TherapeuticsMD Announces Submission of Low Dose BIJUVA® 0.5 mg/100 mg Supplemental New Drug Application to FDA

 

BOCA RATON, Fla.–(BUSINESS WIRE)–May 25, 2021– 
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, announced today that the Company submitted a supplemental New Drug Application (“sNDA”) for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, to the 
U.S. Food and Drug Administration (“FDA”).

The Company expects to learn of the acceptance of the sNDA upon receipt of the Filing Review Notification from the FDA, approximately 74 days after submission. If accepted, the Company expects that the review time under the Prescription Drug User Fee Act (PDUFA) will be within ten months of receipt by the FDA, approximately 
March 21, 2022.

“We are pleased to have identified a path forward for submission to the FDA of our sNDA for low-dose BIJUVA. We believe low-dose BIJUVA will be an important additional therapeutic option for women, if approved, and we look forward to bringing it to market,” said  Robert G. Finizio, Chief Executive Officer of 
TherapeuticsMD.

BIJUVA is the only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule. It is taken once-daily for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

About BIJUVA

BIJUVA is a novel combination of bio-identical estradiol and bio-identical progesterone in a once-daily oral softgel capsule. BIJUVA is approved in the 
U.S. in a 1mg/100mg strength for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.

INDICATION

BIJUVA (estradiol and progesterone) is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.

IMPORTANT SAFETY INFORMATION

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, and PROBABLE DEMENTIA

See full prescribing information for complete boxed warning.

Estrogen Plus Progestin Therapy

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
• The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI)
• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
• The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Estrogen-Alone Therapy

• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
• The WHI estrogen-alone substudy reported increased risks of stroke and DVT
• The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

CONTRAINDICATIONS

BIJUVA is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease (for example, stroke, MI), or a history of these conditions; known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA or any of its ingredients; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

WARNINGS AND PRECAUTIONS

• An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should these occur or be suspected, therapy should be discontinued immediately. Risk factors for arterial vascular disease and/or venous thromboembolism (VTE) should be managed appropriately.
• The WHI substudy of daily estrogen plus progestin after a mean follow-up of 5.6 years reported an increased risk of invasive breast cancer. Observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy after several years of use. The risk increased with duration of use and appeared to return to baseline over about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). The use of estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
• Endometrial hyperplasia (a possible precursor to endometrial cancer) has been reported to occur at a rate of approximately less than one percent with BIJUVA. Clinical surveillance of all women using estrogen plus progestin therapy is important. Adequate diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
• The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.
• In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin when compared to placebo. It is unknown whether these findings apply to younger postmenopausal women.
• Estrogens increase the risk of gallbladder disease.
• Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs.
• Monitor thyroid function in women on thyroid replacement hormone therapy.

The most common adverse reactions (?3%) for BIJUVA are breast tenderness (10.4%), headache (3.4%), vaginal bleeding (3.4%), vaginal discharge (3.4%) and pelvic pain (3.1%).

Please note that this information is not comprehensive. Please see the Full Prescribing Information including BOXED WARNING at BIJUVA.com.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about 
TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: 
TherapeuticsMD.

Forward-Looking Statements

This press release by 
TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the 
Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: whether the FDA will accept and approve the NDA efficacy supplement for the lower dose of BIJUVA; the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by any such divestiture will be utilized; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

Investor Contacts
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com

In-Site Communications, Inc.
Lisa M. Wilson
212-452-2793
lwilson@insitecony.com

Media Contact
Kristen Landon
Vice President, 
Marketing and Corporate Communications
561-961-1900
Klandon@therapeuticsmd.com

Source: 
TherapeuticsMD, Inc.

image credit: This is Engineering, (Flickr)

Rare Metals Play a Strategic and Essential Role in Health

 

The COVID-19 pandemic has highlighted the fact that most countries do not have sufficient health sovereignty to face such a crisis. Shortages of masks, respirators, medicines and now vaccines were felt in many countries, even the most advanced. These problems show that our societies are dependent on certain countries for essential products.

But what about metals?

Our research team has been working for a few years on the interactions between earth sciences and social sciences, especially around the concept of social geology and the dynamics of resource-rich territories.

Strategic Metals

The notion of critical and strategic minerals goes back to the wars of the 19th century. At the end of the Second World War, the United States built up stocks of metals. However, the overabundance of metals at the end of the 20th century and globalization led western states to abandon their proactive policy in this field. Awareness of dependence on imported mineral resources did not return until the late 1990s, with the emergence of Asian economies and new monopolies.

The list of critical and strategic metals varies from country to country, ranging from a dozen for the French National Defense to the 35 metals listed in the decree of President Donald Trump in 2018.

Why do we have these lists of metals? They reflect the major issues of the past, those of the wars of the 20th century and the conflicts feared for the future. More generally, they mark the technological and social crises that have hit our societies during the past 50 years and which have led to what the German sociologist Ulrich Beck has called the risk society.

Each crisis has left in its wake new technological solutions, secure supply chains and an increased awareness of the dependence on various metals. Here are a few examples.

 

From Oil to Gold

In 1973, the oil crisis highlighted the energy fragility of most developed countries. Some countries turned to nuclear power, others to hydroelectricity. Uranium mines were put into production everywhere, from Saskatchewan to Niger. The price of ore soared in 1978 and production peaked in 1980.

The terrorist crisis of 2001 in turn accelerated the development of information technology in the defence industries and the consumption of high-tech metals increased accordingly. The price of tantalum reached its highest point in 2000 and world production peaked in 2004. This demand encouraged artisanal production in eastern Congo, which has been a centre of conflict for 20 years.

