Friday, August 12, 2022

Baudax Bio (BXRX)
Baudax Bio reports 2Q 2022; Headwinds Persist

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Baudax Bio, Inc. reported 2Q 2022 results yesterday.  While there was a revenue shortfall ($.3 million vs $.77 million expected), overall operating expenses of $7.8 million were below our estimate of $10.4 million due to lower severance costs primarily accrued in 1Q, and lower COGS and SG&A in 2Q, offset a bit by higher contingent consideration to Alkermes and a slight bump up in R&D from trial initiations. GAAP loss per share in 2Q was $(1.05) vs our expected $(1.27).

Feeling the impact of Covid.  Revenues came in light as Covid-related problems, including staffing shortages, continue to restrict usage at hospitals and ASCs, although 2Q hospital usage increased 12% as compared to 1Q 2022 and 2Q revenues increased 49% compared to the year ago period. Vials sold increased 67%. That said, in certain cases, procedure volumes are running as much as 50% below normal periods and are expected to not fully resolve until next year, at the earliest. An expected ramp in ANJESO is expected to be muted well into 2023….

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. 

Schwazze Announces Second Quarter Results

Research, News, and Market Data on Schwazze

Record Quarterly Revenue and Adjusted EBITDA

Revenue Increases 44% to $44.3 Million Compared to $30.7 Million
in Q2 2021

Adjusted EBITDA of $15 Million, 33.9% of Revenue

Revised Guidance Driven by Short-Term, Challenging Colorado
Market Conditions
Q4 2022 Projected Revenue Annualized Run Rate: $175 Million – $200 Million
Q4 2022 Projected Adjusted EBITDA Annualized Run Rate: $60 Million – $72
Million

Conference Call & Webcast Scheduled for Today – 5:00 pm EDT

DENVER, Aug. 11, 2022 /PRNewswire/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), today announced financial results for the second quarter ended June 30, 2022 (“Q2 2022”).

Q2 2022 Financial
Summary:

• Revenues of $44.3 million increased 44% compared to $30.7 million in second quarter ended June 30, 2021 (“Q2 2021”)
• Retail sales were $38.1 million up 77% when compared to Q2 2021
• Gross Margin of $25.2 million was up 69% compared to $14.9 million in Q2 2021, this quarter was affected by $0.2M in purchase accounting
• Net Income was $33.8 million compared to a Net Income of $4.4 million for the same period last year
• Adjusted EBITDA of $15 million was 33.9% of revenue, compared to $10 million for the same period last year
• Colorado two year stacked IDs for Q2 2022 compared to Q2 2021 and Q2 2020 for same store sales⁽¹⁾ were 1.8% and one year IDs⁽¹⁾ were (12.7%) comparing Q2 2022 to Q2 2021
• Average basket size ⁽¹⁾ for Q2 2022 was $59.98 down 4.1% compared to Q2 2021
• Recorded customer visits ⁽¹⁾ for Q2 2022 totaled 444,771 down 8.9%, compared to Q2 2021
• New Mexico two year stacked IDs for Q2 2022 compared to Q2 2021 and Q2 2020 for same store sales⁽¹⁾ were 41.0% and one year IDs⁽¹⁾ were 30.4% comparing Q2 2022 to Q2 2021
• Average basket size ⁽¹⁾ for Q2 2022 was $54.56 down 12.7% compared to Q2 2021
• Recorded customer visits ⁽¹⁾ for Q2 2022 totaled 209,591 up 49.4%, compared to Q2 2021

Accomplishments
Since December 2021, Schwazze has closed acquisitions adding 15 cannabis dispensaries, 10 in New Mexico and five in Colorado as well as four cultivation facilities in New Mexico and one in Colorado and one manufacturing asset in New Mexico.

