On August 4, 2020 Astellas reported that Financial Results for 1Q/FY2020 (Press release, Astellas, AUG 4, 2020, View Source [SID1234564041])

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FY2020
Business Results for 1Q (August 4, 2020)
Financial Results (Q1/FY2020) （795KB）
Supplementary Documents (Q1/FY2020) （770KB）
Presentation Material for Information Meeting (Q1/FY2020) （759KB）
On-demand Replay of Information Meeting

FY2019
Business Results (May 14, 2020)
Financial Results (FY2019) （1,291KB）
Supplementary Documents (FY2019) （1,156KB）
Presentation Material for Information Meeting (FY2019) （756KB）
On-demand Replay of Information Meeting
Business Results for 3Q (January 31, 2020)
Financial Results (Q3/FY2019) （334KB）
Supplementary Documents (Q3/FY2019) （791KB）
Presentation Material for Information Meeting (Q3/FY2019) （941KB）
On-demand Replay of Information Meeting
Business Results for 2Q (October 31, 2019)
Financial Results (Q2/FY2019) （328KB）
Supplementary Documents (Q2/FY2019) （423KB）
Presentation Material for Information Meeting (Q2/FY2019) （964KB）
On-demand Replay of Information Meeting
Business Results for 1Q (July 30, 2019)
Financial Results (Q1/FY2019) （253KB）
Supplementary Documents (Q1/FY2019) （1,292KB）
Presentation Material for Information Meeting (Q1/FY2019) （862KB）

FY2018
Business Results (April 25, 2019)
Financial Results (FY2018) （347KB）
Supplementary Documents (FY2018) （294KB）
Presentation Material for Information Meeting (FY2018) （1,492KB）
Business Results for 3Q (January 31, 2019)
Financial Results (Q3/FY2018) （347KB）
Supplementary Documents (Q3/FY2018) （508KB）
Presentation Material for Information Meeting (Q3/FY2018) （871KB）
Business Results for 2Q (October 31, 2018)
Financial Results （312KB）
Supplementary Documents （500KB）
Overview of R&D Pipeline （97KB）
Presentation Material for Information Meeting （634KB）
Business Results for 1Q (July 27, 2018)
Financial Results （305KB）
Supplementary Documents （326KB）
Overview of R&D Pipeline （95KB）
Presentation Material for Information Meeting （507KB）

FY2017
Business Results (April 26, 2018)
Financial Results （429KB）
Supplementary Documents （417KB）
Overview of R&D Pipeline （94KB）
Presentation Material for Information Meeting (April 26, 2018) （695KB）
Business Results for 3Q (January 31, 2018)
Financial Results （263KB）
Supplementary Documents （507KB）
Overview of R&D Pipeline （93KB）
Presentation Material for Information Meeting (January 31, 2018) （585KB）
Business Results for 2Q (October 31, 2017)
Financial Results （259KB）
Supplementary Documents （512KB）
Overview of R&D Pipeline （94KB）
Presentation Material for Information Meeting (October 31, 2017) （557KB）
Business Results for 1Q (July 28, 2017)
Financial Results （366KB）
Supplementary Documents （315KB）
Overview of R&D Pipeline （95KB）
Presentation Material for Information Meeting (July 28, 2017) （793KB）

On August 4, 2020 (the "Effective Date"), Generex Biotechnology Corporation (the "Company") and three (two of whom are affiliates) institutional accredited investors (each a "Buyer" and, collectively, the "Buyers") reported entered into a securities purchase agreement (the "Securities Purchase Agreement") pursuant to which the Company sold and issued to the Buyers an aggregate of 5,102,040 shares (the "Common Shares") of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at an aggregate price of $2,000,000 (the "Private Placement") (Filing, 8-K, Generex, AUG 4, 2020, View Source [SID1234563163]).

