US Market News
1週前
COLLPLANT BIOTECHNOLOGIES REPORTS 2026 FIRST QUARTER FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATEMay 29, 2026 7:00 AM
PR Newswire (US) REHOVOT, Israel, May 29, 2026 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and medical aesthetics company developing innovative technologies and products based on its non-animal-derived recombinant human collagen (rhCollagen) for tissue regeneration and medical aesthetics applications, today announced financial results for the first quarter of 2026 and provided a corporate update. "In the first quarter of 2026, we initiated discussions with several leading strategic players to explore potential collaborations, primarily in the medical aesthetics field," said Yehiel Tal, Chairperson and Chief Executive Officer of CollPlant Biotechnologies. "These discussions are focused on the potential joint development and commercialization of next-generation dermal filler product candidates incorporating CollPlant's rhCollagen technology in combination with hyaluronic acid and additional components. We are actively advancing these discussions and, while no assurance can be provided, remain encouraged by the level of interest and the progress achieved to date."Mr. Tal continued: "CollPlant is also advancing development of its next-generation photocurable dermal filler platform based on rhCollagen technology, designed to provide immediate structural support together with the potential for long-term tissue regeneration. The product candidate, currently in the final preclinical stage, is intended to address age-related volume loss and facial changes associated with significant weight reduction. During the quarter, the Korean Patent Office granted CollPlant a patent covering key aspects of the photocurable dermal filler technology, further strengthening our intellectual property portfolio in regenerative aesthetics.""The Company is planning to establish a broader portfolio of regenerative dermal and soft tissue fillers and is targeting initiation of clinical studies within the next two years. In parallel, we are actively engaging with potential strategic partners to support the next phase of development and future commercialization activities.""With respect to our 3D bioprinting activities, during the first quarter we launched BioFlex, a ready-to-print rhCollagen-based kit optimized for high-resolution DLP bioprinting applications. BioFlex is designed to support advanced tissue modeling, drug discovery, and regenerative medicine research applications."Mr. Tal concluded: "The medical aesthetics market continues to seek safe and innovative solutions capable of delivering improved clinical outcomes and enhanced patient experience. We believe CollPlant's non-animal rhCollagen technology is uniquely positioned to address this need through regenerative approaches aimed at tissue rejuvenation and restoration. The strong interest we are receiving from potential partners further supports our confidence in the value and differentiation of our platform."Eran Rotem, Deputy CEO and Chief Financial Officer, added: "In parallel with our ongoing operational and development activities, we have initiated a process to evaluate strategic alternatives aimed at maximizing shareholder value. This process includes assessment of a broad range of opportunities, including potential acquisitions, strategic transactions, and other business combination opportunities".CollPlant has not established a definitive timetable for this process, nor has it made any decisions regarding a specific strategic transaction at this time. The Company does not intend to provide further updates unless a disclosure is required by law or deemed necessary. First Quarter 2026 Financial ResultsGAAP revenues for the first quarter ended March 31, 2026, were $73,000, compared to $2.1 million for the first quarter ending March 31, 2025. This decrease was primarily due to a $2.0 million development milestone payment from a former business collaborator, which was recognized as revenue in Q1 2025 and did not recur in the current period.GAAP cost of revenues for the first quarter ended March 31, 2026, was $316,000, compared to $188,000 for the first quarter ended March 31, 2025. This $128,000 increase was primarily driven by approximately $183,000 in fixed production facility costs expensed directly to cost of revenues, rather than capitalized into inventory, due to underutilized capacity during the period. This increase was partially offset by a $59,000 decrease in royalty expenses.GAAP gross loss for the first quarter ending March 31, 2026, was $243,000, compared to a gross profit of $1.9 million for the first quarter ending March 31, 2025.GAAP operating expenses for the first quarter ending March 31, 2026, were $2.9 million, compared to $3.5 million, for the first quarter ending March 31, 2025. The decrease of approximately $643,000 is mainly related to the Company's cost reduction plan with: (i) a $217,000 decrease in the workforce expenses, (ii) a $257,000 decrease in research and development subcontractors expenses and materials expenses, and (iii) a $105,000 reduction in general and administrative public company expenses. On a non-GAAP basis, the operating expenses for the first quarter ending March 31, 2026, were $2.7 million, compared to $3.1 million for the first quarter ending March 31, 2025. Non-GAAP measures exclude certain non-cash expenses.GAAP financial income, net, for the first quarter ending March 31, 2026, totaled $18,000, compared to $196,000 for the first quarter ending March 31, 2025. The decrease in financial income, net, is due to a decrease in interest received and exchange rate differences.GAAP net loss for the first quarter ending March 31, 2026, was $3.1 million, or $0.23 basic loss per share, compared to a net loss of $1.5 million, or $0.13 basic loss per share, for the first quarter ending March 31, 2025. Non-GAAP net loss for the first quarter ending March 31, 2026, was $2.9 million, or $0.21 basic loss per share, compared to $1.1 million loss, or $0.1 basic loss per share, for the first quarter ending March 31, 2025. Balance Sheet and Cash FlowThe Company's cash and cash equivalents balance as of March 31, 2026, was $4.3 million.Net cash used in operating activities was $3.0 million during the first quarter ended March 31, 2026, compared to $1.2 million for the first quarter ended March 31, 2025. Cash used during the first quarter ended March 31, 2026, increased compared to the same quarter last year, primarily due to a development milestone achievement in Q1 2025 that triggered a $2.0 million revenue payment from a former business collaborator. In addition, we have undertaken targeted cost-cutting measures, including a reduction in headcount by approximately 50%, to streamline our operations and enhance financial discipline.Net cash used in investing activities was $6,000 during the first quarter ending March 31, 2026, compared to $8,000 for the first quarter ending March 31, 2025.Net cash provided by financing activities was $1.7 million for the first quarter ending March 31, 2026. There was no cash flow from financing activities during the first quarter ending March 31, 2025. The increase is attributed to our registered direct offering in February 2026, which resulted in net proceeds of $1.7 million.
COLLPLANT BIOTECHNOLOGIES LTD.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands)
March 31,
2026
December 31,2025
Unaudited
Assets
Current assets:
Cash and cash equivalents
$4,262
$5,591
Restricted deposit
365
359
Trade receivables, net
8
1
Inventories
679
573
Other accounts receivable and prepaid expenses
225
223
Total current assets
5,539
6,747
Non-current assets:
Restricted deposit
77
76
Operating lease right-of-use assets
2,235
2,426
Property and equipment, net
1,273
1,463
Intangible assets, net
59
73
Total non-current assets
3,644
4,038
Total assets
$9,183
$10,785
COLLPLANT BIOTECHNOLOGIES LTD.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands, except share data)
March 31,
2026
December 31,2025
Unaudited
Liabilities and shareholders' equity
Current liabilities:
Trade payables
$635
$610
Operating lease liabilities
794
814
Accrued liabilities and other payables
1,013
1,248
Total current liabilities
2,442
2,672
Non-current liabilities:
Operating lease liabilities
1,855
2,032
Total non-current liabilities
1,855
2,032
Total liabilities
4,297
4,704
Commitments and contingencies
Shareholders' Equity:
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares as of
March 31, 2026 (unaudited) and December 31, 2025; issued and outstanding:
14,423,253 and 12,803,006 ordinary shares as of March 31, 2026 (unaudited) and
December 31, 2025, respectively
6,265
5,492
Additional paid in capital
127,526
126,397
Accumulated other comprehensive loss
(969)
(969)
Accumulated deficit
(127,936)
(124,839)
Total shareholders' equity
4,886
6,081
Total liabilities and shareholders' equity
$9,183
$10,785
COLLPLANT BIOTECHNOLOGIES LTD.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except share and per share data)(Unaudited)
Three months endedMarch 30
2026
2025
Revenues
$73
$2,055
Cost of revenues
316
188
Gross profit (loss)
(243)
1,867
Operating expenses:
Research and development
1,678
2,105
General, administrative and marketing
1,194
1,410
Total operating loss
(3,115)
(1,648)
Financial income, net
18
196
Net loss
$(3,097)
$(1,452)
Basic and diluted net loss per ordinary share
$(0.23)
$(0.13)
Weighted average number of ordinary shares used in computation of basic and
diluted net loss per share
13,747,204
11,454,512
COLLPLANT BIOTECHNOLOGIES LTD.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(U.S. dollars in thousands)(Unaudited)
Three months ended
March 31,
2026
2025
Cash flows from operating activities:
Net loss
$(3,097)
$(1,452)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
210
244
Share-based compensation to employees and consultants
180
382
Exchange differences on cash and cash equivalents and restricted cash
(10)
6
Accrued interest
(4)
(3)
Changes in assets and liabilities:
Decrease (increase) in trade receivables
(7)
150
Increase in inventories
(103)
(231)
Increase in other accounts receivables and prepaid expenses
(2)
(7)
Decrease in operating lease right-of-use assets
177
165
Increase (decrease) in trade payables
25
(100)
Decrease in operating lease liabilities
(183)
(225)
Decrease in accrued liabilities and other payables
(235)
(96)
Net cash used in operating activities
(3,049)
(1,167)
Cash flows from investing activities:
Purchase of property and equipment
(6)
(9)
Proceeds from sale of property and equipment
-
1
Net cash used in investing activities
(6)
(8)
Cash flows from financing activities:
Proceeds from issuance of shares and warrants less issuance expenses
1,719
-
Net cash provided by financing activities
1,719
-
Effect of exchange rate changes on cash and cash equivalents
7
1
Net decrease in cash and cash equivalents
(1,329)
(1,174)
Cash and cash equivalents at the beginning of the period
5,591
11,909
Cash and cash equivalents at the end of the period
$4,262
$10,735
COLLPLANT BIOTECHNOLOGIES LTD.APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(U.S. dollars in thousands)(Unaudited)
Three months ended
March 31,
2026
2025
Supplemental discloser of non-cash activities:
Right-of-use assets recognized with corresponding lease liabilities
$(14)
$(13)
Capitalization of share-based compensation to inventory
$3
$2
COLLPLANT BIOTECHNOLOGIES LTD.RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES(U.S. dollars in thousands, except per share data)(Unaudited)
Three months ended
March 31,
2026
2025
GAAP operating expenses:
$2,872
$3,515
Change of operating lease accounts
24
4
Share-based compensation to employees, directors and consultants
(180)
(382)
Non-GAAP operating expenses:
2,716
3,137
GAAP operating loss
(3,115)
(1,648)
Change of operating lease accounts
(24)
(4)
Share-based compensation to employees, directors and consultants
180
382
Non-GAAP operating loss
(2,959)
(1,270)
GAAP Net loss
(3,097)
(1,452)
Change of operating lease accounts
(6)
(60)
Share-based compensation to employees, directors and consultants
180
382
Non-GAAP Net loss
$(2,923)
$(1,130)
GAAP basic and diluted loss per ordinary share
$(0.23)
$(0.13)
NON- GAAP basic and diluted loss per ordinary share
$(0.21)
$(0.10)
