18 unchanged sentences
• risks related to our marketing and manufacturing capabilities and strategy;
−Removed: • our business model, strategic plans for our business, product candidates and technology;
+Added: • our business model and strategic plans for our business, product candidates and technology;
• the cost of building a medical affairs and commercial organization, including a sales force in anticipation of commercialization of B-VEC and any additional product candidates;
6 unchanged sentences
• our ability to successfully avoid or resolve any litigation, intellectual property or other claims, that may be brought against us;
−Removed: • global economic conditions;
+Added: • global economic conditions, including the recent rise in inflation;
• the impact of changes in laws and regulations.
18 unchanged sentences
Pipeline Highlights and Recent Developments
−Removed: B-VEC is a topical gel containing our novel vector designed to deliver two copies of the COL7A1 transgene for the treatment of dystrophic epidermolysis bullosa ("dystrophic EB"), a serious rare skin disease caused by missing or mutated type VII collagen protein ("COL7").
+Added: B-VEC is a topical gel containing our novel vector designed to deliver two copies of the COL7A1 transgene for the treatment of dystrophic epidermolysis bullosa ("dystrophic EB"), a serious rare skin disease caused by missing or mutated type VII collagen protein.
Our randomized, double-blind, placebo-controlled GEM-3 pivotal study was designed to evaluate topical B-VEC as compared to placebo in dystrophic EB patients.
−Removed: Following public announcement of topline data from the GEM-3 study trial on November 29, 2021, we presented more detailed results at the 2022 American Academy of Dermatology Annual Meeting on March 26, 2022.
−Removed: We expect to file a BLA with the FDA in 2Q 2022, and an MAA with the EMA in 2H 2022.
−Removed: On March 28, 2022, we announced that detailed results from the Phase 1 and 2 study of B-VEC were published in Nature Medicine .
−Removed: During 2Q 2021, we began enrolling patients into an open label extension ("OLE") study, including patients who participated in the Phase 3 study, as well as new participants who meet all enrollment criteria.
+Added: Following public announcement of topline data from the GEM-3 study trial on November 29, 2021, we presented more detailed results at the 2022 American Academy of Dermatology Annual Meeting on March 26, 2022 and at the Society of Investigative Dermatology Annual Meeting on May 19, 2022.
+Added: On March 28, 2022, we announced that results from the Phase 1 and 2 study of B-VEC were published in Nature Medicine.
+Added: In 2Q 2021, we began enrolling patients into an open label extension ("OLE") study, including patients who participated in the Phase 3 study, as well as new participants who meet all enrollment criteria.
Based on the feedback from the FDA following their review of our human factors validation study report, we announced on April 11, 2022 our plan to offer dystrophic EB patients enrolled in the GEM-3 OLE, the opportunity to be dosed in their homes by a healthcare professional.
+Added: On June 22, 2022, we filed a Biologics License Application with the FDA seeking approval of B-VEC for the treatment of patients with dystrophic EB, and we expect to file a Marketing Authorization Application with the European Medicines Agency in 2H 2022.
+Added: We can provide no assurances as to whether B-VEC will be approved or the ultimate timing of any approval from either agency.
+Added: KB407 is an inhaled (nebulized) formulation of our novel vector designed to deliver two copies of the full-length cystic fibrosis transmembrane conductance regulator ("CFTR") transgene for the treatment of cystic fibrosis, a serious rare lung disease caused by missing or mutated CFTR gene.
+Added: On August 1, 2022, we announced that the FDA had accepted our KB407 Investigational New Drug ("IND") application, and we plan to initiate a Phase 1 clinical study ("CORAL-1/US study") of inhaled KB407 in patients with cystic fibrosis ("CF") in the U.S.
+Added: Previously, on September 29, 2021, we announced that the Bellberry Human Research Ethics Committee in Australia granted approval to conduct a Phase 1 clinical study ("CORAL-1/AU study") of inhaled KB407 in patients with CF.
+Added: We have begun screening patients for enrollment in the CORAL-1/AU study and plan to initiate dosing in 2H22.
KB105 is a topical gel containing our novel vector designed to deliver two copies of the TGM1 transgene for the treatment of TGM1-deficient autosomal recessive congenital ichthyosis ("TGM1-ARCI"), a serious rare skin disorder caused by missing or mutated TGM1 protein.
