electroCore Announces Pricing of $18.0 Million Public Offering of Common Stock

 

ROCKAWAY, NJ, 
June 30, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced the pricing of an underwritten public offering of 18,000,000 shares of its common stock at a public offering price of 
$1.00 per share. The gross proceeds of the offering to the Company are expected to be 
$18.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, the Company granted the underwriters a 45-day option to purchase up to an additional 2,700,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

The closing of the offering is expected to occur on or about 
July 2, 2021, subject to the satisfaction of customary closing conditions.

Ladenburg Thalmann & Co. Inc. is acting as sole book-runner for the offering. 
Paulson Investment Company, LLC is acting as a co-manager for the offering.

The Company intends to use the net proceeds of the offering for sales and marketing, working capital, and general corporate purposes. In addition, it believes that opportunities may exist from time to time to expand its current business through acquisitions or in-licenses of, or investments in, complementary companies, medicines, intellectual property or technologies. While the Company has no current agreements or commitments for any specific acquisitions, in-licenses or investments at this time, it may use a portion of the net proceeds for these purposes.

The securities described above are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-232655) previously filed with the 
Securities and Exchange Commission (“SEC”) on 
July 15, 2019, which registration statement became effective on 
September 5, 2019.

A preliminary prospectus supplement relating to the offering was filed with the 
SEC on 
June 29, 2021 and is available on the SEC’s website at http://www.sec.gov. The final prospectus supplement relating to and describing the terms of the offering will be filed with the 
SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that the Company has filed with the 
SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about the Company and the offering. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, from 
Ladenburg Thalmann & Co. Inc., 
640 Fifth Avenue, 4th Floor, 
New York, NY 10017, or by email at prospectus@ladenburg.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About electroCore
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, including those regarding the anticipated and potential use of proceeds for the proposed offering, satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, stock price volatility and the impact of general business and economic conditions are forward-looking statements. electroCore may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading “Risk Factors” in electroCore’s Annual Report on Form 10-K for the fiscal year ended 
December 31, 2020, filed with the 
SEC on 
March 11, 2021 and in subsequent filings with, or submissions to, the 
SEC. Except as otherwise required by law, electroCore disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

electroCore Announces Proposed Public Offering of Common Stock

 

ROCKAWAY, NJ, 
June 29, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (the “Company”), NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. All the shares to be sold in the offering will be offered by the Company. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. In addition, the Company intends to grant the underwriters a 45-day option to purchase up to an additional 15 percent of shares of its common stock offered in the public offering.

Ladenburg Thalmann & Co. Inc. is acting as sole book-runner for the offering. 
Paulson Investment Company, LLC is acting as a co-manager for the offering.

The Company intends to use the net proceeds of the offering for sales and marketing, working capital, and general corporate purposes. In addition, it believes that opportunities may exist from time to time to expand its current business through acquisitions or in-licenses of, or investments in, complementary companies, medicines, intellectual property or technologies. While the Company has no current agreements or commitments for any specific acquisitions, in-licenses or investments at this time, it may use a portion of the net proceeds for these purposes.

The securities described above are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-232655) previously filed with the 
Securities and Exchange Commission (“SEC”) on 
July 15, 2019, which registration statement became effective on 
September 5, 2019. The securities will be offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the 
SEC and will be available on the SEC’s website at http://www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, from 
Ladenburg Thalmann & Co. Inc., 
640 Fifth Avenue, 4th Floor, 
New York, NY 10017, or by email at prospectus@ladenburg.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About electroCore
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, including those regarding the anticipated use of proceeds for the proposed offering, satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, stock price volatility and the impact of general business and economic conditions are forward-looking statements. electroCore may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading “Risk Factors” in electroCore’s Annual Report on Form 10-K for the fiscal year ended 
December 31, 2020, filed with the 
SEC on 
March 11, 2021 and in subsequent filings with, or submissions to, the 
SEC. Except as otherwise required by law, electroCore disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Tuesday, June 29, 2021

Onconova Therapeutics Inc. (ONTX)
Onconova To Continue Additional Cohorts In Rigosertib Lung Cancer Trial

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Rigosertib Combination Phase 1/2a Trial To Continue Onconova announced the completion of three cohorts in its Phase 1/2a trial testing rigosertib in combination with the checkpoint inhibitor nivolumab (Opdivo). The data show signs of efficacy without reaching a maximum tolerated dose, justifying continuing the trial with higher dosing. We see this continuation and higher dosing as a positive signal of efficacy and safety.


