determined in accordance with certain performance milestones determined by the Board. Mr. Weaver’s offer letter is terminable by either the company or Mr. Weaver upon thirty (30) days’ prior written notice, unless earlier terminated. Mr. Weaver shall be entitled to a six (6) month severance pay including salary and benefits should his employment be terminated by the Company following the first anniversary of his employment or to a decreased pro-rata amount, if his employment is terminated by the Company prior to such first anniversary, in each case, unless earlier terminated by the Company for cause. Mr. Weaver’s offer letter contains customary provisions regarding confidentiality of information and assignment of inventions to the Company, non-solicitation and non-competition provisions. Mr. Weaver’s offer letter also provides for a grant of share options to purchase an aggregate of 399,266 ordinary shares, par value $0.01 each at an exercise price of $7.00 per share, as adjusted to account for the Reverse Stock Split.

 

 

 

 

Employment Arrangement with Pedro Huertas

 

The terms of Dr. Huertas’ compensation for service as an officer of the Company, have not yet been determined.  The Company is currently compensating Dr. Huertas in accordance with the terms of his offer letter from Eloxx, dated as of April 17, 2015, which is attached as Exhibit 10.3 hereto.

 

Pursuant to the terms of his offer letter, Dr. Huertas is entitled to an annual salary of $300,000, and to additional employee benefits, such as paid annual vacation days, severance pay, vision, health and dental insurance, enrollment in the 401k plan and expenses reimbursement. In addition, Dr. Huertas received a one-time cash bonus of $25,000, which was paid in two equal installments, the first upon executing the offer letter and the second six (6) months after his execution of the offer letter. Mr. Huertas is also entitled to an annual target bonus of up to 30% of his base salary, determined in accordance with certain performance milestones determined by the Board. Dr. Huertas’s offer letter is terminable by either the company or Dr. Huertas upon thirty (30) days’ prior written notice, unless earlier terminated. Dr. Huertas’ shall be entitled to a twelve (12) month severance pay including salary and employee benefits should his employment be terminated by the company following the first anniversary of his employment or to a decreased pro-rata amount, if his employment is terminated by the Company prior to such first anniversary, in each case, unless earlier terminated by the Company for cause. In the event Dr. Huertas’ termination by the Company in connection with a Change of Control Event (as defined in his offer letter) or if Dr. Huertas’ resigns for a good reason within twelve (12) months of such Change of Control Event, Dr. Huertas shall be entitled to (i) a continuation of his salary for twelve (12) months, plus a bonus payment equal to the bonus earned in the preceding year, plus employee benefits and (ii) all unvested and outstanding stock options will accelerate and vest in full as of the time of his termination. Dr. Huertas’ offer letter contains customary provisions regarding confidentiality of information and assignment of inventions to the Company, non-solicitation and non-competition provisions. In addition, Dr. Huertas’ was granted (i) on January 2015, an option to purchase 120,363 Ordinary Shares of the Company, in the aggregate, valued at $120,570, (ii) on May 2015, an option to purchase 24,957 Ordinary Shares of the Company, in the aggregate, valued at $25,000, (iii) on July 2017, an option to purchase 14,395 Ordinary Shares of the Company, in the aggregate, valued at $13,757 (the foregoing figures have been adjusted to reflect both the Exchange Ratio and the Reverse Stock Split).

 

Indemnification Agreements

 

On December 20, 2017, the Company entered into indemnification agreements with each of its incoming directors and executive officers, Dr. Heft, Mr. Kariv, Mr. Nussbaum, Dr. Noiman, Mr. Veinrib, Dr. Avnur, Mr. Kleijwegt, Mr. Weaver and Dr. Huertas as well as, Yair Shamir, in his capacity as an observer. Pursuant to the indemnification agreements, the Company has agreed to indemnify and hold harmless its directors and officers to the fullest extent permitted by the Delaware General Corporation Law. The agreements, subject to limitations contained there in, obligate the Company to cover expenses that a director or officer incurs or amounts that a director or officer becomes obligated to pay because of any proceeding to which he or she is made or threatened to be made a party or participant by reason of his service as a current or former director, officer, employee or agent of the Company, provided that he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Company. The indemnification agreements also create certain rights in favor of the Company, including the right to assume the defense of claims and to consent to settlements. The Indemnification Agreement does not exclude any other rights to indemnification or advancement of expenses to which the indemnitee may be entitled under applicable law, the Company’s certificate of incorporation or bylaws of the Company, any agreement, or otherwise.

 

The foregoing description of the indemnification agreements is not complete and is subject to and qualified in its entirety by reference to the form of indemnification agreement, a copy of which is attached as Exhibit 10.4 hereto, and is incorporated herein by reference.

 

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

 

Effective December 20, 2017, the Company’s Board approved a change in its fiscal year end from June 30 to December 31 to align with the fiscal year end of Eloxx. Following such change, the date of the Company’s next fiscal year end is December 31, 2017.

 

The information set forth in Item 3.03 hereof is incorporated by reference into this Item 5.03.

 

Item 8.01 Other Events.

 

Eloxx is a clinical-stage global biopharmaceutical company focused on discovering, developing and commercializing novel medicines to treat patients with cancer or with genetic rare diseases caused by nonsense mutations. A nonsense mutation is a single change in a sequence of DNA in a particular gene that leads to the creation of shortened, or truncated, proteins. A truncated protein is devoid of function and causes the manifestation of disease. The disease depends on the mutated gene, the protein it encodes and the tissue in which the protein is expressed. Our mission is to develop medicines that can profoundly improve the lives of patients suffering from these genetic rare diseases.

 

 

 

 

Our compounds modulate the activity of the ribosome, the organelle within living cells responsible for protein production, a process also known as translation. The compounds allow the ribosome to read through the nonsense mutation in the mRNA (which is conveyed from the DNA sequence), to restore the translation process to produce full length, functional proteins. As our compounds target the general mechanism for protein production in the cell, we believe they have the potential to treat hundreds of genetic diseases and several types of cancer regardless of the mutated gene.

 

Our lead compound, ELX-02, is one of several new chemical entities we are developing that act as translational read through inducing drugs (or TRIDs). ELX-02 is currently in clinical development. We believe that ELX-02 is a disease-modifying therapy that may change the course of hundreds of genetic diseases and improve the lives of many patients. Nonsense mutations account for an average of 12% of all mutations in patients suffering from more than 2,000 genetic diseases. Our preclinical data suggests that ELX-02 has beneficial effects in animal models of nonsense mutations of each of the following diseases: cystic fibrosis, cystinosis, mucopolysaccharidosis type 1, Duchenne muscular dystrophy and Rett syndrome, demonstrating beneficial effects in multiple organs such as lungs, brain, kidney, muscles and others.

 

As part of our clinical program, we have conducted a single ascending dose (SAD) study in healthy volunteers in Israel and Belgium and now we are pursuing a two-pronged approach in an effort to accelerate the development of ELX-02. In November 2017, we started a multiple ascending dose (MAD) study in healthy volunteers in Europe. The MAD study will enable us to start phase 2 studies in multiple indications for ELX-02. In parallel with the MAD study, we are exploring the possibility of commencing a phase 2 trial, based on the results of our SAD study, for genetic disease indications with unmet medical needs where no therapies exist, such as nonsense mutations cystic fibrosis (nmCF). The Israeli Ministry of Health (iMOH) has informed us that the MAD study would be required in Israel, in order to commence a phase 2 trial.

 

nmCF has a significant unmet need. Cystic fibrosis (CF) is the most prevalent genetic disease in the Western World and approximately 10% of the CF patients carry nonsense mutation on the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene. Beyond symptomatic and palliative care, these patients do not have approved, disease-specific, therapies available.

 

The European Medicines Agency (EMA) has designated ELX-02 as an orphan medicine for the treatment of mucopolysaccharidosis type I (MPS I), and the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ELX-02 for the treatment of MPS I and for Rett Syndrome. These diseases are additional indications for ELX-02 under consideration. We believe that, based on the results of our phase 2 trials, additional orphan drug designations may be obtained.

 

Currently, we are also in the early stages of testing ELX-02 or other proprietary compounds to treat oncological diseases caused by acquired nonsense mutations such as the p53 nonsense mutations. These mutations alter the apoptosis pathway of the cell and support cancer cell replication. Cancer genome sequencing has shown that 42% of cases across 12 tumor types carry mutant p53. The prevalence of inactivating nonsense mutations in p53 is about 70% in ovarian cancer, for example. Using our TRIDs to produce wild-type p53, we hope to restore the natural apoptosis process in cancer cells. This represents a novel therapy to treat types of cancers caused by the p53 nonsense mutation.

 

We further intend to explore the combination of ELX-02 with antibodies developed by Fabrus Inc. (“Fabrus”) and controlled by Sevion prior to the Transaction, and to study the Fabrus antibodies’ synergistic effects in the treatment of cancer.

 

Prior to the merger, Sevion controlled an antibody platform technology via Fabrus, allowing the discovery of unique monoclonal antibodies against difficult membrane targets in several therapeutic areas. Several antibodies in the pipeline target important cell surface molecules involved in cancer progression. Sevion has discovered humanized antibodies against oncology targets, including DLL4, ErbB2, ErbB3 and CXCR4, which have been engineered to have activity in in vitro systems. These cell surface proteins are validated, therapeutically high value targets in the disease fields of oncology. Of special interest is the antibody against CXCR4, which is highly expressed in ovarian cancer and its expression is negatively regulated by p53. Thus, combination of a ELX-02 for p53 nonsense mutations and a CXCR4 inactivating antibody might potentially result in a synergistic effect. We are planning to test this effect in several tumor cells.

 

Eloxx holds worldwide development and commercialization rights to ELX-02, and other designer aminoglycosides, for all indications, in all territories, under a license from the Technion Research and Development Foundation Ltd. and Prof. Timor Baasov, the inventor of our compounds who has served as a senior consultant to Eloxx since our incorporation in September 2013.

 

In parallel, Eloxx is pursuing business development activities through royalty-bearing licensing out of certain technologies outside the field of cancer to maximize the Fabrus technology value. This includes SVN-001 an ion channel blocking antibody that has been implicated in a number of different autoimmune disorders, including rheumatoid arthritis, psoriasis and multiple sclerosis.

 

Safe Harbor for Forward-Looking Statements

 

This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All forward-looking statements included in this report are based upon information available to the Company as of the date of this report and expectations and assumptions underlying such statements are inherently subject to uncertainties, risks and changes that are difficult to predict. These forward-looking statements are not guarantees of future performance and actual results could differ materially from those expressed or implied in such statements. A variety of factors could cause or contribute to such differences, including risks and uncertainties detailed from time to time in the Company’s filings with the SEC. Except as required by law, the Company assumes no obligation to, and does not intend to, update these forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

 

 

On December 19, 2017, the Company issued a press release announcing the Reverse Stock Split. A copy of the press release is attached as Exhibit 99.1 to this current Report on Form 8-K.  

 

On December 20, 2017, the Company issued a press release announcing the consummation of the Transaction. A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K.

 

Item 9.01 Financial Statements and Exhibits.

 

(a) Financial Statements of Businesses Acquired.

 

The audited consolidated financial statements of Eloxx as of December 31, 2016, as well as the unaudited consolidated financial statements of Eloxx as of and for the nine months ended September 30, 2017, are filed, respectively, as Exhibits 99.3 and 99.4 to this Current Report on Form 8-K.

 

(b) Pro Forma Financial Information.

 

Unaudited pro forma condensed combined financial statements of the Company and Eloxx as of and for the nine months ended September 30, 2017 and the year ended December 31, 2016 are filed as Exhibit 99.5 to this Current Report on Form 8-K.

 

(d) Exhibits

 

Exhibit
No.

 

Description

2.1   Agreement, dated as of May 31, 2017, by and among Sevion Therapeutics, Inc., Sevion Sub, Ltd. and Eloxx Pharmaceuticals Ltd. (incorporated by reference to Exhibit 2.1 of our Current Report on Form 8-K on June 6, 2017).
   
3.1   Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company.
     
3.2   Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company.
     
10.1   Consulting Agreement, dated December 1, 2014, by and between Eloxx Pharmaceuticals Ltd. and Dr. Silvia Noiman.
     
10.2   Offer to Gregory Weaver from Eloxx Pharmaceuticals Ltd., dated September 11, 2017.
     
10.3   Offer to Pedro Huertas from Eloxx Pharmaceuticals Ltd., dated April 17, 2015.
     
10.4   Form of Indemnification Agreement.
     
16.1   Letter to the SEC from RSM US LLP
     
23.1   Consent of Independent Registered Accounting Firm
     
99.1   Press Release, dated December 19, 2017.
     
99.2   Press Release, dated December 20, 2017.
     
99.3   Audited Consolidated Financial Statements of Eloxx Pharmaceuticals Ltd. as of and for the years ended December 31, 2015 and December 31, 2016.
     
99.4   Unaudited Consolidated Financial Statements of Eloxx Pharmaceuticals Ltd. as of and for the nine months ended September 30, 2016 and September 30, 2017.
     
99.5   Pro Forma Financial Statements of Eloxx Pharmaceuticals Ltd. and Sevion Therapeutics, Inc. as of and for the year ended December 31, 2016 and the nine months ended September 30, 2017.

    

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Eloxx Pharmaceuticals, Inc.
   
Dated: December 21, 2017    
     
  By:

/s/ Gregory Weaver

    Gregory Weaver
    Chief Financial Officer

 

 

 

 

EXHIBIT INDEX

 

Exhibit
No.

 

Description

2.1   Agreement, dated as of May 31, 2017, by and among Sevion Therapeutics, Inc., Sevion Sub, Ltd. and Eloxx Pharmaceuticals Ltd. (incorporated by reference to Exhibit 2.1 of our Current Report on Form 8-K on June 6, 2017).
   
3.1   Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company.
     
3.2   Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company.
     
10.1   Consulting Agreement, dated December 1, 2014, by and between Eloxx Pharmaceuticals Ltd. and Dr. Silvia Noiman.
     
10.2   Offer to Gregory Weaver from Eloxx Pharmaceuticals Ltd., dated September 11, 2017.
     
10.3   Offer to Pedro Huertas from Eloxx Pharmaceuticals Ltd., dated April 17, 2015.
     
10.4   Form of Indemnification Agreement.
     
16.1   Letter to the SEC from RSM US LLP
     
23.1   Consent of Independent Registered Accounting Firm
     
99.1   Press Release, dated December 19, 2017.
     
99.2   Press Release, dated December 20, 2017.
     
99.3   Audited Consolidated Financial Statements of Eloxx Pharmaceuticals Ltd. as of and for the years ended December 31, 2015 and December 31, 2016.
     
99.4   Unaudited Consolidated Financial Statements of Eloxx Pharmaceuticals Ltd. as of and for the nine months ended September 30, 2016 and September 30, 2017.
     
99.5   Pro Forma Financial Statements of Eloxx Pharmaceuticals Ltd. and Sevion Therapeutics, Inc. as of and for the year ended December 31, 2016 and the nine months ended September 30, 2017.

   

 

Exhibit 3.1

 

CERTIFICATE OF AMENDMENT

OF

AMENDED AND RESTATED CERTIFICATE OF INCORPORATION

OF

SEVION THERAPEUTICS, INC.

 

Sevion Therapeutics, Inc. (the “Corporation”), a corporation duly organized and validly existing under and by virtue of the General Corporation Law of the State of Delaware (the “ DGCL ”);

 

DOES HEREBY CERTIFY AS FOLLOWS:

 

FIRST : The name of the corporation (hereinafter, the “Corporation”) is: Sevion Therapeutics, Inc.

 

SECOND : The Amended and Restated Certificate of Incorporation of the Corporation was filed with the office of the Secretary of State of Delaware on January 22, 2007 (the “Restated Certificate”), a Certificate of Amendment of the Restated Certificate was filed with the office of the Secretary of State of Delaware on each of December 13, 2007, September 22, 2009, May 25, 2010, December 22, 2011, April 1, 2013 and October 16, 2013 (effective October 21, 2013), two Certificates of Designations were filed with the office of the Secretary of State of Delaware on March 31, 2010 and one Certificate of Designation was filed with the office of the Secretary of State of Delaware on April 30, 2015 (the “Amendment” together with the Restated Certificate, the “Charter”).

 

THIRD : The Charter is hereby amended as follows:

 

(a) The section of Article FOURTH that was added to the Charter by the Certificate of Amendment of the Restated Certificate, dated October 16, 2013, is hereby deleted in its entirety and replaced by the following new paragraph:

 

“Upon this Certificate of Amendment becoming effective pursuant to the General Corporation Law of the State of Delaware (the “ Effective Time ”), the shares of Common Stock issued and outstanding or held in treasury immediately prior to the Effective Time (the “ Old Common Stock ”) shall be reclassified into a different number of shares of Common Stock (the “ New Common Stock ”) such that each two to one-hundred shares of Old Common Stock shall, at the Effective Time, be automatically reclassified into one share of New Common Stock, the exact ratio within the foregoing range to be determined by the Board of Directors of the Corporation prior to the Effective Time and publicly announced by the Corporation. From and after the Effective Time, certificates representing the Old Common Stock shall represent the number of whole shares of New Common Stock into which such Old Common Stock shall have been reclassified pursuant to the immediately preceding sentence. No fractional shares of Common Stock shall be issued as a result of such reclassification. In lieu of any fractional shares to which the stockholder would otherwise be entitled, the Corporation shall pay cash equal to such fraction multiplied by the then fair value of the Common Stock as determined in good faith by the Board of Directors of the Corporation.

 

From and after the Effective Time, the term “New Common Stock” as used in this Article IV shall mean Common Stock as provided in this Amended and Restated Certificate of Incorporation. The par value of the New Common Stock shall be $0.01 per share.”

 

FOURTH : The foregoing amendment was duly adopted in accordance with the provisions of Section 242 of the DGCL.

 

FIFTH : This Certificate of Amendment shall be deemed effective at 4:00 p.m. on December 19, 2017.

 

 

 

 

 

IN WITNESS WHEREOF , the undersigned has duly executed this Certificate of Amendment on this 18th day of December, 2017.

 

  SEVION THERAPEUTICS, INC.
     
  By:  /s/ David Rector
  Name:  David Rector
  Title:  Chief Executive Officer

 

 

 

Exhibit 3.2

 

CERTIFICATE OF AMENDMENT
TO
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
SEVION THERAPEUTICS, INC.

 

 

 

The undersigned, for purposes of amending the Amended and Restated Certificate of Incorporation of Sevion Therapeutics, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify as follows:

 

FIRST: The name of the corporation is Sevion Therapeutics, Inc. (the “Corporation”).

 

SECOND: The Amended and Restated Certificate of Incorporation of the Corporation was filed with the office of the Secretary of State of Delaware on January 22, 2007 (the “Restated Certificate”), a Certificate of Amendment of the Restated Certificate was filed with the office of the Secretary of State of Delaware on each of December 13, 2007, September 22, 2009, May 25, 2010, December 22, 2011, April 1, 2013 and October 16, 2013 (effective October 21, 2013), and December 18, 2017 (effective December 19, 2017), two Certificates of Designations were filed with the office of the Secretary of State of Delaware on March 31, 2010 and one Certificate of Designation was filed with the office of the Secretary of State of Delaware on April 30, 2015 (the “Amendment” together with the Restated Certificate, the “Charter”).

 

THIRD: Article FIRST of the Charter is hereby amended to read, in its entirety, as follows:

 

FIRST : The name of the Corporation is Eloxx Pharmaceuticals, Inc. (the “Corporation”).”

 

FOURTH: The foregoing amendment was duly adopted in accordance with the provisions of Section 242 of the DGCL.

 

FIFTH : This Certificate of Amendment shall be deemed effective at 4:01 p.m. on December 19, 2017.

 

[Signature Page Follows]

 

 

 

 

 

 

IN WITNESS WHEREOF , the undersigned, being a duly authorized officer of the Corporation, does hereby execute this Certificate of Amendment to the Amended and Restated Certificate of Incorporation this 18th day of December, 2017.

 

  SEVION THERAPEUTICS, INC.  
       
  By: /s/ David Rector  
       
  Name: David Rector  
       
  Title: Chief Executive Officer  
       

 

 

 

 

 

 

 

Exhibit 10.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 10.2

 

 

 

 

 

 

   

 

 

 

 

 

 

 

   

 

 

 

 

   

 

Exhibit 10.3

 

 

 

 

 

 

 

   

 

 

 

 

 

   

 

 

 

 

   

 

Exhibit 10.4

 

INDEMNIFICATION AGREEMENT

 

This Indemnification Agreement (“ Agreement ”) is made and entered into as of December [●], 2017 by and among Eloxx Pharmaceuticals, Inc., a Delaware corporation (the “ Company ”), Eloxx Pharmaceuticals Ltd., an Israeli company, Eloxx Pharmaceuticals U.S. Sub, Inc., a Delaware corporation (together with the Company and Eloxx Pharmaceuticals Ltd., the “ Eloxx Companies ” and each an “ Eloxx Company ”), and [●] (“ Indemnitee ”).

 

WHEREAS, in light of the litigation costs and risks to directors and officers resulting from their service to companies, and the desire of the Eloxx Companies to attract and retain qualified individuals to serve as directors and officers, it is reasonable, prudent and necessary for each of the Eloxx Companies to indemnify and advance expenses on behalf of its and the other Eloxx Companies’ directors and officers to the fullest extent permitted under Applicable Law so that they will serve or continue to serve the Eloxx Companies free from undue concern regarding such risks;

 

WHEREAS, the Eloxx Companies have requested that Indemnitee serve or continue to serve as a director and/or an officer of one or more of the Eloxx Companies or may in the future request that Indemnitee serve one or more of the Eloxx Companies (as hereinafter defined) as a director or an officer or in other capacities;

 

WHEREAS, one of the conditions that Indemnitee requires in order to serve as a director and/or an officer of one or more of the Eloxx Companies is that Indemnitee be so indemnified; and

 

WHEREAS, Indemnitee may have certain rights to indemnification, advancement of expenses and/or insurance provided by one or more of the Designating Stockholders (as hereinafter defined) (or their affiliates) and/or any insurer providing insurance coverage under any policy purchased or maintained by such Designating Stockholders (or their affiliates), which Indemnitee, the Eloxx Companies and the Designating Stockholders (or their affiliates) intend to be secondary to the primary obligation of the Eloxx Companies to indemnify Indemnitee as provided herein, with the Eloxx Companies’ acknowledgement of and agreement to the foregoing being a material condition to Indemnitee’s willingness to serve as a director and/or officer of one or more of the Eloxx Companies.

 

NOW, THEREFORE, in consideration of the premises and the covenants contained herein, the Eloxx Companies and Indemnitee do hereby covenant and agree as follows:

 

1.                   Services by Indemnitee . Indemnitee agrees to serve as a director and/or an officer of one or more of the Eloxx Companies. Indemnitee may at any time and for any reason resign from such position (subject to any contractual obligation the Indemnitee may have under any other agreement).

