On August 2, 2021 Jacobio Pharmaceuticals (1167.HK) reported the first patient was dosed in a Phase I/II clinical trial of KRAS G12C inhibitor JAB-21822 in China (Press release, Jacobio Pharmaceuticals, AUG 2, 2021, View Source [SID1234585554]).

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JAB-21822 is Jacobio’s innovative in-house small molecule anti-cancer drug, which is designed to target the KRAS G12C mutation. It will be used to treat advanced solid tumors with KRAS G12C mutation, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors. The global incidence of the KRAS G12C mutation in patients with NSCLC, ovarian cancer, CRC and pancreatic cancer reached approximately 295,000 in 2019.

JAB-21822 has best-in-class potential among KRAS G12C inhibitors. Internal pre-clinical head-to-head animal studies comparisons have shown JAB-21822 to have a superior pharmacokinetic (PK) profile and favorable tolerability as well as potential for a superior dosing profile in comparison with its competitors.

The Phase I/II trial is a multi-center, open label study of assessing the safety and tolerability of JAB-21822 in patients with advanced solid tumors and the efficacy of JAB-21822 in patients with non-small lung cancer harboring KRAS G12C mutation.

"KRAS is the first oncogene discovered by scientists, it has long been considered ‘undruggable’ for its smooth surface so that it’s hard to bind with small molecule anti cancer drug. We hope that JAB-21822 will benefit more patients with better treatment choice", said Professor Lin Shen of the Beijing Cancer Hospital.

"JAB-21822 is our in-house innovative drug candidate with promising pre-clinical data. We will continue to advance clinical trials with researchers, so that we can bring hope to patients," said Dr. Yinxiang Wang, Chairman and CEO of Jacobio.

The clinical study of JAB-21822 has been initiated after the IND (investigational new drug) approval by the US FDA in May 2021.

On August 2, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCBD) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that The Nasdaq Stock Market LLC (Nasdaq) has approved the listing of the Company’s common stock on Nasdaq (Press release, PharmaCyte Biotech (BioStrat), AUG 2, 2021, View Source [SID1234585552]). The Company’s common stock will be listed on Nasdaq under the symbol "PMCB." PharmaCyte also announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock (or pre-funded warrants to purchase common stock in lieu of common stock) and warrants to purchase shares of common stock in an underwritten public offering.

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With respect to the proposed public offering, the Company expects to grant the underwriter a 30-day option to purchase additional shares of its common stock and/or warrants to purchase shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the securities to be sold in the offering are to be offered by PharmaCyte.

H.C. Wainwright is acting as sole book-running manager for the proposed offering.

The Company’s common stock will continue to trade on the OTC Markets quotation system on the OTCQB Venture Market until trading commences on Nasdaq, which the Company expects to occur following the pricing of the proposed public offering. The offering, however, is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

PharmaCyte intends to use the net proceeds of this offering (i) to complete activities requested by the U.S. Food and Drug Administration (FDA) in order to address the FDA’s clinical hold on its Investigational New Drug application (IND) with respect to the Company’s planned Phase 2b clinical trial in locally advanced, inoperable, pancreatic cancer (LAPC), including conducting several additional preclinical studies and assays and providing the FDA with the additional information it requested, (ii) to begin to fund and conduct the Phase 2b clinical trial in LAPC, if and when the clinical hold on the IND is lifted, and (iii) for general working capital purposes.

The securities described above are being offered by PharmaCyte pursuant to a shelf registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the Securities and Exchange Commission (SEC) on April 14, 2021. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and the accompanying prospectus forming a part of the registration statement.

On August 2, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced translational genomics and diagnostics for cancer, reported the publication of its study "Prediction of immunotherapy response in melanoma through combined modeling of neoantigen burden and immune-related resistance mechanisms,"(1) in Clinical Cancer Research, a journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Personalis, AUG 2, 2021, View Source [SID1234585551]).

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The study details the development of the Personalis Neoantigen Presentation Score (NEOPS), a novel composite biomarker for predicting response to cancer immunotherapy. Enabled by comprehensive tumor immunogenomic profiling from the Personalis NeXT Platform, NEOPS simultaneously models both neoantigen burden and immune-related resistance mechanisms to better predict immunotherapy response in a cohort of late-stage melanoma patients. In this study, NEOPS was more strongly predictive of therapy response than other standard single analyte and investigational biomarkers tested, including tumor mutational burden. Performance of this composite biomarker was initially tested on a cohort of late-stage melanoma patients receiving immune checkpoint blockade therapies and later validated on an independent dataset of similarly treated late-stage melanoma patients.

"Given the varied response to immunotherapy as well as the potential toxicities associated with treatment, there is a need for improved biomarker approaches to better predict which patients will respond to therapy," said Richard Chen, MD, Personalis CMO. "Our findings suggest that integrative, multi-omic biomarkers like NEOPS can be stronger predictors of response than simpler, single-analyte approaches, especially in the setting of new cancer therapies where the underlying biological mechanisms governing response are highly complex. We feel that NEOPS and other composite biomarkers will be important, sharper tools for enabling precision oncology."

NEOPS utilizes technology that Personalis has been developing since 2015 to better predict neoantigens and identify associated escape mechanisms such as HLA LOH. Our ImmunoID NeXT, and clinical NeXT Dx tests make this advanced capability, including NEOPS, available to pharmaceutical researchers and clinicians for clinical trials and investigational use, and additional clinical studies with other tumor types are planned.

On August 2, 2021 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported financial results for the three months ended June 30, 2021 and highlighted recent progress (Press release, Verastem, AUG 2, 2021, View Source [SID1234585550]).

