IGM Biosciences to Present at the 2020 RBC Capital Markets Global Healthcare Conference

MOUNTAIN VIEW, Calif., May 12, 2020IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that Fred Schwarzer, Chief Executive Officer, will present at the 2020 RBC Capital Markets Global Healthcare Conference on Tuesday, May 19 at 4:15 p.m. ET. The conference will be held in a virtual meeting format.

A live webcast of the event will be available on the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investor.igmbio.com/news-and-events/events-and-presentations. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Contact:

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

IGM Biosciences Announces First Quarter 2020 Financial Results and Provides Corporate Update

– Initial data from Phase 1 trial of IGM-2323 in relapsed/refractory non-Hodgkin’s lymphoma expected in the second half of 2020 –

– IND filing for IGM-8444 planned in 2020 –

– Collaboration with Atreca and BeiGene to discover, develop and manufacture novel antibody treatment for COVID-19 announced –

MOUNTAIN VIEW, Calif., May 7, 2020IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the first quarter ended March 31, 2020 and provided an update on recent developments.

“While these unprecedented times have presented many unique challenges, thanks to the hard work and dedication of the entire IGM team, we continue to make good progress,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “Notably, we recently announced a collaboration with Atreca and BeiGene which will allow us to evaluate the potential of our novel IgM and IgA antibodies for the treatment of COVID-19. Beyond this exciting new program, we continue to expect initial data from our Phase 1 trial of IGM-2323 in relapsed/ refractory NHL in the second half of 2020, as well as the filing of an IND for IGM-8444 later this year.”

Recent Highlights and Pipeline Updates:

Collaboration with Atreca and BeiGene for COVID-19: In April 2020, IGM, Atreca, Inc., and BeiGene, Ltd. announced plans to collaborate to help address the COVID-19 pandemic. The companies will leverage their combined technology and expertise in an effort to discover, develop, and manufacture novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19. If research, manufacturing, and regulatory activities proceed very well, then the companies believe that an antibody may be ready to begin clinical testing in the first half of 2021.

 IGM-2323 

  • Phase 1 data expected in the second half of 2020: IGM continues to expect to report initial data from the Phase 1 trial evaluating IGM-2323 in patients with relapsed/refractory B cell NHL, the first-in-human application of IGM’s engineered IgM antibody technology, in the second half of 2020.

IGM-8444 

  • IGM-8444 data to be presented at the ASCO Annual Meeting. The poster, titled “IGM-8444 as a potent agonistic Death Receptor 5 (DR5) IgM antibody: Induction of tumor cytotoxicity, combination with chemotherapy and in vitro safety profile,” will be made available online via the ASCO20 Virtual Scientific Program beginning on Friday, May 29, at 8:00 a.m. ET.
  • IND filing in 2020: IGM continues to expect to file an IND with the FDA for IGM-8444 in 2020, initially for the treatment of patients with solid tumors. IGM-8444 is an IgM antibody targeting the Death Receptor 5 (DR5) protein, which is broadly expressed on a broad range of solid and hematologic malignancies.

 IGM-7354 

  • IND filing in 2021: IGM continues to expect to file an IND with the FDA for IGM-7354, the Company’s third clinical candidate, in 2021. IGM-7354 is a targeted IL-15 immune stimulating antibody which demonstrates another use of IGM’s novel J chain based bispecific technology. In this case, the immune stimulating IL-15 is displayed on the J chain of an anti-PD-L1 IgM antibody, which serves to display the immune stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells.

First Quarter 2020 Financial Results: 

  • Cash and Investments: Cash and investments as of March 31, 2020 were $219.0 million, compared to $236.6 million as of December 31, 2019.
  • Research and Development (R&D) Expenses:  For the first quarter of 2020, R&D expenses were $14.6 million, compared to $5.9 million for the same period in 2019.
  • General and Administrative (G&A) Expenses:  For the first quarter of 2020, G&A expenses were $4.0 million, compared to $1.4 million for the same period in 2019.
  • Net Loss: For the first quarter of 2020, net loss was $17.6 million, or a loss of $0.58 per share, compared with a net loss of $7.5 million, or a loss of $16.86 per share, for the same period in 2019.
  • Shares Outstanding: Weighted-average shares outstanding for the first quarter of 2020 were 30.5 million, compared to 0.4 million for the same period in 2019.

