Life Sciences Supermind Report outlines proposed solutions to re-imagine the global health ecosystem

 

MIT Center for Collective Intelligence | MIT
Media Lab

 

The Covid-19 pandemic sent shockwaves through the life science ecosystem, uniting the scientific community with a common purpose and re-imagining pathways to address global health challenges.

To help accelerate that innovation, the MIT Center for Collective Intelligence, the MIT Media Lab’s Community Biotechnology Initiative, and MilliporeSigma — the U.S. and Canadian life science business of Merck KGaA, Darmstadt, Germany — together convened more than 200 thought leaders from around the world to collaboratively capture the disruptions caused by the pandemic and identify the solutions that will help usher in the future of the life sciences.

A comprehensive
report containing synthesized, data-driven insights from this expert group, known as the “Life Sciences Supermind,” has now been published. The work builds on the collaborators’ research from 2020, which focused on pandemic response efforts, to outline the most promising solutions to build health resilience for now and the future.

The Life Sciences Supermind Report represents 18 months of global collaboration and expert synthesis, applying an accelerated methodology to identify solutions amid the urgency of a pandemic. During the invite-only curation exercise that ran for four weeks in May 2021, the Supermind convened using the Center for Collective Intelligence’s software platform and methodology to address a central challenge question: How do we identify and apply the lessons learned from the Covid-19 pandemic to re-imagine the institutions, processes, policies and tools we use across the life sciences to address global health needs for all?

David Sun Kong, director of the Community Biotechnology Initiative within the MIT Media Lab and author of the report, says, “Building upon last year’s effort, we widened the scope of our exploration to think deeply about the future of the entire life sciences ecosystem. In the coming years, human civilization faces unprecedented challenges that will require the global life sciences community to innovate, coordinate, and act. We believe many of the ideas and strategies presented in this report can help guide our future directions.”

During this sprint, the Supermind identified gaps and innovative solutions across five key technical areas, including the future of scientific research; public health preparedness, science and technologies; science communication; disruptive technologies; and flexible and resilient manufacturing, supply, and distribution chains. Synthesizing the results of this exercise, the Supermind Report was published in thematic installments from June to November 2021 and is now released in full for the first time.

“Typically, Supermind participants contribute ideas to the platform asynchronously throughout the multi-week exercise. This year, we added a new activity to our methodology where Supermind participants collaborated during online video sessions to develop solutions together,” says Kathleen Kennedy, executive director of the Center for Collective Intelligence, who oversaw the Supermind platform. “The combination of synchronous and asynchronous collaboration proved to be a powerful combination.”

The Supermind provided an early signal on new modes of global collaboration that have the potential to build public health resilience for all. Experts identified innovative ideas such as creating a new field of public health technology to unite technology leadership and expertise with the design of public health programs, products and initiatives. This strategy has since been leveraged more broadly in the fight against Covid-19, sparking innovative partnerships between technology, design, medical, and public health professionals to respond to this global health emergency.

The Supermind Report also details key findings on building diverse and open communities to accelerate scientific discovery; deploying novel, open-source technologies for diagnostics and transmission control; combating the “infodemic” through integrated disciplines that tackle information overload; and restructuring talent development in the life sciences, among other innovative strategies identified throughout the exercise.

The initiative’s unique methodology applied natural language processing to cluster and synthesize contributions from the participants. Participants contributed to the online platform asynchronously with daily facilitation. In total, 137 individual ideas were put forward during the 2021 exercise, garnering more than 700 votes cast for the top solutions during an evaluation phase. These were then supplemented by synchronous deliberation geared toward identifying more specific pathways to implementation and actionable outcomes.

“By bringing together a diverse group of experts, we were able to leverage their collective knowledge and compile the findings,” says Patrick Schneider, head of strategy, business development, and innovation for the Research Solutions business unit at MilliporeSigma and chair of the Life Science Innovation Board. “The result is a report that highlights novel ideas that have the ability to impact the future of life sciences. I look forward to taking these ideas and putting them into action.”

The Life Sciences Supermind demonstrates the power of collective intelligence in identifying the most feasible, impactful solutions to re-imagine the global health ecosystem and build health resilience for now and in the future. Looking to a post-pandemic world, these lessons, strengths, and accelerated pathways to solutions have the power to usher in a paradigm shift across scientific and global health industries.

 

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Friday, March 11, 2022

Lineage Cell Therapeutics (LCTX)
FY2021 Reported With Updates For Pipeline Development

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

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

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

Full Year Financials In Line With Expectations.  Lineage Cell reported a 4Q21 loss of $28.2 million or $(0.17) per share, and a loss of $43.0 million or $(0.26) per share for FY21. The larger than expected loss in 4Q21 was due to the accrual of $20.6 million for future obligations payable to its licensors under the December 2021 Genentech/Roche Agreement. The company ended the year with $55.7 million in cash, excluding proceeds from the Genentech agreement.

Genentech/Roche Agreement Transformed The Company.  In December 2021, Lineage Cell made a collaboration and licensing agreement covering OpRegen, its retinal pigmented epithelial cell transplant for ophthalmologic indications. Genentech/Roche will take over the clinical development and commercialization, in exchange for $50 million in upfront fees, $620 million in potential milestone payments, then …

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

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

Thursday, March 10, 2022

Item 9 Labs (INLB)
Begins Capital Raise; Closes on First Dispensary Acquisition

Item 9 Labs Corp. (OTCQX: INLB) is a vertically integrated cannabis operator and dispensary franchisor delivering premium products from its large-scale cultivation and production facilities in the United States. The award-winning Item 9 Labs brand specializes in best-in-class products and user experience across several cannabis categories. The company also offers a unique dispensary franchise model through the national Unity Rd. retail brand. Easing barriers to entry, the franchise provides an opportunity for both new and existing dispensary owners to leverage the knowledge, resources, and ongoing support needed to thrive in their state compliantly and successfully. Item 9 Labs brings the best industry practices to markets nationwide through distinctive retail experience, cultivation capabilities, and product innovation. The veteran management team combines a diverse skill set with deep experience in the cannabis sector, franchising, and the capital markets to lead a new generation of public cannabis companies that provide transparency, consistency, and well-being. Headquartered in Arizona, the company is currently expanding its operations space by 650,000+ square feet on its 50-acre site, one of the largest properties in Arizona zoned to grow and cultivate flower. For additional information, visit item9labscorp.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Capital Raise. Yesterday, Item 9 Labs announced the launch of its global, streamlined Regulation A, Tier 2 public offering for unaccredited and accredited investors. The Company is offering 28 million units, each comprised of one share and one-half of one warrant. Upon the exercise of all warrants, the offering has maximum proceeds of $67.2 million. The offering price is $1.40 per unit and the exercise price is $2.00 per warrant share.