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"There were several achievements of note during the second quarter, specifically the receipt of Breakthrough Therapy designation for VS-6766 in combination with defactinib for the treatment of recurrent low-grade serous ovarian cancer. Updated data from the investigator-initiated FRAME study, which was the basis for Breakthrough Therapy designation, has been accepted for presentation at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021," said Brian Stuglik, CEO of Verastem Oncology. "Further, subsequent to the end of the second quarter, we eliminated substantially all of our outstanding debt through conversion of $28 million of our convertible senior notes, saving the Company over $30 million and enabling a cash runway that is expected to last until at least 2024."

Recent Corporate Highlights

Low-Grade Serous Ovarian Cancer (LGSOC)

Updated results from the investigator-sponsored Phase 1/2 FRAME study in LGSOC were selected for a mini oral presentation at ESMO (Free ESMO Whitepaper) 2021. The presentation will take place on Sunday, September 19, 2021 at 17:50 CEST.
Received Breakthrough Therapy designation for VS-6766 in combination with defactinib for the treatment of recurrent LGSOC, regardless of KRAS status, following one or more prior lines of therapy, including platinum-based chemotherapy.
Continued progress with the company-sponsored, registration-directed Phase 2 study (RAMP 201) investigating VS-6766 alone and in combination with defactinib for the treatment of recurrent LGSOC. The Company expects to report top-line results from the selection phase of RAMP 201 and commence expansion phase during the first half of 2022.
KRAS Mutant Non-small Cell Lung Cancer (NSCLC)

Continued progress in company-sponsored, registration-directed Phase 2 study (RAMP 202) investigating VS-6766 alone and in combination with defactinib for the treatment of patients with KRAS G12V mutant NSCLC. The Company expects to report top-line results from the selection phase of RAMP 202 and commence expansion phase during first half of 2022.
Corporate and Financial

Converted all of the $28.0 million aggregate principal of the Company’s 2020 5.00% Convertible Senior Notes due 2048 in exchange for approximately 8.6 million shares of common stock. The conversion eliminates substantially all outstanding debt and preserves approximately $31.2 million in cash. Cash runway expected until at least 2024 to deliver on current programs.
During the second quarter 2021, Verastem Oncology appointed Paul Bunn, M.D., and Lesley Solomon to its Board of Directors.
Second Quarter 2021 Financial Results

Verastem Oncology ended the second quarter 2021 with cash, cash equivalents and investments of $114.1 million.

Total revenue for the three months ended June 30, 2021 (2021 Quarter) was $0.5 million, compared to $4.3 million for the three months ended June 30, 2020 (2020 Quarter).

Total operating expenses for the 2021 Quarter were $16.4 million, compared to $25.6 million for the 2020 Quarter.

Selling, general and administrative expenses for the 2021 Quarter were $6.7 million, compared to $15.4 million for the 2020 Quarter. The decrease of $8.7 million, or 56%, primarily resulted from the Company’s shift in strategic direction and the COPIKTRA sale to Secura Bio, Inc., which led to lower employee related expenses and consulting and professional fees.

Research and development expenses for the 2021 Quarter were $9.7 million, compared to $9.3 million for the 2020 Quarter. The increase of $0.4 million, or 4%, was primarily related to increased personnel related costs, including non-cash stock-based compensation, partially offset by a decrease in contract research organization costs.

Net loss for the 2021 Quarter was $16.9 million, or $0.10 per share (basic and diluted), compared to $23.0 million, or $0.14 per share (basic and diluted), for the 2020 Quarter.

For the 2021 Quarter, non-GAAP adjusted net loss was $14.0 million, or $0.08 per share (diluted), compared to non-GAAP adjusted net loss of $20.5 million, or $0.12 per share (diluted), for the 2020 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

Financial Guidance and Outlook

With the proceeds and expected milestones and royalties from the sale of COPIKTRA, Verastem Oncology expects that it will have a cash runway until at least 2024 to deliver on the current programs for VS-6766 and defactinib, including expenditures and development in LGSOC and KRAS mutant NSCLC. Verastem Oncology expects its 2021 annual operating expenses to be approximately $55-60 million.

Use of Non-GAAP Financial Measures

To supplement Verastem Oncology’s condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), the Company uses the following non-GAAP financial measures in this press release: non-GAAP adjusted net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with the Company’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to the Company’s operating performance and can enhance investors’ ability to identify operating trends in the Company’s business. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company’s operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three and six months ended June 30, 2021 and 2020 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

About the VS-6766/Defactinib Combination

The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mutant tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRAS mutant NSCLC and colorectal cancer (CRC). The FRAME study was expanded to include new cohorts in pancreatic cancer, KRAS mutant endometrioid cancer and KRAS-G12V NSCLC. Verastem Oncology is also supporting an investigator-initiated Phase 2 trial evaluating VS-6766 with defactinib in patients with metastatic uveal melanoma. Verastem Oncology has initiated Phase 2 registration-directed trials of VS-6766 with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS-G12V mutant NSCLC as part of its RAMP (Raf And Mek Program).

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

On August 2, 2021 TYME Technologies, Inc. (Nasdaq: TYME) (the "Company" or "TYME"), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that the Company will report its first quarter 2022 financial results on Tuesday, August 10, 2021 at 8:30 AM ET (Press release, TYME, AUG 2, 2021, View Source [SID1234585549]).

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Richie Cunningham, Chief Executive Officer, and Frank Porfido, Chief Financial Officer, will host a conference call and webcast as follows:

The webcast will be accessible on the Events & Presentations page of the Investors section of the TYME website, tymeinc.com, and will be archived for 90 days following the event.

Following the Company’s presentation, there will be a Q&A session. Management will address both live questions and those submitted in advance via email to [email protected]. The deadline to submit questions for the conference call is 5:00 PM ET on August 6, 2021.