17 unchanged sentences
Actual results and experience could differ materially from the anticipated results and other expectations expressed in our forward-looking statements as a result of a number of factors, including but not limited to those discussed in this Item and in Item 1A - “Risk Factors.”
−Removed: We are a clinical stage pharmaceutical company with a growing pipeline of clinical programs for the treatment of highly resistant cancers and viruses.
−Removed: We have three core technologies, based substantially on discoveries made at and licensed from MD Anderson Cancer Center (MD Anderson) in Houston, Texas.
−Removed: We have six drug candidates, three of which have now shown human activity in clinical trials.
−Removed: Core Technologies
+Added: We are a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs for hard-to-treat cancers and viruses. We have three core technologies, each of which have had one or more drugs successfully complete a Phase 1 clinical trial 1 , based substantially on discoveries made at and licensed from MD Anderson Cancer Center (MD Anderson) in Houston, Texas.
+Added: Three of our six drug candidates have shown human activity in clinical trials and are currently in Phase 1b/2 or Phase 2 clinical trials.
+Added: Since our inception, our drugs have been in, are currently in, or have received approval to proceed in eleven clinical trials.
+Added: Our Core Technologies
Our core technologies consist of the following:
−Removed: a) Annamycin, a “next generation”
−Removed: anthracycline designed to be different than currently approved anthracyclines by eliminating cardiotoxicity and avoiding the multidrug resistance mechanisms that can limit the efficacy of the approved products.
−Removed: (Annamycin has shown no cardiotoxicity in subjects treated to date in Moleculin’s clinical trials);
+Added: a) Annamycin or L-Annamycin is a “next generation”
+Added: anthracycline designed to be different than currently approved anthracyclines, which are limited in utility because of cardiotoxicity risks and their susceptibility to multidrug resistance mechanisms.
+Added: Annamycin was designed to avoid multidrug resistance and has shown no cardiotoxicity 2  in subjects treated in clinical trials to date.
+Added: Furthermore, we have demonstrated safe dosing beyond the dose limitations imposed by regulatory authorities upon currently prescribed anthracyclines due to their inherent cardiotoxicity;
b) our WP1066 Portfolio, which includes WP1066 and WP1220, two of several Immune/Transcription Modulators in the portfolio designed to inhibit p-STAT3 (phosphorylated signal transducer and activator of transcription) among other transcription factors associated with tumor activity, while also stimulating a natural immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs);
−Removed: and c) our WP1122 Portfolio, which contains compounds (including WP1122, WP1096, WP1097) designed to exploit the potential uses of inhibitors of glycolysis such as 2-deoxy-D-glucose (2-DG), which we believe may provide an opportunity to cut off the fuel supply of tumors by taking advantage of their high level of dependence on glucose in comparison to healthy cells.
−Removed: Clinical Trials
−Removed: In the US and Europe, we have completed or are currently conducting clinical trials for three of our drug candidates –
−Removed: Annamycin, WP1066, and WP1220.
−Removed: All trials are or were in the Phase 1 portion, except the WP1220 trial, which was a proof-of-concept clinical trial.
+Added: c) our WP1122 Portfolio, which contains compounds (including WP1122, WP1096, and WP1097) designed to exploit the potential uses of inhibitors of glycolysis such as 2-deoxy-D-glucose (2-DG), which we believe may provide an opportunity to cut off the fuel supply of tumors by taking advantage of their high level of dependence on glucose in comparison to healthy cells, as well as viruses that depend upon glycolysis and glycosylation to infect and replicate.
+Added: Our Focus  
+Added: We are focused on internally funded (“internally”
+Added: and “externally”
+Added: funded trials are defined in the Funding Strategy section below) development of:
+Added: 1) Annamycin for the treatment of Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases or STS lung mets)
+Added: 2) Annamycin in combination with Cytarabine (also known as Ara-C, the combination with Annamycin of which is referred to as AnnAraC) for the treatment of Relapsed or Refractory Acute Myeloid Leukemia (R/R AML or AML).
