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Item 1A. Risk Factors

2026-03-13 compared with 2025-03-12 · 188 added, 266 removed, 785 unchanged (37% of the section changed)

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We urge investors to carefully consider the risk factors described below in evaluating

our stock and the information in this Annual Report on Form 10-K, including the consolidated financial

our stock and the information in this 2025 Annual Report, including the consolidated financial

statements and the notes thereto and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

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imposes various sublicense fees and other obligations on us.

For example, we are obligated to pay Factor Limited $0.2 million per month

for the first twelve months, $0.1 million per month for the first nine months toward patent costs, certain milestone payments, royalty

payments on net sales of commercialized products and sublicensing fee payments.

The parties have customary termination rights under the

Factor L&C Agreement, including in connection with certain uncured material breaches of the Factor L&C Agreement and specified

bankruptcy events.

Any termination of our existing or future licenses could result in the loss of significant rights and would harm our

business significantly.

For example, we paid Factor Limited $0.2 million per month for the first

twelve months and $0.1 million per month for the first nine months toward patent costs.

We are also obligated to pay certain milestone

payments, royalty payments on net sales of commercialized products and sublicensing fee payments.

The parties have customary termination

rights under the Factor L&C Agreement, including in connection with certain uncured material breaches of the Factor L&C Agreement

and specified bankruptcy events.

Any termination of our existing or future licenses could result in the loss of significant rights and

would harm our business significantly.

may also arise between us and our licensors regarding intellectual property subject to a license agreement, including:

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platform and any other in-licensed intellectual property, our ability to enter into co-development strategic partnerships could materially

intellectual property rights may not adequately

protect our business .

intellectual property rights may not adequately protect our business.

degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations

and may not adequately protect our business.

For example :

or our license partners or current or future collaborators, might not have been the first

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secret or proprietary status.

any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations

and prospects.

any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and

rely heavily on in-licensed intellectual property from Factor Limited.

Loss of this license or termination

of the Factor L&C Agreement could significantly harm our product development and ability to enter co-development strategic partnerships,

materially impacting our business.

Loss of this license or termination of the Factor L&C Agreement

could significantly harm our product development and ability to enter co-development strategic partnerships, materially impacting our

business is substantially dependent upon the synthetic iMSC technology licensed from Factor Limited.

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of, or right to use, intellectual property, which could adversely impact our business, results of operations and financial condition.

have previously identified a material weakness in our internal control over financial reporting.

If we are unable to develop and maintain

an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a

timely manner, which may adversely affect investor confidence in us, and materially and adversely affect our business and operating results.

material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is

a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected

and corrected on a timely basis.

Effective internal controls are necessary for us to provide reliable financial reports and prevent fraud.

prior periods, we identified a material weakness as discussed below.

We were unable to timely file our Quarterly Report on Form 10-Q

for the three months ended March 31, 2022 due to identifying errors in our financial statements reported in the Annual Report on Form

10-K for the years ended December 31, 2021 and 2020 during our preparation of the financial statements for the quarter ended March 31,

On June 30, 2022, we filed an amendment to our Annual Report on Form 10-K for the years ended December 31, 2021 and 2020 to correct

the errors in our financial statements for the years ended December 31, 2021 and 2020 and for the quarters ended June 30, 2020, September

30, 2020, March 31, 2021, June 30, 2021 and September 30, 2021.

Management concluded that the errors were the result of accounting personnel’s

lack of technical proficiency in the accounting for complex matters.

has implemented measures designed to ensure that the deficiencies contributing to the ineffectiveness of our internal control over financial

reporting are remediated, such that the internal controls are designed, implemented and operating effectively.

