7 unchanged sentences
This management’s discussion and analysis
−Removed: of financial condition as of March 31, 2022 and results of operations for the three months ended March 31, 2022 and 2021 should be read
−Removed: in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021, which was
−Removed: filed with the Securities and Exchange Commission (the “ SEC ”) on March 22, 2022.
+Added: of financial condition as of June 30, 2022 and results of operations for the three and six months ended June 30, 2022 and 2021 should
+Added: be read in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021,
+Added: which was filed with the Securities and Exchange Commission (the “ SEC ”) on March 22, 2022.
This report contains forward-looking statements
14 unchanged sentences
results to vary from expected results expressed in our forward-looking statements include, but are not limited to, the impact to our business
−Removed: and operations by the ongoing coronavirus pandemic, the development of our product candidates, our ability to execute on business strategies,
−Removed: our ability to develop our product candidates with collaboration partners, and the success of any such collaborations, the timeline and
−Removed: duration for advancing our product candidates into clinical development, results from our preclinical and clinical activities, the timing
−Removed: or likelihood of regulatory filings and approvals, the success of our efforts to commercialize our product candidates if approved, our
−Removed: ability to manufacture and supply our product candidates for clinical activities, and for commercial use if approved, the scope of protection
−Removed: we are able to establish and maintain for intellectual property rights covering our technology platform, and our ability to obtain future
−Removed: Our actual results and financial condition may differ materially from those indicated in the forward-looking statements as
−Removed: a result of a number of important factors, including those identified in our Annual Report on Form 10-K for the year ended December 31,
−Removed: 2021 under the heading “Risk Factors” and in other filings the Company periodically makes with the SEC.
−Removed: Therefore, you should
−Removed: not rely on any of these forward-looking statements.
−Removed: Forward-looking statements contained in this Quarterly Report on Form 10-Q speak
−Removed: as of the date hereof and the Company does not undertake to update any of these forward-looking statements to reflect a change in its
−Removed: views or events or circumstances that occur after the date of this report.
+Added: and operations by the ongoing coronavirus pandemic, military conflict between Ukraine and Russia, inflationary pressures, rising interest
+Added: rates, recession fears, the development of our product candidates, our ability to execute on business strategies, our ability to develop
+Added: our product candidates with collaboration partners, and the success of any such collaborations, the timeline and duration for advancing
+Added: our product candidates into clinical development, results from our preclinical and clinical activities, the timing or likelihood of regulatory
+Added: filings and approvals, the success of our efforts to commercialize our product candidates if approved, our ability to manufacture and
+Added: supply our product candidates for clinical activities, and for commercial use if approved, the scope of protection we are able to establish
+Added: and maintain for intellectual property rights covering our technology platform, and our ability to obtain future financing.
+Added: results and financial condition may differ materially from those indicated in the forward-looking statements as a result of a number of
+Added: important factors, including those identified in our Annual Report on Form 10-K for the year ended December 31, 2021 under the heading
+Added: “Risk Factors” and in other filings the Company periodically makes with the SEC.
+Added: Therefore, you should not rely on any of
+Added: these forward-looking statements.
+Added: Forward-looking statements contained in this Quarterly Report on Form 10-Q speak as of the date hereof
+Added: and the Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances
+Added: that occur after the date of this report.
Phio Pharmaceuticals Corp.
21 unchanged sentences
therapeutics administered directly, we can also reprogram cells in the TME to help overcome these immunosuppressive mechanisms.
−Removed: Use of INTASYL To Improve
−Removed: Adoptive Cell Therapy Products
+Added: Use of INTASYL To Improve Adoptive Cell
+Added: Therapy Products
ACT consists of the administration
17 unchanged sentences
approach builds on well-established methodologies of ACT and involves the treatment of immune cells with our INTASYL compounds ex
−Removed: vivo while they are growing in the lab and before administering them to the patient.
−Removed: In contrast to other RNA technologies, our
−Removed: INTASYL compounds do not require a delivery vehicle or specialized delivery tools to deliver the RNA drugs into the cells.
−Removed: we are able to enhance the function of these cells by merely adding our INTASYL compounds during the expansion process and without the
−Removed: need for genetic engineering, complex delivery vehicles or formulations, or additional complex manufacturing steps, which in themselves
−Removed: may be detrimental to the cells.
