On December 1, 2020 CollPlant (NASDAQ: CLGN), a regenerative and aesthetics medicine company, reported financial results for the third quarter ended September 30, 2020 and provided an update on the Company’s business developments (Press release, CollPlant, DEC 1, 2020, View Source [SID1234572068]). Certain metrics, including those expressed on an adjusted basis, are non-GAAP measures. See "Use of Non-GAAP Measures" below.

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CollPlant reported revenues of $4.1 million for the third quarter of 2020, a 511% increase from the $679,000 recorded in the third quarter of 2019. The Company ended the third quarter of 2020 with $5.0 million in cash and cash equivalents. Comprehensive income for the third quarter of 2020 was $703,000 on a GAAP basis, or adjusted comprehensive income of $1.1 million, on a non-GAAP basis.

"We are very pleased with the progress of our collaboration with United Therapeutics which started with lungs and is now expanding to cover kidneys, a second lifesaving organ. The $3 million payment for the option exercise which contributed to our profitability in the third quarter of 2020 is part of a larger agreement signed in October 2018 that includes upfront and milestone payments plus royalties," stated Yehiel Tal, CollPlant’s Chief Executive Officer.

"We continue to advance our medical aesthetics line with next-generation, regenerative, photocurable dermal fillers which we believe will yield skin rejuvenation inclusive of the ability to inject into deep wrinkles, as well as other key attributes. During the third quarter of 2020 we shared updates on our photocurable dermal fillers and on our breast implant product pipeline, at the exclusive Science of Aging Virtual Symposium 2020."

"Furthermore, we are moving forward with a development program of an antiviral agent for the potential treatment of COVID-19. We got promising preclinical data showing our platform technology significantly inhibited avian coronavirus infectivity. The data indicated our formulation that is comprised of rhCollagen imbedded with silver nanoparticles (AgNP), targets viral load in COVID-19 patients, thereby potentially assisting the body’s immune system to combat viral infection, reduce transmission rates between people, and ultimately reduce the percentage of patients who need to be treated in critical care settings," Mr. Tal concluded.

Financial Results

Third Quarter 2020 Financial Results on U.S. GAAP basis ("GAAP")

Revenues for the three months ended September 30, 2020 increased by 511% to $4.1 million, compared to $679,000 in the third quarter of 2019. Revenues were derived mainly from sales of CollPlant’s BioInk for the development of 3D bioprinting of human organs, the exercise of an option by United Therapeutics for licensing CollPlant technology to print kidneys, and from sales of rhCollagen for medical aesthetics product development.

Cost of revenue was $1.4 million in the three months ended September 30, 2020, an increase of 123% compared to $645,000 in the same period in 2019. The increase is primarily related to royalties payments to the Israel Innovation Authority on revenue from licensing CollPlant’s technology to United Therapeutics for printing of kidneys.

The Company’s gross profit for the three months ended September 30, 2020 increased by $2.7 million to $2.7 million, or 65% of revenues, in the third quarter of 2020, compared to $34,000, or 5% of revenues in the third quarter of 2019.

Total operating expenses for the three months ended September 30, 2020 were $2.0 million, an increase of 11% compared to $1.8 million in the third quarter of 2019. The increase is primarily related to share-based compensation expenses for options grant.

Operating profit for the three months ended September 30, 2020 was $734,000, compared to an operating loss of $1.7 million in the third quarter of 2019.

Financial expense, net for the three months ended September 30, 2020 was $31,000 compared to $1.4 million in the third quarter of 2019. Financial expense in the three months ended September 30, 2020 and September 30, 2019 mainly derived from non-cash exchange differences of operating lease liabilities under ASC 842, and re-evaluation of financial instruments.

Comprehensive income for the third quarter of 2020 was $703,000, or $0.10 per share, compared to a comprehensive loss of $3.2 million, or $0.68 per share, for the third quarter of 2019.

Cash used in operating activities during the nine months ended September 30, 2020 was $2.9 million compared to $4.1 million in the nine months ended September 30, 2019. As of September 30, 2020, cash and cash equivalents totaled $5.0 million.