The remediation actions

implemented to date include:

enhancing the business process controls related to reviews over technical, complex, and non-recurring transactions;

providing additional training to accounting personnel and using external accounting advisors to review management’s conclusions

on certain technical, complex and non-recurring matters.

a result of the above remediation measures, and as disclosed in Part II, Item 9A to this Annual Report on Form 10-K, our Chief Executive

Officer and Senior Vice President of Finance concluded that the prior material weakness was remediated as of December 31, 2024, and our

disclosure controls and procedures were effective and provided reasonable assurance of achieving the desired control objectives.

we identify any additional material weaknesses in the future, any such newly identified material weakness could limit our ability to

prevent or detect a misstatement of our accounts or disclosures and could result in a material misstatement of our annual or interim

financial statements.

In such case, we may be unable to maintain compliance with securities law requirements regarding timely filing

of periodic reports, investors may lose confidence in our financial reporting and our stock price may decline as a result.

assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to avoid potential

future material weaknesses.

business and operations would suffer in the event of system failures, cyber-attacks or a deficiency in our cyber-security.

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The value to employees of stock options that vest over time will be significantly affected by movements

in the price of the common stock that it will not be able to control and may at any time be insufficient to counteract more lucrative

offers from other companies.

in the price of the common stock, which we cannot control, and may at any time be insufficient to counteract more lucrative offers from

other companies.

for skilled personnel in our industry is intense, and competition for experienced scientists may limit our ability to hire and retain

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and clinical development, manufacture, and regulatory compliance for the initiation and conduct of clinical trials, regulatory approval,

and reimbursement required for successful commercialization of future product candidates.

and reimbursement required for successfully commercializing future product candidates.

Further, the processes and requirements imposed

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development costs, and delay or prevent commercialization of future products, if such products are approved for marketing.

to the rapid advancements in cellular technologies, regulatory processes and requirements in the United States and in other jurisdictions

governing cellular therapy products are evolving and the FDA or other regulatory bodies may change the requirements, or identify different

regulatory pathways, for the clinical testing and approval of these product candidates.

For example, in recent years the FDA has issued

several new guidance documents related to developing and manufacturing cellular therapy products.

In addition, adverse developments in

clinical trials of cellular therapy products conducted by others, or in treated patients after such products are commercialized, may

cause the FDA or other oversight bodies to change the requirements for approval of any of our product candidates.

to the rapid advancements in cellular technologies, regulatory processes and requirements in the U.S.

and in other jurisdictions governing

cellular therapy products are evolving and the FDA or other regulatory bodies may change the requirements, or identify different regulatory

pathways, for the clinical testing and approval of these product candidates.

For example, in recent years the FDA has issued several

new guidance documents related to developing and manufacturing cellular therapy products.

In addition, adverse developments in clinical

trials of cellular therapy products conducted by others, or in treated patients after such products are commercialized, may cause the

FDA or other oversight bodies to change the requirements for approval of any of our product candidates.

For example, in November 2023,

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or more extensively studied technologies.

It is difficult to determine how long it will take or how much it will cost to obtain regulatory

approvals for product candidates using this technology in either the United States or the E.U.

or how long it will take to commercialize

any product candidates.

Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential

product candidate to market could decrease our ability to generate sufficient product revenue, and our business, financial condition,

results of operations and prospects may be harmed.

It is difficult to determine the time or cost required to obtain regulatory approvals for product

candidates using this technology in either the U.S.

or the E.U., or how long it will take to commercialize any product candidates.

or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential product candidate to market

could decrease our ability to generate sufficient product revenue, and our business, financial condition, results of operations and prospects

may be harmed.

are in an industry with intense competition and rapid technological change, and our competitors may develop therapies that are more advanced,

safer, or more effective than any therapy we develop in the future, which may adversely affect our financial condition.

have competitors both in the United States and internationally, including major multinational pharmaceutical companies, biotechnology

companies, universities, and other research institutions.

Many of our competitors have substantially greater financial, technical, research

and human resources than we do, and may also have strategic partnerships and collaborative arrangements with leading companies and research

have competitors both in the U.S.

and internationally, including major multinational pharmaceutical companies, biotechnology companies,

universities, and other research institutions.