To Fuel Growth.  The net proceeds of the offering will be used to fuel growth. Proceeds will be used to fund the Company’s retail dispensary acquisition strategy, for the potential acquisition of additional cultivation properties, and for working capital purposes. Assuming funds are raised, we believe this would be a net positive for Item 9 Labs as the additional capital would enable an acceleration …

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. 

Cocrystal Pharma Initiates Enrollment in Phase 1 Influenza A Study with Novel, Broad-Spectrum, Orally Administrated Antiviral CC-42344

Research, News, and Market Data on Cocrystal Pharma

 

BOTHELL, Wash., March 10, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces dosing of the first subjects in a Phase 1 clinical trial of healthy adults evaluating its novel, broad-spectrum, orally administered antiviral CC-42344 for the treatment of pandemic and seasonal influenza A. The study is designed to assess the safety, tolerability and pharmacokinetics of CC-42344 with results expected later this year.

The randomized, double-blind, placebo-controlled Phase 1 study is expected to enroll up to 56 healthy adults at a single site in Australia. CC-42344 is an oral PB2 inhibitor that blocks an essential step of influenza viral replication and transcription. CC-42344 was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology.

“There is an urgent need for new antiviral medicines that address pandemic and drug-resistant seasonal influenza strains,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “CC-42344 specifically targets the PB2 protein of influenza polymerase complex and exhibits broad-spectrum antiviral activity including against Tamiflu- or Xofluza-resistant strains. In preclinical testing, CC-42344 has shown favorable pharmacokinetic and safety profiles. Advancing CC-42344 into clinical studies further validates our proprietary drug discovery platform technology.”

“Enrolling the first participants represents a significant milestone in advancing the development of CC-42344 for the treatment of this highly contagious viral infection that can have life-threatening complications,” added James Martin, Cocrystal’s CFO and co-interim CEO. “This study is the first of three first-in-human trials we expect to initiate in 2022, with the other two evaluating our novel antiviral therapeutic candidates for SARS-CoV-2.”

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

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our planned initiation of influenza A Phase 1 study in Australia in 2022 , and the potential of CC-42344 to treat seasonal and pandemic influenza The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from any future impact of the COVID-19 pandemic and the Russian invasion of Ukraine on the Australian and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our influenza A program, the ability of the contract research organization to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

Media Contact:
JQA Partners
917-885-7378
Jabraham@jqapartners.com

Source: Cocrystal Pharma, Inc.

TherapeuticsMD Announces Fourth Quarter 2021 Financial Results

Research, News, and Market Data on TherapeuticsMD

 

– Reached definitive agreement to fully divest vitaCare business unit enabling greater focus on achieving leadership position in women’s healthcare –
– Amended credit terms with 
Sixth Street in support of a new capitalization plan –
– Conference call scheduled for 
8:30 a.m. ET today –

BOCA RATON, Fla.–(BUSINESS WIRE)–Mar. 10, 2022– 
TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the fourth quarter ended 
December 31, 2021.

“We spent the past three months executing on four key priorities set forth last quarter, and today we announced that we have accomplished two of them. With the definitive agreement to fully divest our vitaCare business unit, TXMD will emerge as a more focused company aimed at empowering women of all ages through better and affordable healthcare. Amending our credit terms is, in our view, the most prudent way to achieve the necessary financial flexibility to complete the announced sale of vitaCare and ultimately refinance our existing credit facility,” said Hugh O’Dowd, CEO of 
TherapeuticsMD.

“Demand for our flagship product, ANNOVERA®, continues to grow. We are working to ensure ample supply and drive towards uninterrupted access to this important contraceptive. We are excited about our future, and believe we are on a pathway towards serving women as they navigate their healthcare needs,” concluded O’Dowd.

Fourth Quarter 2021 Financial Results and Business Highlights

		Three Months ended
		December 31,
		2021		2020
Product revenue:
ANNOVERA		$ 7,831		$ 9,084
IMVEXXY		6,667		8,820
BIJUVA		2,680		2,244
Prescription vitamin		1,500		2,430
Product revenue, net		18,678		22,578
License revenue		—		—
Total revenue, net		$ 18,678		$ 22,578

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

• ANNOVERA net product revenue of 
  $7.8 million for the fourth quarter of 2021 decreased by 
  $1.3 million compared to 
  $9.1 million for the fourth quarter of 2020.
• Approximately 9,315 ANNOVERA prescriptions were dispensed to patients during the fourth quarter of 2021, an increase of 11% from the third quarter of 2021, and 57% from the fourth quarter of 2020.
• Over 10,750 healthcare providers (HCPs) prescribed ANNOVERA during the fourth quarter, of which nearly 1,300 were new writers.
  • Growth in prescribers of approximately 119% over fourth quarter of 2020.

IMVEXXY^® (estradiol vaginal inserts)

• IMVEXXY net product revenue of 
  $6.7 million for the fourth quarter of 2021 decreased by 
  $2.2 million compared to 
  $8.8 million for the fourth quarter of 2020.
• Approximately 109,300 IMVEXXY prescriptions were dispensed to patients during the fourth quarter of 2021.

BIJUVA^® (estradiol and progesterone) capsules

• BIJUVA net product revenue of 
  $2.7 million for the fourth quarter of 2021 increased by 
  $0.4 million compared to 
  $2.2 million for the fourth quarter of 2020.
• BIJUVA net product revenue for the fourth quarter of 2021 includes 
  $0.7 million of export sales through our international licensing and supply agreement with 
  Theramex HQ UK Limited.

