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Forza Novartis e Merck, riportateci dove eravamo prima del crollo.
Intech pharma
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- Data di inizio
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Non si muove nemmeno un foglia; silenzio totale da parte di Intec.
Ma la società esiste ancora ? Novartis e Merck che fine hanno fatto ?
Ma la società esiste ancora ? Novartis e Merck che fine hanno fatto ?
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Intec Pharma Reports Third Quarter 2019 Financial Results and Provides Business Update
November 12, 2019 at 7:02 AM EST
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JERUSALEM, Nov. 12, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces financial results for the three and nine months ended September 30, 2019.
Highlights of the third quarter 2019 and recent weeks include:
•Presented two posters highlighting data from the Company's Phase 3 clinical development program for the Accordion Pill® Carbidopa/Levodopa (AP-CD/LD) at the International Congress of Parkinson's and Movement Disorder Society (MDS 2019);
•Completed the qualification studies for the commercial scale manufacture of AP-CD/LD with our partner, LTS LohmanTherapie-Systeme (LTS);
•Announced topline results from the Company's pivotal Phase 3 trial (ACCORDANCE) evaluating the safety and efficacy of the AP-CD/LD compared with immediate release CD/LD (IR-CD/LD; Sinemet®) as a treatment for the symptoms of advanced Parkinson's disease (PD), reporting that AP-CD/LD provided treatment for Parkinson's disease symptoms but did not demonstrate statistical superiority to IR-CD/LD in terms of reduction in OFF time from baseline under the conditions established in the protocol; and
•Completed the pharmacokinetic (PK) study of the custom-designed AP developed for a proprietary compound under the previously announced feasibility and option agreement with Novartis Pharmaceuticals.
Management Commentary
"We gained important information and knowledge from the ACCORDANCE study that we believe makes AP-CD/LD an attractive partnership opportunity for late-stage development and commercialization. First, the ACCORDANCE results validate the AP platform and provide very important long-term safety data. The responder analysis and subset analyses provide key insights for future study design and dosing that should be invaluable to a potential partner. We have qualified the commercial scale manufacturing process with LTS, which can also be used to provide clinical supply for the next Phase 3 study. This is a key advantage as Chemistry, Manufacturing and Controls (CMC) is a critical component in drug development and one that often trips up small companies. Importantly, there continues to be a large unmet need for a better baseline LD, which we believe provides a significant market opportunity of between $200 - $500 million," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
"We were delighted to present two posters highlighting AP-CD/LD at MDS 2019 in late September. We were particularly pleased to have our Phase 3 ACCORDANCE clinical trial poster chosen for the conference's Guided Tour, a distinction that drives attendees to view the approximately ten percent of posters selected for inclusion. Consequently, there was considerable interest in our program's results. We believe the data underscored the potential of AP-CD/LD as a better baseline levodopa therapy in PD while highlighting its long-term safety data. In tandem, we are in the process of seeking to partner AP-CD/LD in PD and found it most beneficial to have these data delivered at this important medical meeting. The continued understanding of the full dataset from ACCORDANCE will be important as we seek to partner AP-CD/LD for late-stage clinical development and commercialization in PD patients.
"Moving forward, we continue to glean important learnings from the ongoing data analysis. As we present these to potential partners, we continue to advance the buildout of our commercial manufacturing process with LTS. As noted, having these state-of-the art commercial scale production facilities in place is expected to be of great value to any potential partner. We will also be completing the required regulatory submissions and reports that are necessary for clinical and CMC filings, which we expect to further enhance partnership opportunities.
"In July 2019, Intec provided Novartis with the results from a human PK study of a custom-designed AP for one of Novartis' proprietary compounds. The study demonstrated that the AP met the technical requirements set forth by Novartis. Novartis undertook a full commercial assessment of the program, and to date, has not definitively decided whether they will opt into negotiations for a commercial agreement. As a result, we have determined that we will not need the volume of clinical manufacturing to support that program at this time and plan to restructure those dedicated to the Novartis program in order to reduce our burn.
"We continued to invest in building out the Company's next phase of growth through the AP platform's innovation engine as it can provide multiple opportunities for pipeline expansion. Toward that end, we were delighted to partner with Merck & Co. on a research collaboration to develop a custom-designed AP for one of Merck's proprietary compounds in May 2019. Our team is hard at work constructing the films for this research collaboration and we aim to have a final construct completed and in-vitro tested by the middle of next year.
"The development of our AP containing synthetic tetrahydrocannabinol (THC), one of the primary cannabinoids contained in cannabis, completed an initial PK study earlier this year. The results showed that the delivery of THC did not meet our full expectations for this program. Our R&D team is in the process of refining the AP-THC in order to fully meet our specifications for the oral delivery of THC and CBD. We are seeking to launch a PK study with the optimized AP-THC next year.
"In addition to our current development pipeline, our team continues to advance discussions with other potential pharmaceutical partners for the development of new custom-designed APs. We believe the data from our ACCORDANCE trial enhances those discussions as it validates the AP platform and provides long-term safety data. Our goal remains to add one or two new programs per year. We believe this is the most efficient strategy for building our pipeline and for creating value from our platform.
"Our mission remains steadfast; to build value by leveraging the potential of our AP platform to enhance the characteristics of a number of proprietary compounds and to develop innovative approaches to the treatment of diseases. Our growth strategy continues to focus on advancing a mix of internally-led programs with partnered programs believing that having a variety of 'shots on goal' will provide Intec with a growing pipeline and long-term royalty stream with the potential to create significant value over time," concluded Mr. Meckler.
Financial Highlights for the Three and Nine Months Ended September 30, 2019
Research and development expenses, net, for the three-month period ended September 30, 2019 were approximately $8.4 million, an increase of approximately $600,000 or 8%, compared with approximately $7.8 million for the third quarter of 2018. The increase for the three-month period was primarily due to an increase in expenses related to the open label extension study. This increase was offset by a decrease in expenses related to the ACCORDANCE study and a decrease in expenses related to the scale up activities for the commercial scale production capabilities for AP-CD/LD at LTS. Research and development expenses, net, for the nine-month period ended September 30, 2019 amounted to approximately $24.9 million, a decrease of approximately $200,000, or 1%, compared with approximately $25.1 million in the nine-month period ended September 30, 2018. The decrease for the nine-month period was primarily due to a decrease in expenses related to the ACCORDANCE study. This decrease was offset by an increase in expenses related to the scale up activities for the commercial scale production capabilities for AP-CD/LD at LTS and expenses related to our open label extension study.
General and administrative expenses for the three-month period ended September 30, 2019 were approximately $2.2 million, an increase of approximately $500,000 or 29%, compared with approximately $1.7 million in third quarter of 2018. General and administrative expenses for the nine-month period ended September 30, 2019 amounted to approximately $6.5 million, an increase of approximately $700,000, or 12%, compared with approximately $5.8 million in the nine-month period ended September 30, 2018. The increase for the three and nine-month periods was primarily related to the increase in payroll and related expenses mainly due to salary raises and increase in insurance expenses, offset by a decrease in professional services.
Impairment of long-lived assets was recorded as the top-line results of the ACCORDANCE trial were considered a triggering event for impairment. For the three and nine months ended September 30, 2019, we recorded an impairment charge of approximately $9.8 million. This impairment represents the excess carrying value of the long-lived assets compared to its fair value.
Net loss for the three-month period ended September 30, 2019 was approximately $20.4 million, compared with a net loss of $9.2 million in the prior year's third quarter. Net loss for the nine-month period ended September 30, 2019 was $41.0 million compared with $30.9 million during the nine-month period ended September 30, 2018.
Loss per ordinary share for the three-month period ended September 30, 2019 was $0.61 compared with a loss per ordinary share of $0.28 for the three-month period ended September 30, 2018. Loss per ordinary share for the nine-month period ended September 30, 2019 was $1.23 compared with a loss per ordinary share of $1.01 for the nine-month period ended September 30, 2018.
As of September 30, 2019, the Company had cash and cash equivalents and marketable securities of approximately $15.7 million compared with approximately $40.6 million at December 31, 2018.
Net cash used in operating activities during the nine-month period ended September 30, 2019 was approximately $23.9 million compared with net cash used in operating activities of approximately $30.9 million during the nine-month period ended September 30, 2018. This decrease resulted from changes in operating assets and liabilities items of approximately $6.5 million and a decrease in the net loss for the period in the amount of $500,000.
The Company had negative cash flow from investing activities of approximately $2.5 million during the nine-month period ended September 30, 2019 compared to negative cash flow from investing activities of approximately $5.1 million during the nine-month period ended September 30, 2018. This decrease resulted primarily from a decrease in purchase of property and equipment in the amount of approximately $1.8 million, an increase in proceeds from the disposal of marketable securities in the amount of approximately $576,000 and a decrease of approximately $135,000 in investment in other assets related to the establishment of the commercial scale production capabilities for AP-CD/LD at LTS.
Net cash provided by financing activities during the nine-month period ended September 30, 2019 was approximately $2.2 million, which was provided by approximately $2.0 million in funds received from the sale of 1,716,679 ordinary shares under the Company's "at-the-market" equity offering program and $268,000 in proceeds from the exercise of options by employees.
November 12, 2019 at 7:02 AM EST
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JERUSALEM, Nov. 12, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces financial results for the three and nine months ended September 30, 2019.
Highlights of the third quarter 2019 and recent weeks include:
•Presented two posters highlighting data from the Company's Phase 3 clinical development program for the Accordion Pill® Carbidopa/Levodopa (AP-CD/LD) at the International Congress of Parkinson's and Movement Disorder Society (MDS 2019);
•Completed the qualification studies for the commercial scale manufacture of AP-CD/LD with our partner, LTS LohmanTherapie-Systeme (LTS);
•Announced topline results from the Company's pivotal Phase 3 trial (ACCORDANCE) evaluating the safety and efficacy of the AP-CD/LD compared with immediate release CD/LD (IR-CD/LD; Sinemet®) as a treatment for the symptoms of advanced Parkinson's disease (PD), reporting that AP-CD/LD provided treatment for Parkinson's disease symptoms but did not demonstrate statistical superiority to IR-CD/LD in terms of reduction in OFF time from baseline under the conditions established in the protocol; and
•Completed the pharmacokinetic (PK) study of the custom-designed AP developed for a proprietary compound under the previously announced feasibility and option agreement with Novartis Pharmaceuticals.