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Pursuant to the Securities Purchase Agreement, the Company issued to the Buyers (i) Series A Warrants to purchase 5,102,040 shares of Common Stock in the aggregate (the "Series A Warrants") with an initial exercise price equal to $0.392 per share (the "Series A/B Exercise Price"), (ii) Series B Warrants to purchase 15,306,122 shares of Common Stock in the aggregate (the "Series B Warrants") with an initial exercise price equal to the Series A/B Exercise Price; (iii) Series C Warrants to purchase the number of shares of Common Stock equal to Maximum Eligibility Number (as defined therein) (the "Series C Warrants") at an initial exercise price equal to $0.539 per share; and (iv) Series D Warrants to purchase the number of shares Common Stock equal to the Maximum Eligibility Number (as defined therein) (the "Series D Warrants" and together with the Series A Warrants, the Series B Warrants and the Series C Warrants, the "Warrants" and the Warrants together with the Common Shares and the shares of Common Stock underlying the Warrants, the "Securities") at an exercise price equal to $0.001 per share, in each case, subject to adjustment and beneficial ownership limitations set forth therein. Subject to the satisfaction or waiver of certain conditions set forth in the Series A Warrants, the Company may force the Buyers to exercise the Series A Warrants in full on the twenty second (22nd) trading day (the "Forced Exercise Date") after the effectiveness of the Company’s registration statement that registers all of the Common Shares and shares underlying the Warrants. The exercise price set forth in each of the Series A Warrants, the Series B Warrants and Series C Warrants is subject to adjustment on certain trigger dates as provided in each such Warrant. The holders of the Series A Warrants, Series B Warrants and Series C Warrants shall be allowed a cashless exercise if a registration statement registering the Securities is not effective within 180 days following the issuance of such Warrants. On certain trigger dates as set forth in the Series D Warrants, the Series D Warrants will become exercisable into a number of shares of Common Stock that would have been issued on the issuance date and upon exercise of the Series A Warrants and Series B Warrants had the purchase price per share and exercise price of the Series A Warrants and Series B Warrants been equal to the applicable reset price as set forth in the Series D Warrant.

The Company expects to receive gross proceeds from the Private Placement of $2.0 million initially, before deducting transaction costs, fees and expenses payable by the Company. The Company intends to use the net proceeds of the Private Placement to first pay certain accrued expenses and the remaining proceeds for working capital purposes and acquisitions.

As required by the Securities Purchase Agreement, each director and officer of the Company has previously entered into a lock-up agreement with the Company whereby each director and officer has agreed that during the period commencing from the date of such agreement until 90 days after the earliest to occur of (x) such time as all of the Securities may be sold without restriction or limitation pursuant to Rule 144 ("Rule 144") under the Securities Act of 1933, as amended (the "1933 Act") and without the requirement to be in compliance with Rule 144(c)(1), (y) the one (1) year anniversary of the Issuance of the Warrants, and (z) the date that the initial registration registering the Securities has been declared effective by the Securities and Exchange Commission (the "SEC"); provided, that, this clause (z) shall only apply if there are no limitations as to the number of Securities registrable pursuant to Rule 415 under the 1933 Act, such director or officer will not sell, hypothecate, pledge, grant any option to purchase, make any short sale or otherwise dispose of or agree to dispose of, directly or indirectly, any shares of Common Stock or Common Stock Equivalents, or establish or increase a put equivalent position or liquidate or decrease a call equivalent position with respect to any shares of Common Stock or Common Stock equivalents owned by such director or officer.

The foregoing descriptions of the Securities Purchase Agreement and the Warrants do not purport to be complete and are qualified in their entirety by reference to the complete text of the Securities Purchase Agreement and the forms of Warrants, which are attached hereto as Exhibits 10.1 and 4.1, 4.2, 4.3 and 4.4, respectively, to this Current Report on Form 8-K and are hereby incorporated by reference into this Item 1.01.

Registration Rights

In connection with the Private Placement, the Company and the investors entered into a Registration Rights Agreement dated August 4, 2020 (the "Registration Rights Agreement") providing for the registration for resale of the Securities (the "Registration Statement") to be filed with the SEC on or prior to twelve (12) business days after the Effective Date. The Company has agreed to use its commercially reasonable best efforts to cause the Registration Statement to be declared effective as soon as possible, but in no event later than the earlier of the (x) seventy fifth (75th) day after the Effective Date and (y) fifth (5th) business day after the Company is notified by the SEC that the Registration Statement will not be reviewed. The Company shall also be required to register Securities not covered by the Registration Statement in accordance with the provisions of the Registration Rights Agreement. If the Company does not meet its filing or effectiveness deadlines or does not maintain its listing on the OTC QB, then, the Company must pay a cash amount to the Buyers equal to two percent (2.0%) of the aggregate Purchase Price for each missed deadline or maintenance failure and then again on successive dates until such filing or effectiveness is achieved or such failure is cured. In the event these payments are not timely made interest at a rate of to 1.5% per month on late payments shall accrue until such amounts are paid.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Registration Rights Agreement, which is attached hereto as Exhibit 4.5 to this Current Report on Form 8-K and is hereby incorporated by reference into this Item 1.01.