• Closed Acquisition of Urban Health & Wellness Assets
• Listed Common Stock on the NEO Exchange
• Closed Acquisition of Brow 2 LLC Assets
• Closed Acquisition of Emerald Fields
• Added President of New Mexico Division
• Closed New Mexico Acquisition, Becoming a Regionally Focused MSO
• Added to Key Senior Leadership Team
• Closed Acquisition of Drift Assets

Justin Dye, Chairman and CEO of Schwazze stated
, “Similar to the rest of the country, the cannabis industry in
Colorado is also experiencing a slowdown in growth compared to the last couple
of years. Schwazze, however, is demonstrating that our regional strategy, built
on a customer first approach, developing significant scale, building brands and
leveraging data analytics and technology is not only sound but gaining momentum
as demonstrated by revenue and unit sales growth, customer loyalty and by once
again outpacing the legacy market growth by approximately 12%.  We believe
this model will travel well to other states as we find attractive
opportunities. Despite share price weakness driven by broader market
influences, we remain bullish on our business and have conviction that as
Schwazze continues to deliver superior operating results that our shareholders
will be rewarded.”

Justin continued, “As we look to
the future, we expect continued growth in Colorado and New Mexico through both
organic and inorganic means. Our operations continue to mature and gain
momentum, and we firmly believe that we are winning in our markets. Our team
will continue to focus on growing profitably and generating cash flow from
operations.  When positive federal legislation is passed, Schwazze will be
well-positioned as a market leader to take advantage of banking services and
institutional investment.”

Q2 2022 Revenue
Revenues for the three months ended June 30, 2022, totaled $44.3 million, including (i) retail sales of $38.1 million (ii) wholesale sales of $6.1 million and (iii) other operating revenues of $43,750, compared to revenues of $30.7 million, including (i) retail sales of $21.5 million, (ii) wholesale of $9.2 million, and (iii) other operating revenues of $16,844 during the three months ended June 30, 2021, representing an increase of $13.5 million or 44%. This increase was due to increased sale of our products as well as execution of our growth through acquisition initiatives. In the second quarter of 2022, the Company acquired one additional retail dispensary, which generated additional retail revenue. Additionally, recreational marijuana sales became legal in New Mexico in April 2022, which increased sales volume and revenues in New Mexico. Wholesale revenues in Colorado decreased due to increased cultivation capacity in the state resulting in an over-supply of wholesale cannabis materials.

Cost of goods and services for the three months ended June 30, 2022, totaled $19.1 million compared to cost of services of $15.8 million during the three months ended June 30, 2021, representing an increase of $3.3 million or 21%. The increase in cost of goods is driven by the increase in revenue, however not at the same rate. In the quarter, the Company experienced a reduction in costs driven by vertical integration and third-party price negotiations.

Gross profit increased to $25.2 million for Q2 2022 compared to $14.9 million during the same period in 2021. Gross profit margin increased as a percentage of revenue from 48.5% to 56.8%, and net of purchase accounting, the gross margin increased to 57.4%.  This positive result, net of purchase accounting continues to reflect our consolidated purchasing approach, the implementation of our retail playbook, and vertical product sales in New Mexico.

Operating expenses for the three months ended June 30, 2022, totaled $16.1 million, compared to operating expenses of $10.5 million during the three months ended June 30, 2021, representing an increase of $5.6 million or 54%. This increase is due to increased selling, general and administrative expenses, professional service fees, salaries, benefits, and related employment costs driven by growth from acquisitions.

Other income for the three months ended June 30, 2022, totaled $29.2 million compared to $0.2 million during the three months ended June 30, 2021, representing an increase in income of $29 million or 18,435%. The increase in other income is due to the revaluation of the derivative liability related to the Investor Notes, offset by higher interest payments.

The Company generated net income for the three months ended June 30, 2022, of $33.8 million, compared to net income of $4.4 million for the three months ended June 30, 2021.

Adjusted EBITDA for Q2 2022 was $15 million representing 33.9% of revenue, compared to $10 million and 32.6% of revenue for the same period last year. This is derived from Operating Income and adjusting one-time expenses, merger and acquisition and capital raising costs, non-cash related compensation costs, and depreciation and amortization. See the financial table for Adjusted EBITDA below adjustment for details. 

For six months ending June 30, 2022, the Company used cash for operations of ($8.0) million compared to generating cash of $1.4 million for the same period in 2021.  The Company has cash and cash equivalents of $33.9 million at the end of Q2 2022. 