Use of Non-US GAAP ("non-GAAP")Financial results for 2026 and 2025 are presented on both a GAAP and a non-GAAP basis. GAAP results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The release contains certain non-GAAP financial measures for operating costs and expenses, operating income (or loss), net income (or loss) and basic and diluted net income (or loss) per share that exclude the effects of non-cash expense for share-based compensation to employees, directors and consultants, and change in operating lease accounts. CollPlant's management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company's performance that enhances management's and investors' ability to evaluate the Company's operating costs, net income (or loss) and income (or loss) per share, and to compare them to historical Company results.The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company's business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" in this release. This accompanying table has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.The Company's consolidated financial statements for the first quarter ended March 31, 2026, are presented in accordance with generally accepted accounting principles in the U.S.About CollPlantCollPlant is a regenerative and aesthetic medicine company ushering in a new era of medical solutions with a focus on 3D bioprinting of tissues and organs, tissue repair and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant-based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing.For more information about CollPlant, visit http://www.collplant.com. Forward-Looking Statements This press release includes forward-looking statements. Forward-looking statements include, but are not limited to, statements relating to CollPlant's objectives plans and strategies, including its evaluation of strategic alternatives, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate.Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all, including uncertainties surrounding the methods of fundraising and the Company's preferences regarding such methods, and including its ability to conclude a non-dilutive financing transaction; uncertainties regarding the Company's evaluation of strategic alternatives, including whether or when any acquisition, strategic transaction, business combination or other opportunity may be pursued or consummated, the terms of any such transaction, and the potential impact of any such transaction or other strategic alternative on the Company, its business, financial condition, results of operations and shareholders; the Company's expectations regarding the costs and timing of commencing and/or concluding pre-clinical and clinical trials with respect to dermal and tissue fillers, breast implants, tissues and organs which are based on its rhCollagen based BioInk and other products for medical aesthetics; the Company's or Company's strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen-based bioink and medical aesthetics products or product candidates including, but not limited to, acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D Bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the Company's reliance on third parties to conduct some or all aspects of its product development and manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates, including, with respect to the ongoing war in Israel, projected capital expenditures and liquidity, changes in the Company's strategy and development plans and projects, and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant are contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.ContactsCollPlant:Eran Rotem
Deputy CEO & CFO
+ 972-73-2325600
Eran@collplant.comPhoto - https://mma.prnewswire.com/media/2990248/CollPlant.jpg
Logo - https://mma.prnewswire.com/media/2217353/CollPlant_Logo.jpg View original content to download multimedia:https://www.prnewswire.com/news-releases/collplant-biotechnologies-reports-2026-first-quarter-financial-results-and-provides-corporate-update-302785500.htmlSOURCE CollPlant Original: COLLPLANT BIOTECHNOLOGIES REPORTS 2026 FIRST QUARTER FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
US Market News
2月前
CollPlant Issues Letter to ShareholdersApril 13, 2026 7:00 AM
PR Newswire (US)
REHOVOT, Israel, April 13, 2026 /PRNewswire/ -- CollPlant (NASDAQ: CLGN), a regenerative and aesthetic medicine company developing innovative technologies and products based on its proprietary plant-derived recombinant human collagen (rhCollagen), is pleased to issue the following letter from its Chief Executive Officer, Yehiel Tal.
Dear Shareholders,This morning, we announced the termination of our development agreement with AbbVie. While this represents the close of an important chapter, we see it as the beginning of an even more promising journey. I'd like to share our vision for what lies ahead for CollPlant in 2026.CollaborationsAs noted, Allergan Industrie SAS, an AbbVie company, notified us that it was exercising its right to terminate the development agreement, previously entered into in February 2021, upon 60 days' advance notice. During the prior five years, AbbVie was developing a dermal and soft tissue filler product for commercialization in the medical aesthetics market, using the Company's rhCollagen technology. We view this development as an opportunity, and we are moving forward with confidence.Interest in CollPlant's collagen technology remains strong and we are actively pursuing entering into agreements with new partners, across all types of aesthetic products, including for dermal and soft tissue filler products. The market opportunity before us is significant, and we intend to capture it.Over the past few months, we have engaged with several leading strategic partners and Tier 1 corporations to explore potential joint development opportunities, primarily in the aesthetics sector. These collaborations focus on dermal filler products incorporating CollPlant's technology, hyaluronic acid, and other key components. While these discussions naturally take time, we are actively working to accelerate the process and, while there is no guarantee, are optimistic about reaching a definitive agreement in the coming months.To ensure we are well positioned for the road ahead, we have updated our expense forecast and are implementing a cost-reduction and workforce optimization plan. As part of this initiative, we are in the process of reducing our workforce by approximately 50%. We are confident these measures will sharpen our focus and believe this will extend our cash runway into Q4 2026, positioning us to achieve our next key milestones from a position of strength.As we move forward, we are building on a strong foundation, with three core programs - regenerative dermal and soft tissue fillers, regenerative breast implants, and rhCollagen bioinks for 3D bioprinting of tissues and organs - that we believe have the potential to drive meaningful growth and value creation in the years ahead.Regenerative Dermal and Soft Tissue FillersCollPlant's photocurable dermal filler technology represents a significant leap forward from traditional fillers that provide passive volumization. Designed to deliver immediate structural restoration, it uses light activation to form a stable, crosslinked scaffold in situ, supporting tissue integration and potentially enhancing skin quality and elasticity over time. The clinical potential of this technology is compelling, with meaningful benefits for patients experiencing facial fat atrophy, midface deflation, loss of jawline definition, or skin laxity.Currently in preclinical development, this technology sits at the heart of CollPlant's strategy to define the next-generation of regenerative aesthetic solutions based on rhCollagen, targeting age-related volume loss, skin regeneration, structural soft tissue restoration, and weight-loss-associated facial changes.We are actively evaluating clinical and commercial opportunities for the platform and plan to develop a new portfolio of regenerative dermal and soft tissue fillers, aiming to initiate clinical trials within two years. We are seeking a strategic partner to advance the next phase of development and as noted above, are in active discussions with potential collaborators.Regenerative Breast ImplantsCollPlant's breast implants represent a truly paradigm-shifting approach, designed not only to regenerate breast tissue but also to offer inherent safety advantages. Following upgrades to our bioprinting process and related manufacturing capabilities, we have been able to produce and test commercial-sized implants. We are encouraged by the results observed to date.We are in active discussion with potential strategic partners to advance the program and we look forward to sharing further updates.rhCollagen BioInks Portfolio for 3D Bioprinting We recently announced the launch of BioFlex, a ready-to-print rhCollagen-based kit designed for Digital Light Processing (DLP) 3D bioprinting applications. BioFlex is engineered to support the biofabrication of advanced tissue models for drug discovery, as well as the development of engineered tissues and potentially transplantable organs. The ready-to-use system includes Collink.3D™ 50, a biodegradable polymer component, together with proprietary photoactive agents optimized for high-resolution DLP printing.In October 2025, we announced that a scientific article published in Archives of Dermatological Research reported that researchers at the Mayo Clinic developed the first fully humanized 3D bioprinted skin model using CollPlant's plant-derived rhCollagen. By combining rhCollagen with key human skin cell types, the model provides an innovative, sustainable, and ethical alternative to animal testing in preclinical research, with potential applications in cosmetic and pharmaceutical testing, disease modeling, and drug development.We are in discussions with additional leading research institutions regarding potential collaborations that could further demonstrate the capabilities of our bioinks portfolio.Also in October 2025, we announced the expansion of our distribution footprint into North America through a new partnership with a U.S.-based logistics center. The logistics hub provides full cGMP-compliant storage and distribution services and will serve as a clinical supply depot. With this infrastructure now in place, we are actively seeking to grow our commercial presence across the United States and Canada, targeting new customers for our rhCollagen and BioInk product lines.In ClosingThe aesthetics industry continues to seek innovative products that deliver safe and effective results. CollPlant's high-performance, non-animal rhCollagen technology directly addresses this demand, including its potential for tissue rejuvenation, and the level of interest we are seeing from potential partners and collaborators reflects the strength of what we have built.2026 is a year of opportunity for CollPlant. We are focused, we are energized, and we are executing against a clear and compelling strategy. We look forward to delivering on the promise of our technology while remaining committed to building a more sustainable and equitable world.To our employees - your dedication, resilience, and passion for improving patients' lives are the foundation of everything we do. Thank you. And to our shareholders - your continued trust and support mean a great deal to us. We are excited about what lies ahead and look forward to rewarding that trust.With appreciation and optimism,Yehiel Tal
Chief Executive Officer,
CollPlant BiotechnologiesAbout CollPlantCollPlant is a regenerative and aesthetic medicine company focused on medical aesthetics and 3D bioprinting of tissues and organs. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant-based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine. For more information about CollPlant, visit http://www.collplant.com. Forward-Looking StatementsThis press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives, plans and strategies, including its product pipeline, cash runway and strategic direction as well as statements other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company's expectations regarding the costs and timing of commencing and/or concluding pre-clinical and clinical trials with respect to breast implants, tissues and organs which are based on its rhCollagen based BioInk and other products for medical aesthetics, and specifically the Company's ability to initiate its next large-animal study for its breast implants in a timely manner, or at all; the Company's or it strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based bioink and medical aesthetics products or product candidates including, but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the Company's reliance on third parties to conduct some or all aspects of its product development and manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates, including, with respect to the ongoing war in Israel, projected capital expenditures and liquidity, changes in the Company's strategy, and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant are contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.Contacts:Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Email: Eran@CollPlant.comPDF: https://mma.prnewswire.com/media/2954675/CollPlant_CEO_letter_2026.pdf
Logo: https://mma.prnewswire.com/media/2217353/CollPlant_Logo.jpg
View original content to download multimedia:https://www.prnewswire.com/news-releases/collplant-issues-letter-to-shareholders-302740373.htmlSOURCE CollPlant
Original: CollPlant Issues Letter to Shareholders
US Market News
2月前
COLLPLANT BIOTECHNOLOGIES REPORTS 2025 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATEMarch 26, 2026 8:30 AM
PR Newswire (US)
REHOVOT, Israel, March 26, 2026 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived rhCollagen for tissue regeneration and medical aesthetics, today announced its 2025 financial results and provided a corporate update.
