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 

PDS Biotech Provides Business Update and Reports Third Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., Nov. 10, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, will discuss its financial results for the quarter ended September 30, 2021 and provide a business update on its conference call today.

Recent Business Highlights:

• Achieved several milestones in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA^® for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:
  • Achievement of the preliminary safety benchmark for the first 12 patients
  • Completion of enrollment for the first stage of the checkpoint inhibitor naïve arm (1st line treatment of recurrent or metastatic head and neck cancer).
  • Initiated enrollment of the second arm of the study addressing checkpoint inhibitor refractory patients (2nd line treatment of recurrent or metastatic head and neck cancer)
• Completed a licensing agreement with the National Cancer Institute (NCI) for intellectual property related to the NCI’s proprietary T-cell receptor gamma alternate reading frame protein (TARP) tumor antigen for use in PDS0102.
  • PDS0102 is being developed to treat prostate cancer, breast cancer and acute myeloid leukemia or AML.
  • PDS0102 has demonstrated powerful induction of TARP-specific killer T-cells in preclinical studies.
• Entered agreement to license COBRA (Computationally Optimized Broadly Reactive Antigen) antigens from the University of Georgia for use in the development of PDS0202, a novel Versamune^®-based universal flu vaccine.
• Announced temporary administrative suspension of enrollment into the NCI-led study of the PDS0101 triple combination. PDS Biotech continues to be in contact with the NCI. Treatment of already enrolled patients has continued without interruption.
• Announced the hiring of Matthew Hill as Chief Financial Officer, who has more than 25 years of experience in finance and operational leadership roles for life sciences companies.

“PDS Biotech has continued to build on its momentum from the interim data of the last quarter in 2nd and 3rd line treatment of HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “We have achieved numerous clinical milestones, and formalized agreements with development partners to continue to progress both our Versamune^®-based oncology pipeline and our Versamune^®-based infectious diseases pipeline. We also welcomed Matthew Hill as our new Chief Financial Officer. Matt has decades of experience as a financial leader in publicly traded life sciences companies and will be a key player in our next phase of growth. The groundwork has been laid for the execution of multiple pipeline development milestones in 2022 and into 2023.”

Third Quarter 2021 Financial Results

PDS Biotech reported a net loss of approximately $7.0 million, or $(0.24) per basic and diluted share, for the three months ended September 30, 2021, compared to a net loss of approximately $3.9 million, or $(0.21) per basic and diluted share, for the three months ended September 30, 2020.

Research and development expenses increased to approximately $3.7 million for the three months ended September 30, 2021 from approximately $2.1 million for the three months ended September 30, 2020. The increase of $1.6 million was primarily attributable to an increase of $0.7 million in personnel costs of which $0.5 million was stock compensation costs, and $0.9 million in costs related to clinical studies.

General and administrative expenses increased to approximately $3.2 million for the three months ended September 30, 2021 from approximately $1.8 million for the three months ended September 30, 2020. The increase of $1.4 million is primarily attributable to an increase in personnel costs of $1.6 million, of which $1.0 million was stock compensation costs and $0.4 million was severance, partially offset by a decrease in professional fees of $0.2 million.

 PDS Biotech’s cash and cash equivalents as of September 30, 2021, were approximately $69.7 million.

Conference Call and Webcast

The conference call is scheduled to begin at 8:00 am ET on Wednesday, November 10, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13722558.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s or monitoring committees’ or other third parties’ interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment, significance of milestones, and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
Condensed Consolidated Balance Sheets

	September 30, 2021				December 31, 2020
ASSETS	(unaudited)
Current assets:
Cash and cash equivalents	$	69,744,004			$	28,839,565
Prepaid expenses and other		1,596,810				1,497,665
Total current assets		71,340,814				30,337,230
Property and equipment, net		1,037				5,443
Operating lease right-to-use asset		406,171				547,706
Total assets	$	71,748,022			$	30,890,379
LIABILITIES AND STOCKHOLDERS’ EQUITY
LIABILITIES
Current liabilities:
Accounts payable	$	1,445,585			$	1,415,224
Accrued expenses		1,923,846				1,735,322
Operating lease obligation-short term		207,717				119,904
Total current liabilities		3,577,148				3,270,450
Noncurrent liability:
Operating lease obligation-long term		313,976				490,353
Total Liabilities	$	3,891,124			$	3,760,803
STOCKHOLDERS’ EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2021 and December 31, 2020, 28,435,067 shares and 22,261,619 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively		9,383				7,346
Additional paid-in capital		122,231,115				70,907,315
Accumulated deficit		(54,383,600	)			(43,785,085	)
Total stockholders’ equity		67,856,898				27,129,576
Total liabilities and stockholders’ equity	$	71,748,022			$	30,890,379