Interim Data Should Indicate Improved Responses The announcement indicates evidence of efficacy without side effects that would make treatment intolerable.  Patient enrollment will continue at the current dose as trial protocols are amended to allow higher dosing. We believe this could indicate that rigosertib can improve response rates for checkpoint inhibitor therapies …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Lineage Cell Therapeutics Joins Russell 3000® And Russell Microcap® Indexes

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 28, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that the Company has been added to both the broad-market Russell 3000^® Index as well as the Russell Microcap^® Index. The 2021 Russell indexes annual reconstitution will be effective after the U.S. market opens today.

“Lineage’s addition to both the Russell 3000^® and the Russell Microcap^® Indexes reflects continued progress made in establishing the Company as a leader in cell therapy and regenerative medicine and should help us benefit from the tremendous growth that we foresee in the field of cell therapy,” stated  Brian M. Culley, Lineage’s CEO. “During the past year we have created considerable value for our shareholders by accomplishing significant clinical, manufacturing, and business milestones across our entire novel pipeline. We believe our addition to the Russell indexes can expand awareness of Lineage’s corporate mission and objectives among a broader audience of investors and help drive an increase in the liquidity of our stock.”

Annual Russell indexes reconstitution captures the 4,000 largest 
U.S. stocks as of 
May 7, 2021, ranking them by total market capitalization. Membership in the 
U.S. all-cap Russell 3000^® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000^® Index or small-cap Russell 2000^® Index as well as the appropriate growth and value style indexes. Membership in the Russell Microcap^® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately 
$10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell.

About FTSE Russell

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately 
$17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” “foresee” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to anticipated growth in the field of cell therapy and the potential benefits to Lineage and its shareholders as a result of that growth and as a result of the Company’s inclusion in the Russell indexes. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

The information in this announcement about the Russell indexes and FTSE Russell was obtained from FTSE Russell. Lineage has not independently verified such information and there can be no assurance as to its accuracy.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Onconova Therapeutics Provides An Update On The Phase 1/2a Trial Of Rigosertib-Nivolumab Combination In KRAS+ Non-Small Cell Lung Cancer

 

Expansion of trial underway at highest dose in the current protocol, and continued dose escalation under consideration

Preliminary data support the preclinical observation of rigosertib augmenting the response to immune checkpoint inhibition

NEWTOWN, Pa., June 28, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced an update on the investigator-initiated Phase 1/2a trial of oral rigosertib plus nivolumab in advanced metastatic KRAS mutated (KRAS+) non-small cell lung cancer (NSCLC). The clinical data to date provide preliminary evidence of potential anti-cancer activity of rigosertib-nivolumab combination therapy in advanced metastatic KRAS+ non-small cell lung cancer and show that the maximum tolerated dose of rigosertib in combination with nivolumab was not reached in the three cohorts of the trial’s dose-escalation phase. Patients enrolled in this trial have failed multiple lines of prior therapy and all have failed immune checkpoint inhibitors in various combinations.

The trial continues to recruit patients as part of the expansion phase at the highest dose of oral rigosertib defined in the current protocol. Based on the positive preliminary findings from the trial, a protocol amendment is being prepared that would allow for the evaluation of increased rigosertib doses in combination with the full dose of intravenous nivolumab, as recommended per its product label.

“The preliminary results from this Phase 1/2a trial are very encouraging and demonstrate the potential of rigosertib to address a critical unmet medical need by overcoming checkpoint inhibitor resistance in KRAS mutated lung adenocarcinoma,” said Mark S. Gelder, M.D., Chief Medical Officer of Onconova. “The observation of preliminary evidence of efficacy in combination with acceptable safety of the doublet in this extremely challenging patient population provides a promising signal. This phase 1 study supports the preclinical observation in melanoma of the up regulation of crucial cell surface molecules by rigosertib which may synergize with immune checkpoint blockade, as recently published in Molecular Cancer, and strongly supports the continued clinical development of rigosertib-checkpoint inhibitor combination therapy. We look forward to the presentation of preliminary data at the upcoming 3^rd Annual RAS Targeted Drug Development Summit taking place September 21-23, 2021, and at a future major medical meeting as the data mature.”