"Over the past year, we have made meaningful progress across all fronts-from advancing our collaborative programs to building momentum in our proprietary pipeline and commercial product portfolio. In aesthetic medicine, we achieved a development milestone that triggered a $2 million payment from our collaboration partner, AbbVie. We also expanded our commercial reach by broadening our distribution footprint into North America through a new partnership with a U.S.-based logistics center, while strengthening the European distribution network for our commercial product, Vergenix STR.We further strengthened our pipeline by leveraging new preclinical data to refine the commercial design of our regenerative breast implants. In addition, we expanded our intellectual property portfolio with newly granted patents in the United States and South Korea covering our photocurable dermal filler technology.CollPlant also continued to drive innovation beyond its core development programs. Using our rhCollagen, researchers at Mayo Clinic created the first fully humanized 3D bioprinted skin model designed to serve as an alternative to animal testing in preclinical research. In parallel, we reported results from a comparative study demonstrating that CollPlant's rhCollagen-based bioink, Collink.3D™, outperformed Matrigel®, a leading extracellular matrix, in supporting structured tissue formation. We believe these findings reinforce the potential of Collink.3D™ as a consistent, tunable, and animal-free alternative for advanced tissue engineering and research applications-an opportunity representing an approximately $100 million market that is projected to grow at more than 10% annually.Mr. Tal added, "These achievements collectively highlight how our rhCollagen platform enables animal-free solutions across healthcare and industry. Its applications range from drug discovery and regenerative medicine to advanced tissue modeling and safety testing for cosmetics and pharmaceutical products."2025 and Recent Corporate UpdatesrhCollagen 3D Bioprinting Portfolio In February 2026, CollPlant announced the launch of BioFlex, a ready-to-print rhCollagen-based kit designed for Digital Light Processing (DLP) 3D bioprinting applications. BioFlex is engineered to support the biofabrication of advanced tissue models for drug discovery, as well as the development of engineered tissues and potentially transplantable organs. The ready-to-use system includes Collink.3D™ 50, a biodegradable polymer component, together with proprietary photoactive agents optimized for high-resolution DLP printing.Designed for both academic laboratories and industrial R&D environments, BioFlex enables advanced applications in 3D bioprinting, tissue engineering, and regenerative medicine, helping accelerate the translation of research concepts into functional tissue constructs.In October 2025, CollPlant announced that a scientific article published in Archives of Dermatological Research reported that researchers at the Mayo Clinic developed the first fully humanized 3D bioprinted skin model using CollPlant's plant-derived rhCollagen. By combining rhCollagen with key human skin cell types, the model provides an innovative, sustainable, and ethical alternative to animal testing in preclinical research, with potential applications in cosmetic and pharmaceutical testing, disease modeling, and drug development.Also in October 2025, CollPlant announced the expansion of its distribution footprint into North America through a new partnership with a U.S.-based logistics center. The logistics hub provides full cGMP-compliant storage and distribution services and will serve as a clinical supply depot. This expansion is expected to support CollPlant's growing customer base for its rhCollagen and BioInk product lines across the United States and Canada.AbbVie CollaborationUnder CollPlant's existing development and commercialization agreement with development partner, AbbVie, CollPlant has granted AbbVie a worldwide exclusive license to use CollPlant's rhCollagen technology in combination with AbbVie's proprietary technologies for the development and commercialization of dermal and soft tissue fillers. AbbVie is conducting a review of interim results from the first cohort of patients enrolled under the clinical trials initiated in 2023. Next steps for the program are to be determined by AbbVie upon concluding their assessment.In February 2025, following a development achievement, CollPlant received a $2 million payment from AbbVie, according to the development and commercialization agreement.Regenerative Breast Implants In August 2024, CollPlant initiated a preclinical study evaluating its 200cc clinical-sized regenerative breast implants, which were manufactured with enhanced durability. The surgical protocol was refined to enable implantation through a small incision while minimizing the risk of implant displacement or inversion. Analysis of MRI and ultrasound imaging conducted in 2025 confirmed tissue integration and vascularization, providing valuable diagnostic insights for future clinical applications. At six months post-implantation, one study arm demonstrated promising outcomes, with the implant showing vascularization and rapid tissue ingrowth throughout the clinical-sized implant. No complications, including capsule formation, calcifications, or local tissue reactions, were observed. In addition, implant volume retention and mechanical properties were maintained in the successful study arm.Following completion of this study phase, CollPlant plans to further optimize the regenerative breast implants to support long-term durability and remodeling of the newly vascularized tissue.Mr. Tal added, "CollPlant's breast implants currently under development represent a paradigm-shifting approach, designed not only to regenerate breast tissue but also to offer inherent safety advantages. Following upgrades to our bioprinting process and related manufacturing capabilities, we have been able to produce and test commercial-sized implants. We are encouraged by the results observed to date. This program represents one of our lead development initiatives and has the potential to position CollPlant at the forefront of regenerative medicine."In the United States alone, hundreds of thousands of patients each year experience complications associated with breast implants, ranging from autoimmune-related symptoms to the rare but serious condition of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant's breast implants, composed of the Company's proprietary plant-derived rhCollagen and additional biomaterials, are designed to support the regeneration of breast tissue without eliciting an immune response. As such, they may offer a transformative alternative for both aesthetic and reconstructive procedures, including post-mastectomy breast reconstruction for cancer patients.Intellectual PropertyPhotocurable Dermal Filler Product CandidateIn February 2025, CollPlant announced that it had been granted U.S. Patent No. 12,186,449 related to its photocurable dermal filler product candidate. The patent covers polymerizable solutions comprised of modified rhCollagen and additional components such as hyaluronic acid and is expected to remain in force until 2039.More recently, CollPlant announced that the Korean Patent Office has allowed a patent application covering key aspects of the Company's photocurable dermal filler technology currently under development for the aesthetic medicine market. South Korea represents one of the largest target markets for CollPlant's photocurable dermal filler product candidate.rhCollagen Curable BioInk Product PortfolioIn November 2025, CollPlant announced that the Japan Patent Office (JPO) granted a second patent under Patent Application No. 2023-101072, securing intellectual property protection in Japan for CollPlant's portfolio of rhCollagen-based curable BioInks through 2038.The newly granted patent relates to CollPlant's innovative curable Collink.3D® BioInk product pipeline, which represents the first and only line of human collagen BioInk products based on chemically modified plant-derived rhCollagen that can be mass produced with high purity and consistency. Collink.3D enables scalable and reproducible biofabrication of tissue models, tissues, and potentially organ transplants, while closely mimicking the native properties of biological tissues. In addition, these BioInks are animal-free, exhibit optimal rheological properties at room temperature, support high cell viability across multiple cell types, and are biocompatible and non-immunogenic."These patent allowances and grants represent important milestones in executing our strategy to expand the clinical and commercial applications of our rhCollagen platform into high-value aesthetic and regenerative medicine markets," said Yehiel Tal, Chief Executive Officer of CollPlant. "The United States and South Korea are strategically important markets in aesthetic medicine, and strengthening our intellectual property position in these regions further enhances the long-term value of our technology."Cost Reductions and Program PrioritizationIn November 2025, CollPlant updated its expense forecast and implemented a cost-reduction and workforce optimization plan. As part of this initiative, the Company adjusted its resource allocation and reduced its workforce by approximately 25%. Redesigned Corporate WebsiteIn March 2026 CollPlant announced the launch of its redesigned corporate website at www.collplant.com.The new website provides expanded information regarding the Company's technology platform, product pipeline, strategic collaborations and corporate governance, and is intended to enhance transparency and accessibility for investors, partners, and other stakeholders.Year-Ended December 31, 2025 Financial ResultsGAAP revenues for the year ended December 31, 2025, were $2.4 million compared to $515,000 for the year ended December 31, 2024. The increase in revenues is mainly attributable to a development milestone achievement relating to the dermal filler product candidate, which triggered a $2 million payment from AbbVie to CollPlant according to the AbbVie Development Agreement.GAAP cost of revenues for the year ended December 31, 2025, was $835,000, compared to $1.6 million for the year ended December 31, 2024. The decrease in cost of revenues in the amount of $790,000 is mainly comprised of (i) a $537,000 decrease in inventory impairments, (ii) a $228,000 decrease relating to bioinks and rhCollagen sales, and (iii) a $90,000 insurance reimbursement received in 2025.GAAP gross profit for the year ended December 31, 2025, was $1.5 million, compared to $1.1 million gross loss for the year ended December 31, 2024.GAAP operating expenses for the year ended December 31, 2025, were $13.0 million, compared to $16.1 million for the year ended December 31, 2024. The decrease of approximately $3.1 million is mainly as a result of the Company's cost reduction plan, that includes: (i) a $1.5 million decrease in the workforce expenses and share-based compensation expenses, (ii) a $1.1 million decrease in research and development materials and subcontractors expenses mainly related to the breast implants program, and (iii) a decrease of $145,000 in patents expenses. On a non-GAAP basis, operating expenses for the year ended December 31, 2025, were $12.1 million, compared to $14.4 million in the year ended December 31, 2024.GAAP financial expenses, net, for the year ended December 31, 2025, totaled $6,000, compared to $642,000 financial income, net, for the year ended December 31, 2024. The increase in financial expenses, net is due to (i) a decrease of $358,000 in interest received from our short-term cash deposits, and (ii) an increase of approximately $292,000 in exchange rate differences expenses.GAAP net loss for the year ended December 31, 2025, was $11.5 million, or $0.94 basic loss per share, compared to net loss of $ $16.6 million, or $1.45 basic loss per share, for the year ended December 31, 2024. Non-GAAP net loss for the year ended December 31, 2025, was $10.2 million, or $0.83 loss per share, compared to a net loss of $14.9 million, or $1.3 basic loss per share, for the year ended December 31, 2024.Balance Sheet and Cash FlowThe Company's cash and cash equivalents balance as of December 31, 2025 was $5.6 million.Cash used in operating activities during the year ended December 31, 2025 was $9.4 million compared to $14.1 million during the year ended December 31, 2024.Cash used in investing activities during the year ended December 31, 2025, was $27,000 compared to $539,000 during the year ended December 31, 2024, and related primarily to a decrease in purchases of property and equipment.Cash provided by financing activities during the year ended December 31, 2025 was $3.1 million compared to $9,000 during the year ended December 31, 2024. The increase is mainly attributed to our registered direct offering in June 2025, which resulted in net proceeds of $3.1 million. COLLPLANT BIOTECHNOLOGIES LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$5,591
$11,909
Restricted deposit
359
248
Trade receivables, net
1
150
Inventories
573
440
Other accounts receivable and prepaid expenses
223
433
Total current assets
6,747
13,180
Non-current assets:
Restricted deposit
76