Cost of Goods Sold and Gross Margin

• Cost of goods was 
  $4.7 million with product gross margin of 75% for the fourth quarter of 2022 compared to 
  $5.6 million with product gross margin of 75% for the fourth quarter of 2020.

Operating Expense, Net Loss and Related Information

• Total operating expense of 
  $49.3 million for the fourth quarter of 2021 decreased by 
  $2.3 million compared to 
  $51.6 million for the fourth quarter of 2020. Included in total operating expense for the fourth quarter of 2021 was 
  $5.1 million of severance related expenses recorded for a former executive. Without the executive severance, operating expense for the fourth quarter of 2021 would have been 
  $44.3 million, a decrease of 
  $7.3 million compared to the fourth quarter of 2020.
• Net loss for the fourth quarter of 2021 was 
  $43.0 million, or 
  $0.10 per basic and diluted share, compared to net loss for the fourth quarter of 2020 of 
  $42.1 million, or 
  $0.15 per basic and diluted share. Without the executive severance, net loss for the fourth quarter of 2021 would have been 
  $37.9 million, or 
  $0.09 per basic and diluted share.

Balance Sheet

• As of 
  December 31, 2021, the Company’s cash on hand totaled 
  $65.1 million, compared with 
  $80.5 million as of 
  December 31, 2020.
• For 2021, the Company received 
  $184.1 million in net proceeds from its at-the-market and underwritten equity offerings.
• As of 
  December 31, 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 2021.

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, March 10, 2022
Time:	8:30 a.m. ET
Telephone Access (US):	866-665-9531
Telephone Access (International):	724-987-6977
Access Code for All Callers:	6988467

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: 6988467.

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; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by such divestiture will be utilized; 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 and the company’s ability to refinance such facility; 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 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)
		As of  December 31,
			2021				2020
Assets:
Current assets:
Cash		$	65,122			$	80,486
Accounts receivable, net of allowance for credit losses of  $1,334 and  $1,118 as of December 31, 2021 and 2020, respectively			36,176				32,382
Inventory			7,622				7,993
Prepaid and other current assets			10,548				7,543
Total current assets			119,468				128,404
Fixed assets, net			1,199				1,942
License rights and other intangible assets, net			40,318				41,445
Right of use assets			8,234				9,566
Other non-current assets			253				253
Total assets		$	169,472			$	181,610
Liabilities and stockholders’ equity (deficit):
Current liabilities:
Current maturities of long-term debt		$	188,269			$	—
Accounts payable			20,318				21,068
Accrued expenses and other current liabilities			44,304				38,170
Total current liabilities			252,891				59,238
Long-term debt, net			—				237,698
Operating lease liabilities			8,063				8,675
Other non-current liabilities			2,139				—
Total liabilities			263,093				305,611
Commitments and contingencies
Stockholders’ deficit:
Preferred stock, par value  $0.001; 10,000 shares authorized, none issued			—				—
Common stock, par value  $0.001; 600,000 shares authorized, 429,886 and 299,765 issued and outstanding as of  December 31, 2021 and 2020, respectively			430				300
Additional paid-in capital			957,309				754,644
Accumulated deficit			(1,051,360	)			(878,945	)
Total stockholders’ deficit			(93,621	)			(124,001	)
Total liabilities and stockholders’ deficit		$	169,472			$	181,610

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited – in thousands, except per share data)
		Three Months ended
		December 31,								Year ended  December 31,
			2021				2020				2021				2020
Revenue:
Product revenue, net		$	18,678			$	22,578			$	85,780			$	62,872
License revenue			—				—				1,171				2,000
Total revenue, net			18,678				22,578				86,951				64,872
Cost of goods sold			4,737				5,581				18,838				15,975
Gross profit			13,941				16,997				68,113				48,897
Operating expenses:
Selling and marketing			22,002				25,996				108,195				117,052
General and administrative			25,911				23,214				92,602				76,954
Research and development			1,420				2,394				7,086				10,432
Total operating expenses			49,333				51,604				207,883				204,438
Loss from operations			(35,392	)			(34,607	)			(139,770	)			(155,541	)
Other (expense) income:
Interest expense and other financing costs			(7,576	)			(7,612	)			(32,917	)			(28,581	)
Other income, net			8				132				272				598
Total other (expense), net			(7,568	)			(7,480	)			(32,645	)			(27,983	)
Loss before income taxes			(42,960	)			(42,087	)			(172,415	)			(183,524	)
Provision for income taxes			—				—				—				—
Net loss		$	(42,960	)		$	(42,087	)		$	(172,415	)		$	(183,524	)
Loss per common share, basic and diluted		$	(0.10	)		$	(0.15	)		$	(0.43	)		$	(0.67	)
Weighted average common shares, basic and diluted			427,314				286,607				397,992				275,649

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited – in thousands)
		Year ended  December 31,
			2021				2020
Cash flows from operating activities:
Net loss		$	(172,415	)		$	(183,524	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			4,093				4,067
Charges to provision for doubtful accounts			533				238
Inventory charge			1,082				7,205
Debt financing fees			5,689				2,532
Share-based compensation			18,125				10,679
Other			720				2,673
Changes in operating assets and liabilities:
Accounts receivable			(4,327	)			(8,224	)
Inventory			(711	)			(3,337	)
Prepaid and other current assets			(3,005	)			3,209
Accounts payable			(750	)			1,887
Accrued expenses and other current liabilities			6,134				2,904
Other non-current liabilities			2,139				220
Total adjustments			29,722				24,053
Net cash used in operating activities			(142,693	)			(159,471	)
Cash flows from investing activities:
Payment of patent related costs			(2,189	)			(1,391	)
Purchase of fixed assets			(34	)			(207	)
Net cash used in investing activities			(2,223	)			(1,598	)
Cash flows from financing activities:
Proceeds from sale of common stock, net of costs			184,115				31,703
Proceeds from exercise of options and warrants			322				272
Proceeds from sale of common stock related to employee stock purchase plan			233				—
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			129,552				80,725
Net increase in cash			(15,364	)			(80,344	)
Cash, beginning of period			80,486				160,830
Cash, end of period		$	65,122			$	80,486
Supplemental disclosure of cash flow information:
Interest paid		$	25,068			$	25,849
Supplemental disclosure of noncash financing activities:
Warrants issued in relation to debt financing agreement		$	—			$	7,668

 

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

Lisa M. Wilson

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

Source: 
TherapeuticsMD, Inc.