Management Commentary
"We gained important information and knowledge from the ACCORDANCE study that we believe makes AP-CD/LD an attractive partnership opportunity for late-stage development and commercialization. First, the ACCORDANCE results validate the AP platform and provide very important long-term safety data. The responder analysis and subset analyses provide key insights for future study design and dosing that should be invaluable to a potential partner. We have qualified the commercial scale manufacturing process with LTS, which can also be used to provide clinical supply for the next Phase 3 study. This is a key advantage as Chemistry, Manufacturing and Controls (CMC) is a critical component in drug development and one that often trips up small companies. Importantly, there continues to be a large unmet need for a better baseline LD, which we believe provides a significant market opportunity of between $200 - $500 million," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
"We were delighted to present two posters highlighting AP-CD/LD at MDS 2019 in late September. We were particularly pleased to have our Phase 3 ACCORDANCE clinical trial poster chosen for the conference's Guided Tour, a distinction that drives attendees to view the approximately ten percent of posters selected for inclusion. Consequently, there was considerable interest in our program's results. We believe the data underscored the potential of AP-CD/LD as a better baseline levodopa therapy in PD while highlighting its long-term safety data. In tandem, we are in the process of seeking to partner AP-CD/LD in PD and found it most beneficial to have these data delivered at this important medical meeting. The continued understanding of the full dataset from ACCORDANCE will be important as we seek to partner AP-CD/LD for late-stage clinical development and commercialization in PD patients.
"Moving forward, we continue to glean important learnings from the ongoing data analysis. As we present these to potential partners, we continue to advance the buildout of our commercial manufacturing process with LTS. As noted, having these state-of-the art commercial scale production facilities in place is expected to be of great value to any potential partner. We will also be completing the required regulatory submissions and reports that are necessary for clinical and CMC filings, which we expect to further enhance partnership opportunities.
"In July 2019, Intec provided Novartis with the results from a human PK study of a custom-designed AP for one of Novartis' proprietary compounds. The study demonstrated that the AP met the technical requirements set forth by Novartis. Novartis undertook a full commercial assessment of the program, and to date, has not definitively decided whether they will opt into negotiations for a commercial agreement. As a result, we have determined that we will not need the volume of clinical manufacturing to support that program at this time and plan to restructure those dedicated to the Novartis program in order to reduce our burn.
"We continued to invest in building out the Company's next phase of growth through the AP platform's innovation engine as it can provide multiple opportunities for pipeline expansion. Toward that end, we were delighted to partner with Merck & Co. on a research collaboration to develop a custom-designed AP for one of Merck's proprietary compounds in May 2019. Our team is hard at work constructing the films for this research collaboration and we aim to have a final construct completed and in-vitro tested by the middle of next year.
"The development of our AP containing synthetic tetrahydrocannabinol (THC), one of the primary cannabinoids contained in cannabis, completed an initial PK study earlier this year. The results showed that the delivery of THC did not meet our full expectations for this program. Our R&D team is in the process of refining the AP-THC in order to fully meet our specifications for the oral delivery of THC and CBD. We are seeking to launch a PK study with the optimized AP-THC next year.
"In addition to our current development pipeline, our team continues to advance discussions with other potential pharmaceutical partners for the development of new custom-designed APs. We believe the data from our ACCORDANCE trial enhances those discussions as it validates the AP platform and provides long-term safety data. Our goal remains to add one or two new programs per year. We believe this is the most efficient strategy for building our pipeline and for creating value from our platform.
"Our mission remains steadfast; to build value by leveraging the potential of our AP platform to enhance the characteristics of a number of proprietary compounds and to develop innovative approaches to the treatment of diseases. Our growth strategy continues to focus on advancing a mix of internally-led programs with partnered programs believing that having a variety of 'shots on goal' will provide Intec with a growing pipeline and long-term royalty stream with the potential to create significant value over time," concluded Mr. Meckler.
Financial Highlights for the Three and Nine Months Ended September 30, 2019
Research and development expenses, net, for the three-month period ended September 30, 2019 were approximately $8.4 million, an increase of approximately $600,000 or 8%, compared with approximately $7.8 million for the third quarter of 2018. The increase for the three-month period was primarily due to an increase in expenses related to the open label extension study. This increase was offset by a decrease in expenses related to the ACCORDANCE study and a decrease in expenses related to the scale up activities for the commercial scale production capabilities for AP-CD/LD at LTS. Research and development expenses, net, for the nine-month period ended September 30, 2019 amounted to approximately $24.9 million, a decrease of approximately $200,000, or 1%, compared with approximately $25.1 million in the nine-month period ended September 30, 2018. The decrease for the nine-month period was primarily due to a decrease in expenses related to the ACCORDANCE study. This decrease was offset by an increase in expenses related to the scale up activities for the commercial scale production capabilities for AP-CD/LD at LTS and expenses related to our open label extension study.
General and administrative expenses for the three-month period ended September 30, 2019 were approximately $2.2 million, an increase of approximately $500,000 or 29%, compared with approximately $1.7 million in third quarter of 2018. General and administrative expenses for the nine-month period ended September 30, 2019 amounted to approximately $6.5 million, an increase of approximately $700,000, or 12%, compared with approximately $5.8 million in the nine-month period ended September 30, 2018. The increase for the three and nine-month periods was primarily related to the increase in payroll and related expenses mainly due to salary raises and increase in insurance expenses, offset by a decrease in professional services.
Impairment of long-lived assets was recorded as the top-line results of the ACCORDANCE trial were considered a triggering event for impairment. For the three and nine months ended September 30, 2019, we recorded an impairment charge of approximately $9.8 million. This impairment represents the excess carrying value of the long-lived assets compared to its fair value.
Net loss for the three-month period ended September 30, 2019 was approximately $20.4 million, compared with a net loss of $9.2 million in the prior year's third quarter. Net loss for the nine-month period ended September 30, 2019 was $41.0 million compared with $30.9 million during the nine-month period ended September 30, 2018.
Loss per ordinary share for the three-month period ended September 30, 2019 was $0.61 compared with a loss per ordinary share of $0.28 for the three-month period ended September 30, 2018. Loss per ordinary share for the nine-month period ended September 30, 2019 was $1.23 compared with a loss per ordinary share of $1.01 for the nine-month period ended September 30, 2018.
As of September 30, 2019, the Company had cash and cash equivalents and marketable securities of approximately $15.7 million compared with approximately $40.6 million at December 31, 2018.
Net cash used in operating activities during the nine-month period ended September 30, 2019 was approximately $23.9 million compared with net cash used in operating activities of approximately $30.9 million during the nine-month period ended September 30, 2018. This decrease resulted from changes in operating assets and liabilities items of approximately $6.5 million and a decrease in the net loss for the period in the amount of $500,000.
The Company had negative cash flow from investing activities of approximately $2.5 million during the nine-month period ended September 30, 2019 compared to negative cash flow from investing activities of approximately $5.1 million during the nine-month period ended September 30, 2018. This decrease resulted primarily from a decrease in purchase of property and equipment in the amount of approximately $1.8 million, an increase in proceeds from the disposal of marketable securities in the amount of approximately $576,000 and a decrease of approximately $135,000 in investment in other assets related to the establishment of the commercial scale production capabilities for AP-CD/LD at LTS.
Net cash provided by financing activities during the nine-month period ended September 30, 2019 was approximately $2.2 million, which was provided by approximately $2.0 million in funds received from the sale of 1,716,679 ordinary shares under the Company's "at-the-market" equity offering program and $268,000 in proceeds from the exercise of options by employees.
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Intec Pharma Announces $10 Million Ordinary Shares Purchase Agreement With Aspire Capital
December 3, 2019 at 7:30 AM EST
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JERUSALEM, Dec. 3, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces that the Company has entered into an Ordinary Shares Purchase Agreement for $10.0 million with Aspire Capital Fund, LLC ("Aspire Capital"), a Chicago-based institutional investor. Under the terms of the Agreement, Aspire Capital is committed to purchase up to $10.0 million of Intec Pharma's ordinary shares over a 30-month period extending into 2022, subject to certain terms and conditions. There are no warrants, derivatives, or other share classes associated with this agreement. Proceeds from the Agreement will be used to fund the Company's research and development activites, for working capital and for general corporate purposes.
"We are delighted to partner with Aspire Capital under this Agreement. Aspire Capital has been a long-term institutional shareholder in Intec Pharma and this Agreement gives us the flexibility to access capital when and if we need it. Moreover, we believe this commitment strengthens our negotiating position with any potential partners for our Parkinson's disease program and/or for new research collaborations," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "Controlling the timing and amount of ordinary shares being sold is key, as we can use this Agreement to opportunistically strengthen our balance sheet without unnecessary dilution as we seek to advance our AP platform programs to key inflection points in 2020. We appreciate Aspire Capital's continued support."
"To us, the AP represents a major advance in drug delivery especially considering the significant number of approved and development-stage drugs that possess great therapeutic promise but remain hamstrung by either poor bioavailability or a PK profile that promotes adverse outcomes. Backed by a highly experienced management team, robust manufacturing capabilities and strong, supportive evidence from multiple clinical and non-clinical studies, the AP platform has proven to be an elegant solution for addressing these widespread drug delivery challenges. The available data, including those from the recent ACCORDANCE study, clearly demonstrate the APs ability to enhance the PK profile of drugs that have notoriously challenging absorption rates and short upper gastrointestinal residence times without sacrificing tolerability and ultimately, patient quality of life," said Steven G. Martin, Managing Member of Aspire Capital.
"The company's collaborations with leading pharma companies such as Merck and Novartis further enhance our confidence in the AP platform's broad applicability beyond Parkinson's disease, where the company has already demonstrated proof-of-concept and gives us optimism about additional potential partnerships. As a result, we are thrilled to be expanding our longstanding interest and investment in Intec with this transaction," added Mr. Martin.
Under the terms of the Agreement with Aspire Capital, Intec Pharma retains full control over the timing of any stock sales made under the Agreement and the amount of stock sold to Aspire Capital. The agreement contains no restrictions on the use of proceeds, financial covenants or restrictions on future financings and no rights of first refusal, participation rights, penalties or liquidated damages. Intec Pharma maintains the right to terminate the agreement at any time, at its discretion, without any additional cost or penalty.
As consideration for Aspire Capital's obligations under the Agreement, Intec Pharma also agreed to issue 612,520 ordinary shares to Aspire Capital as a commitment fee. Intec Pharma also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the purchase agreement that requires Intec Pharma to file a registration statement regarding the shares sold to Aspire Capital.
For more information on the Agreement, please refer to Intec Pharma's report on From 8-K filed today with the U.S. Securities and Exchange Commission, which can be found on the Company's website at SEC Filings | Intec Pharma.
December 3, 2019 at 7:30 AM EST
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JERUSALEM, Dec. 3, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces that the Company has entered into an Ordinary Shares Purchase Agreement for $10.0 million with Aspire Capital Fund, LLC ("Aspire Capital"), a Chicago-based institutional investor. Under the terms of the Agreement, Aspire Capital is committed to purchase up to $10.0 million of Intec Pharma's ordinary shares over a 30-month period extending into 2022, subject to certain terms and conditions. There are no warrants, derivatives, or other share classes associated with this agreement. Proceeds from the Agreement will be used to fund the Company's research and development activites, for working capital and for general corporate purposes.
"We are delighted to partner with Aspire Capital under this Agreement. Aspire Capital has been a long-term institutional shareholder in Intec Pharma and this Agreement gives us the flexibility to access capital when and if we need it. Moreover, we believe this commitment strengthens our negotiating position with any potential partners for our Parkinson's disease program and/or for new research collaborations," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "Controlling the timing and amount of ordinary shares being sold is key, as we can use this Agreement to opportunistically strengthen our balance sheet without unnecessary dilution as we seek to advance our AP platform programs to key inflection points in 2020. We appreciate Aspire Capital's continued support."