Cash used in investing activities during the nine months ended September 30, 2020 was $378,000 compared to $1.2 million in the nine months ended September 30, 2019. The decrease is mainly attributable to costs incurred in the establishment in 2019 of CollPlant’s new HQ and R&D center in Rehovot, Israel.

Cash provided by financing activities during the nine months ended September 30, 2020 was $4.5 million, of which $4.4 million are attributable to proceeds from issuance of shares in a private placement in February 2020. Cash provided in the nine months ended September 30, 2019 by financing activities amounted to $5.4 million, and are attributed to proceeds from funding in September 2019.

Third Quarter 2020 Financial Results on Non-U.S. GAAP Basis ("non-GAAP")

On a non-GAAP basis, the operating expenses for the third quarter of 2020 were $1.6 million, a decrease of $106,000 compared to $1.7 million for the third quarter of 2019.

Comprehensive income for the third quarter of 2020 was $1.1 million, or $0.16 per share, compared to comprehensive loss of $1.8 million, or $0.38 per share, for the third quarter of 2019.

Non-GAAP measures exclude certain non-cash expenses. The table on page 10 includes a reconciliation of the Company’s GAAP results to non-GAAP results. The reconciliation reflects non-cash expenses in the amount of $397,000 with respect to (i) change in fair value of financial instruments, (ii) share-based compensation to employees, directors and consultants and (iii) change of operating lease accounts, including related financial expenses.

Use of Non-GAAP Measures

This press release contains certain non-GAAP financial measures for operating costs and expenses, operating loss, comprehensive loss and basic and diluted comprehensive loss per share that exclude the effects of non-cash expense for fair market value attributed to change in fair value of financial instruments, share-based compensation to employees, directors and consultants, and change in operating lease accounts. Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s operating costs, comprehensive loss and loss per share, and to compare them to historical Company results.

The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company’s business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.

For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" table on page 10 in this press release. This accompanying table on page 10 has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.

The Company’s consolidated financial results as of, and for the nine months ended, September 30, 2020 are presented in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP").

On December 1, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it has completed enrolment into the LYMRIT 37-05 Phase 1 clinical trial of Betalutin (177Lu lilotomab satetraxetan) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) not eligible for autologous stem cell transplantation (ASCT) (Press release, Nordic Nanovector, DEC 1, 2020, View Source [SID1234571999]).

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Eighteen DLBCL patients were enrolled into the trial at clinical trial sites in the US and Europe and were dosed with three escalating treatment doses of Betalutin (10MBq/kg, 15MBq/kg and 20MBq/kg). A preliminary data readout is expected in H1’2021.

As announced in April 2020, LYMRIT 37-05 will be paused pending analysis of these data, which is expected to inform plans for the further development of Betalutin in R/R DLBCL.

Nordic Nanovector’s primary focus is the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line follicular lymphoma (3L FL).

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "The completion of recruitment into this dose-finding study in patients with DLBCL is an important milestone. DLBCL remains a significant indication with a large unmet medical need. The data analysis from this trial will form the basis of our considerations for the further development of Betalutin in DLBCL and more broadly across non-Hodgkin’s lymphoma."

The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study in DLBCL designed to determine the dose to be recommended for further studies in DLBCL and assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of a single administration of Betalutin. More information on this study can be found at www.clinicaltrials.gov (NCT02658968).

DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for 30% of all NHL cases1,2. The number of diagnosed incident cases of DLBCL in the seven major markets (US, key five European markets and Japan) was 64,172 in 2018 and is expected to grow to 74,927 in 20283.

Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy. These patients have few therapeutic options, with high-dose chemotherapy and autologous stem cell transplant (ASCT) achieving long-term remissions in only a minority of patients4. Relapsed DLBCL therefore remains a serious unmet medical need.

References

Siegel R, Miller K and Jemal A. Cancer Statistics, 2019. CA Cancer J. Clin. 2019;69(1):7-34
View Source
Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), 2020, Decision Resources Group, Clarivate
Liu Y, Barta SK. Diffuse large B-cell lymphoma: 2019 update on diagnosis, risk stratification, and treatment. Am J Hematol. 2019 May;94(5):604-616.