Many of our competitors have substantially greater financial, technical, research and

human resources than we do, and may also have strategic partnerships and collaborative arrangements with leading companies and research

institutions.

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Any delay or interruption in the supply of preclinical study supplies (or clinical trial supplies in the future)

could delay the completion of such studies, increase the costs associated with the affected development programs and, depending upon

the period of delay, require new studies to be commenced at additional expense or terminated completely.

could delay the completion of such studies, increase the costs associated with the affected development programs and depending upon the

period of delay, require new studies to be commenced at additional expense or terminated completely.

Related to Ownership of our Common Stock

stockholders collectively own a significant percentage of our outstanding common stock, and as a result of such ownership, such stockholders

may influence the election of directors and other matters submitted to stockholders.

to their most recent SEC filings and/or our corporate records, seven stockholders—Charles Cherington, Nicholas Singer, John D.

Halpern, the George Denny Estate, Freebird Partners LP, IAF, LLC and Regolith Capital Investments LP—collectively own approximately

76% of our outstanding shares of common stock.

Although, to our knowledge, such stockholders are not a “group” or “acting

in concert,” they have and we expect them to continue to have, individually and/or collectively, the ability to influence the election

of our board of directors and the outcome of other matters submitted to our stockholders.

The interests of these stockholders may not

always coincide with our interests or the interests of other stockholders, and such stockholders, individually or collectively, may act

in a manner that advances their best interests and not necessarily those of other stockholders.

One consequence to this substantial influence

is that it may be difficult for investors to remove our management and it could also deter unsolicited takeovers, including transactions

in which stockholders might otherwise receive a premium for their shares over then current market prices.

sale of our common stock to Lincoln Park Capital Fund LLC (“Lincoln Park”) may cause dilution to our other stockholders and

the subsequent sale of the shares of common stock acquired by Lincoln Park, or the perception that such sales may occur, could cause

the price of our common stock to fall.

Park committed to purchase up to $10.0 million of our common stock under a standby equity purchase agreement (“SEPA”).

December 31, 2024, we have issued and sold approximately 214,000 shares of our common stock to Lincoln Park for approximately $0.3 million

in gross proceeds under the SEPA, leaving an approximately $9.7 million balance of the $10.0 million total commitment.

The purchase price

for the shares that we may sell to Lincoln Park under the SEPA is subject to a pricing formula in the SEPA and will vary based on the

price of our common stock at the time we initiate the sale.

Depending on market liquidity at the time, sales of such shares may cause

the trading price of our common stock to fall.

generally have the right to control the timing and amount of any future sales of our shares to Lincoln Park under the SEPA.

shares of our common stock to Lincoln Park under the SEPA, if any, will depend upon market conditions and other factors to be determined

We may ultimately decide to sell to Lincoln Park all, some or none of the shares of our common stock that may be available for

us to sell pursuant to the SEPA.

If and when we do sell shares to Lincoln Park, after Lincoln Park has acquired the shares, Lincoln Park

may resell all, some or none of those shares at any time or from time to time in its discretion.

Therefore, sales to Lincoln Park by

us could result in substantial dilution to the interests of other holders of our common stock.

Additionally, the sale of a substantial

number of shares of our common stock to Lincoln Park, or the anticipation of such sales, could make it more difficult for us to sell

equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

may be future sales or other dilution of our equity, which may adversely affect the market price of our common stock.

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common stock or the perception that such sales could occur.

addition, under the terms of the asset purchase agreement pursuant to which we acquired assets from Exacis, we agreed to issue to Exacis

shares of our common stock as contingent consideration.

If our market capitalization equals or exceeds $100 million during the three-year

period commencing on April 26, 2023 and ending on the three-year anniversary thereof, the number of shares of common stock we would issue

is determined by a formula specified in the asset purchase agreement.