Item 3.02 Unregistered Sales of Equity Securities.

The information disclosed in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02. The sale and issuance of the Common Stock and Warrants in the Private Placement have been determined to be exempt from registration under the 1933 Act in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D promulgated thereunder as a transaction by an issuer not involving a public offering, in which the investors are accredited and have acquired the securities for investment purposes only and not with a view to or for sale in connection with any distribution thereof. Such securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Item 3.03 Material Modification to Rights of Security Holders.

On August 4, 2020 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2020 (Press release, Cerus, AUG 4, 2020, View Source [SID1234562785]).

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Recent developments and highlights include:

Q2 2020 Total Revenue of $26.8 million – driven by robust year-over-year platelet kit sales growth in the U.S. and strong plasma and illuminator sales in our EMEA region. Total revenue comprised of (in millions, except %):

Reaffirming 2020 full year product revenue guidance range of $89 million to $93 million – an approximately 20% to 25% increase over 2019 reported product revenue.
Submitted a pre-market approval supplement (PMA-S) to the FDA for pathogen reduced cryoprecipitated fibrinogen complex with 5-day post-thaw storage.
Finalized INTERCEPT Red Cell CE Mark modular submission schedule, in agreement with our notified body, under new MDR submission pathway, providing clarity on the timing and pathway for red blood cells, the most frequently transfused blood component globally.
Reached agreement with FDA on chronic transfusion clinical data required for PMA submission and submitted clinical protocol amendment for the existing Phase 3 RedeS study to allow for enrollment of sickle cell and thalassemia patients.
Announced study results demonstrating that the INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components intended for transfusion.
Awarded a five-year tender by the Hong Kong Red Cross Blood Transfusion Services for INTERCEPT Blood System for platelets.
Cash, cash equivalents, and short-term investments of $136.5 million at June 30, 2020.
"The benefits of pathogen reduced blood products have never been so prominent as they are now during the COVID-19 pandemic. Our Q2 results reflect the highest quarterly product revenue we have recorded to date at $21.5 million. This pandemic has made clear to us not only the resilience of our business during this time, but also the essential role that pathogen inactivation plays in helping ensure the security and safety of the blood supply chain. It has also resulted in greater focus on strategic planning and pandemic preparedness by blood centers," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Demand for INTERCEPT platelet kits continued to be strong in the U.S. as blood centers and hospitals adopt pathogen reduction to be compliant with the FDA guidance document on platelet safety, which has a compliance deadline that is now less than 8 months away."

"Our development programs continued to make progress during the quarter. In May, we submitted our PMA-S for pathogen-reduced cryoprecipitated fibrinogen complex, which could result in potential FDA approval by the end of this year. In addition, meetings with the European and U.S. regulatory agencies in the quarter resulted in more expedited and clear pathways to potentially gain regulatory approvals of the INTERCEPT red blood cell system," continued Greenman.

Revenue

Product revenue during the second quarter of 2020 was $21.5 million, compared to $18.2 million during the same period in 2019. Revenue growth in the quarter benefited from robust year-over-year platelet kit sales in the U.S., in addition to strong plasma kit demand and an increase in illuminator sales in our EMEA region. Year-to-date product revenue totaled $40.1 million, an increase of 12% compared to the same period in 2019.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $5.3 million during the second quarter of 2020, compared to $4.3 million during the same period in 2019, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $11.4 million, compared to $8.7 million in the first half of 2019. The total potential value of the current BARDA agreement is $214 million with $55 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded partially with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the second quarter of 2020 were 55% and consistent with the prior year period. Gross margins during the first half of 2020 were 55% compared to 54% reported in the first half of 2019.

Operating Expenses

Total operating expenses for the second quarter of 2020 were $31.7 million compared to $31.2 million for the same period the prior year. Year-to-date, operating expenses totaled $63.5 million compared to $60.8 million for the first half of 2019.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2020 totaled $16.1 million, compared to $16.7 million for the second quarter of 2019. The year-over-year decline was due to lower travel and marketing related expenses as a result of the COVID-19 pandemic. Year-to-date SG&A expenses totaled $32.0 million compared to $32.9 million for the first half of 2019.

