On March 2, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX) a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that company management will participate in a fireside chat at the 42nd Annual Cowen Healthcare Conference on Monday, March 7, 2022 at 11:10 am PT/2:10 pm ET (Press release, Heron Therapeutics, MAR 2, 2022, View Source [SID1234609375]).

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A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section.

On March 2, 2022 Avalo Therapeutics, Inc. (Nasdaq: AVTX), a leading clinical-stage precision medicine company that discovers, develops, and commercializes targeted therapeutics for patients with significant unmet need in immunology and rare genetic diseases, reported business updates and year-end financial results for 2021 (Press release, Avalo Therapeutics, MAR 2, 2022, View Source [SID1234609391]).

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"2021 was an important year for Avalo in that the Company produced compelling data for AVTX-002 in both acute and chronic inflammatory diseases. Furthermore, it positioned the Company to launch a placebo-controlled trial in NEA (AVTX-002), as well as two rare disease pivotal trials in 2022," said Dr. Garry Neil, Chief Executive Officer of Avalo Therapeutics. "We are focused on the operational execution of these programs and their corresponding milestones, which have great potential to drive shareholder value in the coming year. We believe the recent pipeline prioritization will allow for greater focus on these most promising programs while also allowing for a reduction in cash burn."

Business Updates:

Promoted Dr. Garry Neil to Chief Executive Officer and Chris Sullivan to Chief Financial Officer. Dr. Neil brings to this position extensive clinical development and leadership experience in the biopharmaceutical industry including his current role as Chairman of the Board for Arena Pharmaceuticals and prior senior positions in leading pharmaceutical companies including Johnson & Johnson, Merck and AstraZeneca. Mr. Sullivan brings strong financial leadership to Avalo from his prior senior level finance/accounting positions for various Nasdaq-listed life science companies and Ernst & Young.
Appointed June Almenoff M.D., Ph.D., and Mitchell Chan to the Board of Directors. Dr. Almenoff brings close to 25 years of leadership experience focused on research and development and commercialization including her time as the President and Chief Medical Officer of Furiex Pharmaceuticals. Mr. Chan has more than 15 years of finance experience in the life sciences industry including his time as Chief Financial Officer of Viela Bio and senior financial positions at AstraZeneca and Genentech-Roche.
Announced plans to conduct a new Phase 2 randomized, double-blind, placebo-controlled trial of AVTX-002 for the treatment of moderate to severe NEA; top-line data anticipated in the fourth quarter of 2022. NEA is subtype of asthma with a poor prognosis that encompasses approximately half of asthma patients. Biomarker data suggests that LIGHT plays a strong role in inflammation and airway remodeling in NEA and support the development of AVTX-002 for poorly controlled NEA patients.
Optimized the pipeline, with Avalo winding down internal development efforts of AVTX-006 in lymphatic malformations and AVTX-007 for the treatment of multiple myeloma (as previously announced) while pausing current development efforts for AVTX-802 (MPI-CDG). We plan to pursue strategic alternatives for AVTX-006. Avalo also intends to focus on placebo-controlled trials for AVTX-002 going forward, starting with NEA. We will therefore not be moving forward with the uncontrolled cohort of AVTX-002 in ulcerative colitis (UC) patients. Avalo will consider planning for a possible randomized, double-blind, placebo-controlled clinical study in moderate to severe refractory patients with inflammatory bowel disease.
Presented data from Phase 1b, open-label, dose-escalation, signal-finding, multi-center study evaluated the safety, tolerability, pharmacokinetics, and short-term efficacy of AVTX-002 in adults with moderate to severe, active Crohn’s disease (CD) who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment. Fifty percent (4/8 patients) demonstrated evidence of mucosal healing as determined by colonoscopy and adjudicated by a central reader with one patient achieving remission (SES-CD=0).
Program Updates and Milestones:

AVTX-002: Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases including Non-eosinophilic Asthma and inflammatory bowel disease (Crohn’s disease and Ulcerative Colitis).
Non-eosinophilic Asthma: An investigational new drug (IND) application is active for AVTX-002 for the treatment of NEA and Avalo expects to initiate a Phase 2 randomized, double-blind, placebo-controlled Phase 2 clinical trial in 80 patients with poorly controlled NEA. Top-line data from the trial are currently expected in the fourth quarter of 2022.
Inflammatory Bowel Disease: Presented positive Phase 1b data in CD with efficacy signal demonstrated in heavily pre-treated patients supports further evaluation in inflammatory bowel disease patients’ refractory to three or more treatments, including anti-TNFα and other biologics. As Avalo intends to focus on placebo-controlled trials for AVTX-002 going forward, we will not be moving forward with the uncontrolled cohort of AVTX-002 in UC patients. Avalo will consider planning for a possible randomized, double-blind, placebo-controlled clinical study in moderate to severe refractory patients in inflammatory bowel disease.

AVTX-007: Anti-IL-18 mAb targeting adult-onset Still’s disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA).
AOSD: AVTX-007 is being evaluated in a multicenter, Phase 1b study in 12 refractory or steroid-dependent patients with AOSD in two cohorts. Management is currently reviewing preliminary data and the path forward related to this indication. Top-line data currently expected in 2023, though this is subject to change and refinement pending finalization of the review.
Multiple Myeloma: Data from a multicenter, Phase 1b study in relapsed and refractory multiple myeloma patients indicated AVTX-007 was generally safe and well tolerated at doses up to 14mg/kg. Additionally, pharmacodynamic data indicate deep reductions in IL-18 levels occur withing 24-hours after dosing. However, as previously announced, due to a lack of efficacy signal Avalo is winding down internal development efforts in this indication.
AVTX-006: Dual mTORc1/c2 small molecule inhibitor for lymphatic malformations.
As a result of a portfolio prioritization review, Avalo is winding down internal development of AVTX-006 and has decided to pursue strategic alternatives for this program.

AVTX-800 programs (AVTX-801, AVTX-802, and AVTX-803): Therapeutic doses of monosaccharide therapies for congenital disorders of glycosylation (CDGs).
Avalo is in the process of initiating a single-center (US), double-blind (followed by an open-label extension) pivotal study of AVTX-803 in patients with leukocyte adhesion deficiency type II (LAD II) caused by loss-of-function mutation in the SLC35C1 gene, with pivotal trial data expected in the fourth quarter of 2022.
Avalo and the study sponsor remain in dialogue with the FDA to align on a suitable clinical study design for AVTX-801 (PGM1-CDG). Pivotal trial data are expected in 2023. Avalo is currently working with the study sponsor to refine milestone timing.
The Company is pausing internal development of AVTX-802 (MPI-CDG) at this time due to challenges with study feasibility.
2021 Financial Update:

As of December 31, 2021, Avalo had $54.6 million in cash and cash equivalents, representing a $35.7 million increase as compared to December 31, 2020. The increase was primarily driven by gross proceeds of approximately $72.2 million from underwritten public offerings and $35.0 million from a debt facility. Such increases were partially offset by operating expenditures, the majority of which were related to pipeline development.

Total operating expenses increased $8.0 million for the year ended December 31, 2021 as compared to the year ended December 31, 2020. The increase in operating expenses was largely driven by a $27.6 million increase in research and development expenses to support our maturing pipeline and a $4.4 million increase in general and administrative expenses, partially offset by a $25.5 million reduction in acquired in-process research and development expense as this charge in 2020 did not repeat.

The consolidated balance sheets as of December 31, 2021 and 2020 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.