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We plan to resume dosing in the KB105 Phase 1/2 study later this year.
−Removed: KB407 is an inhaled (nebulized) formulation of our novel vector designed to deliver two copies of the full-length CFTR transgene for the treatment of cystic fibrosis, a serious rare lung disease caused by missing or mutated cystic fibrosis transmembrane conductance regulator ("CFTR") protein.
−Removed: On September 29, 2021, we announced that the Bellberry Human Research Ethics Committee in Australia granted approval to conduct a Phase 1 clinical study of inhaled KB407 in patients with cystic fibrosis, and trial initiation is anticipated in 2Q 2022.
−Removed: We plan to submit an IND and initiate a Phase 1 trial in the U.S.
KB104 is a topical gel formulation of our novel vector designed to deliver two copies of the SPINK5 transgene for the treatment of Netherton Syndrome, a debilitating autosomal recessive skin disorder caused by missing or mutated SPINK5 protein.
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We have several other product candidates in various stages of preclinical development as reflected in the chart above.
−Removed: We are also leveraging the ability of our platform to deliver proteins of interest to cells in the skin in the context of aesthetic medicine via our wholly-owned subsidiary Jeune Aesthetics, Inc ("Jeune").
−Removed: A Summary description of Jeune’s key product candidate and its status is as follows:
+Added: We are also leveraging the ability of our platform to deliver proteins of interest to cells in the skin in the context of aesthetic medicine via our wholly-owned subsidiary Jeune Aesthetics, Inc.
+Added: A summary description of Jeune’s lead product candidate and its status is as follows:
KB301 is a solution formulation of our novel vector for intradermal injection designed to deliver two copies of the COL3A1 transgene to address signs of aging or damaged skin caused by declining levels of, or damaged proteins within the extracellular matrix, including type III collagen.
−Removed: A Phase 1 study is currently ongoing.
On March 22, 2022, we announced positive proof-of-concept efficacy data from Cohort 2 of the PEARL-1 study of KB301.
−Removed: We plan to initiate a Phase 2 trial in 4Q 2022 or early 2023.
+Added: In Q2 2022, subjects from the PEARL-1 Cohort 2 trial were enrolled in a durability trial to evaluate duration of treatment effect, reduction of the unevenness in placebo treated sites, and long term safety monitoring.
+Added: We anticipate announcing data from the durability trial in 2H 2022 and initiating a Phase 2 trial in 4Q 2022 or early 2023.
Jeune has several other aesthetic medicine product candidates in various stages of preclinical development as reflected in the chart above.
−Removed: Business Highlights and Recent Developments
−Removed: • On January 18, 2022, we announced that Jing Marantz, MD, PhD, MBA had resigned from the Board of Directors to accept the position as Chief Business Officer with the Company and E.
−Removed: Rand Sutherland was appointed as a member of the Board of Directors to fill the vacancy.
−Removed: • On March 15, 2022, we announced that we had reached a binding term sheet with PeriphaGen, Inc.
−Removed: ("PeriphaGen") to resolve all claims in the trade secret litigation filed by PeriphaGen on May 20, 2020.
COVID-19 Update
−Removed: The COVID-19 pandemic has prompted governments and businesses across the globe to take unprecedented measures, such as restrictions on travel and business operations, temporary closures of businesses, and quarantines.
−Removed: For example, in an effort to slow the spread of the virus, The Commonwealth of Pennsylvania where the Company’s primary offices, laboratory and manufacturing spaces are located, enacted stay-at-home orders, and sweeping restrictions to travel were initiated by corporations and governments.
−Removed: Although these restrictions have been lifted, it is not known at this time whether they will be reestablished or the extent to which the Company will be impacted.
−Removed: The degree of the pandemic’s effect on the Company’s clinical, operational and financial performance will depend on future developments, including additional protective measures that may be implemented by governmental authorities or the Company to protect its employees, or by investigators, caregivers or patients to minimize exposure, all of which are uncertain and difficult to predict.
−Removed: To date the impact of the pandemic on our business and clinical trials in the U.S.
−Removed: has been minimal and the increased vaccination rates in the U.S.
−Removed: are encouraging.
+Added: To date the impact of the COVID-19 pandemic on our business and clinical trials in the U.S.
+Added: has been minimal.
We will continue to assess the potential impact of the pandemic on our business and operations, including our supply chain and preclinical and clinical trial activities.