Nancy Huber, CFO for Schwazze commented, ”
During Q2 we focused on completing integration of our acquisitions and
made sure that we used our resources effectively. We are focused on reducing
operating and SG&A expenses and judiciously investing growth capital to
ensure adequate liquidity and profitability despite difficult market conditions
in Colorado, which we believe to be transitory and temporary. Our balance sheet
remains strong, and we have ample liquidity.  We are focused on delivering
positive cash flow net of acquisition costs for the year while driving organic
growth and making smart acquisitions.”

2022 Guidance

The Company has revised its guidance for a fourth-quarter 2022 (Q4 2022) annualized run rate, which excludes transactions that are announced but not closed.  Q4 2022 revenue annualized run rate is projected to be $175 million to $200 million, and the Q4 2022 adjusted EBITDA annualized run rate is projected to be from $60 million to $72 million.  

Adjusted EBITDA represents income (loss) from operations, as reported, before
tax, adjusted to exclude non-recurring items, other non-cash items, including
stock-based compensation expense, depreciation, and amortization, and further
adjusted to remove acquisition and capital raise related costs, and other
one-time expenses, such as severance, retention, and employee relocation. The
Company uses adjusted EBITDA as it believes it better explains the results of
its core business. The Company has not reconciled guidance for adjusted EBITDA
to the corresponding GAAP financial measure because it cannot provide guidance
for the various reconciling items. The Company is unable to provide guidance
for these reconciling items because it cannot determine their probable
significance, as certain items are outside of its control and cannot be
reasonably predicted. Accordingly, a reconciliation to the corresponding GAAP
financial measure is not available without unreasonable effort.

Webcast – August 11,
2022 – 5:00 PM EDT
Investors and stakeholders may participate in the conference call by dialing 416 764 8650 or by dialing North American toll free 1-888-664-6383 or listen to the webcast from the Company’s website at https://ir.schwazze.com The webcast will be available on the Company’s website and on replay until August 18, 2022, and may be accessed by dialing 1-888-390-0541 / # 575833

Following their prepared remarks, Chief Executive Officer, Justin Dye and Chief Financial Officer, Nancy Huber will answer investor questions. Investors may submit questions in advance or during the conference call itself through the weblink: https://app.webinar.net/lwXbZbBZmKN  This weblink has been posted to the Company’s website and will be archived on the website. All Company SEC filings can also be accessed on the Company website at https://ir.schwazze.com/sec-filings

About Schwazze
Schwazze (OTCQX: SHWZ, NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious practices. Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking
Statements
Such forward-looking statements may be preceded by the words “plan,” “will,” “may,” “continue,” “anticipate,” “become,” “build,” “develop,” “expect,” “believe,” “poised,” “project,” “approximate,” “could,” “potential,” or similar expressions as they relate to Schwazze. Forward-looking statements include the guidance provided regarding the Company’s Q4 2022 performance and annual capital spending. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and New Mexico and outside the states, (vii) our ability to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, (x) the timing and extent of governmental stimulus programs, (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws, and (xii) our ability to achieve the target metrics, including our annualized revenue and EBIDTA run rates set out in our Q4 2022 guidance. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

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SOURCE Schwazze

Released August 11,
2022

Onconova Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update

News and Market Data on Onconova Therapeutics

Conference call and live webcast at 4:30 p.m. ET today

NEWTOWN, Pa., Aug. 11, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended June 30, 2022, and provided a business update.

Highlights for the second quarter of 2022 and recent weeks include:

• Safety data from the ongoing Phase 1 solid tumor trials of narazaciclib in the United States and China continue to be encouraging with the maximum tolerated dose not yet reached in either study. The trial in the United States is currently enrolling its fifth dose escalation cohort, with continuous dosing. The trial in China is also enrolling its fifth dose escalation cohort but once a day on days 1-21 of 28-day cycles. A protocol amendment to enable further dose escalation in the trial in China is being prepared.
• Data from 
  in
  vitro and cell-based assays that suggest narazaciclib’s inhibitory profile may provide safety and efficacy advantages over currently approved CDK4/6 inhibitors were featured in an abstract published at the American Society of Clinical Oncology (ASCO) Annual Meeting.
• Each of rigosertib’s investigator-sponsored trials continues to progress. A Phase 2 trial evaluating rigosertib plus pembrolizumab in patients with checkpoint inhibitor refractory metastatic melanoma is on schedule to be initiated in the second half of 2022. The expansion cohort of the Phase 1/2a trial of rigosertib plus nivolumab in patients with KRAS-mutated non-small cell lung cancer continues to enroll patients, with additional data from the trial expected in Q3 2022. The Phase 2 trial of rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa also continues to enroll patients.
• Mark Guerin was appointed Chief Operating Officer in addition to his role as Chief Financial Officer and Dr. Adar Makovski Silverstein was promoted to Senior Director and Head of Corporate Development.
• Cash and cash equivalents at June 30, 2022 were $46.5 million, which the Company believes will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Management Commentary

“We saw sustained progress across our pipeline over the past months and are well positioned to complete our current Phase 1 trials as we move through the second half of the year,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “Narazaciclib continues to show a favorable safety profile in its Phase 1 studies, which will be key to informing the design of future trials seeking to address the unmet needs posed by the limitations of currently available CDK4/6 inhibitors. These limitations stem from issues related to safety, tolerability, and primary and acquired drug resistance, which we believe narazaciclib’s differentiated inhibitory profile may overcome. We were pleased to publish preclinical data supporting this hypothesis at the most recent ASCO meeting and look forward to continued efforts to translate these promising findings to the clinic.”

Dr. Fruchtman continued, “Alongside narazaciclib’s advancement, we also made key progress in rigosertib’s investigator-sponsored studies. This includes a Phase 2 trial evaluating rigosertib combined with a PD-1 checkpoint inhibitor in checkpoint inhibitor refractory metastatic melanoma which is on schedule to open for enrollment in the second half of 2022. This study seeks to leverage rigosertib’s immunomodulatory effects and is supported by initial data from the ongoing trial of rigosertib plus anti-PD-1 therapy in KRAS-mutated NSCLC. These data provided strong evidence of the studied doublet’s activity in patients who previously failed checkpoint inhibitor therapy, which is a finding we aim to build upon with the presentation of additional data at a medical meeting later this quarter. Data has been presented, which will be updated, demonstrating that responses seen with rigosertib in this setting are agnostic to the type of KRAS mutation present. This upcoming milestone highlights how rigosertib’s investigator-sponsored studies enable the capital efficient pursuit of value creating opportunities to complement our lead narazaciclib program.”

Second Quarter Financial Results

Cash and cash equivalents as of June 30, 2022, were $46.5 million, compared with $55.1 million as of December 31, 2021. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Research and development expenses were $2.0 million for the second quarter of 2022, compared with $1.9 million for the second quarter of 2021.

General and administrative expenses were $2.1 million for the second quarter of 2022, compared with $2.9 million for the second quarter of 2021.

Net loss for the second quarter of 2022 was $4.0 million, or $0.19 per share on 20.9 million weighted shares outstanding, compared with a net loss of $4.2 million, or $0.27 per share for the second quarter of 2021 on 15.8 million weighted shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the second quarter of 2022, provide a business update, and answer questions. Interested parties can participate by dialing (800) 289-0571 (domestic callers) or (856) 344-9290 (international callers) and using conference ID 3600715.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.

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

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

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

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

Forward-Looking Statements

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

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680

ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200

bmackle@lifesciadvisors.com

ONCONOVA
THERAPEUTICS, INC.

Condensed
Consolidated Balance Sheets

(in
thousands)

ONCONOVA
THERAPEUTICS, INC.