The consolidated statements of operations for the years ended December 31, 2021 and 2020 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

On March 2, 2022 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company"), reported the closing of its previously announced registered direct offering with certain institutional investors of 11,000 shares of Series O redeemable convertible preferred stock and 11,000 shares of Series P redeemable convertible preferred stock (Press release, AIkido Pharma, MAR 2, 2022, View Source [SID1234609408]). Each share of Series O and Series P preferred stock has a purchase price of $952.38, representing an original issue discount of 5% of the $1,000 stated value of each share. Each share of Series O and Series P preferred stock is convertible into shares of AIkido’s common stock at an initial conversion price of $1.00 per share. Shares of the Series O and Series P preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval for a reverse stock split of the Company’s common stock. AIkido will be permitted to compel conversion of the Series O and Series P 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 offering expenses, is approximately $20.9 million. To the extent Series O or P preferred stock is converted or otherwise not redeemed after 120 days from closing, the Company will use the net proceeds from this offering for working capital and general corporate purposes.

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

The Series O and Series P preferred stock permit the holders thereof to vote together with the holders of the Company’s common stock and other voting preferred stock of the Company on a proposal to effectuate a reverse stock split of the Company’s common stock at an annual or special meeting of Company stockholders. The Series O preferred stock permits the holder to cast votes on such proposal on an as-converted to common stock basis. The Series P preferred stock permits the holder to cast votes equal to 30,000 votes per share of Series P preferred stock on such proposal. The Series O and Series P preferred stock will not be permitted to vote on any other matter. The holders of the Series O and P preferred stock agreed not to transfer their shares of preferred stock until after the meeting of Company stockholders. The holders of the Series P preferred stock have the right to vote their shares on such proposal in the same proportions as the shares of common stock, Series O preferred stock and other voting preferred stock of the Company are voted on that proposal. The holders of the Series O and Series P 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 and until 120 days after the closing.

Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K filed with the United States Securities and Exchange Commission ("SEC").

The Series O and Series P preferred stock and shares of common stock into which such preferred stock are convertible were offered pursuant to a registration statement on Form S-3 (333-238172), which was declared effective by the Securities and Exchange Commission on June 18, 2020. The offerings were made only by means of prospectus supplements and a prospectus that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of preferred stock and underlying shares of common stock offered has been filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

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 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.

On March 1, 2022 Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, reported fourth quarter and full year 2021 financial results and provided business updates (Press release, Seres Therapeutics, MAR 1, 2022, View Source [SID1234609213]).

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"The progress made throughout 2021 has set the stage for an exciting year ahead for Seres, highlighted by the anticipated BLA filing for SER-109 with the U.S. Food and Drug Administration (FDA) for recurrent C. difficile infection (rCDI) in mid-2022 which, if approved, we expect to be the first ever microbiome therapeutic" said Eric Shaff, Chief Executive Officer at Seres. "In collaboration with Nestlé Health Science, we are executing on our plans for a successful SER-109 product launch. Together, we are committed to bringing this potentially transformative therapeutic option to patients suffering with rCDI."

"As highlighted during our recent investor event, we are also advancing our earlier stage efforts in Infection Protection, including the recently initiated SER-155 Phase 1b study to evaluate safety and efficacy in individuals undergoing allogeneic hematopoietic stem cell transplantation. We believe that our microbiome approach has the potential to result in transformative new medicines for Infection Protection, a therapeutic category in great need of innovation," continued Mr. Shaff.

Program and Corporate Updates

SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved its primary endpoint of superiority to placebo in reducing CDI recurrence in a Phase 3 clinical trial in patients with rCDI. The Company continues to prepare for a BLA filing with the FDA.

Seres has achieved target enrollment in its open-label study of SER-109 in patients with rCDI (ClinicalTrials.gov identifier: NCT03183141), which also admits patients with a single recurrence of rCDI, to expand the SER-109 safety database. Based on FDA commentary, Seres believes the ECOSPOR III efficacy results should support a BLA filing as a single pivotal study. Seres intends to finalize a BLA submission, including data from the open-label study, in mid-2022.

While executing multiple activities necessary to support the BLA submission, Seres is also preparing for a successful product launch with Aimmune, the division within Nestlé Health Science leading commercialization efforts. The Company believes that a substantial commercial opportunity exists for SER-109. The cost of a patient with recurrence of CDI has been estimated to result in approximately $34,000 in annual direct healthcare expenses; this does not include the substantial indirect costs associated with this disease. There are approximately 170,000 cases of rCDI annually in the U.S. and CDI results in over 20,000 deaths.

