On March 22, 2022 Nuvectis Pharma, Inc (NASDAQ: NVCT), ("Nuvectis" or the "Company") is a biopharmaceutical company focused on the development of precision medicines for serious conditions of unmet medical need in oncology reported its financial results for the fiscal year 2021 and provided an update on recent business progress (Press release, Nuvectis Pharma, MAR 22, 2022, View Source [SID1234610596]).

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"We founded Nuvectis with the goal of becoming a leading biopharmaceutical company focused on the development of innovative treatments for people suffering from serious conditions in oncology for which the prognosis is poor and there are very limited treatment options, and we believe that we are on our way to achieving that," said Ron Bentsur, Chairman and Chief Executive Officer. Mr. Bentsur continued, "2021 was a very exciting year for Nuvectis," "In 2021, we completed two exclusive world-wide licensing deals to develop and commercialize our first two drug candidates, and with our recently completed initial public offering, we are now poised to continue to advance our pipeline.

Mr. Bentsur added, "We are particularly pleased with the recent commencement of the Phase 1 study for NXP800, our potentially first-in-class Heat Shock Factor 1 ("HSF1") pathway inhibitor, and with the progress of NXP900, our selective Proto-oncogene c-Src ("SRC") SRC/YES1 kinase inhibitor. 2022 is expected to be another exciting year for Nuvectis as we look forward to reporting additional data during the year. Importantly, we remain cash prudent, effectively managing our cash position with an emphasis towards value creation activities."

2021 and Recent Highlights

NXP800

We commenced a Phase 1 study for NXP800, an HSF1 pathway inhibitor, which will have two parts: a dose-escalation Phase 1a, initiated in December 2021, which will be followed by an expansion Phase 1b. In the Phase 1a, the safety and tolerability of NXP800 will be evaluated in patients with advanced solid tumors to identify a dose and dosing schedule for the Phase 1b. In the Phase 1b, the safety and preliminary anti-tumor activity of NXP800 will be evaluated in biomarker-selected patients, initially in ovarian clear cell carcinoma and ovarian endometrioid carcinoma, two unmet medical needs.

NXP900

We began Investigational New Drug ("IND")-enabling studies for NXP900, a novel selective SRC/YES1 inhibitor, in the fourth quarter of 2021. To date, several in-vivo preclinical studies have been conducted with NXP900 in triple negative breast cancer with promising results. Nuvectis is currently conducting in vivo studies with NXP900 in various other tumor types to potentially identify additional cancers of focus for future clinical trials. Nuvectis intends to complete the IND-enabling studies for NXP900 in 2022.

Initial Public Offering on Nasdaq Capital Market

We completed our initial public offering ("IPO") in February 2022, raising $16M in gross proceeds.

Full Year 2021 Financial Results

Cash, cash equivalents and short-term investments were $5.7 million as of December 31, 2021, compared to zero as of December 31, 2020. This does not include the $16.0 million in gross proceeds from the Company’s IPO, completed in February 2022.

Research and development expenses were $9.6 million for the year ended December 31, 2021, including $0.9 million of non-cash equity-based compensation expense and $7.0 million of one-time upfront payments made in connection with our world-wide license agreements for NXP800 and NXP900.

General and administrative expenses were $3.3 million for the year ended December 31, 2021, including $1.0 million of non-cash equity-based compensation expense.

The Company’s net loss was $12.9 million for the year ended December 31, 2021, which included $1.9 million of non-cash equity-based compensation expense and the $7.0 million of one-time upfront payments made in connection with our world-wide license agreements for NXP800 and NXP900.