+Added: 3) Developing a better delivery mechanism for WP1066 to further support current and possibly future externally funded oncology clinical trials. 
+Added: We have also recently established a Recommended Phase 2 Dose (RP2D) for WP1122 to potentially enable future externally funded oncology and virology trials.
+Added: Beyond this, we support development of our core technologies through several externally funded clinical trials with the potential for others in the near-term.
+Added: 1 Subject to publishing final Clinical Study Report
+Added: Our Clinical Trials
+Added: In the US and Europe, we or external investigators have approved, are currently conducting or have completed eleven internally or externally funded clinical trials for four of our drug candidates –
+Added: Annamycin, WP1066, WP1220, and WP1122 since inception.
+Added: All clinical trials are or were in the Phase 1 or 2 stage.
During 2021, we had four active clinical trials evaluating either Annamycin or WP1066 in the US and Europe.
−Removed: In 2021 and early 2022, there were also three “right-to-try”
+Added: This increased to six active or just completed trials in 2022 involving Annamycin, WP1066, and WP1122.
+Added: In 2021 and 2022, there were five “right-to-try”
(or their foreign equivalent) uses of Annamycin and WP1066.
−Removed: Of the four clinical trials active in 2021, two of those are internally funded trials (the difference between “internally”
−Removed: and “externally”
−Removed: funded trials is discussed in Item 1.
−Removed: Business above) of Annamycin.
−Removed: One is studying relapsed and refractory acute myeloid leukemia (AML) in Europe, and one is investigating soft tissue sarcoma metastasized to the lungs (STS lung metastases) in the US.
−Removed: The other two trials are externally funded studies of WP1066 in brain tumors, both in the US, one of which was terminated during the year because the Principal Investigator in that trial moved to a new institution. We successfully concluded an internally funded Phase 1 AML clinical trial in Europe in early 2022, establishing a Recommended Phase 2 Dose (RP2D) for Annamycin as a single agent.
−Removed: We are in the process of locking the database and beginning the completion of the Clinical Study Report (CSR) for that study.
−Removed: During 2021, we filed applications or began recruiting for four clinical trials in the US and Europe.
−Removed: The investigational new drug (IND) application in the US for a Phase 1b/2 trial of Annamycin for the treatment of STS lung metastases was filed in late 2020 with the US Food and Drug Administration (FDA).
−Removed: The IND went into effect in early 2021 and this trial began recruiting subjects shortly thereafter.
−Removed: In 2021, we also filed and received clearance for an IND for a Phase 1 trial for WP1122 treating glioblastoma multiforme (GBM) in adults, and consistent with our strategy of leveraging external funding for many of our clinical trials, we intend to seek opportunities for an investigator-initiated clinical trial in cancer patients in 2022.
−Removed: We also filed in October 2021 a clinical trial application (CTA) to commence a Phase 1a clinical trial of WP1122 in the United Kingdom for the treatment of COVID-19 for which we later received the appropriate authorization to proceed.
−Removed: In early March 2022, we filed an amended protocol with both the Riverside Ethics Committee and Medicines and Healthcare Products Regulatory Agency (MHRA).
−Removed: The amendment updated the level of dilution of the oral solution to ensure that WP1122 is fully dissolved in a wider range of pharmacy environments. We believe that the risk/benefit aspect of the study was not affected by this change.
−Removed: Once this amendment is approved, we expect this internally funded trial to begin in the first half of 2022.
−Removed: We also filed a CTA in Poland in November 2021 for a Phase 1/2 trial for the treatment of relapsed and refractory AML with a combination of Annamycin and Cytarabine (AnnAraC) for which we received Central Ethics approval in December 2021.
−Removed: Upon receipt of approval from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), we plan to proceed with this trial. This trial builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials in the US and Europe and is supported by preclinical animal data from our ongoing sponsored research at MD Anderson.