−Removed: Outside of the U.S., we have experienced pandemic-related delays in clinical trial initiation in Australia, and we will continue to closely monitor this rapidly evolving situation.
+Added: Outside of the U.S., we have experienced pandemic-related delays in clinical trial initiation in Australia, and we will continue to closely monitor the impact that future pandemic developments have on this and our other clinical trials, going forward.
For additional information regarding the impact of the coronavirus pandemic, please see "Risk Factor - Business interruptions resulting from the COVID-19 outbreak or similar public health crises could cause a disruption of the development efforts of our product candidates and adversely impact our business." in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021.
2 unchanged sentences
In the future, we may generate revenue from product sales, royalties on product sales, or license fees, milestones, or other upfront payments if we enter into any collaborations or license agreements.
−Removed: We expect that our future revenue will fluctuate from quarter to quarter for many reasons, including the uncertain timing and amount of any such payments and sales.
+Added: We expect that our future revenue will fluctuate from quarter to quarter for many reasons, including the uncertain timing and amount of any such sales.
Research and Development Expenses
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We expect our research and development expenses will increase as we continue the manufacturing of preclinical and clinical materials and manage the clinical trials of, and seek regulatory approval for, our product candidates and expand our product portfolio.
−Removed: In the near term, we expect that our research and development expenses will increase as we continue our open label extension ("OLE") study for B-VEC, resume dosing with KB105 Phase 2 clinical trial, initiate Phase 2 trial for KB301, initiate Phase 1 trial for KB407, and incur preclinical expenses for our other product candidates.
+Added: In the near term, we expect that our research and development expenses will increase as we continue our open label extension study for B-VEC, resume dosing with KB105 Phase 1/2 clinical trial, initiate a Phase 2 trial for KB301, initiate a Phase 1 trial for KB407, initiate a Phase 1 trial for KB104, and incur preclinical expenses for our other product candidates.
Due to the numerous risks and uncertainties associated with product development, we cannot determine with certainty the duration, costs and timing of clinical trials, and, as a result, the actual costs to complete clinical trials may exceed the expected costs.
1 unchanged sentence
General and administrative expenses consist principally of salaries and other related costs, including stock-based compensation for personnel in our executive, commercial, business development and other administrative functions.
−Removed: and administrative expenses also include professional fees associated with corporate and intellectual property-related legal expenses, consulting and accounting services, facility-related costs and expenses associated with obtaining and maintaining patents.
−Removed: Other general and administrative costs include stock-based compensation and travel expenses.
+Added: General and administrative expenses also include professional fees associated with corporate and intellectual property-related legal expenses, consulting and accounting services, facility-related costs and expenses associated with obtaining and maintaining patents.
+Added: Other general and administrative costs include travel expenses.
We anticipate that our general and administrative expenses will increase in the future to support the continued research and development of our product candidates and to operate as a public company.
−Removed: These increases will likely include increased costs for insurance, costs related to the hiring of additional personnel and payments to outside consultants, lawyers and accountants, among other expenses.
−Removed: Additionally, if and when we believe a regulatory approval of our first product candidate appears likely, we anticipate that we will increase our salary and personnel costs and other expenses as a result of our preparation for commercial operations.
+Added: These increases will likely include increased
+Added: costs for insurance, costs related to the hiring of additional personnel and payments to outside consultants, lawyers and accountants, among other expenses.
+Added: Additionally, we anticipate that we will increase our salary and personnel costs and other expenses as a result of our preparation for commercial operations.
ASTRA Capital Expenditures
On March 5, 2021, we closed on the purchase of the building that was constructed to house our second cGMP facility, ASTRA.
−Removed: We are currently in the process of constructing the interior build-out of this facility and we have entered into a contract with Whiting-Turner who will manage the construction of ASTRA.
+Added: We are currently in the process of constructing the interior build-out of this facility and we have entered into a contract with Whiting-Turner who manages the construction of ASTRA.
Further, we have entered into various non-cancellable purchase agreements for long-lead materials to help avoid potential schedule disruptions or material shortages.
6 unchanged sentences
Critical Accounting Policies, Significant Judgments and Estimates
−Removed: There have been no significant changes during the three months ended March 31, 2022 to our critical accounting policies, significant judgments and estimates as disclosed in our management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2021.
+Added: There have been no significant changes during the three and six months ended June 30, 2022 to our critical accounting policies, significant judgments and estimates as disclosed in our management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2021.
