ReCode Therapeutics to Participate in Upcoming July Investor Conferences?

On July 6, 2022 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, reported that Company leadership will participate in two upcoming investor conferences in July (Press release, ReCode Therapeutics, JUL 6, 2022, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-to-participate-in-upcoming-july-investor-conferences [SID1234619534]):

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William Blair Biotech Focus Conference (New York, NY)
Format: Panel Presentation
Date: Wednesday, July 13, 2022
Time: 2:00 – 2:45 p.m. ET
Cowen RNA Therapeutics Summit (Virtual)
Format: Panel Presentation
Date: Thursday, July 21, 2022
Time: 12:55 – 1:40 p.m. ET

Avalo Therapeutics Announces One-for-Twelve Reverse Stock Split

On July 6, 2022 Avalo Therapeutics, Inc. (Nasdaq: AVTX) reported a one-for-twelve reverse stock split of the Company’s common stock, par value $0.001, which will be effective at 5:00 pm Eastern Time tomorrow, July 7, 2022 (Press release, Avalo Therapeutics, JUL 6, 2022, View Source [SID1234616533]). The Company’s common stock will trade on the Nasdaq Capital Market on a split-adjusted basis beginning on July 8, 2022, under the Company’s existing trading symbol "AVTX".

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The Company is implementing the reverse stock split as planned to increase the per share price of its common stock to regain compliance with the listing requirements of the Nasdaq Capital Market. The new CUSIP number following the reverse stock split will be 05338F207.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage ownership interest in the Company, except to the extent that the reverse stock split results in any of the Company’s stockholders owning a fractional share as described below.

The reverse stock split will reduce the number of shares of common stock issued and outstanding from approximately 112,868,677 to approximately 9,405,724. No fractional shares will be issued in connection with the reverse stock split. Each stockholder who would otherwise be entitled to receive a fraction of a share of the Company’s common stock will instead receive one whole share of common stock.

As of the effective date of the reverse stock split, the number of shares of common stock available for issuance under the Company’s equity incentive plans and issuable upon the exercise of stock options and warrants outstanding immediately prior to the reverse stock split will be proportionately affected by the reverse stock split. The exercise prices of the Company’s outstanding options and warrants will be adjusted in accordance with their respective terms.

There will be no change to the number of authorized shares or the par value per share.

American Stock Transfer & Trust Company, LLC ("AST") is acting as the exchange agent for the reverse stock split and will provide instructions to stockholders of record regarding the reverse stock split. AST will be issuing, automatically and without the need for stockholder action, all of the post-split shares in paperless, "book-entry" form, and AST will hold the shares in an account set up for the stockholder. Stockholders who currently hold certificates need not exchange their certificates to receive their "book-entry" accounts at AST; those current certificates do not need to be submitted to AST for exchange in order to receive the "book-entry" accounts. Those stockholders holding common stock in "street name" will receive instructions from their brokers.

Portage Biotech Bolsters Pipeline with Acquisition of Four Candidates Targeting the Adenosine Pathway

On July 6, 2022 Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported that it has signed an agreement to acquire Tarus Therapeutics, a private company developing adenosine receptor antagonists (Press release, Portage Biotech, JUL 6, 2022, View Source [SID1234616528]). Under the terms of the agreement, Portage will acquire Tarus in exchange for 2,425,999 PRTG shares along with the assumption of $3 million of liabilities. Additionally, payments of up to $32M in Portage shares or cash would be triggered upon achievement of future development and sales milestones. As a result of the transaction, Portage acquires four best-in-class assets targeting different aspects of the adenosine pathway, and is now in a unique position to evaluate the role of adenosine in cancer and other diseases.

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"Portage’s development strategy relies on our ability to identify and efficiently develop novel opportunities to improve the landscape of immuno-oncology treatment for patients with cancer. Based on the extensive scientific literature and promising clinical data supporting the role of adenosine in immunosuppression, we expect that these new products represent such an opportunity," said Dr. Ian Walters, Chief Executive Officer of Portage Biotech. "Coupled with the ongoing progress of our invariant natural killer T cell (iNKT) agonists, PORT-2 and PORT-3, which are currently in Phase 1/2 clinical trials, Portage is well-positioned to make important strides over the next year within our expanded portfolio and numerous milestones on the horizon."