−Removed: The AnnAraC trial is expected to begin during the first half of 2022.
−Removed: In addition to the trials described above, we expect that an investigator sponsored trial will be initiated in Europe in 2022 to study an alternative dosing regimen for Annamycin in the treatment of STS lung metastases.
−Removed: During 2022, we may also have another investigator led trial outside of the US (partially internally funded) focused on the use of WP1122 for the treatment of subjects with COVID-19.
−Removed: The volatility and unpredictability of COVID-19 incidence in various countries may limit our ability to recruit certain subjects and could make it infeasible for us to conduct a Phase 2 clinical trial on a timely basis, or at all.
−Removed: As mentioned earlier, the WP1066 brain tumor trial at MD Anderson was terminated in 2021, as the original lead physician investigator moved to another institution.
−Removed: We expect another externally funded Phase 1/2 investigator led trial to replace the MD Anderson trial in 2022.
−Removed: That trial’s IND will likely reference our WP1066 GBM IND filed in early 2022, once cleared by the FDA.
−Removed: We expect this new trial to investigate WP1066 in combination with radiation for the treatment of adult brain tumors.
+Added: Three of the six clinical trials active in 2022 are internally funded trials of Annamycin and one is an internally funded Phase 1 clinical trial for WP1122 setting a RP2D.
+Added: Moving into 2023, we are actively recruiting in three clinical trials in a Phase 1b/2 or Phase 2 stage and have recently concluded one trial.
+Added: These three currently active clinical trials are open label so we expect to be able to announce what human activity is being demonstrated in these trials during 2023. In February 2023, the externally funded Phase 1 clinical trial with WP1066 or the treatment of pediatric brain tumors concluded.
+Added: We expect to have up to three externally funded Phase 1b/2 clinical trial for WP1066 in the treatment of GBM and other brain tumors in 2023.
+Added: During 2022, we or external investigators filed applications or began recruiting for five internally or externally funded clinical trials in the US and Europe.
+Added: Annamycin - The clinical trial application (CTA) in Poland for a Phase 1b/2 trial of Annamycin in combination with Cytarabine or AnnAraC for the treatment of AML was allowed in 2022.
+Added: This trial was later approved to expand into Italy in 2022 and dosing subjects began there in March 2023.
+Added: With preclinical data in mice demonstrating a 68% improvement in activity in AML with AnnAraC over Annamycin alone combined with the human activity demonstrated in the highest dosing cohort in the single agent AML clinical trial, we concluded our single agent Annamycin clinical trial treating AML and focused on this combination trial.
+Added: Annamycin - An investigator sponsored trial (externally funded) was initiated in Poland in 2022 to study an alternative dosing regimen for Annamycin in the treatment of STS lung mets.
+Added: This trial began administering drug to subjects in late 2022.
+Added: WP1066 - In 2022, an investigational new drug (IND) application we filed in the US for a Phase 1 clinical trial studying WP1066 for treating glioblastoma multiforme (GBM) in adults went into effect.
+Added: Consistent with our strategy of leveraging external funding for many of our clinical trials, we intend to seek to capitalize on external funding with opportunities for an investigator-initiated clinical trial in adult cancer patients in 2023.
+Added: We supplied drug product to an externally funded pediatric brain tumor trial with WP1066 up to its conclusion in February 2023.
+Added: WP1122 - Our Phase 1a clinical trial of WP1122 in the United Kingdom for the treatment of COVID-19 for which we later received the appropriate authorization to proceed.
+Added: This trial began recruiting in 2022, and we completed the trial in late 2022, establishing an RP2D.
+Added: We are in the process of completing this trial - locking the database and finalizing a clinical study report (CSR).
+Added: This RP2D will possibly aid in future externally funded trials for the treatment of certain viruses and cancers as we look for investigator led studies.