Results of Operations
−Removed: Three Months Ended March 31, 2022 and 2021
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30, 2022 and 2021
+Added: Three Months Ended June 30,
2022 2021 Change
2 unchanged sentences
General and administrative 17,863 9,799 8,064
+Added: Total operating expenses 28,753 16,393 12,360
+Added: Loss from operations (28,753) (16,393) (12,360)
+Added: Other Income (Expense)
+Added: Interest and other income, net 645 30 615
+Added: Net loss $ (28,108) $ (16,363) $ (11,745)
+Added: Research and Development Expenses
+Added: Research and development expenses increased $4.3 million in the three months ended June 30, 2022 compared to the three months ended June 30, 2021.
+Added: Higher research and development expenses were due to an increase in preclinical, clinical and pre-commercial manufacturing activities of $1.3 million, payroll related expenses of $1.9 million, which were primarily driven by an increase in headcount to support overall growth, and includes a $911 thousand increase in stock-based compensation, outsourced research and development activities of $803 thousand and other research and development expenses of $316 thousand, primarily due to software related costs and rent.
+Added: General and Administrative Expenses
+Added: General and administrative expenses increased $8.1 million in the three months ended June 30, 2022 as compared to the three months ended June 30, 2021.
+Added: Higher general and administrative spending was due largely to increases in payroll related expenses of approximately $6.5 million, which was primarily driven by an increase in headcount in our executive, commercial, business development and other administrative functions to support overall growth, and includes a $3.1 million increase in stock-based compensation, commercial preparedness expenses of approximately $1.7 million, medical affairs costs of $268 thousand, software related costs of $165 thousand, business development costs of $215 thousand, travel related activities of $136 thousand and other administrative expenses of $460 thousand, primarily due to charitable contributions and conference expenses.
+Added: These increases were offset by a net decrease in legal and professional fees of approximately $1.3 million, which includes $68 thousand of insurance proceeds.
+Added: Other Income (Expense)
+Added: Interest and other income for the three months ended June 30, 2022 and 2021 was $645 thousand and $30 thousand, respectively, and consisted of interest and dividend income earned from our cash, cash equivalents and investments.
+Added: Six Months Ended June 30, 2022 and 2021
+Added: Six Months Ended June 30,
+Added: 2022 2021 Change
+Added: (In thousands) (unaudited)
+Added: Research and development $ 20,204 $ 12,795 $ 7,409
+Added: General and administrative 33,771 17,951 15,820
Litigation settlement 25,000 — 25,000
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Research and Development Expenses
−Removed: Research and development expenses increased $3.1 million in the three months ended March 31, 2022 compared to the three months ended March 31, 2021.
−Removed: Higher research and development expenses were due to an increase in preclinical, clinical and pre-commercial manufacturing activities of $1.3 million, payroll related expenses of $1.6 million, which were primarily driven by an increase in headcount to support overall growth, and includes an $848 thousand increase in stock-based compensation, and other research and development expenses of $320 thousand, primarily due to software related costs and rent.
+Added: Research and development expenses increased $7.4 million in the six months ended June 30, 2022 compared to the six months ended June 30, 2021.
+Added: Higher research and development expenses were due to an increase in preclinical, clinical and pre-commercial manufacturing activities of $2.5 million, payroll related expenses of $3.5 million, which were primarily driven by an increase in headcount to support overall growth, and includes a $1.8 million increase in stock-based compensation, outsourced research and development activities of $909 thousand and other research and development expenses of $586 thousand, primarily due to software related costs and rent.
These increases were partially offset by a decrease in travel related activities of approximately $61 thousand.
General and Administrative Expenses
−Removed: General and administrative expenses increased $7.8 million in the three months ended March 31, 2022 as compared to the three months ended March 31, 2021.
−Removed: Higher general and administrative spending was due largely to increases in payroll related expenses of approximately $5.9 million, which was primarily driven by an increase in headcount to personnel in our executive, commercial, business development and other administrative functions to support overall growth, and includes a $3.3 million increase in stock-based compensation, commercial preparedness expenses of approximately $1.0 million, medical affairs costs of $162 thousand, software related costs of $130 thousand, business development costs of $166 thousand, and other administrative expenses of $526 thousand, primarily due to rent and taxes.
