Friday, November 12, 2021

Onconova Therapeutics (ONTX)
3Q Report Highlights Clinical Progress

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.

3Q21 reported. Onconova Therapeutics reported 3Q21 loss of $3.5 million or $(0.22) per share, compared with our estimated loss of $5.2 million or $(0.33) per share. On its quarterly conference call, the company reviewed clinical progress during the quarter and discussed plans for trials in 2022. Cash balance at the end of the quarter was $59.4 million.


Narazaciclib updates.  The company gave an update on the two clinical dose escalation trials for narazaciclib, the new name for ON 123300. The US trial is enrolling its second dose cohort, while the study in China is in its fourth cohort. Data to establish safety and select the dose for Phase 3 is expected in 1H22. This Phase 2 study is expected to include multiple cancer types including patients with …

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. 

Thursday, November 11, 2021

PDS Biotechnology Corp (PDSB)
3Q21 Contained Clinical Progress and New Product Licenses

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

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

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

PDS Biotechnology reported 3Q21 loss of $6.9 million or $(0.24) per share, compared with our estimated loss of $6.1 million or $(0.21) per share. The company held a conference call in which it reviewed two licensing agreements announced earlier in November 2021. These products advance the pipeline and broaden the development of products that use the Versamune technology. Cash balance at the end of the quarter was $69.7 million.


PDS0102 Reached A Development Milestone PDS0102 has been in preclinical testing for prostate cancer, breast cancer, and acute myeloid leukemia (AML) using the TARP antigen with the Versamune platform.  Based on its strong results, PDS made a license agreement with the NCI (National Cancer Institute) that gives the company rights to NCI’s intellectual property related to the antigen. The license …

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. 

TherapeuticsMD Announces Leadership Changes; Appointment of Industry Veteran, Hugh O’Dowd, as Chief Executive Officer

 

– Mr. O’Dowd to succeed  Robert G. Finizio, effective on or before 
December 31, 2021 –

–  Mr. Finizio appointed Vice Chair of the Board –

BOCA RATON, Fla.–(BUSINESS WIRE)–Nov. 11, 2021– 
TherapeuticsMD, Inc. (NASDAQ: TXMD) (TXMD or the Company), an innovative, leading women’s healthcare company, today announced key leadership changes, including the appointment of Hugh O’Dowd, the Company’s current President, as the Company’s Chief Executive Officer and member of the board of directors. Mr. O’Dowd will succeed  Robert G. Finizio, the Company’s Co-founder and current Chief Executive Officer, effective on or before 
December 31, 2021.  Mr. Finizio will continue with the Company and has been appointed Vice Chair of the Board of Directors.

“I want to thank Rob for his strong leadership and vision over the past 13 years,” said Honorable  Tommy Thompson, Chairman of the Board of 
TherapeuticsMD. “Rob is an innovator who has made an indelible mark not only on this company, but on the women’s healthcare industry as a whole.”

“Founding TherapeuticsMD has been one of the highlights of my career. Hugh is an experienced leader with a strong track record of delivering results, and in the few short months since joining the company, he has already made invaluable contributions. I am confident that he is the right person to bring 
TherapeuticsMD to the next level of growth,” said  Mr. Finizio.

“TherapeuticsMD is an innovator in women’s healthcare, and I welcome the opportunity to drive operating performance and craft our long-term strategy,” stated Mr. O’Dowd. “Rob has created a dynamic company and established TXMD’s foundation for growth and I will build upon our mission of empowering women of all ages through better healthcare.”

Mr. O’Dowd previously served as President, Chief Executive Officer, and member of the Board of Directors of 
Neon Therapeutics, Inc., a clinical-state immuno-oncology company until its acquisition by BioNTech SE in 
May 2020. Prior to Neon Therapeutics, Mr. O’Dowd spent more than 20 years in a variety of senior leadership roles at 
Novartis Pharmaceuticals Corporation, where he served as Country President and General Manager of the 
United Kingdom and 
Ireland, Senior Vice President and Chief Commercial Officer of Novartis Oncology, and Vice President, Latin America Region Head for the Oncology business unit. During his time as Chief Commercial Officer Oncology, Mr. O’Dowd was responsible for the oncology portfolio strategy for the world’s then second-largest oncology/hematology organization, including global brand leadership, business development/licensing, and commercialization. Mr. O’Dowd currently serves as Director and Non-executive Chairman of 
ONK Therapeutics Ltd, an innovative natural killer cell therapy company, and as a Director of Polyphor AG, a clinical-stage biopharmaceutical company focused on the discovery and development of antibiotics and immuno-oncology compounds. Mr. O’Dowd received an MBA from the 
Kellstadt Graduate School of Business at 
DePaul University in 
Chicago and a B.A. from 
Loyola University Chicago.

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: 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, or obtain an investment in, its vitaCare business and how the proceeds that may be generated by any such divestiture or investment will be utilized; the effects of supply chain issues on the supply of the company’s products; 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 and the manufacturing supplement for ANNOVERA; 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 impact of leadership transitions; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

Lisa M. Wilson

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

Source: 
TherapeuticsMD, Inc.

TherapeuticsMD Announces Third Quarter 2021 Financial Results

 

– Quarterly total net product revenue of 
$24.5 million, an increase of 41.1% over Q3 2020 –

– ANNOVERA^® TRx of 8,351, an increase of 62.7% over Q3 2020 –

– Cost savings initiative to reduce SG&A by 
$40 million in 2022; anticipated additional savings of approximately 
$20 million annualized tied to the divestiture of vitaCare –

– Hugh O’Dowd, President, to become Chief Executive Officer;  Robert Finizio appointed Vice Chair of the Board –

– Conference call scheduled for 
8:30 a.m. ET today –

BOCA RATON, Fla.–(BUSINESS WIRE)–Nov. 11, 2021– 
TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the third quarter ended 
September 30, 2021. In addition, today the Company announced a significant cost savings initiative designed to reduce its annual costs in 2022 by at least 
$40 million. This figure does not include savings from, or the costs associated with, the divestiture of vitaCare, which are estimated at approximately 
$20 million annually.