 

 

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2.                   Indemnification - General . On the terms and subject to the conditions of this Agreement, the Eloxx Companies shall, to the fullest extent permitted under Applicable Law, indemnify Indemnitee with respect to, and hold Indemnitee harmless from and against, all losses, damages, liabilities, judgments, fines, penalties, costs, amounts paid in settlement, Expenses (as hereinafter defined) and other amounts that Indemnitee reasonably incurs and that result from, arise in connection with or are by reason of Indemnitee’s Corporate Status (as hereinafter defined), including all interest, assessments and other charges paid or payable in connection therewith, and shall advance Expenses to Indemnitee. The obligations of the Eloxx Companies under this Agreement (a) are joint and several obligations of each Eloxx Company, (b) shall continue after such time as Indemnitee ceases to serve as a director or an officer of the Eloxx Companies or in any other Corporate Status and (c) include, without limitation, claims for monetary damages against Indemnitee in respect of any actual or alleged liability or other loss of Indemnitee, to the fullest extent permitted under Applicable Law. A limitation under law of any Eloxx Company on providing indemnification or an advance of expenses to Indemnitee shall not limit the indemnification and advancement obligations of any Eloxx Company not so limited.

 

3.                   Proceedings Other Than Proceedings by or in the Right of the Eloxx Companies . If in connection with or by reason of Indemnitee’s Corporate Status, Indemnitee was, is, or is threatened to be made, a party to or a participant in any Proceeding (as hereinafter defined) other than a Proceeding by or in the right of any of the Eloxx Companies to procure a judgment in its favor, the Eloxx Companies shall, to the fullest extent permitted under Applicable Law, indemnify Indemnitee with respect to, and hold Indemnitee harmless from and against, all losses, damages, liabilities, judgments, fines, penalties, costs, amounts paid in settlement, Expenses and other amounts that Indemnitee reasonably incurs in connection with such Proceeding or any claim, issue or matter therein, including all interest, assessments and other charges paid or payable in connection therewith.

 

4.                   Proceedings by or in the Right of the Eloxx Companies . If in connection with or by reason of Indemnitee’s Corporate Status, Indemnitee was, is, or is threatened to be made, a party to or a participant in any Proceeding by or in the right of any of the Eloxx Companies to procure a judgment in such Eloxx Company’s favor, the Eloxx Companies shall, to the fullest extent permitted under Applicable Law, indemnify Indemnitee with respect to, and hold Indemnitee harmless from and against, all Expenses reasonably incurred by Indemnitee or on behalf of Indemnitee in connection with such Proceeding or any claim, issue or matter therein.

 

5.                   Mandatory Indemnification in Case of Successful Defense . Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of Indemnitee’s Corporate Status, a party to (or a participant in) and is successful, on the merits or otherwise, in defense of any Proceeding (including, without limitation, any Proceeding brought by or in the right of any Eloxx Company), the Eloxx Companies shall, to the fullest extent permitted under Applicable Law, indemnify Indemnitee with respect to, and hold Indemnitee harmless from and against, all Expenses reasonably incurred by Indemnitee or on behalf of Indemnitee in connection therewith. If Indemnitee is not wholly successful in defense of such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Eloxx Companies shall, to the fullest extent permitted under Applicable Law, indemnify Indemnitee against all Expenses reasonably incurred by Indemnitee or on behalf of Indemnitee in connection with each successfully resolved claim, issue or matter.

 

  2  

 

For purposes of this Section 5 and without limitation, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, on substantive or procedural grounds, or settlement of any such claim prior to a final judgment by a court of competent jurisdiction with respect to such Proceeding, shall be deemed to be a successful result as to such claim, issue or matter; provided , however , that any settlement of any claim, issue or matter in such a Proceeding shall not be deemed to be a successful result as to such claim, issue or matter if such settlement is effected by Indemnitee without the Eloxx Companies’ prior written consent, which consent shall not be unreasonably withheld, delayed or conditioned.

 

6.                   Partial Indemnification . If Indemnitee is entitled under any provision of this Agreement or otherwise to indemnification by any of the Eloxx Companies for some or a portion of the losses, damages, liabilities, judgments, fines, penalties, costs, amounts paid in settlement, and Expenses, including all interest, assessments and other charges paid or payable in connection therewith, incurred by Indemnitee or on behalf of Indemnitee in connection with a Proceeding or any claim, issue or matter therein, in whole or in part, the Eloxx Companies shall, to the fullest extent permitted under Applicable Law, indemnify Indemnitee to the fullest extent to which Indemnitee is entitled to such indemnification.

 

7.                   Indemnification for Additional Expenses Incurred to Secure Recovery or as Witness .

 

(a)                The Eloxx Companies shall, to the fullest extent permitted under Applicable Law, indemnify Indemnitee with respect to, and hold Indemnitee harmless from and against, any and all Expenses and, if requested by Indemnitee, shall advance on an as-incurred basis (as provided in Section 8 of this Agreement) such Expenses to Indemnitee, which are incurred by Indemnitee in connection with any action or proceeding or part thereof brought by Indemnitee for (i) indemnification or advance payment of Expenses by the Eloxx Companies under this Agreement, any other agreement, the Certificate of Incorporation, By-laws, limited liability company agreement or other governing document of the applicable Eloxx Company as now or hereafter in effect; or (ii) recovery under any director and officer liability insurance policy maintained by any Eloxx Company.

 

(b)                To the extent that Indemnitee is, by reason of Indemnitee’s Corporate Status, a witness (or is forced or asked to respond to discovery requests) in any Proceeding to which Indemnitee is not a party, the Eloxx Companies shall, to the fullest extent permitted under Applicable Law, indemnify Indemnitee with respect to, and hold Indemnitee harmless from and against, and the Eloxx Companies shall advance on an as-incurred basis (as provided in Section 8 of this Agreement), all Expenses reasonably incurred by Indemnitee or on behalf of Indemnitee in connection therewith.

 

8.                   Advancement of Expenses . The Eloxx Companies shall, to the fullest extent permitted under Applicable Law, pay on a current and as-incurred basis all Expenses incurred by Indemnitee in connection with any Proceeding in any way connected with, resulting from or relating to Indemnitee’s Corporate Status. Such Expenses shall be paid in advance of the final disposition of such Proceeding, without regard to whether Indemnitee will ultimately be entitled to be indemnified for such Expenses and without regard to whether an Adverse Determination (as hereinafter defined) has been or may be made. Upon submission of a request for

 

  3  

 

advancement of Expenses pursuant to Section 9(c) of this Agreement, Indemnitee shall be entitled to advancement of Expenses as provided in this Section 8 , and such advancement of Expenses shall continue until such time (if any) as there is a final non-appealable judicial determination that Indemnitee is not entitled to indemnification. Indemnitee shall repay such amounts advanced if and to the extent that it shall ultimately be determined in a decision by a court of competent jurisdiction from which no appeal can be taken that Indemnitee is not entitled to be indemnified by the Eloxx Companies for such Expenses. Such repayment obligation shall be unsecured and shall not bear interest. The Eloxx Companies shall not impose on Indemnitee additional conditions to advancement or require from Indemnitee additional undertakings regarding repayment. Indemnitee shall, in all events, be entitled to advancement of Expenses, without regard to Indemnitee’s ultimate entitlement to indemnification, until the final determination of the Proceeding.

 

9.                   Indemnification Procedures .

 

(a)                Notice of Proceeding . Indemnitee agrees to notify the Eloxx Companies promptly upon being served with any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding or matter which may be subject to indemnification or advancement of Expenses hereunder. Any failure by Indemnitee to notify any Eloxx Company will not relieve the Eloxx Companies of their advancement or indemnification obligations under this Agreement unless, and only to the extent that, the Eloxx Companies can establish that such omission to notify resulted in actual and material prejudice to them, which prejudice cannot be reversed or otherwise eliminated without any material negative effect on the Eloxx Companies, and the omission to notify the Eloxx Companies will, in any event, not relieve any Eloxx Company from any liability which it may have to indemnify Indemnitee otherwise than under this Agreement. If, at the time of receipt of any such notice, the Eloxx Companies have director and officer liability insurance policies in effect, the Eloxx Companies will promptly notify the relevant insurers in accordance with the procedures and requirements of such policies.

 

(b)                Defense; Settlement . Indemnitee shall have the sole right and obligation to control the defense or conduct of any claim or Proceeding with respect to Indemnitee. The Eloxx Companies shall not, without the prior written consent of Indemnitee, which may be provided or withheld in Indemnitee’s sole discretion, effect any settlement of any Proceeding against Indemnitee or which, in the reasonable opinion of Independent Counsel (as hereinafter defined), could have been brought against Indemnitee or which potentially or actually imposes any cost, liability, exposure or burden on Indemnitee unless (i) such settlement solely involves the payment of money or performance of any obligation by persons other than Indemnitee and includes an unconditional, full release of Indemnitee by all relevant parties from all liability on any matters that are the subject of such Proceeding and an acknowledgment that Indemnitee denies all wrongdoing in connection with such matters and (ii) the Eloxx Companies have fully indemnified the Indemnitee with respect to, and held Indemnitee harmless from and against, all Expenses and other amounts incurred by Indemnitee or on behalf of Indemnitee in connection with such Proceeding. The Eloxx Companies shall not be obligated to indemnify Indemnitee against amounts paid in settlement of a Proceeding against Indemnitee if such settlement is effected by Indemnitee without the Eloxx Companies’ prior written consent, which consent shall not be unreasonably withheld, delayed or conditioned, unless such settlement solely involves the

 

  4  

 

payment of money or performance of any obligation by persons other than the Eloxx Companies and includes an unconditional release of the Eloxx Companies by any party to such Proceeding other than the Indemnitee from all liability on any matters that are the subject of such Proceeding and an acknowledgment that the Eloxx Companies deny all wrongdoing in connection with such matters.

 

(c)                Request for Advancement; Request for Indemnification .

 

(i)                  To obtain advancement of Expenses under this Agreement, Indemnitee shall submit to the Eloxx Companies a written request therefor, together with such invoices or other supporting information as may be reasonably requested by the Eloxx Companies and reasonably available to Indemnitee, and an unsecured written undertaking to repay amounts advanced only to the extent that it is ultimately determined that Indemnitee is not entitled to be indemnified by any of the Eloxx Companies. The Eloxx Companies shall make advance payment of Expenses to Indemnitee no later than five (5) business days after receipt of the written request for advancement (and each subsequent request for advancement) by Indemnitee. If, at the time of receipt of any such written request for advancement of Expenses, the Eloxx Companies have director and officer insurance policies in effect, the Eloxx Companies shall promptly notify the relevant insurers in accordance with the procedures and requirements of such policies. The Eloxx Companies shall thereafter keep such director and officer insurers informed of the status of the Proceeding or other claim (with assistance from the Indemnitee as reasonably required) and take such other actions, as appropriate to secure coverage of Indemnitee for such claim.

 

(ii)       To obtain indemnification under this Agreement, at any time before or after submission of a request for advancement pursuant to Section 9(c)(i) of this Agreement, Indemnitee may submit a written request for indemnification hereunder. The time at which Indemnitee submits a written request for indemnification shall be determined by the Indemnitee in the Indemnitee’s sole discretion. Once Indemnitee submits such a written request for indemnification (and only at such time that Indemnitee submits such a written request for indemnification), a Determination (as hereinafter defined) shall thereafter be made, as provided in and only to the extent required by Section 9(d) of this Agreement. In no event shall a Determination be made, or required to be made, as a condition to or otherwise in connection with any advancement of Expenses pursuant to Section 8 and Section 9(c)(i) of this Agreement. If, at the time of receipt of any such request for indemnification, the Eloxx Companies have director and officer insurance policies in effect, the Eloxx Companies shall promptly notify the relevant insurers and take such other actions as necessary or appropriate to secure coverage of Indemnitee for such claim in accordance with the procedures and requirements of such policies.

 

(d)                Determination . The Eloxx Companies agree that Indemnitee shall be indemnified to the fullest extent permitted under Applicable Law and that no Determination shall be required in connection with such indemnification unless specifically required by Applicable Law which cannot be waived. In no event shall a Determination be required in connection with indemnification for Expenses pursuant to Section 7 of this Agreement or incurred in connection with any Proceeding or portion thereof with respect to which Indemnitee has been successful on the merits or otherwise. Any decision that a Determination is required by Applicable Law in connection with any other indemnification of Indemnitee, and any such Determination, shall be

 

  5  

 

made within twenty (20) days after receipt of Indemnitee’s written request for indemnification pursuant to Section 9(c)(ii) of this Agreement and such Determination shall be made either (i) by the Disinterested Directors (as hereinafter defined), even though less than a quorum, so long as Indemnitee does not request that such Determination be made by Independent Counsel (as hereinafter defined), or (ii) if so requested by Indemnitee, in Indemnitee’s sole discretion, by Independent Counsel in a written opinion to the Eloxx Companies and Indemnitee. If a Determination is made that Indemnitee is entitled to indemnification, payment to Indemnitee shall be made within five (5) business days after such Determination. Indemnitee shall reasonably cooperate with the person, persons or entity making such determination with respect to Indemnitee’s entitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to such Determination. Any Expenses incurred by Indemnitee in so cooperating with the Disinterested Directors or Independent Counsel, as the case may be, making such determination shall be advanced and borne by the Eloxx Companies (irrespective of the Determination as to Indemnitee’s entitlement to indemnification) and each Eloxx Company is liable to indemnify and hold Indemnitee harmless therefrom. If the person, persons or entity empowered or selected under this Section 9(d) to determine whether Indemnitee is entitled to indemnification shall not have made a determination within twenty (20) days after receipt by the Eloxx Companies of the request therefor, the requisite determination of entitlement to indemnification shall, to the fullest extent not prohibited by Applicable Law, be deemed to have been made and Indemnitee shall be entitled to such indemnification, absent (i) a misstatement by Indemnitee of a material fact or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading in connection with the request for indemnification that actually prejudices the Eloxx Companies, or (ii) a prohibition of such indemnification under Applicable Law; provided , however , that such twenty (20) day period may be extended for a reasonable time, not to exceed an additional twenty (20) days, if the person, persons or entity making the determination with respect to entitlement to indemnification in good faith requires such additional time for the obtaining or evaluating of documentation and/or information relating thereto; and provided , further , that the foregoing provisions of this Section 9(d) shall not apply if the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to Section 9(e) of this Agreement.

 

(e)                Independent Counsel . In the event Indemnitee requests that the Determination be made by Independent Counsel pursuant to Section 9(d) of this Agreement, the Independent Counsel shall be selected as provided in this Section 9(e) . The Independent Counsel shall be selected by Indemnitee (unless Indemnitee shall request that such selection be made by the Board of Directors, in which event the Board of Directors shall make such selection on behalf of the Eloxx Companies, subject to the remaining provisions of this Section 9(e) ), and Indemnitee or the Eloxx Companies, as the case may be, shall give written notice to the other, advising the Eloxx Companies or Indemnitee of the identity of the Independent Counsel so selected. The Eloxx Companies or Indemnitee, as the case may be, may, within five (5) days after such written notice of selection shall have been received, deliver to Indemnitee or the Eloxx Companies, as the case may be, a written objection to such selection; provided , however , that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of “Independent Counsel” as defined in Section 15 of this Agreement,

 

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and the objection shall set forth with particularity the factual basis of such assertion. Absent a proper and timely objection, the person so selected shall act as Independent Counsel. If a written objection is so made and substantiated, the Independent Counsel so selected may not serve as Independent Counsel unless and until such objection is withdrawn or a court of competent jurisdiction has determined that such objection is without merit. If, within ten (10) days after submission by Indemnitee of a written request for indemnification pursuant to Section 9(c)(ii) of this Agreement and after a request for the appointment of Independent Counsel has been made, no Independent Counsel shall have been selected and not objected to, either the Eloxx Companies or Indemnitee may petition a court of competent jurisdiction for resolution of any objection which shall have been made by the Eloxx Companies or Indemnitee to the other’s selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by the court or by such other person as the court shall designate, and the person with respect to whom all objections are so resolved or the person so appointed shall act as Independent Counsel under Section 9(d) of this Agreement. Upon the due commencement of any judicial proceeding or arbitration pursuant to Section 9(f) of this Agreement, Independent Counsel shall be discharged and relieved of any further responsibility in such capacity (subject to the applicable standards of professional conduct then prevailing). Any expenses incurred by or in connection with the appointment of Independent Counsel shall be borne by the Eloxx Companies (irrespective of the Determination of Indemnitee’s entitlement to indemnification) and not by Indemnitee.

 

(f)                 Consequences of Determination; Remedies of Indemnitee . The Eloxx Companies shall be bound by and shall have no right to challenge a Favorable Determination. If an Adverse Determination is made, or if for any other reason the Eloxx Companies do not make timely indemnification payments or advances of Expenses, Indemnitee shall have the right to commence a Proceeding before a court of competent jurisdiction to challenge such Adverse Determination and/or to require the Eloxx Companies to make such payments or advances (and the Company shall have the right to defend its position in such Proceeding and to appeal any adverse judgment in such Proceeding). Indemnitee shall be entitled to be indemnified for all Expenses incurred in connection with such a Proceeding and to have such Expenses advanced by the Company in accordance with Section 8 of this Agreement. If Indemnitee fails to challenge an Adverse Determination within twenty (20) business days, or if Indemnitee challenges an Adverse Determination and such Adverse Determination has been upheld by a final judgment of a court of competent jurisdiction from which no appeal can be taken, then, to the extent and only to the extent required by such Adverse Determination or final judgment, the Eloxx Companies shall not be obligated to indemnify Indemnitee under this Agreement.

 

(g)                Presumptions; Burden and Standard of Proof . The parties intend and agree that, to the extent permitted under Applicable Law, in connection with any Determination with respect to Indemnitee’s entitlement to indemnification hereunder by any person, including a court:

 

(i)                  it will be presumed that Indemnitee is entitled to indemnification under this Agreement (notwithstanding any Adverse Determination), and the Eloxx Companies or any other person or entity challenging such right will have the burden of proof to overcome that presumption in connection with the making by any person, persons or entity of any determination contrary to that presumption;

 

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(ii)               the termination of any action, suit or proceeding by judgment, order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in or not opposed to the best interests of the applicable Eloxx Company, and, with respect to any criminal action or proceeding, had reasonable cause to believe that Indemnitee’s conduct was unlawful;

 

(iii)             Indemnitee will be deemed to have acted in good faith if Indemnitee’s action is based on the records or books of account of the applicable Eloxx Company, including financial statements, or on information supplied to Indemnitee by the officers, employees or committees of the board of directors of the applicable Eloxx Company, or on the advice of legal counsel or other advisors (including financial advisors and accountants) for the applicable Eloxx Company or on information or records given in reports made to the applicable Eloxx Company by an independent certified public accountant or by an appraiser or other expert or advisor selected by the applicable Eloxx Company; and

 

(iv)              the knowledge and/or actions, or failure to act, of any director, officer, agent or employee of any of the Eloxx Companies or relevant enterprises will not be imputed to Indemnitee in a manner that limits or otherwise adversely affects Indemnitee’s rights hereunder.

 

The provisions of this Section 9(g) shall not be deemed to be exclusive or to limit in any way the other circumstances in which Indemnitee may be deemed to have met the applicable standard of conduct set forth in this Agreement.

 

10.               Remedies of Indemnitee .

 

(a)                In the event that (i) a determination is made pursuant to Section 9(d) of this Agreement that Indemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to Section 8 and Section 9(c)(i) of this Agreement, (iii) no determination of entitlement to indemnification shall have been made pursuant to Section 9(d) of this Agreement within twenty (20) days after receipt by the Eloxx Companies of the request for indemnification, (iv) payment of indemnification is not made pursuant to Section 5 , 6 or 7 of this Agreement within five (5) business days after receipt by the Eloxx Companies of a written request therefor, (v) payment of indemnification pursuant to Section 3 , 4 or 7 of this Agreement is not made within five (5) business days after a determination has been made that Indemnitee is entitled to indemnification or (vi) the Eloxx Companies or any other person takes or threatens to take any action to declare this Agreement void or unenforceable, or institutes any litigation or other action or Proceeding designed to deny, or to recover from, the Indemnitee the benefits provided or intended to be provided to the Indemnitee hereunder, Indemnitee shall be entitled to an adjudication by a court of his entitlement to such indemnification or advancement of Expenses. Alternatively, Indemnitee, at his option, may seek an award in arbitration to be conducted by a single arbitrator pursuant to the Commercial Arbitration Rules of the American Arbitration Association. The Eloxx Companies shall not oppose Indemnitee’s right to seek any such adjudication or award in arbitration.

 

  8  

 

(b)                In the event that a determination shall have been made pursuant to Section 9(d) of this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding or arbitration commenced pursuant to this Section 10 shall be conducted in all respects as a de novo trial, or arbitration, on the merits, in which (i) Indemnitee shall not be prejudiced by reason of that adverse determination, and (ii) the Eloxx Companies shall bear the burden of establishing that Indemnitee is not entitled to indemnification.

 

(c)                If a determination shall have been made pursuant to Section 9(d) of this Agreement that Indemnitee is entitled to indemnification, the Eloxx Companies shall be bound by such determination in any judicial proceeding or arbitration commenced pursuant to this Section 10 , absent (i) a misstatement by Indemnitee of a material fact or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading in connection with the request for indemnification that actually prejudices the Eloxx Companies, or (ii) a prohibition of such indemnification under Applicable Law.

 

(d)                The Eloxx Companies shall, to the fullest extent not prohibited by Applicable Law, be precluded from asserting in any judicial proceeding or arbitration commenced pursuant to this Section 10 that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court or before any such arbitrator that the Eloxx Companies are bound by all the provisions of this Agreement.

 

11.               Insurance; Subrogation; Other Rights of Recovery, etc .

 

(a)                Each Eloxx Company shall use its reasonable best efforts to purchase and maintain a policy or policies of insurance with reputable insurance companies with A.M. Best ratings of “A” or better, providing Indemnitee with coverage for any liability asserted against, and incurred by, Indemnitee or on Indemnitee’s behalf by reason of Indemnitee’s Corporate Status, or arising out of Indemnitee’s status as such, whether or not any such Eloxx Company would have the power to indemnify Indemnitee against such liability. Such insurance policies shall have coverage terms and policy limits at least as favorable to Indemnitee as the insurance coverage provided to any other director or officer of the Eloxx Companies. If any Eloxx Company has such insurance in effect at the time it receives from Indemnitee any notice of the commencement of an action, suit, proceeding or other claim, such Eloxx Company shall give prompt notice of the commencement of such action, suit, proceeding or other claim to the insurers and take such other actions in accordance with the procedures set forth in the policy as required or appropriate to secure coverage of Indemnitee for such action, suit, proceeding or other claim. Such Eloxx Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of Indemnitee, all amounts payable as a result of such action, suit, proceeding or other claim in accordance with the terms of such policy. Such Eloxx Company shall continue to provide such insurance coverage to Indemnitee for a period of at least ten (10) years after Indemnitee ceases to serve as a director or an officer or in any other Corporate Status.