−Removed: By adding INTASYL to the cell culture media used during the cell expansion, we can reduce or eliminate
−Removed: the expression of genes that make the immune cells less effective.
+Added: vivo , or outside the body, while they are growing in the lab and before administering them to the patient.
+Added: In contrast to other
+Added: RNA technologies, our INTASYL compounds do not require a delivery vehicle or specialized delivery tools to deliver the RNA drugs into
+Added: Therefore, we are able to enhance the function of these cells by merely adding our INTASYL compounds during the expansion process
+Added: and without the need for genetic engineering, complex delivery vehicles or formulations, or additional complex manufacturing steps, which
+Added: in themselves may be detrimental to the cells.
+Added: By adding INTASYL to the cell culture media used during the cell expansion, we can reduce
+Added: or eliminate the expression of genes that make the immune cells less effective.
lead product candidate, and our most advanced program being developed by the Company in ACT, is PH-762.
25 unchanged sentences
focus on conducting a clinical trial for PH-762 treated DP TILs.
−Removed: Under the Clinical Agreement, we will provide financial support to AgonOx
−Removed: to conduct a clinical trial in ACT with their DP TIL technology and PH-762.
−Removed: We will be entitled to certain future development milestones
−Removed: and low single-digit sales-based royalty payments from AgonOx’s licensing of its DP TIL technology.
−Removed: Financial support to AgonOx
−Removed: under the Clinical Agreement has not yet commenced.
−Removed: The Company expects to start the clinical trial evaluating the use of PH-762 and DP
−Removed: TILs in ACT in the third quarter of 2022.
+Added: Under the Clinical Agreement, we will provide financial support of up
+Added: to $4 million to AgonOx to conduct a clinical trial in ACT with their DP TIL technology and PH-762.
+Added: We will be entitled to certain future
+Added: development milestones and low single-digit sales-based royalty payments from AgonOx’s licensing of its DP TIL technology.
+Added: support to AgonOx under the Clinical Agreement has not yet commenced.
+Added: The Company expects to initiate the clinical trial evaluating the
+Added: use of PH-762 and DP TILs in ACT in the fourth quarter of 2022.
use in ACT is not limited to TILs, but can also be used on other forms of T cell-based cell therapy.
16 unchanged sentences
cannot be used and small molecule inhibitors tested to date typically lack the required specificity.
−Removed: As our INTASYL compounds can target
−Removed: intracellular proteins as well as extracellular proteins with a high level of specificity, we believe that PH-894 has significant potential.
−Removed: In collaboration with the Karolinska Institutet in Sweden, PH-894 has been shown to improve T cell function and persistence by differentiating
−Removed: T cells into a more active state (stem-cell like memory phenotype).
−Removed: We have demonstrated that the application of PH-894 can silence BRD4
−Removed: in human T cells during expansion for ACT, which has the potential to confer superior anti-tumor activity.
+Added: As our INTASYL compounds can address
+Added: intracellular as well as extracellular gene targets with a high level of specificity, we believe there is potential for PH-894 to play
+Added: a role in boosting the potency of the next generation of T cell products to enhance ACT for solid tumors, and without using genetic manipulation.
+Added: PH-894 has been shown to improve
+Added: T cell function and persistence by differentiating T cells into a more active state (stem-cell like memory phenotype).
+Added: Recent preclinical
+Added: data was presented showing that silencing BRD4 with PH-894 may be used to improve the characteristics of CAR-T cell products during the
+Added: activation and expansion phases of the cell manufacturing process.
+Added: These data demonstrate that PH-894 could enhance the activity of CAR-T
+Added: cells by improving the quality of the final CAR-T cell product by overcoming immunosuppression, reversing exhaustion, and preserving the
+Added: characteristics associated with cell persistence.
INTASYL compound PH-804 is also being developed for use in ACT.
11 unchanged sentences
Cancer cells have evolved
−Removed: natural defenses that can suppress the immune system surrounding the tumor, in an area called the TME, which decreases the effectiveness
+Added: natural defenses that can suppress the immune system surrounding the tumor, an area called the TME, which decreases the effectiveness
of many traditional immunotherapies.