Condensed
Consolidated Statements of Operations

(in
thousands, except share and per share amounts)

Lineage Cell Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update

Research, News, and Market Data on Lineage Cell Therapeutics

• Advanced RG6501 (OpRegen^®)
  Development in Partnership with Roche and Genentech
• Published OPC1 Phase 1/2a Clinical Study
  Results in Journal of Neurosurgery: Spine
• Completed Key Activities to Support Planned
  Regulatory Interactions for OPC1 and VAC2
• Expanded Collaboration with Advanced BioMatrix
  for HyStem^® Cell Drug Delivery Technology
• Cash, Cash Equivalents, and Marketable
  Securities of $72.0 Million as of June 30,
  2022 Expected to Provide Capital Through Q2 2024

CARLSBAD, Calif.–(BUSINESS WIRE)–Aug. 11, 2022– Lineage Cell
Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the second quarter of 2022. Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2022 financial and operating results and to provide a business update.

“We are pleased with the progress on RG6501 (OpRegen) product development under our collaboration with Roche and Genentech. During the second quarter this year, we have made progress across multiple functional areas, including clinical, regulatory, and technology transfer activities,” stated Brian M. Culley, Lineage CEO. “As we continue to position Lineage as a leader in regenerative medicine through the transplant of specific cell types, our focus is on completing the necessary clinical, regulatory and related activities which can create value and reduce risk across our portfolio of five cell transplant assets. In particular, our efforts have been focused on preparing for OPC1 and VAC2 regulatory interactions to enable their next phases of clinical testing in spinal cord injury and oncology, respectively. In parallel, we are advancing our auditory neuron and photoreceptor programs through preclinical development activities which are necessary to support initial clinical testing. We believe our disciplined use of capital and our increased strategic business development activities can support multiple years of growth and the achievement of important milestones in the months and years to come.”

Second quarter milestones and activities included:

– RG6501 (OpRegen)

• Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including:
  • Conducting additional OpRegen manufacturing runs and supporting Chemistry Manufacturing and Controls (CMC) activities.
  • Continuing technology transfer activities.
  • Actively participating in both Joint Advisory and Joint Manufacturing Committees, forums for discussion and planning with respect to next steps in clinical development and related activities.
• Continuing long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen:
  • Enrolled patients have continued to do well, supporting multi-year durability of a treatment effect with RG6501 (OpRegen).

– OPC1

• Results from a Phase 1/2a clinical study in subacute cervical spinal cord injury were 
  published in the 
  Journal of Neurosurgery: Spine;
  • OPC1 has demonstrated an excellent safety profile, and at one-year post-treatment, 96% of patients had recovered one or more levels of neurological function on at least one side of their body, and 32% of patients had recovered two or more levels of neurological function on at least one side of their body.
• Preclinical testing of a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process, has demonstrated functional recovery, improvement in gait coordination and motor performance with a reduction of the area of cavitation.
• A majority of the verification and validation activities for the novel parenchymal spinal delivery (PSD) system, and its preclinical testing in support of a regulatory submission have been completed.
• Preclinical activities to support upcoming regulatory interactions are near completion.
• Engagement with the California Institute of Regenerative Medicine (CIRM), as well as various patient advocacy organizations and patient advocates, is underway.

– VAC2

• Following technology transfer of the program from Cancer Research UK (CRUK) to Lineage and improvement of manufacturing processes, production scale was increased and accordingly the cost of goods has been reduced significantly, along with marked improvements in the purity and functionality of the manufactured material.
• CRUK continues to follow patients on the Phase 1 NSCLC clinical study; Lineage has received all necessary clinical information from CRUK required to support U.S., or other, regulatory interactions.

– ANP1 & PNC1

• Preclinical activities are continuing, including thought leader engagement to support future preclinical testing.

– Business Development

• Broadened collaboration with Advanced BioMatrix, a division of BICO Group AB (STO: BICO), for the HyStem delivery technology to include clinical/commercial GMP (Good Manufacturing Practice) material, increasing the milestone payments and royalty percentages due to Lineage upon ABM reaching certain development milestones and/or product sales.
• Continued work under our collaboration with our strategic partner, Immunomic Therapeutics (“ITI”); currently awaiting decision on next steps for ITI’s allogeneic cell-based cancer immunotherapy for the treatment of glioblastoma based on the VAC platform.

Some of the key upcoming milestones and activities anticipated
by Lineage include:

– Planned interaction with FDA in Q4 2022 to discuss an OPC1 IND amendment submission to enable clinical performance and safety testing of a novel PSD system.