In addition, if our market capitalization equals or exceeds $200

million during the same three-year period, we agreed to issue to Exacis additional shares of our common stock determined by a formula

specified in the asset purchase agreement.

See Note 4 to the accompanying consolidated financial statements for additional information.

addition, under the terms of an asset purchase agreement pursuant to which we acquired assets from a company (the “Seller”)

in April 2023, we agreed to issue to the Seller shares of our common stock as contingent consideration.

If our market capitalization

equals or exceeds $100 million during the three-year period commencing on April 26, 2023 and ending on the three-year anniversary thereof,

the number of shares of common stock we would issue is determined by a formula specified in the asset purchase agreement.

if our market capitalization equals or exceeds $200 million during the same three-year period, we agreed to issue to the Seller additional

shares of our common stock determined by a formula specified in the asset purchase agreement.

The contingent consideration period expires

on April 26, 2026.

failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.

common stock is listed on The Nasdaq Capital Market.

The Nasdaq Capital Market requires that listed companies satisfy certain continued

listing requirements.

Listing Rule 550(a)(2) requires that listed companies maintain a minimum bid price of their common stock of

at least $1 per share (the “Bid Price Rule”).

Listing Rule 5550(b) requires that listed companies have:

(1) stockholders’

equity of at least $2.5 million (the “Stockholders’ Equity Rule”;

(2) a market value of listed securities (the “MVLS

Rule”) of at least $35 million;

or (3) net income from continuing operations of $500,000 in the company’s most recently completed

fiscal year or in two of the three most recently completed fiscal years.

December 30, 2024, we received notice from Nasdaq that we no longer met the Bid Price Rule and were provided until June 30, 2025 to regain

compliance with the Bid Price Rule.

On January 6, 2025, we received notice from Nasdaq informing us that we no longer met the MVLS Rule

and were provided until July 7, 2025 to regain compliance with the MLVS Rule.

If at any time during the Bid Price Rule compliance period,

our closing bid price is at least $1 per share for a minimum of 10 consecutive business days during the 180-day compliance period, Nasdaq

will provide written confirmation that we regained compliance with that applicable rule.

In the event we do not regain compliance with

the Bid Price Rule by June 30, 2025, we may be eligible for consideration of a second 180-day compliance period if we meet the MLVS Rule

and all other initial listing standards for Nasdaq’s Capital Market, with the exception of the Bid Price Rule.

In addition, we

would also be required to notify Nasdaq of our intent to cure the Bid Price Rule deficiency by effecting a reverse stock split, if necessary.

If it appears to Nasdaq that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq will provide use

will its notice that our securities will be subject to delisting.

if at any time during the MLVS Rule compliance period our MVLS closes at $35 million or more for a minimum of 10 consecutive business

days, Nasdaq will provide written confirmation that we have regained compliance that applicable rule.

In the event we do not regain compliance

with the Market Value Standard by July 7, 2025, Nasdaq will provide us notice that our securities will be subject to delisting, at which

time, we may appeal the delisting determination.

Additionally,

our stockholders’ equity at December 31, 2024 was approximately $1.9 million and we do not currently meet the net income from continuing

operations compliance standards described in Listing Rule 5500(b)(3).

Accordingly, we also expect to receive a notice from Nasdaq informing

us that we do not meet Listing Rule 5550(b)(1).

If we receive such a notice, we expect to be afforded 45 days to submit a plan to regain

compliance with the stockholders’ equity requirement for Nasdaq’s consideration, and if the plan is accepted, to be granted

an extension period of up to 180 calendar days from the date of the deficiency notice to regain compliance.

If the plan is not accepted

or if we are unable to regain compliance within any extension period granted by Nasdaq, Nasdaq would be required to issue a delisting

determination, which we expect we would be entitled to request a hearing before a Nasdaq Hearings Panel to present a plan to regain compliance

and to request a further extension period to regain compliance.

Nasdaq requires that listed companies satisfy certain continued listing requirements.