 

(b)                In the event of any payment by any Eloxx Company under this Agreement, such Eloxx Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee against any other Eloxx Company, and Indemnitee hereby agrees, as a condition to obtaining any advancement or indemnification from the Eloxx Companies, to assign to such Eloxx Company all of Indemnitee’s rights to obtain from such other Eloxx Company such

 

  9  

 

amounts to the extent that they have been paid by such Eloxx Company to or for the benefit of Indemnitee as advancement or indemnification under this Agreement and are adequate to indemnify Indemnitee with respect to the costs, Expenses or other items to the full extent that Indemnitee is entitled to indemnification or other payment hereunder; and Indemnitee will (upon request by the Eloxx Companies) execute all papers required and use reasonable best efforts to take all action reasonably necessary to secure such rights, including execution of such documents as are necessary to enable such Eloxx Company to bring suit or enforce such rights.

 

(c)                Each of the Eloxx Companies hereby unconditionally and irrevocably waives, relinquishes and releases, and covenants and agrees not to exercise (and to cause each of the other Eloxx Companies not to exercise), any rights that such Eloxx Company may now have or hereafter acquire against any Designating Stockholder (or former Designating Stockholder), insurer of such Designating Stockholder (or former Designating Stockholder) or Indemnitee that arise from or relate to the existence, payment, performance or enforcement of the Eloxx Companies’ obligations under this Agreement or under any other indemnification agreement (whether pursuant to contract, by-laws or charter) with any person or entity, including, without limitation, any right of subrogation (whether pursuant to contract or common law), reimbursement, exoneration, contribution or indemnification, or to be held harmless, and any right to participate in any claim or remedy of Indemnitee against any Designating Stockholder (or former Designating Stockholder) or Indemnitee, whether or not such claim, remedy or right arises in equity or under contract, statute or common law, including, without limitation, the right to take or receive from any Designating Stockholder (or former Designating Stockholder), insurer of such Designating Stockholder (or former Designating Stockholder) or Indemnitee, directly or indirectly, in cash or other property or by set-off or in any other manner, payment or security on account of such claim, remedy or right.

 

(d)                The Eloxx Companies shall not be liable to pay or advance to Indemnitee any amounts otherwise indemnifiable under this Agreement or under any other indemnification agreement if, and to the extent that, Indemnitee has otherwise actually received such payment under any insurance policy, contract, agreement or otherwise; provided , however , that (i) the Eloxx Companies hereby agree that they are the indemnitors of first resort under this Agreement and under any other indemnification agreement (i.e., their obligations to Indemnitee under this Agreement or any other agreement or undertaking to provide advancement and/or indemnification to Indemnitee are primary and any obligation of any Designating Stockholder (or any affiliate thereof other than any Eloxx Company) and/or any obligation of any insurer providing insurance coverage under any policy purchased or maintained by such Designating Stockholders (or by any affiliate thereof, other than any Eloxx Company) to provide advancement or indemnification for the same Expenses, liabilities, judgments, penalties, fines and amounts paid in settlement (including all interest, assessments and other charges paid or payable in connection with or in respect of such Expenses, liabilities, judgments, penalties, fines and amounts paid in settlement) incurred by Indemnitee are secondary), (ii) the Eloxx Companies shall be required to advance the full amount of expenses incurred by any such Indemnitee and shall be liable for the full amount of all liability and loss suffered by such Indemnitee (including, but not limited to, Expenses, judgments, fines and amounts paid in

 

  10  

 

settlement actually and reasonably incurred by such Indemnitee in connection with such Proceeding), without regard to any rights any such Indemnitee may have against any Designating Stockholder or against any insurance carrier providing insurance coverage to Indemnitee under any insurance policy issued to a Designating Stockholder and (iii) if any Designating Stockholder (or any affiliate thereof other than any Eloxx Company) pays or causes to be paid, for any reason, any amounts otherwise indemnifiable hereunder or under any other indemnification agreement (whether pursuant to contract, by-laws or charter) with Indemnitee, then (x) such Designating Stockholder (or such affiliate, as the case may be) shall be fully subrogated to all rights of Indemnitee with respect to such payment and (y) the Eloxx Companies shall fully indemnify, reimburse and hold harmless such Designating Stockholder (or such other affiliate) for all such payments actually made by such Designating Stockholder (or such other affiliate).

 

(e)                The Eloxx Companies’ obligation to indemnify or advance Expenses hereunder to Indemnitee in respect of or relating to Indemnitee’s service at the request of any of the Eloxx Companies as a director, officer, employee, fiduciary, trustee, representative, partner or agent of any other Eloxx Company shall be reduced by any amount Indemnitee has actually received as payment of indemnification or advancement of Expenses from such other Eloxx Company, except to the extent that such indemnification payments and advance payment of Expenses when taken together with any such amount actually received from other Eloxx Companies or under director and officer insurance policies maintained by one or more Eloxx Companies are inadequate to fully pay all costs, Expenses or other items to the full extent that Indemnitee is otherwise entitled to indemnification or other payment hereunder.

 

(f)                 Except as provided in Sections 11(c) , 11(d) and 11(e) of this Agreement, the rights to indemnification and advancement of Expenses as provided by this Agreement shall not be deemed exclusive of, and shall be considered supplemental to, any other rights to which Indemnitee may at any time, whenever conferred or arising, be entitled under Applicable Law, under the Eloxx Companies’ Certificates of Incorporation or By-Laws, or under any other agreement, vote of stockholders or resolution of directors of any Eloxx Company, or otherwise. Indemnitee’s rights under this Agreement are present contractual rights that fully vest upon Indemnitee’s first service as a director or an officer of any of the Eloxx Companies. The Parties hereby agree that Sections 11(c) , 11(d) and 11(e) of this Agreement shall be deemed exclusive and shall be deemed to modify, amend and clarify any right to indemnification or advancement provided to Indemnitee under any other contract, agreement or document with any Eloxx Company.

 

(g)                No amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right of Indemnitee under this Agreement in respect of any action taken or omitted by such Indemnitee in Indemnitee’s Corporate Status prior to such amendment, alteration or repeal. To the extent that a change in the General Corporation Law of the State of Delaware (or other Applicable Law), whether by statute or judicial decision, permits greater indemnification or advancement of Expenses than would be afforded currently under the Eloxx Companies’ Certificates of Incorporation or By-Laws and this Agreement, it is the intent of the

 

  11  

 

parties hereto that Indemnitee enjoy by this Agreement the greater benefits so afforded by such change. The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy.

 

12.               Employment Rights; Successors; Third Party Beneficiaries .

 

(a)                This Agreement shall not be deemed an employment contract between the Eloxx Companies and Indemnitee. This Agreement shall continue in force as provided above after Indemnitee has ceased to serve as a director or an officer of the Eloxx Companies or any other Corporate Status.

 

(b)                This Agreement shall be binding upon each of the Eloxx Companies and their successors and assigns and shall inure to the benefit of Indemnitee and Indemnitee’s heirs, executors and administrators. If any of the Eloxx Companies or any of their respective successors or assigns shall (i) consolidate with or merge into any other corporation or entity and shall not be the continuing or surviving corporation or entity of such consolidation or merger or (ii) transfer all or substantially all of its properties and assets to any individual, corporation or other entity, then, and in each such case, proper provisions shall be made so that the successors and assigns of the Eloxx Companies shall assume all of the obligations set forth in this Agreement.

 

(c)                The Designating Stockholders are express third party beneficiaries of this Agreement, are entitled to rely upon this Agreement, and may specifically enforce the Eloxx Companies’ obligations hereunder (including but not limited to the obligations specified in Section 11 of this Agreement) as though a party hereunder.

 

13.               Severability . If any provision or provisions of this Agreement shall be held to be invalid, illegal or unenforceable for any reason whatsoever: (i) the validity, legality and enforceability of the remaining provisions of this Agreement (including without limitation, each portion of any Section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby; (ii) such provision or provisions shall be deemed reformed to the extent necessary to conform to Applicable Law and to give the maximum effect to the intent of the parties hereto; and (iii) to the fullest extent possible, the provisions of this Agreement (including, without limitation, each portion of any Section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall be construed so as to give effect to the intent manifested thereby.

 

14.               Exception to Right of Indemnification or Advancement of Expenses . Notwithstanding any other provision of this Agreement and except as provided in Section 7(a) of this Agreement or as may otherwise be agreed by any Eloxx Company, Indemnitee shall not be entitled to indemnification or advancement of Expenses under this Agreement with respect to any Proceeding brought by Indemnitee (other than a Proceeding by Indemnitee (i) by way of defense or counterclaim or other similar portion of a Proceeding, (ii) to enforce Indemnitee’s

 

  12  

 

rights under this Agreement or (iii) to enforce any other rights of Indemnitee to indemnification, advancement or contribution from the Eloxx Companies under any other contract, by-laws or charter or under statute or other law, including any rights under Section 145 of the Delaware General Corporation Law), unless the bringing of such Proceeding or making of such claim shall have been approved by the board of directors of the applicable Eloxx Company.

 

15.               Definitions . For purposes of this Agreement:

 

(a)                Applicable Law ” means, as applied to each Eloxx Company, any law applicable to such Eloxx Company as in existence on the date hereof and as amended from time to time; provided , however , that under all circumstances Applicable Law shall be construed assuming that Indemnitee is a director or officer of the indemnifying corporation for purposes of determining the availability and scope of any indemnification right afforded to Indemnitee under this Agreement; provided , further , that as applied to Eloxx Pharmaceuticals Ltd., Applicable Law shall be construed to treat Section 145 of the Delaware General Corporation Law (as in existence on the date hereof and as amended from time to time, including any successor provision thereto) as if it was applicable to Eloxx Pharmaceuticals Ltd.

 

(b)                Board of Directors ” means the board of directors of the Company.

 

(c)                By-laws ” means, in each case, the bylaws or similar governing document of the relevant company as amended from time to time.

 

(d)                Certificate of Incorporation ” means, in each case, the certificate of incorporation, articles of incorporation or similar constituting document of the relevant company as amended from time to time.

 

(e)                Corporate Status ” describes the status of a person by reason of such person’s past, present or future service as a director, officer, employee, fiduciary, trustee, or agent of any of the Eloxx Companies (including, without limitation, one who serves at the request of any of the Eloxx Companies as a director, officer, employee, fiduciary, trustee or agent of any other Eloxx Company).

 

(f)                 Designating Stockholder ” means any of the [____________________] , in each case so long as an individual designated (directly or indirectly) by the [____________________] or any of their respective affiliates serves or has served as a director and/or officer of any Eloxx Company.

 

(g)                Determination ” means a determination that either (i) there is a reasonable basis for the conclusion that indemnification of Indemnitee is proper in the circumstances because Indemnitee met a/the particular standard(s) of conduct (a “ Favorable Determination ”) or (ii)

 

  13  

 

there is no reasonable basis for the conclusion that indemnification of Indemnitee is proper in the circumstances because Indemnitee met a/the particular standard(s) of conduct (an “ Adverse Determination ”). An Adverse Determination shall include the decision that a Determination was required in connection with indemnification and the decision as to the applicable standard of conduct.

 

(h)                Disinterested Director ” means a director of the Company (or, if a Determination is necessary with respect to a Eloxx Company other than the Company, a director of such Eloxx Company) who is not and was not a party to the Proceeding in respect of which indemnification is sought by Indemnitee and does not otherwise have an interest materially adverse to any interest of the Indemnitee.

 

(i)                  Expenses ” shall mean all direct and indirect costs, fees and expenses of any type or nature whatsoever and shall specifically include, without limitation, all reasonable attorneys’ fees, retainers, court costs, transcript costs, fees and costs of experts, witness fees and costs, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, any federal, state, local or foreign taxes imposed on Indemnitee as a result of the actual or deemed receipt of any payments under this Agreement, ERISA excise taxes and penalties, and all other disbursements or expenses of the types customarily incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating, being or preparing to be a witness, in, or otherwise participating in, a Proceeding or an appeal resulting from a Proceeding, including, but not limited to, the premium for appeal bonds, attachment bonds or similar bonds and all interest, assessments and other charges paid or payable in connection with or in respect of any such Expenses, and shall also specifically include, without limitation, all reasonable attorneys’ fees and all other expenses incurred by or on behalf of Indemnitee in connection with preparing and submitting any requests or statements for indemnification, advancement, contribution or any other right provided by this Agreement. Expenses, however, shall not include amounts of judgments or fines against Indemnitee.

 

(j)                  Independent Counsel ” means, at any time, any law firm, or a member of a law firm, that (a) is experienced in matters of corporation law and (b) is not, at such time, or has not been in the five years prior to such time, retained to represent: (i) any Eloxx Company or Indemnitee in any matter material to either such party (other than with respect to matters concerning Indemnitee under this Agreement, or of other indemnities under similar indemnification agreements), or (ii) any other party to the Proceeding giving rise to a claim for indemnification hereunder. Notwithstanding the foregoing, the term “Independent Counsel” shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Eloxx Companies or Indemnitee in an action to determine Indemnitee’s rights under this Agreement. The Eloxx Companies agree to pay the reasonable fees and expenses of the Independent Counsel referred to above and to fully indemnify such counsel against any and all Expenses, claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto and to be jointly and severally liable therefor.

 

(k)                Eloxx Company ” means any Eloxx Company, any of their respective subsidiaries and any other corporation, partnership, limited liability company, joint venture, trust, employee benefit plan or other enterprise with respect to which Indemnitee serves as a director,

 

  14  

 

officer, employee, partner, representative, fiduciary, trustee or agent, or in any similar capacity, at the request of any Eloxx Company.

 

(l)                  Proceeding ” includes any actual, threatened, pending or completed action, suit, arbitration, alternate dispute resolution mechanism, investigation (formal or informal), inquiry, administrative hearing or any other actual, threatened, pending or completed proceeding, whether brought by or in the right of any Eloxx Company or otherwise and whether civil, criminal, administrative or investigative in nature, in which Indemnitee was, is, may be or will be involved as a party, witness or otherwise, by reason of Indemnitee’s Corporate Status or by reason of any action taken by Indemnitee or of any inaction on Indemnitee’s part while acting as director, officer, employee, fiduciary, trustee or agent of any Eloxx Company (in each case whether or not Indemnitee is acting or serving in any such capacity or has such status at the time any liability or expense is incurred for which indemnification or advancement of Expenses can be provided under this Agreement). If Indemnitee believes in good faith that a given situation may lead to or culminate in the institution of a Proceeding, this shall be considered a Proceeding under this paragraph.

 

16.               Construction . Whenever required by the context, as used in this Agreement the singular number shall include the plural, the plural shall include the singular, and all words herein in any gender shall be deemed to include (as appropriate) the masculine, feminine and neuter genders.

 

17.               Reliance . The Eloxx Companies expressly confirm and agree that they have entered into this Agreement and assumed the obligations imposed on each of them hereby in order to induce Indemnitee to serve as a director and/or an officer of one or more of the Eloxx Companies, and the Eloxx Companies acknowledge that Indemnitee is relying upon this Agreement in serving as a director and/or an officer of one or more of the Eloxx Companies.

 

18.               Modification and Waiver . No supplement, modification or amendment of this Agreement shall be binding unless executed in a writing identified as such by all of the parties hereto. Except as otherwise expressly provided herein, the rights of a party hereunder (including the right to enforce the obligations hereunder of the other parties) may be waived only with the written consent of such party, and no waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions hereof (whether or not similar) nor shall such waiver constitute a continuing waiver.

 

19.               Notice Mechanics . All notices, requests, demands or other communications hereunder shall be in writing and shall be deemed to have been duly given if (i) delivered by hand and receipted for by the party to whom said notice or other communication shall have been directed, or (ii) mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed:

 

(a)                If to Indemnitee to:

 

[●]

 

(b)                If to any Eloxx Company, to:

 

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c/o Eloxx Pharmaceuticals, Inc.

950 Winter Street,

Waltham, MA 02451

Attn: Gregory Weaver

 

with a copy to: Ropes & Gray LLP

1211 6 th Avenue

New York, NY 10036

Attn: Carl Marcellino

 

or to such other address as may have been furnished (in the manner prescribed above) as follows: (a) in the case of a change in address for notices to Indemnitee, furnished by Indemnitee to the Eloxx Companies and (b) in the case of a change in address for notices to any Eloxx Company, furnished by the Eloxx Companies to Indemnitee.

 

20.               Contribution . To the fullest extent permissible under Applicable Law, if the indemnification provided for in this Agreement is unavailable to Indemnitee for any reason whatsoever, the Eloxx Companies, in lieu of indemnifying Indemnitee, shall contribute to the amount incurred by Indemnitee, whether for judgments, fines, penalties, excise taxes, amounts paid or to be paid in settlement and/or for reasonably incurred Expenses, in connection with any claim relating to an indemnifiable event under this Agreement, in such proportion as is deemed fair and reasonable in light of all of the circumstances of such Proceeding in order to reflect (i) the relative benefits received by the Eloxx Companies and Indemnitee as a result of the event(s) and/or transaction(s) giving cause to such Proceeding; and/or (ii) the relative fault of the Eloxx Companies (and their other directors, officers, employees and agents) and Indemnitee in connection with such event(s) and/or transaction(s).

 

21.               Governing Law; Submission to Jurisdiction; Appointment of Agent for Service of Process . This Agreement and the legal relations among the parties shall, to the fullest extent permitted under Applicable Law, be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, without regard to its conflict of laws rules. The Eloxx Companies and Indemnitee hereby irrevocably and unconditionally (i) agree that any action or proceeding arising out of or in connection with this Agreement shall be brought only in the Court of Chancery of the State of Delaware (the “ Delaware Court ”), and not in any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of the Delaware Court for purposes of any action or proceeding arising out of or in connection with this Agreement, (iii) waive any objection to the laying of venue of any such action or proceeding in the Delaware Court, and (iv) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in the Delaware Court has been brought in an improper or otherwise inconvenient forum.

 

22.               Headings . The headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitute part of this Agreement or to affect the construction thereof.

 

  16  

 

23.               Counterparts . This Agreement may be executed in one or more counterparts, each of which shall for all purposes be deemed to be an original but all of which together shall constitute one and the same Agreement.

 

[Remainder of Page Intentionally Blank]

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IN WITNESS WHEREOF, the parties hereto have executed this Agreement on the date first above written.

 

The Company: ELOXX PHARMACEUTICALS, INC.
   
 

By:___________________________________

Name:

Title:

   
   
[Additional Subsidiaries] [TBD]
   
   
   
   
   
   
   
Indemnitee:

______________________________________

Name: [NAME OF DIRECTOR]

   
   

 

 

[Signature Page to Indemnification Agreement]

   

 

 

 

 

Exhibit 16.1

 

December 22, 2017

 

Securities and Exchange Commission

Washington, D.C. 20549

 

Commissioners:

 

We have read Sevion Therapeutics, Inc.’s statements included under Item 4.01 of Form 8-K filed on December 22, 2017 by Eloxx Pharmaceuticals, Inc. and we agree with such statements concerning our firm.

 

 

/s/ RSM US LLP

  

 

 

 

 

Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We consent to the incorporation by reference in the following Registration Statements:

 

1. Registration Statements on Form S-8 (Nos. 333-201891, 333-178881, 333-177586, 333-167388, 333-157417, 333-140238, 333-104105, 333-187133 and 333-195688) of Eloxx Pharmaceuticals, Inc. (formerly, Sevion Therapeutics Inc.)

 

2. Registration Statements on Form S-3(Nos. 333-170140, 333-166277, 333-148779, 333-146691 and 333-138405) of Eloxx Pharmaceuticals, Inc. (formerly, Sevion Therapeutics Inc.)

 

of our report dated December 4, 2017, relating to the Eloxx Pharmaceuticals, Ltd., financial statements as of December 31, 2016 included in this Current Report on Form 8-K.

 

/s/ KOST FORER GABBAY & KASIERER  
A member of Ernst & Young Global  
   
Tel Aviv, Israel  
December 22, 2017  

 

 

 

 

 

Exhibit 99.1

 

Sevion Therapeutics Announces 1-for-20 Reverse Stock Split

 

San Diego, CA – December 19, 2017 –  Sevion Therapeutics, Inc. (OTCQB: SVON) (“Sevion”) today announced that the Board approved a 1-for-20 reverse stock split, to be effective 4:00 p.m. on Tuesday, December 19, 2017. The Company’s common stock will open for trading on the OTCQB Market on Wednesday, December 20, 2017 on a split-adjusted basis under the current trading symbol "SVON." The reverse stock split was approved by Sevion’s stockholders on December 7, 2017, and is intended, among other things, to increase the per share trading price of the Company's common stock to enable the Company to satisfy the minimum bid price requirement for initial listing on the NASDAQ Capital Market.

 

The 1-for-20 reverse stock split will automatically convert twenty current shares of Sevion’s common stock into one new share of common stock. No fractional shares will be issued in connection with the reverse stock split. Stockholders who would otherwise hold a fractional share of Sevion’s common stock will receive a cash payment in lieu thereof at a price equal to that fraction to which the shareholder would otherwise be entitled multiplied by the closing price of Sevion’s common stock on the OTCQB Market on December 18, 2017. The reverse split will reduce the number of shares of outstanding common stock from approximately 51.4 million shares to approximately 2.6 million shares. Proportional adjustments also will be made to the exercise prices of Sevion’s outstanding stock options, and to the number of shares issued and issuable under Sevion’s stock incentive plan.

 

American Stock Transfer & Trust Company (“AST”) will act as the exchange agent for the reverse stock split. Stockholders holding their shares electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares through a bank, broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to brokers’ particular processes, and will not be required to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, AST will send instructions for exchanging those certificates for shares held electronically in book-entry form or for new certificates, in either case representing the post-split number of shares.

 

In connection with the reverse stock split, the Company's CUSIP number will change to 29014R 103 as of 4:00 pm on December 20, 2017.

 

About Sevion Therapeutics

 

Sevion Therapeutics (Company) is a biopharmaceutical company building and developing a portfolio of innovative therapeutics, from both internal discovery and acquisition, for the treatment of cancer and immunological diseases. The Company's product candidates are derived from multiple key proprietary technology platforms: cell-based arrayed antibody discovery, ultra-long antibody scaffolds and Chimerasome nanocages. Sevion has leveraged these technologies to build a pipeline of innovative product candidates. For more information, please visit SevionTherapeutics.com.