The nuclear crises following the 1986 Chernobyl and 2011 Fukushima accidents encouraged a shift to metal-intensive renewable energies, particularly wind power. The price of rare-earth elements exploded to a peak in 2010 and production doubled in the following decade.

Finally, in 2008, the financial crisis weakened global markets and led to a resumption of gold purchases, particularly by the Russian and Chinese central banks, which helped support the price of the precious metal.

It is therefore understandable that each crisis is accompanied by new needs in minerals and the need to secure these new metal sectors.

Metals and Health Issues

Metals have been used for human health for thousands of years. Ayurveda, a traditional medicine that has been practiced for 3,000 years in India, employs lead, mercury and arsenic to treat various ailments. Toxic in excessive quantities, these metals can, however, become indispensable in certain medicines and medical and orthopedic equipment.

Today, pharmacology uses more than a dozen metals or metalloids for various conditions: iron for anemia, bismuth, cobalt and nickel for gastric problems, lithium for depression, antimony for leishmaniasis, platinum or radioactive metals for cancer, arsenic for psoriasis. Gold can even help with the treatment of rheumatoid arthritis.

Metals are also widely used in prostheses: a mouth treated by a dental technician could contain up to 32 different metals! Medical imaging also uses many metals, from X-rays to nuclear medicine. Nuclear magnetic resonance (NMR) is based on rare-earth magnets, while 20 per cent of the world’s gadolinium is used for solutions that increase the contrast of NMR images.

 

 

Metals and the COVID-19 Crisis

And COVID-19? Metals are found in both the prevention and treatment of this new disease.

Copper has been a favorite for creating anti-microbial surfaces, which can reduce hospital outbreaks and kill viruses and bacteria in less than two hours. Zinc can boost the immune system and has already been used against viruses.

Thus, in addition to strategic metals at the heart of conflicts, there are
metals that are essential to health. The COVID-19 pandemic caused shortages of
hygiene and pharmaceutical products. Advanced medical equipment, full of
electronic components and therefore high-value metals, was sometimes lacking.

Most western countries depend on imported metals. It is therefore time to seriously discern what is really indispensable, what essential metals are in the health sector and how to guarantee their supply for use in the next health crises.

 

This article
was republished with permission from The
Conversation, a news site dedicated to sharing ideas
from academic experts.  Written by:

Michel Jébrak, Professeur émérite en ressources minérales, Université du Québec à Montréal (UQAM)

Jack-Pierre Piguet

Professeur, Laboratoire GeoRessources,
Université de Lorraine

Yann Gunzburger

Professeur des universités, laboratoire GeoRessources, Université de Lorraine

 

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TherapeuticsMD Announces Submission of Low Dose BIJUVA® 0.5 mg/100 mg Supplemental New Drug Application to FDA

 

BOCA RATON, Fla.–(BUSINESS WIRE)–May 25, 2021– 
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, announced today that the Company submitted a supplemental New Drug Application (“sNDA”) for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, to the 
U.S. Food and Drug Administration (“FDA”).

The Company expects to learn of the acceptance of the sNDA upon receipt of the Filing Review Notification from the FDA, approximately 74 days after submission. If accepted, the Company expects that the review time under the Prescription Drug User Fee Act (PDUFA) will be within ten months of receipt by the FDA, approximately 
March 21, 2022.

“We are pleased to have identified a path forward for submission to the FDA of our sNDA for low-dose BIJUVA. We believe low-dose BIJUVA will be an important additional therapeutic option for women, if approved, and we look forward to bringing it to market,” said  Robert G. Finizio, Chief Executive Officer of 
TherapeuticsMD.

BIJUVA is the only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule. It is taken once-daily for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

About BIJUVA

BIJUVA is a novel combination of bio-identical estradiol and bio-identical progesterone in a once-daily oral softgel capsule. BIJUVA is approved in the 
U.S. in a 1mg/100mg strength for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.

INDICATION

BIJUVA (estradiol and progesterone) is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.

IMPORTANT SAFETY INFORMATION

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, and PROBABLE DEMENTIA

See full prescribing information for complete boxed warning.

Estrogen Plus Progestin Therapy

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
• The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI)
• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
• The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Estrogen-Alone Therapy

• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
• The WHI estrogen-alone substudy reported increased risks of stroke and DVT
• The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

CONTRAINDICATIONS

BIJUVA is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease (for example, stroke, MI), or a history of these conditions; known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA or any of its ingredients; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

WARNINGS AND PRECAUTIONS

• An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should these occur or be suspected, therapy should be discontinued immediately. Risk factors for arterial vascular disease and/or venous thromboembolism (VTE) should be managed appropriately.
• The WHI substudy of daily estrogen plus progestin after a mean follow-up of 5.6 years reported an increased risk of invasive breast cancer. Observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy after several years of use. The risk increased with duration of use and appeared to return to baseline over about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). The use of estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
• Endometrial hyperplasia (a possible precursor to endometrial cancer) has been reported to occur at a rate of approximately less than one percent with BIJUVA. Clinical surveillance of all women using estrogen plus progestin therapy is important. Adequate diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
• The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.
• In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin when compared to placebo. It is unknown whether these findings apply to younger postmenopausal women.
• Estrogens increase the risk of gallbladder disease.
• Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs.
• Monitor thyroid function in women on thyroid replacement hormone therapy.

The most common adverse reactions (?3%) for BIJUVA are breast tenderness (10.4%), headache (3.4%), vaginal bleeding (3.4%), vaginal discharge (3.4%) and pelvic pain (3.1%).

Please note that this information is not comprehensive. Please see the Full Prescribing Information including BOXED WARNING at BIJUVA.com.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about 
TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: 
TherapeuticsMD.