On December 1, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that it has entered into a definitive securities purchase agreement in connection with a private placement to existing institutional and other accredited investors as well as new institutional investors (Press release, Regulus, DEC 1, 2020, View Source [SID1234572020]). Upon the closing of the financing, which is anticipated to occur on December 3, 2020, the Company expects to receive gross proceeds of approximately $19.4 million, not including any proceeds that may be received upon exercise of warrants. The closing of the financing is subject to customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the financing.

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Under the securities purchase agreement, the investors have agreed to purchase approximately 24.3 million shares of the Company’s Common Stock ("Common Stock") and accompanying warrants to purchase up to an aggregate of approximately 18.2 million shares of Common Stock, at a combined purchase price of $0.7158 per share and accompanying warrant to purchase 0.75 of a share of Common Stock, except that the price per share for executive officers and directors participating as investors in the financing is $0.7239 per share and accompanying warrant to purchase 0.75 of a share of Common Stock. Certain investors have also agreed to purchase, in lieu of shares of Common Stock, an aggregate of approximately 272,970 shares of non-voting Class A-3 convertible preferred stock at a price of $6.22 per share, and accompanying warrants to purchase an aggregate of up to approximately 2.0 million shares of Common Stock at a price of $0.125 for each share of Common Stock underlying the warrants. Each share of non-voting Class A-3 convertible preferred stock will be convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The warrants will be exercisable for a period of five years following the date of issuance and will have an exercise price of $0.7464 per share, subject to proportional adjustments in the event of stock splits or combinations or similar events. The closing is expected to occur on December 3, 2020, subject to customary closing conditions.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

On December 1, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and Hikma Pharmaceuticals, a multi-national pharmaceutical company and leading licensing partner in the Middle East and North Africa ("MENA") region specializing in the development and commercialization of a broad range of high-quality medicines, reported that the companies have entered into an exclusive licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") and other types of cancer in MENA (Press release, Sesen Bio, DEC 1, 2020, View Source [SID1234572036]). Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review.

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"Sesen is committed to saving and improving the lives of patients, and Hikma is an ideal partner to deliver Vicineum to patients with NMIBC in the MENA region," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "As we continue to work toward regulatory approval in the US and Europe, we also continue to execute partnerships outside of the US as part of our mission to deliver this important medicine to patients around the world. Hikma has strong expertise in commercializing innovative products in the MENA region and a successful track record of serving patients worldwide. This partnership represents a further step in realizing the significant global opportunity for Vicineum."

"At Hikma, we believe that partnerships with innovative pharma companies are a key contributor to the success of our business. We are very pleased to enter into an exclusive partnership with Sesen given their expertise in NMIBC and the strong clinical profile of Vicineum," said Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA. "As a company whose mission is to put better health within reach every day, we regard being the partner of choice to Sesen in MENA as a key collaboration that augments Hikma’s biotechnology and oncology portfolio to deliver on our strategy of bringing innovative products to patients in the region. Vicineum – our first innovative fusion protein – is a highly differentiated product candidate and is positioned to make a meaningful impact on the lives of bladder cancer patients."

Under the terms of the agreement, Sesen Bio granted Hikma an exclusive license to register and commercialize Vicineum in all 19 MENA markets in an arrangement anticipated to deliver equal value share to both parties. Financial terms of the agreement are confidential and include an upfront payment to Sesen Bio, sales related milestone payments and royalties on net sales in the region for the term of the agreement. Sesen Bio retains full development and commercialization rights for Vicineum for the treatment of NMIBC in the US and the rest of the world excluding Greater China and MENA.

Al-Tamimi and Hogan Lovells acted as legal advisors to Sesen Bio for this transaction.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review. Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

About Non-Muscle Invasive Bladder Cancer
Bladder cancer is the sixth most commonly diagnosed cancer in the United States, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and more than 60 percent of all patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.

On December 1, 2020 A cancer-killing virus that City of Hope scientists developed could one day improve the immune system’s ability to eradicate tumors in colon cancer patients, reported a new study in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, City of Hope, DEC 1, 2020, View Source [SID1234572051]).

