Surrozen, Inc./DE

Previous wording

In the third quarter of 2024, we nominated SZN-8141 as a development candidate which combines Frizzled 4, or Fzd4, agonism and Vascular Endothelial Growth Factor, or VEGF, antagonism. SZN-8141 has the potential to provide benefits over treatment with single agents for Diabetic Macular Edema, or DME, and neovascular Age-Related Macular Degeneration, or wet AMD. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in DME in clinical trials. We believe SZN-8141 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth. We expect to file an Investigational New Drug application and commence clinical studies for SZN-8141 in 2026.

Current wording

In the third quarter of 2024, we nominated SZN-8141 as a development candidate which combines Frizzled 4, or Fzd4, agonism and Vascular Endothelial Growth Factor, or VEGF, antagonism. SZN-8141 has the potential to provide benefits over treatment with single agents for Diabetic Macular Edema, or DME, and neovascular Age-Related Macular Degeneration, or wet AMD. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in DME in clinical trials. We believe SZN-8141 has the potential to treat multiple retinal vascular diseases and be differentiated from existing therapies. Data generated in preclinical models of retinal vascular diseases demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth. We expect to file an Investigational New Drug application and commence clinical studies for SZN-8141 in 2026.

Previous wording

In the third quarter of 2024, we nominated SZN-8143 as a development candidate which combines Fzd4 agonism, VEGF antagonism, and interleukin-6, or IL-6, antagonism. SZN-8143 may have benefits over single agents for treatment of DME/wet AMD/uveitic macular edema, or UME. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in these indications in clinical trials for retinal disease. We believe SZN-8143 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.

Current wording

In the third quarter of 2024, we nominated SZN-8143 as a development candidate which combines Fzd4 agonism, VEGF antagonism, and interleukin-6, or IL-6, antagonism. SZN-8143 may have benefits over single agents for treatment of DME/wet AMD/uveitic macular edema, or UME. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in these indications in clinical trials for retinal disease. We believe SZN-8143 has the potential to treat multiple retinal vascular diseases and be differentiated from existing therapies. Data generated in preclinical models of retinal vascular diseases demonstrated that SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.

Previous wording

Since our inception in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, developing and optimizing our Wnt therapeutics platform, identifying potential product candidates, undertaking research and development activities, engaging in strategic transactions, establishing and enhancing our intellectual property portfolio, and providing general and administrative support for these operations. We have incurred operating losses since inception. During the three months ended March 31, 2025 and 2024, we incurred a net loss of $27.0 million and a net loss of $8.8 million, respectively. As of March 31, 2025, we had an accumulated deficit of $312.2 million and cash and cash equivalents of $101.6 million.

Current wording

Since our inception in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, developing and optimizing our Wnt therapeutics platform, identifying potential product candidates, undertaking research and development activities, engaging in strategic transactions, establishing and enhancing our intellectual property portfolio, and providing general and administrative support for these operations. We have incurred operating losses since inception. During the three and six months ended June 30, 2025, we had net income of $39.7 million and $12.8 million, respectively, including noncash gains of $47.6 million and $104.6 million, respectively, on changes in fair value of tranche liability and warrant liabilities during the period. During the three and six months ended June 30, 2024, we incurred net losses of $25.3 million and $34.1 million, respectively. As of June 30, 2025, we had an accumulated deficit of $272.5 million, and cash and cash equivalents of $90.4 million.

Previous wording

During the three months ended March 31, 2025, there were no material changes to our critical accounting policies or in the methodology used for estimates from those described under Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024.

Current wording

During the six months ended June 30, 2025, there were no material changes to our critical accounting policies or in the methodology used for estimates from those described under Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024.

Previous wording

The increase of $1.0 million in research service revenue – related party for three months ended March 31, 2025, compared to three months ended March 31, 2024, is attributable to the research service performed in 2025 in accordance with the Research Collaboration Agreement with TCGFB, Inc.

Current wording

The increase of $1.0 million in research service revenue – related party for the three months ended June 30, 2025, compared to the three months ended June 30, 2024, is attributable to the research service performed in 2025 under our Research Collaboration Agreement with TCGFB, Inc.

Previous wording

The increase of $1.3 million, or 25%, in research and development expenses for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, is primarily due to a $1.2 million increase in manufacturing costs of drug product for SZN-043 in January 2025 and a $0.4 million increase in consulting fees for our ophthalmology programs, offset by a $0.3 million decrease in clinical expenses as a result of the discontinuation of clinical development of SZN-043.