– A pre-IND regulatory interaction in Q4 2022 to seek feedback on a VAC2 CMC, nonclinical, and clinical package to support U.S. clinical development; pre-IND briefing package submission in Q3 2022.

– Submission of a grant application to the California Institute for Regenerative Medicine (CIRM) for the continued support of the clinical development of OPC1.

– Clinical data update from the ongoing VAC2 Phase 1 non-small cell lung cancer (NSCLC) study, pending release from CRUK.

– Preclinical activities for both the ANP1 and PNC1 programs.

– Additional OPC1 publications, including preclinical study results utilizing a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process.

– An additional OPC1 manuscript from a Phase 1/2a clinical study in subacute cervical spinal cord injury, focused on MRI data.

– Evaluation of new partnership opportunities and/or expansion of existing collaborations.

– Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission and accomplishments.

Balance Sheet Highlights

Cash, cash equivalents, and marketable securities totaled $72 million as of June 30, 2022, which is expected to support operations through Q2 2024.

Second Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. Total revenues for the three months ended June 30, 2022 were approximately $4.6 million, a net increase of $4.0 million as compared to $0.5 million for the same period in 2021. The increase was primarily related to licensing fees recognized from deferred revenues in connection with the $50.0 million upfront licensing payment received in the first quarter of 2022 from Roche.

Operating Expenses: Operating expenses are comprised of research and development (“R&D”) expenses and general and administrative (“G&A”) expenses. Total operating expenses for the three months ended June 30, 2022 were $8.6 million, an increase of $1.1 million as compared to $7.5 million for the same period in 2021.

R&D Expenses: R&D expenses for the three months ended June 30, 2022 were $3.3 million, a net increase of $0.4 million as compared to $2.9 million for the same period in 2021. The net increase was driven by $0.1 million in higher OpRegen related expenses to support the Roche Collaboration. Another $0.2 million and $0.1 million of the increase was related to R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively.

G&A Expenses: G&A expenses for the three months ended June 30, 2022 were $5.3 million, a net increase of approximately $0.7 million as compared to $4.5 million for the same period in 2021. The increase was primarily attributable to $0.4 million in payroll and related benefits expense, and $0.5 million in share-based compensation, partially offset by $0.2 million in lower investor relations expense.

Loss from Operations: Loss from operations for the three months ended June 30, 2022 was $4.2 million, a decrease of $2.9 million as compared to $7.1 million for the same period in 2021.

Other Income/(Expenses), Net: Other income (expenses), net for the three months ended June 30, 2022 reflected other expense, net of ($2.5) million, compared to other income, net of $2.1 million for the same period in 2021. The net change was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries, as well as a decrease in the value of marketable equity securities, and partially offset by the gain on extinguishment of debt from Lineage’s Paycheck Protection Program loan forgiveness recognized in the prior year’s quarter.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended June 30, 2022 was $6.8 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $4.8 million, or $0.03 per share (basic and diluted), for the same period in 2021.

Conference Call and Webcast

Interested parties may access today’s conference call by dialing (800) 715-9871 from the U.S. and Canada and (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the “Lineage Cell Therapeutics Call” or provide conference ID number 6448886. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our ability to support our operations for at least two years with our existing cash, cash equivalents and marketable securities; our ability to create value and reduce risk across our portfolio; our ability to support multiple years of progress and achieve important milestones; our collaboration and license agreement with Roche and Genentech and the potential to receive milestone and other consideration thereunder; the potential benefits of treatment with OpRegen; the potential future achievements of our clinical and preclinical programs; the timing of anticipated FDA interactions, preclinical activities, clinical trials, and clinical data updates related to our programs, and the submission of a grant application to the CIRM; plans and expectations regarding publications relating to our programs; plans and expectations regarding potential new partnership opportunities and existing collaborations; our ability to broaden awareness of our mission and accomplishments; plans and expectations regarding our products in development. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that we do not successfully broaden awareness of our mission or accomplishments; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005126/en/

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

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

Source: Lineage Cell Therapeutics, Inc.