"Historical evidence has proven that adenosine is an important target in cancer research, with multiple approaches in development from biotech and big pharma companies," added David Epstein, independent Director of Tarus Therapeutics and former CEO & Division Head of Pharmaceuticals at Novartis. "Furthermore, the potential promise of the adenosine assets, coupled with Portage’s highly experienced development team, underscores the rationale to partner these best-in-class assets with Portage."

The new assets acquired from Tarus Therapeutics include:

TT-10 (now PORT-6): an adenosine receptor type 2A (A2A) inhibitor to treat solid tumors. PORT-6 has received IND clearance and Portage expects to move into a Phase 1/2 clinical trial by the end of 2022 in an enriched patient population.
TT-4 (now PORT-7): an adenosine receptor type 2B (A2B) inhibitor to treat solid tumors, which has received IND clearance and which Portage plans to initiate clinical development in 2023.
TT-53 (now PORT-8): a dual inhibitor of adenosine receptors 2A and 2B (A2A/A2B) to address solid tumors. Portage plans to submit an IND in the near future.
TT-3 (now PORT-9): a gut selective A2B inhibitor to address gastrointestinal cancers, which is currently in preclinical studies.
Portage believes that having the ability to evaluate all four compounds alone or in combination will unlock the best patient populations and best disease settings (oncology and non-oncology) to leverage the adenosine pathway.

Portage also announced that Robert Glassman, M.D., Ph.D., current EVP of Search and Evaluation at Enavate Sciences, and former independent director of Tarus Therapeutics, will join the Portage Board of Directors. Dr. Glassman brings more than 25 years of healthcare banking, venture investing and advisory experience, including as vice chair of Credit Suisse, Global Healthcare Banking and Venture Partner of Public Equity at OrbiMed. He previously served as clinical assistant professor at Weill Cornell Medicine and has also held academic positions at the Hospital University of Pennsylvania, Cornell and Rockefeller University. Dr. Glassman holds an M.D. from Harvard Medical School and is a Board-certified hematologist-oncologist.

"Portage’s team has a long history of successfully identifying promising therapeutic assets and advancing them toward clinical trials for ultimate commercialization," said Dr. Glassman. "I am thrilled to join the Board of Directors and look forward to working closely with Ian and the team to advance these newly acquired adenosine treatments along with Portage’s broader portfolio of immuno-oncology therapies."

Concurrent with the acquisition, Portage has entered into a committed share purchase agreement for up to $30 million with Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor, providing financing flexibility to Portage. Under the terms of the purchase agreement, Portage will have the right at its sole discretion, but not the obligation, to sell to LPC up to $30 million worth of its ordinary shares over the 36-month term of the agreement based on the market prices prevailing at the time of each sale to LPC, subject to certain conditions. In consideration for entering into the agreement, LPC received 94,508 ordinary shares. This commitment helps support the incremental development costs for the adenosine programs, and also provides significant financial flexibility for advancement of Portage’s existing pipeline of novel immunotherapy treatments, potentially extending Portage’s total cash runway into 2024.

The Portage team wishes to thank the founders and leadership of Tarus: Sushant Kumar, Ph.D., Peter Molloy, and Kasim Mookhtiar, Ph.D., for their efforts to progress the adenosine programs to this point, and looks forward to continuing to collaborate with them to advance the assets through the clinic.

Conference Call and Webcast Details
The Company has scheduled a conference call for Thursday, July 7 at 8:30am Eastern Time to discuss its adenosine programs and combined pipeline in greater detail. There will be a question-and-answer session following management’s prepared remarks.

Access to the live conference call will be available five minutes prior to the start of the call by dialing 1-877-704-4453 (U.S.) or 1-201-389-0920 (International). For all callers, please refer to Conference ID: 13731382. The conference call will be webcast live and will be accessible from the Portage Biotech website at www.portagebiotech.com or through this link: View Source;tp_key=8ef53cb012

This press release does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale of 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.