Ceapro Signs Exclusive Long-Term Supply and Distribution Agreement with Leading Global Provider of Active Ingredients, Symrise

Research, News, and Market Data on Ceapro

 

– Symrise to distribute and commercialize Ceapro’s high value active ingredients in the cosmetic market –

– Supply and distribution agreement provides Symrise with exclusivity for several major key international customers in the cosmetic market –

EDMONTON, Alberta, March 10, 2022 (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 announced the signing of a long-term agreement with German-based multinational, Symrise AG, for the distribution and commercialization of Ceapro’s high value active ingredients to major key international players in the cosmetic market.

Under the agreement, Symrise is guaranteed to purchase minimum annual volumes of Ceapro’s high value active ingredients. Financial terms of the agreement were not disclosed.

“Symrise has been and will continue to be a valued, committed partner and we are very pleased to have renewed this agreement with them. This agreement not only provides security for our ongoing cosmeceuticals base business but also is expected to enable us to accelerate the growth of that base business through the potential to expand the list of exclusive customers to Symrise. We are delighted for the vote of confidence towards our Company and especially for the recognition of the quality and uniqueness of Ceapro’s products,” said Gilles Gagnon, President and CEO of Ceapro. “We are confident that our partnership with Symrise, one of the most respected player in our industry, will continue to equally aid in the achievement of our common goals” he added.

“Ceapro and Symrise have a long-standing relationship in product development that has benefitted both companies over the years,” said Joern Andreas, President Cosmetic Ingredients Division, Symrise AG. “We see great value in this partnership and are very pleased to have secured this agreement, which will continue to pave the way for future developments that I believe will benefit both companies in creating value.”

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.

About Symrise
Symrise is a global supplier of fragrances, flavors, food, nutrition and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. Headquartered in Holzminden, Germany, the Group is represented by more than 100 locations in Europe, Africa, the Middle East, Asia, the United States and Latin America. www.symrise.com

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

INVESTOR AND MEDIA CONTACT:
Jenene Thomas
Jenene Thomas Communications, LLC
T (US): 908-938-1475
E: jenene@jenenethomascommunications.com

Source: Ceapro Inc.

Ceapro Signs Exclusive Long-Term Supply and Distribution Agreement with Leading Global Provider of Active Ingredients, Symrise

Research, News, and Market Data on Ceapro

 

– Symrise to distribute and commercialize Ceapro’s high value active ingredients in the cosmetic market –

– Supply and distribution agreement provides Symrise with exclusivity for several major key international customers in the cosmetic market –

EDMONTON, Alberta, March 10, 2022 (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 announced the signing of a long-term agreement with German-based multinational, Symrise AG, for the distribution and commercialization of Ceapro’s high value active ingredients to major key international players in the cosmetic market.

Under the agreement, Symrise is guaranteed to purchase minimum annual volumes of Ceapro’s high value active ingredients. Financial terms of the agreement were not disclosed.

“Symrise has been and will continue to be a valued, committed partner and we are very pleased to have renewed this agreement with them. This agreement not only provides security for our ongoing cosmeceuticals base business but also is expected to enable us to accelerate the growth of that base business through the potential to expand the list of exclusive customers to Symrise. We are delighted for the vote of confidence towards our Company and especially for the recognition of the quality and uniqueness of Ceapro’s products,” said Gilles Gagnon, President and CEO of Ceapro. “We are confident that our partnership with Symrise, one of the most respected player in our industry, will continue to equally aid in the achievement of our common goals” he added.

“Ceapro and Symrise have a long-standing relationship in product development that has benefitted both companies over the years,” said Joern Andreas, President Cosmetic Ingredients Division, Symrise AG. “We see great value in this partnership and are very pleased to have secured this agreement, which will continue to pave the way for future developments that I believe will benefit both companies in creating value.”

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.

About Symrise
Symrise is a global supplier of fragrances, flavors, food, nutrition and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. Headquartered in Holzminden, Germany, the Group is represented by more than 100 locations in Europe, Africa, the Middle East, Asia, the United States and Latin America. www.symrise.com

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

INVESTOR AND MEDIA CONTACT:
Jenene Thomas
Jenene Thomas Communications, LLC
T (US): 908-938-1475
E: jenene@jenenethomascommunications.com

Source: Ceapro Inc.

TherapeuticsMD Announces Fourth Quarter 2021 Financial Results

Research, News, and Market Data on TherapeuticsMD

 

– Reached definitive agreement to fully divest vitaCare business unit enabling greater focus on achieving leadership position in women’s healthcare –
– Amended credit terms with 
Sixth Street in support of a new capitalization plan –
– Conference call scheduled for 
8:30 a.m. ET today –

BOCA RATON, Fla.–(BUSINESS WIRE)–Mar. 10, 2022– 
TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the fourth quarter ended 
December 31, 2021.

“We spent the past three months executing on four key priorities set forth last quarter, and today we announced that we have accomplished two of them. With the definitive agreement to fully divest our vitaCare business unit, TXMD will emerge as a more focused company aimed at empowering women of all ages through better and affordable healthcare. Amending our credit terms is, in our view, the most prudent way to achieve the necessary financial flexibility to complete the announced sale of vitaCare and ultimately refinance our existing credit facility,” said Hugh O’Dowd, CEO of 
TherapeuticsMD.

“Demand for our flagship product, ANNOVERA®, continues to grow. We are working to ensure ample supply and drive towards uninterrupted access to this important contraceptive. We are excited about our future, and believe we are on a pathway towards serving women as they navigate their healthcare needs,” concluded O’Dowd.