Listing Rule 5550(a)(2) requires that listed companies maintain a minimum compliance with the Bid Price Rule.

Listing Rule 5550(b) requires

that listed companies maintain compliance with :

(1) the Stockholders’ Equity Rule;

(2) the MVLS Rule;

or (3) the Net Income Rule.

stockholders’ equity at December 31, 2025 was approximately $2.4 million and we do not currently meet the MVLS or Net Income Rule

However, on February 10, 2026, we completed a public offering for the sale of our common stock and accompanying warrants for net proceeds

of approximately $9.5 million.

As a result, as of the date of this 2025 Annual Report, our stockholders’ equity exceeds $2.5 million,

as required under the Stockholders’ Equity Rule.

February 3, 2026, the closing bid price of our common stock has been trading below $1.00.

Upon the 30 th consecutive business day

of trading below $1.00, we expect to receive a notice from Nasdaq informing us that we do not meet the Bid Price Rule.

To regain compliance, we must maintain a closing bid price of at least $1.00 for a minimum of 10 consecutive business

we effected a reverse stock split within the last 12 months to regain compliance with the Bid Price Rule, Nasdaq rules provide that if our common stock fails to meet the minimum bid price requirement within one year following

that reverse stock split, we would not be eligible for any compliance period under Nasdaq Listing Rule 5810(c)(3)(A).

In such event, Nasdaq

would issue a Staff Delisting Determination with respect to our common stock, which we could appeal to a Nasdaq hearings panel in accordance

with applicable Nasdaq rules.

we fail to satisfy any of the Nasdaq continued listing requirements, Nasdaq may take steps to delist our common stock.

event of a delisting, we can provide no assurance that any action taken by us to restore compliance with Nasdaq continued listing requirements

In the event of

a delisting, we can provide no assurance that any action taken by us to restore compliance with Nasdaq continued listing requirements

would be successful.

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candidates employing medical technology are subject to extensive and rigorous domestic government regulation including regulation by

the FDA, other divisions of the United States Department of Health and Human Services, the United States Department of Justice, state

and local governments, and their respective foreign equivalents.

If products employing our technologies are marketed abroad, they will

also be subject to extensive regulation by foreign governments, whether or not they have obtained FDA approval for one or more uses.

Such foreign regulation may be equally or more demanding than corresponding United States regulation.

the FDA, other divisions of the U.S.

Department of Health and Human Services, the U.S.

Department of Justice, state and local governments,

and their respective foreign equivalents.

If products employing our technologies are marketed abroad, they will also be subject to extensive

regulation by foreign governments, whether or not they have obtained FDA approval for one or more uses.

Such foreign regulation may be

equally or more demanding than corresponding U.S.

regulation substantially increases the cost and risk of researching, developing, manufacturing, and selling medical products.

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healthcare costs.

In both the United States and certain foreign jurisdictions, there have been, and likely will continue to be, legislative

and regulatory proposals at the foreign, federal, and state levels directed at containing or lowering the cost of healthcare.

predict the initiatives that may be adopted in the future.

The continuing efforts of the government, insurance companies, managed care

organizations, and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely

In both the U.S.

and certain foreign jurisdictions, there have been, and likely will continue to be, legislative and

regulatory proposals at the foreign, federal, and state levels directed at containing or lowering the cost of healthcare.

We cannot predict

the initiatives that may be adopted in the future.

The continuing efforts of the government, insurance companies, managed care organizations,

and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

demand for our therapeutic candidates, if we obtain marketing approval;

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availability of capital.

Affordable Care Act of 2010 (“ACA”) includes measures that have significantly changed the way healthcare is financed by both

governmental and private insurers in the United States.

It also included the provisions that created an abbreviated approval pathway

for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product.

The ACA continues

to significantly impact the United States’s pharmaceutical industry.