Current wording

The increase of $0.7 million, or 13%, in research and development expenses for the three months ended June 30, 2025, compared to the three months ended June 30, 2024, is primarily due to a $1.4 million increase in manufacturing costs, lab expenses and consulting fees for our ophthalmology programs, offset by a $0.6 million decrease in clinical expenses as a result of the discontinuation of clinical development of SZN-043.

Previous wording

The gain on change in fair value of tranche liability for the three months ended March 31, 2025 was attributable to the non-cash change in fair value of tranche liability during the period.

Current wording

The gain on change in fair value of tranche liability for the three months ended June 30, 2025 was attributable to the noncash change in fair value of tranche liability during the period.

Previous wording

The loss on amendment and cancellation of warrants for the three months ended March 31, 2025 was due to the non-cash change in the fair value of warrant liabilities resulted from the amendment of Series A and Series B common stock warrants and cancellation of Series C and Series D common stock warrants in connection with a private placement which was executed in March 2025, or the 2025 PIPE.

Current wording

Loss on amendment and cancellation of warrants for the six months ended June 30, 2025 was due to the noncash change in the fair value of warrant liabilities resulting from the amendment of Series A and Series B common stock warrants and cancellation of Series C and Series D common stock warrants in connection with the 2025 PIPE.

Previous wording

The loss on execution of the 2025 PIPE for the three months ended March 31, 2025 reflects the loss recognized upon the execution of the 2025 PIPE as the fair value of tranche liability recognized was greater than the committed proceeds from the first tranche.

Current wording

Loss on execution of the 2025 PIPE for the six months ended June 30, 2025 reflects the loss recognized upon the execution of the 2025 PIPE as the fair value of tranche liability recognized was greater than the committed proceeds from the first tranche.

Previous wording

The gain on settlement of tranche liability for the three months ended March 31, 2025 was related to the issuance of common stock, pre-funded warrants and Series E common stock warrants in the first closing of the 2025 PIPE. The difference in the fair value of the tranche liability immediately prior to the settlement and the fair value of the issued units in excess of proceeds resulted in a gain of $1.1 million upon settlement.

Current wording

The gain on settlement of tranche liability for the six months ended June 30, 2025 was related to the issuance of common stock, pre-funded warrants and Series E common stock warrants in the first closing of the 2025 PIPE. The difference in the fair value of the tranche liability immediately prior to the settlement and the fair value of the issued units in excess of proceeds resulted in a gain of $1.1 million upon settlement.

Previous wording

The increase of $38.1 million in other income (expense), net for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, is primarily attributable to a $40.7 million non-cash change in fair value of warrant liabilities, offset by the transaction costs of $2.7 million allocated to the warrant liabilities in March 2025. Due to the discontinuation of clinical development of SZN-043 in the first quarter of 2025, the fair value of the Series C and Series D common stock warrant liabilities became zero as these warrants would not be exercisable.

Current wording

The increase of $50.6 million in other income, net for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, is primarily attributable to a $51.7 million noncash change in fair value of warrant liabilities, offset by a $1.2 million increase in the financing transaction costs. Due to the discontinuation of clinical development of SZN-043 in the first quarter of 2025, the fair value of the Series C and Series D common stock warrant liabilities became zero as these warrants would not be exercisable.

Previous wording

Since inception, we have only generated revenue from licensing and research collaborations. We incurred significant operating losses and negative cash flows from operations. Historically, we have financed our operations primarily through the sales of our equity securities and the payments received under our collaboration and license agreements. We anticipate that we will continue to incur net losses for the foreseeable future because of additional costs and expenses related to our research and development activities, including increased expenses from pipeline advancement and advancement of our product candidates into and through clinical developments and associated regulatory submissions, as well as increased general and administrative expenses as we scale our organization as a public company.

Current wording

Since inception, we have only generated revenue from licensing and research collaborations. We incurred significant operating losses and negative cash flows from operations. Historically, we have financed our operations primarily through the sales of our equity securities and the payments received under our collaboration and license agreements. We anticipate that we will continue to incur net operating losses for the foreseeable future because of additional costs and expenses related to our research and development activities, including increased expenses from pipeline advancement and advancement of our product candidates into and through clinical developments and associated regulatory submissions, as well as increased general and administrative expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with the rules and regulations of the SEC and Nasdaq.

