What changed in this filing

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Item 1A. Risk Factors

2025-11-13 compared with 2025-08-14 · 29 added, 29 removed, 1400 unchanged (4% of the section changed)

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Since our inception, we have incurred recurring net losses, and we expect that our losses will continue for the foreseeable future.

We incurred net losses of $10.0 million and $47.6 million and used cash in operations of $6.3 million and $49.1 million for the six months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025, we had an accumulated deficit of $703.2 million.

We incurred net losses of $18.5 million and $91.9 million and used cash in operations of $12.2 million and $62.4 million for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, we had an accumulated deficit of $711.7 million.

We cannot predict if we will be profitable in the near future or at all.

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We expect to continue to generate operating losses and consume significant cash resources for the foreseeable future.

We believe that with receipt of the net proceeds from our registered direct offerings in April 2024, July 2024, October 2024 and January 2025, from our ATM Agreement and from the May 2024 from the transaction pursuant to that certain securities purchase agreement dated May 24, 2024 and amended on December 31, 2024, between us and certain accredited investors and JGB Collateral LLC, as collateral agent for the investors (the “JGB Purchase Agreement”) and the restructuring of redemption terms for our debt instruments in January 2025, together with the Company’s existing cash and cash equivalents and short-term investments, and after taking into account inaccessible “restricted cash” under the terms of the transaction under the JGB Purchase Agreement, based on the Company’s current business plans we will be able to fund our operating expenses and capital expenditure requirements into the first quarter of 2026.

We believe that with receipt of the net proceeds from our registered direct offerings in April 2024, July 2024, October 2024 and January 2025, from our September 2025 Offering, from our ATM Agreement and from the transaction pursuant to that certain securities purchase agreement dated May 24, 2024 and amended on December 31, 2024, between us and certain accredited investors and JGB Collateral LLC, as collateral agent for the investors (the “JGB Purchase Agreement”) and the restructuring of redemption terms for our debt instruments in January 2025, together with the Company’s existing cash and cash equivalents and short-term investments, and after taking into account inaccessible “restricted cash” under the terms of the transaction under the JGB Purchase Agreement, based on the Company’s current business plans we will be able to fund our operating expenses and capital expenditure requirements into the third quarter of 2026.

See Note 5 and 6 (Debt and Stockholders’ Equity and Stock-Based Compensation) in the accompanying notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for a further discussion of our recent debt and equity financings.

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As our public float is currently less than $75.0 million, we are currently subject to this limitation.

If our ability to utilize a Form S-3 registration statement for a primary offering of our securities continues to be limited to one-third of our public float, we may need to conduct such an offering pursuant to an exemption from registration under the Securities Act or under a Form S-1 registration statement, which would increase the cost of raising additional capital relative to utilizing a Form S-3 registration statement and be subject to delays in effectiveness due to review by the SEC.

If our ability to utilize a Form S-3 registration statement for a primary offering of our securities continues to be limited to one-third of our public float, we may need to conduct such an offering pursuant to an exemption from registration under the Securities Act or under a Form S-1 registration statement, which would increase the cost of raising additional capital relative to utilizing a Form S-3 registration statement and may be subject to delays in effectiveness due to review by the SEC.

Our corporate cost saving initiatives and the associated headcount reductions we announced in May 2023, October 2023, March 2024, and September 2024 could disrupt our business and may not achieve our intended objectives.

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We expect to continue to spend substantial amounts of cash in order to continue the commercialization of our products and technologies, fund our research and development programs, and execute potential strategic transactions.

In connection with the preparation of our financial statements for the three and six months ended June 30, 2025, we performed an analysis of our ability to continue as a going concern and based on our current business plan, we believed that our existing cash and cash equivalents and short-term investments would not be sufficient for the next twelve months from the issuance of the unaudited condensed consolidated financial statements included in this Quarterly Report and, accordingly, there continued to be substantial doubt about our ability to continue as a going concern within 12 months of the issuance of such financial statements.

In connection with the preparation of our financial statements for the three and nine months ended September 30, 2025, we performed an analysis of our ability to continue as a going concern and based on our current business plan, we believed that our existing cash and cash equivalents and short-term investments would not be sufficient for the next twelve months from the issuance of the unaudited condensed consolidated financial statements included in this Quarterly Report and, accordingly, there continued to be substantial doubt about our ability to continue as a going concern within 12 months of the issuance of such financial statements.

Our ability to execute our operating plan depends on our ability to generate sales and obtain additional funding through equity offerings, debt financings or potential licensing and collaboration arrangements.

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• the effect of competing technological and market developments.

As of June 30, 2025, we had $3.6 million in cash and cash equivalents, $12.9 million in short-term investments, and $11.0 million in restricted short-term investments.