Forward-Looking Statements

This press release by 
TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the 
Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: whether the FDA will accept and approve the NDA efficacy supplement for the lower dose of BIJUVA; the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by any such divestiture will be utilized; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

Investor Contacts
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com

In-Site Communications, Inc.
Lisa M. Wilson
212-452-2793
lwilson@insitecony.com

Media Contact
Kristen Landon
Vice President, 
Marketing and Corporate Communications
561-961-1900
Klandon@therapeuticsmd.com

Source: 
TherapeuticsMD, Inc.

The Sun Sentinel Names TherapeuticsMD, Inc. a Winner of the South Florida Top Workplaces 2021 Award

 

BOCA RATON, Fla.–(BUSINESS WIRE)–May 24, 2021– 
TherapeuticsMD, Inc. (NASDAQ: TXMD), has been awarded a Top Workplaces 2021 honor by 
The Sun Sentinel. The list is based solely on employee feedback gathered through a third-party survey administered by employee engagement technology partner Energage, LLC. The anonymous survey uniquely measures 15 culture drivers that are critical to the success of any organization including alignment, execution, and connection.

“During this very challenging time, Top Workplaces has proven to be a beacon of light for organizations, as well as a sign of resiliency and strong business performance,” said  Eric Rubino, Energage CEO. “When you give your employees a voice, you come together to navigate challenges and shape your path forward. Top Workplaces draw on real-time insights into what works best for their organization, so they can make informed decisions that have a positive impact on their people and their business.”

“I’m incredibly proud of the employees in the 
TherapeuticsMD family. Winning this amazing award is a testament to the culture we have built and maintain– entrepreneurial, respectful, focused on success, and dedicated to our mission of advancing women’s health and improving therapeutic options for women,” said  Robert G. Finizio, Chief Executive Officer of 
TherapeuticsMD. “Getting through these difficult pandemic months has made us all appreciate the value of working with purpose and working together to create a great future for our organization.”

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about 
TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: 
TherapeuticsMD.

About Energage

Making the world a better place to work together.™

Energage is a purpose-driven company that helps organizations turn employee feedback into useful business intelligence and credible employer recognition through Top Workplaces. Built on 14 years of culture research and the results from 23 million employees surveyed across more than 70,000 organizations, Energage delivers the most accurate competitive benchmark available. With access to a unique combination of patented analytic tools and expert guidance, Energage customers lead the competition with an engaged workforce and an opportunity to gain recognition for their people-first approach to culture. For more information or to nominate your organization, visit energage.com or topworkplaces.com.

Forward-Looking Statements

This press release by 
TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the 
Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by any such divestiture will be utilized; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

Investor Contacts
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com

In-Site Communications, Inc.
Lisa M. Wilson
212-452-2793
lwilson@insitecony.com

Media Contact
Kristen Landon
Vice President, 
Marketing and Corporate Communications
561-961-1900
Klandon@therapeuticsmd.com

Source: 
TherapeuticsMD, Inc.

image credit: EUSKALANATO (Flickr)

What Cells Can be Made from Stem Cells?

 

Ever since the discovery of pluripotent stem cells (PSCs) more than 50 years ago and the isolation of the first-ever human embryonic stem cells (hESCs) about 20 years back, great advances have been made in the field of stem cell research. This has prompted the concept of directed differentiation, which now allows PSCs to be transformed into different tissue-specific cell types in vitro by carefully guiding and directing cells to adopt various cellular identities.

The transformation of the cells is usually done directly by either introducing specific transcription factors to PSCs, or indirectly by manipulating an amalgamation of signaling pathways that govern the expression of these transcription factors (by way of small molecules or signaling proteins). Regardless of the technique, the outcome is to faithfully recapitulate the complexities of in vivo development to drive PSCs to develop and differentiate into different cell fates.

Because PSCs are able to self-renew, they can expand and proliferate while maintaining pluripotency. This allows the ability to continuously differentiate and produce large quantities of different cell types, opening up doors to cellular transplantation therapies for the treatment of chronic diseases.

What cells can be made from stem cells in the lab? The last decade has seen an explosion of research that focuses on formulating strategies to direct differentiation of PSCs to all kinds of tissue cell types – from neurons to pancreatic beta cells, and even liver cells. One of the most common methodologies used is to perform step-wise differentiation where PSCs are directed to follow a certain developmental trajectory one stage at a time.

 

Brain

To create functional and mature neurons from human PSCs (hPSCs), hPSCs must first be differentiated into the neuroectoderm lineage and neural progenitor cells (NPCs). This can be achieved by an efficient and simple dual SMAD inhibition method described by Chambers et al. in 2009 [1]. NPCs can then be directed to develop into specific neurons through different combinations of signals [2,3]. At the end of the process, the differentiated neurons will express neuronal markers such as TUJ1 and MAP2 and some PSC-derived neurons can even produce electrophysiological responses [4]. Gunhanlar et al. (2018) described a method to differentiate induced human PSCs (iPSCs) into cortical-lineage neuronal network composed of both neurons and astrocytes that originate from a common forebrain neural progenitor [5]. The differentiated neurons display mature electrophysiological properties just like neurons in the body, such as resting membrane potential and action potential. Researchers have also devised a method to generate ‘mini-brains’ from PSCs. A protocol described by Lancaster & Knoblich (2014) differentiates hPSCs in a step-wise fashion into cerebral organoids that exhibit spatial organization (like the brain) and stains for brain regions such as forebrain, choroid plexus, and hippocampus [6].

