VBL Therapeutics Selected for €17.5 Million of Funding from Horizon Europe EIC Accelerator Program

On December 20, 2021 VBL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported that it has been selected for €17.5 million of blended funding by the European Innovation Council (EIC) Accelerator (Press release, VBL Therapeutics, DEC 20, 2021, View Source [SID1234597463]). The funding is comprised of a €2.5 million grant and an additional €15 million direct equity investment by the EIC.

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The EIC Accelerator is a prestigious competitive program of the European Commission, which offers grants combined with equity investments through the EIC Fund. In addition to financial support, all projects benefit from a range of Business Acceleration Services that provide access to leading expertise, corporates, investors and ecosystem actors.

"We are honored to have been selected in this prestigious and competitive program, where only nine percent of companies got funded, with only a small fraction of those in biopharma," said Dror Harats, M.D., Chief Executive Officer of VBL. "In selecting us for this grant and investment, we believe the EIC recognized the value proposition that ofra-vec (VB-111) potentially offers to patients and the high unmet need that exists in ovarian cancer. Ofra-vec offers a novel targeted gene based approach to the way cancer is treated, and if approved, can potentially address some of the key challenges in treating ovarian cancer and establish a new standard of care. We are grateful for the EIC’s support and alignment in our collective mission to improve the lives of patients with cancer."

The EIC Accelerator’s support comes at a pivotal time for VBL. VBL is nearing the completion of enrollment in the ongoing Phase 3 OVAL registration-enabling clinical trial of ofra-vec (VB-111) in ovarian cancer, with the top-line progression free survival (PFS) co-primary endpoint data readout expected in the second half of 2022. The funds from the EIC will be used to support clinical development, Chemistry Manufacturing and Controls (CMC), and pre-commercialization activities.

For more information about the EIC Accelerator, refer to View Source

Liver Cancer Patient Treated with Can-Fite’s Namodenoson Clears All Cancer
Lesions Under Open Label Extension of Phase II Study

On December 20, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported that the last patient treated under an Open Label Extension program of its concluded Phase II study of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer, experienced a Complete Response (CR) to Can-Fite’s drug, meaning that all cancer lesions have cleared (Press release, Can-Fite BioPharma, DEC 20, 2021, View Source [SID1234597461]).

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Under treatment with Namodenoson, the patient has now survived five years, during which time the clinical benefits of treatment have included the disappearance of ascites, normal liver function, and the disappearance of peritoneal carcinomatosis leading to complete clearance of all cancer lesions.

"Complete Response of HCC in an advanced stage is a rare but highly beneficial result in the field of liver cancer treatment. We are pleased that Namodenoson has contributed to the restored health and quality of life for this patient and family. It is our hope that our upcoming pivotal Phase III study will demonstrate Namodenoson’s efficacy in treating patients with similarly advanced HCC and thereby potentially offer longer survival to liver cancer patients across the world," stated Can-Fite’s Medical Director Dr. Michael Silverman.

In the first quarter of 2022, Can-Fite expects to commence patient enrollment in its pivotal Phase III trial for Namodenoson in the treatment of patients with advanced HCC with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. Both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have agreed with the design of the 471-patient study. Namodenoson has Orphan Drug Designation for HCC in the U.S. and Europe, has Fast Track Status in the U.S., and is currently treating liver cancer patients through a compassionate use program in Israel.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Subscriptions and Placing to raise £3.55 million; Sharing Agreement; to fund Investment in R&D pipeline • Company’s Partner Alora and two longstanding investors including Lanstead to participate at an Issue price of 11p – 80% premium to current share price

On December 20, 2021 ImmuPharma PLC (LSE AIM: IMM), the specialist drug discovery and development company, reported subscriptions and a placing to raise £3.55 million (the "Subscription(s)" and "Placing") through the issue of 32,272,727 new ordinary shares of 10 pence each in the Company ("Ordinary Shares") at a price of 11 pence per Ordinary Share ("Issue Price") utilising the maximum amount of existing authorities to allot shares. The Company has also entered into a sharing agreement ("Sharing Agreement") with Lanstead Capital Investors L.P. ("Lanstead|") (Press release, ImmuPharma, DEC 20, 2021, View Source [SID1234597460]).