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “This Phase 1/2a trial is an important part of our investigator-initiated study program, which enables us to pursue opportunities to develop rigosertib in high-need KRAS mutated indications while maintaining our primary focus on our lead ON 123300 program. We are very pleased both with the safety and preliminary efficacy signal we have seen from the KRAS mutated NSCLC trial to date, considering the multiple lines of therapy many of these patients have previously failed, including checkpoint inhibitors in various combinations. We are supportive of the plan to expand dose-escalation of rigosertib to determine the optimal recommended Phase 2 dose of the combination; and are eagerly anticipating results of important correlative science that is part of the trial. We look forward to the trial’s continued progress and would like to thank the investigator and his team for conducting the trial, as well as the patients who are participating.”

About the Investigator-initiated Phase 1/2a Trial
This Phase 1/2a trial is designed to evaluate the combination of rigosertib and nivolumab in advanced KRAS+ metastatic lung adenocarcinoma patients who have progressed on standard of care with anti-PD-1 monotherapy or anti-PD-1 in combination with chemotherapy. It includes a dose-escalating Phase 1 portion followed by a Phase 2a dose-expansion portion. Patients in the trial receive oral rigosertib twice daily on days 1-21, and intravenous nivolumab on days 1 and 15 of 28-day cycles. The primary endpoints of the trial are safety assessments and overall response rate. Secondary endpoints include progression free survival and overall survival. For more information on the trial, see ClinicalTrials.gov Identifier: NCT04263090.

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of Onconova’s and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, the timing of the Company’s annual stockholder meeting, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Onconova Therapeutics Provides An Update On The Phase 1/2a Trial Of Rigosertib-Nivolumab Combination In KRAS+ Non-Small Cell Lung Cancer

 

Expansion of trial underway at highest dose in the current protocol, and continued dose escalation under consideration

Preliminary data support the preclinical observation of rigosertib augmenting the response to immune checkpoint inhibition

NEWTOWN, Pa., June 28, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced an update on the investigator-initiated Phase 1/2a trial of oral rigosertib plus nivolumab in advanced metastatic KRAS mutated (KRAS+) non-small cell lung cancer (NSCLC). The clinical data to date provide preliminary evidence of potential anti-cancer activity of rigosertib-nivolumab combination therapy in advanced metastatic KRAS+ non-small cell lung cancer and show that the maximum tolerated dose of rigosertib in combination with nivolumab was not reached in the three cohorts of the trial’s dose-escalation phase. Patients enrolled in this trial have failed multiple lines of prior therapy and all have failed immune checkpoint inhibitors in various combinations.

The trial continues to recruit patients as part of the expansion phase at the highest dose of oral rigosertib defined in the current protocol. Based on the positive preliminary findings from the trial, a protocol amendment is being prepared that would allow for the evaluation of increased rigosertib doses in combination with the full dose of intravenous nivolumab, as recommended per its product label.

“The preliminary results from this Phase 1/2a trial are very encouraging and demonstrate the potential of rigosertib to address a critical unmet medical need by overcoming checkpoint inhibitor resistance in KRAS mutated lung adenocarcinoma,” said Mark S. Gelder, M.D., Chief Medical Officer of Onconova. “The observation of preliminary evidence of efficacy in combination with acceptable safety of the doublet in this extremely challenging patient population provides a promising signal. This phase 1 study supports the preclinical observation in melanoma of the up regulation of crucial cell surface molecules by rigosertib which may synergize with immune checkpoint blockade, as recently published in Molecular Cancer, and strongly supports the continued clinical development of rigosertib-checkpoint inhibitor combination therapy. We look forward to the presentation of preliminary data at the upcoming 3^rd Annual RAS Targeted Drug Development Summit taking place September 21-23, 2021, and at a future major medical meeting as the data mature.”

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “This Phase 1/2a trial is an important part of our investigator-initiated study program, which enables us to pursue opportunities to develop rigosertib in high-need KRAS mutated indications while maintaining our primary focus on our lead ON 123300 program. We are very pleased both with the safety and preliminary efficacy signal we have seen from the KRAS mutated NSCLC trial to date, considering the multiple lines of therapy many of these patients have previously failed, including checkpoint inhibitors in various combinations. We are supportive of the plan to expand dose-escalation of rigosertib to determine the optimal recommended Phase 2 dose of the combination; and are eagerly anticipating results of important correlative science that is part of the trial. We look forward to the trial’s continued progress and would like to thank the investigator and his team for conducting the trial, as well as the patients who are participating.”

