Larimar Therapeutics Inc
For the period ended Sep 30, 2024. Filed Oct 30, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Oct 30, 2024
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0000950170-24-093733
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-10-30.
0000950170-24-119100
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 10 previous paragraphs and 8 current paragraphs.
7 unchanged; 1 reworded; 0 added; 2 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
The current filing states there were no material changes to risk factors.
This is the filer’s own statement, not a conclusion from the comparison. Read its qualifications and the report it references.
Current filing’s statement
You should carefully consider the risk factors described in our 2023 Annual Report under the caption “Item 1A. Risk Factors.” The risks described in our 2023 Annual Report are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results. There have been no material changes in our risk factors disclosed in our 2023 Annual Report and Quarterly Reports on Form 10-Q filed on May 9, 2024 and August 8, 2024.
Removed paragraphs (2)
Previous report
We have been selected for participation in the START Pilot Program, however this may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that we will receive marketing approval.
Previous report
In May 2024, we announced that the FDA’s CDER had selected nomlabofusp as one of a few programs for participation in the START Pilot Program. The objective of the START Pilot Program is to accelerate the development of drugs for rare diseases that lead to significant disability or death by facilitating frequent advice and regular communication with the FDA staff to expedite the review process for biologics and drugs. As a pilot program, this expanded communication process will test if reducing wait times associated with the formal FDA meeting process accelerates the pace of development for products intended to address unmet medical needs. Because the START Pilot Program is newly launched by the FDA, its potential advantages are uncertain. While we anticipate that participation in this START Pilot Program may assist us in completing our BLA submission and approval timelines, there can be no assurance that the START Pilot Program will accelerate our development timelines or likelihood of approval for nomlabofusp. In addition, the FDA could withdraw our selection for participation in the START Pilot Program at any time.
Reworded paragraphs (1)
Previous wording
You should carefully consider the risk factors described in our 2023 Annual Report under the caption “Item 1A. Risk Factors.” The risks described in our 2023 Annual Report are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.
Current wording
You should carefully consider the risk factors described in our 2023 Annual Report under the caption “Item 1A. Risk Factors.” The risks described in our 2023 Annual Report are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results. There have been no material changes in our risk factors disclosed in our 2023 Annual Report and Quarterly Reports on Form 10-Q filed on May 9, 2024 and August 8, 2024.