118
Operating lease right-of-use assets
2,426
2,991
Property and equipment, net
1,463
2,290
Intangible assets, net
73
131
Total non-current assets
4,038
5,530
Total assets
$10,785
$18,710
COLLPLANT BIOTECHNOLOGIES LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
December 31,
2025
2024
Liabilities and shareholders' equity
Current liabilities:
Trade payables
$610
$870
Operating lease liabilities
814
806
Accrued liabilities and other payables
1,248
1,294
Total current liabilities
2,672
2,970
Non-current liabilities:
Operating lease liabilities
2,032
2,275
Total non-current liabilities
2,032
2,275
Total liabilities
4,704
5,245
Commitments and contingencies
Shareholders' Equity:
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares as of December 31, 2025 and 2024; issued
and outstanding: 12,803,006 and 11,454,512 ordinary shares as of December 31, 2025 and 2024, respectively
5,492
4,983
Additional paid in capital
126,397
122,801
Accumulated other comprehensive loss
(969)
(969)
Accumulated deficit
(124,839)
(113,350)
Total shareholders' equity
6,081
13,465
Total liabilities and shareholders' equity
$10,785
$18,710
COLLPLANT BIOTECHNOLOGIES LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Year ended December 31,
2025
2024
2023
Revenues
$2,371
$515
$10,959
Cost of revenues
835
1,625
1,991
Gross profit (loss)
1,536
(1,110)
8,968
Operating expenses:
Research and development
8,187
10,515
10,484
General, administrative and marketing
4,832
5,626
5,996
Total operating loss
(11,483)
(17,251)
(7,512)
Financial income (expenses), net
(6)
642
493
Net loss
$(11,489)
$(16,609)
$(7,019)
Basic and diluted net loss per ordinary share
$(0.94)
$(1.45)
$(0.62)
Weighted average number of ordinary shares used in computation
of basic and diluted net loss per share
12,203,269
11,454,180
11,389,168
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2025
2024
2023
Cash flows from operating activities:
Net loss
$(11,489)
$(16,609)
$(7,019)
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on sale of property and equipment
-
-
18
Depreciation and amortization
912
1,038
1,102
Accrued interest
(15)
(11)
(28)
Share-based compensation to employees and consultants
999
1,719
1,937
Exchange differences on cash and cash equivalents and restricted cash
(80)
142
379
Changes in assets and liabilities:
Decrease (increase) in trade receivables
149
(150)
9
Decrease (increase) in inventories
(129)
280
749
Decrease (increase) in other receivables and prepaid expenses
210
(40)
150
Decrease in operating lease right-of-use assets
666
651
527
Decrease in trade payables
(260)
(110)
(153)
Decrease in operating lease liabilities
(336)
(650)
(638)
Increase in accrued liabilities and other payables
(46)
(353)
204
Net cash used in operating activities
(9,419)
(14,093)
(2,763)
Cash flows from investing activities:
Purchase of property and equipment
(28)
(483)
(954)
Investment in restricted deposits
-
(57)
(270
Proceeds from sale of property and equipment
1
1
68
Net cash used in investing activities
(27)
(539)
(1,156)
Cash flows from financing activities:
Proceeds from issuance of shares and warrants less issuance expenses
3,102
-
-
Exercise of options and warrants into shares
-
9
1,108
Net cash provided by financing activities
3,102
9
1,108
Effect of exchange rate changes on cash and cash equivalents and restricted cash
26
(142)
(379)
Net decrease in cash and cash equivalents
(6,318)
(14,765)
(3,190)
Cash and cash equivalents at the beginning of the year
11,909
26,674
29,864
Cash and cash equivalents at the end of the year
$5,591
$11,909
$26,674
COLLPLANT BIOTECHNOLOGIES LTD.
APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2025
2024
2023
Supplemental discloser of non-cash activities:
Right of use assets recognized with corresponding lease liabilities
$101
$572
$886
Capitalization of Share-based compensation to inventory
$4
$6
$33
Supplemental discloser of cash activities:
Cash paid during the year for taxes
$16
$62
$8
COLLPLANT BIOTECHNOLOGIES LTD.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES
(U.S. dollars in thousands, except per share data)
Year ended
December 31,
2025
2024
GAAP operating expenses:
$13,019
$16,141
Change of operating lease accounts
50
(18)
Share-based compensation to employees, directors and consultants
(999)
(1,719)
Non-GAAP operating expenses:
12,070
14,404
GAAP operating loss
(11,483)
(17,251)
Change of operating lease accounts
(50)
18
Share-based compensation to employees, directors and consultants
999
1,719
Non-GAAP operating loss
(10,534)
(15,514)
GAAP Net loss
(11,489)
(16,609)
Change of operating lease accounts
330
1
Share-based compensation to employees, directors and consultants
999
1,719
Non-GAAP Net loss
$(10,160)
$(14,889)
GAAP basic and diluted loss per ordinary share
$(0.94)
$(1.45)
NON- GAAP basic and diluted loss per ordinary share
$(0.83)
$(1.30)
About CollPlantCollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant-based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.For more information about CollPlant, visit http://www.collplant.com. Use of Non-US GAAP ("non-GAAP") Financial results for 2025 and 2024 are presented on both a GAAP and a non-GAAP basis. GAAP results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The release contains certain non-GAAP financial measures for operating costs and expenses, operating income (or loss), net income (or loss) and basic and diluted net income (or loss) per share that exclude the effects of non-cash expense for share-based compensation to employees, directors and consultants, and change in operating lease accounts. CollPlant's management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company's performance that enhances management's and investors' ability to evaluate the Company's operating costs, net income (or loss) and income (or loss) per share, and to compare them to historical Company results. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company's business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" in this release. This accompanying table has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.The Company's consolidated financial statements for the year ended December 31, 2025, are presented in accordance with generally accepted accounting principles in the U.S.A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at www.sec.gov and posted on the Company's investor relations website at http://ir.collplant.com/. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to CollPlant Investor Relations at 4 Oppenheimer, Weizmann Science Park, Rehovot 767104, Israel or by phone at +972-73-232 5600.Forward-Looking StatementsThis press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate.Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company's expectations regarding the costs and timing of commencing and/or concluding pre-clinical and clinical trials with respect to breast implants, tissues and organs which are based on its rhCollagen based BioInk and other products for medical aesthetics, and specifically the Company's ability to initiate its next large-animal study for its breast implants in a timely manner, or at all; the Company's or it strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based bioink and medical aesthetics products or product candidates including, but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations, including its partnership with AbbVie and its ability to continue to receive milestone and royalties payments under the AbbVie agreement; the Company's reliance on third parties to conduct some or all aspects of its product development and manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates, including, with respect to the ongoing war in Israel, projected capital expenditures and liquidity, changes in the Company's strategy, and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant are contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. ContactCollPlant:Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Email: Eran@collplant.comLogo - https://mma.prnewswire.com/media/2217353/CollPlant_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/collplant-biotechnologies-reports-2025-financial-results-and-provides-corporate-update-302726091.htmlSOURCE CollPlant
Original: COLLPLANT BIOTECHNOLOGIES REPORTS 2025 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
US Market News
2月前
CollPlant Biotechnologies Receives Nasdaq Notification Regarding Minimum Bid RequirementMarch 24, 2026 4:01 PM
PR Newswire (US)
REHOVOT, Israel, March 24, 2026 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetic medicine company developing innovative technologies and products based on its proprietary recombinant human collagen (rhCollagen) platform, today announced that on March 23, 2026, the Company received a written notice (the "Notice") from the Nasdaq Stock Market LLC indicating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2), as the Company's closing bid price for its ordinary shares, or Ordinary Shares, was below $1.00 per share for the last 30 consecutive business days.
Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been granted a 180-calendar day compliance period, or until September 21, 2026, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Ordinary Shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the 180-calendar day compliance period.If the Company is not in compliance by September 21, 2026, the Company may be afforded a second 180-calendar day compliance period. To qualify for this additional time, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse share split, if necessary. If the Company does not regain compliance within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company's Ordinary Shares will be subject to delisting.The Company intends to monitor the closing bid price of its Ordinary Shares between now and September 21, 2026, and intends to consider available options to cure the deficiency and regain compliance with the minimum bid price requirement within the compliance period. The Company's Ordinary Shares will continue to be listed and trade on the Nasdaq Capital Market during this period, and are unaffected by the receipt of the written notice from Nasdaq.This announcement is made in compliance with Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of a deficiency notification.About CollPlant
CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant-based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market. For more information about CollPlant, visit http://www.collplant.com. Forward-Looking StatementsThis press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives, plans and strategies, including statements regarding the Company's ability to regain compliance with Nasdaq's minimum bid price requirement, the timing and potential effectiveness of any actions the Company may undertake to cure such deficiency, including the implementation of a reverse share split, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's ability to regain compliance with the Nasdaq minimum bid price requirement, the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company's expectations regarding the costs and timing of commencing and/or concluding pre-clinical and clinical trials with respect to breast implants, tissues and organs which are based on its rhCollagen based BioInk and other products for medical aesthetics; the Company's or it strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based bioink and medical aesthetics products or product candidates including, but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations, including its partnership with AbbVie and its ability to continue to receive milestone and royalties payments under the AbbVie agreement; the Company's reliance on third parties to conduct some or all aspects of its product development and manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates, including, with respect to the ongoing war in Israel, projected capital expenditures and liquidity, changes in the Company's strategy, and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant are contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.Contacts:Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Email: Eran@CollPlant.comLogo - https://mma.prnewswire.com/media/2217353/CollPlant_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/collplant-biotechnologies-receives-nasdaq-notification-regarding-minimum-bid-requirement-302723716.htmlSOURCE CollPlant
Original: CollPlant Biotechnologies Receives Nasdaq Notification Regarding Minimum Bid Requirement
US Market News
3月前
CollPlant Elevates rhCollagen 3D Bioprinting Portfolio with Launch of Ready-to-Print BioFlexFebruary 23, 2026 7:00 AM
PR Newswire (US)
BioFlex Enables Rapid Formulation of Tunable rhCollagen Bioinks with Enhanced Tissue-Mimetic PerformanceBioFlex Expands CollPlant's Animal-Free Bioink Platform for Biopharma companies and Academic institutions Seeking Superior Biofunctionality and ReproducibilityREHOVOT, Israel, Feb. 23, 2026 /PRNewswire/ -- CollPlant (NASDAQ: CLGN), a regenerative and aesthetic medicine company developing innovative technologies and products based on its proprietary recombinant human collagen (rhCollagen) platform, today announced the launch of BioFlex, a ready-to-print rhCollagen-based kit designed for Digital Light Processing (DLP) 3D bioprinting applications.