"To us, the AP represents a major advance in drug delivery especially considering the significant number of approved and development-stage drugs that possess great therapeutic promise but remain hamstrung by either poor bioavailability or a PK profile that promotes adverse outcomes. Backed by a highly experienced management team, robust manufacturing capabilities and strong, supportive evidence from multiple clinical and non-clinical studies, the AP platform has proven to be an elegant solution for addressing these widespread drug delivery challenges. The available data, including those from the recent ACCORDANCE study, clearly demonstrate the APs ability to enhance the PK profile of drugs that have notoriously challenging absorption rates and short upper gastrointestinal residence times without sacrificing tolerability and ultimately, patient quality of life," said Steven G. Martin, Managing Member of Aspire Capital.
"The company's collaborations with leading pharma companies such as Merck and Novartis further enhance our confidence in the AP platform's broad applicability beyond Parkinson's disease, where the company has already demonstrated proof-of-concept and gives us optimism about additional potential partnerships. As a result, we are thrilled to be expanding our longstanding interest and investment in Intec with this transaction," added Mr. Martin.
Under the terms of the Agreement with Aspire Capital, Intec Pharma retains full control over the timing of any stock sales made under the Agreement and the amount of stock sold to Aspire Capital. The agreement contains no restrictions on the use of proceeds, financial covenants or restrictions on future financings and no rights of first refusal, participation rights, penalties or liquidated damages. Intec Pharma maintains the right to terminate the agreement at any time, at its discretion, without any additional cost or penalty.
As consideration for Aspire Capital's obligations under the Agreement, Intec Pharma also agreed to issue 612,520 ordinary shares to Aspire Capital as a commitment fee. Intec Pharma also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the purchase agreement that requires Intec Pharma to file a registration statement regarding the shares sold to Aspire Capital.
For more information on the Agreement, please refer to Intec Pharma's report on From 8-K filed today with the U.S. Securities and Exchange Commission, which can be found on the Company's website at SEC Filings | Intec Pharma.
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Novartis ci abbandona
Intec Pharma Provides Update on Novartis Feasibility and Option Agreement
December 11, 2019 at 7:30 AM EST
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JERUSALEM, Dec. 11, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces the termination of the Feasibility and Option agreement with Novartis for the development of a custom-designed Accordion Pill® (AP) for a proprietary Novartis compound, despite the AP having met the technical and pharmacokinetic (PK) clinical specifications set forth by Novartis. Novartis, following an internal and revised commercial strategic assessment, advised Intec that this program no longer meets Novartis' mid to long-term strategic goals. Novartis agreed to pay Intec Pharma$1.5 million USD on conclusion of the program.
This project was originally announced in January 2018. Under the terms of the agreement, the drug and therapeutic area were not disclosed.
"While we are disappointed that Novartis is not moving forward with this AP, the technical and clinical work conducted as part of this program has added to our growing body of scientific knowledge relating to the Accordion Pill platform and has expanded our tool chest of drug-on-film technology," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "We have enjoyed working with the Novartis team and, given their enhanced understanding of the advantages of our gastric retentive AP oral drug delivery technology, we are now looking to identify additional compounds in the Novartis portfolio that can benefit from the unique characteristics the AP platform."
As previously announced, the Company is in the process of restructuring the clinical manufacturing planned to support this program in order to reduce costs.
Intec Pharma Provides Update on Novartis Feasibility and Option Agreement
December 11, 2019 at 7:30 AM EST
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JERUSALEM, Dec. 11, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces the termination of the Feasibility and Option agreement with Novartis for the development of a custom-designed Accordion Pill® (AP) for a proprietary Novartis compound, despite the AP having met the technical and pharmacokinetic (PK) clinical specifications set forth by Novartis. Novartis, following an internal and revised commercial strategic assessment, advised Intec that this program no longer meets Novartis' mid to long-term strategic goals. Novartis agreed to pay Intec Pharma$1.5 million USD on conclusion of the program.
This project was originally announced in January 2018. Under the terms of the agreement, the drug and therapeutic area were not disclosed.
"While we are disappointed that Novartis is not moving forward with this AP, the technical and clinical work conducted as part of this program has added to our growing body of scientific knowledge relating to the Accordion Pill platform and has expanded our tool chest of drug-on-film technology," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "We have enjoyed working with the Novartis team and, given their enhanced understanding of the advantages of our gastric retentive AP oral drug delivery technology, we are now looking to identify additional compounds in the Novartis portfolio that can benefit from the unique characteristics the AP platform."
As previously announced, the Company is in the process of restructuring the clinical manufacturing planned to support this program in order to reduce costs.
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Fallimento dopo fallimento la INTEC va sempre più indietro. Uno dei peggiori titoli del 2019.
Davvero una grossa delusione e una gran perdita di soldi.
Davvero una grossa delusione e una gran perdita di soldi.
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Intec Pharma Issues Letter to Shareholders
January 9, 2020 at 7:00 AM EST
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JERUSALEM, Jan. 9, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today provides a business and clinical update on its development programs with the Company's proprietary oral drug delivery system, the Accordion Pill® platform, in a Letter to Shareholders. The full text of the letter is below.
Dear Fellow Shareholders:
As we close the books on 2019, I wanted to take this opportunity to review our recent progress and to preview our plans as we move forward into 2020.
Our overarching mission for 2020 remains to create value by leveraging the potential of our Accordion Pill® (AP) platform. With its unique release profiles and gastric retentive properties, the AP platform offers an opportunity to enhance the pharmacokinetic characteristics of a number of proprietary compounds and to develop innovative approaches to the treatment of diseases. Our growth strategy remains to advance a mix of internally-led drug development programs and partnered proprietary programs. We believe this approach provides a variety of "shots on goal" that will provide Intec with a growing pipeline and long-term royalty stream with the potential to create significant value over time.
Driven by Science
Our innovative Research and Development (R&D) team of leading drug reformulation experts and engineers continue to drive our ability to expand our pipeline in order to leverage the potential of the AP platform. Through their ingenuity and creativity, we have developed the Accordion Pill platform and its variety of custom-designed drug delivery systems that are intended to enhance the therapeutic benefits of a number of approved drugs and drugs in development.
In addition to the variety of film technologies and release mechanisms we have developed to date, including those we created for partners, we continue to innovate and are working on next generation AP technologies that will increase gastric retention time (i.e., a 24-hour Accordion Pill). We have also enhanced our delivery profile capabilities, which provide us with greater options for designing and constructing new Accordion Pills that can include films for immediate release, delayed immediate release, extended release, delayed extended release, etc. This optionality allows us to develop custom-designed APs that meet specific PK parameters. We are also working on including larger molecules in the platform such as peptides, which opens up a multitude of opportunities for enhanced delivery of these important therapeutic compounds that are now largely delivered intravenously or via subcutaneous injection.
The Parkinson's Disease Program
In late July we announced the topline data from our Phase 3 ACCORDANCE clinical trial of the Accordion Pill-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release levodopa (IR-LD) in advanced Parkinson's disease (PD) patients. The top-line results showed that AP-CD/LD was numerically superior in reducing daily OFF time but was not statistically superior to IR-LD. We believe the outcome may have been confounded by data from participants who titrated to the maximum available dose of AP-CD/LD, as well as by limitations in the trial design. Following this readout, we have undertaken a partnering process for the late-stage development and commercialization of this program for a better baseline levodopa (LD) therapy.
Analysis of the full data set has provided important information and knowledge that we believe makes AP-CD/LD an attractive partnership opportunity for late-stage development and commercialization.
First, the ACCORDANCE results validate the AP platform and provide very important long-term safety data. Detailed analysis of the primary and secondary results, as well as subset and regional analyses have provided key insights for future study design and dosing that should be invaluable to a potential partner. With our manufacturing partner, LohmanTherapie-Systeme (LTS), we have qualified the commercial scale manufacturing process, which can also be used to provide clinical supply for the next Phase 3 study. This is a key advantage as Chemistry, Manufacturing and Controls (CMC) is a critical component in drug development and one that often delays regulatory submissions at small companies.
Importantly, there continues to be a large unmet need for a better baseline LD, which we believe provides a significant market opportunity of between $200 - $500 million.
We continue to advance the buildout of our commercial scale manufacturing process with LTS, as having these state-of-the art commercial scale production facilities in place is expected to be of great value to any potential partner. We successfully completed our first primary stability batches and are currently producing materials at commercial scale. We received our German Good Manufacturing Practices (GMP) permit for manufacturing, completed the technology transfer and officially executed the handover of the large-scale production machinery to LTS. Consequently, we now plan for LTS to produce the next stability batches, which will also serve as the clinical material for the next Phase 3 clinical trial, in the first quarter of 2020.
We look forward to potentially monetizing this late-stage asset in the first half of 2020, so that a partner can advance it into a final, pivotal Phase 3 study and move toward commercialization in order to benefit the multitude of PD patients suffering from the motor complications associated with the pulsatile delivery of generic LD formulations.
Novartis Feasibility Agreement
In December 2019, we reported the termination of our Feasibility and Option Agreement with Novartis Pharmaceuticals, under which Intec Pharma built a custom-designed Accordion Pill for one of Novartis' proprietary compounds. The AP met the technical and pharmacokinetic (PK) clinical specifications set forth by Novartis. Following an internal and revised commercial strategic assessment for the therapeutic, Novartis decided that this program no longer meets Novartis' mid- and long-term strategic priorities. Novartis has agreed to pay Intec Pharma$1.5 million USD upon conclusion of the program.
While we are disappointed that Novartis is not moving forward with this custom AP, the technical and clinical work conducted as part of this program has added to our growing body of scientific knowledge relating to the Accordion Pill platform and has expanded our tool chest of drug-on-film technology. We have enjoyed working with the Novartis team and, given their enhanced understanding of the advantages of our gastric retentive AP oral drug delivery technology, we are currently working with them to identify additional compounds in the Novartis portfolio that may benefit from the unique characteristics of the AP platform.
Pipeline Progress
In May 2019, we were very pleased to partner with Merck & Co. (MSD) on a research collaboration to develop a custom-designed AP for one of MSD's proprietary compounds in development. I am delighted to report that our Intec team has developed an AP for MSD's proprietary compound that meets the in vitro specifications set forth in the companies' research collaboration. We are now in discussions with MSD to determine next steps. This is an exciting opportunity to leverage the unique drug release profile and gastric retention of our AP platform in a potentially billion-dollar market opportunity.
The development of our AP containing synthetic tetrahydrocannabinol (THC), one of the primary cannabinoids contained in cannabis, completed an initial PK study earlier in 2019. The results showed that the delivery of THC did not fully meet our expectations for this program. The development of custom-designed APs is an iterative process and our ongoing development work provides a deeper understanding of how to best apply gastric retention technology to enhance and control the delivery of this poorly soluble class of molecules. Our R&D team is nearing completion of refinements to the cannabinoid AP product. We expect to launch a PK study evaluating the delivery of THC with the optimized AP later this year.
