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Infinity Announces Proposed Public Offering of Common Stock

On February 11, 2021 Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, an oral, immuno-oncology macrophage reprogramming therapeutic candidate, which is designed to address a fundamental biologic mechanism of immune suppression in cancer, reported that it has commenced an underwritten public offering of its common stock (Press release, Infinity Pharmaceuticals, FEB 11, 2021, View Source [SID1234574918]). In addition, the Company intends to grant the underwriters a 30-day option to purchase an additional 15% of the shares of its common stock offered in the public offering on the same terms and conditions. The offering is subject to market and other conditions and there can be no assurances as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares in the offering will be sold by the Company.

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Piper Sandler & Co. is acting as sole book-running manager for the offering.

Infinity intends to use net proceeds from the offering for the continued clinical development of eganelisib, for general corporate purposes and for working capital.

The offering will be made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-230258) that became effective with the Securities and Exchange Commission (the "SEC") on April 29, 2019, the base prospectus contained therein and a prospectus supplement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering and the shares of common stock being offered will be filed with the SEC. Before you invest, you should read the prospectus in the registration statement, the preliminary prospectus supplement, and other documents the Company has filed with the SEC for more complete information about the Company and this offering. Copies of the registration statement, the preliminary prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or, when available, by contacting: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

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

Kaleido Biosciences Announces the Exercise of the Underwriters’ Option to Purchase Additional Shares of Common Stock

On February 11, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported that, in connection with its previously announced underwritten public offering of common stock, the underwriters have fully exercised their option to purchase an additional 787,500 shares of common stock from the Company (Press release, Kaleido Biosciences, FEB 11, 2021, View Source [SID1234574916]). The exercise of this option increases the size of the offering to an aggregate of 6,037,500 shares at a price to the public of $11.50 per share. The gross proceeds to Kaleido from this offering were approximately $69.4 million, before deducting underwriting discounts and commissions and other offering expenses. The purchase of the additional shares of common stock closed on February 11, 2021.

Morgan Stanley and Piper Sandler acted as joint book-running managers for the offering. Canaccord Genuity acted as lead manager for the offering.

Kaleido intends to use the net proceeds from the offering, in addition to its existing cash resources, to fund its continued research and development activities, including the completion of the ongoing clinical studies of KB109 in patients with mild-to-moderate COVID-19 and the ongoing clinical study of KB295 in patients with mild-to-moderate ulcerative colitis; to conduct additional studies or initiate preparation for commercialization of KB109 if current studies in patients with mild-to-moderate COVID-19 are successful; to generate additional data and/or begin clinical studies in other areas such as immuno-oncology, cardiometabolic and liver diseases and diseases associated with pathogens; to fund any other research and development activities that relate to its current and future clinical and preclinical activities; and the remainder for planned general and administrative expenses, working capital and other general corporate purposes.

The securities described above were offered by Kaleido pursuant to a shelf registration statement on Form S-3 (No. 333-240323) that was declared effective by the Securities and Exchange Commission (SEC) on August 14, 2020. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on February 5, 2021 and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

This press release does not constitute an offer to sell or the 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 that state or jurisdiction.

2 Austin medical companies expect to raise millions with stock offerings

On February 11, 2021 Genprex reported that 4 million shares of its stock to two of the company’s institutional investors for $6.25 per share, according to a filing with the U.S. Securities and Exchange Commission (Press release, Genprex, FEB 11, 2021, View Source [SID1234574915]). Genprex estimates it will net $23.2 million from the stock offering, which it said it expects to close this week.

Genprex – which is working on a gene therapy technologies aimed at treating patients with cancer and diabetes – says it intends to use the net proceeds for working capital and other general corporate purposes, according to the securities filing.

Genprex also raised about $12 million with a stock offering in December. The company also had stock offerings of $8 million and $17.5 million last year. Genprex, which previously operated as Convergen LifeSciences, became a publicly traded company in 2018 through an initial public offering of stock valued at about $6.4 million.

Genprex’s shares were trading at about $7.40 on Wednesday afternoon.

Also this week, Austin-based VolitionRx said it expects to raise about $20 million by selling roughly 4 million shares of its common stock. The company said it expects the offering to close this week, according to a securities filing.

VolitionRx is a life sciences company that develops blood tests to diagnose a range of cancers and other diseases.

VolitionRx plans to use the proceeds from the stock offering for general corporate purposes, "which may include continued product development, clinical studies, product commercialization, working capital and other general corporate purposes, including potential strategic acquisitions," the company said in a securities filing.

Cardiff Oncology Presents Phase 2 mCRPC Trial Data Showing a Two-Fold Increase in Efficacy with an Optimized Onvansertib Dosing Schedule

On February 11, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer, castrate-resistant prostate cancer and leukemias, reported that updated data from its Phase 2 metastatic castrate-resistant prostate cancer (mCRPC) trial were featured in a virtual oral poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU) (Press release, Cardiff Oncology, FEB 11, 2021, View Source [SID1234574914]). The ongoing Phase 2 trial evaluates the all-oral combination of onvansertib, abiraterone and prednisone in patients showing initial abiraterone resistance, as defined by two consecutive rises in prostate-specific antigen (PSA) levels.

