On August 28, 2020 CollPlant (NASDAQ: CLGN), a regenerative and aesthetics medicine company, reported financial results for the second quarter ended June 30, 2020 and provided an update on the Company’s business developments (Press release, CollPlant, AUG 28, 2020, View Source [SID1234564144]). 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’s rhCollagen based BioInk – the ideal building block for tissue and organ manufacturing (PRNewsfoto/CollPlant)
CollPlant reported revenues of $823,000 for the second quarter of 2020, a 36% increase from the $606,000 recorded in the second quarter of 2019. The Company ended the second quarter of 2020 with $3.7 million in cash and cash equivalents. Comprehensive loss for the second quarter of 2020 was $2.0 million on a GAAP basis, or adjusted comprehensive loss of $1.4 million, on a non-GAAP basis.

"We continue to make major strides in revolutionizing the fields of regenerative and aesthetic medicine through our first-in-class, recombinant human collagen (rhCollagen) platform technology. First, we are partnering with United Therapeutics Corporation (NASDAQ: UTHR) in efforts to address global organ shortages. We plan to leverage this experience in 3D bioprinting of lung scaffolds to explore other life-saving organs and tissues in the future," stated Yehiel Tal, the Chief Executive Officer of CollPlant. "Second, the combination of hyaluronic acid and rhCollagen in our next-generation, regenerative, photocurable dermal fillers will provide superior skin rejuvenation inclusive of the ability to inject into deep wrinkles, as well as other key attributes. Moreover, we are looking forward to sharing new data on our innovative photocurable dermal fillers and additional updates on our breast implant product pipeline at the exclusive Science of Aging Virtual Symposium 2020, which will be held digitally on September 16, 2020. Third, we continue to abide by Israeli Health Ministry guidelines for optimal protection of our employees. To accommodate heightened social distancing policies amid the ongoing pandemic, we have concentrated efforts on amplifying corporate visibility through a stronger online and social media presence. Finally, we remain committed to bolstering our workforce with brilliant scientists and support staff from prestigious institutions here in Israel. We are opportunistic about establishing relationships with new strategic partners who can support our pipeline development efforts."

Financial Results

Second Quarter 2020 Financial Results on US GAAP basis ("GAAP")

Revenues for the three months ended June 30, 2020 increased by 36% to $823,000, compared to $606,000 in the second quarter of 2019. Revenues were derived mainly from CollPlant’s BioInk for the development of 3D bioprinting of human organs, and from sales of rhCollagen for medical aesthetics product development.

Cost of revenue was $748,000 in the three months ended June 30, 2020, an increase of 62% compared to $463,000 in the same period in 2019. The increase is primarily related to differences in the mix of products sold, different profitability and the different capacity of production in the reported periods presented.

The Company’s gross profit for the three months ended June 30, 2020 decreased by $68,000 to $75,000 compared to $143,000 in the second quarter of 2019.

Total operating expenses for the three months ended June 30, 2020 were $2.0 million, an increase of 5% compared to $1.9 million in the second quarter of 2019.

Operating loss for the three months ended June 30, 2020 was $1.9 million, an increase of 6% compared to an operating loss of $1.8 million in the second quarter of 2019.

Financial expense, net for the three months ended June 30, 2020 was $58,000 compared to financial income, net of $513,000 in the second quarter of 2019. Financial expense in the three months ended June 30, 2020 derived from non-cash exchange differences of operating lease liabilities under ASC 842, compared to financial income in the three months ended June 30, 2019 which derived from re-evaluation of financial instruments.

Comprehensive loss for the second quarter of 2020 was $2.0 million, or $0.28 per share, compared to a comprehensive loss of $1.2 million, or $0.27 per share, for the second quarter of 2019.

Cash used in operating activities during the six months ended June 30, 2020 was $4.3 million compared to $2.7 million in the six months ended June 30, 2019. As of June 30, 2020, cash and cash equivalents totaled $3.7 million.

Cash used in investing activities during the six months ended June 30, 2020 was $246,000 compared to $1.1 million in the six months ended June 30, 2019. The decrease is mainly attribute 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 six months ended June 30, 2020 was $4.5 million compared to cash used in financing activities of $18,000 in the six months ended June 30, 2019. The increase is mainly attribute to proceeds from issuance of shares in a private placement in February 2020.

Second Quarter 2020 Financial Results on Non-US GAAP Basis ("non-GAAP")

On a non-GAAP basis, the operating expenses for the second quarter of 2020 were $1.4 million, compared to $1.5 million for the second quarter of 2019.

Comprehensive loss for the second quarter of 2020 was $1.4 million, or $0.20 per share, compared to $1.5 million, or $0.31 per share, for the second 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 $555,000 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.

On August 28, 2020 Oncology Venture A/S (OV:ST) ("Oncology Venture") reported the Interim Report for the period January – June 2020 (Press release, Oncology Venture, AUG 28, 2020, View Source [SID1234564143]). The report is available as an attached document and on the company’s website.