 

Lungs

Jacob et al.’s (2017) protocol allows for the generation of functional lung alveolar epithelial type 2 (AT2) cells that produce Surfactant Protein C (STPC), a hydrophobic surfactant protein that is produced specifically by AT2 cells [7]. In 3D cultures, these cells are even able to form monolayered epithelial ‘alveolospheres’. Miller et al. (2019) published a method on generating lung organoids from hPSCs by first patterning hPSCs to ventral-foregut spheroids and then to human lung organoids [8]. At the end of the differentiation process, the lung organoids contain structures resembling bronchi surrounded by mesenchymal cells and both AT1 and AT2 cells.

 

Heart

One of the popular protocols to generate cardiomyocytes from hPSCs is known as the ‘GiWi’ protocol because it involves the temporal modulation of the Wnt signaling pathway by first, inhibiting glycogen synthase kinase 3 “(GSK-3), followed by WNT. This simple protocol drives cardiac differentiation and is able to produce up to 98% pure functional cardiomyocytes that express cardiac troponin-T (an essential protein for cardiomyocytes to contract) and display sarcomeric organization.

 

Infographic Credit: Nicole Pek

 

Liver

There are numerous protocols available today to differentiate hPSCs into hepatocytes. Ang et al. (2018) and Du et al. (2018) both describe similar strategies to obtain hepatocytes from hPSCs by first driving differentiation into the definitive endoderm lineage, then to hepatic progenitors, and finally to hepatocyte-like cells [9,10]. The differentiated cells express key marker Albumin, an essential protein made by the liver, as well as Carbamoyl-phosphate synthase (CPS1), and Alpha-1 antitrypsin (AAT). These cells were also shown to possess drug metabolism enzyme activities.

 

Pancreas

Pagliuca et al. (2014) reported on a 3D-based method to derive insulin-producing pancreatic beta-cells from hPSCs [11] . This highly-cited protocol also utilizes the step-wise differentiation strategy where hPSCs were patterned into the definitive endoderm lineage, followed by further differentiation into pancreatic progenitors which are subsequently matured into pancreatic beta-cells. These cells were shown to respond to glucose stimulation, resemble human islet beta-cells and reverse hyperglycemia in mice models of diabetes.

 

 

Blood Vessels

Blood vessels are composed of vascular endothelial cells (ECs) and vascular smooth muscle cells (SMCs). There are protocols describing methods to generate both vascular cell types from hPSCs. For example, Narmada et al. (2017) described a method to differentiate ECs from hPSCs by directing cells into the mesodermal lineage under hypoxic conditions [12]. After differentiation, CD31-expressing ECs were purified. These cells are able to form tube-like structures in vitro. While the method generates a more generalized type of ECs, Rosa et al. (2019) recently reported on a method to produce specific subtypes of ECs, namely arterial and venous ECs (from arteries and veins respectively, which are distinct from one another [13]. These differentiated cells display mechanical properties similar to blood vessels.

In 2014, Cheung et al. described a comprehensive approach to generate embryonic origin-specific SMCs from hPSCs in a step-wise fashion, under chemically-defined conditions [14]. hPSCs were first directed into three different lineages – neuroectoderm, lateral plate mesoderm, and paraxial mesoderm. Then, these early precursors were further differentiated into contractile SMCs, thus resulting in the production of lineage-specific SMC subtypes that have different identities and are functionally unique. This is important in the context of disease modeling or even transplantation therapies where the appropriate SMC subtype should be used i.e. for neuroectoderm-SMCs should be used to study/ treat stroke.

Lastly, recently, Wimmer et al (2019) described a method to produce self-organizing human blood vessel organoids from hPSCs cardiac trophonin-T [15]. The organoids contain ECs and pericytes that form well-defined capillary networks enveloped by basement membrane. Post-transplantation, these organoids were also able to engraft into the host animal and form stable, mature, and perfusable vascular networks that are composed of arteries and veins. The blood vessel organoids are able to mimic the structure and function of human blood vessels.

 

What’s Next

Now that the field of stem cell research has reached a significant milestone of establishing robust methods to produce different cells from PSCs in vitro, the next steps are to improve the efficiencies of these methods to increase the purity of differentiated cells. This is critical in ensuring that the PSC-derived cells will be safe and suitable sources of cells for transplantation therapies.

 

About the Author:

Nicole Pek is a
stem cell biologist and enthusiastic science communicator. She has worked on using human pluripotent stem cells
to study cellular development in multiple organ systems, to model complex human diseases, and screen for therapeutics that could treat the diseases. Outside of the lab, Nicole plays a pro-active role in communicating to the public through her science blog ‘Two Cells’ and her education podcast ‘The Diploid Duo’.

 

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References

 

1. Chambers SM, Fasano CA, Papapetrou EP et al. Highly efficient neural conversion of human ES and iPS cells by dual inhibition of SMAD signaling. Nat
Biotechnol 2009;27:275–80.

2. Li Y, Liu M, Yan Y et al. Neural differentiation from pluripotent stem cells: The role of natural and synthetic extracellular matrix. World J Stem Cells 2014;6:11–23.

3. Hong YJ, Do JT. Neural Lineage Differentiation From Pluripotent Stem Cells to Mimic Human Brain Tissues. Front
Bioeng Biotechnol 2019;7, DOI: 10.3389/fbioe.2019.00400.

4. Zhang Y, Pak C, Han Y et al. Rapid single-step induction of functional neurons from human pluripotent stem cells. Neuron 2013;
78:785–98.

5. Gunhanlar N, Shpak G, van der Kroeg M et
al. A simplified protocol for differentiation of electrophysiologically mature neuronal networks from human induced pluripotent stem cells. Mol
Psychiatry 2018;23:1336–44.