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Highlights

Subscription for 10,909,091 new Ordinary Shares ("the Alora Subscription Shares") by Alora Pharmaceuticals LLC ("Alora"), the parent company of Avion Pharmaceuticals LLC ("Avion"), with whom the Company signed a licence and development agreement in November 2019 for the exclusive rights to Lupuzor in North America (United States), to raise £1.2 million (the "Alora Subscription").
Subscription for 20,000,000 new Ordinary Shares (the "Lanstead Subscription Shares") by Lanstead at an issue price of 11 pence per Subscription Share to raise £2.2 million (the "Lanstead Subscription").
Placing of 1,363,636 new Ordinary Shares ("Placing Shares") to raise £0.15 million (the "Placing").
The Issue Price represents a 80 per cent. premium to the closing mid-market price (of 6.1p) of the Ordinary Shares on 17 December 2021, the latest business date prior to the Subscriptions and Placing.
The £2.2 million gross proceeds of the Lanstead Subscription will be pledged by the Company pursuant to a Sharing Agreement with Lanstead. The Sharing Agreement, details of which are set out below, entitles the Company to receive back those proceeds on apro rata monthly basis over a period of 24 months, subject to adjustment upwards or downwards each month depending on the Company’s share price at the time. The monthly settlement amounts for the Sharing Agreement are structured to commence approximately two months (or earlier by agreement with Lanstead) following Admission. The Sharing Agreement provides the opportunity for the Company to benefit from positive future share price performance.
The Company has also agreed to issue to each of the Subscribers and Placees warrants (on the basis of 2 warrants for each 1 Subscription Share and Placing Share subscribed). The warrants are exercisable for 10 years at an exercise price of 11 pence, a 80 per cent. premium to the closing mid-market price (of 6.1p) of the Ordinary Shares on 17 December 2021. In total 64,545,454 warrants will be issued under the Subscriptions and Placing.
The proceeds of the Subscriptions, Placing and Sharing Agreement, will be used primarily to fund:
Investment into the Company’s R&D pipeline;
General working capital; and
Cash expenses associated with the Subscriptions, Placing and Sharing Agreement of c.£189k.
Commenting on the fundraising, Tim McCarthy, CEO of ImmuPharma said:

"Our corporate repositioning since the Board changes in August continues at a pace. These have been recognised by our long term shareholder Lanstead, a firm supporter of ImmuPharma since 2016. We are also delighted that our partner, Alora Pharmaceuticals has also recognised the shift in the Company’s investment and corporate proposition, supporting this fundraising at a significant premium to our current share price, together with Lanstead and another longstanding institutional investor. We as a team, remain committed to reaching key milestones over the next period. This includes taking our lead product, Lupuzor into its pivotal Phase 3 study in 2022, progressing our further late stage asset, CIDP, where we are now gaining interest from potential partners to expedite this program and also our earlier stage assets including BioAMB, within our anti-infective portfolio. We look forward to sharing further value enhancing newsflow over the next period."

Dr Tim Franklin, COO of ImmuPharma, added:

"Our partnership with Alora, a dynamic and fast-growing US company, continues to strengthen and their investment into this Subscription provides a new and exciting turning point for ImmuPharma. Operationally we can now unlock the value of our rich product portfolio. We are excited to be working ever more closely with Alora’s team as we move Lupuzor forward towards its Phase 3 clinical trial. Overall, our focus remains on bringing our two late-stage clinical assets, Lupuzor, and CIDP, closer to the market whilst progressing our earlier stage assets."

Art Deas, CEO of Alora and Avion, further commented:

"We met with ImmuPharma’s new management team very recently and were presented with the corporate re-positioning story, since the new Board was established in August. Our previous decision to support the Lupus study and our current decision to invest directly in ImmuPharma, is based on our view that its portfolio has a number of value rich assets which we believe have significant commercial potential. Our commitment to further develop Lupuzor remains our key focus. We are however, also very excited about the potential of the other programs in ImmuPharma’s portfolio."