About the Investigator-initiated Phase 1/2a Trial
This Phase 1/2a trial is designed to evaluate the combination of rigosertib and nivolumab in advanced KRAS+ metastatic lung adenocarcinoma patients who have progressed on standard of care with anti-PD-1 monotherapy or anti-PD-1 in combination with chemotherapy. It includes a dose-escalating Phase 1 portion followed by a Phase 2a dose-expansion portion. Patients in the trial receive oral rigosertib twice daily on days 1-21, and intravenous nivolumab on days 1 and 15 of 28-day cycles. The primary endpoints of the trial are safety assessments and overall response rate. Secondary endpoints include progression free survival and overall survival. For more information on the trial, see ClinicalTrials.gov Identifier: NCT04263090.

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of Onconova’s and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, the timing of the Company’s annual stockholder meeting, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Lineage Cell Therapeutics Joins Russell 3000® And Russell Microcap® Indexes

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 28, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that the Company has been added to both the broad-market Russell 3000^® Index as well as the Russell Microcap^® Index. The 2021 Russell indexes annual reconstitution will be effective after the U.S. market opens today.

“Lineage’s addition to both the Russell 3000^® and the Russell Microcap^® Indexes reflects continued progress made in establishing the Company as a leader in cell therapy and regenerative medicine and should help us benefit from the tremendous growth that we foresee in the field of cell therapy,” stated  Brian M. Culley, Lineage’s CEO. “During the past year we have created considerable value for our shareholders by accomplishing significant clinical, manufacturing, and business milestones across our entire novel pipeline. We believe our addition to the Russell indexes can expand awareness of Lineage’s corporate mission and objectives among a broader audience of investors and help drive an increase in the liquidity of our stock.”

Annual Russell indexes reconstitution captures the 4,000 largest 
U.S. stocks as of 
May 7, 2021, ranking them by total market capitalization. Membership in the 
U.S. all-cap Russell 3000^® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000^® Index or small-cap Russell 2000^® Index as well as the appropriate growth and value style indexes. Membership in the Russell Microcap^® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately 
$10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell.

About FTSE Russell

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately 
$17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” “foresee” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to anticipated growth in the field of cell therapy and the potential benefits to Lineage and its shareholders as a result of that growth and as a result of the Company’s inclusion in the Russell indexes. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

The information in this announcement about the Russell indexes and FTSE Russell was obtained from FTSE Russell. Lineage has not independently verified such information and there can be no assurance as to its accuracy.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Monday, June 28, 2021

Cocrystal Pharma Inc. (COCP)
Cocrystal Announces CC-42334 To Start Clinical Studies in Influenza

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

The Product Pipeline Advances Cocrystal announced that it has completed studies to file an IND for CC-42344, its PB2 inhibitor for the treatment of seasonal and pandemic influenza A.  The first Phase 1 study is planned for 3Q21.


CC-42334 Has A Unique Mechanism Of Action CC-42334 was developed using Cocrystal’s proprietary anti-viral technology, targeting an enzyme early in the process of producing the next viral generation.  This differs from other anti-influenza approaches that are based on stimulating an immune response or blocking viral surface proteins …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

NIH Image Gallery (Flickr)

Research on How Cells Recover from Threats May Lead to New Insights Into Alzheimer’s and ALS

 

The Big Idea

Our bodies contain a special protein tag that plays a role in how cells recover from specific threats to their survival, according to new research I co-authored. Understanding how this process works may be key to future treatments for neurodegenerative diseases, such as Alzheimer’s disease and some forms of dementia.

Cells regularly encounter potentially harmful changes in their environment, such as fluctuating temperature or exposure to UV light or toxins. To ensure survival, cells have evolved complex ways to adapt to these stressful changes. These mechanisms range from temporary changes in metabolism to wholesale shutdown of critical biological processes that might otherwise be permanently damaged.

For example, many cellular stresses temporarily shut down protein production while messenger RNAs, which carry part of the DNA code through the cell, become sequestered in dense structures known as stress granules. When the stress passes, the stress granules are disassembled and cells emerge from this defensive state to resume normal activities.

But until now, molecular biologists like me didn’t understand exactly how this mechanism worked.