We remain confident in the potential of this program as we believe the AP's gastric retentive technology is ideally suited to extend the absorption phase of THC, with the goal of a slower rate of rise and more consistent drug plasma levels after oral delivery. The combination of the slower rate of rise with sustained and consistent plasma levels is expected to lead to an improved therapeutic effect and reduce the adverse events that are correlated with rate of rise and peak THC plasma levels. Also, given the known analgesic properties of cannabinoids, we remain enthusiastic about the potential for these programs and believe our AP-cannabinoids will be applicable to a variety of pain indications, such as post-operative, opioid-sparing pain management, fibromyalgia and/or for breakthrough cancer pain management.
In addition to our current development pipeline, our team continues to advance discussions with other potential pharmaceutical partners for the development of custom-designed APs. The data from our ACCORDANCE trial supports those discussions as it validates the AP platform and provides essential long-term safety data. Our goal remains to add one or two new partner programs per year. We believe this is the most efficient strategy for building our pipeline and for creating value from our platform.
Capital Resources
We are prudently managing our expenses to the level which, in our judgment, is appropriate to advance our pipeline programs. This includes the restructuring of our clinical manufacturing group, which we expect will significantly reduce our burn, while still allowing for ongoing development work and early-stage clinical production.
We continue to explore different avenues through which to finance these efforts and are actively pursuing business development endeavors that may provide non-dilutive financing and which we anticipate will expand our network of partners to assist in moving these clinical programs forward.
In addition, we were delighted to recently report our funding agreement with Aspire Capital, a long-term institutional investor in Intec Pharma. Under the terms of the agreement, Aspire Capital is committed to purchase up to $10 million of Intec Pharma's ordinary shares over a 30-month period extending into 2022, subject to certain terms and conditions. Importantly, there are no warrants, derivatives, or other share classes associated with this agreement.
We believe this commitment strengthens our negotiating position with any potential partners for our Parkinson's disease program and/or for new research collaborations and gives us the flexibility to access capital when and if we need it. Controlling the timing and number of shares being sold is key, as we can use this vehicle to opportunistically strengthen our balance sheet without unnecessary dilution as we seek to advance our AP platform programs to key inflection points in 2020.
We ended the third quarter 2019 with approximately $16 million in cash and cash equivalents. Along with the $1.5 million from Novartis and the cost cutting measures we've undertaken, we believe our cash will now take us into the third quarter of 2020, without tapping into our Aspire commitment.
Closing
We remain steadfast in our commitment to advance the potential of our AP platform in underserved medical indications with large market opportunities where we aim to improve the lives of patients.
On behalf of Intec Pharma's board of directors and our dedicated team of professionals, I thank you for your continued support of our company, our strategy, and the important clinical work we are advancing. I can assure you that all of us at Intec Pharma remain committed to our mission and to delivering sustained performance on behalf of all those we serve. We look forward to sharing our achievements with you as we execute on our strategy to leverage the potential in our AP platform to create value.
All the best for continued health and prosperity in the new decade ahead,
Jeffrey A. Meckler
Vice Chairman and Chief Executive Officer
Intec Pharma
January 9, 2020 at 7:00 AM EST
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JERUSALEM, Jan. 9, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today provides a business and clinical update on its development programs with the Company's proprietary oral drug delivery system, the Accordion Pill® platform, in a Letter to Shareholders. The full text of the letter is below.
Dear Fellow Shareholders:
As we close the books on 2019, I wanted to take this opportunity to review our recent progress and to preview our plans as we move forward into 2020.
Our overarching mission for 2020 remains to create value by leveraging the potential of our Accordion Pill® (AP) platform. With its unique release profiles and gastric retentive properties, the AP platform offers an opportunity to enhance the pharmacokinetic characteristics of a number of proprietary compounds and to develop innovative approaches to the treatment of diseases. Our growth strategy remains to advance a mix of internally-led drug development programs and partnered proprietary programs. We believe this approach provides a variety of "shots on goal" that will provide Intec with a growing pipeline and long-term royalty stream with the potential to create significant value over time.
Driven by Science
Our innovative Research and Development (R&D) team of leading drug reformulation experts and engineers continue to drive our ability to expand our pipeline in order to leverage the potential of the AP platform. Through their ingenuity and creativity, we have developed the Accordion Pill platform and its variety of custom-designed drug delivery systems that are intended to enhance the therapeutic benefits of a number of approved drugs and drugs in development.
In addition to the variety of film technologies and release mechanisms we have developed to date, including those we created for partners, we continue to innovate and are working on next generation AP technologies that will increase gastric retention time (i.e., a 24-hour Accordion Pill). We have also enhanced our delivery profile capabilities, which provide us with greater options for designing and constructing new Accordion Pills that can include films for immediate release, delayed immediate release, extended release, delayed extended release, etc. This optionality allows us to develop custom-designed APs that meet specific PK parameters. We are also working on including larger molecules in the platform such as peptides, which opens up a multitude of opportunities for enhanced delivery of these important therapeutic compounds that are now largely delivered intravenously or via subcutaneous injection.
The Parkinson's Disease Program
In late July we announced the topline data from our Phase 3 ACCORDANCE clinical trial of the Accordion Pill-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release levodopa (IR-LD) in advanced Parkinson's disease (PD) patients. The top-line results showed that AP-CD/LD was numerically superior in reducing daily OFF time but was not statistically superior to IR-LD. We believe the outcome may have been confounded by data from participants who titrated to the maximum available dose of AP-CD/LD, as well as by limitations in the trial design. Following this readout, we have undertaken a partnering process for the late-stage development and commercialization of this program for a better baseline levodopa (LD) therapy.
Analysis of the full data set has provided important information and knowledge that we believe makes AP-CD/LD an attractive partnership opportunity for late-stage development and commercialization.
First, the ACCORDANCE results validate the AP platform and provide very important long-term safety data. Detailed analysis of the primary and secondary results, as well as subset and regional analyses have provided key insights for future study design and dosing that should be invaluable to a potential partner. With our manufacturing partner, LohmanTherapie-Systeme (LTS), we have qualified the commercial scale manufacturing process, which can also be used to provide clinical supply for the next Phase 3 study. This is a key advantage as Chemistry, Manufacturing and Controls (CMC) is a critical component in drug development and one that often delays regulatory submissions at small companies.
Importantly, there continues to be a large unmet need for a better baseline LD, which we believe provides a significant market opportunity of between $200 - $500 million.
We continue to advance the buildout of our commercial scale manufacturing process with LTS, as having these state-of-the art commercial scale production facilities in place is expected to be of great value to any potential partner. We successfully completed our first primary stability batches and are currently producing materials at commercial scale. We received our German Good Manufacturing Practices (GMP) permit for manufacturing, completed the technology transfer and officially executed the handover of the large-scale production machinery to LTS. Consequently, we now plan for LTS to produce the next stability batches, which will also serve as the clinical material for the next Phase 3 clinical trial, in the first quarter of 2020.
We look forward to potentially monetizing this late-stage asset in the first half of 2020, so that a partner can advance it into a final, pivotal Phase 3 study and move toward commercialization in order to benefit the multitude of PD patients suffering from the motor complications associated with the pulsatile delivery of generic LD formulations.
Novartis Feasibility Agreement
In December 2019, we reported the termination of our Feasibility and Option Agreement with Novartis Pharmaceuticals, under which Intec Pharma built a custom-designed Accordion Pill for one of Novartis' proprietary compounds. The AP met the technical and pharmacokinetic (PK) clinical specifications set forth by Novartis. Following an internal and revised commercial strategic assessment for the therapeutic, Novartis decided that this program no longer meets Novartis' mid- and long-term strategic priorities. Novartis has agreed to pay Intec Pharma$1.5 million USD upon conclusion of the program.
While we are disappointed that Novartis is not moving forward with this custom AP, the technical and clinical work conducted as part of this program has added to our growing body of scientific knowledge relating to the Accordion Pill platform and has expanded our tool chest of drug-on-film technology. We have enjoyed working with the Novartis team and, given their enhanced understanding of the advantages of our gastric retentive AP oral drug delivery technology, we are currently working with them to identify additional compounds in the Novartis portfolio that may benefit from the unique characteristics of the AP platform.
Pipeline Progress
In May 2019, we were very pleased to partner with Merck & Co. (MSD) on a research collaboration to develop a custom-designed AP for one of MSD's proprietary compounds in development. I am delighted to report that our Intec team has developed an AP for MSD's proprietary compound that meets the in vitro specifications set forth in the companies' research collaboration. We are now in discussions with MSD to determine next steps. This is an exciting opportunity to leverage the unique drug release profile and gastric retention of our AP platform in a potentially billion-dollar market opportunity.
The development of our AP containing synthetic tetrahydrocannabinol (THC), one of the primary cannabinoids contained in cannabis, completed an initial PK study earlier in 2019. The results showed that the delivery of THC did not fully meet our expectations for this program. The development of custom-designed APs is an iterative process and our ongoing development work provides a deeper understanding of how to best apply gastric retention technology to enhance and control the delivery of this poorly soluble class of molecules. Our R&D team is nearing completion of refinements to the cannabinoid AP product. We expect to launch a PK study evaluating the delivery of THC with the optimized AP later this year.
We remain confident in the potential of this program as we believe the AP's gastric retentive technology is ideally suited to extend the absorption phase of THC, with the goal of a slower rate of rise and more consistent drug plasma levels after oral delivery. The combination of the slower rate of rise with sustained and consistent plasma levels is expected to lead to an improved therapeutic effect and reduce the adverse events that are correlated with rate of rise and peak THC plasma levels. Also, given the known analgesic properties of cannabinoids, we remain enthusiastic about the potential for these programs and believe our AP-cannabinoids will be applicable to a variety of pain indications, such as post-operative, opioid-sparing pain management, fibromyalgia and/or for breakthrough cancer pain management.
In addition to our current development pipeline, our team continues to advance discussions with other potential pharmaceutical partners for the development of custom-designed APs. The data from our ACCORDANCE trial supports those discussions as it validates the AP platform and provides essential long-term safety data. Our goal remains to add one or two new partner programs per year. We believe this is the most efficient strategy for building our pipeline and for creating value from our platform.
Capital Resources
We are prudently managing our expenses to the level which, in our judgment, is appropriate to advance our pipeline programs. This includes the restructuring of our clinical manufacturing group, which we expect will significantly reduce our burn, while still allowing for ongoing development work and early-stage clinical production.
We continue to explore different avenues through which to finance these efforts and are actively pursuing business development endeavors that may provide non-dilutive financing and which we anticipate will expand our network of partners to assist in moving these clinical programs forward.
In addition, we were delighted to recently report our funding agreement with Aspire Capital, a long-term institutional investor in Intec Pharma. Under the terms of the agreement, Aspire Capital is committed to purchase up to $10 million of Intec Pharma's ordinary shares over a 30-month period extending into 2022, subject to certain terms and conditions. Importantly, there are no warrants, derivatives, or other share classes associated with this agreement.