Newly presented data from the Phase 2 mCRPC trial showed that increasing the number of days of treatment with onvansertib from 5 to 14 in a 21-day cycle was associated with a greater than two-fold increase (29% to 63%) in disease control rate (DCR; defined by lack of PSA progression) at 12 weeks, the trial’s primary efficacy endpoint. Six of eight (75%) evaluable patients receiving onvansertib for 14 of 21 days per cycle had stable disease upon radiographic scan at 12 weeks and five of these patients remain on treatment to-date. Across all cohorts, the DCR at 12 weeks is 35% (13/37), indicating the trial is on track to meet the stated criteria for success on its primary efficacy endpoint (30% DCR at 12 weeks).

"The preliminary data presented at ASCO (Free ASCO Whitepaper)-GU support a clinically meaningful onvansertib exposure effect," said David Einstein, M.D., attending physician at Beth Israel Deaconess Medical Center and principal investigator of the onvansertib mCRPC Phase 2 trial. "In the first eight patients treated to-date on Arm C, we are excited to see an increase in DCR with greater time on onvansertib, without excessive toxicity. Together with the clinically meaningful rates of disease control, and duration of disease control, we are seeing across all cohorts, these data demonstrate onvansertib’s potential to address a critical unmet need for patients with abiraterone-resistant mCRPC."

"As data from this trial continue to emerge, we are very pleased to see increased efficacy with an optimized dosing schedule that is both well tolerated and increases the number of days a patient receives onvansertib in combination with abiraterone by nearly 3-fold" said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "These data suggest that the synergy demonstrated between onvansertib and abiraterone in pre-clinical models is being observed clinically. The trial’s biomarker analyses are also promising, as the identification of mutations associated with response to the combination of onvansertib and abiraterone may enable more efficient design of future clinical studies and the identification of patients most likely to benefit from this combination."

Key data and conclusions from the ASCO (Free ASCO Whitepaper)-GU presentation include:

Efficacy:

The optimized dosing schedule of cohort C shows a greater than two-fold improvement in disease control rate compared to cohorts A and B
63% (5/8) of cohort C patients achieved the primary efficacy endpoint compared to 29% (5/17) and 25% (3/12) of cohort A and B patients, respectively
75% (6/8) of evaluable patients in cohort C had radiographic SD at 12 weeks, compared to 53% (9/17) in cohort A, 42% (5/12) in cohort B and 54% (20/37) across all cohorts
All cohort C patients achieving the primary efficacy endpoint remain on treatment
35% (13/37) of evaluable patients across all cohorts (A-C) achieved the primary efficacy endpoint of disease control at 12 weeks
Efficacy was observed in patients harboring androgen receptor (AR) alterations associated with abiraterone resistance across all 3 arms
Biomarker:

Circulating tumor DNA (ctDNA) analysis revealed differences in baseline genomic profiles of patients achieving SD at 12 weeks vs. those progressing at or before 12 weeks
Mutations present exclusively in patients with SD at 12 weeks were associated with cell cycle and DNA repair pathways that may result in increased efficacy of the onvansertib-abiraterone combination
Safety:

Data show that the combination of onvansertib and abiraterone is well tolerated across the three different dosing schedules of cohorts A-C:
Cohort A: 24 mg/m2 onvansertib on Days 1-5 of 21-day cycles, plus abiraterone and prednisone beginning on Day 1 and continuing uninterrupted throughout each cycle
Cohort B: 18 mg/m2 onvansertib on Days 1-5 of 14-day cycles, plus abiraterone and prednisone beginning on Day 1 and continuing uninterrupted throughout each cycle
Cohort C: 12 mg/m2 onvansertib on Days 1-14 of 21-day cycles, plus abiraterone and prednisone beginning on Day 1 and continuing uninterrupted throughout each cycle
The virtual poster, A Phase 2 Study of the Polo-like Kinase 1 (PLK1) Inhibitor Onvansertib in Combination with Abiraterone and Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC), is available on the "Scientific Presentations" section of the Cardiff Oncology website at View Source

About the Phase 2 Trial of Onvansertib in Metastatic Castration-Resistant Prostate Cancer
This trial is a Phase 2 open-label study of onvansertib in combination with abiraterone and prednisone, all administered orally, in patients with metastatic castration-resistant prostate cancer showing signs of early progressive disease (demonstrated by two rising prostate-specific antigen values separated by at least one week with no or minimal symptoms) while on Zytiga/prednisone therapy. The primary efficacy endpoint is the proportion of patients achieving disease control after 12 weeks of study treatment, as defined by a lack of prostate-specific antigen (PSA), radiographic, or symptomatic progression. The trial is being conducted by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber Cancer Institute (Dana-Farber), and Massachusetts General Hospital Cancer Center (MGH). David Einstein, M.D., Genitourinary Oncology Program at BIDMC, is the principal investigator for the trial. For more information on the trial, please visit View Source

Infinity Pharmaceuticals to Present at Upcoming BIO CEO & Investor Conference

On February 11, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer, reported that management will be presenting at the BIO CEO & Investor Conference taking place February 16-18 (Press release, Infinity Pharmaceuticals, FEB 11, 2021, View Source [SID1234574913]). Presentations details are below:

BIO CEO & Investor Conference Presentation Details:
Date:

February 16 – 18

Presentation:

Available on demand starting February 16th at 10am EST

The link for the presentation will be available at www.infi.com.