On May 17, 2021 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAY 17, 2021, View Source [SID1234580124]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from May 10, 2021 to May 14, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 240,306 shares as treasury shares, corresponding to 0.37% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On May 17, 2021 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the quarter ended March 31, 2021 (Press release, Galectin Therapeutics, MAY 17, 2021, View Source [SID1234580123]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said, "The start to the new year has been an exciting and productive time for Galectin Therapeutics in both our NAVIGATE Phase 2b/3 clinical trial in NASH cirrhosis as well as the cancer, combination immunotherapy trial being conducted in collaboration with the Providence Cancer Institute in Portland, Oregon. In addition, since the beginning of the year, we have raised fresh capital and brought on Dr. Ben Carson, Sr., a world-renowned physician and former Secretary of Housing and Urban Development, as a special consultant. We very much look forward to working with Dr. Carson.

"In support of our innovative NAVIGATE study," continued Lewis, "we launched NAVIGATEnash.com, a new information resource about NASH cirrhosis for both patients and physicians. NASH cirrhosis is still largely overlooked and remains a major unmet medical need. I’ve been deeply moved by the determination of this community of NASH cirrhosis patients and the physicians who treat them.

"In our cancer, combination immunotherapy trial, results of the Phase 1 trial were published in the highest ranked fully open access peer-reviewed immunology journal. The study suggests combination therapy with belapectin results in a better objective response rate with fewer adverse events than pembrolizumab (KEYTRUDA) alone. Brendan Curti, M.D., the first author of the paper, noted galectin-3 is an important driver of tumor-induced immunosuppression. This clinical study constitutes proof-of-concept that the addition of our galectin-3 inhibitor, belapectin, to a PD-1 inhibitor can benefit cancer patients.

"Of course," concluded Lewis, "I would be remiss if I did not thank our Chairman, Mr. Richard Uihlein, who continues to demonstrate his strong support and provided additional funding to help advance our NAVIGATE trial, and for which we are deeply grateful."

Richard E. Uihlein, Chairman of the Board, added, "This quarter has been an important one for Galectin Therapeutics, and having Dr. Ben Carson on our team is an investment in the future. The progress being made in both our NASH cirrhosis study and our collaboration on cancer immunotherapy demonstrates the important science behind what we are doing. Galectin-3 is involved in a wide range of human diseases, and my recent investment in the company underscores my commitment to develop belapectin to its full potential."

Dr. Ben Carson, Sr., Engaged as Special Consultant

Engaged Ben Carson, Sr., M.D., a world-renowned neurosurgeon and the 17th Secretary of the U.S. Department of Housing and Urban Development, as a special consultant to assist with development of the Company’s galectin-3 inhibitor, belapectin, as a treatment for NASH cirrhosis and in combination with immunotherapy for the treatment of cancers. In particular, Dr. Carson will help increase awareness of Galectin Therapeutics including our ongoing Phase 2b/3 NAVIGATE clinical trial in NASH cirrhosis, our continuing research in combination with cancer immunotherapy, and its potential in addressing other fibrotic diseases. Dr. Carson will also assist in the formation of a scientific advisory committee for the Company, recruit potential members of the committee, and identify potential strategic commercial and/or academic partners for the Company.
Recent Financings

Raised $10 million in a convertible debt financing with Richard E. Uihlein, the Company’s Chairman and largest individual stockholder. The debt is unsecured and bears interest at a rate of 2% compounded annually. Additional interest of 2.5% per quarter will accrue but will only be paid if the debt and interest are converted into shares of the Company’s common stock, at Mr. Uihlein’s option, on or prior to maturity, which is four years from the date of the loan. The conversion price of the debt and interest is fixed at $5.00 per share of common stock.
NAVIGATE Trial Update

Launched NAVIGATEnash.com, a trial website dedicated to educating patients and physicians about liver cirrhosis resulting from non-alcoholic steatohepatitis (NASH) as well as support NAVIGATE, the Company’s innovative, seamless adaptive Phase 2b/3 study in NASH cirrhosis.