“We have made significant changes to our business strategy, which we believe will help us achieve our goal of EBITDA breakeven in the second half of 2022. Specifically, we put a cost savings plan in place and we have implemented a more concerted focus on healthcare professionals. These refinements are already yielding results, as evidenced by the steady progress made during the third quarter, notably the strong year-over-year growth in ANNOVERA prescriptions,” said Hugh O’Dowd, President of 
TherapeuticsMD.

“I would like to thank Rob for his leadership and vision in creating an innovative healthcare company with products that benefit women across their lifecycles. I would also like to formally welcome  Mark Glickman as our Chief Commercial Officer. His commercial acumen is already having a positive impact on our day-to-day operations. Looking ahead, I am confident that we can reduce our annual expenses significantly, deliver value to shareholders, and most importantly, bring our high-quality products to the women who need them,” concluded O’Dowd.

Third Quarter 2021 Financial Results and Business Highlights

Net Product Revenue (in thousands)

		Three Months Ended
		September 30,
		2021				2020
Product revenue:
ANNOVERA		$	11,807			$	6,419
IMVEXXY			8,016				6,841
BIJUVA			3,298				1,646
Prescription vitamin			1,348				2,436
Product revenue, net			24,469				17,342
License revenue			937				2,000
Total revenue, net		$	25,406			$	19,342

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

• ANNOVERA net product revenue of 
  $11.8 million for the third quarter of 2021 increased by 
  $5.4 million compared to 
  $6.4 million for the third quarter of 2020.
• Approximately 8,350 ANNOVERA prescriptions were dispensed to patients during the third quarter of 2021. Prescriptions increased 62.7% compared to the third quarter of 2020.
• Over 4,500 health care providers (HCPs) prescribed ANNOVERA during the third quarter, of which nearly 29% were new writers.
  • Growth in prescribers of approximately 1,600 over third quarter of 2020.
  • Cumulatively over 9,450 HCPs have prescribed ANNOVERA.

IMVEXXY^® (estradiol vaginal inserts)

• IMVEXXY net product revenue of 
  $8.0 million for the third quarter of 2021 increased by 
  $1.2 million compared to 
  $6.8 million for the third quarter of 2020.
• Approximately 113,000 IMVEXXY prescriptions were dispensed to patients during the third quarter of 2021.
• Full re-targeting initiative taking place in the fourth quarter of 2021, with implementation in the first quarter of 2022.
  • Plan to rejuvenate growth and optimize HCP focus.

BIJUVA^® (estradiol and progesterone)

• BIJUVA net product revenue of 
  $3.3 million for the third quarter of 2021 increased by 
  $1.7 million compared to 
  $1.6 million for the third quarter of 2020.
• BIJUVA net product revenue for the third quarter of 2021 includes 
  $0.7 million of export sales through our international licensing and supply agreement with 
  Theramex HQ UK Limited.
• Re-targeting initiative taking place, similar to the process with IMVEXXY.

Cost of Goods Sold and Gross Margin

• Cost of goods was 
  $5.3 million with product gross margin of 78% for the third quarter of 2021 compared to 
  $3.3 million with product gross margin of 81% for the third quarter of 2020. The lower product gross margin for the third quarter of 2021 reflects the impact of 
  $0.7 million of BIJUVA export sales, which were sold at cost.

Operating Expense, Net Loss and Related Information

• Total operating expense of 
  $60.0 million for the third quarter of 2021 increased by 
  $19.0 million compared to 
  $41.0 million for the third quarter of 2020. Included in total operating expense for the third quarter of 2021 was 
  $7.3 million of severance related expenses recorded for certain former senior executives.
• Net loss for the third quarter of 2021 was 
  $47.4 million, or 
  $0.11 per basic and diluted share, compared to net loss for the third quarter of 2020 of 
  $32.6 million, or 
  $0.12 per basic and diluted share.

Balance Sheet

• As of 
  September 30, 2021, the Company’s cash on hand totaled 
  $104.8 million, compared with 
  $80.5 million as of 
  December 31, 2020.
• For the first nine months of 2021, the Company received 
  $182.9 million in net proceeds from its at-the-market and underwritten equity offerings.
• As of 
  September 30, 2021, the remaining outstanding principal amount under the Company’s Financing Agreement was 
  $200.0 million, which reflects a repayment of 
  $50.0 million of principal during the first nine months of 2021.

The contract manufacturing organization that manufactures ANNOVERA has recently experienced an increase in difficulties with the manufacturing process for ANNOVERA resulting in batch failures. The Company filed a supplemental NDA with the FDA to modify the manufacturing (testing) specification for ANNOVERA to allow for normal manufacturing variation that would increase the consistency of manufacturing and supply of ANNOVERA. The Company expects that the FDA will act on the supplemental NDA by the Prescription Drug User Fee Act (“PDUFA”) date of 
December 12, 2021. If the FDA does not approve the supplemental NDA by the PDUFA date, the Company may not be able to meet the revenue covenants under its Financing Agreement in the near term. The manufacturing difficulties relate only to our ability to meet the release specification, and any ANNOVERA rings currently being sold meet the exacting quality specifications. For more information regarding the covenants under the Financing Agreement, please see the Company’s filings with the 
SEC.

Conference Call and Webcast Details

TherapeuticsMD will host a conference call and live audio webcast today at 
8:30 a.m. ET to discuss these financial results and provide a business update.

Date:	Thursday, November 11, 2021
Time:	8:30 a.m. ET
Telephone Access (US):	866-665-9531
Telephone Access (International):	724-987-6977
Access Code for All Callers:	6341637

A live webcast and audio archive for the event may be accessed on the home page or from the “Investors & Media” section of the 
TherapeuticsMD website at www.therapeuticsmd.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least 30 days. In addition, a digital recording of the conference call will be available for replay beginning two hours after the call’s completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 6341637.