BioFlex is engineered to support the biofabrication of advanced tissue models for drug discovery, as well as the development of engineered tissues and transplantable organs. This ready-to-print system includes Collink.3D™ 50, a biodegradable polymer component, together with proprietary photoactive agents optimized for high-resolution DLP printing.By following the BioFlex formulation and printing guidelines, users can efficiently generate customized, high-performance bioinks with tunable mechanical properties, enabling precise fabrication of complex, biologically relevant structures.This integrated solution eliminates the need for extensive component screening and streamlines formulation development, enabling researchers and industry partners to significantly reduce development time while achieving constructs with precisely controlled physical properties, including enhanced tensile strength, elasticity, reduced brittleness, and improved structural integrity.Designed to serve both academic laboratories and industrial R&D environments, BioFlex supports advanced applications in 3D bioprinting, tissue engineering, and regenerative medicine, facilitating faster translation from concept to functional tissue constructs."We are committed to empowering both biopharma and academic researchers with high-performance 3D bioprinting solutions," said Yehiel Tal, CEO of CollPlant. "BioFlex, our ready-to-use rhCollagen-based bioink kit, significantly streamlines the formulation process while preserving design flexibility. By integrating our standardized recombinant human collagen with biodegradable polymers and photoactive components - supported by expert-developed formulation and printing guidelines - we enable seamless preparation and highly reproducible, high-resolution printing outcomes.""Like our other Collink.3D™ bioinks, the BioFlex kit provides a state-of-the-art, animal-free alternative to conventional commercial systems, enabling high-resolution, scalable, and highly reproducible bioprinting of scaffolds that closely replicate the physical characteristics of native human tissues and organs. Our platform is purpose-built to streamline product development, accelerate innovation timelines, and ultimately reduce overall development costs," concluded Tal.Biofabricated constructs produced using BioFlex demonstrate enhanced mechanical performance, consistency, and safety, supporting advanced applications in tissue engineering and regenerative medicine.For more information, visit www.CollPlant.com or contact CollPlant at info@CollPlant.com.About CollPlantCollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant-based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market. For more information about CollPlant, visit http://www.collplant.com. Forward-Looking StatementsThis press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives, plans and strategies, including its plans to empower biopharma and academic researchers with high-performance 3D bioprinting solutions, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company's expectations regarding the costs and timing of commencing and/or concluding pre-clinical and clinical trials with respect to breast implants, tissues and organs which are based on its rhCollagen based BioInk and other products for medical aesthetics, and specifically the Company's ability to initiate its next large-animal study for its breast implants in a timely manner, or at all; the Company's or it strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based bioink and medical aesthetics products or product candidates including, but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations, including its partnership with AbbVie and its ability to continue to receive milestone and royalties payments under the AbbVie agreement; the Company's reliance on third parties to conduct some or all aspects of its product development and manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates, including, with respect to the ongoing war in Israel, projected capital expenditures and liquidity, changes in the Company's strategy, and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant are contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.Contacts:Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Email: Eran@CollPlant.comPhoto: https://mma.prnewswire.com/media/2918108/CollPlant_BioFlex_Bioink.jpg
Logo: https://mma.prnewswire.com/media/2217353/CollPlant_Logo.jpg
View original content to download multimedia:https://www.prnewswire.com/news-releases/collplant-elevates-rhcollagen-3d-bioprinting-portfolio-with-launch-of-ready-to-print-bioflex-302694478.htmlSOURCE CollPlant
Original: CollPlant Elevates rhCollagen 3D Bioprinting Portfolio with Launch of Ready-to-Print BioFlex
US Market News
4月前
CollPlant Targets New Aesthetic Market Driven by GLP-1 Weight-Loss TreatmentsFebruary 17, 2026 7:00 AM
PR Newswire (US)
Next-generation rhCollagen-based technology aims to restore facial structure and skin quality in patients experiencing volume depletion linked to GLP-1 weight-loss therapiesREHOVOT, Israel, Feb. 17, 2026 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetic medicine company developing innovative technologies and products based on its proprietary recombinant human collagen (rhCollagen), today announced the strategic positioning of its photocurable dermal filler platform to address facial volume loss associated with rapid weight reduction, including patients treated with GLP-1 therapies.
The expanding use of GLP-1 therapies for metabolic health and weight management has created a growing population experiencing loss of facial fat, skin laxity, and structural deflation - commonly referred to in the medical community as weight-loss-related facial volume depletion.CollPlant's photocurable dermal filler is designed to restore volume while providing a supportive regenerative matrix that integrates with surrounding tissue."Rapid weight loss can lead to significant facial volume depletion and skin quality changes," said Yehiel Tal, Chief Executive Officer of CollPlant. "GLP-1 therapies are creating a new category of aesthetic indications. CollPlant's photocurable filler technology was designed for structural tissue restoration - making it particularly relevant for patients experiencing rapid facial volume loss. Our photocurable rhCollagen-based filler platform is designed not only to restore facial contours, but also to provide a scaffold to support tissue regeneration and long-term structural improvement."Dr. Jason Bloom, a double board certified facial plastic surgeon, noted: "We are seeing a growing number of patients presenting facial volume depletion after significant weight loss, particularly those using newer metabolic therapies. Technologies that go beyond temporary filling and instead support tissue integration and regeneration could represent an important evolution in how we approach these cases."Next-Generation Regenerative ApproachUnlike traditional fillers that primarily provide passive volumization, CollPlant's photocurable dermal filler technology is designed to provide immediate structural restoration, form a highly stable, crosslinked scaffold in situ using light activation, support tissue integration and potentially improve skin quality and elasticity over time. This approach may be particularly suited for patients experiencing facial fat atrophy following rapid weight reduction, midface deflation, loss of jawline definition, and skin laxity associated with accelerated metabolic changes.Addressing a Rapidly Emerging Market NeedThe rapid global adoption of GLP-1 therapies is driving increased demand for aesthetic solutions that address changes in facial structure following significant weight loss. Industry experts report growing interest in non-surgical treatments that restore volume while maintaining natural facial dynamics.CollPlant believes its regenerative biomaterial platform positions the company to address this emerging clinical and aesthetic need.Development Status and Strategic VisionCollPlant is advancing its photocurable filler technology, which is in the preclinical stage, as part of its broader strategy to develop next-generation regenerative aesthetic solutions based on rhCollagen, including applications targeting age-related volume loss, skin regeneration, structural soft tissue restoration, and weight-loss-associated facial changes.The company continues to evaluate clinical and commercial opportunities for its photocurable filler platform and plans to further explore its potential role in addressing evolving patient needs in the rapidly growing aesthetic medicine market.About CollPlantCollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant-based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.For more information about CollPlant, visit http://www.collplant.com.Forward-Looking StatementsThis press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives plans and strategies, including its plans to address the GLP-1 weight loss market, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company's expectations regarding the costs and timing of commencing and/or concluding pre-clinical and clinical trials with respect to breast implants, tissues and organs which are based on its rhCollagen based BioInk and other products for medical aesthetics, and specifically the Company's ability to initiate its next large-animal study for its breast implants in a timely manner, or at all; the Company's or it strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based bioink and medical aesthetics products or product candidates including, but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations, including its partnership with AbbVie and its ability to continue to receive milestone and royalties payments under the AbbVie agreement; the Company's reliance on third parties to conduct some or all aspects of its product development and manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates, including, with respect to the ongoing war in Israel, projected capital expenditures and liquidity, changes in the Company's strategy, and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant are contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.ContactsCollPlant:
Eran Rotem
Deputy CEO & CFO
+ 972-73-2325600
Eran@collplant.comPhoto - https://mma.prnewswire.com/media/2904647/CollPlant_Photo.jpg
View original content to download multimedia:https://www.prnewswire.com/news-releases/collplant-targets-new-aesthetic-market-driven-by-glp-1-weight-loss-treatments-302689382.htmlSOURCE CollPlant
Original: CollPlant Targets New Aesthetic Market Driven by GLP-1 Weight-Loss Treatments
US Market News
4月前
COLLPLANT BIOTECHNOLOGIES ANNOUNCES $2.0 MILLION REGISTERED DIRECT OFFERINGFebruary 5, 2026 8:00 AM
PR Newswire (US)
REHOVOT, Israel, Feb. 5, 2026 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived, rhCollagen for tissue regeneration and medical aesthetics, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 1,600,000 of the Company's ordinary shares at a purchase price of $1.25 per share in a registered direct offering. In addition, in a concurrent private placement, the Company will issue unregistered series A warrants to purchase up to 1,600,000 ordinary shares and unregistered series B warrants to purchase up to 1,600,000 ordinary shares. The series A warrants will have an exercise price of $1.25 per share, will be exercisable immediately and will expire five years after the effective date of a registration statement registering the shares issuable upon exercise of the warrants. The series B warrants will have an exercise price of $1.25 per share, will be exercisable immediately and will expire eighteen months after the effective date of a registration statement registering the shares issuable upon exercise of the warrants. The offering is expected to close on or about February 6, 2026, subject to the satisfaction of customary closing conditions.H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses payable by the Company, are expected to be approximately $2.0 million. CollPlant intends to use the net proceeds for general corporate purposes, which may include but are not limited to, working capital and funding its research and development programs.The ordinary shares (but not the warrants offered in the concurrent private placement or the ordinary shares underlying such warrants) are being offered by CollPlant pursuant to a "shelf" registration statement on Form F-3 (File No. 333-292640) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on January 9, 2026 and declared effective by the SEC on January 16, 2026. The ordinary shares to be issued in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.The unregistered warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the ordinary shares underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying ordinary shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.About CollPlantCollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant-based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.For more information about CollPlant, visit http://www.collplant.com.Forward-Looking StatementsThis press release may include forward-looking statements. Forward-looking statements include, but are not limited to, statements relating to the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering, the intended use of proceeds from the registered direct offering, statements relating to CollPlant's objectives plans and strategies and cash runway, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate.Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company's expectations regarding the costs and timing of commencing and/or concluding pre-clinical and clinical trials with respect to breast implants, tissues and organs which are based on its rhCollagen based BioInk and other products for medical aesthetics, and specifically the Company's ability to initiate its next large-animal study for its breast implants in a timely manner, or at all; the Company's or its strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based bioink and medical aesthetics products or product candidates including, but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations, including its partnership with AbbVie and its ability to continue to receive milestone and royalties payments under the AbbVie agreement; the Company's reliance on third parties to conduct some or all aspects of its product development and manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates, including, with respect to the ongoing war in Israel, projected capital expenditures and liquidity, changes in the Company's strategy, and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant are contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.Contacts
CollPlant:
Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Email: Eran@collplant.com
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Original: COLLPLANT BIOTECHNOLOGIES ANNOUNCES $2.0 MILLION REGISTERED DIRECT OFFERING
midastouch017
2年前
COLLPLANT BIOTECHNOLOGIES REPORTS 2023 FULL YEAR FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
https://finance.yahoo.com/news/collplant-biotechnologies-reports-2023-full-110000475.html
Regenerative breast implant program large-animal study underway to evaluate commercial-size implants with topline data expected in Q4
Ends 2023 with $26.7 million in cash and cash equivalents
Conference call to be held on Thursday, April 4, 2024 at 10:00 a.m. U.S. EDT
REHOVOT, Israel, April 4, 2024 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived recombinant human collagen (rhCollagen) for tissue regeneration and organ manufacturing, today announced financial results for the full year ended December 31, 2023 and provided a corporate update.