Galectin Therapeutics continues to actively recruit patients into NAVIGATE, its seamless, adaptive Phase 2b/3 study of belapectin for the prevention of esophageal varices in NASH cirrhosis.
Peer-reviewed publications, Scientific Presentations and Conferences

Published in the Journal for ImmunoTherapy of Cancer (JITC), the highest ranked fully open access immunology journal, a peer-reviewed paper entitled, "Enhancing Clinical and Immunological Effects of anti-PD-1 with Belapectin, a Galectin-3 Inhibitor" (doi:10.1136/jitc-2021-002371), provided further clinical evidence that using belapectin, a potent galectin-3 inhibitor, in combination with pembrolizumab (KEYTRUDA), a PD-1 inhibitor, significantly enhances tumor response to immunotherapy in patients with advanced metastatic melanoma (MM) and head and neck squamous cell carcinoma (HNSCC). The paper describes results from an ongoing Phase 1 clinical study, a collaboration between Galectin Therapeutics and Providence Cancer Institute in Portland, Oregon. An objective response was observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients. This compares favorably to published response rates on pembrolizumab alone.

At the 4th Global NASH Congress, which took place virtually on April 29, 2021, Pol F. Boudes, M.D., Chief Medical Officer, reviewed Galectin Therapeutics’ scientific and clinical activities in NASH cirrhosis in a presentation entitled, "An innovative clinical development program: belapectin for NASH cirrhosis."
Financial Results

For the three months ended March 31, 2021, the Company reported a net loss applicable to common stockholders of $6.3 million, or ($0.11) per share, compared to a net loss applicable to common stockholders of $3.6 million, or ($0.06) per share for the three months ended March 31, 2020. The increase is largely due an increase in 2021 research and development expenses related to the Company’s NAVIGATE trial.

Research and development expense for the three months ended March 31, 2021, was $4.9 million compared with $2.1 million for the three months ended March 31, 2020. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended March 31, 2021, were $1.4 million, compared to $1.4 million for the three months ended March 31, 2020.

As of March 31, 2021, the Company had $20.8 million of cash and cash equivalents. On April 16, 2021, the Company received $10,000,000 in proceeds from an unsecured convertible promissory note from its Board Chairman, Richard E. Uihlein. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least September 30, 2022.

The Company expects that it will require more cash to fund operations after September 30, 2022 and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $35-$40 million to cover costs of the trial to reach the planned interim analysis estimated to occur in the second half of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

About Belapectin (GR-MD-02)

Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (NAVIGATEnash.com), entitled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis" began enrolling patients in June, 2020, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 also has a significant role in cancer, and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and KEYTRUDA in treatment of advanced melanoma and in head and neck cancer.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 8,890 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.

On May 17, 2021 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported financial results and recent corporate highlights for the first quarter ended March 31, 2021 (Press release, Fortress Biotech, MAY 17, 2021, View Source [SID1234580122]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress and our partner companies had an exciting start to the year, including the addition and commercial launch of two dermatology products, bringing our total number of marketed products to seven. Moreover, we continued to achieve significant milestones in the advancement of multiple key development programs. Notably, in February, our partner company, Cyprium Therapeutics ("Cyprium"), and Sentynl Therapeutics ("Sentynl"), a wholly owned subsidiary of the Zydus Group, signed a Development and Asset Purchase Agreement for CUTX-101 for the treatment of Menkes disease. This agreement, which included an $8 million upfront payment for the ongoing development of CUTX-101, in addition to regulatory and sales milestone payments plus royalties, allows us to potentially maximize the value of this important asset as Cyprium continues to advance CUTX-101 toward a rolling submission of a New Drug Application ("NDA") later this year."

Dr. Rosenwald continued, "Our portfolio continues to grow with more than 25 product candidates across our partner companies, including 17 clinical programs, of which four are pivotal programs. We expect to have a multitude of regulatory and clinical inflection points throughout the remainder of 2021, including the availability of clinical data from cosibelimab, CAEL-101 and MB-106. Importantly, our diversified business model is supported by a strong balance sheet, as we ended the first quarter with $291.5 million in consolidated cash, cash equivalents and restricted cash. Our operational catalysts and financial strength have us well-positioned for success and we remain focused on creating long-term shareholder value."