3 unchanged sentences
targets both inside and on the surface of tumor and immune cells, creating multiple ways to prevent tumors from evading immune detection.
−Removed: Our INTASYL compounds can target both intracellular and extracellular targets and are also being developed for use as direct therapeutics
−Removed: to reprogram the TME, including by local administration and activation of immune cells in the TME, and/or lowering the tumor cells
+Added: Our INTASYL compounds can target both intracellular and extracellular gene targets and are also being developed for use as direct therapeutics
+Added: to reprogram the TME, including by local administration and activation of immune cells in the TME, and/or lowering the tumor cell’s
Therefore, we believe INTASYL-based therapeutics can be a novel way of fighting cancer by reprogramming the cells in the TME
to make cancer more responsive to a patient’s immune system and to other anti-cancer drugs.
−Removed: most advanced program being developed by the Company in our direct therapeutic programs, is PH-762.
−Removed: We have shown that we can reprogram
−Removed: the TME with PH-762 and achieve local activation of immune cells.
−Removed: Preclinical studies conducted by the Company demonstrated that local
−Removed: administration of PH-762 through intratumoral injection resulted in potent anti-tumoral effects.
−Removed: Treated animals showed a complete and
−Removed: statistically significant inhibition of tumor growth, whereas placebo treated animals displayed exponential tumor growth.
−Removed: has shown that intratumoral treatment with PH-762 inhibits tumor growth in a dose dependent fashion in PD-1 responsive and refractory
−Removed: Furthermore, on-target efficacy was supported by modulation of immune cell populations toward anti-tumor phenotypes.
−Removed: local administration of PH-762 resulted in activity against distal untreated tumors, indicative of a systemic anti-tumor response.
−Removed: Company believes this data further supports the potential for PH-762 to provide a strong local immune checkpoint blockade without the
−Removed: dose immune-related adverse effects seen with systemic antibody therapy.
+Added: most advanced program in human clinical trials being developed by the Company in our direct therapeutic programs, is PH-762.
+Added: shown that we can reprogram the TME with PH-762 and achieve local activation of immune cells.
+Added: Preclinical studies conducted by the
+Added: Company demonstrated that local administration of PH-762 through intratumoral injection resulted in potent anti-tumoral effects.
+Added: Treated animals showed a complete and statistically significant inhibition of tumor growth, whereas placebo treated animals
+Added: displayed exponential tumor growth.
+Added: In vivo data has shown that intratumoral treatment with PH-762 inhibits tumor
+Added: growth in a dose dependent fashion in PD-1 responsive and refractory models.
+Added: Furthermore, on-target efficacy was supported by
+Added: modulation of immune cell populations toward anti-tumor phenotypes.
+Added: Importantly, local administration of PH-762 resulted in activity
+Added: against distant untreated tumors, indicative of a systemic anti-tumor response.
+Added: The Company believes this data further supports the
+Added: potential for PH-762 to provide a strong local immune checkpoint blockade without the dose immune-related adverse effects seen with
+Added: systemic antibody therapy.
In January 2022, the Company
was granted clinical trial authorization by the French National Agency for the Safety of Medicines and Health Products to proceed
−Removed: with our first in-human clinical trial for PH-762 to treat patients with melanoma at the Gustave Roussy Institute, one of the largest
+Added: with our first in-human clinical trial for PH-762 to treat subjects with melanoma at the Gustave Roussy Institute, one of the largest
cancer centers in Europe.
2 unchanged sentences
Currently, there are no neoadjuvant treatment
−Removed: options approved for these patients.
+Added: options approved for these subjects.
The clinical trial will feature a dose escalation of PH-762 monotherapy with a maximum of 5 dose
−Removed: escalation cohorts and up to a maximum of 21 patients.
−Removed: Patients eligible for enrollment include those with Stage IIIB/IIIC or Stage IV
+Added: escalation cohorts and up to a maximum of 21 subjects.
+Added: Subjects eligible for enrollment include those with Stage IIIB/IIIC or Stage IV
resectable oligometastatic melanoma.
−Removed: Enrolled patients will receive a weekly dose of PH-762 for four weeks and receive surgical resection
+Added: Enrolled subjects will receive a weekly dose of PH-762 for four weeks and receive surgical resection
surgery of their tumor(s) four weeks after treatment with PH-762.