We believe this commitment strengthens our negotiating position with any potential partners for our Parkinson's disease program and/or for new research collaborations and gives us the flexibility to access capital when and if we need it. Controlling the timing and number of shares being sold is key, as we can use this vehicle to opportunistically strengthen our balance sheet without unnecessary dilution as we seek to advance our AP platform programs to key inflection points in 2020.
We ended the third quarter 2019 with approximately $16 million in cash and cash equivalents. Along with the $1.5 million from Novartis and the cost cutting measures we've undertaken, we believe our cash will now take us into the third quarter of 2020, without tapping into our Aspire commitment.
Closing
We remain steadfast in our commitment to advance the potential of our AP platform in underserved medical indications with large market opportunities where we aim to improve the lives of patients.
On behalf of Intec Pharma's board of directors and our dedicated team of professionals, I thank you for your continued support of our company, our strategy, and the important clinical work we are advancing. I can assure you that all of us at Intec Pharma remain committed to our mission and to delivering sustained performance on behalf of all those we serve. We look forward to sharing our achievements with you as we execute on our strategy to leverage the potential in our AP platform to create value.
All the best for continued health and prosperity in the new decade ahead,
Jeffrey A. Meckler
Vice Chairman and Chief Executive Officer
Intec Pharma
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Intec Pharma Reports Fourth Quarter and Year End 2019 Financial Results and Corporate Update
March 13, 2020 at 7:30 AM EDT
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JERUSALEM, March 13, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces financial results for the fourth quarter and year ended December 31, 2019 and provides a corporate update.
Highlights from the Quarter and Recent Weeks
•Developed an Accordion Pill (AP) for a Merck & Co. (MSD) proprietary compound that met the in vitro specifications set forth in the companies' research collaboration and are now in discussions with MSD to determine advancing the program into human pharmacokinetic (PK) studies;
•Concluded the Feasibility and Option Agreement (FOA) with Novartis Pharmaceuticals, under which Intec Pharma built a custom-designed AP for a Novartis proprietary compound that met the technical and PK clinical specifications set forth but following an internal and revised commercial strategic assessment, Novartis determined not to take the program forward;
•Novartis agreed to pay Intec Pharma$1.5 million upon conclusion of the program FOA and those funds were transferred to the Company in February 2020;
•Completed the qualifying production runs for the commercial scale manufacturing of AP Carbidopa/Levodopa (AP-CD/LD) with our manufacturing partner, LTS Lohmann Therapie-Systeme AG (LTS);
•Secured $10 million in committed financing from Aspire Capital, a long-term institutional investor; and
•Enhanced the balance sheet with a $6.5 million public offering.
Management Commentary
"We entered 2020 with a focused agenda for leveraging our Accordion Pill platform in both the near- and long-term, with goals to outlicence our late-stage Parkinson's disease program, to advance our research collaboration with Merck into human PK studies, to move our cannabinoid program into a second PK study and to expand our pipeline by adding new partnered programs, such as the one we have with Merck. Our team is diligently working toward executing these objectives and we look forward to achieving a number of these in the coming months," said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec.
"In tandem with these initiatives, we continue to work with our manufacturing partner, LTS, to advance the commercial scale production of AP-CD/LD, confident that having these critical processes in place enhances our business development efforts. We are pleased to report that LTS has completed the qualification studies for the commercial scale production and have initiated the validation and stability studies of the batches which are expected to serve as the clinical material for the next Phase 3 clinical trial plan. This is particularly beneficial for our partnering discussions for the Parkinson's disease program.
"In addition to advances with commercial manufacturing, we continue to engage in dialogues with potential new partners. Toward that end, our business development and technical operations teams are actively participating in a number of key drug delivery conferences worldwide in the coming months. We expect the enhanced visibility for the AP and its capabilities to increase the interest in the platform among audiences seeking new technologies and improved delivery formulations.
"Importantly, we strengthened our balance sheet believing that a stronger financial position enhances our ability to negotiate with partners and provides us with a longer runway to achieve key objectives. We believe our cash will now take us into the second quarter of 2021, without tapping into our Aspire commitment," added Mr. Meckler.
Financial Highlights for the Fourth Quarter Ended December 31, 2019
Research and development expenses, net, for the three-month period ended December 31, 2019 were approximately $1.8 million, a decrease of $8.5 million, or approximately 82.5%, compared with approximately $10.3 million in the three-month period ended December 31, 2018. The decrease was primarily due to a decrease in expenses related to the ACCORDANCE Phase 3 study of AP-CD/LD and the Open Label Extension study, both of which were completed during 2019 and a decrease in expenses related to the scale up activities for the commercial scale production capabilities for AP-CD/LD at LTS.
General and administrative expenses for the three-month period ended December 31, 2019 were approximately $1.8 million, a decrease of $300,000, or approximately 14.3%, compared with approximately $2.1 million in the three-month period ended December 31, 2018. The decrease was primarily due to a decrease in professional services and expenses related to investor relations activities. This decrease was offset by an increase in insurance expenses.
Impairment of long-lived assets was recorded as the top-line results of the ACCORDANCE trial were considered a triggering event for impairment. For the three-month period ended December 31, 2019, the Company recorded an impairment charge of approximately $3.9 million. This impairment represents the excess carrying value of the long-lived assets compared to its fair value.
The Company recorded other income for the three-month period ended December 31, 2019, of $1.5 million on conclusion of the program with Novartis.
Net loss for the three-month period ended December 31, 2019 was approximately $6.6 million, a decrease of $6.0 million, or approximately 47.6%, compared with the net loss for the three-month period ended December 31, 2018 of approximately $12.6 million. The decrease was mainly due to the decrease in research and development expenses as detailed above and the other income associated with the conclusion of the Novartis program offset by the impairment of the Company's long-lived assets.
Loss per ordinary share for the fourth quarter ended December 31, 2019 was $0.19 compared with $0.38 for the fourth quarter ended December 31, 2018.
Financial Highlights for the Year Ended December 31, 2019
Research and development expenses, net, for the year ended December 31, 2019 were approximately $26.7 million, a decrease of $8.7 million, or approximately 24.6%, compared with approximately $35.4 million in the prior year period. The decrease was primarily due to a decrease in expenses related to the ACCORDANCE Phase 3 study of AP-CD/LD and the Open Label Extension study, both of which were completed during 2019.
General and administrative expenses for the year ended December 31, 2019 were approximately $8.3 million, an increase of $400,000, or approximately 5.1%, compared with approximately $7.9 million in the year ended December 31, 2018. The increase was primarily related to the increase in insurance expenses. This increase was offset by a decrease in professional services.
Impairment of long-lived assets was recorded as the top-line results of the ACCORDANCE trial were considered a triggering event for impairment. For the year ended December 31, 2019, the Company recorded an impairment charge of approximately $13.7 million. This impairment represents the excess carrying value of the long-lived assets compared to its fair value.
The Company recorded other income for the year ended December 31, 2019, of $1.5 million on conclusion of the program with Novartis.
Net loss for the fiscal year ended December 31, 2019 was approximately $47.6 million, an increase of $4.1 million, or approximately 9.4%, compared with the net loss for the year ended December 31, 2018 of approximately $43.5 million. The increase was mainly due to the impairment of the Company's long-lived assets and an increase in general and administrative expenses as detailed above offset by the other income associated with the conclusion of the Novartis program and the decrease in research and development expenses, as detailed above.
Loss per ordinary share for the full-year 2019 was $1.41 compared with $1.40 for the full-year 2018.
As of December 31, 2019, the Company had cash and cash equivalents and marketable securities of approximately $10.1 million compared with approximately $40.6 million at December 31, 2018.
Net cash used in operating activities was approximately $29.0 million for the year ended December 31, 2019 compared with net cash used in operating activities of approximately $39.1 million for the year ended December 31, 2018. This decrease resulted primarily from a decrease in research and development activities in the amount of approximately $8.7 million and changes in operating asset and liability items of approximately $1.2 million.
The Company had negative cash flow from investing activities of approximately $3.2 million for the year ended December 31, 2019 compared with negative cash flow from investing activities of approximately $9.3 million for the year ended December 31, 2018. This decrease resulted primarily from a reduction of approximately $2.1 million in investment in other assets related to the establishment of the commercial scale production capabilities for AP-CD/LD at LTS and a decrease in purchase of property and equipment in the amount of approximately $3.8 million.
Net cash provided by financing activities was approximately $2.4 million for the year ended December 31, 2019 compared with net cash provided by financing activities of approximately $35.1 million for the year ended December 31, 2018. The principal source of the cash provided by financing activities during 2019 was the funds received from the Company's "at-the-market" equity offering program of $2.1 million. The principal source of the cash provided by financing activities during 2018 was the funds received from the Company's April 2018 underwritten public offering of ordinary shares that resulted in net proceeds of approximately $35.0 million.
In January 2020, the Company raised $6.5 million in an underwritten public offering of 16,250,000 ordinary shares (which included pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase up to 16,250,000 ordinary shares, at a public offering price of $0.40 per ordinary share and warrant. The warrants have an exercise price of $0.40 per share, are immediately exercisable, and will expire five years from the date of issuance.
March 13, 2020 at 7:30 AM EDT
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JERUSALEM, March 13, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces financial results for the fourth quarter and year ended December 31, 2019 and provides a corporate update.
Highlights from the Quarter and Recent Weeks
•Developed an Accordion Pill (AP) for a Merck & Co. (MSD) proprietary compound that met the in vitro specifications set forth in the companies' research collaboration and are now in discussions with MSD to determine advancing the program into human pharmacokinetic (PK) studies;
•Concluded the Feasibility and Option Agreement (FOA) with Novartis Pharmaceuticals, under which Intec Pharma built a custom-designed AP for a Novartis proprietary compound that met the technical and PK clinical specifications set forth but following an internal and revised commercial strategic assessment, Novartis determined not to take the program forward;
•Novartis agreed to pay Intec Pharma$1.5 million upon conclusion of the program FOA and those funds were transferred to the Company in February 2020;
•Completed the qualifying production runs for the commercial scale manufacturing of AP Carbidopa/Levodopa (AP-CD/LD) with our manufacturing partner, LTS Lohmann Therapie-Systeme AG (LTS);
•Secured $10 million in committed financing from Aspire Capital, a long-term institutional investor; and
•Enhanced the balance sheet with a $6.5 million public offering.
Management Commentary
"We entered 2020 with a focused agenda for leveraging our Accordion Pill platform in both the near- and long-term, with goals to outlicence our late-stage Parkinson's disease program, to advance our research collaboration with Merck into human PK studies, to move our cannabinoid program into a second PK study and to expand our pipeline by adding new partnered programs, such as the one we have with Merck. Our team is diligently working toward executing these objectives and we look forward to achieving a number of these in the coming months," said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec.
"In tandem with these initiatives, we continue to work with our manufacturing partner, LTS, to advance the commercial scale production of AP-CD/LD, confident that having these critical processes in place enhances our business development efforts. We are pleased to report that LTS has completed the qualification studies for the commercial scale production and have initiated the validation and stability studies of the batches which are expected to serve as the clinical material for the next Phase 3 clinical trial plan. This is particularly beneficial for our partnering discussions for the Parkinson's disease program.
