Histogen Announces $4.75 Million Private Placement

On March 23, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has entered into a securities purchase agreement with certain institutional investors to purchase 2,500 shares of Series A redeemable convertible preferred stock and 2,500 shares of Series B redeemable convertible preferred stock (Press release, Conatus Pharmaceuticals, MAR 23, 2022, View Source [SID1234610984]). Each share of Series A and Series B preferred stock has a purchase price of $952.38, representing an original issue discount of approximately 5% of the $1,000 stated value of each share. Each share of Series A and Series B preferred stock is convertible into shares of Histogen’s common stock at an initial conversion price of $1.00 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval for an amendment to the Company’s certificate of incorporation that allows the Company to effectuate a reverse stock split of the Company’s common stock. Histogen will be permitted to compel conversion of the Series A and Series B preferred stock after the fulfillment of certain conditions and subject to certain limitations. Total net proceeds from the offerings, before deducting the placement agent’s fees and other estimated offering expenses, is approximately $4.75 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Series A and Series B preferred stock permit the holders thereof to vote together with the holders of the Company’s common stock on a proposal to effect a reverse stock split of the Company’s common stock at an annual or special meeting of Company stockholders. The Series A preferred stock permits the holder to vote on such proposal on an as-converted to common stock basis based on the minimum price under Nasdaq rules on the issuance date. The Series B preferred stock permits the holder to cast 30,000 votes per share of Series B preferred stock on such proposal. The Series A and Series B preferred stock will not be permitted to vote on any other matter. The holders of the Series A and B preferred stock agreed not to transfer their shares of preferred stock until after the stockholder meeting. The holders of the Series A preferred stock agreed to vote their shares on the reverse stock split proposal and the holders of the Series B preferred stock agreed to vote their shares on such proposal in the same proportions as the shares of common stock and Series A preferred stock are voted on such proposal. The holders of the Series A and Series B preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares commencing after the earlier of the Company’s stockholders’ approval of the reverse stock split and 90 days after the closing of the issuances of the Series A and Series B preferred stock and until 120 days after such closing.

The closing of the offering is expected to occur on or about March 25, 2022, subject to the satisfaction of customary closing conditions. Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

To the extent Series A or B preferred stock is converted or otherwise not redeemed after 120 days from closing, the Company will use such net proceeds from this offering for working capital and general corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of common stock issuable upon conversion of the preferred stock no later than July 20, 2022, and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than September 18, 2022 (or October 18, 2022, in the event of a "full review" of the registration statement by the SEC).

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

Arcadia Biosciences (RKDA) Announces Date of Fourth-Quarter and Full-Year 2021 Financial Results and Business Highlights Conference Call

On March 23, 2022 Arcadia Biosciences, Inc. (Nasdaq: RKDA), a producer and marketer of innovative, plant-based health and wellness products, reported that it will release its 2021 fourth-quarter and full-year financial and business results after market close on March 30, 2022 (Press release, Arcadia Biosciences, MAR 23, 2022, View Source [SID1234610939]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The company has scheduled a conference call for 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss fourth-quarter and year-end results and the year’s key strategic achievements. Interested participants can join the conference call using the following numbers:

A live webcast of the conference call will be available on the Investors section of Arcadia’s website at www.arcadiabio.com. Following completion of the call, a recorded replay will be available on the company’s investor website.

argenx raises $700 million in gross proceeds in a global offering

On March 23, 2022 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported the pricing of a global offering of ordinary shares represented by American Depository Shares ("ADSs") in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the United Kingdom (Press release, argenx, MAR 23, 2022, View Source,%E2%82%AC273.10%20per%20ordinary%20share. [SID1234610915]). The Company anticipates total gross proceeds of approximately $700 million (approximately €637 million) from the sale of 1,551,044 ADSs at a price of $300.00 per ADS and the sale of 782,290 ordinary shares at a price of €273.10 per ordinary share. Each of the ADSs offered in the offering represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are currently expected to close simultaneously on March 28, 2022, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, argenx has granted the underwriters of the offering a 30-day option to purchase up to 350,000 ordinary shares (which may be represented by ADSs) on the same terms and conditions.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX" and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX".

J.P. Morgan, Morgan Stanley, Cowen and SVB Leerink are acting as joint bookrunning managers for the offering. Wells Fargo Securities, Kempen & Co, H.C. Wainwright & Co., Raymond James and Wedbush PacGrow are acting as co-managers for the offering.

The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities was filed with the SEC on March 22, 2022. The final prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; or from SVB Securities LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected].

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

DURECT Corporation To Present at the 2022 Cantor Fitzgerald Virtual Rare Orphan Disease Summit

On March 23, 2022 DURECT Corporation (Nasdaq: DRRX) reported that Dr. James E. Brown, President and CEO, will be participating in a panel discussion at the Cantor Virtual Rare Orphan Disease Summit hosted by Kristen Kluska, Managing Director, Biotechnology Research Analyst of Cantor Fitzgerald (Press release, DURECT, MAR 23, 2022, https://investors.durect.com/news-releases/news-release-details/durect-corporation-present-2022-cantor-fitzgerald-virtual-rare [SID1234610912]). The title of the panel is "Small but Mighty: Innovative Strategies in Tackling Some of the Larger Rare Orphan Disease Markets" and will take place at 1:00 pm ET on Wednesday, March 30, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