We received net proceeds of approximately $9.3 million after deducting placement agent fees and offering expenses, from the issuance and sale of our securities in anApril 2024 registered direct offering;

As of September 30, 2025, we had $3.1 million in cash and cash equivalents, $18.5 million in short-term investments, and $10.3 million in restricted short-term investments.

net proceeds of approximately $9.3 million after deducting placement agent fees and offering expenses, from the issuance and sale of our securities in a July 2024 registered direct offering;

Based on our current business plans, we believe the net proceeds from such financings together with our existing cash and cash equivalents and short-term investments, and after taking into account inaccessible “restricted cash and restricted investments” under the terms of the JGB Purchase Agreement, and that certain settlement and amendment, dated December 31, 2024, with certain accredited investors and JGB (the “Debentures Amendment”), will be sufficient to fund our operating expenses and capital expenditure requirements into at least the first quarter of 2026.

net proceeds of approximately $2.7 million after deducting placement agent fees and offering expenses, from the issuance and sale of our securities in an October 2024 registered direct offering, net proceeds of approximately $9.3 million after deducting placement agent fees and offering expenses, from the issuance and sale of our securities in a January 2025 registered direct offering, and net proceeds of approximately $9.2 million after deducting placement agent fees and offering expenses, from the issuance and sale of our securities in a September 2025 Offering.

Nevertheless, our existing cash and cash equivalents and short-term investments, will not be sufficient for us to achieve cash-flow break even and we expect to need to seek additional capital in the near future.

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Any equity or debt securities we issue could provide for rights, preferences, or privileges senior to those of holders of our common stock.

Future debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt.

Any debt or equity

financing may contain terms that are not favorable to us or our stockholders.

Future debt financing,

if available, may involve covenants restricting our operations or our ability to incur additional debt.

Any debt or equity financing may contain terms that are not favorable to us or our stockholders.

If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us.

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In order to raise additional capital, we may in the future offer additional shares of our common stock, or other securities convertible into or exchangeable for our common stock and, as a result, our stockholders may experience dilution.

For example, as a result of our registered direct offering in April 2024, July 2024, October 2024, and January 2025, our investors experienced dilution of their ownership interests.

For example, as a result of our registered direct offering in April 2024, July 2024, October 2024, and January 2025, and our September 2025 Offering, our investors experienced dilution of their ownership interests.

We may sell additional shares of our common stock or other securities convertible or exchangeable into common stock in future equity offerings at a price per share that is less than the price per share paid by investors in previous equity offerings, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders.

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Our ability to make scheduled payments of principal or default interest, if any, or to refinance the Debentures or our other permitted indebtedness, depends on our future performance, which is subject to economic, financial, competitive and other factors, some of which are beyond our control.

As of June 30, 2025, we had aggregate principal amount outstanding under the Debentures of $12.1 million.

As of September 30, 2025, we had aggregate principal amount outstanding under the Debentures of $10.3 million.

Notwithstanding the Debentures Amendment pursuant to which we agreed to modify certain terms of the Debentures, including to:

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We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on the Debentures or our other indebtedness.

As of June 30, 2025, there is substantial doubt about our ability to continue as a going concern and servicing the Debentures continues to impact our cash flow and liquidity.

As of September 30, 2025, there is substantial doubt about our ability to continue as a going concern and servicing the Debentures continues to impact our cash flow and liquidity.

The terms of the Debentures and the Debenture Purchase Agreement restrict our current and future operations.

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Wainwright & Co., LLC (“Wainwright”).

In February and March 2025, the Company sold approximately 0.4 million shares of common stock under the ATM Agreement for gross proceeds of approximately $1.4 million before deducting offering costs.

In the three months ended June 30, 2025, the Company sold approximately 0.8 million shares of common stock under the ATM Agreement for gross proceeds of approximately $3.1 million before deducting offering costs.

From February 24, 2025 to September 30, 2025, the Company sold approximately 2.0 million shares of common stock under the ATM Agreement for gross proceeds of approximately $7.4 million before deducting offering costs.

Further, t he exercise of the Registered Warrants (as defined below) issued in the October 2023 offering (as amended in February 2024 and as defined below) will dilute the ownership interests of existing stockholders to the extent we deliver shares upon exercise of the Registered Warrants.

In addition, the existence of the Debentures and Registered Warrants may encourage

short selling by market participants because the conversion of the Debentures and exercise of the Registered Warrants could be used to satisfy short positions, or anticipated conversion of the Debentures or exercise of the Registered Warrants into shares of our common stock could depress the price of our common stock.

In addition, the existence of the Debentures and Registered Warrants may encourage short selling by market participants because the conversion of the Debentures and exercise of the Registered Warrants could be used to satisfy short positions, or anticipated conversion of the Debentures or exercise of the Registered Warrants into shares of

our common stock could depress the price of our common stock.

In addition, we issued shares of our common stock in connection with our acquisitions of Lineagen and BioDiscovery.