"During 2023, the end of which became a challenging year for our nation, we excelled in the advancement of our key programs," said CollPlant's Chief Executive Officer, Yehiel Tal. "We leveraged our pioneering collagen technology platform and dynamic workforce to strengthen existing business collaborations, and advanced our programs - notably with partner, AbbVie. We progressed the dermal filler candidate, which is now in clinical development, and formed a collaboration with industrial 3D printing leader, Stratasys, to refine the manufacturing scale for our breast implants program. Related to our dermal filler partnership with AbbVie, we achieved an important milestone triggering a $10 million milestone payment that we realized in June 2023."
Mr. Tal continued, "As we begin 2024, we believe we are poised to take advantage of the aesthetic and regenerative market this year with a strong balance sheet, lean operating structure, and support from our partners."
2023 and Recent Corporate Highlights
Collaboration Updates
During 2023, CollPlant made significant progress with its development partner, AbbVie, to advance the dermal and soft tissue filler program toward commercialization.
In June 2023, CollPlant announced the achievement of an important milestone under the AbbVie collaboration which triggered a $10 million payment from AbbVie to CollPlant. Per CollPlant's agreement with AbbVie, CollPlant has the potential to receive additional milestones and option product payments, as well as meaningful royalties on product sales.
In April 2023, CollPlant announced a joint development and commercialization agreement with Stratasys Ltd. to collaborate on the development of a solution to bio-fabricate human tissues and organs using Stratasys' P3 technology-based bioprinter and CollPlant's rhCollagen-based bioinks. The first project under the agreement focuses on the development of a bioprinter specific to the creation of CollPlant's regenerative breast implants. It is meant to be an industrial-scale production solution for CollPlant's regenerative breast implants program. CollPlant's state-of-the-art breast implants are being developed to regenerate an individual's natural breast tissue without eliciting immune response, providing a potentially revolutionary alternative for both aesthetic and reconstructive procedures. Under the agreement, both companies have agreed to cross-promote each other's bioprinting products.
CollPlant remains engaged in partnering discussions with several industry leaders in order to leverage its rhCollagen technology and expertise in 3D bioprinting with the mission to develop novel regenerative medical and aesthetics solutions and related applications.
Regenerative Breast Implants
Our regenerative breast implants are targeting the $2.9 billion global breast implant market. The most common breast augmentation or reconstruction procedures today are based on synthetic silicone breast implantations, an artificial substitution for natural regenerated tissue with risks of complications.
Currently, there are no commercial products that allow regeneration of soft tissues such as the breast. In the U.S. alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to the very serious breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant's rhCollagen-based, 3D-bioprinted breast implants that are comprised of CollPlant's proprietary plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response, and therefore may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.
In addition, CollPlant's regenerative breast implants can be a novel solution for women in the breast reconstruction and augmentation market, which is sizeable, as it is the second most common plastic surgery procedure that is performed worldwide today.
In January 2023, CollPlant announced the successful completion of a large-animal study for its regenerative breast implants. This preclinical study demonstrated progressive stages of tissue regeneration after three months, as highlighted by the formation of maturing connective tissue and neovascular networks within the implants, with no adverse events reported. This study was followed by additional large-animal studies that were intended to further optimize the implant design and composition. New tissue formation and neovascularization with no adverse tissue reactions were demonstrated confirming previous results.
In December of 2023, CollPlant initiated a large-animal study to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. This study will be used to obtain data that will be used to support subsequent human studies and future product commercialization. CollPlant expects to report topline data from this study in the fourth quarter of this year.
Intellectual Property
In November 2023, CollPlant announced that the U.S. Patent and Trademark Office granted the Company a patent that relates to its photocuring technology and serves as the basis of its photocurable dermal filler product candidate, being developed for the aesthetics market.
In addition, in March 2024, the same patent application received allowance in Brazil. Patents were also granted in Israel and Australia allowing for protection until 2039 in these regions.
This newly issued patent is related to CollPlant's photocuring technology within its photocurable dermal filler product candidate and represents an integral part of the Company's strategy to expand the uses for its novel, rhCollagen technology into new, high-value markets.
Gut-on-a-Chip Tissue Model
Given CollPlant's focus on the medical aesthetics area and its collaboration with AbbVie, it has decided to place its resources on hold directed toward its gut-on-a-chip program for the treatment of ulcerative colitis. The Company highly values this program, and the rationale for this relates to the extensive projected timing to progress the tissue model as it relates to cell collection, as well as other processes that must first be conducted before even beginning testing. Therefore, in line with prioritizing its resources, CollPlant expects to reinitiate this program once its resources are commensurate with the projected timing of this program.
Corporate Governance
In the second quarter of 2023, CollPlant announced that it hired a dedicated expert to lead its Environment, Social and Governance (ESG) effort. CollPlant plans to file its first ESG report in the second quarter which will outline its ESG objectives.
In September 2023, CollPlant announced that it joined the United Nations Global Compact, the world's largest initiative for sustainable and responsible corporate governance. As a new participant of this voluntary leadership platform, CollPlant strengthens its commitment to operate sustainably.
Year-Ended December 31, 2023 Financial Results
GAAP revenues for the year ended December 31, 2023, were $11.0 million and included mainly revenues from AbbVie, CollPlant's business partner. Revenues increased by $10.7 million, compared to $299,000 for the year ended December 31, 2022. The increase is mainly related to the achievement of a milestone under the AbbVie Agreement, which triggered a $10.0 million payment and a $600,000 increase in sales of rhCollagen products.
GAAP cost of revenues for the year ended December 31, 2023, was $2.0 million, compared to $400,000 for the year ended December 31, 2022. The increase in cost of revenues by approximately $1.6 million is mainly due to: (i) approximately $320,000 in royalty expenses to the IIA, mainly relating to the milestone achievement under the AbbVie Agreement, (ii) approximately $711,000 related to bioinks, VergenixFG, and rhCollagen sales, and (iii) approximately $570,000 related to inventory write offs.
GAAP gross profit for the year ended December 31, 2023, was $9.0 million, compared to gross loss of $101,000 for the year ended December 31, 2022.
GAAP operating expenses for the year ended December 31, 2023, were $16.5 million, compared to $17.0 million, for the year ended December 31, 2022. The decrease of $500,000 is mainly attributed to a decrease of $745,000 in general and administrative expenses, mainly comprised of: (i) a decrease of $224,000 in employees' salaries expense, (ii) a decrease of $364,000 in share-based compensation expenses and (iii) income of $140,000 for insurance indemnification, offset by an increase of $229,000 in research and development expenses. On a non-GAAP basis, the operating expenses for the year ended December 31, 2023 were $14.5 million, compared to $15.2 million in the year ended December 31, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial income, net, for the year ended December 31, 2023, totaled $493,000, compared to $172,000 in the year ended December 31, 2022. The increase in financial income, net, is due to the increase in interest rates and interest received from the Company's short-term cash deposits.
GAAP net loss for the year ended December 31, 2023 was $7.0 million, or $0.62 basic loss per share, compared to a net loss of $16.9 million, or $1.53 basic loss per share, for the year ended December 31, 2022. Non-GAAP net loss for the year ended December 31, 2023, was $5.2 million, or $0.46 basic loss per share, compared to $15.2 million loss, or $1.37 basic loss per share, for the year ended December 31, 2022.
Balance Sheets and Cash Flow
The Company's cash and cash equivalents balance as of December 31, 2023, was $26.7 million.
Cash used in operating activities was $2.8 million during the year ended December 31, 2023, compared to $13.7 million for the year ended December 31, 2022. Cash used during the year ended December 31, 2023 includes the $10 million milestone payment from AbbVie.