Summary background to Avion Pharmaceutical’s licensing agreement with ImmuPharma

As previously announced on 28 November 2019, ImmuPharma and Avion signed an exclusive licence and development agreement and trademark agreement for Lupuzor to continue developing Lupuzor and commercialise the product in the US. ImmuPharma will receive milestone payments of up to $70 million. A $5 million milestone payment will be paid on regulatory approval of Lupuzor in lupus, and $65 million will be based on achievement of overall sales targets. ImmuPharma will also receive tiered double-digit royalties up to 17 percent according to pre-specified annual US sales targets. Avion will also have the right to explore clinical development for other auto-immune indications within US territories. Additional milestone payments of $5 million will be paid to ImmuPharma for each disease indication, outside of lupus, receiving regulatory approval.

Further information on the Alora Subscription and Placing

Alora Subscription

Following a meeting in the US in December between the new management team of ImmuPharma and Art Deas, Alora’s Founder & CEO, Alora confirmed that it would like to participate in this Subscription. This investment into ImmuPharma is based on the potential upside and future value creation of the key assets in ImmuPharma’s portfolio (including Lupuzor).

Alora is subscribing for 10,909,091 Subscription Shares to raise £1.2 million. In addition, Alora will receive 21,818,182 warrants.

The Alora Subscription is conditional, inter alia, on Admission.

The Alora Subscription Shares will be issued credited as fully paid and will rank pari passu in all respects with the Company’s existing issued Ordinary Shares.

Placing

In parallel, a further longstanding institutional shareholder in ImmuPharma was approached to gauge their interest in participating in the current funding round based on the current valuation and potential upside of the business over the next period. They too indicated their agreement in participating alongside Alora and Lanstead.

In connection with the Placing, the Company has today entered into the Placing Agreement ("Placing Agreement") pursuant to which Stanford Capital Partners Limited ("SCP") has agreed, in accordance with its terms, to use reasonable endeavours to procure subscribers for the Placing Shares. The Placing is not underwritten.

The Placing Agreement contains certain customary warranties given by the Company concerning the accuracy of information given in this announcement in respect of the Placing as well as other matters relating to the Group and its business. The Placing Agreement is terminable by SCP and SPARK Advisory Partners Limited ("SPARK") in certain customary circumstances up until the time of Admission, including, inter alia, should there be a breach of a warranty contained in the Placing Agreement which in the opinion of SPARK and SCP is material in the context of the Placing or a force majeure event takes place. The Company has also agreed to indemnify SCP and SPARK against all losses, costs, charges and expenses which SCP and SPARK may suffer or incur as a result of, occasioned by or attributable to the carrying out of its duties under the Placing Agreement.

1,363,636 Placing Shares will be issued to raise £150,000. In addition, the placee will receive 2,727,272 warrants.

The Placing Shares will be issued credited as fully paid and will rank pari passu in all respects with the Company’s existing issued Ordinary Shares.

The Placing is conditional, among other things, upon Admission to AIM becoming effective and the Placing Agreement not being terminated in accordance with its terms.

Further information on the Lanstead Subscription

Pursuant to the subscription agreement between the Company and Lanstead (the "Lanstead Subscription Agreement"), 20,000,000 new Ordinary Shares have today been allotted and will be issued to Lanstead at 11 pence per Lanstead Subscription Share for an aggregate subscription value of £2.2 million.

The Lanstead Subscription proceeds of £2.2 million will immediately following Admission be pledged to Lanstead under the Sharing Agreement under which Lanstead will then make, subject to the terms and conditions of that Sharing Agreement, monthly settlements (subject to adjustment upwards or downwards) to the Company over 24 months, as detailed below. As a result of entering into the Sharing Agreement, the aggregate amount received by the Company under the Lanstead Subscription and the Sharing Agreement may be more or less than £2.2 million, as further explained below. Notwithstanding the Subscription Price of 11 pence, shareholders should note that the share price of the Company needs to be on average over the 24 months of the Sharing Agreement at or above the Benchmark Price of 14.6667 pence per share for the Company to receive at least, or more than, the gross Subscription of £2.2 million.