Management Changes

We are pleased to announce that Michael Carson, who recently joined Nuvectis as Vice President of Finance, is replacing Uri Ben-Or who served as our Interim Chief Financial Officer. Mr. Carson comes to Nuvectis with comprehensive experience in finance, accounting and audit at companies including Abbott Laboratories, Neuronetics, Smiths Medical, and most recently as the Vice President of Finance at Xylocor Therapeutics. Prior to entering private industry, Mr. Carson worked for public accounting firms Deloitte and Crowe in their assurance practices. He is a licensed Certified Public Accountant and holds degrees in Mechanical Engineering and Accounting from Lafayette College. "I believe Michael’s expertise in the life sciences industry, including recent small-company experiences, makes him an ideal fit to help us deliver long-term value to our shareholders", said Mr. Bentsur. "Additionally, I want to thank Uri for his service to the company over the last several months, which included the IPO process.

On March 22, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) and Incyte (Nasdaq: INCY) reported that the Swiss agency for therapeutic products (Swissmedic), has granted temporary approval for Minjuvi (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy including an anti-CD20 antibody, who are not eligible for autologous stem cell transplant (ASCT) (Press release, MorphoSys, MAR 22, 2022, View Source [SID1234610594]). Incyte holds exclusive commercialization rights for Minjuvi in Switzerland.

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"The approval of Minjuvi by Swissmedic is excellent news," said Jonathan Dickinson, Executive Vice President and General Manager, Incyte Europe. "There are a substantial number of people living with relapsed or refractory DLBCL in Switzerland and we’re pleased to be able to offer them a new treatment option."

"DLBCL is a fast-growing cancer and can be very hard to treat. Up to 40% of DLBCL patients either relapse after they have been treated or don’t respond to initial treatment at all," said Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys. "Minjuvi addresses this unmet need and its approval in Switzerland is a crucial milestone for these patients."

The approval is based on the results from the L-MIND study evaluating the safety and efficacy of tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed a best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 43.9 months after a minimum follow up of 35 months (secondary endpoint). Tafasitamab together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable.ii

Incyte and MorphoSys share global development rights to tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the U.S. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi (tafasitamab-cxix) in the U.S., and is marketed by Incyte under the brand name Minjuvi in Europe, the UK and Canada.

About Diffuse Large B-Cell Lymphoma
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all casesiii. Each year around 16,000 patients in Europe are diagnosed with relapsed or refractory DLBCLiv,v,vi. The condition is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organsvii. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafterviii,ix,x,xi.

About L-MIND

The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HDC) or autologous stem cell transplant (ASCT). The study’s primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.

For more information about L-MIND, visit View Source

About Minjuvi (tafasitamab)
Tafasitamab is a humanized Fc-modified CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in Europe, the UK and Canada.

XmAb is a registered trademark of Xencor, Inc.

On March 22, 2022 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT) is a leading commercial cell-engineering company reported that focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization (Press release, MaxCyte, MAR 22, 2022, View Source [SID1234610593]). The Company reported fourth quarter and full year ended December 31, 2021 financial results and provided initial 2022 revenue guidance.

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Fourth Quarter and Year Highlights

Record quarterly revenue of $10.2 million up 19% over Q4 2020 was driven by strength in the core business; with growth in core business revenue from cell therapy customers of 43% and drug discovery customers of 32%.
Record full-year total revenue of $33.9 million, up 30% over 2020, which was driven by total growth in core business revenues of 37%. We generated a total of $2.5 million in SPL Program-related revenue for the full year 2021.
2022 initial guidance includes expectations for core revenue growth of 22% to 25% over 2021 and SPL Program-related revenue of approximately $4 million.
Conference call begins at 4:30 p.m. Eastern time today.
"We are pleased to report very strong fourth quarter and full year results driven by ongoing strength in sales to cell therapy customers," said Doug Doerfler, President and CEO of MaxCyte. "2021 was an excellent year at MaxCyte, as we completed our Nasdaq listing and made important and strategic investments in our business, which are ongoing. We continue to expand our customer base and increase the number of strategic partnerships, now with 16 SPL agreements in place following the announcement of our agreement with Intima Bioscience in February 2022. Overall, MaxCyte remains well-positioned to support growing adoption of the ExPERT platform technology for cellular-based research and next-generation therapeutic development."