 

 

 

 

Forward-Looking Statements

 

Certain statements included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from such statements expressed or implied herein as a result of a variety of factors, including, but not limited to: the Company's ability to continue as a going concern; the ability of the Company to consummate additional financings; the development of the Company's antibody technology; the approval of the Company's patent applications; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products; the timing and success of the Company's preliminary studies, preclinical research and clinical trials; competition and the timing of projects and trends in future operating performance; and the quotation of the Company's common stock on an over-the-counter securities market, as well as other factors expressed from time to time in the Company's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with the Company's periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

 

Contacts

Sevion Therapeutics, Inc.
James Schmidt, 858-909-0749
info@seviontherapeutics.com

 

 

 

 

Exhibit 99.2

 

 

Eloxx Pharmaceuticals Completes Acquisition Transaction with Sevion Therapeutics

 

Company to focus on advancing the clinical development of ELX-02, a disease-modifying therapy for genetic diseases caused by nonsense mutations

 

Waltham, MA, Rehovot, Israel, and San Diego, CA – December 20, 2017 –  Eloxx Pharmaceuticals Ltd. (“Eloxx”) and Sevion Therapeutics, Inc. (OTCQB: SVON) (“Sevion”) today announced the two companies have completed their previously announced acquisition transaction effective as of December 19, 2017. The Company will be known as Eloxx Pharmaceuticals, Inc. following the completion of the transaction, and began trading on OTCQB Market under the new name effective as of December 20, 2017.

 

"This acquisition transaction marks a significant milestone as Eloxx transitions from a private to a publicly-traded company with significantly increased financial resources,” said Silvia Noiman, Ph.D., MBA, founder and Chief Executive Officer of Eloxx Pharmaceuticals. “We are now better positioned to advance our development programs and look forward to initiating multiple Phase 2 studies for ELX-02. In parallel, we intend to strengthen our company on all fronts and, most recently, we hired several key employees to support this effort."

 

At the effective time of the transaction, all of the issued and outstanding ordinary and preferred shares of Eloxx stock were converted, on a pro rata basis, into the right to receive 20,316,656 shares of Sevion common stock, par value $0.01, after giving effect to the 1-for-20 reverse stock split. Following the reverse stock split and acquisition, the combined company has approximately 27.6 million shares outstanding.

 

About Eloxx Pharmaceuticals

Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel small molecule medicines to treat many rare and ultra-rare genetic diseases caused by nonsense mutations. Nonsense mutations are a class of genetic defects that result in premature termination of protein synthesis. As a consequence, patients with a genetic disease caused by nonsense mutations have absent or truncated nonfunctional proteins, accounting for some of the most severe phenotypes in these genetic diseases. Eloxx’s lead product candidate, ELX-02, is an optimized aminoglycoside designed to restore full-length functional proteins. Eloxx was founded in 2013 and maintains offices in Waltham, MA, and Rehovot, Israel.

 

 

 

 

Forward-Looking Statements

 

Certain statements included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Actual results could differ materially from such statements expressed or implied herein as a result of a variety of factors, including, but not limited to: the Company’s ability to continue as a going concern; the ability of the Company to consummate additional financings; the development of the Company’s antibody technology; the approval of the Company’s patent applications; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products; the timing and success of the Company’s preliminary studies, preclinical research and clinical trials; competition and the timing of projects and trends in future operating performance; and the quotation of the Company’s common stock on an over-the-counter securities market, as well as other factors expressed from time to time in the Company’s periodic filings with the Securities and Exchange Commission (the “SEC”). As a result, this press release should be read in conjunction with the Company’s periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and the Company undertakes no obligation to publicly update or revise such forward-looking statements to reflect subsequent events or circumstances.

 

Contacts:
Eloxx Pharmaceuticals
Greg Weaver, CFO
greg@eloxxpharma.com

 

 

 

 

Exhibit 99.3

 

ELOXX PHARMACEUTICAL LTD.

 

CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF DECEMBER 31, 2016

 

IN U.S. DOLLARS

 

INDEX

 

  Page
   
Report of Independent Registered Public Accounting Firm F-2
   
Consolidated Balance Sheets F-3
   
Consolidated Statements of Comprehensive Loss F-4
   
Consolidated Statements of Changes in Shareholders' Equity F-5
   
Consolidated Statements of Cash Flows F-6
   
Notes to Consolidated Financial Statements F-7 - F-25

 

- - - - - - - -

 

  F- 1  

 

 

ELOXX PHARMACEUTICAL LTD.

 

Y:/TOPVIN/2017/12 DEC/21 DEC/SHIFT II/TV481837_SEVION THERAPEUTICS, INC._8K/DRAFT/03-PRODUCTION

 

 

 

Kost Forer Gabbay &
Kasierer

144 Menachem Begin Road,
Building A

Tel-Aviv 6492102, Israel

 

 

 

Tel: +972-3-6232525

Fax: +972-3-5622555

ey.com

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Shareholders of

 

ELOXX PHARMACEUTICAL LTD.

 

We have audited the accompanying consolidated balance sheets of Eloxx Pharmaceutical Ltd. ("the Company") as of December 31, 2015 and 2016, and the related consolidated statements of comprehensive loss, consolidated statements of changes in shareholders' equity and cash flows for each of the three years in the period ended December 31, 2016. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.

 

We conducted our audits in accordance with U.S. Standards of the Public Company Accounting Oversight Board. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. We were not engaged to perform an audit of the Company's internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of the Company and subsidiary at December 31, 2015 and 2016, and the consolidated results of their operations and cash flows for each of the three years in the period ended December 31, 2016, in conformity with U.S. generally accepted accounting principles.

 

Tel-Aviv, Israel KOST FORER GABBAY & KASIERER
December 4, 2017 A Member of Ernst & Young Global

 

  F- 2  

 

 

ELOXX PHARMACEUTICAL LTD.

 

CONSOLIDATED BALANCE SHEETS

 

U.S. dollars in thousands, except share and per share data

 

        December 31,  
    Note   2015     2016  
ASSETS                    
                     
CURRENT ASSETS:                    
Cash and cash equivalents       $ 1,370     $ 2,212  
Restricted bank deposit         24       38  
Other accounts receivable   3     355       837  
                     
Total current assets         1,749       3,087  
                     
Property and equipment, net   4     13       41  
                     
Total assets         1,762       3,128  
                     
LIABILITIES AND SHAREHOLDERS' EQUITY                    
                     
CURRENT LIABILITIES                    
Trade payables         649       1,899  
Other accounts payable   5     470       619  
                     
Total current liabilities         1,119       2,518  
                     
COMMITMENTS AND CONTINGENT LIABILITIES   8                
                     
SHAREHOLDERS' EQUITY:   9                
Ordinary Shares of NIS 0.01 par value -                    
Authorized: 6,000,000 at December 31, 2016 and 2015; Issued and outstanding: 842,500 shares at December 31, 2016 and 2015         2       2  
Series A, B-1 and B-2 Preferred Shares of NIS 0.01 par value                    
Authorized: 4,000,000 at December 31, 2015 and 2016; Issued and outstanding: 820,985 and 1,530,314 at December 31, 2015 and 2016, respectively; Aggregate liquidation preference $20,030 at December 31, 2016         2       4  
Additional paid-in capital         8,538       18,350  
Accumulated deficit         (7,899 )     (17,746 )
                     
Total shareholders' equity         643       610  
                     
Total liabilities and shareholders' equity       $ 1,762     $ 3,128  

 

The accompanying notes are an integral part of the consolidated financial statements.

 

  F- 3  

 

 

ELOXX PHARMACEUTICAL LTD.

 

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

 

U.S. dollars in thousands, except per share and per share data

 

        Year ended
December 31,
 
    Note   2014     2015     2016  
                       
Operating expenses:                            
Research and development, net       $ 1,131     $ 5,842     $ 8,986  
General and administrative expenses         216       429       824  
                             
Operating loss         1,347       6,271       9,810  
                             
Financial expenses, net   11a     60       131       29  
                             
Loss before taxes on income         1,407       6,402       9,839  
                             
Taxes on income   10     -       4       8  
                             
Net loss       $ 1,407     $ 6,406     $ 9,847  
                             
Basic and diluted net loss per share   11b   $ 1.84     $ 8.33     $ 12.99  
                             
Weighted average number of ordinary shares used in computing basic and diluted loss per share         822,500       831,103       842,500  

 

The accompanying notes are an integral part of the consolidated financial statements.

 

  F- 4  

 

 

ELOXX PHARMACEUTICAL LTD.

 

STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY

 

U.S. dollars in thousands, except share data

 

                Additional           Total  
    Ordinary Shares     Preferred Shares     paid-in     Accumulated     Shareholders'  
    Number     Amount     Number     Amount     capital     deficit     Equity  
                                           
Balance as of January 1, 2014     822,500     $ 2       132,500       (*) -     $ 527     $ (86 )   $ 443  
                                                         
Exercise of warrant into Series A Preferred Shares (see Note 9b3)     -       -       37,500       (*) -       150       -       150  
Issuance of Series B-1 Preferred Shares and warrants to purchase Series B-2 Preferred Shares of NIS 0.01 par value, net of $146 issuance expenses (see Note 9b4)     -       -       235,231       1       3,513       -       3,514  
Share-based compensation     -       -       -       -       75       -       75  
Net loss     -       -       -       -       -       (1,407 )     (1,407 )
                                                         
Balance as of December 31, 2014     822,500     $ 2       405,231     $ 1     $ 4,265     $ (1,493 )   $ 2,775  
                                                         
Issuance of Series A Preferred Shares (see Notes 9b5)     -       -       215,000       1       859       -       860  
Issuance of Series B-1 Preferred Shares and warrants to purchase Series B-1 Preferred Shares of NIS 0.01 par value, net of $93 issuance expenses (see Notes 9b6)     -       -       200,754       (*) -       3,022       -       3,022  
Exercise of options into Ordinary Shares (see Notes 9b7)     20,000       (*) -       -       -       (*) -       -       (*) -  
Receipt on account of shares (see Note 6)     -       -       -       -       300       -       300  
Share-based compensation     -       -       -       -       92       -       92  
Net loss     -       -       -       -       -       (6,406 )     (6,406 )
                                                         
Balance as of December 31, 2015     842,500       2       820,985       2       8,538       (7,899 )     643  
                                                         
Issuance of Series B-1 Preferred Shares and warrants to purchase Series B-2 Preferred Shares of NIS 0.01 par value (see Note 9b4)     -       -       235,231       1       3,649       -       3,650  
Issuance of Series B-1 Preferred Shares and warrants to purchase Series B-1 Preferred Shares of NIS 0.01 par value, net of $264 issuance expenses (see Note 9b8)     -       -       385,598       1       5,735       -       5,736  
Exercise of warrants into Series A Preferred Shares (see Note 9b9)     -       -       87,500       (*) -       350       -       350  
Share-based compensation     -       -       -       -       78       -       78  
Net loss     -       -       -       -       -       (9,847 )     (9,847 )
                                                         
Balance as of December 31, 2016     842,500     $ 2       1,530,314     $ 4     $ 18,350     $ (17,746 )   $ 610  

 

(*) Represents an amount lower than $1.

 

The accompanying notes are an integral part of the consolidated financial statements.

 

  F- 5  

 

 

ELOXX PHARMACEUTICAL LTD.

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

U.S. dollars in thousands

 

   

Year ended

December 31,

 
    2014     2015     2016  
Cash flows from operating activities:                        
                         
Net loss   $ (1,407 )   $ (6,406 )   $ (9,847 )
Adjustments to reconcile net loss to net cash used in operating activities:                        
Share-based compensation     75       92       78  
Depreciation     2       5       8  
Change in:                        
Other accounts receivables     (64 )     (276 )     (482 )
Trade payables     92       529       1,250  
Other account payables     125       321       149  
                         
Net cash used in operating activities     (1,177 )     (5,735 )     (8,844 )
                         
Cash flows from investing activities:                        
                         
Investment in restricted bank deposit     (24 )     -       (14 )
Maturity of (investment in) restricted bank deposit     (1,496 )     1,496       -  
Purchase of property and equipment     (7 )     (10 )     (36 )
                         
Net cash (used in) provided by investing activities     (1,527 )     1,486       (50 )
                         
Cash flows from finance activities:                        
Proceeds from exercise of warrants into Series A Preferred Shares     150       -       350  
Proceeds from exercise of warrants into Ordinary Shares     -       (*) -       -  
Proceeds from issuance of Series B-1 Preferred Shares and warrants, net of issuance expenses     3,514       -       3,650  
Proceeds from issuance of Series A Preferred Shares     -       860       -  
Proceeds from issuance of Series B-1 Preferred Shares and warrants, net of issuance expenses     -       3,022       5,736  
                         
Net cash provided by finance activities     3,664       3,882       9,736  
                         
Change in cash and cash equivalents     960       (367 )     842  
Cash and cash equivalents at the beginning of the year     777       1,737       1,370  
                         
Cash and cash equivalents at the end of the year   $ 1,737     $ 1,370     $ 2,212  

 

(*) Represents an amount lower than $1.

 

The accompanying notes are an integral part of the consolidated financial statements.

 

  F- 6  

 

 

NOTE 1: GENERAL

 

a. Eloxx Pharmaceuticals Ltd. (the "Company") was incorporated in Israel on September 17, 2013. The Company focuses its activity on the discovery, development and commercialization of compounds for the treatment of genetic diseases caused by nonsense mutations. In 2013, the Company entered into a license agreement (the "Technion Agreement") with the Technion Research and Development Foundation Ltd. ("TRDF") see Note 7.

 

In April 2015, the Company established a wholly-owned U.S. subsidiary, Eloxx Pharmaceuticals Inc. ("Inc."), which was incorporated under the laws of the State of Delaware. Inc.'s principal business activity is to provide research and development function to the Company.

 

b. As reflected in the accompanying audited consolidated financial statements, the Company has not generated revenue from the sale of any product, and does not expect to generate significant revenue unless and until obtaining of marketing approval and commercializing the drug. The Company incurred a loss for the year ended December 31, 2016 of $9,847 and had a negative cash flow from operating activities of $8,844 during the year ended December 31, 2016. The accumulated deficit as of December 31, 2016 is $17,746.

 

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES

 

The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles in the United States of America ("GAAP").

 

a. Use of estimates:

 

The preparation of the financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions. The Company's management believes that the estimates, judgments and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

 

b. Financial statements in U.S. dollars:

 

Although a portion of the Company's expenses are denominated in New Israeli Shekels ("NIS") (mostly salaries and rent), a substantial portion of its expenses are denominated in U.S. dollars. In addition, a substantial portion of the Company's cash flow transactions and the investing activities and equity transactions are incurred or made in U.S. dollars. The Company's management believes that the dollar is the currency of the primary economic environment in which the Company operates. Thus, the functional and reporting currency of the Company is the dollar.

 

Accordingly, monetary accounts maintained in currencies other than the dollar are re-measured into U.S. dollars in accordance with Accounting Standards Codification ("ASC") 830, "Foreign Currency Matters". All transaction gains and losses of the re-measurement of monetary balance sheet items are reflected in the statements of comprehensive loss as financial income or expenses, as appropriate.

 

c. Principles of consolidation:

 

The consolidated financial statements include the financial statements of the Company and Inc. All intercompany transactions and balances have been eliminated in consolidation.

 

  F- 7  

 

 

 

d. Cash and cash equivalents:

 

Cash equivalents are short-term highly liquid investments that are readily convertible to cash with original maturities of three months or less at the date of purchase to be cash equivalents.

 

e. Restricted bank deposit:

 

Restricted bank deposit includes a deposit with maturities of more than three months and up to one year. The restricted bank deposit is presented at its cost, including accrued interest and is composed of guarantees in respect of the Company's credit card and facilities lease agreements of the Company and Inc.

 

f. Property and equipment:

 

Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets at the following annual rates:

 

    %  
       
Computers and software     33  
Office furniture and equipment      7-15  

 

g. Impairment of long-lived assets:

 

Property and equipment subject to amortization are reviewed for impairment in accordance with ASC 360, "Accounting for the Impairment or Disposal of Long-Lived Assets," whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. During the years ended December 31, 2016, 2015 and 2014, no impairment losses were recorded.

 

h. Concentrations of credit risks:

 

Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents and restricted bank deposit. Cash and cash equivalents and restricted bank deposit are invested mainly in U.S. dollars in one bank in the Israel. Such funds in the Israel may be in excess of insured limits and are not insured in other jurisdictions. Management believes that the financial institutions that hold the Company's investments are financially sound and, accordingly, minimal credit risk exists with respect to these investments.

 

The Company has no off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other foreign hedging arrangements.

 

i. Research and development expenses:

 

Research and development expenses include funding for early-stage biotechnology projects mainly performed by research facilities, and are charged to the statement of comprehensive loss, as incurred except royalty-bearing participation from the Israeli Innovation Authority (previously known as the Office of the Chief Scientist) of the Ministry of Economy ("IIA"), as described in Note 2j.

 

  F- 8  

 

 

j. Government grants:

 

The Company receives royalty-bearing grants, which represents participation of IIA in approved programs for research and development. These amounts are recognized on the accrual basis as a reduction of research and development expenses as such expenses are incurred (see Note 8b).

 

k. Severance pay:

 

The Company's liability for severance pay is pursuant to Section 14 of the Severance Compensation Act, 1963 ("Section 14"), pursuant to which all the Company’s employees are included under Section 14, and are entitled only to monthly deposits, at a rate of 8.33% of their monthly salary, made in the employee's name with insurance companies. Under Israeli employment law, payments in accordance with Section 14 release the Company from any future severance payments in respect of those employees. The fund is made available to the employee at the time the employer-employee relationship is terminated, regardless of cause of termination. The severance pay liabilities and deposits under Section 14 are not reflected in the consolidated balance sheets as the severance pay risks have been irrevocably transferred to the severance funds.

 

Severance expenses for the years ended December 31, 2014, 2015 and 2016 amounted to $26, $35 and $44, respectively.

 

l. Income taxes:

 

The Company account for income taxes in accordance with ASC 740, "Income Taxes" which prescribes the use of the liability method whereby deferred tax assets and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value if it not is more likely than not that a portion or all of the deferred tax assets will be realized.

 

Based on ASC 740, a two-step approach is used to recognize and measure uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. As of December 31, 2015 and 2016, no liability for unrecognized tax positions has been recorded.

 

m. Fair value of financial instruments:

 

ASC 820, "Fair Value Measurements and Disclosures" ("ASC 820"), defines fair value as the price that would be received to sell an asset or paid to transfer a liability (i.e., the "exit price") in an orderly transaction between market participants at the measurement date.

 

In determining fair value, the Company uses various valuation approaches. ASC 820 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company's assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances.

 

  F- 9  

 

 

The hierarchy is broken down into three levels based on the inputs as follows:

 

Level 1  - Valuations based on quoted prices in active markets for identical assets that the Company has the ability to access.
     
Level 2  - Valuations based on one or more quoted prices in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
     
Level 3  - Valuations based on inputs that are unobservable and significant to the overall fair value measurement.

 

The availability of observable inputs can vary from investment to investment and is affected by a wide variety of factors, including, for example, the type of investment, the liquidity of markets and other characteristics particular to the transaction. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment and the investments are categorized as Level 3.

 

The carrying amounts of cash and cash equivalents, restricted bank deposits, other accounts receivable, trade payables and accrued expenses and other accounts payable approximate their fair value due to the short-term maturities of such instruments.

 

n. Accounting for stock-based compensation:

 

The Company accounts for stock-based compensation in accordance with ASC 718, "Compensation-Stock Compensation", ("ASC 718"), which requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in the Company's consolidated statement of comprehensive loss.

 

The Company recognizes compensation expenses for the value of its awards granted based on the straight line method over the requisite service period of each of the awards, net of estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

 

The Company estimates the fair value of stock options granted using the Binomial Option-Pricing Model ("Binomial Model") which requires a number of assumptions, of which the most significant are the fair market value of the underlying Ordinary Shares, expected stock price volatility, suboptimal exercise factor and the expected option term. Expected volatility was calculated based upon historical volatilities of similar entities in the related sector index. The expected option term represents the period that the Company's stock options are expected to be outstanding and is determined based on the simplified method until sufficient historical exercise data will support using expected life assumptions. The suboptimal exercise factor is estimated using historical option exercise information. The suboptimal exercise factor is the ratio by which the stock price must increase over the exercise price before employees are expected to exercise their stock options. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends.

 

The fair value of Ordinary Shares underlying the options was determined by the Company's Board of Directors with the assistance of an independent valuation firm. Because there has been no public market for the Ordinary Shares, the Board of Directors has determined fair value of the Ordinary Shares at the time of grant of by considering a number of objective and subjective factors including data from other comparable companies, sales of series Preferred Shares to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock and general and industry specific economic outlook, amongst other factors. The fair value of the underlying Ordinary Shares shall be determined by management until such time as the Ordinary Shares are listed on the OTCQB Marketplace. For all reported periods, the valuations were performed using the Option Pricing Method ("OPM").

 

  F- 10  

 

 

o. Basic and diluted net loss per share:

 

The Company applies the two class method as required by ASC No. 260-10, "Earnings Per Share" ("ASC 260-10"), which requires the income or loss per share for each class of shares (ordinary and preferred shares) to be calculated assuming 100% of the Company's earnings are distributed as dividends to each class of shares based on their contractual rights.

 

No dividends were declared or paid during the reported periods. According to the provisions of ASC 260-10, the Company's Preferred Shares are not participating securities in losses and, therefore, are not included in the computation of net loss per share.

 

Basic loss per share is computed by dividing the loss for the period applicable to Ordinary Shareholders by the weighted average number of Ordinary Shares outstanding during the period. In computing diluted income per share, basic earnings per share are adjusted to reflect the potential dilution that could occur upon the exercise of share options granted to grantees and upon conversion of shares warrants issued to investors and service providers using the "treasury stock method".

 

For the years ended December 31, 2014, 2015 and 2016, all outstanding Preferred Shares, share options and share warrants have been excluded from the calculation of the diluted net loss per share as all such securities are anti-dilutive for all years presented (see Note 11b).

 

p. Legal and other contingencies:

 

The Company accounts for its contingent liabilities in accordance with ASC 450 "Contingencies". A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. As of December 31, 2015 and 2016, the Company is not a party to any litigation that could have a material adverse effect on the Company's business, financial position, results of operations or cash flows (see Note 7).

 

Legal costs incurred in connection with loss contingencies are expensed as incurred.

 

q. Recent Accounting Pronouncements:

 

1. In August 2014, the FASB issued Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern ("ASU 2014-15"), which provides guidance on management’s responsibility in evaluating whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued (or within one year after the date that the financial statements are available to be issued when applicable). ASU 2014-15 also provide guidance related to the required disclosures as a result of management evaluation.

