On August 19, 2019 BerGenBio reported Results for the Second Quarter and First Half 2019 (Press release, BerGenBio, AUG 19, 2019, View Source [SID1234538837]).

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-Acute Myeloid Leukaemia (AML): Preliminary Phase II clinical shows promising efficacy for bemcentinib in combo with low-intensity chemo in elderly AML patients unfit for intensive therapy

– Non small cell lung cancer (NSCLC): Phase II clinical data continues to show promising clinical activity and improved overall survival, particularly in patients with AXL positive tumours including those with low or no PD-L1 expression.

– Recruitment completed for second stage Phase II bemcentinib and KEYTRUDA combo trial in patients with advanced NSCLC (BGB008)

– Private placement completed, raising gross proceeds of NOK 74.2 million

– Cash and Cash equivalents at end of Q2 2019 NOK 324.4 million

– Operating loss of NOK 52.0 million in Q2 2019 (NOK 50.7 in Q2 2018) and NOK 97.1 million in H1 2019 (NOK 105.5 H2 2018).

BERGEN, Norway, Aug. 19, 2019 /PRNewswire/ — BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, announces its results for the second quarter and first half 2019.

A presentation and live webcast by the Company’s management will take place today at 10.00 am CEST in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"We are pleased to report a period of continued encouraging clinical data and validation of our lead candidate bemcentinib in our AML and NSCLC programmes. We are particularly excited by the LDAC combination data in second line AML patients.

Our focus is now on refining and preparing our late stage clinical trials in light of our recent clinical data and emerging market opportunities, as we continue to leverage our significant scientific and R&D leadership to develop this potentially transformative therapy. We are committed to progressing bemcentinib through to regulatory approval and, in turn, addressing the significant unmet need among AML and NSCLC patients in order to improve outcomes for these patients and create value for stakeholders."

Operational Highlights – second quarter and first half 2019

Acute Myeloid Leukaemia (AML)

– Preliminary Phase II clinical data from AML trial presented at EHA (Free EHA Whitepaper) 24 and ASCO (Free ASCO Whitepaper) 2019

Phase II trial evaluating bemcentinib in combination with low-intensity chemotherapy in elderly AML patients unfit for intensive therapy shows promising efficacy
6 out of 14 patients receiving LDAC combination achieved an Overall Response Rate (ORR) of 43%, with encouraging duration of response – this data is still maturing.
ORR significantly higher than previously reported/historical benchmarks (18%) with single-agent low dose cytarabine
Favourable safety profile continues to be seen in LDAC combination
Initiated preparation of expansion cohort to confirm the clinical signal from bemcentinib in combination with LDAC in elderly relapse/refractory AML patients.
Non-Small Cell Lung Cancer (NSCLC)

– New clinical data from BGB324 in NSCLC presented at ASCO (Free ASCO Whitepaper) 2019

Completed recruitment for second stage of Phase II trial evaluating bemcentinib and KEYTRUDA in previously treated NSCLC patients post chemotherapy (NCT03184571 (BGB008, cohort A)
First stage previously met efficacy endpoint, and reported encouraging median overall survival of 12.2 months
Preliminary Overall Response Rate of 40% continues to be seen in patients with AXL positive tumours including those with weak or no PD-L1 expression
Encouraging safety profile continues to be seen in combination
– Initiation of additional cohort in combination with KEYTRUDA in previously treated NSCLC patients post immunotherapy (NCT03184571, BGB008, cohort B)

Completed private placement, raising gross proceeds of NOK 74 million

Net proceeds from the Private Placement to be used to advance the Company’s clinical programs in AML and lung cancer, as well as for general corporate purposes
The Private Placement attracted strong interest from existing shareholders and new specialist institutional investors
Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at 10:00 am CEST at:

Carnegie AS
Fjordalleen 16, 5. floor,
Aker Brygge,
Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

On August 16, 2019 Abbisko Therapeutics, a clinical-stage biopharmaceutical company focused on creating innovative medicine for unmet medical needs in China and around the world, reported that it has received regulatory approval from US FDA to initiate its Phase 1 trial for ABSK021, a CSF-1R small molecule inhibitor for treating multiple types of tumors, and expects to start dosing patients shortly (Press release, Abbisko Therapeutics, AUG 16, 2019, View Source;article_id=123 [SID1234556288]).

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ABSK021 is independently discovered and developed by Abbisko Therapeutics with full intellectual property rights worldwide. It is an orally administrated, highly potent, and selective small molecule inhibitor of CSF-1R with best-in-class drug-like properties. Through CSF-1R inhibition, ABSK021 could reprogram tumor-associate macrophages (TAMs) and other immune cells, modulate tumor microenvironment, and relieve tumor immunosuppression.

Based on its mechanism of action and a large number of preclinical findings, Abbisko is advancing ABSK021 into a Phase 1 clinical study in patients with advanced malignancies and Tenosynovial Giant Cell Tumors (TGCT) where TAMs are known to be likely contributors of tumorigenesis.

On August 16, 2019 Spherix Incorporated (Nasdaq: SPEX) ("Spherix" or the "Company") reported that the Company filed its Form-10Q for the period ended March 31, 2019, which showed total assets of $11,937,000.00 and liabilities of $982,000.00, with 2,010,074 shares of common stock outstanding (Press release, Spherix, AUG 16, 2019, View Source [SID1234538985]).