+Added: WP1122 - In 2022, we filed an IND with the FDA that then went into effect, allowing us to proceed with a clinical trial using WP1122 for the treatment of GBM.
+Added: This may lead to an oncology investigator-initiated trial (IIT).
+Added: Additionally, an investigator filed independently a CTA in Brazil in 2022 to study WP1122 for the treatment of moderate to severe COVID-19.
+Added: Based on current COVID-19 epidemiology, we do not expect this externally funded trial to be conducted.
+Added: Additionally, we are in discussions with research institutions in the US, Asia, and South America regarding possible externally funded trials or programs involving WP1066 and WP1122.
+Added: In terms of developing preclinical data, we have our own lab and consultants with our employees conducting research and, we sponsor research at MD Anderson to expand the science of our core technologies and possible combinations with other approved drugs.
+Added: We have an National Institutes of Health or NIH funded preclinical study with WP1096 (from the WP1122 portfolio) for the treatment of the Tacaribe Arenavirus.
Moleculin Biotech, Inc.
13 unchanged sentences
Research and Development Expense  
−Removed: Research and development (R&D) expense was $14.4 million and $12.8 million for the years ended December 31, 2021 and 2020, respectively.
−Removed: The increase in R&D of $1.6 million is mainly rela ted to an 
−Removed: increase in the number of internally funded clinical trials and overall clinical trial activity, and costs related to manufacturing of additional drug product . 
+Added: Research and development (R&D) expense w as 
+Added: $19.0  million and $14.4 million for the years ended December 31, 2022 and 2021, respectively.
+Added: The increase in R&D of $4.6 million is mainly rela ted to increased clinical trial activity, as described above, and costs related to manufacturing of additional drug product. 
+Added: 2 In discussions of “no cardiotoxicity”
+Added: of Annamycin, management’s beliefs are based on an expert’s opinion based their review of certain clinical trial subject data including LVEF, ECHO strain analyses, and cardiac biomarkers –
+Added: troponin’s I & T
General and Administrative Expense  
−Removed: General and administrative (G&A) expense was $8.4 million and $6.8 million for the years ended December 31, 2021 and 2020, respectively.
−Removed: The increase in G&A of $1.6 million was mainly attributable to an increase in headcount, consulting & advisory fees, and an increase in our corporate insurance.
+Added: General and administrative (G&A) expense was $11.5  million a nd $8.4 million for the years ended December 31, 2022 and 2021, respectively.
+Added: The increase in G&A of $3.1 million was mainly attributable to an increase in regulatory and legal services, and consulting & advisory fees.
Gain from Change in Fair Value of Warrant Liability
−Removed: We recorded a gain of $6.7 million during the year ended December 31, 2021 as compared to a gain of $2.3 million, during the year ended December 31, 2020, for the change in fair value on revaluation of our warrant liability associated with our warrants issued in conjunction with our stock offerings.
+Added: We recorded a gain of $1.3  million du ring the year ended December 31, 2022 as compared to a gain of $6.7 million, during the year ended December 31, 2021, for the change in fair value on revaluation of our warrant liability associated with our warrants issued in conjunction with our stock offerings.
We are required to revalue certain of the warrants at the time of each warrant exercise and at the end of each reporting period and reflect in the statement of operations a gain or loss from the change in fair value of the warrant in the period in which the change occurred.
1 unchanged sentence
Generally, a gain results principally from a decline in our share price during the period and a loss results principally from an increase in our share price.
−Removed: The net loss for the year ended December 31, 2021 was $15.9 million, which included non-cash gains of $6.7 million on warrants in 2021 as compared to $2.3 million in the prior year and approximately $2.4 million of stock-based compensation expense in 2021 as compared to $1.7 million in 2020.
+Added: The net loss for the year ended December 31, 2022 wa s $29.0  million, which included non-cash gains of $1.3  million on wa rrants in 2022 as compared to $6.7 million in the prior year and approximately $2.3 million o f stock-based compensation expense in 2022 as compared to $2.4 million in 2021.
