On December 14, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reproted the closing of its previously announced underwritten public offering of 7,840,909 shares of its common stock at a price to the public of $22.00 per share (Press release, Syndax, DEC 14, 2022, View Source [SID1234625270]). This includes the exercise in full by the underwriters of their option to purchase up to 1,022,727 additional shares of common stock. The aggregate gross proceeds to Syndax from this offering were $172.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Syndax. Following the closing of the Offering, Syndax has 68,100,918 shares issued and outstanding as of December 14, 2022.

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Goldman Sachs & Co. LLC, J.P. Morgan and Cowen acted as joint book-running managers for the offering. BTIG and B. Riley Securities acted as co-lead managers for the offering.

The shares were offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 14, 2022 Qu Biologics Inc., a clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, reported a new collaboration with Associate Professor Jonas Fuxe and his research team at the Karolinska Institute (KI) in Stockholm, Sweden, to characterize the molecular targets of Qu’s SSI therapy at the tissue level that lead to resolution of disease (Press release, Qu Biologics, DEC 14, 2022, View Source;utm_medium=rss&utm_campaign=qu-biologics-and-karolinska-institute-initiate-important-new-collaboration-to-validate-molecular-mechanisms-of-qu-biologics-first-in-class-immunotherapy-platform [SID1234625268]). This collaboration will include assessment of tissue biopsies from the gastrointestinal (GI) tract of patients with moderate-to-severe Crohn’s disease (CD) who experienced histological healing upon treatment with QBECO, Qu’s GI-targeting SSI.

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Epithelial cells on mucosal surfaces are an important immune interface between microbial invaders and human tissue. Loss of epithelial barrier function is commonly seen in diseases associated with chronic inflammation and can be exceedingly challenging to resolve. Compromised intestinal epithelial barrier function is present in inflammatory bowel diseases (IBD), such as ulcerative colitis and Crohn’s disease, which are currently treated with lifelong aggressive immune suppressive medication to manage symptoms. Despite the arsenal of immune suppressive medication used to treat IBD, most patients experience disease progression. QBECO SSI treatment, which is designed to restore normal innate immune function, immune homeostasis, and barrier function in the GI tract, provides a novel potentially transformative alternative to immunosuppressive therapies for patients living with IBD.

Associate Professor Fuxe, acting Head of the Division of Pathology and from January 1, 2023, Head of the Department of Laboratory Medicine at KI, is a renowned scientist in epithelial cell biology. Qu’s collaboration with his team will initially focus on validating, at the tissue level, data demonstrating that the expression of genes associated with damaging, unproductive inflammation that disrupt epithelial barrier function can be normalized in the GI tract of patients with moderate-to-severe Crohn’s disease upon treatment with QBECO SSI. This partnership is anticipated to further understanding of epithelial integrity and plasticity in the context of immune dysfunction and how SSI treatment helps restore barrier function through targeting innate immune modulation in the GI tract. In addition, this collaboration may help identify patients, based on the tissue profiling of their disease, who may benefit the most from SSI treatment for inflammatory conditions associated with a loss of barrier function, such as Crohn’s disease. Such an advance would enable precision medicine for patients living with CD.

Both the Fuxe team at KI and Qu’s science team are excited about the scientific and medical potential of this collaboration. Dr. Jonas Fuxe states, "We have a long-standing interest in identifying mechanisms and targets that may prevent loss of epithelial integrity in chronic inflammatory and cancer diseases. We are excited by the collaboration with Qu Biologics, which timely opens new avenues to explore links between epithelial and immune dysfunction." Immunologist Dr. Shirin Kalyan, VP Scientific Innovation of Qu Biologics, notes, "Molecular characterization of how QBECO SSI leads to disease resolution in the GI tract in patients with IBD has the potential to identify which patients are most likely to benefit from this innovative approach to restore gastrointestinal health, which could be life-changing for these patients. We are very excited to be working with Associate Professor Fuxe and his team at KI to address this critically important issue." Dr. Hal Gunn, CEO of Qu Biologics, adds, "Given KI’s reputation and high regard in the field of immunology, we are very pleased to be collaborating with Dr. Fuxe and his team on this important project."