ACA includes measures that have significantly changed the way healthcare is financed by both governmental and private insurers in the

It also included the provisions that created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable

with an FDA-licensed reference biological product.

The ACA continues to significantly impact the U.S.’s pharmaceutical industry.

there has been heightened governmental scrutiny over the manner in which prescription drug and biological product manufacturers set prices

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into the law the Inflation Reduction Act of 2022 (“IRA”), which includes (among other things) multiple provisions that may

impact the prices of drug products that are both sold into the Medicare program and throughout the United States.

A manufacturer of drug

products covered by Medicare Parts B or D must pay a rebate to the federal government if their drug product’s price increases faster

than the rate of inflation.

The IRA is in the process of being implemented by CMS and its impact on the pharmaceutical industry in the

United States remains uncertain at this time, in part because multiple large pharmaceutical companies and other stakeholders (e.g., the

Chamber of Commerce) have initiated federal lawsuits against CMS arguing a separate price negotiation program is unconstitutional

for a variety of reasons, among other complaints.

impact the prices of drug products that are both sold into the Medicare program and throughout the U.S..

A manufacturer of drug products

covered by Medicare Parts B or D must pay a rebate to the federal government if their drug product’s price increases faster than

the rate of inflation.

The IRA is in the process of being implemented by CMS and its impact on the pharmaceutical industry in the U.S.

remains uncertain at this time, in part because multiple large pharmaceutical companies and other stakeholders (e.g., the U.S.

of Commerce) have initiated federal lawsuits against CMS arguing a separate price negotiation program is unconstitutional for a variety

of reasons, among other complaints.

Those lawsuits are currently ongoing.

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cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action,

either in the United States or abroad.

either in the U.S.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements

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In addition, the

laws of foreign countries may not protect our rights to the same extent as the laws of the United States.

As a result, any patents we

may in-license in the future may not provide us with adequate and continuing patent protection sufficient to exclude others from commercializing

products similar to future products and product candidates that we or our strategic partners or collaborators may develop.

laws of foreign countries may not protect our rights to the same extent as the laws of the U.S.

As a result, any patents we may in-license

in the future may not provide us with adequate and continuing patent protection sufficient to exclude others from commercializing products

similar to future products and product candidates that we or our strategic partners or collaborators may develop.

patent position of biotechnology and pharmaceutical companies generally is highly uncertain.

No consistent policy regarding the breadth

of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United States or in many foreign jurisdictions.

The standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably.

addition, the determination of patent rights with respect to pharmaceutical compounds commonly involves complex legal and factual questions,

which has in recent years been the subject of much litigation.

As a result, the issuance, scope, validity, enforceability and commercial

value of our patent rights are highly uncertain.

of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the U.S.

or in many foreign jurisdictions.

The standards

applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably.

In addition, the

determination of patent rights with respect to pharmaceutical compounds commonly involves complex legal and factual questions, which

has in recent years been the subject of much litigation.

As a result, the issuance, scope, validity, enforceability and commercial value

of our patent rights are highly uncertain.

Our competitors may also seek approval to market their own products similar to or otherwise

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or unenforceable, or that our competitors are competing in a non-infringing manner.

Thus, we cannot offer any assurances about which,

if any, patents will issue, the breadth of any such patents, whether any issued patents will be found invalid and unenforceable or will

be threatened by third parties or whether any issued patents will effectively prevent others from commercializing competing technologies

and drug candidates.

Thus, we cannot offer any assurances regarding which,

if any, patents will issue, the scope of any such issued patents, whether any such patents will be found invalid and unenforceable, whether

they may be challenged by third parties or whether they will effectively prevent others from commercializing competing technologies and

drug candidates.

addition to patent protection, we expect to rely heavily on trade secrets, know-how and other unpatented technology, which are difficult

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sales of our products may suffer, and our ability to generate revenue could be severely impacted.

the licensor of our in-licensed technology does not obtain patent term extension for future products that we or our strategic partners

the licensor of our in-licensed technology does not obtain patent term extension for future products that we, our strategic partners

or collaborators may successfully develop, our business may be materially harmed.

have a limited lifespan.