Fourth Quarter 2021 Financial Results and Business Highlights

		Three Months ended
		December 31,
		2021		2020
Product revenue:
ANNOVERA		$ 7,831		$ 9,084
IMVEXXY		6,667		8,820
BIJUVA		2,680		2,244
Prescription vitamin		1,500		2,430
Product revenue, net		18,678		22,578
License revenue		—		—
Total revenue, net		$ 18,678		$ 22,578

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

• ANNOVERA net product revenue of 
  $7.8 million for the fourth quarter of 2021 decreased by 
  $1.3 million compared to 
  $9.1 million for the fourth quarter of 2020.
• Approximately 9,315 ANNOVERA prescriptions were dispensed to patients during the fourth quarter of 2021, an increase of 11% from the third quarter of 2021, and 57% from the fourth quarter of 2020.
• Over 10,750 healthcare providers (HCPs) prescribed ANNOVERA during the fourth quarter, of which nearly 1,300 were new writers.
  • Growth in prescribers of approximately 119% over fourth quarter of 2020.

IMVEXXY^® (estradiol vaginal inserts)

• IMVEXXY net product revenue of 
  $6.7 million for the fourth quarter of 2021 decreased by 
  $2.2 million compared to 
  $8.8 million for the fourth quarter of 2020.
• Approximately 109,300 IMVEXXY prescriptions were dispensed to patients during the fourth quarter of 2021.

BIJUVA^® (estradiol and progesterone) capsules

• BIJUVA net product revenue of 
  $2.7 million for the fourth quarter of 2021 increased by 
  $0.4 million compared to 
  $2.2 million for the fourth quarter of 2020.
• BIJUVA net product revenue for the fourth quarter of 2021 includes 
  $0.7 million of export sales through our international licensing and supply agreement with 
  Theramex HQ UK Limited.

Cost of Goods Sold and Gross Margin

• Cost of goods was 
  $4.7 million with product gross margin of 75% for the fourth quarter of 2022 compared to 
  $5.6 million with product gross margin of 75% for the fourth quarter of 2020.

Operating Expense, Net Loss and Related Information

• Total operating expense of 
  $49.3 million for the fourth quarter of 2021 decreased by 
  $2.3 million compared to 
  $51.6 million for the fourth quarter of 2020. Included in total operating expense for the fourth quarter of 2021 was 
  $5.1 million of severance related expenses recorded for a former executive. Without the executive severance, operating expense for the fourth quarter of 2021 would have been 
  $44.3 million, a decrease of 
  $7.3 million compared to the fourth quarter of 2020.
• Net loss for the fourth quarter of 2021 was 
  $43.0 million, or 
  $0.10 per basic and diluted share, compared to net loss for the fourth quarter of 2020 of 
  $42.1 million, or 
  $0.15 per basic and diluted share. Without the executive severance, net loss for the fourth quarter of 2021 would have been 
  $37.9 million, or 
  $0.09 per basic and diluted share.

Balance Sheet

• As of 
  December 31, 2021, the Company’s cash on hand totaled 
  $65.1 million, compared with 
  $80.5 million as of 
  December 31, 2020.
• For 2021, the Company received 
  $184.1 million in net proceeds from its at-the-market and underwritten equity offerings.
• As of 
  December 31, 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 2021.

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, March 10, 2022
Time:	8:30 a.m. ET
Telephone Access (US):	866-665-9531
Telephone Access (International):	724-987-6977
Access Code for All Callers:	6988467

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: 6988467.

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; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by such divestiture will be utilized; 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 and the company’s ability to refinance such facility; 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 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)
		As of  December 31,
			2021				2020
Assets:
Current assets:
Cash		$	65,122			$	80,486
Accounts receivable, net of allowance for credit losses of  $1,334 and  $1,118 as of December 31, 2021 and 2020, respectively			36,176				32,382
Inventory			7,622				7,993
Prepaid and other current assets			10,548				7,543
Total current assets			119,468				128,404
Fixed assets, net			1,199				1,942
License rights and other intangible assets, net			40,318				41,445
Right of use assets			8,234				9,566
Other non-current assets			253				253
Total assets		$	169,472			$	181,610
Liabilities and stockholders’ equity (deficit):
Current liabilities:
Current maturities of long-term debt		$	188,269			$	—
Accounts payable			20,318				21,068
Accrued expenses and other current liabilities			44,304				38,170
Total current liabilities			252,891				59,238
Long-term debt, net			—				237,698
Operating lease liabilities			8,063				8,675
Other non-current liabilities			2,139				—
Total liabilities			263,093				305,611
Commitments and contingencies
Stockholders’ deficit:
Preferred stock, par value  $0.001; 10,000 shares authorized, none issued			—				—
Common stock, par value  $0.001; 600,000 shares authorized, 429,886 and 299,765 issued and outstanding as of  December 31, 2021 and 2020, respectively			430				300
Additional paid-in capital			957,309				754,644
Accumulated deficit			(1,051,360	)			(878,945	)
Total stockholders’ deficit			(93,621	)			(124,001	)
Total liabilities and stockholders’ deficit		$	169,472			$	181,610

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited – in thousands, except per share data)
		Three Months ended
		December 31,								Year ended  December 31,
			2021				2020				2021				2020
Revenue:
Product revenue, net		$	18,678			$	22,578			$	85,780			$	62,872
License revenue			—				—				1,171				2,000
Total revenue, net			18,678				22,578				86,951				64,872
Cost of goods sold			4,737				5,581				18,838				15,975
Gross profit			13,941				16,997				68,113				48,897
Operating expenses:
Selling and marketing			22,002				25,996				108,195				117,052
General and administrative			25,911				23,214				92,602				76,954
Research and development			1,420				2,394				7,086				10,432
Total operating expenses			49,333				51,604				207,883				204,438
Loss from operations			(35,392	)			(34,607	)			(139,770	)			(155,541	)
Other (expense) income:
Interest expense and other financing costs			(7,576	)			(7,612	)			(32,917	)			(28,581	)
Other income, net			8				132				272				598
Total other (expense), net			(7,568	)			(7,480	)			(32,645	)			(27,983	)
Loss before income taxes			(42,960	)			(42,087	)			(172,415	)			(183,524	)
Provision for income taxes			—				—				—				—
Net loss		$	(42,960	)		$	(42,087	)		$	(172,415	)		$	(183,524	)
Loss per common share, basic and diluted		$	(0.10	)		$	(0.15	)		$	(0.43	)		$	(0.67	)
Weighted average common shares, basic and diluted			427,314				286,607				397,992				275,649