Recent Corporate Highlights1:

Marketed Dermatology Products

Our seven dermatology products are marketed by our partner company, Journey Medical Corporation ("Journey").
Our products generated net revenues of $10.7 million for the first quarter of 2021, compared to first quarter 2020 net revenues of $11.9 million. While product demand increased in the first quarter of 2021 compared to the first quarter of 2020, the decrease in net revenue in the first quarter of 2021 is primarily attributable to increased coupon expense costs related to standard insurance deductible resets. We expect year-over-year annual revenue growth in 2021 to exceed the 28% growth Journey achieved in 2020.
In April 2021, Journey acquired and recently launched its seventh prescription dermatology product, QBREXZA.
On April 1, 2021, Journey entered into an agreement with East West Bank ("EWB") in which EWB will provide a $7.5 million working capital line of credit.
On March 31, 2021, Journey completed its first close in connection with its Cumulative Convertible Class A Preferred Stock Offering. In connection with the first close, Journey issued an aggregate of 501,480 Journey Preferred A shares at a price of $25.00 per share, and after deducting commissions, fees, and expenses, for a total of $11.2 million in net proceeds.
We plan on launching one additional prescription product in the second half of this year.
CUTX-101 (Copper Histidinate for Menkes disease)

In February 2021, our partner company, Cyprium, and Sentynl signed a Development and Asset Purchase Agreement for CUTX-101 for the treatment of Menkes disease. Under the terms of the agreement, Cyprium received $8 million upfront to fund the development of CUTX-101 and could receive up to $12 million in regulatory milestone payments through NDA approval, and is eligible to receive sales milestones plus royalties. Royalties start from mid-single digits, scaling up to 25% on sales exceeding $100 million annually. Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101. Cyprium is responsible for the development of CUTX-101 through approval of the NDA by the FDA, and Sentynl will be responsible for commercialization of CUTX-101, as well as progressing newborn screening activities.
We intend to begin the rolling submission of the NDA for CUTX-101 to the FDA in the second half of 2021.
CUTX-101 is currently in development at our partner company, Cyprium Therapeutics, Inc.
CAEL-101 (Light Chain Fibril-reactive Monoclonal Antibody for AL Amyloidosis)

Caelum Biosciences, Inc. ("Caelum") has two on-going Phase 3 studies of CAEL-101 for AL amyloidosis.
Caelum formed a collaboration with Alexion Pharmaceuticals, Inc. in 2019, which includes an option to acquire Caelum. AstraZeneca announced the execution of a definitive agreement to purchase Alexion Pharmaceuticals, Inc. In the event of the closing of such transaction, the timeline for a potential exercise of the option to purchase Caelum will be accelerated to six months following the date of acquisition closing.
In May 2021, we announced that CAEL-101 clinical data were selected for two presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress ("EHA2021") taking place in June. The abstracts can be viewed online through the EHA (Free EHA Whitepaper)2021 website: here and here.
CAEL-101 is currently in development at Caelum Biosciences, Inc., a company founded by Fortress in 2017 and in which Fortress maintains a minority position.
Cosibelimab (formerly CK-301, an anti-PD-L1 antibody)

The registration-enabling study in metastatic cutaneous squamous cell carcinoma is fully enrolled and we are on track to report top-line results by year-end. With a potentially favorable safety profile versus anti-PD-1 therapy and a plan to commercialize at a substantially lower price, we believe cosibelimab has the potential to be a market disruptive product in the $25 billion and growing PD-(L)1 class.
A Phase 3 registration-enabling trial is planned to begin in first-line metastatic non-small cell lung cancer in mid-2021.
Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. ("Checkpoint").
MB-107 and MB-207 (Lentiviral Gene Therapies for X-linked Severe Combined Immunodeficiency)

In February 2021, we announced encouraging MB-107 and MB-207 clinical updates from our investigator-IND X-linked severe combined immunodeficiency ("XSCID") trials, as well as additional consistent safety and efficacy data. On January 28, 2021, the FDA removed a CMC hold on the MB-107 Phase 2 clinical trial Investigational New Drug ("IND") application after reviewing a comprehensive CMC package that was submitted in late December 2020. We expect to enroll the first patient in this pivotal multicenter trial in the second quarter of 2021 and we are targeting top-line data from the trial in the second half of 2022. We also expect to file an IND in the second quarter of 2021 for our pivotal multicenter Phase 2 clinical trial of MB-207.
MB-107 and MB-207 are currently in development at our partner company, Mustang Bio, Inc. ("Mustang Bio").
MB-106 (CD20-targeted CAR T Cell Therapy)