6. Lancaster MA, Knoblich JA. Generation of Cerebral Organoids from Human Pluripotent Stem Cells. Nat Protoc 2014;9:2329–40.

7. Jacob A, Morley M, Hawkins F et al. Differentiation of Human Pluripotent Stem Cells into Functional Lung Alveolar Epithelial Cells. Cell Stem Cell 2017;21:472-488.e10.

8. Miller AJ, Dye BR, Ferrer-Torres D et al. Generation of lung organoids from human pluripotent stem cells in vitro. Nat
Protoc 2019;14:518–40.

9. Ang LT, Tan AKY, Autio MI et al. A Roadmap for Human Liver Differentiation from Pluripotent Stem Cells. Cell
Rep 2018;22:2190–205.

10. Du C, Feng Y, Qiu D et al. Highly efficient and expedited hepatic differentiation from human pluripotent stem cells by pure small-molecule cocktails. Stem Cell Res Ther 2018;9:58.

11. Pagliuca FW, Millman JR, Gürtler M et
al. Generation of functional human pancreatic ? cells in vitro. Cell 2014;
159:428–39.

12. Narmada BC, Goh YT, Li H et al. Human Stem Cell?Derived Endothelial?Hepatic Platform for Efficacy Testing of Vascular?Protective Metabolites from Nutraceuticals. Stem Cells Transl Med 2017;
6:851–63.

13. Rosa S, Praça C, Pitrez PR et al. Functional characterization of iPSC-derived arterial- and venous-like endothelial cells. Sci Rep 2019;9:3826.

14. Cheung C, Bernardo AS, Pedersen RA et
al. Directed differentiation of embryonic origin-specific vascular smooth muscle subtypes from human pluripotent stem cells. Nat Protoc 2014;9:929–38.

15. Wimmer RA, Leopoldi A, Aichinger M et
al. Human blood vessel organoids as a model of diabetic vasculopathy. Nature 2019;565:505–10.

 

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The Sun Sentinel Names TherapeuticsMD, Inc. a Winner of the South Florida Top Workplaces 2021 Award

 

BOCA RATON, Fla.–(BUSINESS WIRE)–May 24, 2021– 
TherapeuticsMD, Inc. (NASDAQ: TXMD), has been awarded a Top Workplaces 2021 honor by 
The Sun Sentinel. The list is based solely on employee feedback gathered through a third-party survey administered by employee engagement technology partner Energage, LLC. The anonymous survey uniquely measures 15 culture drivers that are critical to the success of any organization including alignment, execution, and connection.

“During this very challenging time, Top Workplaces has proven to be a beacon of light for organizations, as well as a sign of resiliency and strong business performance,” said  Eric Rubino, Energage CEO. “When you give your employees a voice, you come together to navigate challenges and shape your path forward. Top Workplaces draw on real-time insights into what works best for their organization, so they can make informed decisions that have a positive impact on their people and their business.”

“I’m incredibly proud of the employees in the 
TherapeuticsMD family. Winning this amazing award is a testament to the culture we have built and maintain– entrepreneurial, respectful, focused on success, and dedicated to our mission of advancing women’s health and improving therapeutic options for women,” said  Robert G. Finizio, Chief Executive Officer of 
TherapeuticsMD. “Getting through these difficult pandemic months has made us all appreciate the value of working with purpose and working together to create a great future for our organization.”

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about 
TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: 
TherapeuticsMD.

About Energage

Making the world a better place to work together.™

Energage is a purpose-driven company that helps organizations turn employee feedback into useful business intelligence and credible employer recognition through Top Workplaces. Built on 14 years of culture research and the results from 23 million employees surveyed across more than 70,000 organizations, Energage delivers the most accurate competitive benchmark available. With access to a unique combination of patented analytic tools and expert guidance, Energage customers lead the competition with an engaged workforce and an opportunity to gain recognition for their people-first approach to culture. For more information or to nominate your organization, visit energage.com or topworkplaces.com.

Forward-Looking Statements

This press release by 
TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the 
Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by any such divestiture will be utilized; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

Investor Contacts
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com

In-Site Communications, Inc.
Lisa M. Wilson
212-452-2793
lwilson@insitecony.com

Media Contact
Kristen Landon
Vice President, 
Marketing and Corporate Communications
561-961-1900
Klandon@therapeuticsmd.com

Source: 
TherapeuticsMD, Inc.

Onconova Therapeutics Announces The Initial Dosing Of The First Patient In The U.S. Phase 1 Clinical Trial Of ON 123300

 

Phase 1 study to evaluate ON 123300 in advanced cancer patients including HR+ HER 2- metastatic breast cancer patients resistant to approved CDK 4/6 inhibitors

NEWTOWN, Pa., May 21, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the first patient has been dosed in the U.S. Phase 1 clinical trial of ON 123300, the Company’s proprietary, novel multi-kinase inhibitor. The trial is expected to include three U.S. sites that will enroll patients with advanced cancer including, but not limited to, HR+ HER 2- metastatic breast cancer patients who are refractory to, or progressing on, currently approved CDK 4/6 inhibitors.

The Phase 1 trial is designed to assess the safety, tolerability, and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily for consecutive 28-day cycles. Following completion of the dose-escalation phase of the trial and once the recommended Phase 2 dose (RP2D) is established, additional patients with HR+ HER 2- metastatic breast cancer with at least one prior line of therapy, which are expected to include approved CDK 4/6 inhibitors, will be enrolled into the trial with the intent to identify signals of efficacy. Additional cancer indications are also under consideration for study, and will be chosen based on preclinical and developing data.