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited – in thousands)
		Year ended  December 31,
			2021				2020
Cash flows from operating activities:
Net loss		$	(172,415	)		$	(183,524	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			4,093				4,067
Charges to provision for doubtful accounts			533				238
Inventory charge			1,082				7,205
Debt financing fees			5,689				2,532
Share-based compensation			18,125				10,679
Other			720				2,673
Changes in operating assets and liabilities:
Accounts receivable			(4,327	)			(8,224	)
Inventory			(711	)			(3,337	)
Prepaid and other current assets			(3,005	)			3,209
Accounts payable			(750	)			1,887
Accrued expenses and other current liabilities			6,134				2,904
Other non-current liabilities			2,139				220
Total adjustments			29,722				24,053
Net cash used in operating activities			(142,693	)			(159,471	)
Cash flows from investing activities:
Payment of patent related costs			(2,189	)			(1,391	)
Purchase of fixed assets			(34	)			(207	)
Net cash used in investing activities			(2,223	)			(1,598	)
Cash flows from financing activities:
Proceeds from sale of common stock, net of costs			184,115				31,703
Proceeds from exercise of options and warrants			322				272
Proceeds from sale of common stock related to employee stock purchase plan			233				—
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			129,552				80,725
Net increase in cash			(15,364	)			(80,344	)
Cash, beginning of period			80,486				160,830
Cash, end of period		$	65,122			$	80,486
Supplemental disclosure of cash flow information:
Interest paid		$	25,068			$	25,849
Supplemental disclosure of noncash financing activities:
Warrants issued in relation to debt financing agreement		$	—			$	7,668

 

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.

Cocrystal Pharma Initiates Enrollment in Phase 1 Influenza A Study with Novel, Broad-Spectrum, Orally Administrated Antiviral CC-42344

Research, News, and Market Data on Cocrystal Pharma

 

BOTHELL, Wash., March 10, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces dosing of the first subjects in a Phase 1 clinical trial of healthy adults evaluating its novel, broad-spectrum, orally administered antiviral CC-42344 for the treatment of pandemic and seasonal influenza A. The study is designed to assess the safety, tolerability and pharmacokinetics of CC-42344 with results expected later this year.

The randomized, double-blind, placebo-controlled Phase 1 study is expected to enroll up to 56 healthy adults at a single site in Australia. CC-42344 is an oral PB2 inhibitor that blocks an essential step of influenza viral replication and transcription. CC-42344 was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology.

“There is an urgent need for new antiviral medicines that address pandemic and drug-resistant seasonal influenza strains,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “CC-42344 specifically targets the PB2 protein of influenza polymerase complex and exhibits broad-spectrum antiviral activity including against Tamiflu- or Xofluza-resistant strains. In preclinical testing, CC-42344 has shown favorable pharmacokinetic and safety profiles. Advancing CC-42344 into clinical studies further validates our proprietary drug discovery platform technology.”

“Enrolling the first participants represents a significant milestone in advancing the development of CC-42344 for the treatment of this highly contagious viral infection that can have life-threatening complications,” added James Martin, Cocrystal’s CFO and co-interim CEO. “This study is the first of three first-in-human trials we expect to initiate in 2022, with the other two evaluating our novel antiviral therapeutic candidates for SARS-CoV-2.”

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

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our planned initiation of influenza A Phase 1 study in Australia in 2022 , and the potential of CC-42344 to treat seasonal and pandemic influenza The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from any future impact of the COVID-19 pandemic and the Russian invasion of Ukraine on the Australian and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our influenza A program, the ability of the contract research organization to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

Media Contact:
JQA Partners
917-885-7378
Jabraham@jqapartners.com

Source: Cocrystal Pharma, Inc.

Thursday, March 10, 2022

Item 9 Labs (INLB)
Begins Capital Raise; Closes on First Dispensary Acquisition

Item 9 Labs Corp. (OTCQX: INLB) is a vertically integrated cannabis operator and dispensary franchisor delivering premium products from its large-scale cultivation and production facilities in the United States. The award-winning Item 9 Labs brand specializes in best-in-class products and user experience across several cannabis categories. The company also offers a unique dispensary franchise model through the national Unity Rd. retail brand. Easing barriers to entry, the franchise provides an opportunity for both new and existing dispensary owners to leverage the knowledge, resources, and ongoing support needed to thrive in their state compliantly and successfully. Item 9 Labs brings the best industry practices to markets nationwide through distinctive retail experience, cultivation capabilities, and product innovation. The veteran management team combines a diverse skill set with deep experience in the cannabis sector, franchising, and the capital markets to lead a new generation of public cannabis companies that provide transparency, consistency, and well-being. Headquartered in Arizona, the company is currently expanding its operations space by 650,000+ square feet on its 50-acre site, one of the largest properties in Arizona zoned to grow and cultivate flower. For additional information, visit item9labscorp.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Capital Raise. Yesterday, Item 9 Labs announced the launch of its global, streamlined Regulation A, Tier 2 public offering for unaccredited and accredited investors. The Company is offering 28 million units, each comprised of one share and one-half of one warrant. Upon the exercise of all warrants, the offering has maximum proceeds of $67.2 million. The offering price is $1.40 per unit and the exercise price is $2.00 per warrant share.

To Fuel Growth.  The net proceeds of the offering will be used to fuel growth. Proceeds will be used to fund the Company’s retail dispensary acquisition strategy, for the potential acquisition of additional cultivation properties, and for working capital purposes. Assuming funds are raised, we believe this would be a net positive for Item 9 Labs as the additional capital would enable an acceleration …

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. 

Tonix Pharmaceuticals Announces Appointment of Jeffrey Rosenfeld, Ph.D., as Executive Director, Genomics and Bioinformatics

Research, News, and Market Data on Tonix Pharmaceuticals

 

CHATHAM, N.J., March 09, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Jeffrey Rosenfeld, Ph.D., as its new Executive Director, Genomics and Bioinformatics. In this role, Dr. Rosenfeld will direct Tonix’s pharmacogenomics efforts including applying artificial intelligence, genome-wide association studies and mathematical modeling techniques to the analysis of patient outcomes in Tonix’s clinical trials.