 

The amendments in ASU 2014-15 became effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Accordingly, management applied the guidance of ASU 2014-15 to these financial statements and has determined that there is a no doubt about the Company’s ability to continue as a going concern. Certain disclosures were provided to conform to the disclosures required under ASU 2014-15

 

  F- 11  

 

 

2. In February 2016, the FASB issued ASU 2016-02, "Leases", on the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for in a manner similar to the accounting under existing guidance for operating leases today. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. ASC 842 supersedes the previous leases standard, ASC 840, "Leases". The guidance is effective for the interim and annual periods beginning on or after December 15, 2018, and early adoption is permitted. This new guidance does not have a material impact on the Company’s consolidated financial statements.

 

3. On March 30, 2016, the FASB issued ASU 2016-09, "Compensation - Stock Compensation", which effects all entities that issue share-based payment awards to their employees. The amendments in this ASU cover such areas as the recognition of excess tax benefits and deficiencies, the classification of those excess tax benefits on the statement of cash flows, an accounting policy election for forfeitures, the amount an employer can withhold to cover income taxes and still qualify for equity classification and the classification of those taxes paid on the statement of cash flows. This ASU is effective for annual and interim periods beginning after December 15, 2016. This guidance can be applied either prospectively, retrospectively or using a modified retrospective transition method. This new guidance does not have a material impact on the Company’s consolidated financial statements.

 

4. In November 2016, the FASB issued Accounting Standards Update No. 2016-18, Statement of Cash Flows (Topic 230): "Restricted Cash" (ASU 2016-18), which requires companies to include amounts generally described as restricted cash and restricted cash equivalents in cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. This new guidance does not have a material impact on the Company’s consolidated financial statements.

 

5. In May 2017, the FASB issued ASU 2017-09 guidance on changes to terms and conditions of share-based payment awards. The amendment provides guidance about which changes to terms or conditions of a share-based payment award require an entity to apply modification accounting. The guidance will be effective for the fiscal year beginning on January 1, 2018, including interim periods within that year (early adoption is permitted). The Company is currently evaluating the potential effect of the guidance on its consolidated financial statements.

 

6. In July 2017, the FASB issued ASU 2017-11, which allows companies to exclude a down round feature when determining whether a financial instrument is considered indexed to the entity’s own stock. As a result, financial instruments with down round features may no longer be required to be accounted classified as liabilities. A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward. For equity-classified freestanding financial instruments, such as warrants, an entity will treat the value of the effect of the down round, when triggered, as a dividend and a reduction of income available to common shareholders in computing basic earnings per share. The guidance in ASU 2017-11 is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted, and the guidance is to be applied using a full or modified retrospective approach. The Company is evaluating the impact of the revised guidance.

 

  F- 12  

 

 

NOTE 3: OTHER ACCOUNTS RECEIVABLES

 

    December 31  
    2015     2016  
             
Prepaid expenses   $ 5     $ 11  
Government grants from IIA     259       605  
Governmental authorities     91       221  
                 
    $ 355     $ 837  

 

NOTE 4: PROPERTY AND EQUIPMENT, NET

 

    December 31  
    2015     2016  
             
Cost:                
                 
Computers and software   $ 19     $ 54  
Office furniture and equipment     1       2  
      20       56  
Accumulated depreciation:                
                 
Computers and software     7       14  
Office furniture and equipment     (*) -       1  
      7       15  
                 
Depreciated cost   $ 13     $ 41  

 

(*) Represents an amount lower than $1.

 

Depreciation expenses for the years ended December 31, 2014, 2015 and 2016 were $2, $5 and $8, respectively.

 

NOTE 5: OTHER ACCOUNTS PAYABLE

 

    December 31,  
    2015     2016  
             
Employees and payroll accruals   $ 11     $ 229  
Social accruals     100       164  
Governmental authorities     22       26  
Accrued expenses     377       200  
                 
    $ 470     $ 619  

 

NOTE 6: RECEIPT ON ACCOUNT OF SHARES

 

On October 16, 2013 (the "Effective Date"), the Company signed a Right of First Negotiation Agreement (the "ROFN Agreement") with a potential investor (the "Investor"), Pursuant to which, the Investor shall pay to the Company a total amount of $900 in two installments (the "ROFN Payments") as follows: (i) amount of $300 within 90 days following the Effective Date (the "First Installment"), and (ii) $600 within 14 days following a written notice signed by the Company's Chief Executive Officer, confirming that the Company has officially reached a clinical candidate selection, as agreed with the Investor (the "Second Installment").

 

In addition, the Investor is entitled to convert the ROFN Payments to preferred securities upon a qualified financing as defined in the ROFN Agreement. In October 2013, the First Installment was transferred to the Company.

 

  F- 13  

 

 

On February 13, 2015, the ROFN Agreement was mutually terminated. Upon the ROFN Agreement's termination, based on the agreement the First Installment shall not be repaid to the Investor and the Investor will not pay the Second Installment. Therefore, the liability related to prepayments on shares was classified into additional paid in capital.

 

NOTE 7: RELATED PARTY

 

In 2013, the Company entered into Technion Agreement with TRDF with respect to certain technology relating to aminoglycosides and the redesign of aminoglycosides for the treatment of human genetic diseases caused by premature stop mutations and further results of the research of the technology, in order to develop and commercialize products based on such technology. Under the agreement, TRDF shall provide the Company research services for an estimated annual payment of $50, with the exact payment to be mutually agreed upon by the parties prior to the beginning of each year of the research period.

 

In addition, TRDF shall grant the Company a license to use, market, sell or sub-license the rights of the product developed under the TRDF research results (the "Licensed Product"), as fully defined in the Technion Agreement, for the following considerations: (a) milestone payments, to be transferred upon meeting certain milestones as defined in the Technion Agreement, up to total consideration of $6,100; (b) royalties on net sales of the Licensed Product, either from sales by the Company or by a sub-licensed entity, at the rate of 2.75%-3.75%, for a period until the later of (i) the expiration of a valid claim on the Licensed Product in each country the Licensed Product is sold to, or (ii) fifteen years from the date of the first commercial sale of the Licensed Product in such country, and (c) 20% of the non-royalty sub-license income received by the Company from a sub-licensed entity. In addition, the Company shall pay certain fee to TRDF upon an exit event as described in the Technion Agreement.

 

Moreover, upon the closing of an Exit Event that is not Initial Public Offering ("IPO"), as defined in the Technion Agreement, TRDF shall be entitled to an amount equal to 3% of all non-refundable, non-contingent consideration, whether in cash or in kind, actually received by the Company and / or its shareholders. Upon the closing of an Exit Event that is IPO, as defined in the Technion Agreement, TRDF shall be entitled to a number of Ordinary Shares of the Company representing 3% of the Company's outstanding shares on a fully diluted basis immediately prior to the closing of such IPO. The Company's management strongly believes TRDF is not entitled to any of the above consideration following the closing of the merger transaction with Sevion Therapeutics Inc. (“Sevion”) (see Note 12e and 12f).

 

During the year ended December 31, 2016, the Company recorded general and administrative expenses amounting to $185 in relation with TRDF reimbursement for the preparation, filling, prosecution and maintenance of TRDF patents rights related to the Company.

 

In addition, during the year ended December 31, 2014, 2015 and 2016, the Company recorded research and development expenses in connection to TRDF amounting to $50, $58 and $33, respectively. As of December 31, 2015 and 2016, the TRDF balance recorded in accrued expenses balance was $26 and $185, respectively.

 

  F- 14  

 

 

NOTE 8: COMMITMENTS AND CONTINGENT LIABILITIES

 

a. The Company and Inc. leased their facilities under an operating lease agreements for the period ending in February 2017 and March 2017, respectively.

 

Future minimum lease commitments as of December 31, 2016 were as follows:

 

As of December 31,   Total  
         
2017   $ 25  
         
    $ 25  

 

The lease expenses that were recorded during the years ended December 31, 2014, 2015 and 2016 amounting to $59, $97 and $130, respectively.

 

Subsequent to December 31, 2016, the Company and Inc. signed on a new lease agreements (see Notes 12b and 12c).

 

b. Royalty commitments to the IIA (previously known as Office of the Chief Scientist):

 

Under the research and development agreements with the IIA and pursuant to applicable laws, the Company is required to pay royalties at the rate of 3%-3.5% on sales to end customers of products developed with funds provided by the IIA, up to an amount equal to 100% of the IIA research and development grants received, linked to the dollar plus interest on the unpaid amount received based on the 12-month LIBOR rate (from the year the grant was approved) applicable to dollar deposits. If the Company does not generate sales of products developed with funds provided by the IIA, the Company is not obligated to pay royalties or repay the grants.

 

The total research and development grants received by the Company from the IIA for the years ended December 31, 2014, 2015 and 2016 were $175, $309 and $1,218, respectively. As of December 31, 2016, the Company has not commenced the payment obligation of the royalties, and has a contingent obligation with respect to royalty-bearing participation received or accrued (including LIBOR interest amounting to $11), amounting to $1,713.

 

c. In November 2014, the Company entered into 2014 Finder Fee Agreement (the "Agreement) with an Independent Contractor (the "Contractor"), for the purpose of presentation to potential strategic partners and potential investors.

 

According to the Agreement, at each closing of financing from certain investors (the "Investment Amount"), the Contractor shall be eligible to a fee equal to either: (a) cash fee of 8.5% of the Investment Amount, or (b) cash fee of 5% of the Investment Amount and a warrant for the purchase of 5% of the shares issued to the certain investors at such equity investment. The exercise price per share for the warrants shall be equal to the price per share of the securities sold in such financing. The warrants' contractual term is 5 years.

 

Until December 31, 2016, the Company paid to the Contractor aggregate amount of $491 and granted 49,784 warrants to purchase 49,784 Series Preferred B-1 Shares as finder fee compensation (see Notes 9b4, 9b6, 9b8 and 9c) (9,667 warrants out of which were expired in November 2016). Subsequent to December 31, 2016, the Company paid to the Contractor and another service provider aggregate amount of $479 and granted 16,367 warrants to purchase 16,367 Series Preferred C Shares as finder fee compensation in connection to 2017 SPA (see Note 12e).

 

d. Technion Agreement (see Note 7).

 

  F- 15  

 

 

NOTE 9: SHAREHOLDERS' EQUITY

 

a. As of December 31, 2015 and 2016, the Company's share capital is composed as follows:

 

    December 31, 2015     December 31, 2016  
    Authorized     Issued and
outstanding
    Authorized     Issued and
outstanding
 
    Number of shares  
                         
Ordinary Shares (1)     6,000,000       842,500       6,000,000       842,500  
Preferred A Shares (2)     1,000,000       385,000       1,000,000       472,500  
Preferred B-1 Shares (2)     2,000,000       435,985       2,000,000       1,057,814  
Preferred B-2 Shares (2)     1,000,000       -       1,000,000       -  
                                 
      10,000,000       1,663,485       10,000,000       2,372,814  

 

(1) The Ordinary Shares confer upon their holders the following rights:

 

(a) The right to participate and vote in the Company's general meetings, whether regular or extraordinary. Each share will entitle its holder, when attending and participating in the voting in person or via agent or letter, to one vote;

 

(b) The right to a share in the distribution of dividends, whether in cash or in the form of bonus shares, the distribution of assets or any other distribution pro rata to the par value of the shares held by them;

 

(c) The right to a share in the distribution of the Company's excess assets upon liquidation pro rata to the par value of the shares held by them.

 

(2) Preferred A, B-1 and B-2 Shares (together refer as "Preferred Shares") confer upon their holders all the rights of Ordinary Shares. In addition, based on the Company's Articles of Association (the "AOA"), the preferred shareholders bear the following rights and privileges:

 

Voting - Holders of series Preferred Shares are entitled to one vote for each Preferred share into which such share Preferred share is convertible. The holders of the Preferred Shares shall be entitled to vote on all matters on which holders of Ordinary Shares are entitled to vote. Certain decisions of the shareholders require the approval of the majority of the holders of Preferred Shares on a pro rata basis.

 

Conversion - Each Preferred Share shall be convertible at the option of the holder thereof, at any time after the date of issuance of such share, into such number of fully paid and non-assessable Ordinary Shares as is determined by dividing the original issue price of such Preferred Share by the applicable conversion price at that time in effect for such Preferred Share.

 

All Preferred Shares shall automatically be converted 1:1 into such number of fully paid and non-assessable Ordinary Shares , upon the earliest to occur of the following: (i) immediately prior to and contingent upon the closing of an IPO where the Company’s pre-money valuation is $150,000 or more with net proceeds to the Company of $50,000 or more ("Qualified IPO"); (ii) immediately prior to and contingent upon the closing of a merger of the Company into a public company in which the merger consideration is shares which are freely traded on a reputable stock exchange, provided that such merger was approved in writing by investor of Preferred shares in advance; or (iii) upon the consent of the majority preferred shareholders (see Note 12e).

 

  F- 16  

 

 

The Company has reserved Ordinary Shares that will be sufficient to effect the conversion of all outstanding shares of Preferred Shares.

 

Liquidation preference - In the event of (i) liquidation, (ii) deemed liquidation, or (iii) any distribution in cash, cash equivalents, Based on preference of distribution, the holders of Preferred Shares shall be entitled to receive, before any payment shall be made or declared to the holders of Ordinary Shares, an amount which is equal to (i) the original issue price of such Preferred Share (subject to adjustments) plus an amount per share equal to 8% per annum of the applicable original issue price compounded annually from the applicable date of issuance thereof, to the date of payment of such distributable proceeds, up to 150% of the applicable original issue price, plus (ii) any declared but unpaid dividends with respect to such Preferred Share, less (iii) all dividends actually paid to the holders of Preferred Shares on account of the Preferred Shares.

 

As of December 31, 2016, the aggregate liquidation preference amounted to $20,030. The foregoing dollar amount does not include dividends, as the Board of Directors has not declared any dividends since inception.

 

Preemptive rights  - Until the closing of an IPO, each shareholder holding at least one percent of the issued and outstanding share capital of the Company on a fully diluted and as converted basis (the "Eligible Shareholders") shall have preemptive rights to purchase all or part of such Eligible Shareholder's pro-rata share of new securities that the Company may sell and issue, from time to time.

 

b. Issuance of shares:

 

1. On October 15, 2013 the Company issued to three investors 822,500 ordinary shares with par value of NIS 0.01 (see Note 1a).

 

2. On November, 2013, the Company entered into a Series A Preferred Shares Purchase Agreement (the "2013 SPA") whereby the Company issued to new and existing investors (the "2014 Investors") 347,500 Series A Preferred Shares with par value of NIS 0.01 and 125,000 warrants to one of the investors to purchase 125,000 Series A Preferred Shares with an exercise price of $4 (the "2013 Warrants") for an aggregate gross amount of $1,390, representing a price per unit of $4, that should be transferred to the Company in two closing.

 

3. In January 2014, certain shareholder exercised its warrants to purchase 37,500 Series A Preferred Shares for a total amount of $150.

 

4. On October 30, 2014, the Company entered into a Series B-1 Preferred Shares Purchase Agreement (the "2014 SPA") whereby the Company issued to new and existing investors (the "2014 Investors") 470,462 Series B-1 Preferred Shares with par value of NIS 0.01 and 235,232 warrants to purchase 235,232 Series B-2 Preferred Shares with an exercise price of $23.28 (the " 2014 Warrants") for an aggregate gross amount of $7,300, representing a price per unit of $15.52, that should be transferred to the Company in two closing.

 

The warrants shall be exercisable by each investor as follows: (i) half of the underlying Preferred B-2 Share upon the first closing and (ii) half of the underlying Preferred B-2 Shares upon the achievement by 2014 Investors of its respective portion of the investment amount following the commencement of First In Man ("FIM") trial, which is defined in the 2014 SPA as the Milestone Closing. The exercise period of the aforementioned warrants ends on the second anniversary of the date of which such warrants became exercisable.

 

  F- 17  

 

 

Following the signing of the 2014 SPA, the consideration was paid in two installments, whereby the 2014 Investors transferred to the Company amount of $3,650 for issuance of 235,231 Series B-1 Preferred Shares and 117,616 warrants to purchase 117,616 Series B-2 Preferred Shares as first closing. In addition, in September 2016, upon meeting of the Milestone Closing, the 2014 Investors transferred to the Company the additional amount of $3,650 for 235,231 Series B-1 Preferred Shares with par value of NIS 0.01 and 117,616 warrants to purchase 117,616 Series B-2 Preferred Shares as a second closing.

 

As discussed in Note 8c, in connection to the 2014 SPA, the Company paid to the Contractor cash consideration of $115 as a finder fee and granted an amount 34,796 warrants to purchase 34,796 Series B-1 Preferred Shares with an exercise price of $15.52 (7,331 warrants out of this total were granted upon the achievement of the Milestone Closing). The warrants are subject to standard anti-dilution protection clauses.

 

5. In April 2015, the Company met a clinical milestone in connection with the share purchase agreements signed in 2013 SPA, pursuant to which, the Company issued to participated investors 215,000 Series A Preferred Shares with par value of NIS 0.01 for an aggregate amount of $860.

 

6. On July 16, 2015, the Company entered into a Series B-1 Preferred Shares Purchase Agreement (the "2015 SPA") whereby the Company issued to existing investors (the "2015 Investors") 200,754 Series B-1 Preferred Shares with par value of NIS 0.01 and 301,130 warrants to purchase 301,130 Series B-1 Preferred Shares with an exercise price of $15.52 (the "2015 Warrants") for an aggregate gross amount of $3,115, representing a price per unit of $15.52.

 

The warrants are eligible for exercise into Series B-1 Preferred Shares over a period that terminates upon the earlier of the following events to occur: (i) consummation of a Deemed Liquidation as defined in the 2015 SPA; or (ii) July 23, 2022; or (iii) the later of: (a) July 23, 2017); or (b) Expiration of 180 day period as of the completion of FIM trial.

 

As discussed in Note 8c, in connection to the 2015 SPA, the Company paid the Contractor cash consideration of $112 as a finder fee and granted 6,123 warrants to purchase 6,123 Series B-1 Preferred Shares with exercise price of $15.52. The warrants are subject to standard anti-dilution protection clauses.

 

7. In July 2015, one of the Company's employee exercised its 20,000 options with an exercise price of 0.01 NIS to purchase 20,000 Ordinary Shares.

 

8. In February 2016, the Company entered into a Series B-1 Preferred Shares Purchase Agreement (the "2016 SPA") whereby the Company issued to existing investors (the "2016 Investors") 386,598 Series B-1 Preferred Shares with par value of NIS 0.01 and 579,898 warrants to purchase 579,898 Series B-1 Preferred Shares with an exercise price of $15.52 (the "2016 Warrants") for an aggregate gross amount of $6,000, representing a price per unit of $15.52, that should be transferred to the Company in two closing.

 

The warrants shall be exercisable by each investor as follows: (i) half of the underlying Preferred B-2 Share upon the first closing and (ii) half of the underlying Preferred B-1 Shares upon the achievement by 2016 Investors of its respective portion of the investment amount following the commencement FIM trial, which defined in the 2016 SPA as the Milestone Closing. The exercise period of the aforementioned warrants end upon the occurrence of earlier of the following events: (i) consummation of a Deemed Liquidation as defined in the Company's AOA; or (ii) the fifth anniversary of the applicable closing.

 

Following the signing of the 2016 SPA, the 2016 Investors transferred to the Company $3,500 for issuance of 225,516 Series B-1 Preferred Shares and 338,275 warrants to purchase 338,275 Series B-1 Preferred Shares as a first closing. In addition, in November 2016, upon meeting a certain milestone as described in the 2016 SPA, the 2016 Investors transferred to the Company an additional amount of $2,500 for 161,082 Series B-1 Preferred Shares and 241,623 warrants to purchase 241,623 Series B-1 Preferred Shares as a second closing.

 

  F- 18  

 

 

As discussed in Note 8c, in connection to the 2016 SPA, the Company paid to the Contractor cash consideration of $264 as a finder fee and granted an amount 5,638 warrants to purchase 9,665 Series B-1 Preferred Shares with exercise price of $15.52. The warrants are subject to standard anti-dilution protection clauses.

 

9. In August 2016, two shareholders exercised 25,000 and 62,500 warrants to purchase Series A Preferred shares, respectively, for a total consideration of $350.

 

10. Subsequent to December 31, 2016, the Company issued 1,421,838 Series C Preferred Shares with par value of NIS 0.01 for total gross consideration of $21,000 (see Notes 12d and 12e).

 

c. The table below summarizes the outstanding warrants as of December 31, 2016:

 

    Amount    

Weighted

average

exercise

price

 
             
Warrants to purchase Ordinary Shares     12,897       4.00  
Warrants to purchase Series B-1 Preferred Shares (*)     911,478       15.52  
Warrants to purchase Series B-2 Preferred Shares     235,232       23.28  
                 
Total outstanding warrants     1,159,607          

 

(*) Including 40,117 warrants that were granted to the Contractor as finder fee compensation for the purpose of presentation to potential strategic partners and potential investors (see Note 8c).

 

Subsequent to December 31, 2016, the Company granted to certain service providers 16,367 warrants to purchase 16,367 Series Preferred C Shares upon the closing of the 2017 SPA as finder fee compensation (see Note 12e).

 

d. Stock-based compensation:

 

In 2013, the Company's Board of Directors adopted the 2013 Share Ownership and Option Plan in accordance with the amended section 102 and 3(i) of Israel’s Income Tax Ordinance (the "2013 Plan"). Under the 2013 Plan, options to purchase Ordinary Shares of the Company may be granted to employees, officers, directors and consultants of the Company. Each option granted can be exercised for one Ordinary Shares of the Company. Options granted generally become fully exercisable after two to four years and expire no later than 10 years from the approval date of the option plan under terms of grant. Any option forfeited or cancelled before expiration become available for future grants. As of December 31, 2016, the options pool amounted to 390,300 Ordinary Shares, and therefore there were no Ordinary Shares available for future grant under the 2013 Plan.

 

  F- 19  

 

 

Transactions related to the grant of options to employees and directors under the 2013 Plan during the year ended December 31, 2016, were as follows:

 

    Amount    

Weighted

average

exercise

price

   

Weighted
average
remaining
contractual
life

    Aggregate
intrinsic
value
 
                         
Options outstanding at beginning of year     312,800     $ 1.67       8.58     $ 335  
Granted     77,500     $ 4.93                  
                                 
Options outstanding at end of year     390,300     $ 2.32       7.93       1,571  
                                 
Vested and expected to be vested at end of year     390,300     $ 2.32       7.93     $ 1,571  
                                 
Options exercisable at end of year     279,545     $ 0.34       7.55     $ 1,407  

 

The aggregate intrinsic value represents the total intrinsic value (the difference between the deemed fair value of the Company's Ordinary Shares on the last day of fiscal 2016 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on December 31, 2016. The aggregate intrinsic value is impacted by the changes in the fair value of the Company's shares.

 

The weighted average grant date fair value of the options granted during the years ended December 31, 2014, 2015 and 2016 were $0.79, $0.87 and $0.69, respectively.