Previous wording

In March 2025, we entered into a securities purchase agreement with certain investors to issue and sell an aggregate of 15,086,236 units in a two-tranche private placement (the 2025 PIPE) at a purchase price of $11.60 per share and $11.5999 per pre-funded warrant, for gross proceeds of approximately $175.0 million to fund multiple ophthalmology programs through initial Phase 1 safety, tolerability and efficacy studies. Each unit consists of one share of common stock, or pre-funded warrant in lieu thereof, and an accompanying one half of a warrant to purchase common stock, or Series E common stock warrant. At the closing of the first tranche of the 2025 PIPE on March 26, 2025, (i) 5,213,415 shares of common stock, (ii) pre-funded warrants to purchase up to 1,373,000 shares of common stock, and (iii) Series E common stock warrants to purchase up to 3,293,207 shares of common stock were issued and sold for aggregate net proceeds of approximately $71.3 million, after deducting placement agent fees and other expenses. None of the warrants issued in the 2025 PIPE have been exercised as of the filing of this Quarterly Report. In the second tranche of the 2025 PIPE, which is contingent upon the public announcement of the receipt of clearance from the U.S. Food and Drug Administration on or prior to October 31, 2026 of our Investigation New Drug Application for SZN-8141, or the Second Closing Milestone, we expect to issue a (i) 6,043,321 shares of common stock, (ii) pre-funded warrants to purchase up to 2,456,500 shares of common stock, and (iii) Series E common stock warrants to purchase up to 4,249,910 shares of common stock; provided that the second tranche may not occur prior to September 27, 2026. If we terminate our SZN-8141 program prior to October 31, 2026, then we will provide written notice to each purchaser, referred to as the Termination Notice, and each purchaser will have the right, but not the obligation, for 30 calendar days following the receipt of such notice, upon written notice to us, to purchase the additional shares of common stock, pre-funded warrants, and Series E common stock warrants subscribed for by such purchaser in the second closing. In addition, at any time prior to October 31, 2026 or the date of the Termination Notice (if earlier), in lieu of the requirement to purchase units in the second closing, each purchaser has the right, but not the obligation, upon five trading days’ prior written notice to us to purchase all (but not a portion) of the units subscribed for by such purchaser in the second closing, which we refer to as an Optional Closing. If a purchaser fails to purchase in full its subscribed for units after the achievement of the Second Closing Milestone in the second closing, or previously at the first closing or an Optional Closing, then the Series E common stock warrants issued to such purchaser shall automatically be cancelled and cease to be exercisable. Please see Note 8 to the unaudited condensed consolida…

Excerpt shortened here; the source contains the full paragraph.

Current wording

In March 2025, we entered into a securities purchase agreement with certain investors to issue and sell an aggregate of 15,086,236 units in a two-tranche private placement (the 2025 PIPE) at a purchase price of $11.60 per share and $11.5999 per pre-funded warrant, for gross proceeds of approximately $175.0 million to fund multiple ophthalmology programs through initial Phase 1 safety, tolerability and efficacy studies. Each unit consists of one share of common stock, or pre-funded warrant in lieu thereof, and an accompanying one half of a warrant to purchase common stock, or Series E common stock warrant. At the closing of the first tranche of the 2025 PIPE on March 26, 2025, (i) 5,213,415 shares of common stock, (ii) pre-funded warrants to purchase up to 1,373,000 shares of common stock, and (iii) Series E common stock warrants to purchase up to 3,293,207 shares of common stock were issued and sold for aggregate net proceeds of approximately $71.2 million, after deducting placement agent fees and other expenses. 68,000 of the warrants issued in the 2025 PIPE have been exercised as of the filing of this Quarterly Report. In the second tranche of the 2025 PIPE, which is contingent upon the public announcement of the receipt of clearance from the U.S. Food and Drug Administration on or prior to October 31, 2026 of our Investigation New Drug Application for SZN-8141, or the Second Closing Milestone, we expect to issue a (i) 6,043,321 shares of common stock, (ii) pre-funded warrants to purchase up to 2,456,500 shares of common stock, and (iii) Series E common stock warrants to purchase up to 4,249,910 shares of common stock; provided that the second tranche may not occur prior to September 27, 2026. If we terminate our SZN-8141 program prior to October 31, 2026, then we will provide written notice to each purchaser, referred to as the Termination Notice, and each purchaser will have the right, but not the obligation, for 30 calendar days following the receipt of such notice, upon written notice to us, to purchase the additional shares of common stock, pre-funded warrants, and Series E common stock warrants subscribed for by such purchaser in the second closing. In addition, at any time prior to October 31, 2026 or the date of the Termination Notice (if earlier), in lieu of the requirement to purchase units in the second closing, each purchaser has the right, but not the obligation, upon five trading days’ prior written notice to us to purchase all (but not a portion) of the units subscribed for by such purchaser in the second closing, which we refer to as an Optional Closing. If a purchaser fails to purchase in full its subscribed for units after the achievement of the Second Closing Milestone in the second closing, or previously at the first closing or an Optional Closing, then the Series E common stock warrants issued to such purchaser shall automatically be cancelled and cease to be exercisable. Please see Note 8 to the unaudited condensed consoli…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