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In addition, the Company announced a restructuring of the terms of its proposed merger with CBM BioPharma, Inc. (CBM), a Delaware corporation. In lieu of the previously announced merger, the Company announced the terms of an Asset Purchase Agreement with CBM, whereby the Company purchased substantially all of CBM’s assets including, among other things, a license agreement, university contracts, and contracts with a Chief Scientific Officer, as well as a Scientific advisory board. The revised agreement is significantly less dilutive to Spherix shareholders, as Spherix is paying $8,000,000.00 to CBM in total compensation, as opposed to the previously announced $16,500,000.00, as more fully set forth in the Company’s filings. The acquisition of CBM’s assets is pending shareholder approval.

In addition, the Company announced that it purchased a 20% shareholder’s stake in CBM along with certain interests in DatChat, Inc. Spherix was successful in acquiring these interests in CBM at a substantial discount to CBM’s valuation. The 20% shareholder stake in CBM will give Spherix the ability to participate in any dividends declared by CBM in the future.

Mr. Anthony Hayes, CEO of Spherix stated, "The revised negotiated terms with CBM BioPharma in the Asset Purchase Agreement will introduce valuable assets into the Spherix family. The new agreement will be less dilutive to Spherix shareholders. I am also pleased to note that CBM has received some early, favorable correspondence from the Patent Office about its University of Texas patent applications. We will provide additional information as it comes available, but it is certainly a positive development for CBM."

"Post-closing, Spherix shareholders will still own a majority interest in the Company. Further, Spherix’s 20% ownership in CBM is an accretive benefit to Spherix shareholders and by having an ownership interest in CBM, Spherix will participate in any dividend distributions made by CBM in the future. This may include cash dividends that might result from the future sale of Spherix stock. We look forward to sharing additional information with our shareholders about the proposed asset purchase in the upcoming weeks through both investor outreach and our upcoming SEC filings."

In addition to the CBM announcement, the Company’s Board of Directors under authority granted by the Company’s stockholders at the Company’s 2019 Annual Meeting, approved a reverse stock split of its common shares at a ratio of 1-for-4.25. The reverse stock split became effective on May 10, 2019, when the shares began trading on the split-adjusted basis on the Nasdaq Capital Market, under the Company’s existing trading symbol "SPEX".

Further information about the proposed asset purchase agreement and reverse stock split are provided in the Company’s Form 10-Q which was filed on May 15, 2019, with the Securities and Exchange Commission.

On August 16, 2019 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that an amendment to the FameWave acquisition deal was signed (Press release, Kitov Pharmaceuticals , AUG 16, 2019, View Source [SID1234538873]). According to the amendment, the parties agreed that all major closing conditions have been met other than finalizing the tax ruling for the sellers and the issuance and exchange of shares in the companies. Importantly, the amendment facilitates the advance of activities in the development of the oncology asset CM-24, including the preparation for a Phase 1/2 clinical trial in patients with non-small cell lung cancer in collaboration with Bristol Myers Squibb (BMS). CM-24 is a monoclonal antibody antagonist of CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways.

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The parties also agreed that Orbimed, Pontifax and Arkin Holdings will deposit in escrow their aggregate $3.5 million investment in Kitov priced at $1.23 per share until the tax ruling is received and the shares are issued and transferred.

"Moving towards finalizing the acquisition of FameWave is an important milestone in Kitov shift towards an oncology focused company. It allows us to advance the clinical development of CM-24 in parallel to advancing our second oncology product NT-219 into clinical trials," said Isaac Israel, chief executive officer of Kitov. "We look forward to initiating the planned Phase 1/2 trial in collaboration with BMS to evaluate the combination of CM-24 with BMS’s PD-1 inhibitor Opdivo in patients with non-small cell lung cancer. CM-24 has the potential to be an effective therapy for cancer patients and we are excited to advance this drug candidate into the clinic soon and provide patients with a long-lasting treatment alternative."

In connection with the progress made toward closing of the acquisition, FameWave has entered into a manufacturing agreement for CM-24 to facilitate the initiation of the Phase 1/2 trial and to advance R&D activities in preparation for the study.

About Kitov Pharma

Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, to create successful long-lasting treatments for people with cancer. Kitov’s oncology pipeline includes NT-219, a small molecule targeting the novel cancer drug resistance pathways IRS1/2 and STAT3. Kitov is currently advancing NT-219 in combination with cetuximab as a third-line or second-line treatment op

On August 16, 2019 Merrimack Pharmaceuticals (Nasdaq: MACK) (the "Company" or "Merrimack") reported it is rescheduling its 2019 Annual Meeting of Shareholders (the "2019 Annual Meeting") for October 17, 2019 (Press release, Merrimack, AUG 16, 2019, View Source [SID1234538821]). As a result, the record date for the 2019 Annual Meeting will now be September 16, 2019.

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The decision to postpone the meeting was made by Merrimack’s Board of Directors based on ongoing recent discussions with significant shareholders and a desire to reach a constructive solution to avoid a potentially costly and distracting proxy contest with JFL Capital Management LLC, which has nominated four director candidates for the Company’s Board.

Preliminary proxy statement materials for the 2019 Annual Meeting are under review with the Securities and Exchange Commission ("SEC") and have not yet been filed in definitive form nor been distributed to shareholders. It is expected that these materials will be filed with the SEC and sent to shareholders in the near-term.