 

The following table presents the assumptions used to estimate the fair values of the options granted in the period presented:

 

    December 31,
    2014   2015   2016
             
Dividend yield   0%   0%   0%
Volatility   75.04%-88.38%   73.70%-88.72%   64.46%-105.57%
Risk free interest   0.15%-2.02%   0.25%-1.87%   0.47%-2.35%
Contractual term (years)   10   10   10
Suboptimal exercise   2.3   2.3   2.3

 

As of December 31, 2016, there was $75 of total unrecognized compensation cost related to non-vested stock options granted under the 2013 Plan. This cost is expected to be recognized over a weighted-average period of 1.16 years.

 

  F- 20  

 

 

The total equity-based compensation expense related to all of the Company's equity-based awards, recognized for the years ended December 31, 2014, 2015 and 2016, was comprised as follows:

 

   

Year ended

December 31,

 
    2014     2015     2016  
                   
Research and development   $ 68     $ 68     $ 61  
General and administrative     7       24       17  
                         
Total stock-based compensation expenses   $ 75     $ 92     $ 78  

 

NOTE 10: TAXES ON INCOME

 

a. Tax rates applicable to the Company:

 

1. Taxable income of the Company is subject to a corporate tax rate in Israel as follow: 2015 - 26.5% and 2016 - 25%.

 

2. On January 4, 2016, the Israeli Parliament officially published the Law for the Amendment of the Israeli Tax Ordinance (Amendment 216), which reduces the standard corporate income tax rate from 26.5% to 25%.

 

3. In December 2016, the Israeli Parliament approved the Economic Efficiency Law (Legislative Amendments for Applying the Economic Policy for the 2017 and 2018 Budget Years), which reduces the corporate income tax rate to 24% (instead of 25%) effective from January 1, 2017 and to 23% effective from January 1, 2018 and thereafter.

 

b. Tax rates applicable to Inc.:

 

Inc. is subject to U.S. income taxes. The tax rates are compounded from a progressive federal tax of 35% in addition to state and local taxes.

 

c. Income taxes on the Company’s foreign subsidiary:

 

Foreign subsidiaries are taxed according to the tax laws in its respective country of residence. Neither Israeli income taxes, foreign withholding taxes nor deferred income taxes were provided in relation to undistributed earnings of the Company's foreign subsidiary. This is because the Company has the intent and ability to reinvest these earnings indefinitely in its foreign subsidiary and therefore those earnings are continually redeployed in foreign jurisdictions.

 

d. Net operating losses carryforward:

 

The Company has accumulated operating losses for tax purposes as of December 31, 2016 in the amount of approximately $12,220, which may be carried forward and offset against taxable income in the future for an indefinite period.

 

  F- 21  

 

 

e. Deferred income taxes:

 

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets are as follows:

 

    December 31,  
    2015     2016  
             
Deferred tax assets:                
Net operation loss carryforward   $ 1,174     $ 2,811  
Reserves and allowances     10       17  
Research and development     719       864  
                 
Net deferred tax asset before valuation allowance     1,903       3,692  
Valuation allowance     (1,903 )     (3,692 )
                 
Net deferred tax asset   $ -     $ -  
                 

 

In assessing the realization of deferred tax assets, management considers whether it is more likely than not that all or some portion of the deferred tax assets will not be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income during the periods in which temporary differences are deductible and net operating losses are utilized. Based on consideration of these factors, the Company recorded a full valuation allowance at December 31, 2015 and 2016.

 

f. The components of income (loss) before taxes on income are as follows:

 

    Year ended December 31,  
    2014     2015     2016  
                   
Domestic   $ (1,407 )   $ (6,418 )   $ (9,883 )
Foreign     -       16       44  
                         
Income (loss) before taxes on income   $ (1,407 )   $ (6,402 )   $ (9,839 )

 

g. Taxes on income for the years ended December 31, 2015 and 2016 are comprised from taxes incurred as a result of the implementation of the cost plus method between the Company and Inc.

 

h. The main reconciling item between the statutory tax rate of the Company and the effective tax rate is the recognition of valuation allowances in respect to deferred taxes relating to accumulated net operating losses carried forward and temporary differences due to the uncertainty of the realization of such deferred taxes.

 

NOTE 11: SELECTED STATEMENTS OF COMPREHENSIVE LOSS

 

a. Financial expense, net:

 

   

Year ended

December 31,

 
    2014     2015     2016  
                   
Financial expenses:                        
Bank commissions and others   $ 1     $ 9     $ 22  
Exchange rate differences     59       122       7  
                         
Total financial expense, net   $ 60     $ 131     $ 29  

 

  F- 22  

 

 

b. The loss and the weighted average number of shares used in computing basic and diluted net loss per share for the years ended December 31, 2014, 2015 and 2016, is as follows:

 

   

Year ended

December 31,

 
    2014     2015     2016  
                   
Numerator:                        
Net loss   $ 1,407     $ 6,406     $ 9,847  
Dividends accumulated for the period (*)     102       516       1,100  
                         
Net loss available to shareholders of Ordinary Shares   $ 1,509     $ 6,922     $ 10,947  
                         
Denominator:                        
Shares used in computing net loss per share of Ordinary shares, basic and diluted     822,500       831,103       842,500  
Net loss per share of Ordinary Share, basic and diluted   $ 1.84     $ 8.33     $ 12.99  

 

(*) The net loss used for the computation of basic and diluted net loss per share include 8% per share per annum compounded annually which shall be distributed to shareholders in case of distributable assets determined in the AOA under the liquidation preference right (See Note 9a2).

 

Convertible securities, including 1,159,607 warrants to purchase Ordinary Shares and 472,500 Series Preferred A Shares, 1,057,815 Series Preferred B-1 Shares and 390,300 options to grantees under the 2013 Plan, are not included in this calculation due to their anti-dilutive effect.

 

NOTE 12: SUBSEQUENT EVENTS

 

a. The Company evaluates events or transactions that occur after the balance sheet date but prior to the issuance of the consolidated financial statements to identify matters that require additional disclosure. For its annual consolidated financial statements as of December 31, 2016 and for the year then ended, the Company evaluated subsequent events through December 4, 2017, the date that the consolidated financial statements were issued. Except as described below, the Company has concluded that no subsequent event has occurred that require disclosure.

 

b. On February 22, 2017, the Company entered into a new Operating Lease Agreement (the "Agreement") for its premises for a period of 3 years commencing March 8, 2017 and continuing until April 30, 2020 with an option to extend the lease period for additional 2 years. According to the terms of the Agreement, the Company has a grace period of 2 months from payments, after which the Company will pay a monthly fee of $5.

 

In addition, in January 2017, Inc. renewed its operating lease agreement, pursuant to which the Company leased its facilities for a period of 1 year commencing April 1, 2017 and continuing until March 31, 2018. According to the terms of the Agreement, the Company will pay a monthly fee of $5.

 

c. In March 2017, the Company entered into an agreement with an unrelated party to occupy a laboratory for its clinical needs for a period of 1 year commencing March 8, 2017 and continuing until March 8, 2018 with an option to extend the lease period for additional 1 year. According to the terms of the agreement, the Company will pay a monthly fee of $4.

 

  F- 23  

 

 

 

d. On January 26, 2017 (the "Closing Date"), the Company entered into a Convertible Loan Agreement (the "Agreement") with five of its shareholders (the "Lenders"), pursuant to which the Company raised an aggregate amount of $2,500 (the "Convertible Loan"). The Convertible Loan should bear a 5% annual interest rate. According to the Agreement, the outstanding portion of the Convertible Loan (without accrued interest) should be automatically converted upon the consummation of equity investment by third party of an aggregate amount of at least $5,000 (the "Qualified Equity Investment"), prior to the lapse of 2 years from the Closing Date (the "Maturity Date"), into equity securities of the same class issued by the Company in a Qualified Equity Investment, in a conversion price which is equal to 80% of the price per share paid by the third party is such Qualified Equity Investment (the "Automatic Conversion"). In addition, upon the earlier of (i) the Maturity Date or (ii) an Event of Default as defined in the Agreement, the outstanding portion of the Convertible Loan (including accrued interest) should be converted into an equity investments of the then existing most senior class, at a conversion price per share which is equal to 65% of the original issue price per share applicable to such class. At the end of May 2017, the Lenders signed a waiver agreement, pursuant to which they waived the potential discount described above. On May 31, 2017, the Convertible Loan was converted into 165,326 Series C Preferred Shares, according to the price per share that was paid in the 2017 SPA (see Note 12e).

 

e. On May 22, 2017 the Company entered into a Share Purchase Agreement with certain existing and new investors, in an aggregate amount of $34,500, which included, inter alia, the conversion of the loan as detailed in Note 12d (excluding the interest, which was waived), into Preferred C Shares of the Company (the “2017 SPA”). According to the 2017 SPA, at the first closing, the investors (including the conversion of the loan amount as aforesaid) invested a gross amount of $14,500 in the Company by issuance of 958,887 Series Preferred C Shares (the “First Closing”). At the second closing, which shall take place no later than December 31, 2017, an additional investment of $12,000 shall be invested in the Company (the “Second Closing”). In addition, according to the 2017 SPA, the Company is entitled to raise an additional amount of up to $8,000 in two tranches, whereby the first closing of which shall be consummated by the end of June 2017, and the second closing shall be held at the Second Closing of the 2017 SPA (together, the “Deferred Closing”).

 

In parallel with the First Closing, the Company entered into a reverse merger agreement with Sevion Sub Ltd., an Israeli wholly owned subsidiary of Sevion Therapeutics Inc. (which is also a party to the agreement), a U.S public company (“Sevion”) (the “Merger Agreement”). According to the Merger Agreement, the Company shall be the surviving entity upon the merger and shall become a wholly owned subsidiary of Sevion. The shareholders of the Company shall receive in consideration for their shares in the Company, shares of Sevion constituting 71.6% of the share capital of Sevion (such ratio was later updated to 68.74% to reflect additional investments, as set forth below). The closing of the merger shall take place prior to December 31, 2017 and in such event the amount undertaken to be invested in the Company at the Second Closing shall be invested instead in Sevion under separate subscription agreements.

 

On June 27, 2017, the Company consummated the first closing of the Deferred Closing in a gross amount of $3,000 for issuance of 198,390 Series Preferred C Shares, such that the aggregate amount invested under the First Closing is $15,000, and additional $15,000 shall be invested at the Second Closing.

 

In connection to the First Closing and the first closing of the Deferred Closing, the Company incurred incremental and direct issuance costs amounting to $331 (excluding grant to certain service providers of 16,367 warrants to purchase 16,367 Series Preferred C Shares as finder fee compensation).

 

On July 23, 2017, pursuant to a second joinder to the SPA, an additional aggregate amount of $8,000 was raised from investors. Half of the amount was invested in the Company on August 2, 2017 for the issuance of 264,561 Series Preferred C Shares (excluding incremental and direct issuance costs amounting to $205), and the remainder shall be invested by same investor in the Company, upon Second Closing even if the closing of the Merger Agreement takes place, notwithstanding, the second installment of $4,000 shall be deemed an investment in Sevion for the purpose of the exchange ratio under the Merger Agreement.

 

  F- 24  

 

 

Consummation of the merger was conditioned upon certain closing conditions, including, among other things: (i) approval of the merger by the stockholders of the Company (simultaneously with the execution of the Merger Agreement, Sevion received a voting agreement executed by the holders of at least 60% of the Company’s capital stock agreeing to vote in favor of the Transaction); (ii) the successful consummation of equity financings resulting in cash investments in each of Sevion and the Company of no less than $19,000, each pursuant to the terms of subscription agreements to be entered into in connection with the Agreement; (iii) the entering into of a lockup agreement and registration rights agreement by and among Sevion, certain shareholders of Sevion and certain holders of Registrable Securities (as defined in the Agreement); (iv) the compliance of Sevion with its obligations to prepare, file, negotiate and perform all acts with respect to the uplisting of Sevion’s common stock to the Nasdaq Capital Market; (v) termination and/or cancellation of various Sevion agreements; (vi) delivery to the Company of executed resignation letters by each of the directors and officers of Sevion, with an effective date to be as agreed upon by Sevion and the Company; (vii) the adoption by Sevion of an amendment to its certificate of incorporation to affect a change in the name of Sevion to “Eloxx Pharmaceuticals, Inc.”; and (viii) conversion of all shares of Preferred Stock of Sevion into shares of common stock of Sevion. Additionally, at the consummation of the merger, Sevion was required to hold an amount of available cash not less than $10,500.

 

f. On August 9, 2017, the Company received a legal claims letter from TRDF regarding TRDF’s alleged entitlement to an exit fee in accordance with the Technion Agreement. The Company rejected all claims made by TRDF.

 

g. On July 16, 2017, the Company's Board of Directors approved the grant of 14,378 options to certain employees of the Company with an exercise price of $4.77 and a vesting schedule of four years on a quarterly basis.

 

h. On July 18, 2017, one of the Company's employees exercised 700 options with an exercise price of $5 per share for a total consideration of $4.

 

i. On October 15, 2017, Inc. entered into a new Operating Lease Agreement (the "Agreement") with an unrelated party, regarding its premises pursuant to which the Inc. leased its facilities for a period of 37 months commencing November 15, 2017 and continuing until December 17, 2020 with an option to extend the lease period for additional 3 years. According to the terms of the Agreement, Inc. will pay a monthly fee of $14.

 

- - - - - - - - - - - - - - - - - - - - - - - -

 

  F- 25  

 

Exhibit 99.4

 

ELOXX PHARMACEUTICAL LTD.

 

INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF SEPTEMBER 30, 2017

 

IN U.S. DOLLARS

 

UNAUDITED

 

INDEX

 

  Page
   
Consolidated Balance Sheets F-2
   
Consolidated Statements of Comprehensive Loss F-3
   
Statements of Changes in Shareholders' Equity F-4
   
Consolidated Statements of Cash Flows F-5
   
Notes to Unaudited Interim Consolidated Financial Statements F-6 - F-17

 

- - - - - - - -

 

  F- 1  

 

 

ELOXX PHARMACEUTICAL LTD.

 

CONSOLIDATED BALANCE SHEETS

 

U.S. dollars in thousands, except share and per share data

 

   

September 30,

2017

   

December 31,

2016

 
    Unaudited        
ASSETS                
                 
CURRENT ASSETS:                
Cash and cash equivalents   $ 13,538     $ 2,212  
Restricted and short-term deposit     61       38  
Other account receivable     179       837  
                 
Total current assets     13,778       3,087  
                 
PROPERTY AND EQUIPMENT, NET     172       41  
                 
Total assets     13,950       3,128  
                 
LIABILITIES AND SHAREHOLDERS' EQUITY                
                 
CURRENT LIABILITIES                
Trade payables     1,159       1,899  
Other accounts payable     1,142       619  
                 
Total current liabilities     2,301       2,518  
                 
COMMITMENTS AND CONTINGENT LIABILITIES                
                 
SHAREHOLDERS' EQUITY:                
Ordinary shares of NIS 0.01 par value -                
Authorized: 6,000,000 at December 31, 2016 and September 30, 2017 (unaudited); Issued and outstanding: 842,500 and 843,200 shares at December 31, 2016 and September 30, 2017 (unaudited), respectively     2       2  
Series A, B-1, B-2 and C Preferred shares of NIS 0.01 par value -                
Authorized: 4,000,000 shares at December 31, 2016 and September 30, 2017 (unaudited); Issued and outstanding: 1,530,314 and 2,952,152 shares at December 31, 2016 and September 30, 2017 (unaudited), respectively; Aggregate liquidation preference of $43,198 at September 30, 2017 (unaudited)     7       4  
Additional paid-in capital     39,982       18,350  
Accumulated deficit     (28,342 )     (17,746 )
                 
Total shareholders' equity     11,649       610  
                 
Total liabilities and shareholders' equity   $ 13,950     $ 3,128  

 

The accompanying notes are an integral part of the consolidated financial statements.

 

  F- 2  

 

 

ELOXX PHARMACEUTICAL LTD.

 

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

 

U.S. dollars in thousands, except share and per share data

 

    Three months ended
September 30,
    Nine months ended
September 30,
 
    2017     2016     2017     2016  
    Unaudited  
                         
Operating expenses:                                
Research and development, net   $ 3,280     $ 2,091     $ 8,230     $ 5,670  
General and administrative expenses     720       226       1,579       432  
                                 
Operating loss     4,000       2,317       9,809       6,102  
                                 
Financial expenses, net     40       15       785       40  
                                 
Loss before taxes on income     4,040       2,332       10,594       6,142  
                                 
Taxes on income     (*) -       (*) -       2       (*) -  
                                 
Net loss   $ 4,040     $ 2,332     $ 10,596     $ 6,142  
                                 
Basic and diluted net loss per share   $ 5.74     $ 3.10     $ 14.56     $ 8.14  
                                 
Weighted average number of ordinary shares used in computing basic and diluted loss per share     843,063       842,500       842,690       842,500  

 

(*) Represents an amount lower than $1.

 

The accompanying notes are an integral part of the consolidated financial statements.

 

  F- 3  

 

 

ELOXX PHARMACEUTICAL LTD.

 

STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY

 

U.S. dollars in thousands, except share data

 

                Additional           Total  
    Ordinary Shares     Preferred Shares     paid-in     Accumulated     shareholders'  
    Shares     Amount     Shares     Amount     capital     deficit     equity  
                                           
Balance as of January 1, 2017     842,500       2       1,530,314       4       18,350       (17,746 )     610  
                                                         
Issuance of Series C Preferred Shares of NIS 0.01 par value, net of $573 issuance expenses (see Note 7b4)     -       -       1,256,512       3       18,423       -       18,426  
Conversion of convertible loan into Series C Preferred Shares of NIS 0.01 par value (see Notes 6 and 7b4)                     165,326       (*) -       3,168               3,168  
Exercise of options into Ordinary Shares     700       (*) -       -       -       3       -       3  
Share-based compensation     -       -       -       -       38       -       38  
Net loss     -       -       -       -       -       (10,596 )     (10,596 )
                                                         
Balance as of September 30, 2017 (unaudited)     843,200     $ 2       2,952,152     $ 7     $ 39,982     $ (28,342 )   $ 11,649  

 

(*) Represents an amount lower than $1.

 

The accompanying notes are an integral part of the consolidated financial statements.

 

  F- 4  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

   

Nine months ended

September 30,

 
    2017     2016  
    Unaudited  
Cash flows from operating activities:                
                 
Net loss   $ (10,596 )   $ (6,142 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Share-based compensation     38       65  
Depreciation     24       5  
Amortization and revaluation of discount in respect to convertible loan     625       -  
Accrued interest on convertible loan     43       -  
Change in:                
Other accounts receivable     658       203  
Trade payables     (740 )     989  
other accounts payable     280       (114 )
                 
Net cash used in operating activities     (9,668 )     (4,994 )
                 
Cash flows from investing activities:                
                 
Investment in restricted bank deposit     (23 )     -  
Purchase of property and equipment     (155 )     (11 )
                 
Net cash used for investing activities     (178 )     (11 )
                 
Cash flows from finance activities:                
                 
Proceeds from exercise of warrants into Series A Preferred Shares     -       350  
Proceeds from exercise of options into Ordinary Shares     3       -  
Proceeds from issuance of Series B-1 Preferred Shares and warrants, net of  issuance expenses     -       3,650  
Proceeds from issuance of Series B-1 Preferred Shares and warrants, net of issuance expenses     -       3,194  
Proceeds from issuance of Series C Preferred Shares, net of $331 issuance expenses     18,669       -  
Proceeds from convertible loan and related financial derivative into Series C Preferred Shares of NIS 0.01 par value     2,500       -  
                 
Net cash provided by finance activities     21,172       7,194  
                 
Change in cash and cash equivalents     11,326       2,189  
Cash and cash equivalents at the beginning of the period     2,212       1,370  
                 
Cash and cash equivalents at the end of the period   $ 13,538     $ 3,559  
                 
Supplemental disclosure of non-cash financing activities:                
                 
Conversion of convertible loan into Series Preferred C Shares   $ 3,168     $ -  
Issuance expenses of Series C Preferred Shares   $ 242     $ -  

 

The accompanying notes are an integral part of the consolidated financial statements.

 

  F- 5  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 1: GENERAL

 

a. Eloxx Pharmaceuticals Ltd. (the "Company") was incorporated in Israel on September 17, 2013. The Company focuses its activity on the discovery, development and commercialization of compounds for the treatment of genetic diseases caused by nonsense mutations. In 2013, the Company entered into a license agreement (the "Technion Agreement") with the Technion Research and Development Foundation Ltd. ("TRDF").

 

In April 2015, the Company established a wholly-owned U.S. subsidiary, Eloxx Pharmaceuticals Inc. ("Inc."), which was incorporated under the laws of the State of Delaware. Inc.'s principal business activity is to provide research and development to the Company.

 

In parallel with the First Closing, the Company entered into a reverse merger agreement with Sevion Sub Ltd., an Israeli wholly owned subsidiary of Sevion Therapeutics Inc. (which is also a party to the agreement), a U.S public company (“Sevion”) (the “Merger Agreement”). According to the Merger Agreement, the Company shall be the surviving entity upon the merger and shall become a wholly owned subsidiary of Sevion. The shareholders of the Company shall receive in consideration for their shares in the Company, shares of Sevion constituting 68.74% of the share capital of Sevion in ratio of 1:4.99. The closing of the merger took place on December 19, 2017 (See also note 7b).

 

Consummation of the merger was subject to certain closing conditions, including, among other things: (i) approval of the merger by the stockholders of the Company (simultaneously with the execution of the Merger Agreement, Sevion received a voting agreement executed by the holders of at least 60% of the Company’s capital stock agreeing to vote in favor of the Transaction); (ii) the successful consummation of equity financings resulting in cash investments in each of Sevion and the Company of no less than $19,000, each pursuant to the terms of subscription agreements to be entered into in connection with the Agreement; (iii) the entering into of a lockup agreement and registration rights agreement by and among Sevion, certain shareholders of Sevion and certain holders of Registrable Securities (as defined in the Agreement); (iv) the compliance of Sevion with its obligations to prepare, file, negotiate and perform all acts with respect to the uplisting of Sevion’s common stock to the Nasdaq Capital Market; (v) termination and/or cancellation of various Sevion agreements; (vi) delivery to the Company of executed resignation letters by each of the directors and officers of Sevion, with an effective date to be as agreed upon by Sevion and the Company; (vii) the adoption by Sevion of an amendment to its certificate of incorporation to affect a change in the name of Sevion to Eloxx Pharmaceuticals Inc.; and (viii) conversion of all shares of Preferred Stock of Sevion into shares of common stock of Sevion. Additionally, at the Consummation of the merger, Sevion was required to hold an amount of available cash not less than $10,500.

 

The Merger was accounted for as a reverse recapitalization, which is outside the scope ASC 805, "Business Combinations". Under reverse capitalization accounting, the Company is considered the acquirer for accounting and financial reporting purposes, and acquired the assets and assumed the liabilities of Sevion. Assets acquired and liabilities assumed are reported at their historical amounts. The interim consolidated financial statements of the Company do not reflect the accounting treatment as the closing date of the merger took place on December 19, 2017, subsequent to the period of the interim consolidated financial statements.

 

b. As reflected in the accompanying unaudited interim consolidated financial statements, the Company has not generated revenue from the sale of any product, and does not expect to generate significant revenue unless and until obtaining marketing approval and commercializing the drug. The Company incurred a loss for the nine month period ended September 30, 2017 of $10,596 and had a negative cash flow from operating activities of $9,425 during the nine month period ended September 30, 2017. The accumulated deficit as of September 30, 2017 is $28,342.

 

  F- 6  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES

 

The significant accounting policies applied in the annual consolidated financial statements of the Company as of December 31, 2016 are applied consistently in these interim consolidated financial statements except the below:

 

On March 30, 2016, the FASB issued ASU 2016-09, "Compensation - Stock Compensation", which effects all entities that issue share-based payment awards to their employees. The amendments in this ASU cover such areas as the recognition of excess tax benefits and deficiencies, the classification of those excess tax benefits on the statement of cash flows, an accounting policy election for forfeitures, the amount an employer can withhold to cover income taxes and still qualify for equity classification and the classification of those taxes paid on the statement of cash flows. This ASU is effective for annual and interim periods beginning after December 15, 2016. This guidance can be applied either prospectively, retrospectively or using a modified retrospective transition method. The Company decided to adopt the new guidance prospectively. This new guidance does not have a material impact on the Company’s consolidated financial statements.

 

NOTE 3: UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the nine month period ended September 30, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017 or for any other interim period. The accompanying consolidated financial statements and related notes should be read in conjunction with the consolidated financial statements and related notes for the fiscal years ended December 31, 2015 and 2016. The accompanying consolidated balance sheet as of December 31, 2016 have been derived from those audited consolidated financial statements.

 

NOTE 4: COMMITMENTS AND CONTINGENT LIABILITIES

 

a. On February 22, 2017, the Company entered into an Operating Lease Agreement (the "Agreement"), pursuant to which the Company leased its facilities for a period of 3 years commencing March 8, 2017 and continuing until April 30, 2020 with an option to extend the lease period for additional 2 years. According to the terms of the Agreement, the Company has a grace period of 2 months from payments and then the Company will pay a monthly fee of $6.

 

In March 2017, the Company entered into agreement to occupy a laboratory for its clinical needs for a period of 1 year commencing March 8, 2017 and continuing until March 8, 2018 with an option to extend the lease period for additional 1 year. According to the terms of the agreement, the Company will pay a monthly fee of $4.

 

In addition, in January 2017, Inc. renewed its operating lease agreement pursuant to which the Company leased its facilities for a period of 1 years commencing April 1, 2017 and continuing until March 31, 2018. According to the terms of the Agreement, the Company will pay a monthly fee of $5.

 

  F- 7  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 4: COMMITMENTS AND CONTINGENT LIABILITIES (Cont.)

 

Future minimum lease commitments as of September 30, 2017 were as follows:

 

As of September 30,   Total  
       
2017   $ 61  
2018     93  
2019     69  
2020     23  
         
    $ 246  

 

The lease expenses that were recorded during the three and nine months period ended September 30, 2016 amounted to $32 and $88, respectively, and the lease expenses that were recorded during the three and nine months period ended September 30, 2017 amounted to $53 and $145, respectively.

 

Subsequent to September 30, 2017, Inc. signed on a new operating lease agreement (see Note 9b).

 

b. Royalty commitment to the Israeli Innovation Authority (previously known as Office of the Chief Scientist) of the Ministry of Economy ("IIA"):

 

Under the research and development agreements with the IIA and pursuant to applicable laws, the Company is required to pay royalties at the rate of 3%-3.5% on sales to end customers of products developed with funds provided by the IIA, up to an amount equal to 100% of the IIA research and development grants received, linked to the dollar plus interest on the unpaid amount received based on the 12-month LIBOR rate (from the year the grant was approved) applicable to dollar deposits. If the Company does not generate sales of products developed with funds provided by the IIA, the Company is not obligated to pay royalties or repay the grants.

 

The total research and development grants received by the Company from the IIA for the nine month periods ended September 30, 2016 and 2017 were $778 and $890, respectively. As of September 30, 2017, the Company has not commenced the payment obligation of the royalties, and has a contingent obligation with respect to royalty-bearing participation received or accrued (including LIBOR interest amounting to $14), amounting to $2,351.

 

c. Since inception date, the Company has entered into Finder Fee Agreements (the "Agreements) with Independent Contractors (the "Contractors"), for the purpose of presentation to potential strategic partners and potential investors, pursuant to which at each closing of financing from certain investors (the "Investment Amount"), the Contractors shall be eligible to a cash or equity fees by issuance of warrants with an exercise price per share which is equal to the price per share of the securities sold in such financing. The warrants' contractual term is 5 years.

 

Until September 30, 2017, the Company paid the Contractors aggregate amount of $894 and granted 49,784 warrants to purchase 49,784 Series Preferred B-1 Shares (of which 9,667 warrants expired in November 2016) and 16,367 warrants to purchase 16,367 Series Preferred C Shares as finder fee compensation (see Note 7c).

 

d. See Note 5 with respect to the Technion Agreement.

 

  F- 8  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 5: RELATED PARTY

 

In 2013, the Company entered into Technion Agreement with TRDF with respect to certain technology relating to aminoglycosides and the redesign of aminoglycosides for the treatment of human genetic diseases caused by premature stop mutations and further results of the research of the technology, in order to develop and commercialize products based on such technology. Under the agreement, TRDF shall provide the Company research services for an estimated annual payment of $50, with the exact payment to be mutually agreed upon by the parties prior to the beginning of each year of the research period.

 

In addition, TRDF shall grant the Company a license to use, market, sell or sub-license the rights of the product developed under the TRDF research results (the "Licensed Product"), as fully defined in the Technion Agreement, for the following considerations: (a) milestone payments, to be transferred upon meeting certain milestones as defined in the Technion Agreement, up to total consideration of $6,100; (b) royalties on net sales of the Licensed Product, either from sales by the Company or by a sub-licensed entity, at the rate of 2.75%-3.75%, for a period until the later of (i) the expiration of a valid claim on the Licensed Product in each country the Licensed Product is sold to, or (ii) fifteen years from the date of the first commercial sale of the Licensed Product in such country, and (c) 20% of the non-royalty sub-license income received by the Company from a sub-licensed entity. In addition, the Company shall pay certain fee to TRDF upon an exit event as described in the Technion Agreement.

 

Moreover, upon the closing of an Exit Event which is not Initial Public Offering ("IPO"), as defined in the Technion Agreement, TRDF shall be entitled to an amount equal to 3% of all non-refundable, non-contingent consideration, whether in cash or in kind, actually received by the Company and / or its shareholders. Upon the closing of an exit event which is IPO, as defined in the Technion Agreement, TRDF shall be entitled to a number of Ordinary Shares of the Company representing 3% of the Company's outstanding shares on a fully diluted basis immediately prior to the closing of such IPO.

 

On August 9, 2017, the Company received a legal claims letter by TRDF regarding TRDF’s alleged entitlement to an exit fee in accordance with the Technion Agreement. The Company's management believes TRDF is not entitled to any of the above consideration following the closing of the merger transaction with Sevion (see also Note 1b).

 

During the nine month period ended September 30, 2016, the Company recorded research and development expenses in connection with TRDF amounting to $14. In addition, during the nine month period ended September 30, 2017, the Company recorded general and administrative and research and development expenses in connection with TRDF amounting to $7 and $24, respectively. As of December 31, 2016, the TRDF balance recorded in accrued expenses balance was $185. As of September 30, 2017, there was no outstanding balance with TRDF.

 

NOTE 6: CONVERTIBLE LOAN

 

On January 26, 2017 (the "Closing Date"), the Company entered into a Convertible Loan Agreement (the "Agreement") with five of its shareholders (the "Lenders"), pursuant to which the Company raised an aggregate amount of $2,500 (the "Convertible Loan"). The Convertible Loan shall bear a 5% annual interest rate. According to the Agreement, the outstanding portion of the Convertible Loan (without accrued interest) shall be automatically converted upon the consummation of equity investment by third party of an aggregate amount of at least $5,000 (the "Qualified Equity Investment"), prior to the lapse of 2 years from the Closing Date (the "Maturity Date"), into equity securities of the same class issued by the Company in such Qualified Equity Investment, in a conversion price which is equal to 80% of the price per share paid by the third party is such Qualified Equity Investment (the "Automatic Conversion"). In addition, upon the earlier of (i) Maturity Date or (ii) Event of Default as defined in the Agreement, the outstanding portion of the Convertible Loan (including accrued interest) shall be converted into an equity investments of the then existing most senior class, at a conversion price per share which is equal to 65% of the original issue price per share applicable to such class. At the end

 

  F- 9  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 6: CONVERTIBLE LOAN (Cont.)

 

of May 2017, the Lenders signed a waiver agreement pursuant to which they waived the potential discount as described above.

 

In accordance with ASC 815 "Derivatives and Hedging", features related to convertible loans qualify as embedded derivative instruments at the date of issuance, since these are considered stock settled debt. In determining fair value, the Company uses various valuation approaches. ASC 820 establishes a hierarchy for inputs used in measuring fair value. The embedded conversion feature is classified under level 3 in the hierarchy. The fair value assigned to the embedded conversion feature on the issuance dates amounted to $308. The embedded instruments are marked to market in each reporting period and changes are recorded in financial expenses. The discount is amortized using the effective interest over the loan period.

 

On May 31, 2017, the Convertible Loan (without accrued interest) was converted into 165,326 Series C Preferred Shares, according to the price per share that was paid pursuant to the 2017 SPA (see Note 7b4). During the nine months ended September 30, 2017, the Company recorded $668 as financial expenses, net, as a result of changes in the embedded instruments. In connection with the conversion, the embedded instrument together with all accrued interest in the amount of $668 was classified as additional paid in capital.

 

The following table presents reconciliations for the Company’s liabilities measured and recorded at fair value on a recurring basis, using significant unobservable inputs (Level 3):

 

    Level 3  
       
Balance at January 26, 2017   $ (308 )
         
Amortization and revaluation embedded conversion feature     (317 )
Conversion of convertible loan into Series C Preferred Shares     625  
         
Balance at September 30, 2017   $ -  

 

NOTE 7: SHAREHOLDERS' EQUITY

 

a. As of December 31, 2016 and September 30, 2017, the Company's share capital is composed as follows:

 

    December 31, 2016     September 30, 2017  
    Authorized     Issued and
outstanding
    Authorized     Issued and
outstanding
 
    Number of shares  
                         
Ordinary Shares (1)     6,000,000       842,500       2,500,000       843,200  
Preferred A Shares (2)     1,000,000       472,500       1,000,000       472,500  
Preferred B-1 Shares (2)     2,000,000       1,057,814       2,000,000       1,057,814  
Preferred B-2 Shares (2)     1,000,000       -       1,000,000       -  
Preferred C shares (2)     -       -       3,500,000       1,421,838  
                                 
      10,000,000       2,372,814       10,000,000       3,795,352  

 

  F- 10  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 7: SHAREHOLDERS' EQUITY (Cont.)

 

(1) The Ordinary Shares confer upon their holders the following rights:

 

(a) The right to participate and vote in the Company's general meetings, whether regular or extraordinary. Each share will entitle its holder, when attending and participating in the voting in person or via agent or letter, to one vote;

 

(b) The right to a share in the distribution of dividends, whether in cash or in the form of bonus shares, the distribution of assets or any other distribution pro rata to the par value of the shares held by them;

 

(c) The right to a share in the distribution of the Company's excess assets upon liquidation pro rata to the par value of the shares held by them.

 

(2) Preferred A, B-1, B-2 and C Shares (together refer as "Preferred Shares") confer upon their holders all the rights of Ordinary Shares. In addition, based on the Company's Articles of Association (the "AOA"), the preferred shareholders bear the following rights and privileges:

 

Voting - Holders of series Preferred Shares are entitled to one vote for each Preferred Share into which such share Preferred share is convertible. The holders of the Preferred Shares shall be entitled to vote on all matters on which holders of Ordinary Shares are entitled to vote. Certain decisions of the shareholders require the approval of the majority of the holders of Preferred Shares on a pro rata basis.

 

Conversion - Each Preferred Share shall be convertible at the option of the holder thereof, at any time after the date of issuance of such share, at the office, into such number of fully paid and non-assessable Ordinary Shares as is determined by dividing the original issue price of such Preferred Share by the applicable conversion price at that time in effect for such Preferred Share.

 

All Preferred Shares shall automatically be converted 1:1 into such number of fully paid and non-assessable Ordinary Shares , upon the earliest to occur of the following: (i) immediately prior to and contingent upon the closing of an IPO where the Company’s pre-money valuation is $150,000 or more with net proceeds to the Company of $50,000 or more ("Qualified IPO"); or (ii) upon the consent of the majority preferred shareholders.

 

The Company has reserved Ordinary Shares that will be sufficient to effect the conversion of all outstanding shares of Preferred Shares.

 

Liquidation preference - In the event of (i) liquidation, (ii) deemed liquidation, or (iii) any distribution in cash, cash equivalents, Based on preference of distribution, the holders of Preferred Shares shall be entitled to receive, before any payment shall be made or declared to the holders of Ordinary Shares, an amount which is equal to (i) the original issue price of such Preferred Share (subject to adjustments) plus an amount per share equal to 8% per annum of the applicable original issue price compounded annually from the applicable date of issuance thereof, to the date of payment of such distributable proceeds, up to 150% of the applicable original issue price, plus (ii) any declared but unpaid dividends with respect to such Preferred Share, less (iii) all dividends actually paid to the holders of Preferred Shares on account of the Preferred Shares.

 

  F- 11  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 7: SHAREHOLDERS' EQUITY (Cont.)

 

As of December 31, 2016 and September 30, 2017, the aggregate liquidation preference amounted to $20,030 and $43,198, respectively. None of the foregoing dollar amounts include dividends, as the Board of Directors has not declared any dividends since inception.

 

Preemptive rights  - Until the closing of an IPO, each shareholder holding at least one percent of the issued and outstanding share capital of the Company on a fully diluted and as converted basis (the "Eligible Shareholders") shall have preemptive rights to purchase all or part of such Eligible Shareholder's pro-rata share of new securities that the Company may sell and issue, from time to time.

 

b. Issuance of shares:

 

1. In February 2016, the Company entered into a Series B-1 Preferred Shares Purchase Agreement (the "2016 SPA") whereby the Company issued to existing investors (the "2016 Investors") 386,598 Series B-1 Preferred Shares with par value of NIS 0.01 and 579,898 warrants to purchase 579,898 Series B-1 Preferred Shares with an exercise price of $15.52 (the "2016 Warrants") for an aggregate gross amount of $6,000, representing a price per unit of $15.52, that should be transferred to the Company in two closing.

 

The warrants are subject to standard anti-dilution protection clauses and shall be exercisable by each investor as follows: (i) half of the underlying Preferred B-2 Share upon the first closing and (ii) half of the underlying Preferred B-1 Shares upon the achievement by 2016 Investors of its respective portion of the investment amount following the commencement FIM trial, which defined in the 2016 SPA as the Milestone Closing. The exercise period of the aforementioned warrants will terminate upon the occurrence of the earliest of the following events: (i) consummation of a Deemed Liquidation as defined in the Company's AOA; or (ii) the fifth anniversary of the applicable closing.

 

Following the signing of the 2016 SPA, the 2016 Investors transferred to the Company $3,500 for issuance of 225,516 Series B-1 Preferred Shares and 338,275 warrants to purchase 338,275 Series B-1 Preferred Shares as first closing. In addition, in November 2016, upon meeting a certain milestone described in the 2016 SPA, the 2016 Investors transferred to the Company additional amount of $2,500 for 161,082 Series B-1 Preferred Shares and 241,623 warrants to purchase 241,623 Series B-1 Preferred Shares as second closing.

 

As discussed in Note 8c to the annual consolidated financial statements as of December 31, 2016, in connection to the 2016 SPA, the Company paid to the Contractor a cash consideration of $264 as finder fee and granted an amount 5,638 warrants to purchase 5,638 Series B-1 Preferred Shares with an exercise price of $15.52. The warrants are subject to standard anti-dilution protection clauses.

 

2. In August 2016, Technion Investment Opportunities Fund L.P (the “TIOF”) and TRDF exercised 25,000 and 62,500 warrants to purchase Series A Preferred shares, respectively, for a total consideration of $350.

 

3. In September 2016, the Company met a certain milestone in connection to the share purchase agreements signed in 2014, pursuant to which, the Company issued to investors 235,231 Series B-1 Preferred Shares with par value of NIS 0.01 and 117,616 warrants to purchase 117,616 Series B-2 Preferred Shares for an aggregate amount of $3,650.

 

  F- 12  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 7: SHAREHOLDERS' EQUITY (Cont.)

 

4. On May 22, 2017 the Company entered into a Share Purchase Agreement with certain existing and new investors, in an aggregate amount of $34,500, which included, inter alia, the conversion of the loan as detailed in Note 6 (excluding the interest, which was waived), into Preferred C Shares of the Company (the “2017 SPA”). According to the 2017 SPA, at the first closing, the investors (including the conversion of the loan amount as aforesaid) invested a gross amount of $14,500 in the Company by issuance of 958,887 Series Preferred C Shares (the “First Closing”). As of the second closing, which took place on December 19, 2017, an additional investment of $12,000 was invested in the Company (the “Second Closing”). In addition, according to the 2017 SPA, the Company is entitled to raise an additional amount of up to $8,000 in two tranches, whereby the first closing of which shall be consummated by the end of June 2017, and the second closing shall be held at the Second Closing of the 2017 SPA (together, the “Deferred Closing”).

 

On June 27, 2017, the Company consummated the first closing of the Deferred Closing in a gross amount of $3,000 for issuance of 198,390 Series Preferred C Shares, such that the aggregate amount invested under the First Closing is $15,000, and additional $15,000 shall be invested at the Second Closing.

 

On July 23, 2017, pursuant to a second joinder to the SPA, an additional aggregate amount of $8,000 was raised from new investor. Half of the amount was received on August 10, 2017 for issuance of 264,561 Series Preferred C Shares, and the remainder shall be invested upon Second Closing even if the closing of the Merger Agreement takes place, notwithstanding, the second installment of $4,000 shall be deemed an investment in Sevion for the purpose of the exchange ratio under the Merger Agreement.

 

In connection to the First Closing and the first closing of the Deferred Closing, the Company incurred incremental and direct issuance costs amounting to $573 (excluding grant to certain service providers of 16,367 warrants to purchase 16,367 Series Preferred C Shares as finder fee compensation), $242 out of which has not been paid as of September 30, 2017.

 

c. The table below summarizes the outstanding warrants as of September 30, 2017:

 

    Amount     Weighted
average
exercise
price
 
             
Warrants to purchase Ordinary Shares     12,897       4.00  
Warrants to purchase Series B-1 Preferred Shares (*)     610,348       15.52  
Warrants to purchase Series B-2 Preferred Shares     117,616       23.28  
Warrants to purchase Series C Preferred Shares (*)     16,367       15.12  
                 
Total outstanding warrants     757,228          

 

(*) Including 40,117 warrants to purchase 40,117 Series Preferred B-1 and 16,367 warrants to purchase 16,367 Series Preferred C Shares that have been granted to Contractors as finder fee compensation for the purpose of presentation to potential strategic partners and potential investors (see Note 4c).

 

d. Stock-based compensation:

 

In 2013, the Company's Board of Directors adopted the 2013 Share Ownership and Option Plan in accordance with the amended section 102 and 3(i) of Israel’s Income Tax Ordinance (the "2013 Plan"). Under the 2013 Plan, options to purchase Ordinary Shares of the Company may be granted to employees, officers, directors and consultants of the Company. Each option granted can be exercised for one Ordinary Shares of the Company. Options granted generally become fully exercisable after two to four years and expire no later than 10 years from the approval date of the option plan under terms of grant. Any option forfeited or cancelled before expiration becomes available for future grants. As of September 30, 2017, the options pool amounted to 403,978 Ordinary Shares, and therefore 20,148 Ordinary Shares were available for future grant under the 2013 Plan.

 

  F- 13  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 7: SHAREHOLDERS' EQUITY (Cont.)

 

Transactions related to the grant of options to employees and directors under the 2013 Plan during the nine months period ended September 30, 2017 were as follows:

 

    Amount    

Weighted

average

exercise

price

    Weighted
average
remaining
contractual
life
    Aggregate
intrinsic
value
 
                         
Options outstanding at beginning of year     390,300     $ 2.32       7.93     $ 1,571  
Granted     14,378                          
Exercised     (700 )                        
Forfeited     (20,148 )     4.91       -          
                                 
Options outstanding at end of year     383,830     $ 2.27       6.67       3,684  
                                 
Options exercisable at end of year     318,989     $ 1.74       6.27     $ 3,228  

 

The aggregate intrinsic value represents the total intrinsic value (the difference between the deemed fair value of the Company's Ordinary Shares on the last day of third quarter of 2017 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on September 30, 2017. This amount is impacted by the changes in the fair value of the Company's shares.

 

The weighted average grant date fair value of the options granted during the nine months periods ended September 30, 2016 and 2017 were $0.68 and $9.59, respectively.

 

The following table presents the assumptions used to estimate the fair values of the options granted in the period presented:

 

   

Nine months ended

September 30,

    2016   2017
         
Dividend yield   0%   0%
Volatility   64.46%-82.72%   87.17%-116.69%
Risk free interest   0.47%-1.81%   1.22%-2.13%
Contractual term (years)   10   10
Suboptimal exercise   2.3   2.3

 

As of September 30, 2017, there was $165 of total unrecognized compensation cost related to non-vested stock options granted under the 2013 Plan. This cost is expected to be recognized over a weighted-average period of 1.79 years.

 

  F- 14  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 7: SHAREHOLDERS' EQUITY (Cont.)