Please see the Full Prescribing Information, including indication and Boxed WARNING, for each 
TherapeuticsMD product as follows:

• IMVEXXY (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf
• BIJUVA (estradiol and progesterone) capsules at https://www.bijuva.com/pi.pdf
• ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf

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, or obtain an investment in, its vitaCare business and how the proceeds that may be generated by any such divestiture or investment will be utilized; the effects of supply chain issues on the supply of the company’s products; 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 and the manufacturing supplement for ANNOVERA; 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 impact of leadership transitions; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

– Financial Statements to Follow –

TherapeuticsMD, Inc. and Subsidiaries Consolidated Balance Sheets (In thousands, except per share data)
		September 30, 2021				December 31, 2020
		(Unaudited)
Assets:
Current assets:
Cash		$	104,841			$	80,486
Accounts receivable, net of allowance for credit losses of  $1,351 and  $1,118 as of  September 30, 2021 and  December 31, 2020, respectively			37,402				32,382
Inventory			7,362				7,993
Prepaid and other current assets			10,374				7,543
Total current assets			159,979				128,404
Fixed assets, net			1,388				1,942
License rights and other intangible assets, net			39,617				41,445
Right of use assets			8,391				9,566
Other non-current assets			253				253
Total assets		$	209,628			$	181,610
Liabilities and stockholders’ equity (deficit):
Current liabilities:
Current maturities of long-term debt		$	15,000			$	—
Accounts payable			19,592				21,068
Accrued expenses and other current liabilities			51,674				38,170
Total current liabilities			86,266				59,238
Long-term debt, net			171,738				237,698
Operating lease liabilities			8,226				8,675
Other non-current liabilities			758				—
Total liabilities			266,988				305,611
Commitments and contingencies
Stockholders’ equity (deficit):
Preferred stock, par value  $0.001; 10,000 shares authorized, none issued			—				—
Common stock, par value  $0.001; 600,000 shares authorized, 424,879 and 299,765 issued and outstanding as of  September 30, 2021 and  December 31, 2020, respectively			425				300
Additional paid-in capital			950,615				754,644
Accumulated deficit			(1,008,400	)			(878,945	)
Total stockholders’ deficit			(57,360	)			(124,001	)
Total liabilities and stockholders’ equity (deficit)		$	209,628			$	181,610

TherapeuticsMD, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited – in thousands, except per share data)
		Three Months Ended								Nine Months Ended
		September 30,								September 30,
		2021				2020				2021				2020
Product revenue, net		$	24,469			$	17,342			$	67,102			$	40,294
License revenue			937				2,000				1,171				2,000
Total revenue, net			25,406				19,342				68,273				42,294
Cost of goods sold			5,282				3,279				14,101				10,394
Gross profit			20,124				16,063				54,172				31,900
Operating expenses:
Selling and marketing			30,005				22,373				86,193				91,056
General and administrative			28,435				16,637				66,691				53,740
Research and development			1,605				2,027				5,666				8,038
Total operating expenses			60,045				41,037				158,550				152,834
Loss from operations			(39,921	)			(24,974	)			(104,378	)			(120,934	)
Other (expense) income:
Interest expense and other financing costs			(7,518	)			(7,680	)			(25,341	)			(20,969	)
Other income, net			19				42				264				466
Total other (expense), net			(7,499	)			(7,638	)			(25,077	)			(20,503	)
Loss before income taxes			(47,420	)			(32,612	)			(129,455	)			(141,437	)
Provision for income taxes			—				—				—				—
Net loss		$	(47,420	)		$	(32,612	)		$	(129,455	)		$	(141,437	)
Loss per common share, basic and diluted		$	(0.11	)		$	(0.12	)		$	(0.33	)		$	(0.52	)
Weighted average common shares, basic and diluted			422,216				272,565				388,111				271,969

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited – in thousands)
		Nine Months Ended  September 30,
		2021				2020
Cash flows from operating activities:
Net loss		$	(129,455	)		$	(141,437	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			3,091				3,039
Charges (credits) to provision for doubtful accounts			540				(47	)
Inventory charge			1,082				5,744
Debt financing fees			4,158				1,645
Share-based compensation			12,779				8,502
Other			726				1,719
Changes in operating assets and liabilities:
Accounts receivable			(5,560	)			384
Inventory			(451	)			(3,816	)
Prepaid and other current assets			(2,831	)			2,038
Accounts payable			(1,476	)			(3,072	)
Accrued expenses and other current liabilities			13,504				(3,813	)
Other non-current liabilities			758				—
Total adjustments			26,320				12,323
Net cash used in operating activities			(103,135	)			(129,114	)
Cash flows from investing activities:
Payment of patent related costs			(675	)			(1,065	)
Purchase of fixed assets			(34	)			(39	)
Net cash used in investing activities			(709	)			(1,104	)
Cash flows from financing activities:
Proceeds from sale of common stock, net of costs			182,881				—
Proceeds from exercise of options and warrants			302				272
Proceeds from sale of common stock related to employee stock purchase plan			134				—
Repayments of debt			(50,000	)			—
Borrowings of debt			—				50,000
Payment of debt financing fees			(5,118	)			(1,250	)
Net cash provided by financing activities			128,199				49,022
Net increase in cash			24,355				(81,196	)
Cash, beginning of period			80,486				160,830
Cash, end of period		$	104,841			$	79,634
Supplemental disclosure of noncash financing activities:
Warrants issued in relation to debt financing agreement			—				7,428
Supplemental disclosure of cash flow information:
Interest paid		$	19,675			$	12,032

 

James D’Arecca
Chief Financial Officer
561-961-1900

Lisa M. Wilson

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

Source: 
TherapeuticsMD, Inc.

Ceapro Inc. Provides Update on Development of an Inhalable Therapeutic Using Yeast Beta Glucan Processed with Pressurized Gas eXpanded Technology (PGX-YBG)

 

McMaster’s research team discovers new mechanism of action for PGX-YBG

PGX-YBG demonstrates ability to reprogram macrophages on its own

PGX-YBG may be a suitable therapeutic solution for patients with fibrotic lung disease and late stage COVID-19 patients

EDMONTON, Alberta, Nov. 11, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today provided an update on its ongoing collaboration with McMaster University to develop an inhalable therapeutic for COVID-19 which could also be used to treat post-COVID-19 conditions.