The Lanstead Subscription Shares will be issued credited as fully paid and will rank pari passu in all respects with the Company’s existing issued Ordinary Shares.

Application has been made to the London Stock Exchange for admission of the Lanstead Subscription Shares to trading on AIM ("Admission"). The Lanstead Subscription is conditional, inter alia, on Admission and there being: (i) no breach of certain customary warranties given by the Company to Lanstead at any time prior to Admission; and (ii) no force majeure event occurring prior to Admission.

The Sharing Agreement

In addition to the Lanstead Subscription, the Company has entered into the Sharing Agreement, pursuant to which ImmuPharma will pledge the £2.2 million gross proceeds of the Lanstead Subscription to Lanstead. The Sharing Agreement will enable the Company to share in any share price appreciation over the Benchmark Price (as defined below). However, if the Company’s share price is less than the Benchmark Price then the amount received by the Company under the Sharing Agreement will be less than the gross proceeds of the Lanstead Subscription which were pledged by the Company to Lanstead at the outset.

The Sharing Agreement provides that the Company will receive 24 equal monthly settlement amounts (of £91,667) as measured against a benchmark share price of 14.6667 pence per Ordinary Share (the "Benchmark Price"). The monthly settlement amounts for the Sharing Agreement are structured to commence approximately three months (or earlier by agreement with Lanstead) following Admission.

If the measured share price (the "Measured Price"), calculated as the average of each day’s volume weighted share price ("VWAP") of the Company’s Ordinary Shares over a 20 day period prior to the monthly settlement date, exceeds the Benchmark Price, the Company will receive more than 100 per cent. of that monthly settlement due on a pro rata basis according to the excess of the Measured Price over the Benchmark Price. There is no upper limit placed on the additional proceeds receivable by the Company as part of the monthly settlements and the amount available in subsequent months is not affected. Should the Measured Price be below the Benchmark Price, the Company will receive less than 100 per cent. of the monthly settlement calculated on a pro rata basis and the Company will not be entitled to receive the shortfall at any later date. As such the final determination of the total amounts to be received under the Sharing Agreement will only be known after the 24 months have elapsed.

For example, if on a monthly settlement date the calculated Measured Price exceeds the Benchmark Price by 10 per cent., the settlement on that monthly settlement date will be 110 per cent. of the amount due from Lanstead on that date. If on the monthly settlement date the calculated Measured Price is below the Benchmark Price by 10 per cent., the settlement on the monthly settlement date will be 90 per cent. of the amount due on that date. Each settlement as so calculated will be in final settlement of Lanstead’s obligation on that settlement date.

Assuming the Measured Price equals the Benchmark Price on the date of each and every monthly settlement, ImmuPharma would receive aggregate proceeds of £2.2 million (before expenses) from the Lanstead Subscription and Sharing Agreement. Examples of the proceeds from the Sharing Agreement to be received each month, based upon varying levels of average share price in the month, are shown in the Appendix to this announcement.

The Company will pay Lanstead’s legal costs incurred in the Lanstead Subscription and in entering into the Sharing Agreement and, in addition, has agreed to issue to Lanstead 1,400,000 new Ordinary Shares ("Value Payment Shares") in connection with entering into the Sharing Agreement, together with warrants over 40 million Ordinary Shares with an exercise price of 11 pence per share. These warrants have an exercise period expiring on the tenth anniversary of Admission.

In no event will fluctuations in the Company’s share price result in any increase in the number of Lanstead Subscription Shares issued by the Company or received by Lanstead. The Sharing Agreement allows both Lanstead and the Company to benefit from future share price appreciation.

In total, Lanstead will be issued with 20,000,000 new Ordinary Shares pursuant to the Lanstead Subscription which, when issued, will equate (together with the Value Payment Shares) to approximately 7.5 per cent of the Company’s enlarged issued share capital following the Placing and the Subscriptions.

No shares, warrants or additional fees are owed to Lanstead at any point during this agreement other than those disclosed above.