In a pair of peer-reviewed studies published in the journal Science on June 25, 2021, my colleagues and I working in J. Paul Taylor’s cell and molecular biology lab explain how a protein known as ubiquitin is responsible for getting cells back up and running once the coast is clear.

In the first study, I discovered that different types of stress lead to specific proteins in cells getting tagged with ubiquitin in distinct ways. I exposed cells to either heat stress or a toxic chemical, then blocked the ubiquitin-tagging process after seemingly identical stress granules formed. To my surprise, blocking ubiquitin tagging only prevented stress granule disassembly for heat shock. Importantly, I also found that cells were unable to restart key biological processes like protein production and transport when these stress granules remained present, even after a return to normal temperatures.

In the second study, my colleague Youngdae Gwon looked closer into this process. He discovered that heat stress triggers ubiquitin tagging of a key protein that allows an enzyme to disassemble stress granules. This enzyme grabs onto the ubiquitin tag and uses it as a handle to pull the structure apart.

 

 

Why It Matters

Researchers have linked stress granule biology and the stress response process in general to several neurodegenerative diseases, including Alzheimer’s disease, ALS or Lou Gehrig’s disease, and some forms of dementia.

For example, mutations in the same protein, which we found to be necessary to dissemble stress granules, can cause inherited neurodegenerative diseases. Understanding how stress granules are regulated is critical to getting a better grasp on how these diseases work and potentially finding new treatments for them.

 

What Still Isn’t Known

Although we identified several key factors in the role ubiquitin plays in the disassembly of stress granules, many molecular details of this process remain unknown. To gain further insight, scientists will need to identify which enzymes are responsible for putting the ubiquitin tag on proteins during stress in the first place. Additionally, it will be important to understand how mutations that lead to neurodegenerative diseases might also affect the stress recovery process.

What Other Research is Being Done

Researchers are investigating various aspects of stress granule biology and its links to neurodegenerative disease. Some are working to recreate stress granules in a test tube to explore questions not easily answered by working in cells. And others are looking inside live neurons, mice and fruit flies to understand how disease mutations affect stress recovery in living cells and creatures.

 

This article was republished with permission from The Conversation, a news
site dedicated to sharing ideas from academic experts.  It was written by
and represents the research-based opinions of Brian Andrew Maxwell Scientist
in Cell Biology, St. Jude Children’s Research Hospital Graduate School of
Biomedical Sciences.

 

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NIH Image Gallery (Flickr)

Research on How Cells Recover from Threats May Lead to New Insights Into Alzheimer’s and ALS

 

The Big Idea

Our bodies contain a special protein tag that plays a role in how cells recover from specific threats to their survival, according to new research I co-authored. Understanding how this process works may be key to future treatments for neurodegenerative diseases, such as Alzheimer’s disease and some forms of dementia.

Cells regularly encounter potentially harmful changes in their environment, such as fluctuating temperature or exposure to UV light or toxins. To ensure survival, cells have evolved complex ways to adapt to these stressful changes. These mechanisms range from temporary changes in metabolism to wholesale shutdown of critical biological processes that might otherwise be permanently damaged.

For example, many cellular stresses temporarily shut down protein production while messenger RNAs, which carry part of the DNA code through the cell, become sequestered in dense structures known as stress granules. When the stress passes, the stress granules are disassembled and cells emerge from this defensive state to resume normal activities.

But until now, molecular biologists like me didn’t understand exactly how this mechanism worked.

In a pair of peer-reviewed studies published in the journal Science on June 25, 2021, my colleagues and I working in J. Paul Taylor’s cell and molecular biology lab explain how a protein known as ubiquitin is responsible for getting cells back up and running once the coast is clear.

In the first study, I discovered that different types of stress lead to specific proteins in cells getting tagged with ubiquitin in distinct ways. I exposed cells to either heat stress or a toxic chemical, then blocked the ubiquitin-tagging process after seemingly identical stress granules formed. To my surprise, blocking ubiquitin tagging only prevented stress granule disassembly for heat shock. Importantly, I also found that cells were unable to restart key biological processes like protein production and transport when these stress granules remained present, even after a return to normal temperatures.

In the second study, my colleague Youngdae Gwon looked closer into this process. He discovered that heat stress triggers ubiquitin tagging of a key protein that allows an enzyme to disassemble stress granules. This enzyme grabs onto the ubiquitin tag and uses it as a handle to pull the structure apart.