The project, entitled “PGX-processed yeast beta-glucans as an inhalable immunomodulating therapeutic for COVID-19 patients,” jointly funded by Mitacs and Ceapro, is being conducted under the leadership of Dr. Kjetil Ask, a pulmonary fibrosis expert, and Dr. Todd Hoare from departments of Medicine and Chemical Engineering, respectively, at McMaster University.

This project was initiated in August 2019 when McMaster University and Ceapro researchers were reviewing preliminary data collected as part of a collaborative research program where one of the goals was to develop delivery systems to optimize drug formulations used for chronic diseases such as Idiopathic Pulmonary Fibrosis (IPF). While yeast beta glucan appeared to be a promising compound, researchers thought that the ideal formulation to treat fibrotic lung disorders would be to develop an inhalable complex produced by loading a drug onto PGX-processed yeast beta glucan (PGX-YBG). Following preliminary experiments with PGX-YBG alone and/or combined with a drug they realized that PGX-YBG could be much more than a carrier and that it could be used as the active component in a new antifibrotic treatment for the most severe lung diseases including COVID-19 patients.

“We have shown that the PGX technology can convert materials that can’t easily be inhaled, in particular, a YBG-based particle that has inherent immunomodulatory properties, into materials that can readily access the lung,” commented Dr. Hoare. “Combining this property with the very high internal surface area of the PGX-processed microparticles that enables high-concentration drug loading using Ceapro’s supercritical drug impregnation process, we are very excited about the potential of this technology for treating diseases of the lung, including potentially late-stage COVID-19.”

The team has successfully demonstrated that Ceapro’s PGX technology can produce low density, highly porous, and purified YBG microparticles with a small and uniform size distribution. These unique particles were found to possess improved aerodynamic properties, allowing them to be inhaled and deposited in the deep lung where fibrotic development occurs.

At the heart of this project is fibrosis: the unregulated and excessive production of scar tissue in organs. Key immune cells called macrophages apparently play a crucial role in maintaining and progressing the fibrotic state. “M1” macrophages express pro-inflammatory properties and “M2” macrophages express the complete opposite anti-inflammatory properties. During fibrosis, M2-like macrophages persist in the fibrotic lung and secrete cytokines (cell signaling molecules) that stimulate the cells around them to constantly produce and deposit scar tissue in the deep lung. These recent findings indicate that PGX-YBG, which binds specifically to Dectin-1 receptors at the surface of macrophages, can repolarize or “reprogram” M2-like macrophages into M1-like macrophages thereby putting an end to tissue deposition (fibrosis) and initiating the much-needed removal of excess tissues.

“We have shown, in vitro, that PGX-YBG have the ability to prevent the activation of macrophages toward a pro-fibrotic phenotype. In addition, PGX-YBG treatment to macrophages that have already acquired a pro-fibrotic phenotype result in the reprogramming of the macrophages toward a classical phenotype not known to be pro-fibrotic. Using cells from animals lacking the beta-glucan receptor Dectin-1, we showed that this was dependent on the presence of the Dectin-1 receptor. These findings are very exciting as macrophage reprogramming is seen as a viable therapeutic strategy toward fibrotic disease and PGX-YBG seem to have this ability. In vivo, we have shown that PGX-YBG can be safely administered to mice, and preliminary data shows an ability to prevent fibrogenesis in an experimental model of lung fibrosis. We are looking forward to validating these in vivo findings over the next few months,” reported Dr. Ask.

To advance this promising technology to human clinical trials, the Company is working to ensure that the delivery of PGX-YBG to the lung is optimized. It will also be important to further validate PGX-YBG’s performance for reducing lung fibrosis, both alone and loaded with an anti-inflammatory drug currently used for lung fibrosis and COVID-19 therapy. The potential impact of this project is considerable since, one of the most common and deadly fibrotic diseases is IPF for which there are no cure and a short (3-5 year) survival rate. It was recently also shown that lung fibrosis can occur and persists for months in some COVID-19 patients thereby suggesting that COVID-19 survivors may suffer from post-infection pulmonary fibrosis complications.

“We are very pleased with the progress made in this research project. Considering these recent, exciting findings, we believe it certainly becomes necessary to conduct additional animal studies before initiating human trials to develop the best possible tool in the fight against lung fibrotic diseases including COVID-19 and post COVID-19 complications,” commented Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro. “We are thankful for the collaborative work with the team at McMaster University and look forward to further development.”

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

Source: Ceapro Inc.

Thursday, November 11, 2021

Axcella Therapeutics (AXLA)
3Q21 Marked By Clinical Progress

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator (EMM) compositions. The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

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

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

3Q21 Reported A Smaller Loss Than Expected. During the quarter, Axcella made significant progress enrolling its two clinical trials, had scientific studies accepted for presentation, and announced a new indication for AXA1125. The company’s loss for the quarter was $15.6 million or $(0.41) per share, compared with our estimated loss of $16.1 million or $(0.43) per share. The quarter ended with $66.1 million in cash.


A New Trail For AXA1125 In Long COVID.  Recent studies have indicated that COVID-19 infection can have damaging effects on mitochondria, changing energy production in the cells, and causing long-term fatigue. The AXA1125 mechanism of action impacts mitochondria and may be able to restore normal activity. A Phase 2a study in Long COVID patients is planned, with a target enrollment is about 40 …

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. 

Ceapro Inc. Provides Update on Development of an Inhalable Therapeutic Using Yeast Beta Glucan Processed with Pressurized Gas eXpanded Technology (PGX-YBG)

 

McMaster’s research team discovers new mechanism of action for PGX-YBG

PGX-YBG demonstrates ability to reprogram macrophages on its own

PGX-YBG may be a suitable therapeutic solution for patients with fibrotic lung disease and late stage COVID-19 patients

EDMONTON, Alberta, Nov. 11, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today provided an update on its ongoing collaboration with McMaster University to develop an inhalable therapeutic for COVID-19 which could also be used to treat post-COVID-19 conditions.