About Adenosine
A critical mechanism of cancer immune evasion is the generation of high levels of immunosuppressive adenosine within the tumor microenvironment (TME). Research suggests that the TME has significantly elevated concentrations (100-500 fold) of extracellular adenosine. Engagement with adenosine receptors A2A and A2B triggers a dampening effect on the immune response, suppressing effector cell function and stabilizing immunosuppressive regulatory cells. Over-expression of the A2A and A2B receptors leads to poor prognosis in multiple cancers, including prostate cancer, colorectal cancer and lung adenocarcinoma, driven by a reduced ability to generate an immune response against the tumor. These findings have made A2A and A2B high-priority targets for immunotherapeutic intervention. Portage is advancing four first-in-class adenosine inhibitors which together represent the full suite of adenosine-targeting approaches and will enable a comprehensive exploration of how targeting the adenosine pathway could improve response in multiple cancer and non-cancer indications.

Sequoia Raises $9 Billion for Healthcare/Tech Investments in China

On July 6, 2022 Sequoia Sciences reported that New investments in China life science may have declined over the last year, but large investment companies continue to raise large sums to invest, apparently convinced the current slowdown won’t last for long (Press release, Sequoia Sciences, JUL 6, 2022, View Source [SID1234616523]). According to unofficial sources, Sequoia China has raised about $9 billion to make investments in China’s healthcare and tech companies, above its $8 billion target. Investors would have raised the total by 50%, but Sequoia allowed only a $1 billion increase over their goals. So far, Sequoia has declined to comment on the news, which was unofficially leaked to The Information.

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Calithera Biosciences Announces First Patient Enrolled in Phase 2 Clinical Trial of Sapanisertib in Relapsed/Refractory NRF2 (NFE2L2)-Mutated Squamous Non-Small Cell Lung Cancer

On July 6, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, reported that it has enrolled the first patient in a phase 2 clinical trial of sapanisertib (CB-228) in patients with relapsed/refractory NRF2 (NFE2L2)-mutated squamous non-small cell lung cancer (sqNSCLC) (Press release, Calithera Biosciences, JUL 6, 2022, View Source [SID1234616522]).

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NRF2 mutations are found in a considerable sub-population of patients across multiple solid tumor types. Sapanisertib is a potent and selective, dual mTORC 1/2 inhibitor that targets a key survival mechanism in tumors harboring these mutations. The compound previously demonstrated single-agent clinical activity in patients with relapsed/refractory NRF2-mutated sqNSCLC. Approximately 50,000 to 60,000 individuals are diagnosed with sqNSCLC in the United States alone each year, and about 15% of all sqNSCLC tumors harbor the NRF2 mutation.

"Our experience enrolling biomarker-driven clinical trials has allowed us to quickly advance sapanisertib since acquiring it from Takeda in the fourth quarter of last year. Enrollment of the first patient in this phase 2 study marks an important milestone for the program," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Sapanisertib has the potential to be a first-in-class treatment for patients with NRF2-mutated squamous lung cancer, a patient population with poor prognosis and high unmet need. This study is designed to further validate the NRF2 mutation as a selection biomarker, and we plan to share data from the trial by the first quarter of 2023."

The phase 2 trial (NCT05275673) is a multicenter, open-label study of sapanisertib monotherapy in patients with NRF2-mutated sqNSCLC whose disease has progressed on or after platinum-doublet chemotherapy and immune checkpoint inhibitor therapy (anti-PD-L1) with or without anti-CTLA-4, administered as separate lines of therapy or in combination. The study will evaluate sapanisertib 2 mg twice a day or 3 mg once a day in patients with sqNSCLC harboring either wild-type (WT) or mutated NRF2, as detected by next-generation sequencing.

The study is designed to confirm the selective activity of sapanisertib in NRF2-mutated tumors compared to WT tumors, and to refine dose in this biomarker-defined population. The primary endpoints of the study are investigator-assessed overall response rate (ORR) per RECIST v1.1, and safety. Secondary endpoints include duration of response, progression-free survival and overall survival.

Data from this study could position Calithera to initiate a study with registrational intent in biomarker-specific sqNSCLC populations.