“We are excited to begin dosing patients in this Phase 1 study and are pleased to be advancing ON 123300’s clinical development in the United States,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics. “Our goal is to provide an innovative treatment option for patients with advanced breast cancer who have become resistant to the commercial CDK 4/6 inhibitors, and other refractory solid tumors driven by the overexpression of tyrosine kinases targeted by ON 123300. Notably, ON 123300’s ability to target multiple kinase pathways that are overexpressed in cancer may allow for single-agent efficacy and better tolerability compared to existing treatment regimens.”

Dr. Fruchtman added, “We are also pleased by the progress our partner HanX Biopharmaceuticals is making with their ongoing Phase 1 trial with ON 123300 in China. While the administration schedule differs between these two Phase 1 trials, the maximum tolerated dose has not yet been reached in the first two dose-escalation cohorts of this trial, which is a promising sign for ON 123300’s safety profile. Collectively, we expect these two complementary Phase 1 studies to provide important insights that will inform the design of subsequent trials.”

For more information on the U.S. Phase 1 clinical trial of ON 123300 see ClinicalTrials.gov identifier: NCT04739293.

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 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 registered direct offering, its patents and clinical development plans including patient enrollment timelines and indications for its 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 and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, 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 Announces The Initial Dosing Of The First Patient In The U.S. Phase 1 Clinical Trial Of ON 123300

 

Phase 1 study to evaluate ON 123300 in advanced cancer patients including HR+ HER 2- metastatic breast cancer patients resistant to approved CDK 4/6 inhibitors

NEWTOWN, Pa., May 21, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the first patient has been dosed in the U.S. Phase 1 clinical trial of ON 123300, the Company’s proprietary, novel multi-kinase inhibitor. The trial is expected to include three U.S. sites that will enroll patients with advanced cancer including, but not limited to, HR+ HER 2- metastatic breast cancer patients who are refractory to, or progressing on, currently approved CDK 4/6 inhibitors.

The Phase 1 trial is designed to assess the safety, tolerability, and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily for consecutive 28-day cycles. Following completion of the dose-escalation phase of the trial and once the recommended Phase 2 dose (RP2D) is established, additional patients with HR+ HER 2- metastatic breast cancer with at least one prior line of therapy, which are expected to include approved CDK 4/6 inhibitors, will be enrolled into the trial with the intent to identify signals of efficacy. Additional cancer indications are also under consideration for study, and will be chosen based on preclinical and developing data.

“We are excited to begin dosing patients in this Phase 1 study and are pleased to be advancing ON 123300’s clinical development in the United States,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics. “Our goal is to provide an innovative treatment option for patients with advanced breast cancer who have become resistant to the commercial CDK 4/6 inhibitors, and other refractory solid tumors driven by the overexpression of tyrosine kinases targeted by ON 123300. Notably, ON 123300’s ability to target multiple kinase pathways that are overexpressed in cancer may allow for single-agent efficacy and better tolerability compared to existing treatment regimens.”

Dr. Fruchtman added, “We are also pleased by the progress our partner HanX Biopharmaceuticals is making with their ongoing Phase 1 trial with ON 123300 in China. While the administration schedule differs between these two Phase 1 trials, the maximum tolerated dose has not yet been reached in the first two dose-escalation cohorts of this trial, which is a promising sign for ON 123300’s safety profile. Collectively, we expect these two complementary Phase 1 studies to provide important insights that will inform the design of subsequent trials.”

For more information on the U.S. Phase 1 clinical trial of ON 123300 see ClinicalTrials.gov identifier: NCT04739293.

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 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 registered direct offering, its patents and clinical development plans including patient enrollment timelines and indications for its 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 and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, 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

Ceapro Inc. Reports 2021 First Quarter Financial Results and Highlights

 

– Maintained production operations during COVID-19 pandemic, providing customers essential products while ensuring the health and safety of Company’s employees –

– Increased R&D investments for the development of innovative delivery systems and for accelerating recruitment of patients in a clinical trial for oat beta glucan as a cholesterol reducer –

– First quarter 2021 sales increased 10% vs. first quarter 2020 –

EDMONTON, Alberta, May 20, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced financial results and operational highlights for the first quarter ended March 31, 2021.

“While ensuring safety of our employees remained a top priority, we obtained solid results once again during the first quarter of this year and were successful at both growing our base business and also advancing some key research and development projects despite mandated stay-at-home orders in some Canadian provinces due to the ongoing COVID-19 pandemic. These results are a clear testament to the dedication and hard work of each of our employees during these challenging times and we are very proud of their commitment to support our customers heightened demand by delivering high quality products,” stated Gilles Gagnon, M.Sc., MBA, President and CEO.

Corporate and Operational Highlights

Pipeline Development:

• Deployed additional efforts and resources in accelerating enrollment and randomization of patients for the clinical trial with beta glucan as a cholesterol reducer. To date, with outreach initiatives put in place by the team at the Montreal Heart Institute, more than 200 patients are part of the study. A total of 264 randomized patients are required for statistical significance.
  

• Continued to monitor stability studies for liquid beta glucan and avenanthramides produced at Ceapro’s new manufacturing site as well as for the pharmaceutical-grade dry powder formulation of avenanthramides to be used in a human Phase 1 bioavailability and safety study.
  