The Sharing Agreement is similar to those undertaken by the Company with Lanstead in February 2016, June 2019 and March 2020. The first two of these arrangements have completed their settlement periods. The February 2016 agreement yielded a net gain to ImmuPharma of approximately £0.6 million more than originally subscribed by Lanstead and the June 2019 agreement yielded approximately £0.9 million less than originally subscribed by Lanstead. The third arrangement runs to June 2022 and is currently yielding approximately £0.6 million less than the pro rata amount originally subscribed by Lanstead on cumulative settlements to date.

The Directors believe that the Sharing Agreement provides a number of benefits to the Company and its shareholders including: the certainty of additional investment, albeit the quantum is dependent on the Company’s share price; the opportunity to benefit from positive future share price performance; and that the amount of shares issued is fixed, together with the cost of their issue.

Related Party Transactions

Lanstead is a shareholder in the Company, and is interested in 14,182,329 Ordinary Shares (representing 5.67% of the current issued share capital). Until 31 December 2020 Lanstead was a substantial shareholder, therefore the participation by Lanstead in the Lanstead Subscription and Sharing Agreement constitute related party transactions under the AIM Rules for Companies.

Lanstead Subscription and Sharing Agreement

The Directors (all of whom are independent of Lanstead), having consulted with SPARK, the Company’s nominated adviser, consider that the terms of the Lanstead Subscription and the Lanstead Sharing Agreement are fair and reasonable insofar as the Company’s shareholders are concerned.

Other Share Issues

The Company has issued 90,909 and 1,000,000 new Ordinary Shares ("Fee Shares") at an issue price of 11 pence per share to SPARK and SCP respectively, in lieu of fees. The Fee Shares will be issued credited as fully paid and will rank pari passu in all respects with the Company’s existing issued Ordinary Shares.

Application for admission to trading on AIM, and expected date of Admission

Application has been made for the the Lanstead Subscription Shares, the Alora Subscription Shares, the Placing Shares, the Value Payment Shares and the Fee Shares to be admitted to trading on the AIM market of the London Stock Exchange. It is anticipated that Admission to AIM will occur at 8.00am on or around 23 December 2021.

Total Voting Rights

Following Admission, the Company’s issued share capital will comprise 284,984,933 Ordinary Shares with one voting right each. As the Company does not hold any shares in Treasury, the total number of voting rights in the Company is also 284,984,933 and this figure of Ordinary Shares may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the share capital of the Company under the FCA’s Disclosure Guidance and Transparency Rules.

The allotment of the Lanstead Subscription Shares, the Alora Subscription Shares, the Placing Shares, the Value Payment Shares and the Fee Shares is being made pursuant to existing authorities to allot shares and other relevant securities and to disapply pre-emption rights under section 551 of the Companies Act 2006, which the Directors were given at the Company’s Annual General Meeting held on 28 June 2021.

L1 and Lind Convertible Security Deeds

On 15 December 2021, ImmuPharma repaid in full the remaining outstanding balance of $950,000 (plus accrued interest) due to L1 Capital Global Opportunities Master Fund ("L1"). The Company confirms that both convertible security deeds with L1 and Lind Global Macro Fund, LP ("Lind") have now been repaid in full and/or converted.

About Lanstead

Lanstead is an institutional investor that since 2007 has provided funding for ongoing business objectives to listed small and mid-cap growth companies. Lanstead focuses on equity investments in listed companies with management teams with a clear growth strategy.

Lanstead’s extensive experience allows it to invest in most industries, focusing on providing supportive, longer-term capital that rewards company growth. Companies with Lanstead on the shareholder register via an equity placement to Lanstead with an accompanying sharing agreement benefit from a unique and flexible approach to finance growth. This provides the opportunity for companies to benefit from additional cash beyond the original placing proceeds without having to issue additional shares.

Cellesce Appoints New CEO

On December 20, 2021 Cellesce reported the promotion of Vicky Marsh-Durban as the company’s first full time CEO (Press release, Cellesce, DEC 20, 2021, View Source [SID1234597459]). Vicky joined Cellesce in 2019 as Lead Scientist and was promoted to COO and the Board in Jan ’21.