2020 Financial Guidance:

IGM reiterates its previously issued financial guidance which consisted of non-GAAP operating expenses for 2020 of approximately $75 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $8 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 of $83 – $93 million. IGM also expects to end 2020 with a balance of over $140 million in cash and investments.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding, the Company’s IgM technology platform, statements regarding the Company’s Phase 1 clinical trial of IGM-2323, including the timing of reporting initial data from the clinical trial, the timing of filing an IND for IGM-8444, the timing of filing an IND for IGM-7354, the Company’s future financial and operating performance, including its guidance for the full year 2020 and year end 2020 cash and investments balance, statements relating to the collaboration among IGM, Atreca and BeiGene, the possible nature and scope of any such collaboration, statements regarding the potential timing of clinical testing of an antibody for the potential treatment of COVID-19, and statements by IGM’s Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 coronavirus pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its current clinical trials,  enrollment in its current and future clinical trials and on the collaboration and related efforts; the risks that IGM, Atreca and/or BeiGene may ultimately decide to not pursue the collaboration, that one or more of them decide to leave the collaboration or that they do not reach agreement on the definitive terms and conditions of such collaboration; the risks that antibodies with the desired characteristics cannot be isolated from the COVID-19 patient samples obtained by Atreca, that any antibodies developed are not safe and effective in treating COVID-19 or that such antibodies are not safer and/or more effective than alternatives to treating or otherwise addressing COVID-19; the potential benefits of the collaboration and these efforts do not outweigh their costs; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; IGM’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; IGM’s ability to enroll patients in its ongoing and future clinical trials; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; IGM’s ability to accurately forecast future financial results in the current environment; IGM’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (“SEC”), including IGM’s Annual Report on Form 10-K filed with the SEC on March 26, 2020, IGM’s Quarterly Report on Form 10-Q filed with the SEC on May 7, 2020 and in IGM’s future reports to be filed with the SEC.  Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact:
Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

Atreca, BeiGene, and IGM Biosciences Agree to Collaborate on Novel Antibody Treatment for COVID-19

– Companies to utilize proprietary platforms to discover, develop, and manufacture potential therapeutic antibodies to combat ongoing COVID-19 pandemic –

SOUTH SAN FRANCISCO, Calif., CAMBRIDGE, Mass., BEIJING, China, and MOUNTAIN VIEW, Calif., April 29, 2020 – Atreca, Inc. (Nasdaq: BCEL), BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), and IGM Biosciences, Inc. (Nasdaq: IGMS), today announced their plans to collaborate to help address the COVID-19 pandemic. The companies will leverage their combined technology and expertise in an effort to discover, develop, and manufacture novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19. Given the urgency of the global COVID-19 pandemic, the parties have agreed to begin work immediately and plan to finalize financial details and other terms in the future.

Immunoglobulin M (IgM) and immunoglobulin A (IgA) are classes of antibodies naturally produced by the human immune system and are differentiated from immunoglobulin G (IgG) antibodies in part by their greater number of binding domains (IgM: 10, IgA: 4, IgG: 2). IGM Biosciences engineers IgM and IgA antibodies with greater binding power per antibody, relative to comparable IgG antibodies. This greater binding power could potentially result in better activity against a broader range of variants of the virus which causes COVID-19, as compared to traditional IgG antibodies. IgA and IgM antibodies also have the inherent property of active transport from the blood stream to mucosal surfaces, such as in the lung, which may provide a therapeutic advantage for respiratory diseases such as COVID-19.

The alliance will utilize Atreca’s proprietary discovery platform to generate the sequences of antibodies made by particular B cells found in blood obtained from acutely infected COVID-19 patients. IGM’s technology platform will then be leveraged in an effort to develop and manufacture engineered IgM and IgA therapeutic antibodies from the identified sequences.

BeiGene has agreed to provide global clinical development support by leveraging its more than 1,100-person global development team across China, the United States, Europe, and Australia, including leading global regulatory interactions for any potential drug candidate that is developed. BeiGene is a leader in global clinical development with 26 potentially registration-enabling trials ongoing and over 60 studies enrolling patients in more than 35 countries. Its large, global clinical development team is focused on high-quality, efficient drug development optimized for global regulatory submissions.

Atreca and IGM have entered into a Material Transfer and Collaboration Agreement to enable the parties to begin working together immediately. Atreca, IGM, and BeiGene plan to discuss further terms and arrangements in the future. If research, manufacturing, and regulatory activities proceed very well, then the companies believe that an antibody may be ready to begin clinical testing in the first half of 2021.

“Atreca has a history of successfully generating potent, neutralizing antibodies against a number of infectious disease pathogens, and we are proud to join BeiGene and IGM in working to identify a potential therapy to help address this unprecedented international health crisis,” said John Orwin, Chief Executive Officer of Atreca. “We believe our discovery platform is uniquely positioned to rapidly isolate a broad range of relevant antibody sequences from COVID-19 patients that can then be used to create potentially effective targeted therapies. We have begun processing samples obtained from acutely infected COVID-19 patients and are focused on analyzing single plasmablast B cells isolated from these samples to identify antibodies targeting potentially novel epitopes that may be missed by other approaches that rely on a specific viral protein to select B cells.”

“Helping patients is core to our mission, and we believe IGM may be the only company in the world that is currently positioned to produce IgM and IgA antibodies with high yield and high quality,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “As such, we feel that we have a responsibility to explore the utility of these antibodies in COVID-19 patients. We believe that IgM and IgA antibodies created from sequences identified with Atreca’s platform may produce better binding, cross-reactivity, neutralization, and mucosal transport than the corresponding IgG antibodies. These characteristics, plus IGM’s ability to efficiently manufacture IgM and IgA antibodies, gives us confidence in the collaboration and hope that we may develop a product that will be of significant benefit to public health.”

“While the COVID-19 pandemic has presented new challenges to the biotechnology and pharmaceutical industries, equally notable is the desire for international scientific collaboration and cooperation,” said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. “We are grateful for the opportunity to lend our global clinical development resources to this critical cause, with both Atreca and IGM to leverage their innovative discovery and development platforms in an effort to combat COVID-19.”

Atreca’s proprietary discovery platform, including its Immune Repertoire Capture® (IRC™) technology, generates bias- and error-corrected, natively paired heavy and light chain sequences of the antibodies expressed by single plasmablast B cells isolated from patient blood samples, enabling analyses of patient antibody repertoires generated in an active immune response in a target agnostic fashion, and permitting selection of antibody sequences for immediate gene synthesis and expression. IGM’s proprietary platform expands upon the inherent characteristics of IgM and IgA antibodies and enables the rapid development of engineered therapeutics. IGM’s technology allows it to create IgM and IgA antibodies with higher affinity and avidity than naturally occurring IgM and IgA antibodies, and the company has also overcome the historical difficulties in recombinantly expressing and manufacturing IgM and IgA antibodies.

About Atreca, Inc.

Atreca is a biopharmaceutical company developing novel antibody-based immunotherapeutics generated by its differentiated discovery platform. Atreca’s platform allows access to an unexplored landscape in oncology through the identification of unique antibody-target pairs generated by the human immune system during an active immune response against tumor. These antibodies provide the basis for first-in-class therapeutic candidates, such as our lead product candidate ATRC-101. A Phase 1b study evaluating ATRC-101 in multiple solid tumor cancers is currently enrolling patients. For more information on Atreca, please visit www.atreca.com.

About BeiGene

BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 3,500+ employees in China, the United States, Australia, and Europe are committed to expediting the development of a diverse pipeline of novel therapeutics for cancer. BeiGene currently markets two internally-discovered oncology products: BTK inhibitor BRUKINSA™ (zanubrutinib) in the United States, and anti-PD-1 antibody tislelizumab in China. BeiGene also markets or plans to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Atreca Forward-Looking Statements

This release contains forward-looking statements regarding Atreca’s strategy and future plans, including statements regarding the anticipated isolation of relevant antibody sequences from COVID-19 patients using Atreca’s proprietary discovery platform, the development of ATRC-101 and Atreca’s clinical and regulatory plans, and the timing thereof. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “plan,” “will,” “believe,” “may,” “future,” “potential” and similar words, although some forward-looking statements are expressed differently. Atreca’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the initiation, timing, progress and results of its research and development programs, preclinical studies, any clinical trials and Investigational New Drug application and other regulatory submissions, and other matters that are described in Atreca’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 filed with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Atreca undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

BeiGene Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s plans to work together with Atreca and IGM in the development of a novel IgM or IgA antibody targeting SARS-CoV-2 for the potential treatment of COVID-19, the services to be provided by BeiGene, and the parties’ efforts to finalize further terms and arrangements in the future.  Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the ability of Atreca, BeiGene and IGM to discover, develop and manufacture a novel IgM or IgA antibody targeting SARS-CoV-2 for the treatment of COVID-19; the risk that Atreca, BeiGene or IGM decide not to pursue the collaboration or that the parties are unable to agree to further terms and arrangements for the collaboration in the future; the risk that the potential benefits of the collaboration do not materialize or do not outweigh the costs; BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on BeiGene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

IGM Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements.  These statements include, but are not limited to, statements relating to the contemplated collaboration among IGM, Atreca and BeiGene; the possible nature and scope of any such collaboration; the capabilities of IGM’s technology platform, both generally and specifically with respect to development, testing and manufacture of antibodies targeted at COVID- 19; the potential safety and efficacy of such antibodies; and the capabilities of Atreca and BeiGene.

Such statements are subject to numerous important risks and uncertainties that may cause actual events or results to differ materially, including, but not limited to, the risks that: IGM, Atreca and/or Beigene ultimately decide to not pursue the collaboration; IGM, Atreca and BeiGene do not reach agreement on the definitive terms and conditions of such collaboration; one or more of IGM, Atreca, BeiGene decide to leave the collaboration; antibodies with the desired characteristics cannot be isolated from the COVID-19 patient samples obtained by Atreca;  any antibodies developed are not safe and effective in treating COVID – 19; such antibodies are not safer and/or more effective than alternatives to treating or otherwise addressing COVID – 19; IGM is not able to successfully manufacture such antibodies; any preclinical studies and clinical trials do not proceed successfully; all necessary regulatory approvals cannot be obtained; the potential benefits of the collaboration and these efforts do not outweigh their costs; the collaboration and related efforts are delayed or disrupted by the COVID-19 pandemic itself  or by governmental responses to the pandemic; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (“SEC”), including IGM’s Annual Report on Form 10-K filed with the SEC on March 26, 2020 and in IGM’s future reports to be filed with the SEC.  Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Atreca Contact:
Herb Cross
Chief Financial Officer
info@atreca.com

Atreca Investor Contact:
Alex Gray
+1 650-779-9251
agray@atreca.com

Atreca Media Contact:
Sheryl Seapy
+1 213-262-9390
sseapy@w2ogroup.com

BeiGene Investor Contact:
Craig West
+1 857-302-5189
ir@beigene.com

BeiGene Media Contact:
Liza Heapes or Vivian Ni
+1 857-302-5663 or +1 857-302-7596
media@beigene.com

IGM Biosciences Contact:
Argot Partners
David Pitts
+1 212-600-1902
igmbio@argotpartners.com

IGM Biosciences to Participate in Canaccord Genuity Horizons in Oncology Virtual Event

MOUNTAIN VIEW, Calif., April 3, 2020IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that Fred Schwarzer, Chief Executive Officer, will participate in a panel discussion on bispecific therapies at the Canaccord Genuity Horizons in Oncology Virtual Event on Wednesday, April 8 at 10:15 a.m. ET.

A live webcast of the event will be available on the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investor.igmbio.com/news-and-events/events-and-presentations. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Contact:

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

IGM Biosciences Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update

– Initial data from Phase 1 trial of IGM-2323 in relapsed/refractory non-Hodgkin’s lymphoma expected in the second half of 2020 –

– IND filing for IGM-8444 planned in 2020 –

– Company to host conference call today at 4:30 p.m. ET –

MOUNTAIN VIEW, Calif., March 26, 2020IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on recent developments.

“2019 was a transformational year for IGM.  The many highlights of the year included our successful initial public offering and the initiation of our first-in-human trial for our lead product candidate, IGM-2323, a CD20 x CD3 bispecific IgM antibody, in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL),” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “We expect continued progress in 2020, with the filing of an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) for our second product candidate, IGM-8444 and the presentation of initial data from our clinical trial of IGM-2323. With thanks to the IGM team, we believe we are well positioned to remain the global leader in the research and development of engineered therapeutic IgM antibodies.”

Recent Highlights and Pipeline Updates

IGM-2323 – Phase 1 trial initiated: In October 2019, IGM announced dosing of the first patient in its Phase 1 clinical trial evaluating IGM-2323 in patients with relapsed/refractory B cell NHL. This Phase 1 clinical trial represents the first-in-human application of IGM Biosciences’ engineered IgM antibody technology. IGM expects to report initial data from this Phase 1 trial in the second half of 2020.

IGM-8444 – IND filing planned: IGM expects to file an IND application with the FDA for IGM-8444 in 2020, initially for the treatment of patients with solid tumors.  IGM-8444 is an IgM antibody targeting the Death Receptor 5 (DR5) protein, which is broadly expressed on a broad range of solid and hematologic malignancies.

IGM-7354 – Next candidate announced: IGM nominated IGM-7354 as its third clinical candidate. IGM-7354 is a targeted IL-15 immune stimulating antibody which demonstrates another use of IGM’s novel J chain based bispecific technology.  In this case, the immune stimulating IL-15 is displayed on the J chain of an anti-PD-L1 IgM antibody, which serves to display the immune stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells. IGM expects to file an IND with the FDA for IGM-7354 in 2021.

Fourth Quarter and Full Year 2019 Financial Results

 Cash and Investments: Cash and investments as of December 31, 2019 were $236.6 million.

  • Research and Development (R&D) Expenses:  For the fourth quarter and year ended 2019, R&D expenses were $12.8 million and $35.3 million, respectively.
  • General and Administrative (G&A) Expenses:  For the fourth quarter and year ended 2019, G&A expenses were $3.2 million and $9.2 million, respectively.
  • Net Loss: For the fourth quarter of 2019, net loss was $14.8 million, or a loss of $0.49 per share. For the year ended 2019, net loss was $43.1 million, or a loss of $4.80 per share.
  • Shares Outstanding: Weighted-average shares outstanding for the fourth quarter of 2019 were 30.5 million and for the full year of 2019 were 9.0 million shares.

2020 Financial Guidance

IGM estimates non-GAAP operating expenses for 2020 of approximately $75 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $8 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 of $83 – $93 million. IGM also expects to end 2020 with a balance of over $140 million in cash and investments.

Conference Call and Webcast

IGM will host a conference call and webcast to discuss this announcement today, March 26, at 4:30 p.m. ET. To access the live call by phone please dial (866) 649-1996 (domestic) or (409) 217-8769 (international); the conference ID is 2991398. A live audio webcast of the event may also be accessed through the “Investors” section of IGM’s website at www.igmbio.com. A replay of the webcast will be available for 30 days following the event through 11:59p.m. ET on April 25, 2020.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding, the Company’s IgM technology platform, statements regarding the Company’s Phase 1 clinical trial of IGM-2323, including the timing of reporting initial data from the clinical trial, the timing of filing an IND for IGM-8444, the Company’s future financial and operating performance, including its guidance for the full year 2020 and year end 2020 cash and investments balance, and statements by IGM’s Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 coronavirus pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its current clinical trials, and enrollment in its current and future clinical trials; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; IGM’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; IGM’s ability to enroll patients in its ongoing and future clinical trials; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; IGM’s ability to accurately forecast future financial results in the current environment; IGM’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (“SEC”), including IGM’s Annual Report on Form 10-K filed with the SEC on March 26, 2020 and in IGM’s future reports to be filed with the SEC.  Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

 

 

Contact:
Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

 

IGM Biosciences to Announce Fourth Quarter and Year-end 2019 Financial Results and Host Conference Call and Webcast on March 26, 2020

MOUNTAIN VIEW, Calif., March 19, 2020IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that it will report its fourth quarter and year-end 2019 financial results on Thursday, March 26, 2020.

In connection with the earnings release, IGM’s management team will host a live conference call and webcast at 4:30 p.m. ET on Thursday, March 26, 2020, to discuss the Company’s financial results and provide a corporate update.

Conference ID: 2991398
Domestic Dial-in Number: (866) 649-1996
International Dial-in Number: (409) 217-8769
Live Webcast: https://edge.media-server.com/mmc/p/vw87ve5n

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.igmbio.com.

About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Contact:

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

Office Manager

We are looking for a full-time Office Manager to help in the day-to-day operations of our offices in Mountain View.  This key position will report to the VP of HR, and will work closely with all of the departments within our organization.

Responsibilities:

  • Coordinate company events and meetings, as necessary
  • Maintain conference rooms, lunch-rooms, and work areas
  • Assist in new hire onboarding; setting up desks and ordering supplies
  • Support general administrative functions for the office
  • Provide administrative back-up for the Purchasing group
  • Monitor and maintain kitchen and office supplies
  • Assist in the coordination of office operations, procedures, and resources to facilitate effectiveness and efficiency
  • Oversee reception desk and answer phones, as necessary
  • Act as the “face” of IGM to recruits and visitors
  • Assist with projects, as necessary

Qualifications: 

  • 5+ years of experience working in a busy office setting
  • Extremely organized and detail oriented
  • Strong oral and written communication skills
  • Start-up experience is helpful
  • Must enjoy working as part of a team
  • Proficient in the Microsoft Office suite
  • Able to shift gears quickly
  • Able to successfully prioritize with limited direction
  • Able to anticipate and resolve challenges
  • Must be able to commute to Mountain View and work normal business hours

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 

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Director of Manufacturing

Our Manufacturing and Process Sciences group is seeking a Director of Manufacturing.   In this critical role, you will be responsible for providing functional leadership to supply chain strategy logistics and warehousing/distribution, manufacturing, facility safety and operations, drug product quality, and employee management.

Requirements:

  • B.S. degree in Engineering, Science or related field, and 15+ years in manufacturing biologics.
  • Minimum of 5 years of management and leadership experience.
  • Knowledge of cGMP manufacturing requirements related to clinical production and commercial manufacturing of injectable products.
  • Lean Manufacturing implementation experience.
  • Strong leader and mentor.
  • Excellent verbal and written communication.
  • Extremely well organized with great attention to detail.
  • Able to work in a fast-paced, start-up environment.
  • “Roll up the sleeves” mentality.
  • Must be able to commute to Mountain View.

 Responsibilities:

  • Development of manufacturing plan and establishment of standard operating procedures to ensure high standards of quality, safety, efficiency and schedule compliance.
  • Oversee the internal construction of manufacturing capability, while managing ongoing external manufacturing to meet clinical requirements.
  • Hire, train, develop and evaluate team. Hold direct reports accountable for performance.
  • Partner with Quality and Safety to ensure compliance with quality and safety best practices.
  • Partner with the Clinical Program team to ensure constant supply of released Drug Product.
  • Drive process improvement and metric progress in key areas of responsibility: safety/culture, quality/delivery, cost-effectiveness, efficiency.
  • Head the RFP and diligence process for all external manufacturing contracts.
  • Preparation of CMC documentation for regulatory submissions.
  • Provide design input and key stake holder during construction phase and work in tandem with quality to complete commissioning and validation of the GMP manufacturing facility.
  • Direct responsibility for GMP facility operations.

Must be able to travel ~10% of the time.

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 

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Clinical Development Project Manager

We are looking for a Project Manager to be part of the IGM Biosciences Clinical Research & Development team.  In this key role, you’ll manage projects across a broad range of areas, initially, primarily early clinical development studies in oncology. You will be responsible for delivering the project on time, within budget and meeting the strategic business, strategic and technical requirements, and you’ll consult with management on an ongoing basis to maintain a strategic link to our business needs.

Responsibilities:

  • Responsible for projects and/or program deliverables on behalf of the whole team
  • Drives efficient team meetings with stakeholders including creating agendas, documenting and distributing minutes (including risks and mitigation log, issues and actions log and decisions log)
  • Proactively identify potential program level risks and develop mitigation strategies to address risks
  • Represent the organization as the prime project contact and interact with internal stakeholders and external partners on significant technical matters often requiring coordination between individuals and groups
  • Ensure complex project decisions are made with stakeholder input and discussion and utilizing good single-decision maker model
  • Design and implement new processes by operating as the subject matter expert
  • Communicate appropriate information (complexities, strategies, issues, solutions) within the organization
  • Create partnerships and take responsibility for building effective and high performing teams
  • Guide and influence teams, committees or other forum decision-making bodies and foster a collaborative team environment that excels at leveraging diversity of thinking, innovation and expertise
  • Responsible for the stewardship of multiple projects, programs and respective teams.  Key influencer in decisions, solutions and issues resolution within projects and programs
  • Determine methods and procedures on new assignments and coordinate the activities of others as a team lead. Help define and operate functional solutions to achieve value delivery and business objectives
  • Accountable for managing competing priorities, resources and activities within and across multiple projects and programs
  • Lead, develop, and proactively manage and maintain execution of high quality cross-functional project development plans with detailed timelines and budgets and monitor progress of team in meeting objectives and deliverables.

Qualifications:

  • BA or BS degree and a minimum of 5 to 7 years of leading projects in the pharmaceutical/biotechnology, or healthcare industry
  • Proven track record and complete/full understanding and demonstrated abilities in project management skills and other related disciplines
  • Post-grad coursework is desirable
  • Certified ScrumMaster and PMP Certification is preferable
  • Have successfully led large-scale early clinical development projects (with multiple tracks of work and teams in multiple locations) from concept to delivery
  • Minimum of 3 years of vendor management including strong understanding of business process and operations needed for success and negotiation experience
  • Strong skills in leading teams, problem solving, influencing, teamwork, initiative and communication
  • Demonstrated skills in innovation and creative approaches in building new business process solutions
  • Ability to work flexible hours as needed
  • Experience with T cell engagers, synthetic immunity, cancer immunotherapy and antibody-based therapeutics is preferred

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 

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