In January 2022, the New England Journal of Medicine (NEJM) published data from the SER-109 Phase 3 ECOSPOR III study evaluating SER-109 for the treatment of rCDI. The publication highlights key results including that SER-109 was superior to placebo in reducing CDI recurrence, with 88% of SER-109 patients achieving a sustained clinical response compared to 60% on placebo. SER-109 was well tolerated, with a side effect profile comparable to placebo and no serious drug-related adverse events observed.

In November 2021, the Company initiated a SER-109 expanded access program at various sites across the U.S. The program is designed to enable eligible adults with rCDI to obtain access to SER-109 prior to a potential FDA product approval.

In October 2021, Seres announced the presentation of an exploratory analysis of its SER-109 Phase 3 ECOSPOR III study at the American College of Gastroenterology 2021 Annual Meeting. Data demonstrate that SER-109 reduced the risk of rCDI, as compared to subjects administered placebo, in individuals with risk factors for recurrence, including those taking acid-reducing medications such as proton pump inhibitors and H2 blockers.

In November 2021, Seres announced a collaboration with Bacthera, a specialized contract development and manufacturing organization to manufacture SER-109, Seres’ lead product candidate for rCDI. The collaboration is designed to expand upon existing production capacity to meet demand growth beyond the initial phase of an anticipated product launch.

SER-155 Phase 1b clinical study activities: In December 2021, Seres announced the enrollment of the first patient in the Company’s Phase 1b clinical study of SER-155 designed to evaluate safety, microbiome alterations, and the impact on infections and/or graft versus host disease (GvHD) associated with SER-155 in adult subjects who are undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study is currently being conducted with Memorial Sloan Kettering Cancer Center and the University of Chicago.

SER-155 is an investigational oral, rationally designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal infections, bloodstream infections, and graft versus host disease (GvHD) in patients receiving allo-HSCT. SER-155 is a consortium of bacterial species selected using Seres’ reverse translation discovery and development platforms. The design incorporates microbiome biomarker data from human clinical data and nonclinical human cell-based assays and in vivo disease models. The SER-155 composition aims to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD. In addition to SER-109, SER-155 represents Seres’ second active development program in its Infection Protection franchise.

Infection Protection Investor Event: In January 2022, Seres held a webcast event that highlighted development of microbiome therapeutics as a novel approach for Infection Protection in medically compromised individuals. Building upon SER-109, and in addition to SER-155, Seres is also evaluating additional preclinical stage programs in indications such as cancer neutropenia, solid organ transplant, and antimicrobial resistant infections more broadly.

Ulcerative colitis (UC) development efforts: In July 2021, Seres announced topline results from the Phase 2b ECO-RESET study evaluating SER-287, a donor-derived investigational microbiome therapeutic candidate, in patients with mild-to-moderate UC. The study did not meet its primary endpoint of improving clinical remission rates compared to placebo. Both dosing regimens of SER-287 were generally well tolerated. In December 2021, Seres announced preliminary microbiome drug pharmacology analyses from the study. Engraftment of SER-287 bacteria was statistically significant in patients receiving SER-287 versus placebo (p ≤ 0.001 at all timepoints), however, unlike the Phase 1b study, anticipated changes in disease-relevant metabolites post-administration with SER-287 in the Phase 2b study were not observed. As previously reported, SER-287 Phase 2b clinical and microbiome data suggest that there may be an opportunity to utilize biomarker-based patient selection in future UC development efforts.