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)

	Three Months Ended September 30,								Nine Months Ended September 30,
	2021				2020				2021				2020
Operating expenses:
Research and development expenses	$	3,687,999			$	2,060,815			$	7,865,249			$	5,446,718
General and administrative expenses		3,274,325				1,846,214				7,252,371				5,428,098
Total operating expenses		6,962,324				3,907,029				15,117,620				10,874,816
Loss from operations		(6,962,324	)			(3,907,029	)			(15,117,620	)			(10,874,816	)
Other income:
Interest income		1,358				1,207				2,617				54,242
Loss before income taxes		(6,960,966	)			(3,905,822	)			(15,115,003	)			(10,820,574	)
Benefit from income taxes		–				–				4,516,488				–
Net loss and comprehensive loss		(6,960,966	)			(3,905,822	)			(10,598,515	)			(10,820,574	)
Per share information:
Net loss per share, basic and diluted	$	(0.24	)		$	(0.21	)		$	(0.43	)		$	(0.73	)
Weighted average common shares outstanding, basic and diluted		28,425,850				18,961,619				24,639,299				14,892,764

PDS Biotech Provides Business Update and Reports Third Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., Nov. 10, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, will discuss its financial results for the quarter ended September 30, 2021 and provide a business update on its conference call today.

Recent Business Highlights:

• Achieved several milestones in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA^® for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:
  • Achievement of the preliminary safety benchmark for the first 12 patients
  • Completion of enrollment for the first stage of the checkpoint inhibitor naïve arm (1st line treatment of recurrent or metastatic head and neck cancer).
  • Initiated enrollment of the second arm of the study addressing checkpoint inhibitor refractory patients (2nd line treatment of recurrent or metastatic head and neck cancer)
• Completed a licensing agreement with the National Cancer Institute (NCI) for intellectual property related to the NCI’s proprietary T-cell receptor gamma alternate reading frame protein (TARP) tumor antigen for use in PDS0102.
  • PDS0102 is being developed to treat prostate cancer, breast cancer and acute myeloid leukemia or AML.
  • PDS0102 has demonstrated powerful induction of TARP-specific killer T-cells in preclinical studies.
• Entered agreement to license COBRA (Computationally Optimized Broadly Reactive Antigen) antigens from the University of Georgia for use in the development of PDS0202, a novel Versamune^®-based universal flu vaccine.
• Announced temporary administrative suspension of enrollment into the NCI-led study of the PDS0101 triple combination. PDS Biotech continues to be in contact with the NCI. Treatment of already enrolled patients has continued without interruption.
• Announced the hiring of Matthew Hill as Chief Financial Officer, who has more than 25 years of experience in finance and operational leadership roles for life sciences companies.

“PDS Biotech has continued to build on its momentum from the interim data of the last quarter in 2nd and 3rd line treatment of HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “We have achieved numerous clinical milestones, and formalized agreements with development partners to continue to progress both our Versamune^®-based oncology pipeline and our Versamune^®-based infectious diseases pipeline. We also welcomed Matthew Hill as our new Chief Financial Officer. Matt has decades of experience as a financial leader in publicly traded life sciences companies and will be a key player in our next phase of growth. The groundwork has been laid for the execution of multiple pipeline development milestones in 2022 and into 2023.”

Third Quarter 2021 Financial Results

PDS Biotech reported a net loss of approximately $7.0 million, or $(0.24) per basic and diluted share, for the three months ended September 30, 2021, compared to a net loss of approximately $3.9 million, or $(0.21) per basic and diluted share, for the three months ended September 30, 2020.

Research and development expenses increased to approximately $3.7 million for the three months ended September 30, 2021 from approximately $2.1 million for the three months ended September 30, 2020. The increase of $1.6 million was primarily attributable to an increase of $0.7 million in personnel costs of which $0.5 million was stock compensation costs, and $0.9 million in costs related to clinical studies.