Research and development (R&D) expenses for the second quarter of 2020 were $15.6 million, compared to $14.4 million for the second quarter of 2019. The increase in year-over-year R&D expenses was due to higher expenses associated with initiatives to expand platelet label claims and development of our INTERCEPT red blood cell system. Year-to-date R&D expenses totaled $31.4 million compared to $27.9 million for the first half of 2019.

Net Loss

Net loss for the second quarter of 2020 was $14.9 million, or $0.09 per diluted share, compared to a net loss of $17.6 million, or $0.13 per diluted share, for the second quarter of 2019. Year-to-date net loss was $31.3 million, or $0.19 per diluted share, compared to $36.4 million, or $0.26 per diluted share, in the first half of 2019.

Cash, Cash Equivalents and Investments

At June 30, 2020, the Company had cash, cash equivalents and short-term investments of $136.5 million, compared to $85.7 million at December 31, 2019.

At June 30, 2020, the Company had approximately $39.5 million in outstanding term loan debt, compared to $39.4 million in outstanding term loan debt at December 31, 2019.

2020 Product Revenue Guidance

The Company expects 2020 product revenue to be in the range of $89 million to $93 million, unchanged from the guidance originally provided on January 13, 2020. The guidance range represents approximately 20% to 25% growth compared to 2019 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 6681405. The replay will be available approximately three hours after the call through August 18, 2020.

On August 4, 2020 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, reported financial results and corporate update for the three months ended June 30, 2020 (Press release, Aptose Biosciences, AUG 4, 2020, View Source [SID1234562865]).

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The net loss for the quarter ended June 30, 2020 was $15.8 million ($0.21 per share) compared with $6.2 million ($0.13 per share) for the quarter ended June 30, 2019. Total cash and cash equivalents and investments as of June 30, 2020 were $82.7 million. Based on current operations, we expect that cash on hand and proceeds from the recent public offering provide the Company with sufficient resources to fund all planned operations including research and development into 2023.

"Aptose’s two distinctive clinical assets, CG-806 and APTO-253, are advancing well through dose escalation in their respective clinical trials, both with signs of pharmacologic activity and favorable safety and tolerability to date," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "For CG-806 in particular, we believe these higher doses provide momentum toward the goal of delivering responses in R/R-CLL patients. Plus, with the FDA’s recent allowance of our IND for CG-806 in AML patients at a potentially therapeutic starting dose of 450 mg BID, we continue to execute on our broad strategic plan and are hopeful that CG-806 will deliver benefit to yet another fragile patient population in great need of new therapies."

Key Corporate Highlights

CG-806 Phase 1 a/b B-cell Malignancy Clinical Study – Aptose has completed dose level four (600 mg BID dose cohort) of the CG-806 trial in patients with CLL and other B-cell malignancies. The safety review committee then advanced CG-806 to the fifth dose level of 750 mg BID, and potential patients are being screened for enrollment into this cohort. To date, CG-806 continues to be well-tolerated, and initial indications of desired pharmacologic activity continue to be observed, including strong inhibition of multiple oncogenic driver kinases and a robust increase in peripheral blood lymphocytes – or lymphocytosis – classically ascribed as a response to the inhibition of BTK. Currently, 23 U.S. sites are open for screening and enrolling patients for the study, and more information is available at www.clinicaltrials.gov.

FDA Allowance of IND for CG-806 in AML – In June, Aptose announced that the U.S. Food and Drug Administration (FDA) allowed the company’s Investigational New Drug (IND) application for the initiation of a Phase 1a/b clinical study of CG-806, the company’s highly potent, oral FLT3/BTK inhibitor, in patients with acute myeloid leukemia (AML). Importantly, the desired starting dose of 450mg BID was allowed, as this dose is expected to be pharmacologically active in patients with FLT3 mutated AML. Aptose is working with key AML sites to start enrollment for this study (NCT04477291) in late Q3. Despite recent advances in the treatment of AML, many patients continue to have a poor overall prognosis. CG-806 is the only BTK inhibitor that also possesses strong FLT3 inhibitory activity and is applicable therefore to both lymphoid and myeloid malignancies.