The project, entitled “PGX-processed yeast beta-glucans as an inhalable immunomodulating therapeutic for COVID-19 patients,” jointly funded by Mitacs and Ceapro, is being conducted under the leadership of Dr. Kjetil Ask, a pulmonary fibrosis expert, and Dr. Todd Hoare from departments of Medicine and Chemical Engineering, respectively, at McMaster University.

This project was initiated in August 2019 when McMaster University and Ceapro researchers were reviewing preliminary data collected as part of a collaborative research program where one of the goals was to develop delivery systems to optimize drug formulations used for chronic diseases such as Idiopathic Pulmonary Fibrosis (IPF). While yeast beta glucan appeared to be a promising compound, researchers thought that the ideal formulation to treat fibrotic lung disorders would be to develop an inhalable complex produced by loading a drug onto PGX-processed yeast beta glucan (PGX-YBG). Following preliminary experiments with PGX-YBG alone and/or combined with a drug they realized that PGX-YBG could be much more than a carrier and that it could be used as the active component in a new antifibrotic treatment for the most severe lung diseases including COVID-19 patients.

“We have shown that the PGX technology can convert materials that can’t easily be inhaled, in particular, a YBG-based particle that has inherent immunomodulatory properties, into materials that can readily access the lung,” commented Dr. Hoare. “Combining this property with the very high internal surface area of the PGX-processed microparticles that enables high-concentration drug loading using Ceapro’s supercritical drug impregnation process, we are very excited about the potential of this technology for treating diseases of the lung, including potentially late-stage COVID-19.”

The team has successfully demonstrated that Ceapro’s PGX technology can produce low density, highly porous, and purified YBG microparticles with a small and uniform size distribution. These unique particles were found to possess improved aerodynamic properties, allowing them to be inhaled and deposited in the deep lung where fibrotic development occurs.

At the heart of this project is fibrosis: the unregulated and excessive production of scar tissue in organs. Key immune cells called macrophages apparently play a crucial role in maintaining and progressing the fibrotic state. “M1” macrophages express pro-inflammatory properties and “M2” macrophages express the complete opposite anti-inflammatory properties. During fibrosis, M2-like macrophages persist in the fibrotic lung and secrete cytokines (cell signaling molecules) that stimulate the cells around them to constantly produce and deposit scar tissue in the deep lung. These recent findings indicate that PGX-YBG, which binds specifically to Dectin-1 receptors at the surface of macrophages, can repolarize or “reprogram” M2-like macrophages into M1-like macrophages thereby putting an end to tissue deposition (fibrosis) and initiating the much-needed removal of excess tissues.

“We have shown, in vitro, that PGX-YBG have the ability to prevent the activation of macrophages toward a pro-fibrotic phenotype. In addition, PGX-YBG treatment to macrophages that have already acquired a pro-fibrotic phenotype result in the reprogramming of the macrophages toward a classical phenotype not known to be pro-fibrotic. Using cells from animals lacking the beta-glucan receptor Dectin-1, we showed that this was dependent on the presence of the Dectin-1 receptor. These findings are very exciting as macrophage reprogramming is seen as a viable therapeutic strategy toward fibrotic disease and PGX-YBG seem to have this ability. In vivo, we have shown that PGX-YBG can be safely administered to mice, and preliminary data shows an ability to prevent fibrogenesis in an experimental model of lung fibrosis. We are looking forward to validating these in vivo findings over the next few months,” reported Dr. Ask.

To advance this promising technology to human clinical trials, the Company is working to ensure that the delivery of PGX-YBG to the lung is optimized. It will also be important to further validate PGX-YBG’s performance for reducing lung fibrosis, both alone and loaded with an anti-inflammatory drug currently used for lung fibrosis and COVID-19 therapy. The potential impact of this project is considerable since, one of the most common and deadly fibrotic diseases is IPF for which there are no cure and a short (3-5 year) survival rate. It was recently also shown that lung fibrosis can occur and persists for months in some COVID-19 patients thereby suggesting that COVID-19 survivors may suffer from post-infection pulmonary fibrosis complications.

“We are very pleased with the progress made in this research project. Considering these recent, exciting findings, we believe it certainly becomes necessary to conduct additional animal studies before initiating human trials to develop the best possible tool in the fight against lung fibrotic diseases including COVID-19 and post COVID-19 complications,” commented Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro. “We are thankful for the collaborative work with the team at McMaster University and look forward to further development.”

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

Source: Ceapro Inc.

TherapeuticsMD Announces Third Quarter 2021 Financial Results

 

– Quarterly total net product revenue of 
$24.5 million, an increase of 41.1% over Q3 2020 –

– ANNOVERA^® TRx of 8,351, an increase of 62.7% over Q3 2020 –

– Cost savings initiative to reduce SG&A by 
$40 million in 2022; anticipated additional savings of approximately 
$20 million annualized tied to the divestiture of vitaCare –

– Hugh O’Dowd, President, to become Chief Executive Officer;  Robert Finizio appointed Vice Chair of the Board –

– Conference call scheduled for 
8:30 a.m. ET today –

BOCA RATON, Fla.–(BUSINESS WIRE)–Nov. 11, 2021– 
TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the third quarter ended 
September 30, 2021. In addition, today the Company announced a significant cost savings initiative designed to reduce its annual costs in 2022 by at least 
$40 million. This figure does not include savings from, or the costs associated with, the divestiture of vitaCare, which are estimated at approximately 
$20 million annually.

“We have made significant changes to our business strategy, which we believe will help us achieve our goal of EBITDA breakeven in the second half of 2022. Specifically, we put a cost savings plan in place and we have implemented a more concerted focus on healthcare professionals. These refinements are already yielding results, as evidenced by the steady progress made during the third quarter, notably the strong year-over-year growth in ANNOVERA prescriptions,” said Hugh O’Dowd, President of 
TherapeuticsMD.