The following table provides details regarding the sources of our revenue for the periods presented.

Three Months Ended Year Ended
December 31,
(Unaudited) December 31,
(Unaudited)
2021 2020 % 2021 2020 %
(in thousands, except percentages)
Cell therapy $ 7,264 $ 5,072 43 % $ 22,984 $ 15,769 46 %
Drug discovery 2,885 2,191 32 % 8,395 7,143 18 %
Program-related 3 1,252 (100 )% 2,515 3,257 (23 )%
Total revenue $ 10,152 $ 8,515 19 % $ 33,894 $ 26,169 30 %
Operational Highlights

With the addition of Myeloid Therapeutics, Inc., Celularity, Inc., Sana Biotechnology, Inc., and Nkarta, Inc. signed in 2021, and Intima Bioscience signed in early 2022, the total number of Strategic Platform Licenses (SPLs) signed with our cell therapy partners now stands at 16.
Our 16 active SPL partner agreements now allow an aggregate of over 95 potential programs; over 15% of these have entered in the clinic (defined as programs as with at least a cleared IND, or equivalent). If all allowed programs successfully progress though the clinic to commercial approval, we have the potential to generate pre-commercial milestones of over $1.25 billion before potential sales-based commercial revenue to MaxCyte. This compares to the update from the prior year (January 2021) of 12 SPLs covering over 75 programs (with total potential pre-commercial milestones exceeding $950 million), over 15% of which had entered the clinic.
We closed 2021 with over 500 instruments placed with customers, compared to over 400 instruments as of the end of 2020.
We successfully released the VLx under our ExPERT platform, our large-scale Flow Electroporation platform under the ExPERT brand; we have seen strong initial interest from prospects in using the VLx for large-scale bioprocessing applications.
Dr. Cenk Sumen, Ph.D. recently joined our team as Chief Scientific Officer. Dr Sumen was previously CTO at Stemson Therapeutics and holds a Ph.D. in Microbiology and Immunology from Stanford University, completed his post-doctoral training at Harvard and a fellowship at the Cancer Research Institute and worked at Memorial Sloan Kettering Cancer Center under Nobel Laureate Dr. Jim Allison.
We also launched three new processing assemblies (our single-use disposables), the R50x3, the R50x8 and the G1000, which were directly targeted to both research and GMP customer needs and contributed to our growth in fiscal 2021; particularly in the fourth quarter.
Finally, we are on track to move into our new corporate headquarters facility in 2022, which includes new office space, expanded applications and process development lab facilities, and more than tripling of our manufacturing space.
As of the dates presented, our key metrics described above were as follows:

As of December 31,
2021 2020* 2019
Installed base of instruments (sold or leased) >500 >400 >320
Number of active SPLs 15 12 8
Total number of licensed clinical programs (SPLs only) >95 >75 >55
Total number of licensed clinical programs under SPLs currently in the clinic ** >15% >15% >5%
Total potential pre-commercial milestones under SPLs >$1.25 billion >$950 million >$650 million
* Amounts presented as of December 31, 2020, give effect to one SPL entered into and additional INDs cleared in January 2021.

** Number of licensed clinical programs under SPLs are by number of product candidates and not by indication.

Fourth Quarter and Full Year 2021 Financial Results

Total revenue for the fourth quarter of 2021 was $10.2 million, compared to $8.5 million in the fourth quarter of 2020, representing growth of 19%. Revenue from cell therapy customers were collectively up 43% before program-related revenues compared to the same period last year.

Our SPL partners did not achieve any milestone events in the fourth quarter and thus there was no SPL Program-related revenue in the quarter, as compared to $1.3 million in SPL Program-related revenue in the fourth quarter of 2020.

Gross profit for the fourth quarter of 2021 was $8.9 million (88% gross margin), compared to $7.6 million (89% gross margin) in the same period of the prior year. The decrease in gross margin was driven by the lower SPL Program-related revenues; excluding SPL Program-related revenues, gross margin was relatively unchanged.