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CEO of Oncology Venture Steve Carchedi states, "I am pleased to report on our achievements in Q2 and year to date. In spite of the current environment with the pandemic, we have made significant progress toward our new company strategy and have exceeded our goals. Only two days ago, we announced positive data from our pre-clinical testing of Stenoparib as a potential treatment of Covid-19, and that we plan to advance into human clinical studies. Earlier in the year we announced the licensing of LiPlaCis and 2X-111 to Smerud Medical Research, a deal which can result in several hundred million Swedish kronor in milestone fees – followed by significant royalties. We also secured the full development control of our Dovitinib and Stenoparib projects, and our financials are improving on all parameters. The general cost-efficiency measures we put in place are bearing fruit. Our efforts to reduce financial expenses are becoming very visible in our financial reporting, and more. As a result, I am pleased to report that our current half-year company financials for 2020 are 50% better than compared to first half-year of 2019."

Summary of the Half Year Report

Consolidated group revenue amounted to 0 MDKK (0.5 MDKK).
Consolidated group loss before depreciation amounted to -22.5 MDKK (-28.1 MDKK).
Consolidated group loss before net financials amounted to -23.1 MDKK (-28.6 MDKK).
Consolidated net result amounted to -18.9 MDKK (-36.9 MDKK).
Consolidated earnings per share (EPS) amounted to -0.14 DKK (-0.65 DKK).
2019 numbers in brackets.

Highlights during Q2 2020

On April 3, the company announced a draw-down of the first tranche of SEK 10 million under its convertible note agreement with Negma Group LTD and Park Partners GP.

On April 7, the company announced a notice to convene Annual General Meeting 2020, to be held on 22 April 2020.

On April 17, Oncology Venture announced a directed issue of 925,925 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 22 April, the company announced that it would test the activity of its PARP inhibitor, 2X-121, as a potential therapy for Coronavirus. The testing would be conducted by the Pathogen and Microbiome Institute at Northern Arizona University.

On 22 April, the minutes from the Annual General Meeting 2020 was published.

On May 6, Oncology Venture announced that the company had entered into a USD 5 million equity investment agreement with a new US based investor named Global Corporate Finance. The agreement runs for 36 months, during which time Oncology Venture can solely decide to exercise investments by GCF, sequentially, in a number of tranches.

On May 7, the company announced a directed share issue of 1,952,475 new shares in connection with debt conversion directed to Global Corporate Finance and a consultant.

On 29 May, Oncology Venture published its Q1 2020 report, covering the period January – March 2020.

On 8 June, the company announced that it had acquired the remaining 37% ownership in its priority Dovitinib program from investor Sass & Larsen ApS and thereby had gained full control of the company’s Dovitinib program.

On 9 June, Oncology Venture announced a directed issue of 751,879 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 9 June, Oncology Venture calls the first investment tranche under its share subscription agreement with Global Corporate Finance.

On 10 June, Oncology Venture announced a directed issue of 2,255,639 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 11 June, the company announced the termination of the agreement with its liquidity provider Sedermera Fondkommission.

On 10 June, the company announced a directed issue of 5,177,584 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 29 June, Oncology Venture made public that it had signed an agreement to out-license two pipeline assets as part of its prioritized portfolio strategy to Smerud Medical Research International. The deal concerned the two clinical pipeline assets, LiPlaCis and 2X-111. As a part of the terms of the deal, Oncology Venture is eligible to receive significant milestone payments as well as royalties.

On 30 June, the company announced a directed issue of 1,574,803 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.
Highlights after the period

On 13 July, Oncology Venture announced that it had acquired full ownership of its PARP inhibitor (2X-121) program, and thereby Oncology Venture had gained full control of all three of the Company’s prioritized programs, 2X-121, Dovitinib and Ixempra, an important step in the execution of the Company’s strategy to eliminate external ownership of its key assets and retain maximum value of its priority programs.

On 14 July, the company announced a directed issue of 2,255,639 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 18 August, the company announced a directed issue of 1,893,939 shares under its convertible note agreement with Negma Group LTD and Park Partners GP. Thereby all outstanding convertible loan notes were converted.

On 21 August, Oncology Venture announced it has called upon the second investment tranche under its share subscription agreement with Global Corporate Finance and was issuing 5,980,020 shares at SEK 1.34 per share.

On 21 August, Oncology Venture announced that it will offer new shares in exchange for previously annulled warrants as part of clean-up of remaining obligations incurred prior to former management departure.