1 unchanged sentence
recommended Phase 2 dose.
−Removed: The clinical trial site is open for enrollment and the Company anticipates top-line data from the first group
−Removed: of patients in the first quarter of 2023.
−Removed: However, the impact of the ongoing coronavirus pandemic on the enrollment of patients in the
−Removed: clinical trial is not yet known and highly difficult to predict and therefore, may result in delays to our expected timelines.
+Added: The Company has initiated dosing of subjects and the site is open for continued enrollment.
+Added: The Company anticipates
+Added: top-line data from the first group of subjects in the first quarter of 2023, however, the impact of the ongoing coronavirus pandemic on
+Added: the enrollment of subjects in the clinical trial is not yet known and highly difficult to predict;
+Added: and therefore, may result in delays
+Added: to our expected timelines.
second direct to tumor product candidate is PH-894.
−Removed: In a study conducted in collaboration with the Karolinska Institutet in Sweden, we
−Removed: demonstrated that PH-894 resulted in a strong, concentration dependent and durable silencing of BRD4 in T cells, and in various cancer
−Removed: Data published with PH-894 in a hepatocellular carcinoma model showed potent and statistically significant anti-tumoral effects
−Removed: when administered locally.
−Removed: These data show that our PH-894 compound can reprogram T cells and other cells in the TME to provide enhanced
−Removed: immunotherapeutic activity.
−Removed: In vivo data by the Company has shown that local administration of PH-894 also resulted in a systemic
−Removed: anti-tumor response, similar to PH-762.
−Removed: Data recently presented at the 2022 American Association for Cancer Research Annual Meeting demonstrated
−Removed: that PH-894 provided abscopal efficacy toward untreated distal tumors and potentiated the efficacy of systemic anti-PD-1 antibody therapy.
−Removed: After local administration of PH-894 in in vivo studies conducted in colon and liver cancer models, strong anti-tumor efficacy
−Removed: was seen in directly treated, as well as distal untreated tumors.
−Removed: Additionally, intratumoral treatment with PH-894 enhanced the anti-tumor
−Removed: efficacy of systemic anti-PD-1 antibody therapy for both the locally treated tumors and the untreated tumors.
−Removed: With this data, there is
−Removed: potential for PH-894 to be used in treating patients who do not respond to anti-PD-1 therapy, or patients who progress after initially
−Removed: responding to such therapy.
−Removed: PH-894 demonstrates the power of our INTASYL compounds to modulate the expression of intracellular and/or
−Removed: commonly considered “undruggable” targets, a limitation for small molecule and antibody therapies.
−Removed: The Company currently expects
−Removed: to finalize IND-enabling studies for PH-894 in the second half of 2022.
−Removed: We are also investigating
−Removed: the use of INTASYL to target multiple genes in a single formulation.
−Removed: New study data showed that PH-3861, a dual-targeting INTASYL towards
−Removed: PD-1 and BRD4, elicited a complete cure of tumors in an in vivo hepatoma model and outperformed the efficacy of the small
−Removed: molecule and antibody control treatments toward the same targets.
−Removed: In addition, local INTASYL therapy was shown to induce a systemic anti-tumor
−Removed: response with the clearance of untreated distal tumors.
−Removed: The animals which showed a complete cure of their tumors were then rechallenged
−Removed: over two months after the original treatment of PH-3861 by re-implanting hepatoma cancer cells at a different location than the original
−Removed: All of the animals that were rechallenged with new tumors were cured again without requiring further treatment, while tumors grew
−Removed: steadily in the control group as expected.
−Removed: We believe that these data demonstrate that local administration of PH-3861 provides a durable
−Removed: and systemic anti-tumor immune response that can combat tumor growth.
+Added: We have presented data demonstrating that PH-894 resulted in a strong, concentration
+Added: dependent and durable silencing of BRD4 in T cells, and in various cancer cells.
+Added: Data published with PH-894 in a hepatocellular carcinoma
+Added: model showed potent and statistically significant anti-tumoral effects when administered locally.
+Added: These data show that our PH-894 compound
+Added: can reprogram T cells and other cells in the TME to provide enhanced therapeutic activity.