In May 2021, we announced that the FDA approved Mustang Bio’s IND application to initiate a multicenter Phase 1/2 clinical trial investigating the safety and efficacy of MB-106, a CD20-targeted CAR T for relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL").
Also in May 2021, we announced that CD20-targeted CAR T data were selected for presentation at EHA (Free EHA Whitepaper)2021 scheduled to take place in June. Dr. Mazyar Shadman of Fred Hutchinson Cancer Research Center will present updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL. A copy of the abstract can be viewed online through the EHA (Free EHA Whitepaper)2021 website here.
MB-106 is currently in development at our partner company, Mustang Bio.
Dotinurad (Urate Transporter (URAT1) Inhibitor)

In May 2021, we announced an exclusive license agreement with Fuji Yakuhin Co. Ltd. to develop Dotinurad in North America and Europe. Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor for gout and possibly other hyperuricemic indications including chronic kidney disease and heart failure. Dotinurad (URECE tablet) was approved in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia. Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials.
Dotinurad is currently in development at our partner company, FBIO Acquisition Corp. VIII.
IV Tramadol

In October 2020, Avenue Therapeutics ("Avenue") announced that it had received a Complete Response Letter ("CRL") from the FDA regarding Avenue’s NDA for IV tramadol. The FDA held a Type A meeting with Avenue in November 2020 to discuss the issues outlined in the CRL. On February 12, 2021, Avenue resubmitted its NDA to the FDA for IV tramadol. The NDA resubmission followed the receipt of the official minutes from Avenue’s Type A meeting with the FDA. The NDA resubmission included revised language relating to the proposed product label and a report relating to terminal sterilization validation. On February 26, 2021, Avenue received an acknowledgment letter from the FDA stating that Avenue’s resubmission of its NDA is a complete, class 1 response to the CRL, and a Prescription Drug User Free Act ("PDUFA") goal date was set for April 12, 2021. On April 13, 2021, Avenue announced that the FDA was still reviewing its NDA for IV tramadol and had not provided a decision regarding the NDA. As of May 1, 2021, Avenue had not received approval from the FDA for IV tramadol. Accordingly, under the Stock Purchase and Merger Agreement ("SPMA"), InvaGen retains an option to consummate the second stage closing until October 31, 2021 (after which Avenue can choose to terminate the SPMA), and also retains the option to terminate the SPMA.
IV tramadol is currently in development at our partner company, Avenue.
General Corporate

In February 2021, Fortress partner company, Aevitas Therapeutics, appointed Markus Peters, Ph.D., M.Sc., as Chief Executive Officer.
Financial Results:

To assist our stockholders in understanding our company, we have prepared non-GAAP financial results for the three months ended March 31, 2021 and 2020. These results exclude the operations of our three public partner companies: Avenue, Checkpoint, and Mustang Bio. The goal in providing these non-GAAP financial metrics is to highlight the financial results of Fortress’ core operations, which are comprised of our commercial-stage business, our privately held development-stage entities, as well as our business development and finance functions.

As of March 31, 2021, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $291.5 million, compared to $235.0 million as of December 31, 2020, an increase of $56.5 million during the quarter.
On a GAAP basis, Fortress’ net revenue totaled $11.6 million for the first quarter of 2021, which included $10.7 million in net revenue generated from our marketed dermatology products. This compares to net revenue totaling $12.9 million for the first quarter of 2020, which included $11.9 million in net revenue generated from our marketed dermatology products.
On a GAAP basis, consolidated research and development expenses including license acquisitions were $20.2 million for the first quarter of 2021, compared to $15.1 million for the first quarter of 2020. On a non-GAAP basis, research and development expenses including license acquisitions were $4.1 million for the first quarter of 2021, compared to $2.3 million for first quarter of 2020.
On a GAAP basis, consolidated selling, general and administrative expenses were $17.5 million for the first quarter of 2021, compared to $15.5 million for the first quarter of 2020. On a non-GAAP basis, consolidated selling, general and administrative expenses were $13.0 million, of which $6.2 million is attributed to Journey, for the first quarter of 2021, compared to $11.6 million, of which $5.6 million is attributed to Journey, for the first quarter of 2020.
On a GAAP basis, consolidated net loss attributable to common stockholders was $8.8 million, or $0.11 per share, for the first quarter of 2021, compared to consolidated net loss attributable to common stockholders of $12.4 million, or $0.19 per share for the first quarter of 2020.
Fortress’ non-GAAP loss attributable to common stockholders was $7.3 million, or $0.09 per share, for the first quarter of 2021, compared to Fortress’ non-GAAP loss attributable to common stockholders of $4.2 million, or $0.07 per share, for the first quarter of 2020.