Liquidity and Capital Resources 
As of December 31, 2022 , we had cash and cash equivalents of $43.1  million and prepaid expenses and other current assets of $2.5  million.
−Removed: We also had $1.4  million of accounts payable and $2.3  million of accru ed expenses and other current liabilities.
+Added: We also had $2.1  million of accounts payable and $2.7  million of accrued expenses and other current liabilities.
A significant portion of the accounts payable and accrued expenses are due to work performed in relation to our preclinical activities and our clinical trials.
−Removed: For the years ended December 31, 2021 and 2020, we used approximately $19.0  million a nd $17.8 million of cash in operating activities, respectively, which represents cash outlays for research and development and general and administrative expenses in such periods.
−Removed: The increased cash outflows in 2021 reflect the increase in preclinical and clinical activity over 2020.
−Removed: For the year ended December 31, 2021, net proceeds from financing activities were $74.7  million, pre dominately from the sale of our common stock and warrants.
+Added: For the years ended December 31, 2022 and 2021, we used approxima tely $27.6  million and $19.0  million of cash in operating activities, respectively, which represents cash outlays for research and development and general and administrative expenses in such periods.
+Added: The increased cash outflows in 2022  was primarily due to payments for increased clinical trial activity, costs related to manufacturing of additional drug product, and increased consulting, legal, and advisory fees.
+Added: For the year ended December 31, 2022, there were no net proceeds from financing activities.
In 2021, approximately $74.7 million was raised predominately through the sale of shares of common stock and the exercise of warrants.
Cash used in investing activities for the year ended December 31, 2022 was approximately$0.1  million.
−Removed: We believe that our cash resources as of December 31, 2021, along with the additional funding received subsequent to year-end, will be sufficient to meet our projected operating requirements, which include a potential increase over our current R&D rate of expenditures, into the year 2024.
+Added: We believe that our cash resources as of December 31, 2022, will be sufficient to meet our projected operating requirements 
+Added: into the third quarter of 2024.
Such projections are subject to changes in our internally funded preclinical and clinical activities, including unplanned preclinical and clinical activity.
3 unchanged sentences
A failure to raise sufficient capital could adversely impact our ability to achieve our intended business objectives and meet our financial obligations as they become due and payable.
+Added: In March 2022, we received a subpoena from the SEC requesting information and documents, including materials related to certain individuals (none of which are our officers or directors) and entities, and materials related to the development of and statements regarding our drug candidate for the treatment of COVID-19.
+Added: We have received, and expect to continue to receive, periodic further requests from the SEC staff with respect to this matter.
+Added: We are not aware of the specific nature of the underlying investigation by the SEC, and to the extent that this investigation relates to prior public disclosures that we have made, we believe in the accuracy and adequacy of such prior disclosures.
+Added: The correspondence from the SEC transmitting the subpoena to us states that the SEC is trying to determine whether there have been any violations of federal securities laws, but that its investigation does not mean that the SEC has concluded that anyone has violated the law or that the SEC has a negative opinion of any person, entity, or security. We cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation.
+Added: During the year ended December 31, 2022, we have expensed approximately $2.4 million in related legal fees and expenses.
+Added: We estimate that potentially an additional $1 million in legal costs will be incurred in 2023 in connection with our response to this subpoena.
Stock Offerings
3 unchanged sentences
On February 10, 2021, the underwriters of the public offering exercised in full their option to purchase an additional 2,141,052 shares of common stock at the public offering price of $4.75 per share, bringing total gross proceeds to approximately $78.0 million before underwriting discount.
−Removed: In February 2020 we entered into subscription agreements with certain institutional investors for the sale of up to 1,250,000 shares of our common stock (taking into account the one-for-six reverse stock split completed January 29, 2021) and warrants to purchase 937,501 shares of common stock (taking into account the one-for-six reverse stock split completed January 29, 2021) at a combined public offering price of $4.80 per share and related warrant.