On December 14, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products issued a positive opinion on Panbela’s application for orphan designation of ivospemin (SBP-101) in combination with gemcitabine and nabPaclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA) (Press release, Panbela Therapeutics, DEC 14, 2022, View Source;utm_medium=rss&utm_campaign=panbela-receives-positive-ema-opinion-on-orphan-designation-for-ivospemin-sbp-101-in-combination-with-gemcitabine-and-nab-paclitaxel-in-patients-with-metastatic-pancreatic-ductal-adenocarcinoma [SID1234625267]). Previously, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to SBP-101.

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"We are pleased to receive a notification of positive opinion for orphan drug designation from EMA’s Committee Orphan Medicinal Products following its December plenary meeting," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "The opinion is timely, as we only a few weeks ago announced first patients enrolled in Europe in our ASPIRE trial. We continue to advance the global clinical trial, as we aim for interim analysis in early 2024."

Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products. The EMA’s orphan designation is available to companies developing treatments for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the EU. Medicines that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization.

Panbela is continuing to focus on site initiation and enrollment to ultimately deliver a more effective treatment for pancreatic cancer, a deadly disease with few treatment options. The Company expects that a significant number of global sites will be open by year-end with the full complement of sites open by early-to-mid 2023.

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101

Ivospemin Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. For more information, please visit View Source

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigatorinitiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.

On December 14, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that the European Commission (EC) has designated upifitamab rilsodotin (UpRi) as an orphan medicinal product for the treatment of ovarian cancer (Press release, Mersana Therapeutics, DEC 14, 2022, View Source [SID1234625266]). UpRi is Mersana’s first-in-class NaPi2b-targeting ADC with a novel scaffold-linker-payload that is designed to enable a high drug-to-antibody ratio and controlled bystander effect.

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"Receiving this orphan designation in the European Union is an important regulatory milestone for Mersana as we seek to expedite UpRi’s global development," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "This designation reinforces the unmet needs that patients with ovarian cancer continue to face today. We look forward to advancing our ongoing clinical trials, which aim to establish UpRi as a foundational medicine in ovarian cancer."

The European Commission designates drugs as orphan medicinal products based on positive opinions adopted by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). Orphan designations are granted for potential treatments for rare diseases that are life-threatening or chronically debilitating that affect fewer than five in 10,000 people across the European Union. Medicines designated as orphan medicinal products by the EMA may qualify for financial and regulatory incentives, including protocol assistance at reduced fees during product development, access to centralized marketing authorization and 10 years of marketing exclusivity in the European Union after product approval.

On December 14, 2022 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug development company focused on DNA-based immunotherapy and next-generation vaccines, reported that the Compensation Committee of the Company’s Board of Directors approved the grant of (i) inducement stock options (the "Inducement Option Grants") to purchase a total of 19,000 shares of common stock and (ii) restricted stock grants (the "Inducement Stock Grants") totaling 4,000 shares of common stock as a material inducement to the employment to four individuals hired by IMUNON during the fourth quarter of 2022 (Press release, IMUNON, DEC 14, 2022, View Source [SID1234625265]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635 (c)(4).

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The Inducement Option Grants have an exercise price per share equal to $1.40 which is equal to the closing price of IMUNON’s common stock as reported by Nasdaq on December 13, 2022. The Inducement Option Grants vest in thirds over three years with the vesting starting on the one-year anniversary of each employee’s first day of employment with the Company and thereafter vest in two additional installments so all Inducement Option Grants will be fully vested and exercisable as of December 13, 2025, subject to each employee’s continued service relationship with the Company on each such date. Each Inducement Option Grant has a ten-year term.

Each of the Inducement Stock Grants will vest on the one-year anniversary of each employee’s first date of employment with the Company and are subject to each such employee’s continued service relationship with the Company on such vesting date.