General and administrative expenses increased to approximately $3.2 million for the three months ended September 30, 2021 from approximately $1.8 million for the three months ended September 30, 2020. The increase of $1.4 million is primarily attributable to an increase in personnel costs of $1.6 million, of which $1.0 million was stock compensation costs and $0.4 million was severance, partially offset by a decrease in professional fees of $0.2 million.

 PDS Biotech’s cash and cash equivalents as of September 30, 2021, were approximately $69.7 million.

Conference Call and Webcast

The conference call is scheduled to begin at 8:00 am ET on Wednesday, November 10, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13722558.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s or monitoring committees’ or other third parties’ interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment, significance of milestones, and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
Condensed Consolidated Balance Sheets

	September 30, 2021				December 31, 2020
ASSETS	(unaudited)
Current assets:
Cash and cash equivalents	$	69,744,004			$	28,839,565
Prepaid expenses and other		1,596,810				1,497,665
Total current assets		71,340,814				30,337,230
Property and equipment, net		1,037				5,443
Operating lease right-to-use asset		406,171				547,706
Total assets	$	71,748,022			$	30,890,379
LIABILITIES AND STOCKHOLDERS’ EQUITY
LIABILITIES
Current liabilities:
Accounts payable	$	1,445,585			$	1,415,224
Accrued expenses		1,923,846				1,735,322
Operating lease obligation-short term		207,717				119,904
Total current liabilities		3,577,148				3,270,450
Noncurrent liability:
Operating lease obligation-long term		313,976				490,353
Total Liabilities	$	3,891,124			$	3,760,803
STOCKHOLDERS’ EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2021 and December 31, 2020, 28,435,067 shares and 22,261,619 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively		9,383				7,346
Additional paid-in capital		122,231,115				70,907,315
Accumulated deficit		(54,383,600	)			(43,785,085	)
Total stockholders’ equity		67,856,898				27,129,576
Total liabilities and stockholders’ equity	$	71,748,022			$	30,890,379

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)

	Three Months Ended September 30,								Nine Months Ended September 30,
	2021				2020				2021				2020
Operating expenses:
Research and development expenses	$	3,687,999			$	2,060,815			$	7,865,249			$	5,446,718
General and administrative expenses		3,274,325				1,846,214				7,252,371				5,428,098
Total operating expenses		6,962,324				3,907,029				15,117,620				10,874,816
Loss from operations		(6,962,324	)			(3,907,029	)			(15,117,620	)			(10,874,816	)
Other income:
Interest income		1,358				1,207				2,617				54,242
Loss before income taxes		(6,960,966	)			(3,905,822	)			(15,115,003	)			(10,820,574	)
Benefit from income taxes		–				–				4,516,488				–
Net loss and comprehensive loss		(6,960,966	)			(3,905,822	)			(10,598,515	)			(10,820,574	)
Per share information:
Net loss per share, basic and diluted	$	(0.24	)		$	(0.21	)		$	(0.43	)		$	(0.73	)
Weighted average common shares outstanding, basic and diluted		28,425,850				18,961,619				24,639,299				14,892,764

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 

Ocugen Provides Business Update and Third Quarter 2021 Financial Results

 

Conference Call and Webcast Today at 8:30 a.m. ET

• Emergency Use Authorization application filed with the U.S. FDA for the COVID-19 vaccine candidate, COVAXIN™ (BBV152), for children aged 2 – 18 years
• Investigational New Drug application filed with the U.S. FDA for COVAXIN™ (BBV152)
• Investigational New Drug application filed with the U.S. FDA for breakthrough modifier gene therapy candidate, OCU400
• Collaboration with CanSinoBIO expanded to include OCU410 for chemistry, manufacturing, and controls development and manufacturing

MALVERN, Pa. , Nov. 09, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today reported third quarter 2021 financial results along with a general business update.

“We’ve been relentless in our efforts to launch our innovative medicines onto regulatory pathways here in the United States. The submission of COVAXIN for Emergency Use Authorization for pediatrics is another example of Ocugen contributing to public health efforts to curb the pandemic, giving parents another option for protecting their children. Two Investigational New Drug submissions within a span of two weeks is a phenomenal achievement resulting from the work of international teams aligned around serving people with serious diseases. Our capabilities in the areas of R&D, clinical development, manufacturing, and commercial continue to expand with our workforce nearly doubling since the last quarter to deliver for the future. I’m really proud of the teams for their commitment to meeting our mission,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.