1. Includes Research and development expense and Research and development – licenses acquired expense for the quarter ended March 31, 2021 and 2020, respectively.
2. Excludes $0.1 million for Fortress MSA for the quarter ended March 31, 2021; excludes $0.1 million for Fortress MSA for the quarter ended March 31, 2020.
3. Excludes $0.1 million of Fortress MSA expense and $0.6 million Fortress financing fee for the quarter ended March 31, 2021; and $0.1 million of Fortress MSA expense for the quarter ended March 31, 2020.

4. Excludes $0.1 million of Fortress MSA expense and $1.2 million Fortress financing fee for the quarter ended March 31, 2021; and $0.1 million of Fortress MSA expense and $0.1 million Fortress financing fee for the quarter ended March 31, 2020.

On May 17, 2021 Charles River Laboratories International, Inc. (NYSE: CRL) reported that it has signed a definitive agreement to acquire Vigene Biosciences, Inc., a premier, U.S.-based gene therapy contract development and manufacturing organization (CDMO) providing viral vector-based gene delivery solutions (Press release, Charles River Laboratories, MAY 17, 2021, View Source [SID1234580121]). The purchase price is expected to be $292.5 million in cash, subject to customary closing adjustments. In addition to the initial purchase price, the transaction includes contingent additional payments of up to $57.5 million based on future performance. The transaction is expected to close in the beginning of the third quarter of 2021, subject to regulatory requirements and customary closing conditions.

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James C. Foster, Chairman, President and Chief Executive Officer of Charles River Laboratories, commented, "The addition of Vigene Biosciences’ extensive gene therapy expertise will enable us to expand our comprehensive cell and gene therapy portfolio to span each of the major CDMO platforms – cell therapy, viral vector, and plasmid DNA production. In these emerging, high-growth, value-added segments, we intend to continue to differentiate ourselves by bringing our high-science, customizable approach to support the complex needs of cell and gene therapy developers and innovators worldwide. Our goal is to become our clients’ scientific partner of choice for advanced drug modalities from discovery and non-clinical development to CGMP manufacturing. We look forward to welcoming Vigene’s dedicated employees to the Charles River family."

Strategic Rationale

The acquisition of Vigene Biosciences will enhance Charles River’s gene therapy capabilities in the high-growth, value-added cell and gene therapy CDMO sector.

Expands Charles River’s Gene Therapy CDMO Capabilities for Viral Vectors and Plasmid DNA – Vigene offers its clients contract manufacturing solutions across several key gene therapy platforms, enhancing Charles River’s ability to meet its clients’ evolving scientific needs. Its primary area of expertise is CGMP viral vector manufacturing, which is used for gene therapies and gene-modified cell therapies. Vigene has significant expertise in adeno-associated virus (AAV) CGMP production, which is the most commonly used delivery solution for gene therapies, as well as for other major viral vectors, including lentivirus. Vigene also offers high-quality, research grade and CGMP plasmid DNA, which is a foundational tool used in the development of viral vectors for gene-modified cell therapies, gene therapies, and vaccine production.
Complements Charles River’s existing non-clinical development and manufacturing portfolio – The addition of Vigene will be complementary to Charles River’s existing, non-clinical development and manufacturing capabilities and provide clients access to a comprehensive cell and gene therapy solution. With operations based in Rockville, Maryland, Vigene will geographically expand and be highly complementary to Charles River’s existing gene therapy CDMO capabilities in the United Kingdom and Sweden, which were acquired through the March 2021 acquisition of Cognate BioServices. Vigene will also support Charles River’s existing, U.S.-based cell therapy production capabilities and establish an end-to-end, gene-modified cell therapy solution. In addition, the acquisition will enable clients to seamlessly conduct analytical testing, process development, and manufacturing for advanced modalities with the same scientific partner, enabling them to achieve their goal of driving greater efficiency and accelerating their speed to market for advanced drug modalities.
Enhances Charles River’s growth potential with increased exposure in the high-growth market sector – Vigene will enhance Charles River’s growth potential by expanding Charles River’s portfolio of comprehensive cell and gene therapy solutions with viral vector and plasmid DNA manufacturing. The addressable market for cell and gene therapy CDMO services, principally for cell therapy, plasmid DNA, and viral vector production, is currently estimated at approximately $2.5 billion globally and is expected to grow at least 25% annually over the next five years.
Expected to drive profitable growth and shareholder value – The acquisition is expected to generate attractive financial returns that are consistent with Charles River’s disciplined investment criteria. It is also expected to be accretive to Charles River’s long-term revenue and earnings per share growth. Vigene is expected to generate annual revenue of $30 to $35 million in 2021, and is expected to grow at least 25% annually over the next five years.
Additional Financial and Transaction Details