Operating expenses for the fourth quarter of 2021 were $13.9 million, compared to operating expenses of $10.0 million in the fourth quarter of 2020. The overall increase in operating expenses was primarily driven by increased headcount across all areas of the business and an increase in stock-based compensation.

Fourth quarter 2021 net loss was $4.9 million compared to net loss of $2.7 million for the same period in 2020; EBITDA, a non-GAAP measure, was a loss of $4.5 million for the fourth quarter 2021, compared to a loss of $2.3 million for the fourth quarter of prior year; stock-based compensation expense was $2.4 million versus $0.8 million for the same period in the prior year.

Full Year Financial Results

Total revenue for 2021 was $33.9 million, compared to $26.2 million in 2020, representing growth of 30%. The increase was primarily driven by growth in sales and licenses of instruments and sales of disposables to cell therapy customers.

The Company recognized $2.5 million in SPL Program-related revenue during 2021 (comprised of pre-commercial milestone revenues) as compared to $3.3 million in SPL Program-related revenue in 2020.

Gross profit for 2021 was $30.2 million (89% gross margin), compared to $23.4 million (89% gross margin) in the prior year.

Operating expenses for 2021 were $48.4 million, compared to operating expenses of $34.5 million in 2020. The overall increase in operating expenses was principally driven by an increase in expenses associated with increased headcount, increased stock-based compensation, and increased expenses due to our recent NASDAQ public listing. Partially offsetting this expense increase was a $5.8 million decline in CARMA-related expenses compared with last year. The Company had no material CARMA related expenses after March 2021.

Full year 2021 net loss was $19.1 million compared to a loss of $11.8 million in 2020; full year 2021 EBTIDA was a loss of $17.4 million versus a loss of $10.4 million for the prior year; total stock-based compensation for the full year was $8.0 million versus $2.5 million for the prior year.

Total cash, cash equivalents and short-term investments were $255.0 million as of December 31, 2021.

2022 Revenue Guidance

Management is providing initial 2022 revenue guidance based on our expectations for the existing business.

We expect revenue from our core business (instruments and disposables to cell therapy and drug discovery customers) to grow between 22% and 25% over 2021. We also expect SPL Program-related revenue to be approximately $4 million in 2022.

We intend to provide more context for the trajectory of our SPL Program-related revenue on the earnings call (details below).

Webcast and Conference Call Details

MaxCyte will host a conference call today, March 22, 2022, at 4:30 p.m. Eastern Time. Interested parties may access the live teleconference by dialing (844) 679-0933 for domestic callers, (918) 922-6914 for international callers, for 0203 1070 289 U.K domestic callers, or for 0800 0288 438 U.K. international callers followed by Conference ID: 2675034. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

Non-GAAP Financial Measures

This press release contains EBITDA, which is a non-GAAP measure defined as net loss excluding depreciation, amortization, income tax (benefit) expense and net interest expense. MaxCyte believes that EBITDA provides useful information to management and investors relating to its results of operations. The company’s management uses this non-GAAP measure to compare the company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The company believes that the use of EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.

Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation tables of the net loss, the most comparable GAAP financial measure to EBITDA, is included at the end of this release. MaxCyte urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business.

On March 22, 2022 Cytel Inc. reported that it has appointed Albert Kim, MD, PhD, as its first Chief Medical Officer (CMO), driving expansion of the advanced analytics capabilities available to clinicians looking to streamline therapeutic development. Dr Kim brings more than 21 years of interdisciplinary experience in medicine and drug development across a range of therapeutic modalities, and has held senior leadership roles at both Novartis and Pfizer (Press release, Lifescience Newswire, MAR 22, 2022, View Source [SID1234610592]). The appointment will fortify Cytel’s strategic consulting capabilities to support efficient navigation of uncertainties in product development.