−Removed: The warrants were exercisable commencing six months from the date of issuance at a price of $6.30 per share and will expire five years from the date they are first exercisable.
−Removed: The offering closed on February 10, 2020 and gross proceeds of the offering were approximately $6.0 million, prior to deducting the placement agent fees and other estimated offering expenses.
Lincoln Park Equity Lines
3 unchanged sentences
As of the date of this report, there have been no issuances under the Lincoln Park Agreement.
−Removed: In November 2020, we entered into a purchase agreement (the 2020 Purchase Agreement) with Lincoln Park Capital Fund, LLC (Lincoln Park).
−Removed: Pursuant to the terms of the 2020 Purchase Agreement, Lincoln Park agreed to purchase from us up to $22.0 million of our common stock (subject to certain limitations) from time to time during the term of the 2020 Purchase Agreement. Pursuant to the terms of the 2020 Purchase Agreement, at the time we signed the 2020 Purchase Agreement, we issued 126,699 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the 2020 Purchase Agreement.
−Removed: During the year ended December 31, 2020, pursuant to the 2020 Purchase Agreement, we sold Lincoln Park 638,203 shares of common stock, and issued a total of 133,017 commitment shares, at an average price of $4.30 per share, resulting in gross proceeds of $2.7 million.
−Removed: We terminated the 2020 Purchase Agreement on February 2, 2021. 
ATM Agreements
2 unchanged sentences
As of the date of this report, there have been no issuances under the 2021 ATM Agreement.
−Removed: In January 2021, we issued 468,684 shares for gross proceeds of $2.9 million using our 2020 ATM Agreement with Oppenheimer & Co., Inc. 
−Removed: In July 2020, we entered into a new At Market Issuance Sales Agreement with Oppenheimer & Co.
−Removed: (the 2020 ATM Agreement).
−Removed: Pursuant to the terms of the 2020 ATM Agreement, we were able to sell from time to time through Oppenheimer shares of our common stock with an aggregate sales price of up to $15.0 million.
−Removed: During the year ended December 31, 2020, pursuant to the 2020 ATM Agreement, we issued 471,405 shares of common stock at an average price of $6.11 per share, resulting in net proceeds of $2.8 million.
−Removed: In addition, at December 31, 2020, we had 26,966 shares of our common stock subscribed in ATM transactions under the 2020 ATM Agreement for net proceeds, after deducting commissions and other transaction costs, of approximately $0.1 million at an average selling price of $4.96 per share.
−Removed: Accordingly, we have recorded a subscription receivable of $0.1 million as a reduction of stockholders' equity in our consolidated balance sheet as of December 31, 2020.
+Added: The Company terminated the 2021 ATM Agreement on February 3, 2023.
+Added: In January 2021, we issued 468,684 shares for gross proceeds of $2.9 million using our 2020 ATM Agreement with Oppenheimer & Co., Inc.
We terminated the 2020 ATM Agreement on February 2, 2021.
−Removed: In July 2019, we entered into an at-the-market equity agreement (the 2019 ATM Agreement) with Oppenheimer & Co.
−Removed: During the year ended December 31, 2021, pursuant to the 2019 ATM Agreement, we issued 1,412,017 shares of common stock at an average price of $8.68 per share, resulting in net proceeds of $11.9 million.
−Removed: We paid a commission to Oppenheimer equal to 3.0% of the gross proceeds from the sale of our common stock under the 2019 ATM Agreement.
−Removed: In the third quarter of 2020, the 2019 ATM Agreement expired and was terminated.
+Added: Additionally, during the first quarter of 2021, 10,000 shares were issued due to the exercise of warrants related to past public offerings.
+Added: Gross proceeds received due to these exercises approximated $63,000.