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The preclinical research is a first step to showing that City of Hope’s oncolytic virus CF33 can target hard-to-treat tumors that "handcuff" the immune system and keep T cells from activating the immune system to kill cancer cells. More specifically, the researchers demonstrated in mouse models that CF33 appears to increase PD-L1 expression in tumor cells and causes them to die in a way that stimulates an influx of activated immune cells.

"CF33 is a safe, innovative virus City of Hope developed that can become a game changer because of how potent it is and because of its ability to recruit and activate immune cells," said Susanne Warner, M.D., a surgical oncologist at City of Hope and senior author of the study. "Our oncolytic virus trains the immune system to target a specific cancer cell. Preclinical models show that a combination treatment of oncolytic virus CF33 with anti-PD-L1 checkpoint inhibition leads to lasting anti-tumor immunity, meaning if a similar cancer cell ever tries to regrow, the immune system will be ready and waiting to shut it down."

Colorectal cancer is the third leading cause of cancer-related deaths in the United States and is expected to cause 53,200 deaths in 2020, according to the American Cancer Society. City of Hope researchers are excited about the potential of CF33 to enhance colon cancer treatment and point out that CF33 has been effective preclinically against a wide variety of cancers.

Yuman Fong, M.D., the Sangiacomo Family Chair in Surgical Oncology at City of Hope, and his team created oncolytic virus CF33 and expect to open a clinical trial to test the safety of this treatment in human patients in 2021. This treatment addresses a problem in cancer: Most solid tumors do not respond to checkpoint inhibitors because the "uncloaked tumor cell" still isn’t recognized by the immune system, Fong said.

"CF33 selectively infects, replicates in and kills cancer cells. This study demonstrates that a designer virus we created to infect a wide variety of cancers can make tumor cells very recognizable to the immune system," Fong said. He, Warner and other City of Hope physician-scientists are working on turning "cold tumors" resistant to treatment into "hot tumors" that can be killed by a well-trained immune system.

The U.S. Food and Drug Administration has approved only one oncolytic virus thus far: T-VEC, which is a local immunotherapy treatment that kills melanoma cells.

To confirm their hypothesis, City of Hope scientists tested four groups: control with no treatment, anti-PD-L1 alone, CF33 alone, and a combination of CF33 and anti-PD-L1. Results indicated that a combined treatment of City of Hope’s oncolytic virus and anti-PD-L1 appeared to be most effective. It also increased CD8+ T cells, which are immune cells that remember previous diseases and are trained to kill them if they are reintroduced later. In other words, the models developed anti-tumor immunity. This means that animals cured of their cancer were effectively immune to future tumor growth.

Fong and colleagues have demonstrated CF33’s anti-tumor immune efficacy against triple-negative breast cancer cell lines, in brain tumor cells, in liver cancer models, and in pancreatic, prostate, ovarian, lung and head and neck cancer. Moreover, a recent City of Hope-led study found that CF33 could be combined with chimeric antigen receptor (CAR) T cell therapy to target and eliminate solid tumors that are otherwise difficult to treat with CAR T therapy alone. City of Hope has licensed CF33 to Imugene Limited, a company developing novel therapies that activate the immune system against cancer.

Notably, the CF33 virus may be tracked by non-invasive PET scanning. "If we can perfect the technique, we can give someone a viral injection and watch it work – see where it goes and identify cancer cells that we didn’t even know existed," Warner said. "Doctors would have real-time data and know if we should give a patient a higher dose or where to direct the treatment based on tumors that have not yet been killed."

What Warner describes is a developing field called theranostic precision medicine, meaning doctors are able to give patients therapies and concurrently diagnose them to provide the most appropriate treatment for that patient. It is one of many precision medicine approaches City of Hope is developing and offering to patients.

The next step for the current study is to test the innovative CF33 virus platform in different solid tumor models.

This research was supported by the American Cancer Society Mentored Research Scholar Grant (MRSG-16-047-01-MPC) and through the generosity of the Natalie and David Roberts Family.