"In addition to advances with commercial manufacturing, we continue to engage in dialogues with potential new partners. Toward that end, our business development and technical operations teams are actively participating in a number of key drug delivery conferences worldwide in the coming months. We expect the enhanced visibility for the AP and its capabilities to increase the interest in the platform among audiences seeking new technologies and improved delivery formulations.
"Importantly, we strengthened our balance sheet believing that a stronger financial position enhances our ability to negotiate with partners and provides us with a longer runway to achieve key objectives. We believe our cash will now take us into the second quarter of 2021, without tapping into our Aspire commitment," added Mr. Meckler.
Financial Highlights for the Fourth Quarter Ended December 31, 2019
Research and development expenses, net, for the three-month period ended December 31, 2019 were approximately $1.8 million, a decrease of $8.5 million, or approximately 82.5%, compared with approximately $10.3 million in the three-month period ended December 31, 2018. The decrease was primarily due to a decrease in expenses related to the ACCORDANCE Phase 3 study of AP-CD/LD and the Open Label Extension study, both of which were completed during 2019 and a decrease in expenses related to the scale up activities for the commercial scale production capabilities for AP-CD/LD at LTS.
General and administrative expenses for the three-month period ended December 31, 2019 were approximately $1.8 million, a decrease of $300,000, or approximately 14.3%, compared with approximately $2.1 million in the three-month period ended December 31, 2018. The decrease was primarily due to a decrease in professional services and expenses related to investor relations activities. This decrease was offset by an increase in insurance expenses.
Impairment of long-lived assets was recorded as the top-line results of the ACCORDANCE trial were considered a triggering event for impairment. For the three-month period ended December 31, 2019, the Company recorded an impairment charge of approximately $3.9 million. This impairment represents the excess carrying value of the long-lived assets compared to its fair value.
The Company recorded other income for the three-month period ended December 31, 2019, of $1.5 million on conclusion of the program with Novartis.
Net loss for the three-month period ended December 31, 2019 was approximately $6.6 million, a decrease of $6.0 million, or approximately 47.6%, compared with the net loss for the three-month period ended December 31, 2018 of approximately $12.6 million. The decrease was mainly due to the decrease in research and development expenses as detailed above and the other income associated with the conclusion of the Novartis program offset by the impairment of the Company's long-lived assets.
Loss per ordinary share for the fourth quarter ended December 31, 2019 was $0.19 compared with $0.38 for the fourth quarter ended December 31, 2018.
Financial Highlights for the Year Ended December 31, 2019
Research and development expenses, net, for the year ended December 31, 2019 were approximately $26.7 million, a decrease of $8.7 million, or approximately 24.6%, compared with approximately $35.4 million in the prior year period. The decrease was primarily due to a decrease in expenses related to the ACCORDANCE Phase 3 study of AP-CD/LD and the Open Label Extension study, both of which were completed during 2019.
General and administrative expenses for the year ended December 31, 2019 were approximately $8.3 million, an increase of $400,000, or approximately 5.1%, compared with approximately $7.9 million in the year ended December 31, 2018. The increase was primarily related to the increase in insurance expenses. This increase was offset by a decrease in professional services.
Impairment of long-lived assets was recorded as the top-line results of the ACCORDANCE trial were considered a triggering event for impairment. For the year ended December 31, 2019, the Company recorded an impairment charge of approximately $13.7 million. This impairment represents the excess carrying value of the long-lived assets compared to its fair value.
The Company recorded other income for the year ended December 31, 2019, of $1.5 million on conclusion of the program with Novartis.
Net loss for the fiscal year ended December 31, 2019 was approximately $47.6 million, an increase of $4.1 million, or approximately 9.4%, compared with the net loss for the year ended December 31, 2018 of approximately $43.5 million. The increase was mainly due to the impairment of the Company's long-lived assets and an increase in general and administrative expenses as detailed above offset by the other income associated with the conclusion of the Novartis program and the decrease in research and development expenses, as detailed above.
Loss per ordinary share for the full-year 2019 was $1.41 compared with $1.40 for the full-year 2018.
As of December 31, 2019, the Company had cash and cash equivalents and marketable securities of approximately $10.1 million compared with approximately $40.6 million at December 31, 2018.
Net cash used in operating activities was approximately $29.0 million for the year ended December 31, 2019 compared with net cash used in operating activities of approximately $39.1 million for the year ended December 31, 2018. This decrease resulted primarily from a decrease in research and development activities in the amount of approximately $8.7 million and changes in operating asset and liability items of approximately $1.2 million.
The Company had negative cash flow from investing activities of approximately $3.2 million for the year ended December 31, 2019 compared with negative cash flow from investing activities of approximately $9.3 million for the year ended December 31, 2018. This decrease resulted primarily from a reduction of approximately $2.1 million in investment in other assets related to the establishment of the commercial scale production capabilities for AP-CD/LD at LTS and a decrease in purchase of property and equipment in the amount of approximately $3.8 million.
Net cash provided by financing activities was approximately $2.4 million for the year ended December 31, 2019 compared with net cash provided by financing activities of approximately $35.1 million for the year ended December 31, 2018. The principal source of the cash provided by financing activities during 2019 was the funds received from the Company's "at-the-market" equity offering program of $2.1 million. The principal source of the cash provided by financing activities during 2018 was the funds received from the Company's April 2018 underwritten public offering of ordinary shares that resulted in net proceeds of approximately $35.0 million.
In January 2020, the Company raised $6.5 million in an underwritten public offering of 16,250,000 ordinary shares (which included pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase up to 16,250,000 ordinary shares, at a public offering price of $0.40 per ordinary share and warrant. The warrants have an exercise price of $0.40 per share, are immediately exercisable, and will expire five years from the date of issuance.
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Pacifico
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Intec Pharma Reports First Quarter 2020 Financial Results and Provides Corporate Update
May 11, 2020 at 4:15 PM EDT
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JERUSALEM, May 11, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces financial results for the first quarter ended March 31, 2020 and provides a corporate update.
Highlights from the Quarter and Recent Weeks
•Announced that the Accordion Pill (AP) developed for a Merck & Co. (MSD) proprietary compound met the in vitro specifications set forth in the companies' research collaboration and the Company is now in discussions with MSD regarding advancing the program into the clinic;
•Enhanced the balance sheet with a $6.5 million public offering in February 2020 and with a $5 million registered direct offering in May 2020;
•Received a $1.5 million payment from Novartis related to the conclusion of the Feasibility Option Agreement the Company had with Novartis;
•Initiated AP-Carbidopa/Levodopa (AP CD/LD) commercial manufacturing stability lots with LTS Lohmann Therapie-Systeme AG (LTS);
•Completed the redesign of AP-Tetrahydrocannabinol (AP-THC) and are awaiting delivery of synthetic THC to initiate clinical material production; and
•Initiated next generation AP technologies to include longer retention times (e.g. 24 hour gastric retention) as well as larger molecules (e.g. peptides).
Management Commentary
"We continue to build the company's scientific and technical expertise in oral drug delivery and drug-on-film technologies. Our research and manufacturing teams continue to drive innovation as we expand our capabilities and build out our portfolio of potential applications," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
"In collaboration with our partner, LTS, we demonstrated our ability to manufacture at commercial scale. This proficiency, coupled with our recent successes in developing unique APs to meet the technical specifications set forth by Novartis and Merck, enhances our ability to engage in partnership discussions with other large biopharma companies as we actively seek to add more collaborative agreements in 2020.
"Our partnering activities for the AP-CD/LD program in Parkinson's disease continue and there remain multiple parties with interest in this program. Unfortunately, this has not progressed to an agreement and believe this is related to certain commercialization concerns as well as to the overall market environment as a result of the COVID-19 pandemic. In addition, we continue our discussions with Merck with an aim to advance that program into human pharmacokinetic (PK) trials.
"We are delighted to report the completion of a new AP design for our AP-THC program that we expect will meet our stringent PK specifications. We are currently awaiting receipt of the active pharmaceutical ingredients so we can initiate clinical material production and, hopefully, advance this program into the clinic later this year.
"In February and May 2020 we strengthened our balance sheet believing that a stronger financial position enhances our ability to negotiate with partners and provides us with a longer runway to achieve key objectives.
"As the COVID-19 situation rapidly evolves, we are committed to protecting and supporting our workforce and the communities where we live and work and we implemented remote working and workplace protocols for our employees in accordance with government requirements. Our partnering efforts depend in part, on attendace at in-person meetings, industry conferences and other events, and as a result there has been disruption to our efforts to advance this process. We continue to closely evaluate the evolving pandemic as it unfolds and look forward to the end of this healthcare crisis," added Mr. Meckler.
Financial Highlights for First Quarter Ended March 31, 2020
Research and development expenses, net, for the three-month period ended March 31, 2020 were approximately $2.0 million, a decrease of $6.5 million, or approximately 76%, compared with approximately $8.5 million in the three-month period ended March 31, 2019. The decrease was primarily due to the ACCORDANCE study and Open Label Extension study, both of which were completed during 2019, decrease in expenses related to the scale up activities for the commercial scale manufacturing and a decrease in payroll and related expenses, mostly due to a reduction in headcount.
General and administrative expenses for the three-month period ended March 31, 2020 were approximately $1.7 million, a decrease of $500,000, or approximately 23%, compared with approximately $2.2 million in the three-month period ended March 31, 2019. The decrease was primarily related to a decrease in payroll and related expenses, including reduction in headcount, share-based compensation and reduction in certain expenses related to investor relations activities and professional services.
Net loss for the three-month period ended March 31, 2020 was approximately $3.9 million, a decrease of $6.8 million, or approximately 64%, compared with the net loss for the three-month period ended March 31, 2019 of approximately $10.7 million. The decrease was mainly due to a decrease in research and development expenses, net and general and administrative expenses, as detailed above.
Loss per ordinary share for the first quarter ended March 31, 2020, was $0.08 compared with $0.32 for the first quarter ended March 31, 2019.
As of March 31, 2020, the Company had cash and cash equivalents of approximately $10.9 million. As of December 31, 2019, the Company had cash and cash equivalents and marketable securities of approximately $10.1 million. In February 2020, the Company raised $6.5 million in an underwritten public offering of 16,250,000 ordinary shares (which included pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase up to 16,250,000 ordinary shares, at a public offering price of $0.40 per ordinary share and warrant. The warrants have an exercise price of $0.40 per share, are immediately exercisable, and will expire five years from the date of issuance.
Net cash used in operating activities was approximately $5.1 million for the quarter ended March 31, 2020 compared with net cash used in operating activities of approximately $7.3 million for the quarter ended March 31, 2019. This decrease resulted primarily from a decrease in research and development activities in the amount of approximately $6.5 million, offset by changes in operating asset and liability items of approximately $4.3 million.
The Company had positive cash flow from investing activities of approximately $769,000 for the quarter ended March 31, 2020 compared to negative cash flow from investing activities of approximately $640,000 for the quarter ended March 31, 2019. This change resulted primarily from an investment in the establishment of the commercial scale manufacturing in the amount of approximately $1.2 million in the quarter ended March 31, 2019 and an increase in proceeds from the disposal of marketable securities in the amount of approximately $200,000.