+Added: Similar to PH-762, we’ve shown that local
+Added: administration of PH-894 in vivo has resulted in a systemic anti-tumor response.
+Added: After local administration of PH-894 in in
+Added: vivo studies conducted in colon and liver cancer models, strong anti-tumor efficacy was seen in directly treated, as well as in distant
+Added: untreated tumors.
+Added: Additionally, PH-894 enhanced the anti-tumor efficacy of systemic anti-PD-1 antibody therapy for both the locally treated
+Added: tumors and the untreated tumors.
+Added: With these data, there is potential for PH-894 to be used in treating patients who do not respond to
+Added: anti-PD-1 therapy, or with patients who progress after initially responding to such therapy.
+Added: PH-894 demonstrates the power of our INTASYL
+Added: compounds to modulate the expression of intracellular and/or commonly considered “undruggable” targets, a limitation for small
+Added: molecule and antibody therapies.
+Added: The Company currently expects to finalize IND-enabling studies for PH-894 in the fourth quarter of 2022.
+Added: investigating the use of INTASYL to target multiple genes in a single formulation.
+Added: New study data showed that PH-3861, a
+Added: dual-targeting INTASYL towards PD-1 and BRD4, elicited a complete cure of tumors in an in vivo hepatoma model and
+Added: outperformed the efficacy of the small molecule and antibody control treatments toward the same targets.
+Added: In addition, local INTASYL
+Added: therapy was shown to induce a systemic anti-tumor response with the clearance of untreated distal tumors.
+Added: The animals which showed a
+Added: complete cure of their tumors were then rechallenged over two months after the original treatment of PH-3861 by re-implanting
+Added: hepatoma cancer cells at a different location than the original tumor.
+Added: All of the animals that were rechallenged with new tumors
+Added: were cured again without requiring further treatment, while tumors grew steadily in the control group as expected.
+Added: We believe that
+Added: these data demonstrate that local administration of PH-3861 provides a durable and systemic anti-tumor immune response that can
+Added: combat tumor growth.
of the Coronavirus Pandemic
1 unchanged sentence
The Company’s corporate headquarters and research
−Removed: facility have seen limited impact and, during the three months ended March 31, 2022, continued to
−Removed: operate with safety measures in place for the health and well-being of its employees, such as working remotely and flexible scheduling,
+Added: facility have seen limited impact and, during the three and six months ended June 30, 2022, continued
+Added: to operate with safety measures in place for the health and well-being of its employees, such as working remotely and flexible scheduling,
in accordance with guidance from federal, state and local authorities.
The Company believes that that coronavirus pandemic has not had
−Removed: a significant impact on its financial condition and results of operations for the three months ended March 31, 2022.
−Removed: However, the Company
−Removed: may experience delays in enrollment with its current clinical trial and with its clinical trial expected to commence in the middle of
−Removed: The extent to which the coronavirus pandemic will materially impact our financial results and operations will depend on a number
−Removed: of factors, including delays in our operations due to the limited availability of supplies and services we rely on, the ability to enroll
−Removed: patients in our clinical trials and the duration of the coronavirus pandemic, which remain difficult to predict and are highly uncertain.
+Added: a significant impact on its financial condition and results of operations for the three and six months ended June 30, 2022.
+Added: the extent to which the coronavirus pandemic may materially impact our financial results and operations will depend on a number of factors,
+Added: including the availability of supplies and services we rely on, the ability to enroll subjects in our clinical trials and the duration
+Added: of the coronavirus pandemic, which remain difficult to predict and are highly uncertain.
+Added: While we believe that the coronavirus
+Added: pandemic has not had a significant impact on our financial condition and results of operations at this time, the potential economic impact
+Added: brought by the coronavirus pandemic, which may be exacerbated by the global macroeconomic uncertainty from the ongoing conflict between
+Added: Russia and Ukraine, is difficult to assess or predict.
+Added: There may be developments outside of our control that require us to adjust our
+Added: operating plans.
+Added: Given the nature of the situation, we cannot reasonably estimate the impact of the coronavirus pandemic on our financial
+Added: condition, results of operations or cash flows in the future.