If you have interest in participating in the Cantor Virtual Rare Orphan Disease Summit, please reach out to your Cantor Fitzgerald representative.

iTeos Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

On March 23, 2022 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided recent corporate highlights (Press release, iTeos Therapeutics, MAR 23, 2022, View Source [SID1234610910]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2021, we laid a strong foundation for both of our differentiated clinical-stage immunotherapy programs EOS-448, our FcγR-engaging anti-TIGIT antibody, and inupadenant, our adenosine A2A receptor antagonist. The data we shared over the course of the year validates our excitement around both candidates as potentially differentiated therapies capable of harnessing the immune system to improve outcomes for patients with several types of advanced cancers," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Anticipating the advancement of both EOS-448 and inupadenant from early to late-stage clinical development with novel combinations, we have built a global team to fuel the execution of our robust clinical development plans throughout 2022. This year is expected to be critical in terms of data generation for the TIGIT and adenosine fields, and we’re excited to play a key role in growing the body of evidence that will inform how these targets can be harnessed for patients as safely and quickly as possible."

Program Highlights

EOS-448: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance the anti-tumor response through multifaceted mechanisms.

In collaboration with GSK, iTeos is initiating various combinations to advance this next generation immuno-oncology agent:
Began dosing in a Phase 1b clinical trial in patients with non-small cell lung cancer (NSCLC) assessing the doublet of GSK’s anti-PD-1 (Jemperli) with EOS-448.
Planning three registration-directed trials combining EOS-448 with Jemperli in 1L NSCLC PDL1 high, head and neck squamous cell carcinoma (HNSCC) and a third indication targeting an additional immune-responsive tumor.
Initiating Phase 1b trials with novel triplets, including Jemperli with EOS-448 and inupadenant in patients with advanced solid tumors and EOS-448 with Jemperli and GSK’s investigational anti-CD96 antibody in patients with NSCLC.
iTeos is evaluating the doublets of pembrolizumab with EOS-448 and inupadenant with EOS-448 in patients with solid tumors in an ongoing Phase 1 trial.
In December 2021, favorable preclinical data generated in collaboration with Fred Hutchinson Cancer Research Center were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. Based on this data, iTeos is advancing an open-label dose-escalation/expansion Phase 1/2 trial of EOS-448 as a monotherapy and in combination with Bristol Myers Squibb’s iberdomide – a novel, potent oral cereblon E3 ligase modulator (CELMoD) with or without dexamethasone, in adults with relapsed or refractory multiple myeloma.
The company will present preclinical and clinical analyses supporting the multifaceted mechanism of action of EOS-448, including data on pharmacodynamics within the tumor microenvironment, as part of a late-breaking poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 8-13, 2022 in New Orleans, Louisiana.
Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on different immune cells found in the tumor micro-environment.

iTeos is initiating a randomized Phase 2 trial to evaluate the combination of inupadenant with chemotherapy compared to standard of care in an undisclosed solid tumor indication.
The Company is also evaluating inupadenant in combination with pembrolizumab in PD-1 resistant melanoma in an ongoing Phase 2a trial
iTeos is evaluating patient and indication selection biomarkers in an ongoing Phase 1b/2a trial of inupadenant as a monotherapy in patients with solid tumors.
Preclinical programs: Building on the company’s successful track record of advancing differentiated programs from discovery into the clinic, iTeos continues to progress research programs focused on additional targets that address pathways of immunosuppression. In 2021, iTeos nominated an additional candidate targeting a new mechanism in the adenosine pathway for Investigational New Drug-enabling studies.

Upcoming Events

AACR Annual Meeting, April 8-13, 2022
Late-Breaking Abstract Title: Pharmacodynamic assessment of a-TIGIT mAb EOS-448 highlights multiple FcγR-mediated mode-of-actions in blood and tumor of patients with advanced solid tumors; Wednesday, April 13 from 9:00am – 12:30pm CDT
Session Title: Late Breaking Research: Experimental and Molecular Therapeutics 2
Abstract Number: LB189 / Section 16
Fourth Quarter and Full Year 2021 Financial Results

Cash Position: The Company’s cash and cash equivalent position was $848.5 million as of December 31, 2021, as compared to $336.3 million as of December 31, 2020. Cash balance provides runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $17.4 million for the quarter and $59.4 million for the full year ended December 31, 2021, as compared to $9.2 million for the fourth quarter and $29.9 million for the full year of 2020. The increase was primarily due to an increase in activities related to clinical trials for EOS-448 and Inupadenant, as well as preclinical programs.
General and Administrative (G&A) Expenses: G&A expenses were $9.6 million for the quarter and $40.5 million for the full year ended December 31, 2021, as compared to $5.7 million for the fourth quarter and $15.3 million for the full year of 2020. The increase was primarily due to an increase in professional fees related to the Company’s collaboration with GSK, in addition to an increase in professional fees associated with the Company’s status as a publicly traded company.
Net Income/Loss: Net income attributable to common shareholders was $184.9 million, or a net income of $5.24 per basic share and $4.88 per diluted share, for the quarter ended December 31, 2021, as compared to a net loss of $14.9 million, or a net loss of $0.43 per basic and diluted share, for the fourth quarter of 2020. Net income was $214.5 million, or a net income of $6.10 per basic share and $5.68 per diluted share, for the year ended December 31, 2021, as compared to a net loss of $43.4 million, or a net loss of $2.88 per basic and diluted share, for the full year of 2020.