In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally

20 years from its earliest U.S.

In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years

from its earliest U.S.

non-provisional filing date.

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A patent term extension cannot extend the remaining term of a patent beyond

a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug,

a total of 14 years from the date of product approval.

Only one patent may be extended, and only those claims covering the approved drug,

a method for using it or a method for manufacturing it may be extended.

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expiration, and our revenue could be reduced, possibly materially.

in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability

to protect future products and product candidates that we or our strategic partners or collaborators may develop.

in either the patent laws or the interpretation of the patent laws in the United States or other jurisdictions could increase the uncertainties

in patent law in the U.S.

and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect

future products and product candidates that we or our strategic partners or collaborators may develop.

in either the patent laws or the interpretation of the patent laws in the U.S.

or other jurisdictions could increase the uncertainties

and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents.

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In particular, the

Leahy-Smith Act also included provisions that switched the United States from a “first-to-invent” system to a “first-to-file”

Leahy-Smith Act also included provisions that switched the U.S.

from a “first-to-invent” system to a “first-to-file”

system, allowed third- party submission of prior art to the USPTO during patent prosecution and set forth additional procedures to attack

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The USPTO developed new regulations and procedures governing the administration

of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the

first to file provisions, only became effective on March 16, 2013.

of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, in particular, the first

to file provisions, only became effective on March 16, 2013.

Some of the Company’s patents and patent applications have effective

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prosecuting, maintaining, defending and enforcing patents on products and product candidates in all countries throughout the world would

be prohibitively expensive, and our intellectual property rights in some countries outside the United States could be less extensive

than those in the United States.

be prohibitively expensive, and our intellectual property rights in some countries outside the U.S.

could be less extensive than those

The requirements for patentability may differ in certain countries, particularly in developing countries;

thus, even in countries where we do pursue patent protection, there can be no assurance that any patents will issue with claims that

cover our products.

There can be no assurance that we will obtain or maintain patent rights in or outside the United States under any

future license agreements.

In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent

as federal and state laws in the United States.

Consequently, we may not be able to prevent third parties from utilizing our inventions

in all countries outside the United States, even in jurisdictions where we pursue patent protection, or from selling or importing products

made using our inventions in and into the United States or other jurisdictions.

Competitors may use our technologies in jurisdictions

where we have not pursued and obtained patent protection to develop their own products and, further, may export otherwise infringing

products to territories where we have patent protection, but enforcement is not as strong as that in the United States.

These products

may compete with future products and product candidates that we or our strategic partners or collaborators may develop and our patents

or other intellectual property rights may not be effective or sufficient to prevent them from competing with us.

thus, even in

countries where we do pursue patent protection, there can be no assurance that any patents will issue with claims that cover our products.

There can be no assurance that we will obtain or maintain patent rights in or outside the U.S.

under any future license agreements.

addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws

Consequently, we may not be able to prevent third parties from utilizing our inventions in all countries outside the U.S.,

even in jurisdictions where we pursue patent protection, or from selling or importing products made using our inventions in and into

or other jurisdictions.

Competitors may use our technologies in jurisdictions where we have not pursued and obtained patent

protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection,

but enforcement is not as strong as that in the U.S.

These products may compete with future products and product candidates that we or

our strategic partners or collaborators may develop and our patents or other intellectual property rights may not be effective or sufficient

to prevent them from competing with us.

our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual

property laws.

Additionally, laws of some countries outside of the United States and Europe do not afford intellectual property protection

to the same extent as the laws of the United States and Europe.

Many companies have encountered significant problems in protecting and

defending intellectual property rights in foreign jurisdictions.