Net cash provided by financing activities for the quarter ended March 31, 2020 was approximately $6.1 million, which was provided by the proceeds from the Company's underwritten public offering in February 2020 that resulted in net proceeds of approximately $5.7 million and by the funds received from the sale of our ordinary shares under the "at-the-market" equity offering program that resulted in net proceeds of approximately $421,000. Net cash provided by financing activities for the quarter ended March 31, 2019 was approximately $161,000, which was provided by the proceeds from the exercise of options by employees.
In May, 2020, the Company raised $5 million in a registered direct offering of 16,291,952 ordinary shares at a purchase price of $0.3069 per share. In addition, in a concurrent private placement, the Company also sold and issued to the purchasers in the offering unregistered warrants to purchase 8,145,976 ordinary shares. The warrants have an exercise price of $0.245 per share, are immediately exercisable, and will expire five and one-half years from the date of issuance.
May 11, 2020 at 4:15 PM EDT
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JERUSALEM, May 11, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces financial results for the first quarter ended March 31, 2020 and provides a corporate update.
Highlights from the Quarter and Recent Weeks
•Announced that the Accordion Pill (AP) developed for a Merck & Co. (MSD) proprietary compound met the in vitro specifications set forth in the companies' research collaboration and the Company is now in discussions with MSD regarding advancing the program into the clinic;
•Enhanced the balance sheet with a $6.5 million public offering in February 2020 and with a $5 million registered direct offering in May 2020;
•Received a $1.5 million payment from Novartis related to the conclusion of the Feasibility Option Agreement the Company had with Novartis;
•Initiated AP-Carbidopa/Levodopa (AP CD/LD) commercial manufacturing stability lots with LTS Lohmann Therapie-Systeme AG (LTS);
•Completed the redesign of AP-Tetrahydrocannabinol (AP-THC) and are awaiting delivery of synthetic THC to initiate clinical material production; and
•Initiated next generation AP technologies to include longer retention times (e.g. 24 hour gastric retention) as well as larger molecules (e.g. peptides).
Management Commentary
"We continue to build the company's scientific and technical expertise in oral drug delivery and drug-on-film technologies. Our research and manufacturing teams continue to drive innovation as we expand our capabilities and build out our portfolio of potential applications," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
"In collaboration with our partner, LTS, we demonstrated our ability to manufacture at commercial scale. This proficiency, coupled with our recent successes in developing unique APs to meet the technical specifications set forth by Novartis and Merck, enhances our ability to engage in partnership discussions with other large biopharma companies as we actively seek to add more collaborative agreements in 2020.
"Our partnering activities for the AP-CD/LD program in Parkinson's disease continue and there remain multiple parties with interest in this program. Unfortunately, this has not progressed to an agreement and believe this is related to certain commercialization concerns as well as to the overall market environment as a result of the COVID-19 pandemic. In addition, we continue our discussions with Merck with an aim to advance that program into human pharmacokinetic (PK) trials.
"We are delighted to report the completion of a new AP design for our AP-THC program that we expect will meet our stringent PK specifications. We are currently awaiting receipt of the active pharmaceutical ingredients so we can initiate clinical material production and, hopefully, advance this program into the clinic later this year.
"In February and May 2020 we strengthened our balance sheet believing that a stronger financial position enhances our ability to negotiate with partners and provides us with a longer runway to achieve key objectives.
"As the COVID-19 situation rapidly evolves, we are committed to protecting and supporting our workforce and the communities where we live and work and we implemented remote working and workplace protocols for our employees in accordance with government requirements. Our partnering efforts depend in part, on attendace at in-person meetings, industry conferences and other events, and as a result there has been disruption to our efforts to advance this process. We continue to closely evaluate the evolving pandemic as it unfolds and look forward to the end of this healthcare crisis," added Mr. Meckler.
Financial Highlights for First Quarter Ended March 31, 2020
Research and development expenses, net, for the three-month period ended March 31, 2020 were approximately $2.0 million, a decrease of $6.5 million, or approximately 76%, compared with approximately $8.5 million in the three-month period ended March 31, 2019. The decrease was primarily due to the ACCORDANCE study and Open Label Extension study, both of which were completed during 2019, decrease in expenses related to the scale up activities for the commercial scale manufacturing and a decrease in payroll and related expenses, mostly due to a reduction in headcount.
General and administrative expenses for the three-month period ended March 31, 2020 were approximately $1.7 million, a decrease of $500,000, or approximately 23%, compared with approximately $2.2 million in the three-month period ended March 31, 2019. The decrease was primarily related to a decrease in payroll and related expenses, including reduction in headcount, share-based compensation and reduction in certain expenses related to investor relations activities and professional services.
Net loss for the three-month period ended March 31, 2020 was approximately $3.9 million, a decrease of $6.8 million, or approximately 64%, compared with the net loss for the three-month period ended March 31, 2019 of approximately $10.7 million. The decrease was mainly due to a decrease in research and development expenses, net and general and administrative expenses, as detailed above.
Loss per ordinary share for the first quarter ended March 31, 2020, was $0.08 compared with $0.32 for the first quarter ended March 31, 2019.
As of March 31, 2020, the Company had cash and cash equivalents of approximately $10.9 million. As of December 31, 2019, the Company had cash and cash equivalents and marketable securities of approximately $10.1 million. In February 2020, the Company raised $6.5 million in an underwritten public offering of 16,250,000 ordinary shares (which included pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase up to 16,250,000 ordinary shares, at a public offering price of $0.40 per ordinary share and warrant. The warrants have an exercise price of $0.40 per share, are immediately exercisable, and will expire five years from the date of issuance.
Net cash used in operating activities was approximately $5.1 million for the quarter ended March 31, 2020 compared with net cash used in operating activities of approximately $7.3 million for the quarter ended March 31, 2019. This decrease resulted primarily from a decrease in research and development activities in the amount of approximately $6.5 million, offset by changes in operating asset and liability items of approximately $4.3 million.
The Company had positive cash flow from investing activities of approximately $769,000 for the quarter ended March 31, 2020 compared to negative cash flow from investing activities of approximately $640,000 for the quarter ended March 31, 2019. This change resulted primarily from an investment in the establishment of the commercial scale manufacturing in the amount of approximately $1.2 million in the quarter ended March 31, 2019 and an increase in proceeds from the disposal of marketable securities in the amount of approximately $200,000.
Net cash provided by financing activities for the quarter ended March 31, 2020 was approximately $6.1 million, which was provided by the proceeds from the Company's underwritten public offering in February 2020 that resulted in net proceeds of approximately $5.7 million and by the funds received from the sale of our ordinary shares under the "at-the-market" equity offering program that resulted in net proceeds of approximately $421,000. Net cash provided by financing activities for the quarter ended March 31, 2019 was approximately $161,000, which was provided by the proceeds from the exercise of options by employees.
In May, 2020, the Company raised $5 million in a registered direct offering of 16,291,952 ordinary shares at a purchase price of $0.3069 per share. In addition, in a concurrent private placement, the Company also sold and issued to the purchasers in the offering unregistered warrants to purchase 8,145,976 ordinary shares. The warrants have an exercise price of $0.245 per share, are immediately exercisable, and will expire five and one-half years from the date of issuance.
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Ci stiamo pericolosamente avvicinando allo zero.
Ma cosa stanno facendo a Gerusalemme ?
Ma cosa stanno facendo a Gerusalemme ?
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Intec Pharma Reports Second Quarter 2020 Financial Results and Provides Corporate Update
August 5, 2020 at 7:00 AM EDT
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JERUSALEM, Aug. 5, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces financial results for the second quarter ended June 30, 2020 and provides a corporate update.
"We have worked diligently over the past quarter to address the challenges of an evolving landscape for both our business and clinical development initiatives given the global COVID-19 pandemic," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
"Despite constraints on our ability to conduct in-person meetings, our partnering activities to identify new opportunities and compounds for our unique gastric retentive oral delivery system as well as our partnering efforts for the AP-CD/LD program in Parkinson's disease remain ongoing. Looking into the second half of the year, we continue to seek to advance these productive conversations towards a deal that demonstrates appropriate value for both the Company and our shareholders.
"We look forward to advancing our newly designed AP-THC program into clinical development later this year as we recently received the active pharmaceutical ingredients needed for the clinical material production.
"Earlier this year, we announced we met the in vitro specifications for Merck's compound. At this time, we do not anticipate the compound entering an in vivo study this year. We continue to discuss development opportunities for the Accordion Pill with Merck.
"Our recent registered direct offering not only strengthens our balance sheet but, more importantly, provides the financial support and flexibility to position the Company for its next stage of development," added Mr. Meckler.
Financial Highlights for Second Quarter Ended June 30, 2020
Research and development expenses, net, for the three-month period ended June 30, 2020 were approximately $1.3 million, a decrease of $6.6 million, or approximately 84%, compared with approximately $7.9 million in the three-month period ended June 30, 2019. Research and development expenses, net, for the six-month period ended June 30, 2020 were approximately $3.3 million, a decrease of approximately $13.1 million, or approximately 80%, compared with approximately $16.4 million in the six-month period ended June 30, 2019. The decrease was primarily due to the completion of the ACCORDANCE study and Open Label Extension study during 2019, decrease in expenses related to the scale up activities for the commercial scale manufacturing and a decrease in payroll and related expenses, mostly due to a reduction in headcount, and share-based compensation.
General and administrative expenses for the three-month period ended June 30, 2020 were approximately $1.6 million, a decrease of $500,000, or approximately 24%, compared with approximately $2.1 million in the three-month period ended June 30, 2019. General and administrative expenses for the six-month period ended June 30, 2020 amounted to approximately $3.3 million, a decrease of approximately $1.0 million, or approximately 23%, compared to approximately $4.3 million for the six-month ended June 30, 2019. The decrease for the three and six-month periods was primarily related to a decrease in payroll and related expenses, including reduction in headcount, share-based compensation and reduction in associated expenses.
Net loss for the three-month period ended June 30, 2020 was approximately $2.9 million, a decrease of $7.1 million, or approximately 71%, compared with the net loss for the three-month period ended June 30, 2019 of approximately $10.0 million. The decrease for the three and six-month periods was mainly due to a decrease in research and development expenses, net, and general and administrative expenses, as detailed above.
Loss per ordinary share for the three-month period ended June 30, 2020, was $0.05 compared with $0.30 for the three-month period ended June 30, 2019. Loss per ordinary share for the six-month period ended June 30, 2020, was $0.12 compared with $0.62 for the six-month period ended June 30, 2019.
As of June 30, 2020, the Company had cash and cash equivalents of approximately $13.8 million. As of December 31, 2019, the Company had cash and cash equivalents and marketable securities of approximately $10.1 million.
Net cash used in operating activities was approximately $6.8 million for the six-month period ended June 30, 2020 compared with net cash used in operating activities of approximately $17.7 million for the six-month period ended June 30, 2019. This decrease resulted primarily from a decrease in research and development activities in the amount of approximately $13.1 million, offset by changes in operating asset and liability items of approximately $2.0 million.