The following table sets forth the primary sources and uses of cash for the years indicated (in thousands):
2 unchanged sentences
Net cash used in investing activities
−Removed: Net cash provided by financing activities
+Added: Net cash provided by (used in) financing activities
Effect of exchange rate changes on cash and cash equivalents
Net change in cash and cash equivalents
−Removed: As of December 31, 2021, there was $0.3 million of cash on hand in a bank account in Australia and we know of no related limitations impacting our liquidity in Australia.
+Added: As of December 31, 2022, there was $0.3 million of cas h on hand in a bank account in Australia and we know of no related limitations impacting our liquidity in Australia.
Cash used in operating activities
−Removed: Net cash used in operating activities was $19.0  million f or the year ended December 31, 2021 compared to $17.8 million for the year ended December 31, 2020.
−Removed: This increase in use of cash for operations was mainly due to payments for increased clinical trial activity, costs related to manufacturing of additional drug product, and increased consulting and advisory fees as well as an increase in our corporate insurance.
+Added: Net cash used in operating activities was$27.6  million for the year ended December 31, 2022 compared to $19.0 million for the year ended December 31, 2021.
+Added: This increase in use of cash for operations was mainly due to payments for increased clinical trial activity, costs related to manufacturing of additional drug product, and increased consulting, legal and advisory fees.
These are all a reflection of the ongoing clinical and pre-clinical activity and the associated increase in G&A support for our three core drug technologies.
Cash used in investing activities
−Removed: Net cash used in investing activities w as $0.02  million f or the year ended December 31, 2021 compared to $0.4 million for the year ended December 31, 2020.
−Removed: The decrease relates to mass spectrometer equipment purchased for the lab in 2020.
−Removed: The equipment is being used to analyze uptake, metabolism, and tissue organ distribution of anti-cancer and anti-viral agents, which is critical for determination of pharmacokinetic and pharmacodynamic parameters of the drug.
+Added: Net cash used in investing activities w as de minimis  f or the years ended December 31, 2022 and December 31, 2021, respectively. 
Cash provided by financing activities
−Removed: Net cash provided by financing activities was $74.7  million f or the year ended December 31, 2021 compared to the prior period of $22.5 million.
−Removed: Net cash provided by financing in 2021 consisted primarily of $74.6 million net proceeds from the issuance of common stock, and $0.1 million net proceeds from the exercise of warrants.
−Removed: The prior period financing activities consisted primarily of net proceeds from the issuance of common stock.
+Added: Net cash provided by financing activities was de minimis  f or the year ended December 31, 2022 compared to the prior period of $74.7 million.
+Added: Net cash provided by financing in 2021 consisted primarily of $74.6 million net proceeds from the issuance of common stock, and $0.1 million net proceeds from the exercise of warrants. 
Off-Balance Sheet Transactions
2 unchanged sentences
We have implemented all new accounting pronouncements that are in effect and may impact our financial statements and we do not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on our financial position or results of operations.
−Removed: Critical Accounting Policies and Significant Judgments and Estimates
−Removed: Basis of Presentation
+Added: Critical Accounting Policies and Significant Judgments and Estimates 
The accompanying consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP) for financial information, and in accordance with the rules and regulations of the United States Securities and Exchange Commission (SEC).
19 unchanged sentences
If such review indicates that the carrying amount of IPR&D assets is not recoverable, the carrying amount of such asset is reduced to fair value.
−Removed: Components of our Results of Operations and Financial Condition
+Added: Components of our Results of Operations, Net Loss and Financial Condition
Operating expenses
18 unchanged sentences
We expect our general and administrative expense to increase due to the anticipated growth of our business and related infrastructure as well as accounting, insurance, investor relations and other costs associated with becoming a public company.
−Removed: Depreciation.
−Removed: Depreciation expense consists of depreciation on our property and equipment.
+Added: Depreciation and Amortization.
+Added: Depreciation and amortization expense consists of depreciation on our property and equipment.
We depreciate our assets over their estimated useful life.
45 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.