“I would like to thank Rob for his leadership and vision in creating an innovative healthcare company with products that benefit women across their lifecycles. I would also like to formally welcome  Mark Glickman as our Chief Commercial Officer. His commercial acumen is already having a positive impact on our day-to-day operations. Looking ahead, I am confident that we can reduce our annual expenses significantly, deliver value to shareholders, and most importantly, bring our high-quality products to the women who need them,” concluded O’Dowd.

Third Quarter 2021 Financial Results and Business Highlights

Net Product Revenue (in thousands)

		Three Months Ended
		September 30,
		2021				2020
Product revenue:
ANNOVERA		$	11,807			$	6,419
IMVEXXY			8,016				6,841
BIJUVA			3,298				1,646
Prescription vitamin			1,348				2,436
Product revenue, net			24,469				17,342
License revenue			937				2,000
Total revenue, net		$	25,406			$	19,342

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

• ANNOVERA net product revenue of 
  $11.8 million for the third quarter of 2021 increased by 
  $5.4 million compared to 
  $6.4 million for the third quarter of 2020.
• Approximately 8,350 ANNOVERA prescriptions were dispensed to patients during the third quarter of 2021. Prescriptions increased 62.7% compared to the third quarter of 2020.
• Over 4,500 health care providers (HCPs) prescribed ANNOVERA during the third quarter, of which nearly 29% were new writers.
  • Growth in prescribers of approximately 1,600 over third quarter of 2020.
  • Cumulatively over 9,450 HCPs have prescribed ANNOVERA.

IMVEXXY^® (estradiol vaginal inserts)

• IMVEXXY net product revenue of 
  $8.0 million for the third quarter of 2021 increased by 
  $1.2 million compared to 
  $6.8 million for the third quarter of 2020.
• Approximately 113,000 IMVEXXY prescriptions were dispensed to patients during the third quarter of 2021.
• Full re-targeting initiative taking place in the fourth quarter of 2021, with implementation in the first quarter of 2022.
  • Plan to rejuvenate growth and optimize HCP focus.

BIJUVA^® (estradiol and progesterone)

• BIJUVA net product revenue of 
  $3.3 million for the third quarter of 2021 increased by 
  $1.7 million compared to 
  $1.6 million for the third quarter of 2020.
• BIJUVA net product revenue for the third quarter of 2021 includes 
  $0.7 million of export sales through our international licensing and supply agreement with 
  Theramex HQ UK Limited.
• Re-targeting initiative taking place, similar to the process with IMVEXXY.

Cost of Goods Sold and Gross Margin

• Cost of goods was 
  $5.3 million with product gross margin of 78% for the third quarter of 2021 compared to 
  $3.3 million with product gross margin of 81% for the third quarter of 2020. The lower product gross margin for the third quarter of 2021 reflects the impact of 
  $0.7 million of BIJUVA export sales, which were sold at cost.

Operating Expense, Net Loss and Related Information

• Total operating expense of 
  $60.0 million for the third quarter of 2021 increased by 
  $19.0 million compared to 
  $41.0 million for the third quarter of 2020. Included in total operating expense for the third quarter of 2021 was 
  $7.3 million of severance related expenses recorded for certain former senior executives.
• Net loss for the third quarter of 2021 was 
  $47.4 million, or 
  $0.11 per basic and diluted share, compared to net loss for the third quarter of 2020 of 
  $32.6 million, or 
  $0.12 per basic and diluted share.

Balance Sheet

• As of 
  September 30, 2021, the Company’s cash on hand totaled 
  $104.8 million, compared with 
  $80.5 million as of 
  December 31, 2020.
• For the first nine months of 2021, the Company received 
  $182.9 million in net proceeds from its at-the-market and underwritten equity offerings.
• As of 
  September 30, 2021, the remaining outstanding principal amount under the Company’s Financing Agreement was 
  $200.0 million, which reflects a repayment of 
  $50.0 million of principal during the first nine months of 2021.

The contract manufacturing organization that manufactures ANNOVERA has recently experienced an increase in difficulties with the manufacturing process for ANNOVERA resulting in batch failures. The Company filed a supplemental NDA with the FDA to modify the manufacturing (testing) specification for ANNOVERA to allow for normal manufacturing variation that would increase the consistency of manufacturing and supply of ANNOVERA. The Company expects that the FDA will act on the supplemental NDA by the Prescription Drug User Fee Act (“PDUFA”) date of 
December 12, 2021. If the FDA does not approve the supplemental NDA by the PDUFA date, the Company may not be able to meet the revenue covenants under its Financing Agreement in the near term. The manufacturing difficulties relate only to our ability to meet the release specification, and any ANNOVERA rings currently being sold meet the exacting quality specifications. For more information regarding the covenants under the Financing Agreement, please see the Company’s filings with the 
SEC.

Conference Call and Webcast Details

TherapeuticsMD will host a conference call and live audio webcast today at 
8:30 a.m. ET to discuss these financial results and provide a business update.

Date:	Thursday, November 11, 2021
Time:	8:30 a.m. ET
Telephone Access (US):	866-665-9531
Telephone Access (International):	724-987-6977
Access Code for All Callers:	6341637

A live webcast and audio archive for the event may be accessed on the home page or from the “Investors & Media” section of the 
TherapeuticsMD website at www.therapeuticsmd.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least 30 days. In addition, a digital recording of the conference call will be available for replay beginning two hours after the call’s completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 6341637.