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In connection with the January 2025 registered direct offering, we agreed to issue and sell to certain institutional investors (i) an aggregate of approximately 382,000 shares of common stock, (ii) pre-funded warrants to purchase up to an aggregate of approximately 280,000 shares of common stock, and (iii) warrants to purchase up to approximately 661,000 shares of common stock (in each case, as adjusted for the reverse stock split).

In connection with the September 2025 Offering, we issued and sold an aggregate of (i) 4.9 million shares of common stock, (ii) pre-funded warrants to purchase up to an aggregate of 75,000 shares of common stock, (iii) Series E warrants to purchase up to an aggregate of 5.0 million shares of common stock, and (iv) Series F warrants to purchase up to an aggregate of 5.0 million shares of common stock.

As a result of these issuances, our investors experienced dilution of their ownership interests.

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In order to provide persons who have a responsibility for our management and/or growth with additional incentive, to increase their proprietary interest in our success, and to support and increase our ability to attract and retain individuals of exceptional talent, we maintain multiple equity incentive plans.

As of June 30, 2025, we had outstanding equity awards underlying those plans accounting for 0.2 million underlying shares (as adjusted for the reverse stock split).

The total number of shares of our common stock available for the grant of awards under these plans is 13,000, 1,000 and 35,000 (as adjusted for the reverse stock split) for our 2018 Equity Incentive Plan, as amended, 2018 Employee Stock Purchase Plan and 2020 Inducement Plan, as amended, respectively, subject to adjustment, including pursuant to automatic “evergreen” increases in certain of our plans.

As of September 30, 2025, we had outstanding equity awards underlying those plans accounting for 0.2 million underlying shares.

The total number of shares of our common stock available for the grant of awards under these plans is 13,000, 1,000 and 35,000 for our 2018 Equity Incentive Plan, as amended, 2018 Employee Stock Purchase Plan and 2020 Inducement Plan, as amended, respectively, subject to adjustment, including pursuant to automatic “evergreen” increases in certain of our plans.

We may also adopt one or more additional employee equity benefit plans in the future.

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We expect to generate a substantial portion of our revenue internationally in the future and can become further subject to various risks relating to our international activities, which could adversely affect our business, operating results and financial condition.

During the six months ended June 30, 2025 and 2024, approximately 61% and 59%, respectively, of our revenue was generated from customers located outside of the United States.

We believe that a substantial percentage of our future revenue will continue to come from international sources as we maintain our existing overseas operations and aim to develop opportunities

in additional areas.

During the nine months ended September 30, 2025 and 2024, approximately 63% and 62%, respectively, of our revenue was generated from customers located outside of the United States.

We believe that a substantial percentage of our future revenue will continue to come from international sources as we maintain our existing overseas operations and aim to develop

opportunities in additional areas.

We have limited experience operating internationally and engaging in international business involves a number of difficulties and risks, including:

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Our stock price has been and may continue to be volatile.

The daily closing market price for our common stock has varied significantly in the last 12 months, ranging between a high price of $33.42 on August 19, 2024 and a low price of $2.79 on March 31, 2025 (as adjusted for the reverse stock split effectuated on January 24, 2025).

The daily closing market price for our common stock has varied significantly in the last 12 months, ranging between a high price of $19.00 on January 3, 2025 and a low price of $1.66 on September 26, 2025 (as adjusted for the reverse stock split effectuated on January 24, 2025).

During this time, the price per share of common stock has ranged from an intra-day low of $1.50 per share to an intra-day high of $22.80 per share (as adjusted for the reverse stock split effectuated on January 24, 2025).

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in connection with the October 2024 registered direct offering, we issued and sold, among other things, warrants to purchase approximately 330,000 shares of our common stock (as adjusted for the reverse stock split) following stockholder approval;

and in connection with the January 2025 registered direct offering, we issued and sold, among other things, warrants to purchase approximately 661,000 shares of our common stock (as adjusted for the reverse stock split) following stockholder approval.

in connection with the January 2025 registered direct offering, we issued and sold, among other things, warrants to purchase approximately 661,000 shares of our common stock (as adjusted for the reverse stock split) following stockholder approval, and in connection with the September 2025 Offering, we issued and sold, among other things, warrants to purchase approximately 10.0 million shares of our common stock.

Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our securities and may prevent or frustrate attempts by our security holders to replace or remove our current management.

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In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General Corporation Law of the State of Delaware, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock.

These anti-takeover provisions and other provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors and could also delay or impede a merger, tender offer or proxy contest involving our company.

These provisions could also discourage

proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing or cause us to take other corporate actions you desire.

also delay or impede a merger, tender offer or proxy contest involving our company.

These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing or cause us to take other corporate actions you desire.

Any delay or prevention of a change of control transaction or changes in our board of directors could cause the market price of our securities to decline.

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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.

What changed 10-Q

Item 1A. Risk Factors