The Company had positive cash flow from investing activities of approximately $769,000 for the six-month period ended June 30, 2020 compared to negative cash flow from investing activities of approximately $1.0 for the six-month period ended June 30, 2019. This change resulted primarily from an investment in the establishment of the commercial scale manufacturing in the amount of approximately $1.4 million in the six-month period ended June 30, 2019 and an increase in proceeds from the disposal of marketable securities in the amount of approximately $200,000.
Net cash provided by financing activities for the six-month period ended June 30, 2020 was approximately $10.6 million, which was provided primarily by the proceeds from the Company's registered direct offering in May 2020 that resulted in net proceeds of approximately $4.5 million, proceeds from the company's underwritten public offering in February 2020 that resulted in net proceeds of approximately $5.7 million and by the funds received from the sale of our ordinary shares under the Company's "at-the-market" equity offering program that resulted in net proceeds of approximately $421,000.
In May 2020, the Company raised $5.0 million in a registered direct offering of 16,291,952 ordinary shares at a purchase price of $0.3069 per share. In addition, in a concurrent private placement, the Company also sold and issued to the purchasers in the offering unregistered warrants to purchase 8,145,976 ordinary shares. The warrants have an exercise price of $0.245 per share, are immediately exercisable, and will expire five and one-half years from the date of issuance.
August 5, 2020 at 7:00 AM EDT
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JERUSALEM, Aug. 5, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces financial results for the second quarter ended June 30, 2020 and provides a corporate update.
"We have worked diligently over the past quarter to address the challenges of an evolving landscape for both our business and clinical development initiatives given the global COVID-19 pandemic," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
"Despite constraints on our ability to conduct in-person meetings, our partnering activities to identify new opportunities and compounds for our unique gastric retentive oral delivery system as well as our partnering efforts for the AP-CD/LD program in Parkinson's disease remain ongoing. Looking into the second half of the year, we continue to seek to advance these productive conversations towards a deal that demonstrates appropriate value for both the Company and our shareholders.
"We look forward to advancing our newly designed AP-THC program into clinical development later this year as we recently received the active pharmaceutical ingredients needed for the clinical material production.
"Earlier this year, we announced we met the in vitro specifications for Merck's compound. At this time, we do not anticipate the compound entering an in vivo study this year. We continue to discuss development opportunities for the Accordion Pill with Merck.
"Our recent registered direct offering not only strengthens our balance sheet but, more importantly, provides the financial support and flexibility to position the Company for its next stage of development," added Mr. Meckler.
Financial Highlights for Second Quarter Ended June 30, 2020
Research and development expenses, net, for the three-month period ended June 30, 2020 were approximately $1.3 million, a decrease of $6.6 million, or approximately 84%, compared with approximately $7.9 million in the three-month period ended June 30, 2019. Research and development expenses, net, for the six-month period ended June 30, 2020 were approximately $3.3 million, a decrease of approximately $13.1 million, or approximately 80%, compared with approximately $16.4 million in the six-month period ended June 30, 2019. The decrease was primarily due to the completion of the ACCORDANCE study and Open Label Extension study during 2019, decrease in expenses related to the scale up activities for the commercial scale manufacturing and a decrease in payroll and related expenses, mostly due to a reduction in headcount, and share-based compensation.
General and administrative expenses for the three-month period ended June 30, 2020 were approximately $1.6 million, a decrease of $500,000, or approximately 24%, compared with approximately $2.1 million in the three-month period ended June 30, 2019. General and administrative expenses for the six-month period ended June 30, 2020 amounted to approximately $3.3 million, a decrease of approximately $1.0 million, or approximately 23%, compared to approximately $4.3 million for the six-month ended June 30, 2019. The decrease for the three and six-month periods was primarily related to a decrease in payroll and related expenses, including reduction in headcount, share-based compensation and reduction in associated expenses.
Net loss for the three-month period ended June 30, 2020 was approximately $2.9 million, a decrease of $7.1 million, or approximately 71%, compared with the net loss for the three-month period ended June 30, 2019 of approximately $10.0 million. The decrease for the three and six-month periods was mainly due to a decrease in research and development expenses, net, and general and administrative expenses, as detailed above.
Loss per ordinary share for the three-month period ended June 30, 2020, was $0.05 compared with $0.30 for the three-month period ended June 30, 2019. Loss per ordinary share for the six-month period ended June 30, 2020, was $0.12 compared with $0.62 for the six-month period ended June 30, 2019.
As of June 30, 2020, the Company had cash and cash equivalents of approximately $13.8 million. As of December 31, 2019, the Company had cash and cash equivalents and marketable securities of approximately $10.1 million.
Net cash used in operating activities was approximately $6.8 million for the six-month period ended June 30, 2020 compared with net cash used in operating activities of approximately $17.7 million for the six-month period ended June 30, 2019. This decrease resulted primarily from a decrease in research and development activities in the amount of approximately $13.1 million, offset by changes in operating asset and liability items of approximately $2.0 million.
The Company had positive cash flow from investing activities of approximately $769,000 for the six-month period ended June 30, 2020 compared to negative cash flow from investing activities of approximately $1.0 for the six-month period ended June 30, 2019. This change resulted primarily from an investment in the establishment of the commercial scale manufacturing in the amount of approximately $1.4 million in the six-month period ended June 30, 2019 and an increase in proceeds from the disposal of marketable securities in the amount of approximately $200,000.
Net cash provided by financing activities for the six-month period ended June 30, 2020 was approximately $10.6 million, which was provided primarily by the proceeds from the Company's registered direct offering in May 2020 that resulted in net proceeds of approximately $4.5 million, proceeds from the company's underwritten public offering in February 2020 that resulted in net proceeds of approximately $5.7 million and by the funds received from the sale of our ordinary shares under the Company's "at-the-market" equity offering program that resulted in net proceeds of approximately $421,000.
In May 2020, the Company raised $5.0 million in a registered direct offering of 16,291,952 ordinary shares at a purchase price of $0.3069 per share. In addition, in a concurrent private placement, the Company also sold and issued to the purchasers in the offering unregistered warrants to purchase 8,145,976 ordinary shares. The warrants have an exercise price of $0.245 per share, are immediately exercisable, and will expire five and one-half years from the date of issuance.
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Ottima notizia: prosegue la collaborazione con Merck
Intec Pharma Announces New Research Collaboration Agreement with MSD
October 8, 2020 at 7:00 AM EDT
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JERUSALEM, Oct. 8, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces it has entered into a new research collaboration agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. Details of the agreement are confidential.
"We are very excited to continue to work with MSD," said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "This new agreement builds upon the relationship we have enjoyed in prior research and allows the companies to leverage their combined experience in delivery."
Intec Pharma Announces New Research Collaboration Agreement with MSD
October 8, 2020 at 7:00 AM EDT
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JERUSALEM, Oct. 8, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces it has entered into a new research collaboration agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. Details of the agreement are confidential.
"We are very excited to continue to work with MSD," said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "This new agreement builds upon the relationship we have enjoyed in prior research and allows the companies to leverage their combined experience in delivery."
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Speriamo che questa volta dalla collaborazione con Merck esca qualche cosa di concreto e non arrivino altri fallimenti, come con Novartis.
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Intec Pharma Announces 1-for-20 Reverse Share Split
October 29, 2020 at 8:00 AM EDT
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JERUSALEM, Oct. 29, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces a 1-for-20 reverse share split of its outstanding ordinary shares. The reverse share split is scheduled to become effective after trading closes on October 29, 2020, and the Company's ordinary shares will begin trading on a split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on October 30, 2020 under the Company's existing symbol "NTEC." The Company's ordinary shares have been assigned a new CUSIP number of M53644148 in connection with the reverse share split. As previously disclosed, at the Company's Annual Meeting of Shareholders held on July 15, 2020, the Company's shareholders approved a proposal to amend the Company's Articles of Association to effect a reverse share split of the Company's ordinary shares at a ratio with the range from 1-for-5 to 1-for-25, to be effective at the ratio and on a date to be determined by the Company's board of directors in its sole discretion.
The Company's board of directors has determined to effect the reverse share split at a ratio of 1-for-20. As a result, upon effectiveness of the reverse share split, every 20 shares of the Company's outstanding ordinary shares will be combined into to one ordinary share. In addition, proportionate adjustments will be made to the exercise prices of the Company's outstanding options, warrants and pre-funded warrants and to the number of shares issuable under the Company's existing option plans.
The reverse share split will not affect any shareholder's ownership percentage of the Company's ordinary shares, except to the extent that the reverse share split would result in any shareholder owning a fractional share. Fractional ordinary shares will be rounded up to the nearest whole share. As a result of the reverse share split, the number of outstanding shares will be reduced from approximately 79 million to approximately 3.9 million and the total number of ordinary shares the Company is authorized to issue will change from 350 million ordinary shares to 17.5 million ordinary shares, no par value.
October 29, 2020 at 8:00 AM EDT
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JERUSALEM, Oct. 29, 2020 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces a 1-for-20 reverse share split of its outstanding ordinary shares. The reverse share split is scheduled to become effective after trading closes on October 29, 2020, and the Company's ordinary shares will begin trading on a split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on October 30, 2020 under the Company's existing symbol "NTEC." The Company's ordinary shares have been assigned a new CUSIP number of M53644148 in connection with the reverse share split. As previously disclosed, at the Company's Annual Meeting of Shareholders held on July 15, 2020, the Company's shareholders approved a proposal to amend the Company's Articles of Association to effect a reverse share split of the Company's ordinary shares at a ratio with the range from 1-for-5 to 1-for-25, to be effective at the ratio and on a date to be determined by the Company's board of directors in its sole discretion.
The Company's board of directors has determined to effect the reverse share split at a ratio of 1-for-20. As a result, upon effectiveness of the reverse share split, every 20 shares of the Company's outstanding ordinary shares will be combined into to one ordinary share. In addition, proportionate adjustments will be made to the exercise prices of the Company's outstanding options, warrants and pre-funded warrants and to the number of shares issuable under the Company's existing option plans.
The reverse share split will not affect any shareholder's ownership percentage of the Company's ordinary shares, except to the extent that the reverse share split would result in any shareholder owning a fractional share. Fractional ordinary shares will be rounded up to the nearest whole share. As a result of the reverse share split, the number of outstanding shares will be reduced from approximately 79 million to approximately 3.9 million and the total number of ordinary shares the Company is authorized to issue will change from 350 million ordinary shares to 17.5 million ordinary shares, no par value.
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Implacabile
Pacifico
- Registrato
- 24/10/07
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Adesso siamo a -24%.
Anch'io ho detto addio ai dollari investiti.
Ci mancava anche il Reverse split.
visal
In cul@ al nasdaq
- Registrato
- 20/6/01
- Messaggi
- 23.858
- Punti reazioni
- 304
-26% per essere precisi
MA gli shorter si dovranno ricoprire prima di domani???
Faccio sta semplice domanda