−Removed: These increases were offset by a decrease in legal and professional fees of approximately $92 thousand, which includes $509 thousand of insurance proceeds.
+Added: General and administrative expenses increased $15.8 million in the six months ended June 30, 2022 as compared to the six months ended June 30, 2021.
+Added: Higher general and administrative spending was due largely to increases in payroll related expenses of approximately $12.2 million, which was primarily driven by an increase in headcount in our executive, commercial, business development and other administrative functions to support overall growth, and includes a $6.4 million increase in stock-based compensation, commercial preparedness expenses of approximately $3.2 million, medical affairs costs of $336 thousand, software related costs of $295 thousand, business development costs of $378 thousand, travel related activities of $189 thousand, and other administrative expenses of $948 thousand, primarily due to rent, taxes, charitable contributions and conference expenses.
+Added: These increases were offset by a net decrease in legal and professional fees of approximately $1.7 million, which includes $577 thousand of insurance proceeds.
Litigation settlement
−Removed: Litigation settlement expenses increased $25.0 million in the three months ended March 31, 2022 as compared to the three months ended March 31, 2021 and consisted of the settlement of litigation with PeriphaGen.
+Added: Litigation settlement for the six months ended June 30, 2022 and 2021 was $25.0 million and zero, respectively, and consisted of the settlement of litigation with PeriphaGen.
See "Legal Proceedings" in Note 6 of the notes to condensed consolidated financial statements included in this Form 10-Q for more information.
Other Income (Expense)
−Removed: Interest and other income for the three months ended March 31, 2022 and 2021 was $257 thousand and $33 thousand, respectively, and consisted of interest and dividend income earned from our cash, cash equivalents and investments.
−Removed: Interest expense for the three months ended March 31, 2022 and 2021 was zero and $1.5 million, respectively, and related to accretion of the financial obligation for the build to suit lease liability during the three months ended March 31, 2021 to a balance that equaled the purchase consideration for ASTRA.
+Added: Interest and other income for the six months ended June 30, 2022 and 2021 was $902 thousand and $64 thousand, respectively, and consisted of interest and dividend income earned from our cash, cash equivalents and investments.
+Added: Interest expense for the six months ended June 30, 2022 and 2021 was zero and $1.5 million, respectively, and related to accretion of the financial obligation for the build to suit lease liability during the six months ended June 30, 2021 to a balance that equaled the purchase consideration for ASTRA.
Liquidity and Capital Resources
−Removed: At March 31, 2022, our cash, cash equivalents and short-term investments balance was approximately $434.6 million.
+Added: At June 30, 2022, our cash, cash equivalents and short-term investments balance was approximately $425.6 million.
Since operations began, we have incurred operating losses.
−Removed: Our net losses were $50.0 million and $15.8 million for the three months ended March 31, 2022 and 2021, respectively.
−Removed: At March 31, 2022, we had an accumulated deficit of $190.7 million.
−Removed: With the net proceeds raised from our previous public and private securities offerings and our ability to issue additional shares under our current ATM program, the Company believes that our cash, cash equivalents and short-term investments as of March 31, 2022 will be sufficient to allow the Company to fund operations for at least 12 months from the filing date of this Form 10-Q.
+Added: Our net losses were $28.1 million and $78.1 million for the three and six months ended June 30, 2022, respectively, and $16.4 million and $32.2 million for the three and six months ended June 30, 2021, respectively.
+Added: At June 30, 2022, we had an accumulated deficit of $218.9 million.
+Added: With the net proceeds raised from our previous public and private securities offerings and our ability to issue additional shares under our current ATM program, the Company believes that our cash, cash equivalents and short-term investments as of June 30, 2022 will be sufficient to allow the Company to fund operations for at least 12 months from the filing date of this Form 10-Q.
As the Company continues to incur losses, a transition to profitability is dependent upon the successful development, approval and commercialization of our product candidates and the achievement of a level of revenues adequate to support the Company’s cost structure.
−Removed: Furthermore, we expect to incur increasing costs associated with operating as a public company, meeting financial controls, satisfying regulatory and quality standards, maintaining product and clinical trials, and furthering our efforts around our current and future product candidates.
+Added: Furthermore, we expect to incur increasing costs associated with satisfying regulatory and quality standards, maintaining product and clinical trials, and furthering our efforts around our current and future product candidates.
The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital or obtain financing from other sources.