Seres has completed preliminary data analysis data from the first cohort of the SER-301 Phase 1b study in subjects with mild-to-moderate UC, which included 15 subjects. Evaluation of the first cohort data by an independent Data Safety Monitoring Board indicated that it would be safe to proceed to the placebo-controlled second cohort. While clinical efficacy was not a defined endpoint in the first cohort, evaluation of outcome data indicated that no subjects achieved clinical remission as defined by the FDA using the Three-Component Modified Mayo Score after 10 weeks of treatment, though there were improvements in one or more individual components, (endoscopic, stool frequency and rectal bleeding sub scores) in some patients.

SER-301 led to modulation of the metabolic landscape in the gastrointestinal tract, including in short-chain and medium-chain fatty acids, tryptophan-derived metabolites, bile acids, and other microbe-associated metabolites, as well as host metabolites associated with a non-disease state. SER-301 strains were observed to engraft in subjects across the trial period. The degree of metabolic changes observed following SER-301 administration appeared to be dependent on the baseline metabolic profile of the study subjects, providing support for the potential for microbiome therapeutics to be developed in biomarker-identified UC patient subpopulations.

The SER-287 and SER-301 clinical and drug pharmacology data sets obtained to date provide a robust set of insights into the role of the microbiome in UC, and Seres continues to conduct analyses of data from our SER-287 and SER-301 programs to inform next steps for further development.

Appointment of Executive Vice President, Chief People Officer: In February 2022, Seres announced that Paula Cloghessy joined Seres, bringing more than 20 years of human resources expertise with broad business experience. She most recently served as Chief People Officer at Translate Bio, Inc., where she led the talent architecture and people strategy. She previously served as vice president of human resources at Joule Unlimited Technologies, Inc. She has also held human resources positions at Interleukin Genetics, Inc. and NUCRYST Pharmaceuticals, Inc.

Financial Results

Seres reported a net loss of $65.6 million for the full year of 2021, as compared to a net loss of $89.1 million for the prior year. Seres reported a net loss of $50.0 million for the fourth quarter of 2021, as compared to a net loss of $18.3 million for the same period in 2020.

Research and development expenses for the fourth quarter of 2021 were $36.8 million, as compared to $24.9 million for the same period in 2020. The research and development expenses were primarily related to Seres’ late-stage SER-109 clinical development program and manufacturing costs, as well as personnel expenses.

General and administrative expenses for the fourth quarter were $20.5 million, as compared to $10.6 million for the same period in the prior year. General and administrative expenses were primarily related to personnel expenses, professional fees, including SER-109 commercial readiness and pre-launch expenses, and facility costs.

Seres amended its debt financing agreement with Hercules Capital in February 2022, providing the Company with an additional $50 million in capital, for up to $100 million in total. Upon closing, Hercules advanced $50 million to the Company under the facility, of which $22.1 million was previously outstanding, resulting in proceeds of $27.6 million, net of fees and expenses. The Company will make interest only payments through December 31, 2023, extendable to December 31, 2024 with SER-109 approval. There are two subsequent tranches of $25 million each, one of which becomes available to the Company upon the FDA’s approval of the BLA for SER-109 by December 15, 2023 and the second of which becomes available upon the satisfaction of certain conditions, including Hercules’ investment committee approval.

Seres ended the 2021 year with approximately $291.2 million in cash, cash equivalents and short and long-term investments as compared with approximately $353.2 million at the end of the third quarter 2021.

Conference Call Information

Seres’ management will host a conference call today, March 1, 2022, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 6277858. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

On March 1, 2022 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will present at the Cowen 42nd Annual Health Care Conference and the Barclays Global Healthcare Conference (Press release, PerkinElmer, MAR 1, 2022, View Source [SID1234609246]).

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Cowen 42nd Annual Health Care Conference – Virtual
Monday, March 7, 2022
10:30 a.m. ET – Jamey Mock, senior vice president and chief financial officer

Barclays Global Healthcare Conference – Miami, FL
Tuesday, March 15, 2022
1:30 p.m. ET – Prahlad Singh, president and chief executive officer

Attendees will receive an overview of the Company and its strategic priorities.

Live audio webcasts will be available on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the presentations will be posted on the PerkinElmer website after the event and will be available for 90 days following.