APTO-253 Phase 1b Clinical Study – Aptose recently completed dose level four (100 mg/m2) of the APTO-253 study in patients with AML and MDS and the safety review committee then escalated dosing to 150 mg/m2. Approval of the current protocol amendment with accelerated dosing will allow enrollment at 8 sites. APTO-253 is the only known clinical-stage molecule that can directly target and inhibit expression of the MYC oncogene, shown to reprogram survival signaling pathways and contribute to drug resistance in many malignancies, including AML and B cell malignancies. In the ongoing Phase 1b trial, Aptose has observed MYC suppression in the peripheral blood mononuclear cells (PBMCs) from treated patients with AML and MDS. More information is available at www.clinicaltrials.gov.

Public Offering of Common Shares – In July, Aptose completed an underwritten public offering of 10,500,000 common shares (the "Offering") at the public offering price of US$5.25 per share. Piper Sandler & Co. acted as the sole active book-running manager for the Offering and has been granted a 30-day option to purchase up to an additional 1,575,000 common shares in the Offering, under the same terms and conditions. Gross proceeds from the Offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Aptose, are approximately US$55.125 million.

The net loss for the three-month period ended June 30, 2020 increased by $9.5 million to $15.8 million as compared with $6.2 million for the comparable period in 2019, primarily as a result of an increase of $7.1 million in stock-based compensation in the current period, a combined increase in program costs and related labor costs of approximately $2.6 million on our CG-806 and APTO-253 development programs, and offset by lower general and administrative expenses, after adjusting for stock option compensation, of $185 thousand.

The net loss for the six-month period ended June 30, 2020 increased by $15.6 million to $27.3 million as compared with $11.7 million for the comparable period, primarily as a result of an increase of $10.9 million in stock-based compensation in the current period, a combined increase in program costs and related labor costs of approximately $4.5 million on our CG-806 and APTO-253 development programs, and higher cash-based general and administrative expenses of $384 thousand. These expenses were partially offset by an increase in net finance income of $217 thousand in the current period compared to the comparative period, mostly as a result of higher interest earned on larger balances of cash equivalents and investments held during the six-month period ended June 30, 2020.

Research and development expenses increased by $3.4 million to $6.9 million for the three-month period ended June 30, 2020 as compared with $3.5 million for the comparative period. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for CG-806 increased by approximately $2.1 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation, higher costs associated with the CG-806 Phase 1a/b trial, and the costs associated with start-up for the CG-806 AML trial.

Personnel-related expenses increased by $392 thousand, mostly related to new positions hired since the second quarter of 2019 to support the conduct of the CC-806 Phase 1a/b and APTO-253 Phase 1b clinical trials, and start-up of the CG-806 AML Phase 1 a/b clinical trial.

Stock-based compensation increased by approximately $776 thousand in the three months ended June 30, 2020, compared with the three months ended June 30, 2019, mostly related to an increase in the number of options granted during the six months ended June 30, 2020 and a higher grant date fair value of options as compared with the six months ended June 30, 2019.
Research and development expenses increased by $6.0 million to $12.8 million for the six-month period ended June 30, 2020 as compared with $6.8 million for the comparative period for the same reasons as described above for the three-month period ended June 30, 2020.

General and administrative expenses for the three-month period ended June 30, 2020 were $9.0 million as compared with $2.9 million for the comparative period, an increase of approximately $6.2 million. The increase was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, decreased by approximately $185 thousand in the three months ended June 30, 2020, primarily as a result of lower financing costs in the current period, offset by higher personnel related costs mostly related to two additional hires, including a Chief Business Officer, in the second quarter of 2019, higher insurance and professional and regulatory costs, and higher office administrative costs.

Stock-based compensation increased by approximately $6.4 million in the three months ended June 30, 2020, compared with the three months ended June 30, 2019 mostly related to an increase in the number of restricted share units (RSUs) and options granted during the six-month period ended June 30, 2020, and a higher grant date fair value of options as compared with June 30, 2019.
General and administrative expenses for the six-month period ended June 30, 2020 were $14.9 million as compared with $5.1 million for the comparative period, an increase of approximately $9.8 million. The increase was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, increased by approximately $384 thousand in the six months ended June 30, 2020 primarily as a result of higher personnel related costs mostly related to two additional hires, including a Chief Business Officer, in the second quarter of 2019, higher insurance and professional and regulatory costs, and higher office administrative costs.