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While we are in the process of building out our internal vector manufacturing capacity, some of our manufacturing activities will be contracted out to third parties.
−Removed: Additionally, we currently utilize third-party contract research organizations to carry out our clinical development activities.
−Removed: As we seek to obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses as we prepare for product sales, marketing, manufacturing, and distribution.
+Added: Additionally, we currently utilize third-party contract research organizations to carry out some of our clinical development activities.
+Added: As we seek to obtain regulatory approval for any of our product candidates, we expect to continue to incur significant commercialization expenses as we prepare for product sales, marketing, manufacturing, and distribution.
+Added: Furthermore, pursuant to our settlement agreement with PeriphaGen, we will be required to pay $12.5 million upon the approval of our first product by the FDA, followed by three additional $12.5 million contingent milestone payments upon reaching $100.0 million in total cumulative sales, $200.0 million in total cumulative sales and $300.0 million in total cumulative sales.
Our funds may not be sufficient to enable us to conduct pivotal clinical trials for, seek marketing approval for or commercially launch B-VEC, KB105, KB301 or any other product candidate.
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Operating Capital Requirements
−Removed: Our primary uses of capital are, and we expect will continue to be for the near future, compensation and related expenses, manufacturing costs for preclinical and clinical materials, third party clinical trial research and development services, laboratory and related supplies, clinical costs, legal and other regulatory expenses and general overhead costs.
−Removed: In order to complete the process of obtaining regulatory approval for any of our product candidates and to build the sales, manufacturing, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional funding.
+Added: Our primary uses of capital are, and we expect will continue to be for the near future, compensation and related expenses, manufacturing costs for preclinical and clinical materials, third party clinical trial research and development services, laboratory and related supplies, clinical costs, legal and other regulatory expenses, payments of settlement amounts to PeriphaGen and general overhead costs.
+Added: In order to complete the process of obtaining regulatory approval for any of our product candidates and to build the sales, manufacturing, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we may require substantial additional funding.
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner than we expect.
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• the progress, timing and costs of manufacturing of B-VEC;
−Removed: • the continued development and the filing on an IND application for future product candidates;
+Added: • the continued development and the filing of an IND application for future product candidates;
• the initiation, scope, progress, timing, costs and results of drug discovery, laboratory testing, manufacturing, preclinical studies and clinical trials for any other product candidates that we may pursue in the future, if any;
2 unchanged sentences
• the costs associated with the manufacturing process development and evaluation of third-party manufacturers;
−Removed: • the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, in the event we receive marketing approval for our current and future product candidates;
• the extent to which the costs of our product candidates, if approved, will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or will be reimbursed by government authorities, private health coverage insurers and other third-party payors;
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Sources and Uses of Cash
−Removed: The following table summarizes our sources and uses of cash (in thousands):
−Removed: Three Months Ended March 31,
+Added: The following table summarizes our sources and uses of cash for the six months ended June 30, 2022 (in thousands):
+Added: Six Months Ended June 30,
Net cash used in operating activities $ (58,552) $ (19,783)
Net cash used in investing activities (94,132) (63,064)
−Removed: Net cash provided (used in) by financing activities (542) 144,304
+Added: Net cash provided by financing activities 30,158 144,105
Net increase (decrease) in cash $ (122,526) $ 61,258
Operating Activities
−Removed: Net cash used in operating activities for the three months ended March 31, 2022 was $15.5 million and consisted primarily of a net loss of $50.0 million adjusted for non-cash items primarily of depreciation and amortization and stock-based compensation expense of $7.3 million, and increases in net operating liabilities of approximately $27.2 million which includes an increase in accrued legal settlement of $25.0 million.
−Removed: Net cash used in operating activities for the three months ended March 31, 2021 was $9.7 million and consisted primarily of a net loss of $15.8 million adjusted for non-cash items primarily of depreciation and amortization and stock-based compensation expense of approximately $2.8 million and build to suit interest expense of $1.5 million, as well as decreases in net operating assets of approximately $1.8 million.
+Added: Net cash used in operating activities for the six months ended June 30, 2022 was $58.6 million and consisted primarily of a net loss of $78.1 million adjusted for non-cash items primarily comprised of depreciation and amortization and stock-based compensation expense of $16.4 million, and including net changes in operating assets and liabilities of approximately $3.1 million.