Based on the anticipated completion of the acquisition in the beginning of the third quarter, Vigene is expected to add approximately 50 basis points to Charles River’s reported revenue growth rate in 2021. The transaction is expected to be neutral to non-GAAP earnings per share in the first full year after the acquisition closes, and accretive thereafter. Items excluded from non-GAAP earnings per share are expected to include all acquisition-related costs, which primarily include amortization of intangible assets, advisory fees, certain costs associated with efficiency initiatives, and certain third-party integration costs.

The acquisition and associated fees are expected to be financed through Charles River’s existing credit facility and cash. Vigene is expected to be reported as part of Charles River’s Manufacturing segment.

Advisors

Davis Polk & Wardwell LLP is acting as Charles River’s transactional legal counsel, and Weil, Gotshal & Manges LLP is acting as antitrust counsel.

Vigene Biosciences is supported by its institutional investor, Signet Healthcare Partners. Robert W. Baird & Co. is acting as the exclusive financial advisor, and Shulman Rogers and Sheppard Mullin Richter & Hampton LLP are acting as legal counsel to Vigene.

On May 17, 2021 F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation bispecific immunotherapies to transform the lives of patients with cancer, reported that first quarter 2021 financial results and provides a corporate update (Press release, F-star, MAY 17, 2021, View Source [SID1234580120]).

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Strengthens balance sheet with successful closing of $65 million public offering of common stock and;
Received $9.2 million in net proceeds under its "at-the-market" equity offering program
LAG-3 and PD-(L)1 co-targeting validation with LAG-3 validated in late-stage clinical trial as third checkpoint inhibitor pathway
FS118 patent protection granted in Europe expanding F-star’s extensive IP portfolio
FS222 presentation at AACR (Free AACR Whitepaper) on the importance of tuning both affinity and avidity for differentiation
Nature publication on STING agonist demonstrating that SB 11285 enhances preclinical efficacy of radiation therapy
Merck KGaA, Darmstadt, Germany exercises option to bring third target into pipeline
Eliot Forster, CEO of F-star Therapeutics, Inc., said, "I’m very proud of what F-star accomplished in our first full quarter as a publicly traded company. The successful close of our public offering means we have now strengthened our financial position to ensure delivery on our future milestones. We have made excellent progress across all four clinical stage programs. We have also delivered with our partners, as noted in the recent update on our collaboration with Merck KGaA. We have added new insights into the unique properties of our platform technology, including presenting new data on FS222, our potentially best-in-class bispecific antibody targeting CD137 and PD-L1. This year will be another exciting one for F-star with clinical data expected and huge potential to provide transformational treatment options for patients with cancer."

"We have had a great start to 2021 and are very pleased to complete our $65 million underwritten public offering," said Darlene Deptula-Hicks, Chief Financial Officer of F-star Therapeutics. "Based on our current operating plans we believe our current cash and cash equivalents will be sufficient to meet our capital requirements into the second half of 2023."

FIRST QUARTER 2021 AND RECENT HIGHLIGHTS

Clinical validation of LAG-3: Aligning with F-star’s promising internal data, new headline phase 3 data reported during the quarter by a global pharmaceutical company has potentially validated LAG-3 as an immuno-oncology target. Importantly for FS118, these data also confirm the necessity of co-targeting the LAG-3 and PD-1/PD-L1 pathways to achieve efficacy in patients.