Business Highlights

FORWARD MOMENTUM FOR COVAXIN™ AND OPHTHALMIC PIPELINE

• The Company filed an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for the use of the COVID-19 vaccine candidate, COVAXIN™ (BBV152), for children aged 2 – 18 years. The Company believes its vaccine candidate has the potential to fulfill an unmet need in the national arsenal of COVID-19 vaccines. The inactivated virus platform has been used for decades in vaccines for pediatric populations.
• The Company also filed an Investigational New Drug (IND) application with the FDA to initiate a Phase 3 clinical trial evaluating COVAXIN™ (BBV152) in support of an upcoming Biologics License Application (BLA) submission. The observer-blind, immuno-bridging study of the whole-virion, inactivated SARS-CoV-2 vaccine candidate in healthy adults, if allowed to proceed, will help demonstrate that the Phase 3 data from the studies conducted by Bharat Biotech International Limited (Bharat Biotech) in India will be applicable to the U.S. population. Under the IND, the Company will also initiate a safety-bridging study, if required.
• The Company filed an IND application with the FDA for OCU400 for the Phase 1/2 study to assess the safety of OCU400 (NR2E3) in patients with a mutation in NR2E3 and RHO mutation-associated retinal degeneration. If allowed to proceed, the Company is planning to initiate this clinical trial in the United States around the end of 2021.
• In September 2021, the Company entered into a Development and Commercial Supply Agreement with Bharat Biotech, pursuant to which Bharat Biotech will supply the Company with clinical trial materials and commercial supplies of COVAXIN™ finished drug product prior to the completion of the Company’s technology transfer to Jubilant HollisterStier.

• In September 2021, the Company and CanSino Biologics, Inc. (“CanSinoBIO”) expanded their current collaboration on the development of OCU400 to now include OCU410. With that, CanSinoBIO will be responsible for the chemistry, manufacturing, and controls (CMC) development and manufacture of clinical supplies of both products and be responsible for the costs associated with such activities.
  

Third Quarter 2021 Financial Results

• Ocugen’s cash, cash equivalents, and restricted cash totaled $107.5 million as of September 30, 2021, compared to $24.2 million as of December 31, 2020. Ocugen had 198.9 million shares of common stock outstanding as of September 30, 2021.
• Research and development expenses for the three months ended September 30, 2021 were $6.3 million compared to $1.5 million for the three months ended September 30, 2020. General and administrative expenses for the three months ended September 30, 2021 were $4.5 million compared to $1.7 million for the three months ended September 30, 2020. Ocugen reported a $0.05 net loss per share for the three months ended September 30, 2021 compared to a $0.07 net loss per share for the three months ended September 30, 2020, which includes the in-process research and development expense of $7.0 million related to the reduction of the carrying value of an asset that was previously recorded as held for sale.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. eastern time today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 8198297. To access a live audio webcast of the call on the “Investors” section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugen’s website for approximately 45 days following the call.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing?a vaccine to?save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.?We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets.?For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including with respect to our belief that COVAXIN™ has the potential to fulfill an unmet need in the national arsenal of COVID-19 vaccines, our plans to initiate the Phase 1/2 study for OCU400, if authorized to proceed, near the end of 2021, and our belief that the results from the Phase 3 study for COVAXIN™, if allowed to proceed, will help demonstrate that the Phase 3 data from the studies conducted by Bharat Biotech Bharat Biotech in India will be applicable to the U.S. population. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, including whether the FDA will authorize COVAXIN™ for administration as a vaccine for pediatric uses against COVID-19 pursuant to the EUA we submitted with the FDA and the timing and scope of any such authorization, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA or IND submissions, as applicable; whether the FDA will accept our IND submissions without any changes, or if we are required to submit additional information to the FDA in support of our IND submissions, the extent and significance of any such changes; the size, scope, timing, and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA for COVAXIN™; any additional CMC information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN™ will be submitted to or approved by the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada, or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

(tables to follow)

OCUGEN, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands)

(Unaudited)

OCUGEN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)