+Added: has increased during the period covered by this report and is expected to continue to remain at elevated levels or even increase for the
+Added: Inflation generally affects us by increasing our cost of labor and certain research and development contract costs.
+Added: not believe inflation has had a material effect on our results of operations during the three and six months ended June 30, 2022.
Critical Accounting Policies and Estimates
15 unchanged sentences
operations for the periods indicated, in thousands:
−Removed: Three Months Ended
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Operating expenses
Operating loss
−Removed: Comparison of the Three Months Ended March 31, 2022 and 2021
+Added: Comparison of the Three and Six Months Ended June 30, 2022 and
Operating Expenses
1 unchanged sentence
expenses, for the periods indicated, in thousands:
−Removed: Three Months Ended
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Research and development
10 unchanged sentences
portion of our total operating expenses and are expected to constitute the majority of our spending for the foreseeable future.
−Removed: and development expenses for the three months ended March 31, 2022 decreased 35% as compared with the three months ended March 31, 2021.
−Removed: The decrease in research and development expenses was primarily due to the preclinical studies required for the Company’s clinical
−Removed: trial with PH-762 as a direct therapeutic and manufacturing costs for PH-762, both of which were conducted in the prior year period, offset
−Removed: by increases in CRO costs in preparation for the start of the Company’s clinical trial with PH-762 as a direct therapeutic and personnel-related
−Removed: expenses due to an increase in headcount as compared to the prior year period.
+Added: and development expenses for the three months ended June 30, 2022 decreased 16% as compared with the three months ended June 30, 2021.
+Added: The decrease in research and development expenses was primarily due to the completion of the preclinical studies with PH-762 required
+Added: for the Company’s clinical trial as a direct therapeutic and the manufacturing costs of PH-894 totaling approximately $315,000 in
+Added: the prior year period offset by an increase of approximately $77,000 in personnel-related expenses as a result of a higher headcount.
+Added: and development expenses for the six months ended June 30, 2022 decreased 28% as compared with the six months ended June 30, 2021.
+Added: decrease in research and development expenses was primarily due to the completion of the preclinical studies with PH-762 required for
+Added: the Company’s clinical trial as a direct therapeutic and the manufacturing costs for PH-762 and PH-894 totaling approximately $1,460,000
+Added: offset by an increase of approximately $149,000 in personnel-related expenses as a result of a higher headcount and increased third-party
+Added: professional service fees of approximately $207,000 as the Company prepared for and began its clinical trial with PH-762.
General and Administrative
1 unchanged sentence
fees for legal, audit, tax and consulting services, as well as other general corporate expenses.
−Removed: and administrative expenses for the three months ended March 31, 2022 decreased 13% as compared with the three months ended March 31,
−Removed: 2021, primarily due to decreases in legal and patent fees offset by an increase in stock-based compensation expense.
−Removed: income for the three months ended March 31, 2022 decreased by $233,000 as compared with the three months ended March 31, 2021, primarily
−Removed: due to the full forgiveness of the Company’s PPP loan in the first quarter of 2021.
+Added: General and administrative
+Added: expenses for the three months June 30, 2022 increased 8% as compared with the three months ended June 30, 2021.
+Added: The increase in general
+Added: and administrative expenses was primarily due to a total net increase of $130,000 in payroll and executive search-related expenses as
+Added: a result of the departure of the Company’s CEO.
+Added: General and administrative
+Added: expenses for the six months ended June 30, 2022 decreased 3% as compared with the six months ended June 30, 2021.
+Added: The decrease in general
+Added: and administrative expenses was primarily due to decreases in legal and patent fees of approximately $255,000 offset by a total net increase
+Added: of $130,000 in payroll and executive search-related as a result of the departure of the Company’s CEO.
+Added: Total Other (Expense) Income
+Added: Total other expense for the
+Added: three months ended June 30, 2022 and 2021 was consistent quarter over quarter.
+Added: Total other income for the six months ended June 30, 2022
+Added: decreased by $240,000 as compared with the six months ended June 30, 2021, primarily due to the full forgiveness of the Company’s
+Added: PPP loan in the first quarter of 2021.
Liquidity and Capital Resources
−Removed: Historically, the Company’s primary source
−Removed: of funding has been through the sale of its securities.