Stock-based compensation increased by approximately $9.4 million in the six months ended June 30, 2020, compared with the six months ended June 30, 2019 for the same reasons as described above for the three-month period ended June 30, 2020.
COVID-19 did not have a significant impact on our results of operations for the quarter ended June 30, 2020; although the pandemic did necessitate reconfiguration of office space and the introduction of numerous policies and processes to ensure safety of employees and guests. We have not experienced and do not foresee material delays to the enrollment of patients or timelines for the CG-806 Phase 1a/b trial due to the variety of clinical sites that we have actively recruited for this trial. APTO-253 is administered intravenously, which requires the need for hospital / clinical site resources to assist and monitor patients during each infusion and based on the current conditions caused by COVID-19, future enrollment of patients on this trial is likely to be negatively impacted. Monitoring across all ongoing and planned studies will be impacted by COVID-19, necessitating more remote visits versus on-site; risk-based monitoring plans will minimize the impact on deliverables. As of the date of this report, we have not experienced material delays in the manufacturing of CG-806 or APTO-253 related to COVID-19. Should our manufacturers be required to shut down their facilities due to COVID-19 for an extended period of time, our trials may be negatively impacted.

Conference Call and Webcast

Aptose will host a conference call to discuss results for the quarter ended June 30, 2020 today, Tuesday, August 4, 2020 at 5:00 PM ET. Participants can access the conference call by dialing 1-844-882-7834 (North American toll-free number) and 1-574-990-9707 (international/toll number) and using conference ID # 8367033. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call for seven days by dialing 1-855-859-2056 (toll free number) and 1-404-537-3406 (international/toll number), using the conference ID # 8367033.

On August 4, 2020 Menarini Silicon Biosystems, the pioneer of liquid biopsy technology, reported two new studies describing genetic changes in circulating cancer cells that may improve cancer prognosis and help guide treatment (Press release, Menarini Silicon Biosystems, AUG 4, 2020, View Source [SID1234562854]). These studies were presented as posters at the June 22-24 virtual annual meeting II of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) . Menarini’s CELLSEARCH and DEPArrayTM NxT technologies were used to capture and isolate the circulating tumor cells for analysis. In one study, Massimo Cristofanilli, M.D., F.A.C.P., Associate Director of Translational Research at the Robert H. Lurie Cancer Center of Northwestern University, and colleagues collected blood samples from 239 patients with stage III/IV breast cancer, then isolated and selected more than 200 individual tumor cells from patients with HER2+ cells*. The scientists then sequenced the genetic codes of each of those cells.

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Previously, Dr. Cristofanilli had shown that one specific genetic change in circulating tumor cells, the overexpression of a gene called HER2, was associated with more aggressive metastatic cancer and a worse prognosis. The new study revealed additional genetic alterations that occur more frequently in metastatic breast cancer cells, the most important being a genetic variant called the PTPN1 mutation.

"The new findings are exciting because they deepen our understanding of the mechanisms underlying the critical process of cancer metastasis," said Dr. Cristofanilli. "The genetic alterations we found also could lead to the development of drugs that specifically target the mutations to improve the treatment of this deadly disease."

In the second study, scientists led by Claudio Forcato, PhD, head of the Bioinformatics Unit at Menarini Silicon Biosystems, captured, isolated, and sequenced circulating cancer cells from three patients with multiple myeloma*. They then looked for a genetic phenomenon called "loss-of-heterozygosity" (LoH), in which one of the two alleles that are normally found at a specific spot in the genetic code is lost. They found such LoH events in the cancer cells from all of the multiple myeloma patients. "Our results suggest that loss-of-heterozygosity may be pervasive in multiple myeloma, and may offer a prognostic and predictive biomarker for the disease," explained Dr. Forcato.

"These two new studies show how our technologies are advancing the understanding of cancers like metastatic breast cancer and multiple myeloma, and may lead to improved, more personalized treatment options for patients with these diseases," said Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems, Inc.

CELLSEARCH** is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs to aid physicians in managing patients with metastatic breast, prostate, and colorectal cancers when used in conjunction with other clinical methods of monitoring. The test is also approved by the China Food & Drug Administration for use in monitoring patients with Metastatic Breast Cancer (MBC). The CELLSEARCH System is the most extensively studied CTC technology, with research published in more than 650 peer-reviewed publications.

DEPArray NxT is an image-based digital cell-sorting and isolation platform that enables clinical researchers to conduct molecular analyses on live or fixed cells with single-cell precision.