Please see the Full Prescribing Information, including indication and Boxed WARNING, for each 
TherapeuticsMD product as follows:

• IMVEXXY (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf
• BIJUVA (estradiol and progesterone) capsules at https://www.bijuva.com/pi.pdf
• ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf

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, or obtain an investment in, its vitaCare business and how the proceeds that may be generated by any such divestiture or investment will be utilized; the effects of supply chain issues on the supply of the company’s products; 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 and the manufacturing supplement for ANNOVERA; 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 impact of leadership transitions; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

– Financial Statements to Follow –

TherapeuticsMD, Inc. and Subsidiaries Consolidated Balance Sheets (In thousands, except per share data)
		September 30, 2021				December 31, 2020
		(Unaudited)
Assets:
Current assets:
Cash		$	104,841			$	80,486
Accounts receivable, net of allowance for credit losses of  $1,351 and  $1,118 as of  September 30, 2021 and  December 31, 2020, respectively			37,402				32,382
Inventory			7,362				7,993
Prepaid and other current assets			10,374				7,543
Total current assets			159,979				128,404
Fixed assets, net			1,388				1,942
License rights and other intangible assets, net			39,617				41,445
Right of use assets			8,391				9,566
Other non-current assets			253				253
Total assets		$	209,628			$	181,610
Liabilities and stockholders’ equity (deficit):
Current liabilities:
Current maturities of long-term debt		$	15,000			$	—
Accounts payable			19,592				21,068
Accrued expenses and other current liabilities			51,674				38,170
Total current liabilities			86,266				59,238
Long-term debt, net			171,738				237,698
Operating lease liabilities			8,226				8,675
Other non-current liabilities			758				—
Total liabilities			266,988				305,611
Commitments and contingencies
Stockholders’ equity (deficit):
Preferred stock, par value  $0.001; 10,000 shares authorized, none issued			—				—
Common stock, par value  $0.001; 600,000 shares authorized, 424,879 and 299,765 issued and outstanding as of  September 30, 2021 and  December 31, 2020, respectively			425				300
Additional paid-in capital			950,615				754,644
Accumulated deficit			(1,008,400	)			(878,945	)
Total stockholders’ deficit			(57,360	)			(124,001	)
Total liabilities and stockholders’ equity (deficit)		$	209,628			$	181,610

TherapeuticsMD, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited – in thousands, except per share data)
		Three Months Ended								Nine Months Ended
		September 30,								September 30,
		2021				2020				2021				2020
Product revenue, net		$	24,469			$	17,342			$	67,102			$	40,294
License revenue			937				2,000				1,171				2,000
Total revenue, net			25,406				19,342				68,273				42,294
Cost of goods sold			5,282				3,279				14,101				10,394
Gross profit			20,124				16,063				54,172				31,900
Operating expenses:
Selling and marketing			30,005				22,373				86,193				91,056
General and administrative			28,435				16,637				66,691				53,740
Research and development			1,605				2,027				5,666				8,038
Total operating expenses			60,045				41,037				158,550				152,834
Loss from operations			(39,921	)			(24,974	)			(104,378	)			(120,934	)
Other (expense) income:
Interest expense and other financing costs			(7,518	)			(7,680	)			(25,341	)			(20,969	)
Other income, net			19				42				264				466
Total other (expense), net			(7,499	)			(7,638	)			(25,077	)			(20,503	)
Loss before income taxes			(47,420	)			(32,612	)			(129,455	)			(141,437	)
Provision for income taxes			—				—				—				—
Net loss		$	(47,420	)		$	(32,612	)		$	(129,455	)		$	(141,437	)
Loss per common share, basic and diluted		$	(0.11	)		$	(0.12	)		$	(0.33	)		$	(0.52	)
Weighted average common shares, basic and diluted			422,216				272,565				388,111				271,969

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited – in thousands)
		Nine Months Ended  September 30,
		2021				2020
Cash flows from operating activities:
Net loss		$	(129,455	)		$	(141,437	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			3,091				3,039
Charges (credits) to provision for doubtful accounts			540				(47	)
Inventory charge			1,082				5,744
Debt financing fees			4,158				1,645
Share-based compensation			12,779				8,502
Other			726				1,719
Changes in operating assets and liabilities:
Accounts receivable			(5,560	)			384
Inventory			(451	)			(3,816	)
Prepaid and other current assets			(2,831	)			2,038
Accounts payable			(1,476	)			(3,072	)
Accrued expenses and other current liabilities			13,504				(3,813	)
Other non-current liabilities			758				—
Total adjustments			26,320				12,323
Net cash used in operating activities			(103,135	)			(129,114	)
Cash flows from investing activities:
Payment of patent related costs			(675	)			(1,065	)
Purchase of fixed assets			(34	)			(39	)
Net cash used in investing activities			(709	)			(1,104	)
Cash flows from financing activities:
Proceeds from sale of common stock, net of costs			182,881				—
Proceeds from exercise of options and warrants			302				272
Proceeds from sale of common stock related to employee stock purchase plan			134				—
Repayments of debt			(50,000	)			—
Borrowings of debt			—				50,000
Payment of debt financing fees			(5,118	)			(1,250	)
Net cash provided by financing activities			128,199				49,022
Net increase in cash			24,355				(81,196	)
Cash, beginning of period			80,486				160,830
Cash, end of period		$	104,841			$	79,634
Supplemental disclosure of noncash financing activities:
Warrants issued in relation to debt financing agreement			—				7,428
Supplemental disclosure of cash flow information:
Interest paid		$	19,675			$	12,032

 

James D’Arecca
Chief Financial Officer
561-961-1900

Lisa M. Wilson

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

Source: 
TherapeuticsMD, Inc.

TherapeuticsMD Announces Leadership Changes; Appointment of Industry Veteran, Hugh O’Dowd, as Chief Executive Officer

 

– Mr. O’Dowd to succeed  Robert G. Finizio, effective on or before 
December 31, 2021 –

–  Mr. Finizio appointed Vice Chair of the Board –

BOCA RATON, Fla.–(BUSINESS WIRE)–Nov. 11, 2021– 
TherapeuticsMD, Inc. (NASDAQ: TXMD) (TXMD or the Company), an innovative, leading women’s healthcare company, today announced key leadership changes, including the appointment of Hugh O’Dowd, the Company’s current President, as the Company’s Chief Executive Officer and member of the board of directors. Mr. O’Dowd will succeed  Robert G. Finizio, the Company’s Co-founder and current Chief Executive Officer, effective on or before 
December 31, 2021.  Mr. Finizio will continue with the Company and has been appointed Vice Chair of the Board of Directors.

“I want to thank Rob for his strong leadership and vision over the past 13 years,” said Honorable  Tommy Thompson, Chairman of the Board of 
TherapeuticsMD. “Rob is an innovator who has made an indelible mark not only on this company, but on the women’s healthcare industry as a whole.”