−Removed: In the future, we will be dependent on obtaining funding from third parties, such
−Removed: as proceeds from the issuance of debt, sale of equity or strategic opportunities, in order to maintain our operations.
−Removed: We have reported
−Removed: recurring losses from operations since inception and expect that we will continue to have negative cash flows from our operations for
−Removed: the foreseeable future.
−Removed: At March 31, 2022, we had cash of $20,459,000 as compared with $24,057,000 at December 31, 2021.
−Removed: For information regarding our cash commitments related to the clinical
−Removed: co-development agreement with AgonOx, see Note 10 to our condensed consolidated financial statements.
+Added: Historically, the Company’s
+Added: primary source of funding has been through the sale of its securities.
+Added: In the future, we will be dependent on obtaining funding from third
+Added: parties, such as proceeds from the issuance of debt, sale of equity or strategic opportunities, in order to maintain our operations.
+Added: have reported recurring losses from operations since inception and expect that we will continue to have negative cash flows from our operations
+Added: for the foreseeable future.
+Added: At June 30, 2022, we had cash of $18,020,000 as compared with $24,057,000 at December 31, 2021.
+Added: We believe that our existing
+Added: cash at June 30, 2022 should be sufficient to fund operations for at least the next 12 months from the date of the release of the
+Added: associated financial statements.
+Added: For information regarding
+Added: our cash commitments related to the clinical co-development agreement with AgonOx, see Note 9 to our condensed consolidated financial
In August 2019, the Company
entered into a purchase agreement (the “ Purchase Agreement ”) with Lincoln Park Capital, LLC (“ LPC ”),
−Removed: pursuant to which the Company has the right to sell to LPC up to $10,000,000 in shares of the Company’s common stock, subject to
+Added: pursuant to which the Company had the right to sell to LPC up to $10,000,000 in shares of the Company’s common stock, subject to
certain limitations and conditions set forth in the agreement.
−Removed: The Company is initially limited to the issuance of 19.99% of the Company’s
−Removed: shares outstanding on the date of the Purchase Agreement unless stockholder approval is obtained to issue more than such amount or the
−Removed: average price of all sales under the Purchase Agreement exceeds certain amounts set forth in the agreement.
−Removed: The Purchase Agreement expires
−Removed: To date, no shares of common stock have been sold to LPC under the Purchase Agreement.
−Removed: We believe that our existing
−Removed: cash at March 31, 2022 should be sufficient to fund operations for at least the next 12 months from the date of the release of the
−Removed: associated financial statements.
+Added: The Purchase Agreement expired in May 2022 and no shares of common stock
+Added: were sold to LPC under the Purchase Agreement.
The following table summarizes
our cash flows for the periods indicated, in thousands:
−Removed: Three Months Ended
+Added: Six Months Ended
Net cash used in operating activities
4 unchanged sentences
Net cash used in operating
−Removed: activities increased primarily due to the changes in operating assets and liabilities due to prepayments made for the required IND-enabling
−Removed: studies for PH-894 and payments for the manufacturing of clinical supply batches of PH-762 partially offset by a decrease in net loss
+Added: activities decreased primarily due to a decrease in net loss of $921,000 offset by the changes in operating assets and liabilities of
+Added: $608,000 due to prepayments made for the required IND-enabling studies for PH-894 and payments for the manufacturing of clinical supply
+Added: batches of PH-762 and PH-894 and $310,000 in non-cash related items primarily due to the full forgiveness of the Company’s PPP loan
+Added: in the prior year period.
Net Cash Flow from Investing Activities
Net cash used in investing
−Removed: activities was primarily related to the purchase of laboratory and computer equipment for the Company’s facility for the three months
−Removed: ended March 31, 2022 and 2021.
+Added: activities was primarily related to an increase of $93,000 in purchases of laboratory and computer equipment for the Company’s facility
+Added: as compared to the prior year period.
Net Cash Flow from Financing Activities
Net cash from financing activities
−Removed: decreased primarily due to the net proceeds received by the Company from capital raising activities and warrant exercises in the comparable
−Removed: prior year period.
+Added: decreased primarily due to the net proceeds of $21,723,000 received by the Company from capital raising activities and warrant exercises
+Added: in the comparable prior year period.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
2 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.