FS118 European patent protection granted: The European Patent Office (EPO) granted a patent in January 2021 with claims protecting the composition of matter of F-star’s FS118 molecule giving protection until June 2037. The phase 2 proof-of-concept trial of FS118 is proceeding on plan and the Company plans to provide an update on progress in the first half of 2022.

FS222 Poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in 2021: F-star presented a poster at AACR (Free AACR Whitepaper) 2021 entitled ‘FS222, a Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is Designed for Optimal CD137 Interactions Resulting in Potent T cell Activation Without Toxicity’. This poster and the associated data showcased the differentiation of FS222 from competitor molecules and highlighted the importance of ‘tuning’ for both the affinity and avidity of bispecific antibodies. The ongoing phase 1 clinical trial is proceeding on plan and the Company plans to provide an update on progress before the end of 2021.

SB 11285 in Nature publication: F-star published on its second-generation STING agonist, SB 11285, in the April 2021 issue of Nature Communications. The study, entitled ‘STING enhances cell death through regulation of reactive oxygen species and DNA damage’ demonstrated that systemic administration of a STING agonist in combination with radiation in a preclinical model enhances local control in Head and Neck Squamous Cell Carcinoma (HNSCC) and suggests that STING expression in the tumor is required for maximal therapeutic benefit. The Company plans to provide an update on the progress of SB 11285 in the phase 1 clinical trial in mid-2021.

Merck, KGaA, Darmstadt, Germany exercised third target option: F-star continued to deliver on the collaboration with Merck, KGaA, Darmstadt, Germany. The third option to license an F-star preclinical immuno-oncology program was exercised in the ongoing collaboration in March 2021. The companies entered into the agreement in 2019 with the first option to license. In July 2020, Merck KGaA, Darmstadt, Germany brought the second program from the collaboration into its pipeline, and has recently exercised its third option, taking over future development and commercialization of the program.

Denali Therapeutics announcement: F-star is pleased by the announcement from Denali Therapeutics that following positive preliminary data in a Phase 1/2 study, the Food and Drug Administration (FDA) has granted Fast Track designation to DNL310, which is derived from F-star’s unique Fcab technology, for the treatment of patients with Hunter syndrome.

Strengthened balance sheet in 2021: In April the Company completed the sale of $9.5 million in gross proceeds through its previously announced "at-the-market" (ATM) equity offering program. In addition, in April the Company entered into and drew down $5 million under its $10 million debt facility with Horizon Technology Finance Corporation and in May raised gross proceeds of $65 million, before deductions of underwriting discounts and commissions, in a public offering.

FIRST QUARTER 2021 FINANCIAL SUMMARY

Cash and cash equivalents as of March 31, 2021 were $3.7 million, compared to $18.5 million at December 31, 2020. Based on the Company’s current operating plan, the Company believes its cash and cash equivalents at March 31, 2021, together with the net proceeds from the recent sales of common stock in the underwritten public offering and under the ATM, and funds from its debt facility will be sufficient to fund its current operating plans into the second half of 2023.

Research & Development (R&D) expenses were $7.3 million for the quarter ended March 31, 2021, compared to $3.4 million for the same quarter in 2020. The increase of $3.9 million in R&D expense was primarily related to manufacturing costs and clinical costs with Q1 being the first full quarter with four programs in the clinic.

General & Administrative (G&A) expenses were $6.4 million for the quarter ended March 31, 2021, compared to $3.2 million for the first quarter of 2020. This $3.2 million increase in G&A expense was primarily due to increased non-cash stock-based compensation expense, professional fees and insurance associated with operating as a public company and rent expense associated with building leases assumed in the share exchange.

Net loss was $9.9 million or a loss per share of $1.08 (basic and diluted), for the quarter ended March 31, 2021, compared to a net loss of $7.2 million or a loss per share of $3.92 (basic and diluted) for the quarter ended March 31, 2020.

CONFERENCE CALL AND WEBCAST

F-star will host a conference call today, May 17, 2021 beginning at 9:00 AM EDT. To join the webcast, go to website. To join by phone, participants may dial 1-833-471-0868 in the US/Canada or 1-914-987-7751 for International calls or 0800 0288438 or 0203 1070289 for the United Kingdom, at least 10 minutes prior to the start of the call.

A recording of the conference call will be available on the ‘Events & Presentations’ section of the Company’s website at www.f-star.com from May 18, 2021.