“Dr. Rosenfeld brings substantial genomics expertise to Tonix that will support our efforts in pharmacogenomics and companion diagnostics,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “As we continue to advance our pipeline and programs, Dr. Rosenfeld’s abilities and his passion for genomics will support the future success of our drug development efforts.”

“I am excited to join Tonix to lead the Company’s efforts to integrate genomics with clinical trials,” said Dr. Rosenfeld. “I look forward to working closely with the team to fully realize the potential of the Company’s deep portfolio of product candidates.”

Dr. Rosenfeld has a record of achievement in genomics and bioinformatics. Over his 15-year career in genomics, he has contributed to a wide range of biological and genetic projects, including genetic association studies of schizophrenia and clinical cancer genome sequencing. Most recently, he led an effort to investigate markers for autism in paternal sperm. For the past seven years, Dr. Rosenfeld has been an Assistant Professor of Pathology and Laboratory Medicine and the Manager of the Biomedical Informatics Shared Resource at the Rutgers Cancer Institute of New Jersey. In 2013, he founded Genome Liberty which developed tools for direct-to-consumer pharmacogenomics testing. Dr. Rosenfeld earned his B.S. in Biology and M.S. in Biotechnology from the University of Pennsylvania and a Ph.D. in Biology from New York University. He completed doctoral research at the Cold Spring Harbor Laboratory.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, central nervous system (CNS) and infectious disease product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including Tonix’s lead immunology candidate TNX-1500¹, which is a humanized monoclonal antibody targeting CD40 ligand being developed for the prevention of allograft rejection and the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to start in the second half of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL², (cyclobenzaprine HCl sublingual tablets), is a small molecule drug in mid-Phase 3 development for the management of fibromyalgia, with a new Phase 3 study expected to start in the first half of 2022. TNX-102 SL is also being developed to treat Long COVID, a chronic post-COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. TNX-1300³ is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first half of 2022. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Tonix’s lead vaccine program is TNX-801 (live horsepox virus for percutaneous administration) for preventing smallpox and monkeypox⁴. Horsepox is also the basis for Tonix’s recombinant pox vaccine (RPV) platform. Tonix’s lead vaccine candidates designed for COVID-19, TNX-1840 and TNX-1850⁵, are live virus vaccines in development based on the RPV platform. Finally, TNX-3500⁶ (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development.

¹TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
²TNX-102 SL is an investigational new drug and has not been approved for any indication.
³TNX-1300 is an investigational new biologic and has not been approved for any indication.
⁴TNX-801 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
⁵TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. TNX-1840 and TNX-1850 are designed to express the spike protein of SARS-CoV-2 from omicron and BA.2 variants, respectively, based on the experience from TNX-1800, which expresses the spike protein from the ancestral Wuhan strain.
⁶TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(212) 688-9421

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Ayala Pharmaceuticals to Present at the 32nd Annual Oppenheimer Healthcare Conference

Research, News, and Market Data on Ayala Pharmaceuticals

 

REHOVOT, Israel and WILMINGTON, Del., March 09, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today announced that it will present at the 32^nd Annual Oppenheimer Healthcare Conference, taking place on March 15-17, 2022. The company will also participate in one-on-one investor meetings at the conference.

Details on the presentation can be found below.

A webcast of the presentation will be available on the “Events and Presentations” section of the Ayala Pharmaceuticals website.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com  

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com

 

Lifeist Portfolio Company, Mikra, Begins Presales of CELLF™

Research, News, and Market Data on Lifeist Wellness

 

With a waitlist of over 40,000 subscribers, Mikra launches presale of innovative cellular therapeutic to help combat oxidative stress

TORONTO, March 09, 2022 (GLOBE NEWSWIRE) — Lifeist Wellness Inc. (“Lifeist” or the “Company”) (TSXV: LFST) (FRANKFURT: M5B) (OTCMKTS: NXTTF), a health-tech company that leverages advancements in science and technology to build breakthrough companies that transform human wellness, today announced a number of business updates regarding its wholly owned U.S. subsidiary, Mikra, Cellular Sciences Inc. (“Mikra”), including the commencement of presales in the U.S. for its novel cellular therapeutic compound, CELLF™, targeted at combating oxidative stress.

“Lifeist’s U.S. portfolio company Mikra is demonstrating meaningful momentum with today’s launch of presale activities for CELLF™, founded upon clear consumer research insight,” said Meni Morim, CEO of Lifeist. “We believe that Mikra has the real potential to help accelerate Lifeist’s path to profitability and value creation for shareholders, while simultaneously improving human health and wellness, and we fully support Faraaz and the team’s plan.”

Added Faraaz Jamal, COO of Lifeist and CEO of Mikra, “We are building a different type of biological sciences company. The real health crisis is not reduced longevity. Humans are living longer, but they’re not able to enjoy those extra years because they’re plagued with many chronic issues. But it’s so hard for us to evaluate longevity or health span because it requires lifetimes. Multi-omics data is the name of the game now – we’ve entered an era of precision medicine and wellness. For every product we launch, we look at how it affects you on a cellular level by mapping what gene expression pathways are triggered, positively and negatively. That way, we know that our product is actually affecting you positively at the most microscopic level: your cells.”

Mikra, Cellular Sciences has commenced its genomic and transcriptomic clinical trials to gather evidence for CELLF™ at a molecular and cellular level.

Lifeist recognizes Mikra’s potential to help accelerate the Company’s path to profitability and increasing its total addressable markets outside of Canada, through a predominantly subscription based product pipeline, differentiated through its transparent R&D pillar that pledges rigorous clinical testing, the sharing of test result data, and launching new and improved iterations of existing products. With this unique selling point, Mikra intends to drive consumer trust and capture share of a $105 billion U.S. nutraceutical market through clear distribution pathways both online and offline.

Lifeist has approved a budgetary allocation to Mikra of up to $8.5 million for the fiscal year 2022, subject to ongoing achievement of internal milestones governing each new product, and assuming reinvestment of all anticipated Mikra profits back into Mikra.

CELLF[1] Presale Commences

With a waitlist of over 40,000 subscribers and positive feedback at levels of testing, Mikra has launched presale of its innovative cellular therapeutic CELLF to help combat oxidative stress, which may manifest in symptoms such as systemic fatigue, inflammation, and brain fog.

Monthly subscriptions at www.wearemikra.com start at US$88.00 + applicable taxes, for a 30-day supply of 10ml single-serve sachets, with sales on Amazon USA targeted to commence shortly afterward. With respect to distribution in Canada, Mikra is in the process of obtaining a Natural Product Number (NPN) from Health Canada. Subject to NPN receipt, Mikra anticipates launching a Canadian retail distribution strategy in calendar Q3 2022.

Mikra’s Data-Driven Product Pipeline

Mikra subscribes to the mentality that nutraceuticals specifically meant to affect change at a cellular level should be more akin to how software and pharmaceutical companies continually improve and upgrade their products. To do so Mikra is partnering with precision clinical partners, commencing with InVivo Biosystems, to accurately evaluate CELLF on a cellular level and to better understand, with precision and speed, which human cellular pathways relate to healthy aging and performance. This insight will fuel CELLF’s data warehouse creating a pipeline of iterative and more effective versions of CELLF. Mikra intends to share publicly complete data on all trials related to CELLF, adhering to Mikra’s brand pillar of “Transparent R&D” ensuring a changelog for all subsequent versions of CELLF.

Complementing this transparent R&D approach, Mikra is in the process of establishing a scientific advisory group, composed of distinguished physicians and medical researchers to consult on CELLF iterations and new products in development.

As part of Mikra’s marketing activities, Mikra has concurrently issued a U.S. consumer facing press release found here.

About Lifeist Wellness Inc.

Sitting at the forefront of the post-pandemic wellness revolution, Lifeist leverages advancements in science and technology to build breakthrough companies that transform human wellness. Portfolio business units include: CannMart, which operates a B2B wholesale distribution business facilitating recreational cannabis sales to Canadian provincial government control boards; CannMart Labs, a BHO extraction facility for the production of high margin cannabis 2.0 products; the CannMart.com marketplace, which provides U.S. customers with access to hemp-derived CBD and smoking accessories; Australian Vapes, the country’s largest online retailer of vaporizers and accessories; Findify, a leading AI-powered search and discovery platform; and Mikra, a biosciences and consumer wellness company seeking to develop innovative therapies for cellular health.

Information on Lifeist and its businesses can be accessed through the links below:

www.lifeist.com
www.cannmart.com
www.australianvaporizers.com.au
www.wearemikra.com

Contacts

Lifeist Wellness Inc.
Meni Morim, CEO
Matt Chesler, CFA, Investor Relations
Ph: 647-362-0390
Email: ir@lifeist.com 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release or has in any way approved or disapproved of the contents of this press release.

Forward Looking Information

This news release contains “forward-looking information” within the meaning of applicable securities laws. All statements contained herein that are not historical in nature contain forward-looking information. Forward-looking information can be identified by words or phrases such as “may”, “expect”, “likely”, “should”, “would”, “plan”, “anticipate”, “intend”, “potential”, “proposed”, “estimate”, “believe” or the negative of these terms, or other similar words, expressions and grammatical variations thereof, or statements that certain events or conditions “may” or “will” happen.

The forward-looking information contained herein, including, without limitation, statements related to Mikra’s contribution to the Company’s anticipated path to profitability and value creation for shareholders, the anticipated therapeutic benefits of Mikra’s first product CELLF™, the anticipated budget allocated to Mikra’s development and the development of its products, the establishment of a scientific advisory group and the launch of Mikra’s Canadian retail strategy in the third quarter of this calendar year are made as of the date of this news release and is based on assumptions management believed to be reasonable at the time such statements were made, including, without limitation, that: pre-clinical trials will prove successful, the Company’s previously filed application for a patent will be granted, expectations that CELLF will gain market acceptance along with the expansion of the market for nutraceutical products, expectations that the allocated budget to Mikra will be sufficient to pursue its business strategy as anticipated and that future sales of Mikra’s products through a subscription based model is the appropriate sales model to contribute to the Company’s path to profitability, Mikra will be able to attract the distinguished medical personnel it seeks to consult on iterations of CELLF™ and new products in development, Mikra will obtain a Natural Product Number from Health Canada, in a timely manner, enabling Mikra to distribute products in Canada, management’s perceptions of the Company’s standing in the online marketplace for nutraceutical and well products, Lifeist’s beliefs regarding the expected demand for nutraceutical and wellness products and the expected growth of the nutraceutical market, the timing of product availability, as well as other considerations that are believed to be appropriate in the circumstances. While we consider these assumptions to be reasonable based on information currently available to management, there is no assurance that such expectations will prove to be correct. While we consider these assumptions to be reasonable based on information currently available to management, there is no assurance that such expectations will prove to be correct. By its nature, forward-looking information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this press release. Such factors include, without limitation: unforeseen developments that would delay Mikra’s ability to launch CELLF as anticipated and in a timely manner, the risk that preclinical trials are not as successful as anticipated and do not demonstrate the expected therapeutic benefits and/or fail to strengthen the Company’s patent claim, the risk that the expected demand for nutraceutical products in general and those of Mikra in particular does not develop as anticipated, the failure to convert the current number of subscribers on the pre-sales waitlist to actual sales, the inability to attract qualified physicians and medical researchers to consult on product development, the failure to obtain the requisite Natural Product Number from Health Canada resulting in Mikra not being able to distribute products in Canada, unforeseen budgetary constraints, redeployment of capital and/or Mikra’s failure to meet internal milestones governing the development of any new product, regulatory risk, risks relating to the Company’s ability to execute its business strategy and the benefits realizable therefrom and risks specifically related to the Company’s operations. Additional risk factors can also be found in the Company’s current MD&A and annual information form, both of which have been filed under the Company’s SEDAR profile at www.sedar.com. Readers are cautioned not to put undue reliance on forward-looking information. The Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

Source: Lifeist Wellness Inc.