SPRB 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• We believe that based on our current operating plan, our cash and cash equivalents of $96.3 million as of June 30, 2026 and the proceeds from the August 2026 private placement will be sufficient to fund our planned operations and debt obligations for at least 12 months following the issuance date of…

• advance TA-ERT through our planned TrAnsform confirmatory study in patients with MPS IIIB and expanded access programs, both of which are expected to initiate in the fourth quarter of 2026 and are expected to enroll approximately 14 and 10 participants, respectively;

• On January 7, 2026 (the “Avenue Closing Date”), we entered into a Loan and Security Agreement (the “Avenue Loan and Security Agreement”) and a Supplement to the Loan and Security Agreement (together with the Avenue Loan and Security Agreement, the “Avenue Loan Agreement”), with Avenue Capital Manage…

• The Avenue Loan Agreement makes available to us term loans in an aggregate principal amount of up to $50.0 million with (i) $15.0 million funded within 5 business days after the Avenue Closing Date (“Tranche 1”), (ii) up to $10.0 million to be made available to us between March 1, 2026 and September…

• Research and development expenses increased by $9.3 million during the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase in clinical development expenses of $0.8 million was primarily related to increased expenses for TA-ERT of $9.6 million, offset by lower …

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• We believe that based on our current operating plan, our cash and cash equivalents of $54.1 million as of March 31, 2026 and

• the net proceeds from our April 2026 underwritten public offering of common stock and pre-funded warrants will be sufficient to fund our planned operations and debt obligations for at least 12 months following the issuance date of these financial statements included elsewhere in this Quarterly Repor…

• advance TA-ERT through a planned confirmatory study in patients with MPS IIIB and expanded access programs;

• advance pre-clinical and clinical development of SPR202 in congenital adrenal hyperplasia (“CAH”);

• On January 7, 2026 (the “Avenue Closing Date”), we entered into a Loan and Security Agreement (the “Avenue Loan and Security Agreement”) and a Supplement to the Loan and Security Agreement (together with the Avenue Loan and Security

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• trade developments have and may continue to heighten the risks related to the other risk factors described elsewhere in this Quarterly Report.

• In addition, certain foreign activities related to drugs, biologics, and research, especially with regard to China, have come under increased scrutiny in the United States. Chinese contract manufacturing organizations may become subject to legislation, trade restrictions, sanctions, tariffs and othe…

• entered into before the applicable effective date. Under the NDAA BIOSECURE Act related language we may be restricted in our ability to work with certain Chinese biotechnology manufacturing companies to the extent we would contract with, or otherwise receive funding from, the U.S. government. In add…

• We may form or seek strategic alliances, create joint ventures or collaborations or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product c…

• business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. If we license products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate …

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• In addition, certain foreign activities related to drugs, biologics, and research, especially with regard to China, have come under increased scrutiny in the United States. Chinese contract manufacturing organizations may become subject to legislation, trade restrictions, sanctions, tariffs and othe…

• Moreover, in order to obtain reimbursement for our products in some European countries, including some EU Member States, we may be required to compile additional data comparing the cost-effectiveness of our products to other available therapies. The

• We may form or seek strategic alliances, create joint ventures or collaborations or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product c…

• operational, financial, sales, marketing, and other personnel. Future growth would impose significant added responsibilities on members of management, including:

• In order to service this indebtedness and any additional indebtedness we may incur in the future, we need to generate cash from our operating activities. Our ability to generate cash is subject, in part, to our ability to successfully execute our business strategy, as well as general economic, finan…

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• On August 7, 2026, we entered into a Stock Purchase Agreement (the “Purchase Agreement”) with the National MPS Society and the Cure Sanfilippo Foundation (the “Purchasers”), pursuant to which we agreed to sell and issue to the Purchasers 121,203 shares of the Company’s common stock in a private plac…

• The Purchase Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the Purchase Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the Purchase Agreemen…

• The foregoing is only a summary of the terms of the Purchase Agreement and does not purport to be complete and is qualified in its entirety by reference to the full text of the form of Purchase Agreement, a copy of which is attached to this report as Exhibit 10.5.

• The securities described above have not been registered under the Securities Act. We relied on the exemption from the registration requirements of the Securities Act by virtue of Rule 506 of Regulation D thereunder. Each of the Purchasers has represented that it is an “accredited investor” as define…

• During the three months ended June 30, 2026, no director or Section 16 officer of the Company adopted, modified or terminated any "Rule 10b5-1 trading arrangement" or any "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K.

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• During the three months ended March 31, 2026, no director or Section 16 officer of the Company adopted, modified or terminated any "Rule 10b5-1 trading arrangement" or any "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K.