“Founding TherapeuticsMD has been one of the highlights of my career. Hugh is an experienced leader with a strong track record of delivering results, and in the few short months since joining the company, he has already made invaluable contributions. I am confident that he is the right person to bring 
TherapeuticsMD to the next level of growth,” said  Mr. Finizio.

“TherapeuticsMD is an innovator in women’s healthcare, and I welcome the opportunity to drive operating performance and craft our long-term strategy,” stated Mr. O’Dowd. “Rob has created a dynamic company and established TXMD’s foundation for growth and I will build upon our mission of empowering women of all ages through better healthcare.”

Mr. O’Dowd previously served as President, Chief Executive Officer, and member of the Board of Directors of 
Neon Therapeutics, Inc., a clinical-state immuno-oncology company until its acquisition by BioNTech SE in 
May 2020. Prior to Neon Therapeutics, Mr. O’Dowd spent more than 20 years in a variety of senior leadership roles at 
Novartis Pharmaceuticals Corporation, where he served as Country President and General Manager of the 
United Kingdom and 
Ireland, Senior Vice President and Chief Commercial Officer of Novartis Oncology, and Vice President, Latin America Region Head for the Oncology business unit. During his time as Chief Commercial Officer Oncology, Mr. O’Dowd was responsible for the oncology portfolio strategy for the world’s then second-largest oncology/hematology organization, including global brand leadership, business development/licensing, and commercialization. Mr. O’Dowd currently serves as Director and Non-executive Chairman of 
ONK Therapeutics Ltd, an innovative natural killer cell therapy company, and as a Director of Polyphor AG, a clinical-stage biopharmaceutical company focused on the discovery and development of antibiotics and immuno-oncology compounds. Mr. O’Dowd received an MBA from the 
Kellstadt Graduate School of Business at 
DePaul University in 
Chicago and a B.A. from 
Loyola University Chicago.

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: 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, or obtain an investment in, its vitaCare business and how the proceeds that may be generated by any such divestiture or investment will be utilized; the effects of supply chain issues on the supply of the company’s products; 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 and the manufacturing supplement for ANNOVERA; 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 impact of leadership transitions; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

Lisa M. Wilson

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

Source: 
TherapeuticsMD, Inc.

Thursday, November 11, 2021

Axcella Therapeutics (AXLA)
3Q21 Marked By Clinical Progress

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator (EMM) compositions. The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

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

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

3Q21 Reported A Smaller Loss Than Expected. During the quarter, Axcella made significant progress enrolling its two clinical trials, had scientific studies accepted for presentation, and announced a new indication for AXA1125. The company’s loss for the quarter was $15.6 million or $(0.41) per share, compared with our estimated loss of $16.1 million or $(0.43) per share. The quarter ended with $66.1 million in cash.


A New Trail For AXA1125 In Long COVID.  Recent studies have indicated that COVID-19 infection can have damaging effects on mitochondria, changing energy production in the cells, and causing long-term fatigue. The AXA1125 mechanism of action impacts mitochondria and may be able to restore normal activity. A Phase 2a study in Long COVID patients is planned, with a target enrollment is about 40 …

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. 

Noble Capital Markets Senior Research Analyst Robert LeBoyer interviews Axcella Therapeutics President & CEO Bill Hinshaw. Research, News, and Advanced Market Data on AXLA View all C-Suite Interviews About Axcella Therapeutics Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator (EMM) compositions. The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Wednesday, November 10, 2021

Ocugen (OCGN)
Ocugen Reports 3Q21 and Reviews Recent Progress

Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.

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

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

Financial Results For 3Q21 Within Expectations Ocugen reported 3Q21 financial results of a loss of $10.8 million or $(0.05) per share, compared with our estimated loss of $8.8 million or $(0.04) per share.  The difference was largely due to higher R&D spending related to regulatory expenses and the start of the Covaxin immune-bridging study. The company ended the quarter with $107.3 million in cash.


Covaxin Continues Making Progress Toward Approval The company held a conference call in which it reviewed progress during the quarter, including an FDA application for Emergency Use Authorization in children ages 2 to 18.  The approval process in Canada is proceeding as expected. We continue to expect product approval during 2022 in Canada and 2023 in the US …

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. 

Helius Medical Technologies, Inc. Announces Pricing of $9.6 Million Underwritten Public Offering of Common Stock

 

NEWTOWN, Pa., Nov. 10, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq: HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the pricing of an underwritten registered public offering of 1,204,375 shares of its common stock at a price to the public of $8.00 per share.

All of the shares of common stock to be sold in the offering will be sold by the Company. In addition, the Company has granted the underwriter a 45-day option to purchase up to an additional 180,656 shares of its common stock at the public offering price less the underwriting discount.

The gross proceeds to the Company from this offering, before deducting underwriting discounts and commissions and offering expenses, but excluding any exercise of the underwriters’ option to purchase additional shares, are expected to be approximately $9.6 million. The offering is scheduled to close on or about November 12, 2021, subject to customary closing conditions.

The Company intends to use the net proceeds from this proposed offering for funding operations, working capital and other general corporate purposes.  

Ladenburg Thalmann & Co. Inc. is acting as the sole book-running manager for the offering.

The shares will be issued pursuant to a shelf registration statement on Form S-3 (File No. 333-236101) that was declared effective by the U.S. Securities and Exchange Commission (“SEC”), on February 6, 2020. The Company will file a final prospectus supplement with the SEC relating to such shares of common stock. Copies of the final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, at the SEC’s website at www.sec.gov or by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th floor, New York, NY 10019 by email at prospectus@ladenburg.com.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

Forward Looking Statements

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “intends to,” “expect,” “will,” “goal,” “aim to” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s anticipated closing of the public offering and anticipated use of proceeds therefrom.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include risks and uncertainties related to market and other conditions, the satisfaction of customary closing conditions related to the proposed public offering, the impact of general economic, industry or political conditions in the United States or internationally and other risks described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

Investor Relations Contact:

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