• Initiated the design of a protocol for a Phase 1 clinical trial with pharmaceutical grade avenanthramides. Subsequent to quarter end, signed a service agreement for the development and manufacturing of an oral solid dosage formulation of avenanthramide to be administrated during the Phase 1 study.
• Conducted additional in vitro dose response study with PGX processed yeast beta glucan to correlate with upcoming McMaster animal study results. Animal studies should resume at the beginning of June 2021 upon lifting of stay-at-home orders in Ontario.
• Developed and fine-tuned new PGX-dried chemical complexes mostly using sodium alginate as a carrier. Subsequent to quarter end, the Company announced the successful completion of its long-term research collaboration with University of Alberta. This project allowed for the expansion of a PGX pipeline which now includes proteins/enzymes in addition to polysaccharides like beta glucan. One of these enzymes, lysozyme was presented at the European Meeting on Supercritical Fluids by Dr. Ricardo Couto, a member of Ceapro’s PGX team who demonstrated that enzymatic activity is preserved following PGX processing. Lysozyme might have several applications since it is recognized as a remarkable natural antimicrobial and antiviral enzyme that boosts the immune defense while increasing shelf life in foods, cosmetics and pharmaceuticals. Lysozyme can also be integrated in skin care products to treat acne or promote wound repair.

Technology:

• Upgraded and commissioned PGX pilot scale processing unit in Edmonton. This will allow the generation of larger and more consistent batches of PGX polymer carriers for impregnation scale-up.
  
  
• Advanced the installation and further scaled up the PGX impregnation unit in Edmonton. Many trials were successfully conducted with the new impregnation vessel system mostly using sodium alginate.
  
  
• Retained and conducted several virtual meetings with a seasoned high-pressure engineering and manufacturing company capable to design and build a new PGX industrial plant with equipment recently purchased in Germany. Timelines and cost estimates are being assessed.
  

Financial Highlights for the First Quarter Ended March 31, 2021

• Total sales of $4,702,000 for the first quarter of 2021 compared to $4,273,000 for the comparative period in 2020; an increase of 10% over last year. Beta glucan sales volumes increased by 318% for Q1 2021 vs Q1 2020. With sales being made in US dollars, the decreased exchange rate $US/CDN as compared to the prior period negatively impacted 2021 sales by approximately $364,000.
  
  
• Net profit of $515,000 for the first quarter of 2021 compared to a net profit of 1,126,000 for the comparative period in 2020.
  
  
• Research and Development of $817,000 in Q1 2021 vs. $502,000 in 2020. This increased investment was partly due to an accelerated pace for the recruitment of patients for the beta glucan trial as a cholesterol reducer.
  
  
• Cash generated from operations of $305,000 in Q1 2021 vs. $531,000 in Q1 2020.
  
  
• Positive working capital balance of $8,246,972 as of March 31, 2021.
  

“As we respond to the potential impacts and uncertainties of COVID-19 by taking the necessary steps to preserve our financial position, we continue to execute on our expansion to a new business model from a contract manufacturer/commodity company to a high-value life science/biopharmaceutical company. We remain dedicated to executing on our milestones ahead and should the Company be able to service its customers without disruption, we strongly believe the prospects for the Company remain very strong for the upcoming year,” concluded Mr. Gagnon.

CEAPRO INC.
Consolidated Balance Sheets
Unaudited
	March 31,	December 31,
	2021	2020
	$	$
ASSETS
Current Assets
Cash and cash equivalents	5,239,071	5,369,029
Trade receivables	2,907,013	2,019,723
Other receivables	29,576	102,224
Inventories (note 3)	998,911	1,210,079
Prepaid expenses and deposits	198,804	348,845
	9,373,375	9,049,900
Non-Current Assets
Investment tax credits receivable	607,700	607,700
Deposits	82,124	82,124
Licences (note 4)	17,773	18,514
Property and equipment (note 5)	18,473,734	18,591,189
Deferred tax assets	874,304	874,304
	20,055,635	20,173,831
TOTAL ASSETS	29,429,010	29,223,731
LIABILITIES AND EQUITY
Current Liabilities
Accounts payable and accrued liabilities	791,089	1,067,622
Current portion of lease liabilities (note 6)	260,307	250,658
Current portion of CAAP loan (note 8)	75,007	72,263
	1,126,403	1,390,543
Non-Current Liabilities
Long-term lease liabilities (note 6)	2,577,698	2,648,917
Deferred tax liabilities	874,304	874,304
	3,452,002	3,523,221
TOTAL LIABILITIES	4,578,405	4,913,764
Equity
Share capital (note 7 (b))	16,549,875	16,511,067
Contributed surplus (note 7 (e))	4,669,347	4,682,393
Retained earnings	3,631,383	3,116,507
	24,850,605	24,309,967
TOTAL LIABILITIES AND EQUITY	29,429,010	29,223,731

CEAPRO INC.
Consolidated Statements of Net Income and Comprehensive Income
Unaudited
	2021		2020
Three Months Ended March 31,	$		$
Revenue (note 14)	4,701,743		4,273,374
Cost of goods sold	2,443,800		1,901,223
Gross margin	2,257,943		2,372,151
Research and product development	816,847		502,542
General and administration	712,207		865,034
Sales and marketing	13,238		48,228
Finance costs (note 11)	93,910		101,609
Income from operations	621,741		854,738
Other (expenses) income (note 10)	(106,865	)	271,317
Income before tax	514,876		1,126,055
Income taxes	–		–
Total comprehensive income for the period	514,876		1,126,055
Net income per common share (note 17):
Basic	0.01		0.01
Diluted	0.01		0.01
Weighted average number of common shares outstanding (note 17):
Basic	77,651,031		77,538,314
Diluted	78,709,975		77,880,861