 

 

Why It Matters

Researchers have linked stress granule biology and the stress response process in general to several neurodegenerative diseases, including Alzheimer’s disease, ALS or Lou Gehrig’s disease, and some forms of dementia.

For example, mutations in the same protein, which we found to be necessary to dissemble stress granules, can cause inherited neurodegenerative diseases. Understanding how stress granules are regulated is critical to getting a better grasp on how these diseases work and potentially finding new treatments for them.

 

What Still Isn’t Known

Although we identified several key factors in the role ubiquitin plays in the disassembly of stress granules, many molecular details of this process remain unknown. To gain further insight, scientists will need to identify which enzymes are responsible for putting the ubiquitin tag on proteins during stress in the first place. Additionally, it will be important to understand how mutations that lead to neurodegenerative diseases might also affect the stress recovery process.

What Other Research is Being Done

Researchers are investigating various aspects of stress granule biology and its links to neurodegenerative disease. Some are working to recreate stress granules in a test tube to explore questions not easily answered by working in cells. And others are looking inside live neurons, mice and fruit flies to understand how disease mutations affect stress recovery in living cells and creatures.

 

This article was republished with permission from The Conversation, a news
site dedicated to sharing ideas from academic experts.  It was written by
and represents the research-based opinions of Brian Andrew Maxwell Scientist
in Cell Biology, St. Jude Children’s Research Hospital Graduate School of
Biomedical Sciences.

 

Suggested Content:

Longeveron C-Suite Interview at World Stem Cell Summit (June 2021)	Caladrius C-Suite Interview at World Stem Cell Summit (June 2021)

Celularity C-Suite Interview at World Stem Cell Summit (June 2021)	Gid Bio C-Suite Interview at World Stem Cell Summit (June 2021)

 

 

 

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Cocrystal Pharma Completes IND-enabling Studies with CC-42344 for the Treatment of Seasonal and Pandemic Influenza A, Plans to initiate a Phase 1 Trial in the Third Quarter

 

BOTHELL, Wash., June 23, 2021 — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, coronaviruses, hepatitis C viruses and noroviruses, announces the completion of IND-enabling studies with its potent, broad-spectrum PB2 inhibitor CC-42344 for the treatment of seasonal and pandemic influenza A and plans to initiate Phase 1 clinical development of CC-42344 in the third quarter of 2021.

“We are highly encouraged by the potential of CC-42344 to treat seasonal and pandemic influenza, both of which are major global health concerns,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “We recently completed a 14-day GLP toxicology study, which was the final pre-IND enabling step prior to advancing this potent inhibitor into a first-in-human study.

“There is a pressing need for new antivirals to treat influenza, as currently approved antiviral therapeutics are prone to viral resistance,” added Dr. Lee. “CC-42344 stops the first step of viral replication by binding to a highly conserved PB2 site of the influenza polymerase complex that is essential to replication. This uniquely positions CC-42344 to be an effective therapeutic against all significant A strains of the influenza virus, including avian pandemic strains as well as strains that are resistant to Tamiflu^® (oseltamivir) and Xofluza^® (baloxavir marboxil).”

“The planned Phase 1 study with CC-42344 will be conducted in Australia, which offers favorable regulatory policies and a clinical trial environment that aligns with our strategy for quickly and cost-efficiently moving into clinical development,” said James Martin, Cocrystal’s CFO and interim co-CEO. “The Australian regulatory agency allows for a streamlined path for early-stage study initiation and the Australian government offers generous incentives for clinical studies performed in that country. Importantly, clinical studies conducted in Australia have a reputation for generating high-quality data. In preparing to initiate this study, we have already established a subsidiary in Australia and have selected a contract research organization.”

According to the World Health Organization (WHO) estimates, approximately 1 billion people are infected with seasonal influenza annually, resulting in 3 million to 5 million cases of severe illness and 250,000 to 500,000 deaths worldwide. Approved influenza therapies have limited efficacy due to drug resistance and viral mutation.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our strategy with respect to the clinical development of CC-42344, including the planned initiation of influenza A Phase 1 study in Australia in the third quarter of 2021, and the potential of CC-42344 to treat seasonal and pandemic influenza. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the impact of the COVID-19 pandemic on the Australian and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our influenza A program, the ability of the contract research organization to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.