On 26 August, Oncology Venture announced that the company’s novel PARP inhibitor Stenoparib had shown anti-viral activity against Coronavirus in pre-clinical studies. In addition, it was announced that based on these findings, the company planned to advance the compound into human clinical trials, and moreover an update on the studies of Stenoparib as a treatment of ovarian cancer were also communicated. Finally, the announcement also made public that Stenoparib was the new name of the drug, until then known as 2X-121.
The report is available on:

View Source

On August 28, 2020 Antengene, reported that three-year old Shanghai startup originally backed by Celgene, will conduct a Hong Kong IPO that is expected to raise $200 million (Press release, Antengene, AUG 28, 2020, View Source [SID1234564141]). Focused on oncology, Antengene has 12 projects in its portfolio, a mix of in-licensed drugs and in-house R&D that it expects to test as monotherapies and in combinations. Six of its assets have started clinical trials. Last month, the company completed a $97 million Series C financing. In 2018, Antengene announced a $162 million deal to develop four Karyopharm assets in China.

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On August 28, 2020 Adaptimmune Therapeutics plc ("Adaptimmune")(Nasdaq: ADAP), a leader in cell therapy to treat cancer,reported that data from its Phase 1 trial with SPEAR T-cells targeting AFP at the virtual International Liver Congress (ILC) (Press release, Adaptimmune, AUG 28, 2020, View Source [SID1234564140]). One patient out of four dosed with 5 billion or more cells had a complete response, which was reported previously. The data also demonstrate an acceptable safety profile in patients with hepatocellular carcinoma (HCC).

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"A complete response in a patient with advanced liver cancer, and the anti-tumor activity we have reported in other patients with an acceptable safety profile, to date, further support the continued investigation of ADP-A2AFP," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "We remain encouraged by the potential of this therapy and we are fully committed to developing ADP-A2AFP for people with HCC. We have reported results for four patients at doses of 5 billion cells or more and we are looking forward to sharing more data as we continue to treat patients in the expansion phase of the trial. Further, we continue to review our translational findings and are evaluating ways to improve the therapy, if necessary."

Dr. Bruno Sangro of Clinica Universidad de Navarra presented data from Cohort 3 and the expansion phase of the ADP-A2AFP Phase 1 trial during an oral presentation at ILC. Tim Meyer of University College London presented additional data from Cohorts 1 and 2 during a poster presentation. A video is available on Adaptimmune’s website (View Source) of Elliot Norry, and Mark Dudley, SVP of Early Stage Development, discussing these data. The oral presentation and poster presentation are available online through the congress web site.

Topline data from ILC 1

·One patient had a complete response and also demonstrated a sustained reduction in serum AFP. This patient experienced disease progression, having developed new lesions at Week 32
·Overall, nine patients have been treated as of the data cutoff, of those
-Four patients have been treated with ~5 billion or more transduced cells (three in Cohort 3 and one in the expansion phase): 1 patient with the complete response, 1 with stable disease (SD), and 2 had progressive disease (PD)
-Five patients were previously treated in the first two dose cohorts with doses of 100 million and 1 billion transduced cells, respectively, and all patients had best responses of SD
·ADP-A2AFP SPEAR T-cells were associated with an acceptable safety profile with no evidence of significant T-cell related hepatotoxicity and no protocol-defined dose limiting toxicities
·Evidence of dose-dependent persistence of ADP-A2AFP SPEAR T-cells post-infusion
·Further translational evaluation is ongoing to understand indicators of response

1All data summarized are for patients with HCC with a data cut-off of July 6, 2020. Data from non-HCC patients to be presented at a future congress

Overview of Trial Design

·This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of ADP-A2AFP in patients with HCC or other AFP-expressing tumors who are not amenable to transplant, resection, or loco-regional therapy, and who failed or were intolerant to or refused standard-of-care treatment
·Dose escalation is complete, and this trial is enrolling in the expansion phase intended to treat up to 25 patients with doses up to 10 billion cells

On August 28, 2020 Merck & Co. reported that Keytruda (pembrolizumab) in combination with Pfizer’s Inlyta (axitinib) has been turned down by NICE as first-line treatment for patients with advanced renal cell carcinoma (RCC) (Press release, Merck & Co, AUG 28, 2020, View Source [SID1234564138]).

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The anti-PD-1 therapy combo was approved in Europe in September 2019 based on findings from the pivotal Phase III KEYNOTE-426 trial, which demonstrated that the drug reduced the risk of death by 47% compared with sunitinib in the indication.

However, NICE says while "short-term clinical trial evidence" shows that the combination is more effective than sunitinib for people with untreated renal cell carcinoma, "it is uncertain if there is a long-term benefit," which means that "cost-effectiveness estimates are uncertain".

Kidney cancer UK has slammed the decision.

"The decision by NICE concerning axitinib and pembrolizumab is extremely disappointing for the kidney cancer community," said the charity’s health professional nurse Susanna Smith.

"This is a combination which showed great results in the clinical trial and has been very well tolerated by people. The combination has been used widely in the US to great success since its approval…so unfortunately this decision will be leave us lagging behind in proving affective, cutting edge treatment options for patients in England and Wales."

"Axitinib and pembrolizumab improves survival significantly and has an important role to play in the treatment of kidney cancer. Rejecting the most active cancer treatments is disappointing for patients," added Professor Thomas Powles, consultant medical oncologist at St Bartholomew’s Hospital, London.