CEAPRO INC.
Consolidated Statements of Cash Flows
Unaudited
	2021		2020
Three Months Ended March 31,	$		$
OPERATING ACTIVITIES
Net income for the period	514,876		1,126,055
Adjustments for items not involving cash
Finance costs	36,166		40,947
Transaction costs	–		554
Depreciation and amortization	468,153		460,088
Accretion	2,744		5,108
Share-based payments	3,742		93,548
Net income for the period adjusted for non-cash items	1,025,681		1,726,300
CHANGES IN NON-CASH WORKING CAPITAL ITEMS
Trade receivables	(887,290	)	(264,398	)
Other receivables	72,648		(24,076	)
Inventories	211,168		(347,853	)
Prepaid expenses and deposits	72,574		(54,186	)
Accounts payable and accrued liabilities relating to operating activities	(153,619	)	(463,443	)
Total changes in non-cash working capital items	(684,519	)	(1,153,956	)
Net income for the period adjusted for non-cash and working capital items	341,162		572,344
Interest paid	(36,166	)	(40,947	)
CASH GENERATED FROM OPERATIONS	304,996		531,397
INVESTING ACTIVITIES
Purchase of property and equipment	(253,018	)	(20,099	)
Purchase of leasehold improvements	(19,472	)	–
Accounts payable and accrued liabilities relating to investing activities	(122,914	)	–
CASH USED IN INVESTING ACTIVITIES	(395,404	)	(20,099	)
FINANCING ACTIVITIES
Stock options exercised	22,020		–
Repayment of long-term debt	–		(48,520	)
Repayment of lease liabilities	(61,570	)	(64,987	)
CASH USED IN FINANCING ACTIVITIES	(39,550	)	(113,507	)
(Decrease) increase in cash and cash equivalents	(129,958	)	397,791
Cash and cash equivalents at beginning of the period	5,369,029		1,857,195
Cash and cash equivalents at end of the period	5,239,071		2,254,986

The complete financial statements are available for review on SEDAR at https://sedar.com/Ceapro and on the Company’s website at www.ceapro.com.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

Issuer:
Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

Source: Ceapro Inc.

Onconova Therapeutics Announces Reverse Stock Split And Decrease In Authorized Shares

 

NEWTOWN, Pa., May 20, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (Nasdaq: ONTX) (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced a one-for-fifteen reverse stock split of its common stock, effective May 20, 2021. Beginning at the open of trading on May 21, 2021, Onconova’s common stock will trade on the Nasdaq Capital Market on a split-adjusted basis.

At Onconova’s 2021 reconvened annual meeting of stockholders on April 30, 2021, Onconova stockholders authorized the Company’s Board of Directors to amend the Tenth Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to effect a reverse stock split at a ratio in the range of one-for-five to one-for-fifteen. Onconova’s Board of Directors subsequently approved a reverse stock split ratio of one-for-fifteen, and the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment (the “Certificate of Amendment”) to its Certificate of Incorporation to effect the reverse stock split, which became effective upon the filing of the Certificate of Amendment with the Secretary of State of the State of Delaware on May 20, 2021.

• Upon effectiveness of the reverse stock split, each fifteen shares of Onconova’s common stock, par value of $0.01 per share, issued and outstanding immediately prior to the effective time automatically were reclassified, combined, converted and changed into one fully paid and non-assessable share of common stock, par value of $0.01 per share.
  

• In addition, a proportionate adjustment will be made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding options, warrants, and convertible preferred stock entitling the holders to purchase shares of our common stock. In particular, at the effective time of the reverse stock split, the Company adjusted its outstanding tradable warrants currently trading on the Nasdaq Capital Market under the symbol “ONTXW” in accordance with the terms of such tradable warrants to reflect the reverse stock split. As a result of these adjustments (and the adjustments effected on September 25, 2018 for a prior one-for-fifteen reverse stock split of the Company’s Common Stock), each tradable warrant now entitles its holder to purchase one- two hundred and twenty-fifth (1/225) of a share of Onconova’s common stock at an exercise price of $1,107.00 per share of common stock.
  

• No fractional shares will be issued as a result of the reverse stock split. Instead, Onconova’s stockholders who otherwise would have been entitled to a fraction of a share, will receive a full share of common stock. If a holder of the tradable warrant would be entitled to receive a fraction of a share upon the exercise of the warrant, such fractional share will be rounded down to the nearest whole share. Fractional shares resulting from exercise of other common stock warrants and conversion of outstanding convertible preferred stock (if any) will be rounded in accordance with the terms of such securities.
  

• The reverse stock split will decrease the number of common shares issued and outstanding from approximately 236.714 million shares to approximately 15.781 million shares.
  

Onconova’s transfer agent, EQ Shareowner Services, will provide instructions to stockholders of record regarding the process for exchanging share certificates and all book-entry or other electronic positions representing issued and outstanding shares of Onconova common stock will be automatically adjusted.

Onconova’s common stock will continue to trade on the Nasdaq Capital Market under the trading symbol “ONTX.” The new CUSIP number for the common stock following the reverse stock split is 68232V 801.

In addition, at the Company’s reconvened 2021 Special Meeting of Stockholders on April 30, 2021, the Company’s stockholders also approved a proposal to amend the Certificate of Incorporation to decrease, upon the effectiveness of the Reverse Stock Split, the number of authorized shares of capital stock of the Company from 255,000,000 to 130,000,000 shares in order to decrease the number of authorized shares of common stock from 250,000,000 to 125,000,000 shares (the “Authorized Shares Decrease”). On May 20, 2021, the Company filed the Certificate of Amendment for Authorized Shares Decrease (the “Authorized Shares Decrease Certificate of Amendment”) with the Secretary of State of the State of Delaware. The Authorized Shares Decrease Certificate of Amendment became effective on May 20, 2021 upon the effectiveness of the Reverse Stock Split.

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. 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 registered direct offering, its patents and clinical development plans including patient enrollment timelines and indications for its 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 and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, 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