What changed in this filing

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Item 1A. Risk Factors

2021-11-12 compared with 2021-08-12 · 14 added, 12 removed, 541 unchanged (5% of the section changed)

21 unchanged sentences

The Company has experienced recurring net losses and negative cash flows from operating activities since its inception.

The Company’s net loss for the six months ended June 30, 2021 is $15.9 million.

As of June 30, 2021, the Company had cash and cash equivalents of $101.1 million, working capital of $99.9 million and an accumulated deficit of $96.3 million.

The Company’s net loss for the nine months ended September 30, 2021 is $25.7 million.

As of September 30, 2021, the Company had cash and cash equivalents of $94.0 million, working capital of $91.5 million and an accumulated deficit of $106.1 million.

We have not generated any revenues from product sales, have not completed the development of any product candidate and may never have a product candidate approved for commercialization.

297 unchanged sentences

With respect to the commercialization of all or certain of our product candidates, we may choose to collaborate, either globally or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems.

If we are unable to enter into such arrangements when needed on acceptable terms or at all, we may not be able to successfully commercialize any of our product candidates that receive regulatory approval, or any such commercialization may experience delays or limitations.

If we are unable to enter into such arrangements when needed on acceptable terms or at all, we may not be able to successfully commercialize any of

our product candidates that receive regulatory approval, or any such commercialization may experience delays or limitations.

If we are not successful in commercializing our product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer, and we may incur significant additional losses.

9 unchanged sentences

Multiple companies are working on islet cell and kidney transplant solutions that may ultimately potentially negate the need for immunosuppressive agents in these indications altogether.

If approved, we expect AT-1501 will face competition from other FDA-approved therapeutics for the treatment of LN, FSGS or IgAN, including LUPKYNIS™ and BENLYSTA®, and numerous other branded and generic medicines are already being used “off-label” to treat them.

If approved, we expect AT-1501 will face competition from other FDA-approved therapeutics for the treatment of IgAN, Lupus Nephritis (“LN”) or focal segmental glomerulosclerosis (“FSGS”), including LUPKYNIS™ and BENLYSTA®, and numerous other branded and generic medicines are already being used “off-label” to treat them.

We expect that AT-1501 will face competition from FDA-approved therapeutics for the treatment of ALS including RADICAVA ® , riluzole, and numerous other branded and generic immunosuppressive agents.

45 unchanged sentences

We may need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of our product candidates.

Insurance coverage is increasingly expensive.

coverage is increasingly expensive.

We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

31 unchanged sentences

Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside the United States.

Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.

Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result

in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.

Additionally, macro-economic conditions may adversely affect these third parties, causing them to suffer liquidity or operational problems.

7 unchanged sentences

As a result, our success will depend partially on the success of these third parties in performing their responsibilities.

adequacy and timeliness of the resources and expertise that they apply to these activities.

Although we intend to pre-qualify our CROs and other contractors and we believe that the contractors selected will be fully capable of performing their contractual obligations, we cannot directly control the adequacy and timeliness of the resources and expertise that they apply to these activities.

Additionally, macro-economic conditions may affect our development partners and vendors, which could adversely affect their ability to timely perform their tasks.

15 unchanged sentences

Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.

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

patent rights are highly uncertain.

Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products.

30 unchanged sentences

To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming.

Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents.

Any claims we assert against perceived infringers

could provoke these parties to assert counterclaims against us alleging that we infringe their patents.

In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly, or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.

4 unchanged sentences

A third party may hold intellectual property, including patent rights, that are important or necessary to the development of our products.

It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our products, in which case we would be required to obtain a license from these third parties on commercially reasonable terms,

or our business could be harmed, possibly materially.

If we were not able to obtain a license, or are not able to obtain a license on commercially reasonable terms, our business could be harmed, possibly materially.

64 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.

What changed 10-Q

Item 1A. Risk Factors