Net cash used in investing activities was $1.2 million during the year ended December 31, 2023 compared to $28.9 million in net cash that was provided by investing activities during the year ended December 31, 2022. The decrease is mainly attributed to repayment and investment in short-term cash deposits during the year ended December 31, 2022.
Cash provided by financing activities was $1.1 million for the year ended December 31, 2023 compared to $1.9 million in the year ended December 31, 2022. Cash provided by financing activities is attributed to proceeds from the exercise of warrants and options into shares.
Conference call information
To participate in the conference call, please use the dial-in information below:
U.S. investors: 1-877-407-9716
Investors outside of the U.S.: 1-201-493-6779
Israel investors: 1-809-406-247
Conference ID: 13744114
Note, you can avoid long wait times for the operator by using the Call me™ feature and clicking the link below 15 minutes prior to the scheduled call start time:
https://callme.viavid.com/viavid/?callme=true&passcode=13728588&h=true&info=company&r=true&B=6
Webcast information
A live webcast will also be available in listen-only mode and can be accessed here or via the link to be posted on the News & Events section of the CollPlant Investor relations website. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company's website for a limited time.
Submit questions to management in advance of the call and webcast
To ask management a question ahead of the call, please email Dan Ferry at LifeSci Advisors LLC up until 24 hours before the event at daniel@lifesciadvisors.com.
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
26,674
$
29,653
Restricted deposit
241
23
Trade receivables, net
-
9
Other accounts receivable and prepaid expenses
393
543
Inventories
714
1,430
Total current assets
28,022
31,658
Non-current assets:
Restricted deposit
57
188
Operating lease right-of-use assets
3,070
2,711
Property and equipment, net
2,789
2,966
Intangible assets, net
188
245
Total non-current assets
6,104
6,110
Total assets
$
34,126
$
37,768
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
December 31,
2023
2022
Liabilities and shareholders' equity
Current liabilities:
Trade payables
$
980
$
1,133
Operating lease liabilities
624
529
Accrued liabilities and other payables
1,647
1,443
Total current liabilities
3,251
3,105
Non-current liabilities:
Operating lease liabilities
2,535
2,382
Total non-current liabilities
2,535
2,382
Total liabilities
5,786
5,487
Commitments and contingencies
Shareholders' Equity:
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares
as of December 31, 2023 and , 2022; issued and outstanding: 11,452,672
and 11,186,481 ordinary shares as of December 31, 2023 and 2022,
respectively
4,982
4,873
Additional paid in capital
121,068
118,099
Accumulated other comprehensive loss
(969)
(969)
Accumulated deficit
(96,741)
(89,722)
Total shareholders' equity
28,340
32,281
Total liabilities and shareholders' equity
$
34,126
$
37,768
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Year ended December 31,
2023
2022
2021
Revenues
$
10,959
$
299
$
15,641
Cost of revenues
1,991
400
2,005
Gross profit (loss)
8,968
(101)
13,636
Operating expenses:
Research and development
10,484
10,255
7,631
General, administrative and marketing
5,996
6,741
5,940
Total operating income (loss)
(7,512)
(17,097)
65
Financial income, net
493
172
172
Net income (loss)
$
(7,019)
$
(16,925)
$
237
Basic net income (loss) per ordinary share
$
(0.62)
$
(1.53)
$
0.02
Diluted net income (loss) per ordinary share
$
(0.62)
$
(1.53)
$
0.02
Weighted average number of ordinary shares used in
computation of basic net income (loss) per share
11,389,168
11,033,310
9,968,972
Weighted average number of ordinary shares used in
computation of diluted net income (loss) per share
11,389,168
11,033,310
11,966,788
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2023
2022
2021
Cash flows from operating activities:
Net income (loss)
$
(7,019)
$
(16,925)
$
237
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Loss on sale of property and equipment
18
-
-
Depreciation and amortization
1,102
1,076
773
Accrued interest
(28)
(87)
(151)
Share-based compensation to employees and consultants
1,937
2,174
1,597
Exchange differences on cash and cash equivalents
379
608
(143)
Remeasurement of Derivatives liability
-
-
(28)
Changes in assets and liabilities:
Decrease in trade receivables
9
261
560
Decrease (increase) in inventories
749
(312)
181
Decrease (increase) in other receivables and prepaid expenses
150
(119)
(185)
Decrease in operating lease right-of-use assets
527
461
400
Increase (decrease) in trade payables
(153)
99
236
Decrease in operating lease liabilities
(638)
(916)
(337)
Increase (decrease) in accrued liabilities and other payables
204
14
(464)
Decrease in deferred revenues
-
(32)
(175)
Net cash provided by (used in) operating activities
(2,763)
(13,698)
2,501
Cash flows from investing activities:
Capitalization of intangible assets
-
(42)
(161)
Purchase of property and equipment
(954)
(1,274)
(1,428)
Proceed from short term deposit
-
50,238
-
Investment in restricted deposits
(270)
-
-
Investment in deposits
-
(20,000)
(30,000)
Proceeds from sale of property and equipment
68
-
33
Net cash provided by (used in) investing activities
(1,156)
28,922
(31,556)
Cash flows from financing activities:
Proceeds from issuance of shares and warrants less issuance expenses
-
-
32,743
Exercise of options and warrants into shares
1,108
1,874
6,017
Net cash provided by financing activities
1,108
1,874
38,760
Effect of exchange rate changes on cash and cash equivalents and restricted deposits
(379)
(608)
143
Net increase (decrease) in cash and cash equivalents and restricted deposits
(3,190)
16,490
9,848
Cash and cash equivalents and restricted cash at the beginning of the year
29,864
13,374
3,526
Cash and cash equivalents and restricted deposits at the end of the year
$
26,674
$
29,864
$
13,374
COLLPLANT BIOTECHNOLOGIES LTD.
APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2023
2022
2021
Supplemental discloser of non-cash activities:
Right of use assets recognized with corresponding lease liabilities
$
886
$
219
$
557
Classification of issuance costs liability to equity
$
-
$
-
$
50
Capitalization of Share-based compensation to inventory
$
33
$
37
$
-
Supplemental discloser of cash activities:
Cash paid during the year for taxes
$
8
$
31
$
-
Reconciliation of cash, cash equivalents and restricted cash at the end of the year
Cash and cash equivalents
$
26,674
$
29,653
$
13,148
Restricted deposits short term
-
23
13
Restricted deposits long term
-
188
213
Total cash and cash equivalents and restricted deposits
$
26,674
$
29,864
$
13,374
CollPlant Biotechnologies Ltd.
Reconciliation of GAAP to Non-GAAP Financial Measures
(U.S. dollars in thousands, except per share data)
Year ended December 31,
2023
2022
GAAP operating expenses:
$
16,480
$
16,996
Change of operating lease accounts
-
455
Share-based compensation to employees, directors and consultants
(1,937)
(2,211)
Non-GAAP operating expenses:
14,543
15,240
GAAP operating loss
(7,512)
(17,097)
Change of operating lease accounts
-
(455)
Share-based compensation to employees, directors and consultants
1,937
2,211
Non-GAAP operating loss
(5,575)
(15,341)
GAAP Net loss
(7,019)
(16,925)
Change of operating lease accounts
(111)
(455)
Share-based compensation to employees, directors and consultants
1,937
2,211
Non-GAAP Net loss
$
(5,193)
$
(15,169)
GAAP basic and diluted loss per ordinary share
$
(0.62)
$
(1.53)
NON- GAAP basic and diluted loss per ordinary share
$
(0.46)
$
(1.37)
About CollPlant
CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.
In 2021 CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.
For more information about CollPlant, visit http://www.collplant.com.
Use of Non-US GAAP ("non-GAAP")
Financial results for 2023 and 2022 are presented on both a GAAP and a non-GAAP basis. GAAP results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The release contains certain non-GAAP financial measures for operating costs and expenses, operating income (or loss), net income (or loss) and basic and diluted net income (or loss) per share that exclude the effects of non-cash expense for share-based compensation to employees, directors and consultants, and change in operating lease accounts. CollPlant's management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company's performance that enhances management's and investors' ability to evaluate the Company's operating costs, net income (or loss) and income (or loss) per share, and to compare them to historical Company results.
The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company's business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.
For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" later in this release. This accompanying table has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.
The Company's consolidated financial statements for the year ended December 31, 2023, are presented in accordance with generally accepted accounting principles in the U.S.
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2023 has been filed with the U.S. Securities and Exchange Commission at www.sec.gov and posted on the Company's investor relations website at http://ir.collplant.com/. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to CollPlant Investor Relations at 4 Oppenheimer, Weizmann Science Park, Rehovot 767104, Israel or by phone at +972-73-232 5600.
midastouch017
3年前
CollPlant Biotechnologies Announces Second Quarter Financial Results For 2023 with Revenues of $10.2 Million
https://finance.yahoo.com/news/collplant-biotechnologies-announces-second-quarter-110000369.html
Received in July 2023, $10 million from partner, AbbVie, for achieving a major milestone in the second quarter, for the clinical-phase dermal filler product in accordance with the strategic collaboration agreement
Entered into collaboration with Stratasys, a world-leading 3D printing company, with initial focus on the development of a bioprinting solution for the fabrication of CollPlant's regenerative breast implants
Readying breast implant study in large animals for initiation by year end
Continued positive sales trajectory for 3D bioinks
Cash and cash equivalents totaled $22.3 million as of June 30, 2023; cash runway extended with additional $10 million milestone payment received in July 2023 from AbbVie
Revenues of $10.6 million and operating income of $5.7 million for the first six months of 2023
Conference call to be held on August 24, 2023 at 10:00 am U.S. ET; Dial-in information herein
REHOVOT, Israel, Aug. 24, 2023 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived collagen for tissue regeneration and organ manufacturing, today announced financial results for the second quarter ended June 30, 2023, and provided a corporate update on its programs.
CollPlant achieved a milestone related to its dermal filler program in collaboration with AbbVie, which triggered a related milestone payment in the second quarter of 2023.
CollPlant achieved a milestone related to its dermal filler program in collaboration with AbbVie, which triggered a related milestone payment in the second quarter of 2023.