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The appointment will also help direct the evolution of the Solara clinical trial strategy platform towards greater insight and collaboration across the full ecosystem of clinical development stakeholders. Solara facilitates clinical trial strategy by applying high throughput screening approaches to study design selection. Leveraging massive, cloud based computational power enables deeper exploration of a larger opportunity space that enables clinicians, statisticians and other stakeholders to identify optimal design options. To accelerate the delivery of new therapies to patients, the ability to quickly optimize clinical trial design, extract insights from scarce information, and foresee roadblocks is crucial. For 35 years, Cytel has pioneered a unique blend of quantitative insight and powerful software tools that has made this possible for pharmaceutical companies across the globe. The hire of physician-scientist Dr Kim marks the latest step in this journey.

"Innumerable challenges can hinder clinical development success, not least the potential communications gaps between statisticians and clinicians," said Joshua Schultz, CEO of Cytel. "Empowering and connecting teams that speak different scientific languages makes navigating hurdles in clinical research dramatically more efficient. Dr Kim, with his multi-domain expertise, will be an accelerating force as Cytel expands our application of advanced analytics to the entire product development team — from patient recruitment to market access."

Dr Kim has rich expertise in cardiovascular disease, translational medicine, and drug development. After receiving degrees from Harvard and UCLA, completing residency at Brigham and Women’s Hospital, and undertaking further specialty training at Mass General Hospital and UCSF, he achieved board certification in internal medicine, cardiology, and clinical cardiac electrophysiology.

Most recently, he was Vice President, Clinical Research Head for Pfizer’s Internal Medicine Research Unit. His roles at Pfizer and at Novartis saw him lead early and late phase programs for common and rare diseases. Dr Kim has contributed to development efforts for several candidate medicines utilizing different therapeutic modalities and has authored a body of work including numerous publications in leading medical journals. He was also a medical reviewer in the Division of Cardiac Devices at the FDA.

"The pace of development in today’s biotherapeutics landscape is incredibly demanding and involves many uncertainties and risks. Making difficult decisions with limited information is par for the course," said Dr Kim, CMO of Cytel. "Cytel’s quantitative thought leadership and renowned tools have enabled sponsors to better analyze and understand their data and make confident decisions quickly. I am delighted to join such a talented team and add my perspective to help an even broader audience benefit from Cytel’s capabilities and platforms such as Solara."

Launched in late 2020, Solara is a first-in-class digital development platform that harnesses the power of simulation-driven clinical trial design for multiple stakeholders. Using massive cloud computation, the platform can test thousands of trial designs against varied business scenarios in minutes rather than months, combining this with visualizations for shared context across technical and strategic considerations (e.g., statistical, clinical, and commercial specialists). In addition to its scenario visualization capabilities, Solara use cases have demonstrated numerous trial design improvements including markedly shorter trial durations and ~10-20% reductions in cost.

To learn about the powerful capabilities of Solara or to discover more about Cytel’s renowned consulting services, please visit www.cytel.com/software/solara.

On March 22, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that its Board of Directors has authorized an extension through July 31, 2022 of Lantern’s existing share repurchase program to acquire up to $7 million of the Company’s common stock (Press release, Lantern Pharma, MAR 22, 2022, View Source [SID1234610591]).

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Since the initiation of the share repurchase program in November 2021, a total of 475,157 shares of common stock have been repurchased pursuant to Lantern’s share repurchase program. Total expenditures for share repurchases from the time of initiation of the share repurchase program through March 21, 2022 were approximately $3.4 million, including purchase fees. Lantern is authorized to purchase up to an additional $3.6 million of the Company’s common stock pursuant to the repurchase program. As of December 31, 2021, Lantern had cash, cash equivalents and marketable securities of approximately $70.7 million.

The Company may purchase common stock on the open market, through privately negotiated transactions, or otherwise, in compliance with the rules of the United States Securities and Exchange Commission and other applicable legal requirements. The timing, amount of shares repurchased and prices paid for the stock under the repurchase program will depend on market conditions as well as corporate and regulatory limitations, including blackout period restrictions. The repurchase program does not obligate the Company to acquire any particular amount of shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion.