On May 11, 2022 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported financial results, and provided a business update for the first quarter ended March 31, 2022 (Press release, BiomX, MAY 11, 2022, View Source [SID1234614242]).

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"We are continuing to make progress with our pipeline. In our cystic fibrosis ("CF") program, we are working actively to enroll patients in our Phase 1b/2a trial and continue to expect initial data from the first part of the trial in the third quarter of 2022," said Jonathan Solomon, Chief Executive Officer of BiomX. "We are also proud to have the support of the Cystic Fibrosis Foundation for the CF program through its recent equity investment in BiomX. The Cystic Fibrosis Foundation continues to play an instrumental role in bringing life-saving medicines to CF patients, and we appreciate their support for our program.

"I am also pleased to announce the clearance of an investigational new drug application ("IND") for BX005 for the treatment of atopic dermatitis ("AD"). Supported by Maruho Co. Ltd., we are developing the topical phage cocktail, BX005, to address disease pathology in the AD patient population by targeting Staphylococcus aureus, a bacteria thought to promote and exacerbate inflammation in AD skin. As we look forward to providing updates from our CF and AD programs later this year, we continue to have sufficient cash runway through multiple clinical readouts.

"We also looking forward to our upcoming KOL Webinar on May 12th, which will feature perspectives from leading CF experts on the current treatment landscape and the unmet medical need for patients with chronic Pseudomonas aeruginosa respiratory infections."

RECENT CORPORATE HIGHLIGHTS

In January 2022, BiomX announced that the Company received a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation. The first tranche of this Award closed on December 21, 2021, with the Cystic Fibrosis Foundation investing $3 million in shares of BiomX common stock. Upon completion of patient dosing in Part 1 of the Company’s Phase 1b/2a study of BX004, BiomX would have the right to receive the second tranche of $2 million, also as an equity investment.
Clinical Program Updates

Cystic Fibrosis (BX004)

BX004 is being developed for the treatment of chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF.
The Phase 1b/2a trial is composed of two parts and is planned to start imminently. Part 1 of the trial will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the third quarter of 2022. Part 2 of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected by the first quarter of 2023.
Atopic Dermatitis (BX005)

In April 2022, the United States Food and Drug Administration cleared the Company’s IND application for BX005, which is being developed for the treatment of mild-to-moderate AD.
BX005 is currently in the final stages of GMP production. The Company continues to expect the first data readout from its Phase 1/2 proof-of-concept trial evaluating the safety and efficacy of BX005 in the fourth quarter of 2022.
Inflammatory Bowel Disease ("IBD") and Colorectal Cancer Programs ("CRC")

Efforts to advance the Company’s IBD product candidate, BX003, and colorectal cancer product candidate are currently expected to resume during 2023.
First Quarter 2022 Financial Results

Cash balance, short-term deposits and restricted cash as of March 31, 2022, were $55.7 million, compared to $63.1 million as of December 31, 2021. The decrease was primarily due to net cash used in operating activities. Based upon the Company’s strategic focus on the CF and AD programs, the existing cash and cash equivalents are expected to be sufficient to fund the current operating plan through the end of 2023. Additional tranches that would become available to the Company under its venture debt facility upon satisfaction of certain specified milestones can further extend the Company’s cash runway to the first half of 2024.
Research and development ("R&D") expenses, net were $4.9 million for the three months ended March 31, 2022, compared to $5.7 million for the same period in 2021. The decrease was primarily due to pauses in the development of BX003, the product candidate for the treatment of IBD and primary sclerosing cholangitis, pauses in the development efforts in the CRC program, as well as the discontinuing of BX001, the product candidate for the treatment of acne. In addition, the decrease in R&D expenses is due to an increase in grants from the Israeli Innovation Authority, offset by an increase in expenses related to conducting pre-clinical and clinical trials of the Company’s CF and AD product candidates, BX004 and BX005, respectively.
There was no material change to general and administrative expenses that impacted earnings for the three months ended March 31, 2022, compared to the three months ended March 31, 2021.
Net loss for the first quarter of 2022 was $8.2 million, compared to $8.4 million for the same period in 2021.
Net cash used in operating activities for the three months ended March 31, 2022 was $7.4 million, compared to $6.4 million for the same period in 2021.
Conference Call and Webcast Information

BiomX management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the first quarter ended March 31, 2022. To participate in the conference, please dial 1-877-407-0724 (U.S.) or 1-201-389-0898 (International). A live and archived webcast of the call will be available on the Investors section of the Company’s website at www.biomx.com.

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On May 11, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the first quarter of 2022 ended March 31, 2022, and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, MAY 11, 2022, View Source [SID1234614182]).

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"Pieris and our partners have made steady progress across the pipeline over the past quarter, and we are reiterating guidance on both cinrebafusp alfa phase 2 data in HER2-high gastric cancer in 2023 and PRS-220 clinical initiation this year. With IND acceptance for PRS-344/S095012, enrollment continues as planned and, separately, we are expecting an IND filing for PRS-342/BOS-342 in the next 12 months. At the same time, geopolitical and pandemic-driven challenges are affecting enrollment on certain programs. We are announcing a heightened risk to maintaining current guidance on reporting topline results for PRS-060/AZD1402 this year, despite AstraZeneca’s continued commitment to execute on this program. Additionally, more time is needed for the enrollment of the HER2-low arm for cinrebafusp alfa. Notwithstanding these challenges, with our efficient program funding strategies and committed alliance partners, Pieris can advance its core assets with sufficient cash reach beyond the efficacy readout for PRS-060/AZD1402, which will be a significant milestone for us," said Stephen S. Yoder, President and Chief Executive Officer of Pieris.

PRS-060/AZD1402 and AstraZeneca Collaboration: Enrollment continues for part 2a (efficacy of 1 mg and 3 mg cohorts) and part 1b (safety of 10 mg cohort) of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated PRS-060/AZD1402, an IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Given the geopolitical situation, along with broader challenges amidst an ongoing pandemic, there is a heightened risk that more time will be required to deliver the topline study results by the end of the year as planned. AstraZeneca is currently in the process of conducting a thorough timeline reforecast and working on strategies to mitigate any potential delays. Upon completion of the study, which is being sponsored and funded by AstraZeneca, Pieris may choose to exercise its co-development option, which would be on a 25% cost-share basis with a cost cap or a 50% cost-share basis without a cost cap. Separately, Pieris will have a future option to co-commercialize PRS-060/AZD1402 in the United States.
Cinrebafusp Alfa (PRS-343): Enrollment continues in the two-arm, multicenter, open-label phase 2 study of cinrebafusp alfa, a 4-1BB/HER2 Anticalin-based bispecific for the treatment of HER2-expressing gastric cancer. The first arm of the study is evaluating the efficacy, safety, and tolerability of cinrebafusp alfa in combination with standard of care agents ramucirumab and paclitaxel in patients with HER2-high gastric cancer. The Company is reiterating its guidance and expects to report data from this arm in 2023. The second arm of the study is evaluating the efficacy, safety, and tolerability of cinrebafusp alfa in combination with tucatinib in patients with HER2-low gastric cancer. The Company is revising its guidance and now expects to report data from this arm next year due to slower than anticipated enrollment.
PRS-344/S095012 and Servier Collaboration: Enrollment continues and now includes the U.S., where Pieris holds exclusive commercialization rights, in the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 Anticalin-based bispecific for the treatment of solid tumors that Pieris is developing in collaboration with Servier. Pieris also will receive royalties on any ex-U.S. sales for this program. Additionally, Servier is continuing development of PRS-352/S095025, an OX40/PD-L1 bispecific, for which the companies recently presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting 2022. PRS-352/S095025 has demonstrated superior potency to anti-PD-L1 and combination OX40 and PD-L1 therapy benchmarks in different in vitro assays, inhibits the PD-1/PD-L1 pathway with comparable potency to anti-PD-L1 antibodies, stimulates human CD4 T cells, drives T cell stimulation in ex vivo cynomolgus monkey assays, and demonstrated an antibody-like PK profile in vivo.
PRS-220: PRS-220, a proprietary inhaled Anticalin protein targeting connective tissue growth factor for the treatment of IPF, remains on track to enter a phase 1 trial in healthy volunteers this year.
PRS-342/BOS-342: Boston Pharmaceuticals continues to advance PRS-342/BOS-342, a 4-1BB/GPC3 bispecific, towards the clinic, with an IND filing expected within the next 12 months.
First Quarter Financial Update:

Cash Position – Cash, cash equivalents and investments totaled $100.3 million for the quarter ended March 31, 2022, compared to a cash and cash equivalents balance of $117.8 million for the quarter ended December 31, 2021. The decrease is due to funding operations in 2022. The Company believes reported cash is sufficient to fund operations into the fourth quarter of 2023.

R&D Expense – R&D expenses were $14.1 million for the quarter ended March 31, 2022, compared to $16.6 million for the quarter ended March 31, 2021. The decrease is due to lower program costs, as work related to the Company’s sponsored phase 1 trial of PRS-060/AZD1402 was largely complete in 2021, and due to lower manufacturing costs for cinrebafusp alfa. These lower costs were partially offset by higher clinical costs for cinrebafusp alfa and higher clinical and manufacturing costs for PRS-344/S095012. Separately, higher personnel costs due to higher headcount were partially offset by a reduction in consulting and other professional service costs.

G&A Expense – G&A expenses were $4.4 million for the quarter ended March 31, 2022, compared to $4.1 million for the quarter ended March 31, 2021. The increase was driven primarily by higher non-cash amortization of deferred costs related to collaboration revenue earned and partially offset by slightly lower legal and audit costs.

Other Income – For the quarter ended March 31, 2022, $2.1 million of grant income was recorded on PRS-220.

Net Loss – Net loss was $5.1 million or $(0.07) per share for the quarter ended March 31, 2022, compared to a net loss of $4.2 million or $(0.07) per share for the quarter ended March 31, 2021.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Wednesday, May 11, 2022, to discuss the first quarter financial results and provide a corporate update. Individuals can join the call by dialing (888) 428-7458 (US & Canada) or (862) 298-0702 (International). Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.

On May 11, 2022 Genmab reported that Interim Report for the First Quarter Ended March 31, 2022 (Press release, Genmab, MAY 11, 2022, View Source [SID1234614209])

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Highlights

DARZALEX net sales as reported by Johnson & Johnson increased 36% compared to the first three months of 2021 to USD 1,856 million, resulting in royalty revenue of DKK 1,501 million
Genmab updates its 2022 financial guidance
"During the first quarter of 2022, there were continued advancements in our pipeline, including the first patient dosed with DuoBody-CD3xB7H4 (GEN1047), the presentation of data from the tisotumab vedotin innovaTV 207 study, and the U.S. Food and Drug Administration (U.S. FDA) granting orphan-drug designation to epcoritamab for the treatment of follicular lymphoma (FL). Together these events help to progress us further in our evolution into a fully integrated biotech innovation powerhouse," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2022

Net sales of DARZALEX by Janssen were USD 1,856 million in the first three months of 2022 compared to USD 1,365 million in the first three months of 2021, an increase of USD 491 million, or 36%.
Royalty revenue was DKK 1,836 million in the first three months of 2022 compared to DKK 1,017 million in the first three months of 2021, an increase of DKK 819 million, or 81%. The increase was driven by higher net sales of DARZALEX, TEPEZZA and Kesimpta resulting in higher royalties.
Revenue was DKK 2,119 million for the first three months of 2022 compared to DKK 1,581 million for the first three months of 2021. The increase of DKK 538 million, or 34%, was primarily driven by higher DARZALEX, TEPEZZA and Kesimpta royalties achieved under our collaborations with Janssen, Roche and Novartis, respectively, partly offset by milestones achieved under our collaborations with AbbVie and Janssen in the first three months of 2021.
Operating expenses were DKK 1,605 million in the first three months of 2022 compared to DKK 1,049 million in the first three months of 2021. The increase of DKK 556 million, or 53%, was driven by the continued advancement of multiple pipeline projects, the increase in new employees to support Tivdak post launch and expansion of our product pipeline, as well as the continued development of commercialization capabilities and Genmab’s broader organizational infrastructure.
Operating profit was DKK 514 million in the first three months of 2022 compared to DKK 532 million in the first three months of 2021.

Subsequent Events

April: Genmab and AbbVie Inc. (AbbVie) announced topline results for epcoritamab from the first cohort of the EPCORE NHL-1 phase 1/2 clinical trial evaluating epcoritamab. The study cohort includes 157 patients with relapsed / refractory large B-cell lymphoma who received at least two prior lines of systemic therapy, including 38.9% who received prior treatment with chimeric antigen receptor T-cell therapy. The topline results from this cohort demonstrated an overall response rate of 63.1% as confirmed by an independent review committee, which exceeded the protocol prespecified threshold for efficacy. The observed median duration of response was 12 months. The most common treatment-emergent adverse event was cytokine release syndrome with 49.7%, including 2.5% grade 3. Based on the topline results, the companies will engage global regulatory authorities to determine next steps.
April: The arbitral tribunal issued an award in the binding arbitration of two matters arising under Genmab’s license agreement with Janssen relating to daratumumab. Genmab did not seek a review of the award, and the award is now final. The arbitral tribunal decided both issues in favor of Janssen. The first issue concerned the question as to whether Janssen’s obligation to pay royalties on sales of licensed product extends, in each applicable country, until the expiration or invalidation of the last-to-expire relevant Genmab-owned patent or the last-to-expire relevant Janssen-owned patent covering the product, as further defined and described in the license agreement. As to that issue, the tribunal determined by majority opinion that Janssen’s obligation to pay royalties to Genmab on sales of licensed product, in each applicable country, extends through the expiration or invalidation of the last-to-expire relevant Genmab-owned patent covering the product or use thereof, but not the relevant Janssen-owned patent. The relevant Genmab-owned issued U.S., European and Japanese patents will expire in the late 2020s and early 2030s. The second issue concerned the question as to whether Genmab is required to share in Janssen’s royalty payments to Halozyme Therapeutics, Inc. (Halozyme) for the Halozyme enzyme technology used in the subcutaneous (SC) formulation of daratumumab (marketed as DARZALEX FASPRO in the U.S.). The royalties Janssen pays to Halozyme represent a mid-single digit percentage rate of SC daratumumab sales. As to that issue, the tribunal ruled by majority opinion that Janssen is permitted to continue reducing its royalty payments to Genmab as an offset against a share of Janssen’s royalty payments made to Halozyme.
Outlook
Genmab is updating the lower end of its 2022 financial guidance published on February 16, 2022, driven by increased royalty revenue related to net sales of DARZALEX.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2022 today, Wednesday, May 11, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial .A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

On May 11, 2022 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the first quarter, ended March 31, 2022 (Press release, Monte Rosa Therapeutics, MAY 11, 2022, View Source [SID1234614227]).

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"Our first quarter was marked by exciting progress across our pipeline of molecular glue degraders and our proprietary QuEEN platform," said Markus Warmuth, M.D., CEO of Monte Rosa. "Last month, we presented compelling preclinical data underscoring the therapeutic potential of MRT-2359 as a potent inducer of degradation of GSPT1 in Myc-driven solid tumors, and we look forward to submitting our IND for MRT-2359 in mid-2022. We are also thrilled to work with Professor Bruno Correia and the world experts at EPFL to further realize the potential of our proprietary AI engine to identify next-generation molecular glue degraders that can eliminate therapeutically relevant proteins previously considered undruggable."

FIRST QUARTER 2022 & RECENT HIGHLIGHTS

Presented preclinical data highlighting potential of GSPT1-directed molecular glue degrader MRT-2359 to target Myc-driven cancers. The data were featured in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans. Collectively, the data support the clinical development of MRT-2359 in Myc-driven solid tumors, with an initial focus in non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

Initiated research collaboration with Dr. Correia and the Laboratory of Protein Design & Immunoengineering at EPFL. The collaboration integrates Monte Rosa’s AI engine with EPFL’s MaSIF (Molecular Surface Interaction Fingerprinting) technology. This combination will uniquely accelerate Monte Rosa’s ability to identify both novel cereblon-based MGDs and novel E3 ligases to target therapeutically relevant proteins.
UPCOMING MILESTONES & DATA PRESENTATIONS

Submission of IND application to the U.S. Food and Drug Administration (FDA) for MRT-2359 expected in mid-2022
Initiation of at least one additional lead optimization program expected in 2022
UPCOMING INVESTOR EVENTS
Monte Rosa will be participating in the following upcoming investor conferences:

UBS Global Healthcare Conference, May 23-25
Jefferies Global Healthcare Conference, June 8-10
Wells Fargo Healthcare Conference, Sept. 7-9
FIRST QUARTER 2022 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2022 were $17.9 million, compared to $9.3 million for the first quarter of 2021. These increases were due to the expansion of research and development activities, including the advancement of MRT-2359 toward clinical development, the development the company’s QuEEN platform and discovery and lead optimization efforts of its preclinical programs, as well as increased headcount and laboratory-related expenses due to the company’s continued growth as a research and development organization. R&D expenses included non-cash stock-based compensation of $1.2 million for the first quarter of 2022, compared to $0.1 million for the same period in 2021.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2022 were $6.4 million compared to $2.2 million for the first quarter of 2021. The increase in G&A expenses was a result of increased headcount and expenses in support of the company’s growth and operations as a public company. G&A expenses included non-cash stock-based compensation of $1.1 million for the first quarter of 2022, compared to $0.2 million for the same period in 2021.

Net Loss: Net loss for the first quarter of 2022 was $23.9 million, compared to $12.3 million for the first quarter of 2021.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash and marketable securities as of March 31, 2022, were $322.5 million, compared to cash, cash equivalents and restricted cash of $351.4 million as of December 31, 2021. The decrease primarily related to cash used to fund operations of $27.4 million and cash used to purchase laboratory equipment of $1.7 million, partially off-set by proceeds from the exercise of stock options of $0.2 million. The company expects that its cash and cash equivalents will be sufficient to fund planned operations and capital expenditures into late 2024.