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Victoria Marsh Durban

Vicky completed her Ph.D. at Cardiff University in 2008 in the field of cancer genetics. Subsequently she moved to University of California, San Francisco (UCSF), where she held a post-doctoral research scholarship investigating targeted therapeutic approaches in malignant melanomas. In 2014 she was enticed back to Cardiff to take up a Research Fellowship at the European Cancer Stem Cell Research Institute. In 2016 Vicky joined ReNeuron in her first commercial role, as Principal Investigator and Head of Cell Biology.

Vicky has played a vital role in helping the Company to make significant commercial and scientific progress despite the challenges of the CV-19 global pandemic and we are all excited that she will now take full responsibility for running the company as it enters the next phase of its development.

At the same time Paul Jenkins will be stepping down from the Board. Paul has made an invaluable contribution to Cellesce and the Board would like to place on record its thanks for all his hard work over the last 2 years. We are delighted that he will continue to support the Company in a consultancy capacity going forward.

Lineage Establishes Exclusive Worldwide Collaboration With Genentech for the Development and Commercialization of OpRegen® RPE Cell Therapy for the Treatment of Ocular Disorders

On December 20, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), reported that Lineage and its subsidiary, Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Roche and Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA) (Press release, Lineage Cell Therapeutics, DEC 20, 2021, View Source [SID1234597458]).

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Genentech will assume responsibility for further clinical development and commercialization of Lineage’s OpRegen program, which currently is being evaluated in a Phase 1/2a open-label, dose escalation clinical safety and efficacy study in patients with advanced dry AMD with GA. Under the terms of the collaboration agreement, Lineage will complete activities related to the ongoing clinical study, for which enrollment is complete, and perform certain manufacturing activities. Genentech will pay Lineage a $50 million upfront payment and Lineage is eligible to receive up to $620 million in additional development, approval and sales milestone payments, in addition to tiered double- digit royalties.

"Genentech is a clear global leader in ophthalmology and has demonstrated a longstanding commitment to patients, innovative research and successful product development," said Brian M. Culley, Lineage’s CEO. "Their desire to combine our cell therapy technology with their ophthalmology expertise and capabilities will help advance the OpRegen program more rapidly and we believe successfully to patients with serious ocular disorders, such as dry age-related macular degeneration. Lineage’s objective is to pioneer a new branch of regenerative medicine, based on transplanting whole cells into the body to restore activity lost to aging, injury or disease. We believe the results we have demonstrated to date with OpRegen represent a paradigm change many did not believe possible with cell therapy, by restoring retinal tissue and potentially halting or reversing the expansion of geographic atrophy. I am incredibly proud of what the Lineage team has accomplished with the OpRegen program and look forward to joining forces with the Genentech team as they work to take this program to the next level and potentially to patients in need of treatment."

Mr. Culley continued, "Looking ahead, Lineage will remain focused on advancing our spinal cord injury and oncology programs as well as announcing new disease settings where we plan to deploy our technology, either on our own or through strategic alliances. All of us at Lineage are immensely proud to have the opportunity and responsibility to advance a new and exciting branch of medicine, and our aim is to make a profound impact on the patients who serve as our inspiration."

"Genentech has a longstanding commitment to discovering and developing novel drugs for the treatment of serious eye disorders such as with advanced dry AMD with GA, which is one of our focus areas within ophthalmology," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "We are excited to partner with Lineage Cell Therapeutics to advance potential new therapies in an area of high unmet medical need."

Conference Call Information

Lineage will host a live conference call and webcast today beginning at 8 a.m. ET to discuss the collaboration with the Roche Group and Genentech. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". 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 December 27, 2021, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 5174206.

About OpRegen

OpRegen has been developed in part through contributions and financial grants made by Hadasit Medical Research Services and Development Ltd. ("Hadasit") and the Israeli Innovation Authority (the "IIA"). Lineage is obligated to pay a portion of upfront, milestone and royalty payments it receives to Hadasit and the IIA. OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events related to OpRegen or study procedures that have not been previously reported.