+Added: Net cash used in operating activities for the six months ended June 30, 2021 was $19.8 million and consisted primarily of a net loss of $32.2 million adjusted for non-cash items primarily comprised of depreciation and amortization and stock-based compensation expense of approximately $7.7 million and build to suit interest expense of $1.5 million, including net changes in operating assets and liabilities of approximately $3.2 million.
Investing Activities
−Removed: Net cash used in investing activities for the three months ended March 31, 2022 was $55.9 million and consisted primarily of expenditures of $17.2 million on the build-out of our ASTRA facility, leasehold improvement of new office space, and purchases of computer and laboratory equipment, $62.8 million on the purchase of short-term and long-term investments, partially offset by proceeds of $24.0 million received from the maturities of short-term investments.
−Removed: Net cash used in investing activities for the three months ended March 31, 2021 was $747 thousand and consisted primarily of expenditures of $2.5 million on the build-out of our ASTRA facility, leasehold improvement of new office space, and purchase of computer and laboratory equipment, partially offset by proceeds of $1.7 million received from the maturities of short-term investments.
+Added: Net cash used in investing activities for the six months ended June 30, 2022 was $94.1 million and consisted primarily of expenditures of $33.7 million on the build-out of our ASTRA facility, leasehold improvement of new office space, and purchases of computer and laboratory equipment, $147.3 million on the purchase of short-term and long-term investments, partially offset by proceeds of $86.8 million received from the maturities of short-term investments.
+Added: Net cash used in investing activities for the six months ended June 30, 2021 was $63.1 million and consisted primarily of expenditures of $6.5 million on the build-out of our ASTRA facility, leasehold improvement of new office space, and purchases of computer and laboratory equipment, $59.6 million on the purchase of short-term and long-term investments, partially offset by proceeds of $3.0 million received from the maturities of short-term investments.
Financing Activities
−Removed: Net cash used by financing activities for the three months ended March 31, 2022 was $542 thousand and consisted primarily of proceeds of $107 thousand received from exercises of stock options and offset by $649 thousand used for the employee tax withholding payment for settlement of vested restricted stock awards.
−Removed: Net cash provided by financing activities for the three months ended March 31, 2021 was $144.3 million and consisted primarily of proceeds of $152.3 million received from our ATM Program, a public offering, and exercises of stock options, partially offset by $8.0 million used for the purchase of the ASTRA building.
+Added: Net cash provided by financing activities for the six months ended June 30, 2022 was $30.2 million and consisted primarily of proceeds of $30.8 million received from our ATM Program and exercises of stock options and offset by $649 thousand used for the employee tax withholding payment for settlement of vested restricted stock awards.
+Added: During the six months ended June 30, 2022, the Company issued and sold 434,782 shares of common stock at a weighted average price of $69.00 per share for net proceeds of $29.1 million after deducting underwriting discounts and commissions of approximately $900 thousand.
+Added: For the six months ended June 30, 2022, the Company received proceeds of $1.7 million from the exercise of stock options.
+Added: Net cash provided by financing activities for the three months ended June 30, 2021 was $144.1 million and consisted primarily of proceeds of $152.1 million received from our ATM Program, a public offering, and exercises of stock options, partially offset by $8.0 million used for the purchase of the ASTRA building.
On February 1, 2021, the Company completed a public offering of 2,211,538 shares of its common stock at $65.00 per share.
Net proceeds to the Company from the offering were $134.9 million after deducting underwriting discounts and commissions of approximately $8.6 million and other offering expenses of approximately $198 thousand.
−Removed: During the three months ended March 31, 2021, pursuant to the ATM Program the Company issued 262,500 shares of common stock at a weighted average price of $66.50 per share for net proceeds of $16.9 million after deducting underwriting discounts and commissions of approximately $524 thousand.
+Added: During the six months ended June 30, 2021, pursuant to the ATM Program the Company issued 262,500 shares of common stock at a weighted average price of $66.50 per share for net proceeds of $16.9 million after deducting underwriting discounts and commissions of approximately $524 thousand.
The Company also incurred $172 thousand of other offering expenses related to the ATM Program.
−Removed: For the three months ended March 31, 2021, the Company received proceeds of $346 thousand from the exercise of stock options.
+Added: For the six months ended June 30, 2021, the Company received proceeds of $360 thousand from the exercise of stock options.
Off-Balance Sheet Arrangements
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.