As of March 31, 2025, we had cash and cash equivalents of $101.6 million and accumulated deficit of $312.2 million. We believe, based on our current operating plan, that our existing cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months from the filing date of this Quarterly Report. The Food and Drug Administration clearance of SZN-8141’s IND application would trigger funding of the $98.6 million private placement tranche (2025 PIPE) which is expected to fund operations through efficacy, safety and tolerability studies for SZN-8141 and SZN-8143. We expect that in the long-term we will need to raise additional capital through public or private equity offerings, debt financings or other capital sources, including government grants, potential collaborations with other companies or other strategic transactions until we are able to generate revenue on our own. Our ability to continue as a going concern in the long-term is dependent upon our ability to successfully secure sources of financing and ultimately achieve profitable operations. There can be no assurance that sufficient funds will be available to us at all or on attractive terms when needed from these sources. If we are unable to obtain additional funding from these or other sources when needed, we may be necessary to significantly reduce expenses through reductions in staff and delaying, scaling back operations, or stopping certain research and development programs.

Current wording

As of June 30, 2025, we had cash and cash equivalents of $90.4 million and accumulated deficit of $272.5 million. We believe, based on our current operating plan, that our existing cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months from the filing date of this Quarterly Report. The Food and Drug Administration clearance of SZN-8141’s IND application would trigger funding of the $98.6 million private placement tranche (2025 PIPE), which is expected to fund operations through efficacy, safety and tolerability studies for SZN-8141 and SZN-8143. We expect that in the long-term we will need to raise additional capital through public or private equity offerings, debt financings or other capital sources, including government grants, potential collaborations with other companies or other strategic transactions until we are able to generate revenue on our own. Our ability to continue as a going concern in the long-term is dependent upon our ability to successfully secure sources of financing and ultimately achieve profitable operations. There can be no assurance that sufficient funds will be available to us at all or on attractive terms when needed from these sources. If we are unable to obtain additional funding from these or other sources when needed, we may be necessary to significantly reduce expenses through reductions in staff and delaying, scaling back operations, or stopping certain research and development programs.

Previous wording

Cash used in operating activities of $9.3 million for the three months ended March 31, 2025 was primarily due to the use of funds in our operations, and the resulting a net loss of $27.0 million and a net change of $1.4 million in our net operating assets and liabilities, offset by $19.1 million in non-cash charges. Cash used in operating activities of $8.7 million for the three months ended March 31, 2024 was primarily due to the use of funds in our operations, and the resulting net loss of $8.8 million and a net change of $1.8 million in our net operating assets and liabilities, offset by $1.9 million in non-cash charges.

Current wording

Cash used in operating activities of $15.4 million for the six months ended June 30, 2025 was primarily due to the use of funds in our operations, and the resulting a net income of $12.8 million, offset by a net change of $0.8 million in our net operating assets and liabilities and $27.4 million in noncash charges. Cash used in operating activities of $14.4 million for the six months ended June 30, 2024 was primarily due to the use of funds in our operations, the resulting net loss of $34.1 million and a net change of $0.9 million in our net operating assets and liabilities, offset by $20.6 million in noncash charges.

Previous wording

Cash used in investing activities for the three months ended March 31, 2025 and 2024 was related to the purchases of lab equipment.

Current wording

Cash used in investing activities for the six months ended June 30, 2025 and 2024 was related to the purchases of lab equipment.

Previous wording

Cash provided by financing activities of $76.4 million for the three months ended March 31, 2025 was the proceeds from the issuance and sale of common stock, pre-funded warrants and warrants in the 2025 PIPE. There were no financing activities for the three months ended March 31, 2024.

Current wording

Cash provided by financing activities of $71.3 million for the six months ended June 30, 2025 was primarily the proceeds from the issuance and sale of common stock, pre-funded warrants and warrants in the 2025 PIPE. Cash provided by financing activities of $16.1 million for the six months ended June 30, 2024 was primarily related to the issuance and sale of common stock, pre-funded warrants and warrants to investors and certain members of management in the 2024 PIPE.

Previous wording

In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, if, as an EGC, we intend to rely on such exemptions, we are not required to, among other things: (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act; (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act; (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board; and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation.

Current wording

(i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act; (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act; (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board; and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation.