3 unchanged sentences
We have limited capital resources, a cumulative deficit of approximately $328.7 million since inception and expect to incur further losses for the foreseeable future.
−Removed: As of June 30, 2020, we had approximately $40.0 million of cash, cash equivalents and investments available-for-sale, and working capital of $40.0 million.
−Removed: Net cash used in operating activities for the six months ended June 30, 2020 was approximately $16.2 million.
+Added: As of September 30, 2020, we had approximately $67.3 million of cash, cash equivalents and investments available-for-sale, and working capital of $65.2 million.
+Added: Net cash used in operating activities for the nine months ended September 30, 2020 was approximately $21.1 million.
On March 22, 2019, the Company entered into a sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
2 unchanged sentences
The Company paid $0.3 million in commissions and offering fees related to the sales.
−Removed: During the six months ended June 30, 2020, the Company sold 987,716 of shares of its common stock pursuant to the Sales Agreement with the Agent for proceeds of $2.0 million, net of issuance costs.
−Removed: As of June 30, 2020, approximately $32.6 million remains available for sale under this facility.
−Removed: On February 4, 2020, the Company entered into an underwriting agreement with Cantor Fitzgerald & Co., as underwriter, pursuant to which the Company agreed to issue and sell an aggregate of up to 3,670,212 shares of its common stock, which included 478,723 optional shares that may be sold pursuant to an over-allotment option granted to the underwriters.
+Added: During the nine months ended September 30, 2020, the Company sold 1,128,608 of shares of its common stock pursuant to the Sales Agreement with the Agent for proceeds of $2.3 million, net of issuance costs.
+Added: As of September 30, 2020, approximately $32.3 million remains available for sale under this facility.
+Added: On February 4, 2020, the Company entered into an underwriting agreement with Cantor Fitzgerald & Co., as underwriter, pursuant to which the Company agreed to issue and sell an aggregate of up to 3,670,212 shares of its common
+Added: stock, which included 478,723 optional shares that may be sold pursuant to an over-allotment option granted to the underwriters.
On February 6, 2020, the Company closed the sale of 3,191,489 shares of its common stock at the public offering price of $2.22 per share (the “Offering”).
4 unchanged sentences
Funding of the first $22.5 million tranche was completed on March 16, 2020.
−Removed: The Company will be eligible to draw on a second tranche of $5.0 million upon achievement of certain milestones, including the FDA approval of the Company’s New Drug Application for Triferic AVNU.
−Removed: The Company will be eligible to draw on a third tranche of $7.5 million upon the achievement of certain additional milestones, including the achievement of certain Triferic sales thresholds.
+Added: The Company is no longer eligible to draw on a second tranche of $5.0 million, which was tied to the achievement of certain milestones by a specified date.
+Added: The Company may be eligible to draw on a third tranche of $7.5 million upon the achievement of certain additional milestones, including the achievement of certain Triferic sales thresholds.
Net draw down proceeds were $21.2 million with closing costs of $1.3 million.
3 unchanged sentences
The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc.
−Removed: and contains customary representations and warranties and covenants, subject to customary carve outs, and includes financial covenants related to liquidity and trailing twelve months sales of Triferic, with the latter beginning with the period ending December 31, 2020, or September 30, 2020 if the Company draws the second tranche of $5.0 million.
+Added: and contains customary representations and warranties and covenants, subject to customary carve outs, and includes financial covenants related to liquidity and trailing twelve months sales of Triferic, with the latter beginning with the period ending December 31, 2020.
+Added: We cannot assure you that we can maintain compliance with the covenants under our Loan Agreement, which may result in an event of default.
+Added: Our ability to comply with these covenants may be adversely affected by events beyond our control.
+Added: For example, the Loan Agreement contains certain financial covenants relating to sales and, as a result of the ongoing COVID-19 pandemic and its effect on our sales activities, among other factors, we may not be able to satisfy such covenants in the future.
+Added: Based on our annualized Triferic sales through September 30, 2020, we may not satisfy this covenant as of December 31, 2020.
+Added: If we are unable to comply with the covenants under our Loan Agreement, we intend to pursue all available cure options in order to regain compliance.
+Added: However, we may not be able to mutually agree with Innovatus on appropriate remedies to cure a breach of a covenant, which could give rise to an event of default.
+Added: If we are unable to avoid an event of default, any required repayments could have an adverse effect on our liquidity.
+Added: As of September 30, 2020, the Company was in compliance with all reporting and financial covenants.
+Added: On September 23, 2020, the Company entered into a Securities Purchase Agreement with certain purchasers named therein, pursuant to which the Company agreed to issue and sell to several institutional and accredited investors in a registered direct offering 21,818,544 shares of its common stock and warrants to purchase up to 23,178,809 shares of its common stock (the “Warrants”) at a combined purchase price equal to $1.51 per share.
+Added: Each Warrant is exercisable for one share of common stock at an exercise price of $1.80 per share.
+Added: The Warrants are immediately exercisable and will expire on September 25, 2022.
+Added: The Company also offered to certain purchasers pre-funded warrants to purchase up to an aggregate of 1,360,265 shares of common stock (the “Pre-Funded Warrants”), in lieu of shares of common stock.
+Added: The purchase price of each Pre-Funded Warrant is equal to the price at which a share of common stock is sold to the public in the offering, minus $0.001, and the exercise price of each Pre-Funded Warrant is $0.001 per share.
+Added: The Pre-Funded Warrants were exercised at the same time as the issuance of common stock under the Securities Purchase Agreement.
+Added: The Company received gross proceeds of approximately $35.0 million in connection with the offering, before deducting placement agent fees and related offering expenses of approximately $2.3 million.
Based on the equity offerings and the Loan Agreement described above, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report.
−Removed: The Company will require additional capital to sustain its operations and make the investments it needs to execute upon its longer-term business plan, including the launch of Triferic Dialysate and Triferic AVNU.
+Added: The Company will require additional capital to sustain its operations and make the investments it needs to execute upon its longer-term business plan, including the current launch of Triferic Dialysate and Triferic AVNU.
If the Company is unable to generate sufficient revenue from its existing long-term business plan, the Company will need to obtain additional equity or debt financing.
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• the effectiveness of our marketing, sales and distribution strategies and operations for development and commercialization;
−Removed: the impact of Triferic Dialysate and Triferic AVNU on established customer protocols, formularies and operational practices;
+Added: • the impact of Triferic Dialysate and Triferic AVNU on established customer protocols, formularies, administration methods and operational practices;
• The ability and willingness of dialysis centers to adopt their protocols and utilize the drugs in a manner consistent with state regulatory agencies.
23 unchanged sentences
Furthermore, some of our manufacturers and suppliers are in Europe and may be impacted by port closures and other restrictions resulting from the COVID-19 pandemic, which may disrupt our supply chain or limit our ability to obtain sufficient materials for our drug products.
−Removed: We commercially launched Triferic Dialysate in the United States in May 2019 and we intend to initiate a sample evaluation program for Triferic AVNU during the third quarter of 2020 in order to prepare for a commercial launch.
+Added: We commercially launched Triferic Dialysate in the United States in May 2019 and we began recruiting clinics to participate in a sample evaluation program for Triferic AVNU during the third quarter of 2020 in order to prepare for a commercial launch.
Quarantines, shelter-in-place, executive and similar government orders, or changes in prospective customer practices in response to the COVID-19 outbreak, may negatively impact our sales and marketing activities, particularly if our sales representatives are unable to interact with current and potential customers to the same extent as before onset of the COVID-19 pandemic.
8 unchanged sentences
In addition, meetings between Sun Pharma and the regulatory authorities in India related to our Triferic products have been postponed due to government restrictions in India.
+Added: Lastly, meetings between Jeil Pharma and the regulatory authorities in South Korea could be postponed due to potential government restrictions in South Korea.
If COVID-19 continues to spread in the United States and elsewhere, we or our partners may experience additional disruptions that could severely impact our business and clinical trials, including:
28 unchanged sentences
• incur additional indebtedness;
+Added: • grant liens;
• make distributions, including dividends;
3 unchanged sentences
These terms of the Loan Agreement could prevent us from taking certain actions without the consent of our lenders, which may limit our flexibility in operating our business and our ability to take actions that might be advantageous to us and our stockholders, placing us at a competitive disadvantage compared to our competitors who have less leverage and who therefore may be able to take advantage of opportunities that our leverage prevents us from exploiting.
−Removed: Our ability to comply with these covenants may be adversely affected by events beyond our control, and we cannot assure you that we can maintain compliance
−Removed: with these covenants, which may result in an event of default.
−Removed: These covenants could limit our ability to make needed capital expenditures or otherwise conduct necessary or desirable business activities.
+Added: These covenants could also limit our ability to make needed capital expenditures or otherwise conduct necessary or desirable business activities.
+Added: We cannot assure you that we can maintain compliance with the covenants under our Loan Agreement, which may result in an event of default.
+Added: Our ability to comply with these covenants may be adversely affected by events beyond our control.
+Added: For example, the Loan Agreement contains certain financial covenants relating to sales and, as a result of the ongoing
+Added: COVID-19 pandemic and its effect on our sales activities, among other factors, we may not be able to satisfy such covenants in the future.
+Added: Based on our annualized Triferic sales through September 30, 2020, we may not satisfy this covenant as of December 31, 2020.
+Added: If we are unable to comply with the covenants under our Loan Agreement, we intend to pursue all available cure options in order to regain compliance.
+Added: However, we may not be able to mutually agree with Innovatus on appropriate remedies to cure a breach of a covenant, which could give rise to an event of default.
The Loan Agreement also includes customary events of default, including, among other things, a change of control or a failure to comply with certain of the covenants in the Loan Agreement.
16 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.