On January 29, 2021, Aileron Therapeutics, Inc., a Delaware corporation (the "Company"), reported that it entered into a Capital on Demand Sales Agreement (the "Sales Agreement") with JonesTrading Institutional Services LLC and William Blair & Company, L.L.C. (each, an "Agent" and collectively, the "Agents"), pursuant to which the Company may offer and sell shares of its common stock, $0.001 par value per share, having an aggregate offering price of up to $30,000,000 (the "Shares") from time to time through or to the Agents (the "Offering") (Filing, 8-K, Aileron Therapeutics, JAN 29, 2021, View Source [SID1234574417]). On January 29, 2021, the Company filed a prospectus supplement with the Securities and Exchange Commission in connection with the Offering (the "Prospectus Supplement") under its existing Registration Statement on Form S-3 (File No. 333-226650), which became effective on August 7, 2018 (the "Registration Statement").

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Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the Shares in accordance with the terms set forth in the placement notice and by methods deemed to be "at the market offerings" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act").

The Company or the Agents may suspend or terminate the offering of Shares upon notice to the other party and subject to certain conditions. An Agent will act as sales agent using commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of the Nasdaq Stock Market LLC.

The Company has agreed to pay the Agents commissions for their services in acting as agents in the sale of the Shares in the amount of up to 3.0% of gross sales price per share sold under the Sales Agreement. The Company has also agreed to provide the Agents with indemnification and contribution with respect to certain liabilities, including civil liabilities under the Securities Act.

A copy of the Sales Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares will be sold pursuant to the Registration Statement and offerings of the Shares will be made only by means of the Prospectus Supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

On January 29, 2021 Incyte (Nasdaq:INCY) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory, after at least one line of systemic therapy (Press release, Incyte, JAN 29, 2021, View Source [SID1234574416]).

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"The positive CHMP opinion is a crucial milestone for patients with cholangiocarcinoma, who often have very limited treatment options due to the difficulty of identifying patients during the early disease stages," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "Following the recent FDA approval of pemigatinib (Pemazyre), we are delighted to be closer to offering the first targeted therapy in Europe to benefit these patients."

The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. The CHMP’s opinion to recommend the use of pemigatinib is now being reviewed by the European Commission, which has the authority to grant marketing authorizations for medicinal products in the European Union (EU). If approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement and would be commercialized under the brand name Pemazyre.

Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor1,2. In Europe, the incidence of cholangiocarcinoma ranges between 6,000 – 8,0003,4. FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16 percent of patients5,6,7.

About FIGHT-202
The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

The primary endpoint of FIGHT-202 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

For more information about FIGHT-202, visit View Source

About FIGHT
The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or fusions/rearrangements, irrespective of tumor type.

FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

About FGFR and Pemigatinib
Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

On January 29, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that the underwriter of its previously announced underwritten public offering has exercised its option and purchased an additional 70,000 shares of common stock at a price of $40.00 per share (Press release, Greenwich LifeSciences, JAN 29, 2021, View Source [SID1234574415]). Total gross proceeds to the Company from the offering, including the funds received from the prior closing and exercise of this option, are approximately $29.2 million, before deducting underwriting discounts, commissions and other offering expenses payable by the Company.

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Aegis Capital Corp. acted as sole bookrunner for the offering.

A registration statement relating to the shares of common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on December 17, 2020. The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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 January 29, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it filed a certificate of amendment to its certificate of incorporation with the Secretary of State of the State of Delaware to effect a 1-for-6 reverse stock split of its common stock (Press release, Moleculin, JAN 29, 2021, View Source [SID1234574414]). The reverse stock split will take effect at 5:00 pm (Eastern Time) on January 29, 2021, and the Company’s common stock will open for trading on The Nasdaq Capital Market on February 1, 2021 on a post-split basis, under the existing ticker symbol "MBRX" but with a new CUSIP number 60855D200.

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

As a result of the reverse stock split, every six shares of the Company’s common stock issued and outstanding prior to the opening of trading on February 1, 2021 will be consolidated into one issued and outstanding share, with no change in the nominal par value per share of $0.001. No fractional shares will be issued as a result of the reverse stock split. Stockholders of record who would otherwise be entitled to receive a fractional share will be entitled to the rounding up of the fractional share to the nearest whole number.