"This quarter, we were very pleased to announce the achievement of an important milestone related to the dermal filler product developed in collaboration with our partner, AbbVie, for which we received a $10 million payment. We also announced a joint development and commercialization agreement with Stratasys, a world-leader in additive manufacturing that will initially focus on developing a bioprinting solution for the fabrication of our regenerative breast implants in development. Both collaborations are expected to allow us to continue our momentum towards reaching important upcoming milestones related to these programs, with the former providing a vehicle to maintain our strong cash position," said CollPlant's Chief Executive Officer, Yehiel Tal.
Mr. Tal continued, "One of our upcoming milestones will be initiating by the end of this year a second large-animal study to evaluate our regenerative breast implants. We have already established the trial infrastructure and look forward to providing an update as soon as we conclude this study."
Q2 and recent corporate highlights
Program development
CollPlant is planning to initiate a second large-animal study to evaluate commercial sized 3D bioprinted regenerative breast implants, by year end. This study follows the completion of the first large-animal study, the results of which were announced in January of this year. The first study demonstrated progressive stages of tissue regeneration after three months, as highlighted by the formation of maturing connective tissue and neovascular networks within the implants, with no adverse events reported.
In the U.S. alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to the very serious breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant's breast implants that are comprised of CollPlant's proprietary plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response, and thus may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.
Collaboration updates
In June, CollPlant announced the achievement of a milestone with respect to the clinical phase dermal filler product, which is under its collaboration agreement with AbbVie. According to the agreement, the achievement of this milestone triggered a $10 million payment from AbbVie to CollPlant. CollPlant has the potential to receive additional milestone payments as well as future royalties in accordance with its long-term collaboration with AbbVie for the dermal filler product.
In April, CollPlant announced a joint development and commercialization agreement with Stratasys to collaborate on the development of a printing solution to bio-fabrication of human tissues and organs using Stratasys' P3 technology-based bioprinter and CollPlant's rh-Collagen-based bioinks. The bioprinting solution is being designed to enable the production of scaffolds that will accurately mimic the physical properties of human tissues and organs. These scaffolds are to meet the product specification including resolution and reproducibility. The combined proprietary technologies are expected to enable the fabrication of tissues and organs that also possess differentiated regenerative properties. The first project focuses on the development of an industrial-scale solution for CollPlant's regenerative breast implants program. Under the agreement, both companies have also agreed to cross-promote each other's bioprinting products.
CollPlant is developing, together with Tel Aviv University and Sheba Medical Center, a system that enhances the physiological relevance of the human gut to provide a predictive personalized platform. CollPlant mimics the gut structure by 3D printing the gut tissue geometry in high resolution using its unique rhCollagen-based bioink formulation. This tissue model is to be used for evaluating therapy response in patients suffering from ulcerative colitis. Recently, the CollPlant team managed to successfully grow epithelial cells on the 3D printed scaffolds that mimic the gut tissue geometry. The Company expects to be able to provide an update on next steps for this program by the end of this year.
CollPlant remains engaged in partnering dialogs with several industry leaders and academic institutions interested in the Company's rhCollagen technology and expertise in 3D bioprinting to develop therapeutics and medical applications.
Commercial portfolio of bioink solutions
CollPlant's bioink platform is intended to enable its customers to streamline the process of new product development while also accelerating timelines and reducing overall costs. CollPlant's new bioink, Collink.3D-50L is the first bioink available in powder form which provides enhanced operational specificity and flexibility for the end-user because of its mechanical properties to address additional printing requirements of soft and hard tissues. These features of CollPlant's new bioink enable the end user to address a wide range of 3D bioprinting applications, including drug discovery, drug screening and tissue testing, as well as the development of transplantable tissues and organs.
Operational updates
In line with CollPlant's mission to build a company that operates and works towards solutions that support a sustainable environment, CollPlant recently recruited a dedicated manager to analyze, formulate and execute upon the set of standards for its Environmental, Social and Governance (ESG) program. This initiative is designed to help CollPlant meet the evolving standards applicable to publicly listed companies in the U.S., as well as help business partners and socially conscious investors better understand CollPlant's alignment with sustainable values – both operationally and as a component of its overall company mission.
Second quarter ended June 30, 2023 financial results
GAAP revenues for the second quarter ended June 30, 2023 were $10.2 million, an increase of $10.1 million compared to $66,000 in the second quarter ended June 30, 2022. The increase in revenues was mainly related to the achievement of a milestone with respect to the AbbVie agreement, which triggered a $10 million payment.
GAAP cost of revenues for the second quarter ended June 30, 2023, was $615,000, an increase of $572,000 compared to $43,000 in the second quarter ended June 30, 2022. Cost of revenue mainly includes the cost of the Company's rhCollagen based products, and royalties to the Israeli Innovation Authority (IIA) for our sales. The increase in cost of revenues in the amount of approximately $572,000 is mainly comprised of: (i) $305,000 in royalty expenses to the IIA mainly related to the milestone payment received from AbbVie, and (ii) $171,000 relating to the BioInk, VergenixFG, and rhCollagen sales.
GAAP gross profit for the second quarter ended June 30, 2023 was $9.6 million, compared to gross profit of $23,000 in the second quarter ended June 30, 2022.
GAAP operating expenses for the second quarter ended June 30, 2023 were $3.9 million, compared to $4.2 million in the second quarter ended June 30, 2022. The decrease of $300,000 is mainly related to general and administrative expenses and comprised of (i) $223,000 in employees' salaries expense including a decrease in accrued vacation liability and alterations in employment contractual terms implemented in 2022, and (ii) $194,000 share-based compensation expenses mainly related to a directors grant in May 2022, offset by an increase of approximately $116,000 in professional services expenses and patents expenses. On a non-GAAP basis, operating expenses for the second quarter ended June 30, 2023 were $3.6 million, compared to $3.9 million in the second quarter ended June 30, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial income, net, for the second quarter ended June 30, 2023 totaled $85,000, compared to financial expenses, net, of $100,000 in the second quarter of 2022. The increase in financial income is due to interest received from our short-term cash deposits and exchange rate differences.
GAAP net income for the second quarter ended June 30, 2023 was $5.8 million, or $0.51 basic income per share, compared to a net loss of $4.3 million, or $0.39 basic loss per share, for the second quarter ended June 30, 2022. Non-GAAP net income for the second quarter ended June 30, 2023 was $6.0 million, or $0.53 income per share, compared to a net loss of $4.0 million, or $0.36 basic loss per share, for the second quarter ended June 30, 2022.
Cash and cash equivalents as of June 30, 2023, were $22.3 million.
Cash used in operating activities during the three months ended June 30, 2023 was $3.8 million, compared to $4.0 million cash used in operating activities during the three months ended June 30, 2022.
Cash used in investing activities during the three months ended June 30, 2023 and during the three months ended June 30, 2022 was $337,000.
Cash provided by financing activities during the three months ended June 30, 2023 was $89,000. During the three months ended June 30, 2022, there was no cash provided by financing activities.
Year-to-date (six-month) period ended June 30, 2023 financial results
GAAP revenues for the six months ended June 30, 2023, were $10.6 million and included mainly revenues from the AbbVie Agreement as well as income from sales of the Company's BioInk and rhCollagen. Revenues increased by $10.5 million, compared to $132,000 in the six months ended June 30, 2022. The increase is related almost entirely to the achievement of a milestone under the AbbVie Agreement and $500,000 increase in sales of rhCollagen.
GAAP cost of revenues for the six months ended June 30, 2023, was $940,000, an increase of $866,000 compared to $74,000 in the six months ended June 30, 2022. The increase in cost of revenues in the amount of approximately $866,000 is mainly comprised of: (i) $316,000 in royalty expenses to the IIA mainly related to the milestone payment received from AbbVie, and (ii) $424,000 relating to the sales of BioInk, VergenixFG, and rhCollagen.
GAAP gross profit for the six months ended June 30, 2023, was $9.7 million, compared to gross profit of $58,000 in the six months ended June 30, 2022.
GAAP operating expenses for the six months ended June 30, 2023, were $7.5 million, compared to $8.0 million, in the six months ended June 30, 2022. The decrease of $500,000 in expenses is mainly related to general and administrative expenses and comprised of: (i) $278,000 in employees' salaries expense including a decrease in accrued vacation liability and alterations in employment contractual terms implemented in 2022, and (ii) $124,000 share-based compensation expenses mainly related to options granted in 2022. On a non-GAAP basis, the operating expenses for the six months ended June 30, 2023 were $6.7 million, compared to $7.4 million in the six months ended June 30, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial expenses, net for the six months ended June 30, 2023, totaled $111,000, compared to $192,000 in the six months ended June 30, 2022. The decrease in financial expenses, net, is due to interest received from the Company's short-term cash deposits.
GAAP net income for the six months ended June 30, 2023 was $2.0 million, or $0.18 basic income per share, compared to a net loss of $8.1 million, or $0.74 basic loss per share, for the six months ended June 30, 2022. Non-GAAP net income for the six months ended June 30, 2023, was $2.7 million, or $0.24 basic loss per share, compared to $7.5 million loss, or $0.69 basic loss per share, for the six months ended June 30, 2022.
Cash used in operating activities during the six months ended June 30, 2023 and June 30, 2022, remain unchanged at $7.2 million.
Cash used in investing activities during the six months ended June 30, 2023 was $541,000, compared to $29.5 million cash provided by investing activities during the six months ended June 30, 2022. The decrease is mainly attributed to repayment and investment in short term cash deposits during the six months ended June 30, 2022.
Cash provided by financing activities during the six months ended June 30, 2023 was $892,000, compared to cash provided by financing activities of $1.5 million during the six months ended June 30, 2022. Cash provided by financing activities is attributed to proceeds from the exercise of options and warrants into shares.
Conference call information
CollPlant will hold a conference call to discuss its second quarter 2023 financial results along with corporate updates on August 24, 2023 at 10 am ET.
To participate in the conference call, please use the dial-in information below:
U.S. investors: 1-877-407-9716
Investors outside of the U.S.: 1-201-493-6779
Israel investors: 1-809-406-247
Conference ID: 13739191
Note, you can avoid long wait times for the operator by using the Call me™ feature and clicking the link below 15 minutes prior to the scheduled call start time:
https://callme.viavid.com/viavid/?callme=true&passcode=13728588&h=true&info=company&r=true&B=6
Submit questions to management in advance of the call
To ask management a question ahead of the call, please email John Mullaly at LifeSci Advisors LLC up until 24 hours before the event at jmullaly@lifesciadvisors.com.