The legal systems of certain countries, particularly certain developing

countries including India and China, do not favor the enforcement of patents, trade secrets and other intellectual property protection,

particularly those relating to biotechnology and pharmaceutical products, which could make it difficult for us to stop the infringement

of our in-licensed patents or marketing of competing products in violation of our proprietary rights generally.

For example, many foreign

countries have compulsory licensing laws under which a patent owner must grant licenses to third parties.

Consequently, we may not be

able to prevent third parties from practicing our inventions in certain countries outside the United States and Europe.

many countries limit the enforceability of patents against government authorities or government contractors.

In these countries, the

patent owner may have limited remedies, which could materially diminish the value of such patent.

If we are forced to grant a license

to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial

condition, results of operations, and prospects may be adversely affected.

Additionally, laws of some countries outside of the U.S.

and Europe do not afford intellectual property protection to

the same extent as the laws of the U.S.

Many companies have encountered significant problems in protecting and defending

intellectual property rights in foreign jurisdictions.

The legal systems of certain countries, particularly certain developing countries

including India and China, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly

those relating to biotechnology and pharmaceutical products, which could make it difficult for us to stop the infringement of our in-licensed

patents or marketing of competing products in violation of our proprietary rights generally.

For example, many foreign countries have

compulsory licensing laws under which a patent owner must grant licenses to third parties.

Consequently, we may not be able to prevent

third parties from practicing our inventions in certain countries outside the U.S.

In addition, many countries limit the

enforceability of patents against government authorities or government contractors.

In these countries, the patent owner may have limited

remedies, which could materially diminish the value of such patent.

If we are forced to grant a license to third parties with respect

to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of

operations, and prospects may be adversely affected.

to enforce our patent rights, even if obtained, in foreign jurisdictions could result in substantial costs and divert our efforts and

attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent

applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that

we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful.

While we intend to protect our intellectual

property rights in major markets for our products, we cannot ensure that we will be able to initiate or maintain similar efforts in all

jurisdictions in which we may wish to market our products.

Accordingly, our efforts to enforce our intellectual property rights around

the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop.

attention from other aspects of our business.

They could also put our patents at risk of being invalidated or interpreted narrowly, put

our patent applications at risk of not issuing and provoke third parties to assert claims against us.

We may not prevail in any lawsuits

that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

While we intend to protect our

intellectual property rights in major markets for our products, we cannot ensure that we will be able to initiate or maintain similar

efforts in all jurisdictions in which we may wish to market our products.

Accordingly, our efforts to enforce our intellectual property

rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop.

may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent,

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or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party

patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our drug

candidates in any jurisdiction.

patent and pending application in the U.S.

and abroad that is relevant to or necessary for the commercialization of our drug candidates

in any jurisdiction.

scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution

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pending application will issue with claims of relevant scope.

Our determination of the expiration date of any patent in the United States

or abroad that we consider relevant may be incorrect.

Our failure to identify and correctly interpret relevant patents may negatively

impact our ability to develop and market our products.

Our determination of the expiration date of any patent in the U.S.

that we consider relevant may be incorrect.

Our failure to identify and correctly interpret relevant patents may negatively impact our

ability to develop and market our products.

may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming

105 unchanged sentences

associated with our trademarks and trade names.

any proprietary name we have proposed to use with our drug candidates in the United States must be approved by the FDA, regardless of

whether we have registered it, or applied to register it, as a trademark.

any proprietary name we have proposed to use with our drug candidates in the U.S.

must be approved by the FDA, regardless of whether

we have registered it, or applied to register it, as a trademark.

Similar requirements exist in Europe.

The FDA typically conducts

a review of proposed proprietary product names, including an evaluation of potential for confusion with other product names.

The FDA typically conducts a

review of proposed proprietary product names, including an evaluation of potential for confusion with other product names.

(or an equivalent administrative body in a foreign jurisdiction) objects to any of our proposed proprietary product names, we may be

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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-K

Item 1A. Risk Factors