As a result of the reverse stock split, the number of shares of common stock outstanding will be reduced from approximately 72.0 million shares to approximately 12.0 million shares, and the number of authorized shares of common stock will remain at 100 million shares. As a result of the reverse stock split, proportionate adjustments will be made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all outstanding stock options, restricted stock unit awards and warrants, which will result in a proportional decrease in the number of shares of the Company’s common stock reserved for issuance upon exercise or vesting of such stock options, restricted stock awards and warrants, and, in the case of stock options and warrants, a proportional increase in the exercise price of all such stock options and warrants. In addition, the number of shares reserved for issuance under the Company’s equity compensation plan immediately prior to the reverse stock split will be reduced proportionately.

On January 29, 2021 The NRG Oncology and the American College of Radiology Network (ACRIN) multicenter, reported that phase II trial, NRG-RTOG 1106/ACRIN 6697 is the first randomized trial to demonstrate the feasibility and safety of performing adaptive radiotherapy escalation in patients with locally advanced non-small cell lung cancer (NSCLC) (Press release, NRG Oncology, JAN 29, 2021, View Source [SID1234574411]). The improvement of in-field tumor control appeared similar to the level (1% improvement with 1Gy dose escalation) of the Single Institutional Study of adaptive radiotherapy performed at University of Michigan, and different from that of RTOG617 with non-adaptive high dose radiation in stage III NSCLC. The results were presented at the virtual edition of the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer, Singapore.

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The NRG Oncology randomized phase III trial NRG-RTOG 0617 offered the insight that a higher dose of radiotherapy delivered with chemoradiotherapy actually worsened tumor control and survival for this patient population. NRG-RTOG 1106/ACRIN 6697 was designed to bridge this treatment gap by testing adaptive radiotherapy dose escalation with chemotherapy to see if this treatment could enhance 2-year local-regional tumor control compared to the 60 Gy standard dose of radiotherapy this patient population typically receives. The use of fluorodeoxyglucose-positron emission tomography (FDG-PET/CT) imaging would help identify resistant aggressive tumor identified mid-treatment and adapt personalized treatment plans per each individual’s tolerance.

Patients with Stage III NSCLC were randomly assigned in a 2:1 ratio to receive either the standard radiotherapy at 60 Gy (Standard Arm) or the adaptive radiotherapy treatment that resulted in a median dose escalation of 11 Gy (Adaptive Arm). Patients on both treatment arms received FDG-PET/CT imaging at mid-treatment for radiation. The Standard Arm included 43 eligible patients whereas the Adaptive Arm included 84 eligible patients. The Standard Arm had a median follow up of 3.7 years for surviving patients with acceptable overall radiotherapy compliance rates (92.9% and 50% per protocol). The 2-year overall local-regional progression free rate was 59.5% (95% CI: 37.9, 75.7). Median local-regional progression free time was 27.5 months (95% CI: 14.3, not reached) in the Standard Arm. The Adaptive Arm had a median follow up of 3.4 years for surviving patients with acceptable overall radiotherapy compliance rates (95.8% for the initial course of treatment and 32.4% for adaptive course per protocol) and 2-year overall local-regional progression free rates were 54.6% (95% CI: 39.9, 67.0). Median local-regional progression free time was 28.4 months (95% CI: 19.1, not reached) in the Adaptive Arm. There were no significant differences in grade 3 or worse toxicity of lung, esophagus, and heart or overall survival, progression-free survival, and lung cancer specific survival between treatment arms. Adaptive radiotherapy did increase in-field local-regional tumor control by 11% and in-field primary tumor control by 17% during the trial.

"Not all patients respond the radiation dose escalation in the same way. We have already learned from a genotypic study of RTOG617 (which was recently presented in ASTRO 2020) that only one third of stage III patients with radiation resistant genotype on DNA repair pathway genes will benefit from dose escalation. Future trial designs should be focused on individualizing radiotherapy dose prescriptions according to patient’s intrinsic sensitivity in order to improve survival. Additionally, further research should investigate if adaptive radiotherapy could increase normal tissue sparing factor (Sp) to improve survival on top of dose optimization in each individual," stated Feng-Ming (Spring) Kong, MD, PhD, FACR, FASTRO of the Clinical Oncology Center, the University of Hong Kong – Shenzhen Hospital; and Li Ka Shing Faculty of Medicine, The University of Hong Kong; Department of Radiation Oncology, Case Western Reserve University, and the lead author of the NRG-RTOG 1106/ACRIN 6697 abstract.

This project was supported in parts by National Cancer Institute (NCI) National Institutes of Health (NIH) grants U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), U24CA196067 (NRG Biospecimen Bank), R01CA142840 (Kong), Shenzhen KQTD20180411185028798 (Kong), and NRG NCORP grant.