 

The total equity-based compensation expense related to all of the Company's equity-based awards, recognized for the three and nine months periods September 30, 2016 and 2017, was comprised as follows:

 

   

Three months ended

September 30,

   

Nine months ended

September 30,

 
    2016     2017     2016     2017  
    Unaudited  
                         
Research and development   $ 16     $ 12     $ 53     $ 24  
General and administrative     4       5       12       14  
                                 
    $ 20     $ 17     $ 65     $ 38  

 

NOTE 8:- SELECTED STATEMENTS OF COMPREHENSIVE LOSS

 

a. Financial expense, net:

 

   

Three months ended

September 30,

   

Nine months ended

September 30,

 
    2016     2017     2016     2017  
    Unaudited  
                         
Financial expenses:                                
Bank commissions and others   $ 9     $ 9     $ 16     $ 21  
Exchange rate differences     6       31       24       96  
Amortization and revaluation of embedded conversion feature in respect to convertible loan     -       -       -       625  
Interest expenses in respect to convertible loan     -       -       -       43  
                                 
Total financial expense, net   $ 15     $ 40     $ 40     $ 785  

 

  F- 15  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

NOTE 8:- SELECTED STATEMENTS OF COMPREHENSIVE LOSS (Cont.)

 

b. The loss and the weighted average number of shares used in computing basic and diluted net loss per share for the three and nine months periods ended September 30, 2016 and 2017 is as follows:

 

   

Three months ended

September 30,

   

Nine months ended

September 30,

 
    2016     2017     2016     2017  
    Unaudited  
                         
Numerator:                                
Net loss   $ 2,332     $ 4,040     $ 6,142     $ 10,596  
Dividends accumulated for the period (*)     275       802       715       1,669  
                                 
Net loss available to shareholders of Ordinary Shares   $ 2,607     $ 4,842     $ 6,857     $ 12,265  
                                 
Denominator:                                
Shares used in computing net loss per share of Ordinary shares, basic and diluted     842,500       843,063       842,500       842,690  
Net loss per share of Ordinary Share, basic and diluted   $ 3.10     $ 5.74     $ 8.14     $ 14.56  

 

(*) The net loss used for the computation of basic and diluted net loss per share include 8% per share per annum compounded annually which shall be distributed to shareholders in case of distributable assets determined in the AOA under the liquidation preference right (See Note 7a2)

 

Convertible securities, including 757,228 warrants to purchase Ordinary Shares and 472,500 Series Preferred A Shares, 1,057,814 Series Preferred B-1 Shares, 1,421,838 Series Preferred C Shares and 383,830 options to grantees under the 2013 Plan, have not been taken into account due to their anti-dilutive effect.

 

NOTE 9: SUBSEQUENT EVENTS

 

a. The Company evaluates events or transactions that occur after the balance sheet date but prior to the issuance of the interim consolidated financial statements to identify matters that require additional disclosure. For its interim consolidated financial statements as of September 30, 2017 and for the nine months period then ended, the Company evaluated subsequent events through December 20, 2017 the date that the interim consolidated financial statements were issued. Except as described below, the Company has concluded that no subsequent event has occurred that require disclosure.

 

b. On October 15, 2017, Inc. entered into a new Operating Lease Agreement (the "Agreement") with an unrelated party, regarding its premises pursuant to which the Inc. leased its facilities for a period of 37 months commencing November 15, 2017 and continuing until December 17, 2020 with an option to extend the lease period for an additional 3 years. According to the terms of the Agreement, Inc. will pay a monthly fee of $14.

 

  F- 16  

 

 

ELOXX PHARMACEUTICAL LTD.

 

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

U.S. dollars in thousands, except share and per share data

 

c. On December 18, 2017, the Company executed a binding term sheet with respect to the licensing of SVN-001 antibody technology to Taurus Biosciences Inc, for the development and commercialization of a product based on the SVN-001 antibody for use solely in the field of immunology.

 

d. The closing of the Merger Agreement took place on December 19, 2017 (See also note 1b).

 

  F- 17  

 

Exhibit 99.5

 

UNAUDITED PRO FORMA CONSOLIDATED FINANCIAL STATEMENTS

 

On December 19, 2017,  Eloxx Pharmaceuticals Ltd., an Israeli company (“Eloxx”) and Sevion Sub Ltd., an Israeli company (“Acquisition Sub”) a wholly-owned subsidiary of Sevion Therapeutics, Inc., a Delaware corporation ("Sevion"), completed the previously announced merger of Acquisition Sub with and into Eloxx, with Eloxx surviving the merger as a wholly-owned subsidiary of Sevion (the “Transaction”). The Transaction was effected pursuant to an Agreement, dated May 31, 2017, by and among Sevion, Acquisition Sub and Eloxx as amended on August 1, 2017 and on November 23, 2017 (the “Agreement”).

 

Pursuant to the terms and conditions of the Agreement, at the effective time of the Transaction (the “Effective Time”), each of the holders of the issued and outstanding ordinary and preferred shares of Eloxx (collectively referred to herein as the Eloxx shareholders) received 4.99 shares of the common stock of Sevion for each ordinary and preferred share of Eloxx they held prior to the Effective Time, or an aggregate of 18,983,585 shares of Sevion's common stock at closing (after giving effect to the reverse stock split in a ratio of 1-for-20) (the “Exchange Ratio”). The foregoing Exchange Ratio assumes that, (i) as part of a private placement that Eloxx conducted for an aggregate gross amount of $38,000,000, of which $19,000,000 has closed, Eloxx will close the remaining $19,000,000 simultaneous to the Transaction and (ii) Sevion's liabilities together with the transaction expenses upon the Transaction Effective Time are not exceeding $1,500,000 Immediately following the Effective Time, pre-merger Eloxx shareholders are expected to own approximately 68.74% of the outstanding common stock of Sevion on a fully diluted basis while pre-merger Sevion stockholders are expected to own the remaining approximate 31.26%. At the Effective Time, pre-merger Sevion stockholders will continue to own and hold their existing shares of Sevion common stock.

 

The following unaudited pro forma consolidated financial statements give effect to the Transaction. The Transaction is structured as a reverse merger and Eloxx was determined to be the accounting acquirer based upon the terms of the Transaction and other factors including: (i) Eloxx security holders will own approximately 68.74% of Sevion immediately following the Effective Time, (ii) the entire board of directors of post-Transaction Sevion is expected to be filled by Sevion appointed directors and (iii) Eloxx’s management will hold all key positions in the management of post-Transaction Sevion. The transaction will be accounted for as an assets acquisition under U.S. GAAP whereby Sevion’s identified assets (tangible and intangible) acquired and liabilities assumed are recorded at their carrying amount at the closing of the Transaction. Any excess of purchase price (allocated shares of common stock that were issued to former stockholders of Sevion) over carrying amount of identified assets acquired and liabilities assumed will be recognized as reduction of equity. A final determination of these estimated fair values will be based on the actual net assets acquired of Sevion that exist as of the date of completion of the transaction.

 

Pro Forma Information

 

The unaudited pro forma consolidated balance sheet as of September 30, 2017 and the unaudited pro forma consolidated statements of operations for the year ended December 31, 2016 and the nine months period ended September 30, 2017 are based on (i) the historical consolidated results of operations of Eloxx and Eloxx Pharmaceutical Inc., Eloxx’s wholly owned U.S. subsidiary; (ii) and the historical consolidated results of operations of Sevion and Senesco Inc. and Fabrus, Inc., Sevion’s wholly owned Inc. subsidiaries for the same periods.

 

The unaudited pro forma consolidated balance sheet as of September 30, 2017 assumes that the Transaction took place on September 30, 2017 and combines the historical balance sheets of Sevion and Eloxx as of September 30, 2017. The unaudited pro forma consolidated statements of operations for for the year ended December 31, 2016 and the nine months period ended September 30, 2017 assumes that the Transaction occurred on the first day of each of the periods presented, and combines the historical results of Sevion and Eloxx for the same periods.

 

The unaudited pro forma consolidated financial statements are based on the assumptions and adjustments that are described in the accompanying notes. The unaudited pro forma consolidated financial statements and pro forma adjustments have been prepared based on preliminary estimates. Differences between these preliminary estimates and the final Transaction may occur and these differences could have a material impact on the accompanying unaudited pro forma consolidated financial statements and the consolidated Eloxx’s future results of operations and financial position. The actual amounts recorded as of the completion of the Transaction may differ materially from the information presented in these unaudited pro forma consolidated financial statements as a result of the timing of the closing of the Transaction; and other changes in the Eloxx or Sevion assets and liabilities that occur prior to the completion of the Transaction.

 

The unaudited pro forma consolidated financial statements do not give effect to the potential impact of current financial conditions, regulatory matters, operating efficiencies or other savings or expenses that may be associated with the Transaction. The unaudited pro forma consolidated financial statements have been prepared for illustrative purposes only and are not necessarily indicative of the financial position or results of operations in future periods or the results that actually would have been realized had Sevion and Eloxx been a consolidated company during the specified periods. The unaudited pro forma consolidated financial statements, including the notes thereto, should be read in conjunction with the audited consolidated financial statements of Sevion and Eloxx for the year ended December 31, 2016 and the unaudited interim consolidated financial statements of Sevion and Eloxx for the nine months period ended September 30, 2017. All ordinary shares and per share data included in these pro forma consolidated financial statements for all periods presented have been retroactively adjusted to reflect the Exchange Ratio.

 

 

 

 

Unaudited Pro Forma Consolidated Balance Sheet

(In thousands)

As of September 30, 2017

 

    Historical
Eloxx
Pharmaceutical
Ltd.
    Historical
Sevion
Therapeutics
Inc.
    Pro forma
Transaction
Adjustments
    Note   Pro forma
Consolidated
 
                             
ASSETS                                    
                                     
Current Assets:                                    
Cash and cash equivalents   $ 13,538     $ 958     $ 18,514     G   $ 33,010  
Restricted bank deposit     61       -       -           61  
Other accounts receivable     179       80       -           259  
                                     
Total current assets     13,778       1,038       18,514           33,330  
                                     
Non-current Assets:                                    
Property and equipment, net     172       43       -           215  
Acquired research and development     -       5,500       (2,512 )   E     2,988  
Security deposits     -       10       -           10  
                                     
Total non-current assets     172       5,553       (2,512 )         3,213  
                                     
Total assets   $ 13,950     $ 6,591     $ 16,002         $ 36,543  
                                     
LIABILITIES AND STOCKOLDERS’ EQUITY (DEFICIT)                                    
                                     
Current liabilities:                                    
Trade payables   $ 1,159     $ 109     $ -         $ 1,268  
Other accounts payable     1,142       255       773     D     2,170  
Convertible promissory notes     -       712       (712 )   H     -  
                                     
Total current liabilities     2,301       1,076       61           3,438  
                                     
Non-current liabilities:                                    
Deferred tax liability     -       2,200       (1,005 )   F     1,195  
                                     
Total non-current liabilities     -       2,200       (1,005 )         1,195  
                                     
Stockholders’ equity:                                    
Common stock     2       514       (240 )   A, B, C, G, H     276  
Preferred stock     7       -       (7 )   B     -  
Additional paid- in capital     39,982       126,007       (105,240 )   A, B, C, G, H     60,749  
Accumulated deficit     (28,342 )     (123,206 )     122,433     A, D     (29,115 )
                                     
Total stockholders' equity     11,649       3,315       16,946           31,910  
                                     
Total liabilities and stockholders’ equity   $ 13,950     $ 6,591     $ 16,002         $ 36,543  

 

 

 

 

Unaudited Pro Forma Consolidated Statements of Comprehensive Loss

For the Year Ended December 31, 2016

(In thousands, except share and per share data)

 

   

Historical

Eloxx
Pharmaceutical
Ltd.

    Historical
Sevion
Therapeutics
Inc.
    Pro forma
Transaction
Adjustments
    Note   Pro forma
Consolidated
 
                             
Operating expenses:                                    
Research and development expenses, net   $ 8,986     $ 1,398     $ -         $ 10,384  
General and administrative expenses     824       1,475       -           2,299  
Impairment of goodwill     -       2,981       -           2,981  
Impairment of acquired R&D     -       4,300       -           4,300  
Gain on sale of patents     -       (150 )     -           (150 )
                                     
Operating loss     9,810       10,004       -           19,814  
                                     
Other non-operating income (expense):                                    
Change in fair value of stock right     -       (1,332 )     -           (1,332 )
Change in fair value of warrant liability     -       (999 )     -           (999 )
Financial expense, net     29       3       -           32  
                                     
Total other non-operating income (expense)     29       (2,328 )     -           (2,299 )
                                     
Net loss before income tax benefit     9,839       7,676       -           17,515  
                                     
Income tax benefit     8       (1,720 )     -           (1,712 )
                                     
Net comprehensive loss   $ 9,847     $ 5,956     $ 0         $ 15,803  
                                     
Preferred dividends     -       42       (42 )   J     -  
                                     
Comprehensive loss   $ 9,847     $ 5,998     $ (42 )       $ 15,803  
                                     
Net basic and diluted loss per share   $ 2.34                         $ 0.62  
                                     
Weighted average number of common stock used in computing basic and diluted net loss per share     4,205,277                           25,631,053  

 

 

 

 

Unaudited Pro Forma Consolidated Statements of Comprehensive Loss

For the Nine Months Period Ended September 30, 2017

(In thousands, except share and per share data)

 

    Historical
Eloxx
Pharmaceutical
Ltd.
   

Historical
Sevion
Therapeutics

Inc.

    Pro forma
Transaction
Adjustments
    Note   Pro forma
Consolidated
 
                             
Operating expenses:                                    
Research and development expenses, net   $ 8,230     $ 382     $ -         $ 8,612  
General and administrative expenses     1,049       670       -           1,719  
Impairment of acquired R&D                     2,512     E     2,512  
Transaction related costs     530       451       (981 )   I     -  
                                     
Operating loss     9,809       1,503       1,531           12,843  
                                     
Other non-operating expense:                                    
Change in fair value of warrants liability     -       56       -           56  
Change in fair value of note derivitive     -       1,688       (1,688 )   H     -  
Stock Issuance for anti dilution right     -       1,418       -           1,418  
Modification of warrant exercise price     -       285       -           285  
Financial expense, net     785       391       (28 )   H     1,148  
                                     
Total other non-operating expense     785       3,838       (1,716 )         2,907  
                                     
Net loss before income tax benefit     10,594       5,341       (185 )         15,750  
                                     
Income tax benefit     2       -       (1,005 )   E     (1,003 )
                                     
Net comprehensive loss   $ 10,596     $ 5,341     $ (1,190 )       $ 14,747  
                                     
Preferred dividends     -       487       (487 )     J     -  
                                     
Comprehensive loss   $ 10,596     $ 5,828     $ (1,677 )       $ 14,747  
                                     
Net basic and diluted loss per share   $ 2.52                         $ 0.53  
                                     
Weighted average number of common stock used in computing basic and diluted net loss per share     4,206,224                           27,614,532  

 

 

 

 

Notes to the Unaudited Pro Forma Interim Consolidated Financial Information

 

1. Description of the Acquisition and Basis of Presentation

 

On May 31, 2017, Eloxx entered into the Agreement with Acquisition Sub, which is also wholly owned Israeli subsidiary of Sevion, a company whose common stock is quoted on the OTCQB Market. At the Transaction Effective Time, Acquisition Sub will merge with and into Eloxx. Upon completion of the Transaction, the separate corporate existence of Acquisition Sub will cease, and Eloxx will continue as the surviving entity and as a wholly owned subsidiary of Sevion. Immediately prior to the Transaction, Sevion will change its name to “Eloxx Pharmaceuticals, Inc.” Sevion is a development-stage biotech company developing a portfolio of innovative therapeutics, from both internal discovery and acquisition, for the treatment of cancer and immunological diseases.

 

Subject to the terms and conditions of the Agreement, at the Effective Time of the Transaction, each share of Eloxx common stock and preferred stock that is issued and outstanding will be automatically cancelled and converted into fully paid and non-assessable shares of Sevion's common stock equal to an initial exchange ratio of 4.99 shares of Sevion’s common stock for each one Eloxx's ordinary share (after giving effect to the Reverse Stock Split). For each one Eloxx's ordinary share. Each warrant to purchase preferred shares of Eloxx’s (the “Warrants”) existing at the time of the Effective Time will be cancelled, except 69,381 warrants issued to certain service providers which will be converted into warrants to purchase the number of shares of Sevion common stock equal to the number of Eloxx shares that were subject to the Warrants immediately prior to the Effective Time, multiplied by the Exchange Ratio. Each option to purchase Eloxx’s ordinary shares existing at the Effective Time (the “Options”) will be converted into options to purchase the number of shares of Sevion common stock equal to the number of Eloxx ordinary shares that were subject to the Options immediately prior to the Effective Time, multiplied by the Exchange Ratio. In this respect, it was further agreed that the conversion of all or part of such Warrants and/or Options, whether before or after the Effective Time, shall not modify the Exchange Ratio.

 

Pursuant to the terms of the Agreement, immediately prior to the Effective Time, Sevion’s Certificate of Incorporation will be amended to effect the Reverse Stock Split of its common stock and to change Sevion’s name to “Eloxx Pharmaceuticals, Inc.”

 

Consummation of the Transaction was subject to certain closing conditions, including, among other things: (i) approval of the Transaction by the stockholders of Eloxx (simultaneously with the execution of the Agreement, Sevion received a voting Agreement executed by the holders of at least 60% of Eloxx’s capital stock agreeing to vote in favor of the Transaction); (ii) the successful consummation of equity financings resulting in cash investments in each of Sevion and Eloxx of no less than $19,000,000, each pursuant to the terms of subscription agreements entered into in connection with the Agreement; (iii) the entering into of a lockup agreement and registration rights agreement by and among Sevion, certain shareholders of Sevion and certain holders of Registrable Securities (as defined in the Agreement); (iv) the compliance of Sevion with its obligations to prepare, file, neogotiate and perform all acts with respect to the uplisting of Sevion’s common stock to the Nasdaq Capital Market; (v) termination and/or cancellation of various Sevion agreements; (vi) delivery to Eloxx of executed resignation letters by each of the directors and officers of Sevion, with an effective date to be as agreed upon by Sevion and Eloxx; (vii) the adoption by Sevion of an amendment to its certificate of incorporation to affect a change in the name of Sevion to Eloxx Pharmaceuticals, Inc.; and (viii) conversion of all shares of Preferred Stock of Sevion into shares of common stock of Sevion. Additionally, at the Effective Time, Sevion will have an amount of available cash of no less than $10,500,000.

 

The organizational history of Eloxx is described in Eloxx’s interim consolidated financial statements as of September 30, 2017.

 

2. Basis of Presentation

 

The unaudited pro forma consolidated financial statements were prepared in accordance with the rules and regulations of the Securities and Exchange Commission Regulation S-X. The unaudited pro forma consolidated balance sheet as of September 30, 2017 is presented as if the Transaction had been completed on September 30, 2017. The unaudited pro forma consolidated statement of operations for the year ended December 31, 2016 and the nine months period ended September 30, 2017 assume that the merger occured on the first day of the period presented, and combines the historical results of Sevion and Eloxx.

 

Based on the terms of the Transaction, Eloxx is deemed to be the acquiring company for accounting purposes and the Transaction will be accounted for under an assets acquisition whereby the net acquired assets of Sevion will be recorded at their carrying amounts as of the completion of the Transaction. Consequently, the interim consolidated financial statements of Eloxx as of September 30, 2017 reflect the operations of Eloxx as the acquirer for accounting purposes together with a deemed issuance of shares, equivalent to the shares held by the former stockholders of Sevion, the legal acquirer, and a recapitalization of the equity of the accounting acquirer. These interim consolidated financial statements include the accounts of Sevion since the effective date of the reverse recapitalization and the accounts of Eloxx since inception.

 

 

 

 

To the extent there are significant changes to the business following completion of the Transaction, the assumptions and estimates set forth in the unaudited pro forma consolidated financial statements could change significantly. Accordingly, the pro forma purchase price adjustments are subject to further adjustment as additional information becomes available and as additional analyses are conducted following the completion of the Transaction. There can be no assurances that these additional analyses will not result in material changes to the estimates of fair value.

 

3. Pro Forma Adjustments and Assumptions

 

The pro forma adjustments were based on the preliminary information available at the time of the preparation of the unaudited pro forma interim consolidated financial information. The unaudited pro forma interim consolidated financial information, including the notes thereto, are qualified in their entirety by reference to, and should be read in conjunction with, the historical interim consolidated financial information of Eloxx and Sevion as of September 30, 2017.

 

A. To reflect the elimination of Sevion’s historical stockholders’ equity balances, including accumulated deficit, and to reflect the adjustments to the fair value to Sevion’s net assets recorded in the preliminary allocation of the estimated total purchase price, at the close of the merger referred to in Note 2 above.

 

Elimination of Sevion’s accumulated deficit   $ (123,206 )
Elimination of Sevion’s common stock     514  
Fair value adjustment to intangible asset (acquired research and development) (see E below)     (2,512 )
Adjustment to deferred tax liability (see F below)     1,005  
Total   $ (124,199 )

 

B. To reflect the reclassification Eloxx’s ordinary shares and preferred shares with NIS 0.01 par value to Sevion’s common stock with $0.01 par value, pursuant to the Exchange Ratio.

 

C. To reflect issuance of 2,297,876 shares of Sevion's common stock to former stockholders of Sevion upon the closing of the Transaction, pursuant to the Exchange Ratio.

 

D. To record $773,000 of estimated transaction costs that were not incurred as of September 30, 2017.

 

E. To record intangible assets (IPR&D) acquired in the Transaction and eliminate Sevion’s historical intangible asset (IPR&D).

 

To record intaigible assets acquired in the Transaction   $ 2,988  
To eliminate historical Sevion's intangible assets     (5,500 )
Total   $ (2,512 )

 

F. To eliminate Sevion’s deferred tax liability related to prior acquisitions that arose from amortizing, for tax purposes, intangible asset (IPR&D) (see E above) from business combination transactions prior to this Transaction (assumes a 40% tax rate applied to intangible asset acquired) and record deferred tax liability related to the Transaction (assumes a 40% tax rates applied to intangible assets acquired (IPR&D)).

 

To record deferred tax liability related to the Transaction   $ 1,195  
To eliminate deferred tax liability related to Sevion's intangible assets from prior acquisitions     (2,200 )
Total   $ (1,005 )

 

G. To reflect the deferred closing amounted to gross proceeds of $19,000,000 for issuance of 6,333,333 shares of common stock, as part of the 2017 SPA, as described in Note 12e to the consolidated financial statements of Eloxx Pharmaceuticals Ltd. as of December 31, 2016. Incremental and direct costs amounted to $486 thousand.

 

H. To reflect (i) conversion of $712,000 in aggregate principal of, and accrued interest on, Sevion’s convertible promisorry notes into shares of Sevion's common stock and (ii) elimination of expenses in respect to revaluation of derivative of conversion feature on Sevion’s convertible promissory notes and related interest expenses that were incurred during the nine months period ended September 30, 2017 amounted to $1,688,000 and $28,000, respectively.

 

I. To eliminate nonrecurring directly related Transaction costs of $981,000 that were incurred during the nine-month period ended September 30, 2017.

 

J. To reflect elimination of preferred stock dividends recognized by Sevion on its outstanding preferred stock since all preferred stock were exchanged for Sevion’s common stock at the Exchange Ratio.